Surgical Suite. Standards and Recommendations REPORTS, STUDIES AND RESEARCH 2011 MINISTRY OF HEALTH, SOCIAL POLICY AND EQUALITY

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1 Surgical Suite Standards and Recommendations REPORTS, STUDIES AND RESEARCH 2011 MINISTRY OF HEALTH, SOCIAL POLICY AND EQUALITY

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5 Surgical Suite Standards and Recommendations REPORTS, STUDIES AND RESEARCH 2011 MINISTRY OF HEALTH, SOCIAL POLICY AND EQUALITY

6 Edita y distribuye: MINISTERIO DE SANIDAD, POLÍTICA SOCIAL E IGUALDAD CENTRO DE PUBLICACIONES PASEO DEL PRADO, Madrid NIPO EN LINEA: Depósito Legal: M Imprime: ESTILO ESTUGRAF IMPRESORES, S.L. Pol. Ind. Los Huertecillos, nave CIEMPOZUELOS (Madrid) El copyright y otros derechos de propiedad intelectual de este documento pertenecen al Ministerio de Sanidad, Política Social e Igualdad. Se autoriza a las organizaciones de atención sanitaria a reproducirlo total o parcialmente para uso no comercial, siempre que se cite el nombre completo del documento, año e institución.

7 Surgical Suite Standards and Recommendations GOBIERNO DE ESPAÑA MINISTERIO DE SANIDAD, POLÍTICA SOCIAL E IGUALDAD

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9 Team for the elaboration of the document on quality and safety Standards and Recommendations at centres and healthcare services: Surgical Suite Experts Jordi Colomer Mascaró. Cirujano. Hospital de Viladecans. Scientific coordinator. Javier Arias Díaz. Asociación Española de Cirujanos (Spanish Society of Surgeons). Fernando Barturen Fernández. Vicepresident of the Sociedad Española de Anestesiología y Reanimación (Spanish Society of Anaesthesiology and Resuscitation). Policlínica Miramar. Palma de Mallorca. Juan García Caballero. Chief Doctor of the Preventive Medicine Department of the Hospital Universitario La Paz. Madrid. Juan Ignacio Gómez-Arnau. Head of the Area of Anaesthesia, Resuscitation and Critical Care. Hospital Universitario Fundación Alcorcón. Madrid. Antonio González Arévalo. Doctor at the Area of Anaesthesia, Resuscitation and Critical Care. Hospital Universitario Fundación Alcorcón. Madrid. Francisco López Cano. Facilities engineer. Grupo JG. José León Paniagua. Architect. Héctor Ortiz Hurtado. Chief of the Surgery Deparment of the Hospital Virgen del Camino Pamplona. President of the Spanish Society of Surgeons. Hospital Virgen del Camino. Universidad Pública de Navarra. Josefina Ortiz Valdepeñas. Head of the Nurse Service. H. C. Real. Castilla-La Mancha. Antonio Pajuelo Gallego. Head of the Anaesthesiology Department. Hospital Virgen del Camino. Sevilla. Pedro Ruiz López. Coordinator of the Quality Service. Hospital Universitario 12 de Octubre. Spanish Association of Surgeons. SURGICAL SUITE. STANDARDS AND RECOMMENDATIONS 5

10 Ángels Sáncho Giner. Head of the Spanish Association of Surgery Nursing. Ministry of Health, Social Policy and Equality Concepción Colomer Revuelta. Vice-Director of the Healthcare Planning and Quality Department. Director of the Observatory for Women s Health. Spanish National Health Service Quality Agency of the Ministry of Health, Social Policy and Equality Inés Palanca Sánchez. Technical Adviser. Planning and Quality Agency. Spanish National Health Service Quality Agency of the Ministry of Health, Social Policy and Equality. Technical and institutional direction. María Santaolaya. Planning and Quality Agency. Spanish National Health Service Quality Agency of the Ministry of Health, Social Policy and Equality. Alberto Segura Fernández-Escribano. Planning and Quality Agency. Spanish National Health Service Quality Agency of the Ministry of Health, Social Policy and Equality (Administrative support). Technical and methodological support José Luis Bernal Sobrino. Javier Elola Somoza. María José Ruiz (Administrative support). 6 REPORTS, STUDIES AND RESEARCH

11 Index Executive summary Introduction Current situation Standards and recommendations in Spain Standards and recommendations in other countries Experience in Spain and abroad Patient s rights and guarantees Information to patients and relatives Ensuring patient s rights Patient s safety Efficient communication in the theatre Error prevention on determining the surgical site, the type of procedure and patient identification Fire safety Nosocomial infection prevention Deep vein thrombosis and management of anticoagulation and antiplatelet prevention Drugs and fluids management. Medication error prevention Blood products management Anaesthetic and intraoperative risk prevention Prevention of retained bodies Mobile phones at the SS Patient s safety and healthcare risk management Patients engagement on their safety Self-protection plan Organization and management Relation of the SS with other units Service portfolio Criteria for patient admission Structure and typologies Management and operation of the SS SS management structure. Organization requirements Organization and operation manual 84 SURGICAL SUITE. STANDARDS AND RECOMMENDATIONS 7

12 5.8. Patient management IT system Physical structure and material resources Functional design programme Equipment and facilities Medical supplies. Sterilization Cleaning protocols Waste management Systems Electricity Air conditioning Mechanical systems Setting into operation and maintaining operating theatres Human resources Healthcare staff register Personal file Qualifications Identification and discrimination of staff members Documentation Undergraduate and postgraduate training on health science Continued training Criteria for the calculation of staffing levels Quality indicators Criteria for the review and follow up of the standards and recommendations 187 Annexes A.1. Informed consent sample, including section for rejecting blood transfusion at procedures 189 A.2. Surgical safety checklist (WHO, Spanish Surgeon Association) 195 A.3. Communication system in the operating theatre 197 A.4. Surgery site marking recommendations (NPSA) 199 A.5. Prevention of surgical site prevention 201 A.6. Pre-operative hand washing with alcohol based solution. 205 A.7. Informed consent protocol 207 A.8. Patient circulation flow protocol at the SS 211 A.9. SS sectoring and patient circulation flow REPORTS, STUDIES AND RESEARCH

13 A.10. Request of additional medical tests 215 A.11. Anaesthesia registry. Criteria to be followed for the documentation and anaesthetic attention. Monitoring criteria (SEDAR-Spanish Society of anaesthesiology and resuscitation) 219 A.12. PACU admittance protocol 225 A.13. PACU care protocol 229 A.14. Circulating record/surgery record 231 A.15. Resource sizing criteria 237 A.16. Functional design programme for a general SS with 12 operating theatre 243 A.17. Equipment of the SS 251 A.18. Alphabetic index of definitions and reference terms 263 A.19. Proposal of the definition to measure the usage rate of the theatre room of the Spanish National Health Service 271 A.20. Abbreviations 275 A.21. Bibliography 277 Tables 1.1. Surgical procedures with hospitalization per people D.S. surgery procedures per people SS healthcare regulations Proposal objectives of the British National Health Service Structural characteristics of the preoperative area Characteristics of the logistics area Operative area structural characteristics Structural characteristics of the post operative area Structural characteristics of the anaesthesia, surgery and nurse staff area SS functional design programme Compressed medical air ystem Oxygen system Vacuum system Nitrogen protoxide system Quality indicators at the SS 185 A Criteria for the request of additional medical tests for the preoperative assessment in scheduled surger 216 SURGICAL SUITE. STANDARDS AND RECOMMENDATIONS 9

14 A Aldrete test 230 A Example 1. Calculation of the expected number of surgery procedures with conventional hospitalization to be performed in a year (based in the information of the global frequentation of procedures) 238 A Example 2. Calculation of the number of SS operating theatres only on a morning shift basis 240 A Example 3. Calculation of the number of operating theatres (scheduled procedures in morning and afternoon shifts basis) 240 A Functional programme for a general SS with 12 operating theatres 244 A List of equipment 251 Figures 5.1. Corridor organization at the SS Relation between operating theatres and traffic division policies Possible configuration of air conditioning Legends and symbols 150 A.6.1. Educational poster of handwashing 205 A.8.1. Surgery area signposting 211 A.8.2. Sign indicating highly restricted area of surgery 212 A.9.1. Surgical clothes and circulation rules in surgery areas 214 A Proposal of the definition to measure the usage rate of theatre room of the Spanish National Health Service REPORTS, STUDIES AND RESEARCH

15 Executive summary Introduction 1. Surgery is the only cause of admission to hospital for many patients, both in Spain and in other developed countries. In 2005, surgical acts were performed at Spanish hospitals. The frequency of surgery in Spain in 2005 was 95 7 per one thousand people, being 49 6 for the surgical procedures which required admission and 22 7 for Day Surgery (DS) procedures. 2. In the whole country there are operating theatres, located mainly at general and acute hospitals (3.651 operating theatres). The percentage of operating theatres in Spain is 84 operating theatres per one million people. 3. This report on Standards and Recommendations for the Surgical Suite (SS) is not a legal document as it does not settle the minimum requirements or the standards for the opening or working conditions of Surgical Suites, or for their accreditation. 4. The SS, from a structural point of view, is the area in which all operating theatres are sited, with the necessary equipment and characteristics to perform any surgical procedure. The SS includes the premises in which the surgical procedure is accomplished (operating theatre and the post anaesthesia care unit) and its utility rooms. 5. From a functional point of view, the SS may be defined as an organization of healthcaring professionals which provides multidisciplinary surgery in a specific functional area; which holds the required theatres, utility rooms and facilities and which complies with the specific structural and functional means and resources to ensure efficiency, high quality and a safe environment. 6. The Quality Agency of the Spanish Ministry of Health, Social Policy and Equality has recently published a guide on the Standards and Recommendations for Day Surgery. It recommends that if the structural and functional conditions of the centre, as well as the volume of activity, allow it, the SS of the Day Unit should be separated from the general SS ( autonomous DSU). 7. Office-based surgery or the procedures performed at minor surgery rooms, nor at the medical investigation units for endoscopies or at the units for haemodynamic or electrophysiology procedures are not included within the SS. 8. The SS is an intermediate unit which carries out its activity for final health services (those that discharge patients) that usually correspond SURGICAL SUITE. STANDARDS AND RECOMMENDATIONS 11

16 to the surgical specialities services or units. On accounting terms, the SS invoices the final units. 9. Both the State and the regional governments have issued legislation on the authorization and registration of healthcare centres. Patients rights and guarantees. 10. Since the patient arrival to the SS privacy, humane treatment, psychological support and information concerning any of the actions performed during the procedure should be guaranteed. 11. The welcoming information (leaflet, booklet) should include, at least, a description of the different stages the patient will go through and special recommendations or warnings. Pictures of the SS may help patients to understand the procedure. 12. On a specific surgical framework, the informed consent will particularly include aspects relating to the surgical act and the type of healthcaring modality (day/admittance), and a minimum of information. Patient s safety 13. Working with clearly defined processes and under a system of constant evaluation provides a safety guarantee. This continuous registry, on a scheduled and sequential basis ensures tracing the procedures, allows identifying adverse events and provides continuous improvement. 14. Adverse events related to the surgical procedure mean the 40% of all the informed events at hospitals. Good practices in terms of patient safety imply a risk management focused organization. 15. The WHO has published a guide for the implementation of a safety checklist at surgical processes (Surgical Safety Checklist) which has been adopted by the Spanish Association of Surgeons. 16. Efficient structural communication is a key element to guarantee safety at the operating room. Organizational culture must focus on team work and replace hierarchic relationships with leadership. 17. To help hospitals reduce mistakes concerning the patient, the area or the procedure involved, the Joint Commission has established a universal protocol made out of the following items: 1. Conduct a pre-procedure verification process; 2. Mark the procedure site to identify it without ambiguity; 3. Conduct a final assessment before starting the procedure. The National Patient Safety Society and the Royal College of Surgeons of England recommend preoperational marking to clearly identify the intended site for the procedure. 12 REPORTS, STUDIES AND RESEARCH

17 18. Surgical site infections have been to shown to figure up to 14% of all nosocomial infections. Preventing them implies introducing a strategy based on carrying out basic hygienic principles to avoid microorganism infection. The NICE (National Institute for Health and Clinical Excellence) has recently published a guide for the prevention of surgical site infection. 19. Recent investigation has proved that washing without scrubbing can be as or even more efficient than the traditional scrubbing. The Spanish Ministry of Health, Social Policy and Equality has published a guide which summarizes the guidelines of the WHO regarding hand hygiene in health-care settings. 20. Concerning environmental agents, the most outstanding factors are: air quality and circulation; operating room cleanness; instrument cleanness; linen cleanness. Pressurization in the SS site must guarantee that air flows from the cleanest areas towards the less clean ones. 21. Several studies have proved that the rate of infection is lower on those patients who have not been shaved. When an organization settles a hair removal policy, it must consider this procedure only on those cases in which it is strictly necessary. Razors, which should be avoided at any healthcare centre, must not be used. 22. The CDC (Centres for Disease Control and Prevention) have published a set of guidelines to prevent nosocomial infection. Efficiency of antibiotics rests on three critical factors: 1. Adequate selection of the antibiotic; 2. Adequate time for the administration of the first dose of antibiotic not over minutes before skin incision; 3. Adequate time to interrupt prophylaxis, which should be protocolled. 23. The NICE has recently published a guide to reduce the risk of deep vein thrombosis which recommends mechanical emergency measures combined with the use of low molecular weight heparin for patients at risk. A protocol of perisurgical administration of antiplatelet agents and anticoagulants should be established, as it is one of the problems which bring up more adverse events and the reason for many cancellations of surgery procedures. 24. To avoid medication mistakes, at least two patient identification methods should be taken into account (being none of them the room number), when administering drugs or when providing any other treatment or procedure. 25. Drugs must be conveniently and safely stored. The list of drugs whose name and external appearance can be mistaken must be identified and, at least once a year, checked. Actions to prevent confusion on their administration must be developed (in these cases, using different packing systems is recommended). SURGICAL SUITE. STANDARDS AND RECOMMENDATIONS 13

18 26. Storing hyper, hypo tonic or potassium based solutions should be avoided at the SS. These solutions must be centralized at the chemist service or unit and should be requested only on individual use basis. 27. Good practice is recommended for the gauzes, needles and instrument count. Patients with higher risk of retaining foreign bodies after surgery are those who undergo emergency surgery, those who experience an unplanned alteration on the surgical procedure and those who suffer from a high body mass index (BMI) (10% per BMI unit increase ). 28. At SS, risk management must be supervised and coordinated by a management group of the SS, headed by a senior doctor and made up of a multidisciplinary commission which must meet on a periodic basis. Risk management procedures must be written down, including compulsory awareness and revision sentinel events. Multidisciplinary training on risk management should be promoted. 29. Patients must have an active role on their safety improvement, getting informed and involved in their healthcare process, and participate in the decisions regarding their treatment. 30. Healthcare centres with SS will have a self-protection plan which will settle the human resources organization and the material available for risk prevention. Management 31. SS must be close to the intensive care unit, be easily accessible from the E&R services and the polyvalent units allotted to surgical specialities and with adequate communication systems (telematic, by means of a pneumatic tube, etc.) with the pathologic anatomy service, image diagnosis units and laboratories. 32. Operating theatres multi-functionality should be maximized. It is recommended that operating theatres should not be speciality-classified, distributing thus procedures according to scheduling criteria. 33. Circulation separation does not reduce the risk of infection and it is generally based on management reasons, on simplifying staff discipline, on distributing the unit interior circulation according to fire protection measures, or on habit. Single corridor circulation design for the different traffic routes of the unit (patients, staff, sterile material and dirty instrument) is a proved solution with high levels of satisfaction among users. It does not encourage mistakes or ambiguous working situations, even though it requires training and discipline from the unit staff demandable for any other design. 34. People, when moving around, are the main source of microorganisms. The amount of bacteria may be reduced by bringing down the number 14 REPORTS, STUDIES AND RESEARCH

19 of people and their movements, and by assuring an adequate air flow and its renewal. 35. Access to the several areas of the SS should be restricted, and the traffic elements at the SS segregated: general access areas, limited access areas, restricted access areas and surgical areas. 36. Patients may come from their homes, from the E&R services or from other hospital wards. It is recommended to schedule adequately surgical procedures to avoid waiting times, especially to those patients coming from their homes; they must have a specifically designed waiting area. 37. Patients reception protocol will be followed at the pre-surgical preparation area, including the patients identification check (bracelet with the patient identity, diagnosis and surgical procedure) and the review of the complete clinical record and of the additional tests. 38. To all patients that have undergone an anaesthetic procedure, the anaesthetist must have previously planned: 1. The designated service area after the procedure and 2. The specific protocol for the anaesthetic recovery. 39. It is important that patients should be transferred to a unit in which they could be taken care of according to their situation and to the type of procedures performed in order to avoid later transferrals and, in case of an extended stay at the unit, it will not prevent other patients from attending the unit or will not imply surgery cancellations. 40. The anaesthetist will designate the patient s discharge when he/she meets the criteria defined at the PACU (post-anaesthetic recovery area) protocol, which, at the same time, must take into account the characteristics of the centre. Working times of the PACU must respond to the specific characteristics of the SS, in accordance with the number of patients, their scheduling and healthcare needs, preventing that the PACU occupation may block the admission and discharge of patients from the SS. On a general rule, patients should not stay at the PACU more than 6 hours. If lengthy stays are required, admission to a level III healthcare attention (intensive) may be considered. 41. Intensive care units (ICU) must have their own admission and discharge protocols to avoid beds being blocked. A reservation system for the scheduled admissions should be foreseen, even though the availability of beds should be checked before conducting any scheduled surgical procedure. 42. The highest rate of occupation of the SS should be achieved. A reasonable target for the occupation of operation theatres under scheduled surgery should be, at least, of 10 hours a day (working days) and 7 hours each Friday which will allow and occupation rate of 47 hours a week. SURGICAL SUITE. STANDARDS AND RECOMMENDATIONS 15

20 43. The multifunctionality of operating theatres should be maximized. It is recommended that theatres should not be allocated according to specialties but designated regarding the scheduling procedures which may be established. 44. Centres with SS should identify the average length of their surgical procedures and have the appropriate information in order to schedule them properly. 45. The rate of cancellations can be reduced by using an adequate preoperative protocol; establishing a complete management system of the process; implying all parts concerned and providing a preoperative preparation area for admissions that take place on the same day as the procedure. 46. The NCEPOD (National Confidential Enquiry into Patient Outcome and Death) has published several reports proving that there is a higher risk of perioperative death in patients who have undergone surgery at night (after 21:00) and thus recommends that, whenever possible, surgery procedures be hold over so that they can be performed within the first 24 hours (urgent surgery). 47. The Royal College of Surgeons of England has suggested a higher centralisation of the emergency surgical services, which will reach a broader range of the population and will make possible the availability of a reference service for the emergency services with 24 hour emergency operation devoted theatres % of emergency surgical procedures can be performed at working hours, as far as there are surgery sessions specially allotted for this kind of procedures and which have the necessary human resources and equipment available. 49. It is recommended to perform trauma surgery to elderly patients within the first hours, avoiding delays for non-clinical reasons. 50. The SS is an intermediate unit that carries out its activity (surgery) for the final health services. According to the needs derived from the healthcare process at the SS, the following organization is recommended: medical coordinator of the SS, nursing supervisor, and operating room committee. 51. If the SS is considered as a management unit, its director must have authority over the budget and be responsible for it, have appropriate wages, answer for his management and have the appropriate IT and administrative systems. 52. It is recommended that a team from the Spanish National Health Service will work on the definitions of the indicators which, in the same way as surgical time, will allow the evaluation and comparison between centres that belong to the Service. 16 REPORTS, STUDIES AND RESEARCH

21 53. In order to reach a good output of operating theatres it is important that the first case of the day begin on due time, that the time between the cases be as shorter as possible, that the cancellation rate be low, that the agenda mistakes will be scarce and that the scheduling be properly set tight. Functional programme 54. Each SS should define its functional programme and its management structure, which implies a demographic study of the area, a research on the theoretical demand, an analysis of the production capacity, etc. 55. In the SS functional programme processes and design, there should be taken into account the trends and changes in the request of the surgical activity. For the last few years this activity has gone through a series of changes which have implied deriving specific procedures, which were previously performed at an operating room, to diagnosis and medical investigation and treatment units within the Day Hospital Units. 56. It is a an obsolete practice gathering two operation rooms per floor at single-block buildings so that there could be a direct connection with the hospitalization units. A general SS should have at least four operating theatres. 57. Ideal ventilation, humidity (<68%) and temperature conditions are required to grant staff comfort, and to avoid environmental conditions which could facilitate the growth and spreading of microorganisms. 58. Operating theatres should be kept at positive pressure regarding the corridors and the adjacent areas. The usage of laminar flow air has been suggested as an accessory means to reduce the risk of nosocomial infection; however its efficiency has not been proved, nor the usage of ultraviolet light. Facilities 59. Chapters 6 and 7 provide the information and the recommendations regarding the structure, the functionality and the facilities of the SS. Human resources 60. Centres must have an updated register of healthcare professionals, whichever their contractual relationship with the centre, the way or the place in which they render their services might be. SURGICAL SUITE. STANDARDS AND RECOMMENDATIONS 17

22 61. Healthcare staff are obliged to identify themselves when required by patients or users, indicating their full name, professional qualifications, category and role, when previously defined. Quality 62. According to the available information it has been established a set of indicators concerning the specific activity of the SS: technical quality, usage and quality level perceived by users. Criteria for the reviewing and monitoring standards and recommendations In the immediate future relevant changes on the management of SS may occur. It is thus recommended a revision and update of these standards and recommendations within the next ten years at the most. However, this period of time may be shorter if changes make it necessary to modify any important aspect and/or any of the strong recommendations of this document. From the analysis of the authorization and register of the SS which some regions have performed, it can be drawn the need to carry out a revision and harmonization of these regulations and their adequacy to the standards and recommendations issued on this document, so as to base them on scientific evidence. The next review of this document should include the following information or studies: To collect information regarding the discharges under the CMBD code and grouped by procedures (DRG o gathering index used by the Spanish National Health Service), including those of private hospitals. To have a taxonomy or a glossary of safety items and a register of events for the notification and evaluation of events applicable to the Spanish National Health Service. To conduct a study regarding procedural times at the Spanish National Health Service which would ease the resource planning based on a case-mix index, and would allow benchmarking processes at each hospital in relation with the standards of the Spanish National Health Service. 18 REPORTS, STUDIES AND RESEARCH

23 To share a common definition within the Spanish National Health Service of all the data that will allow the evaluation and comparison between all the centres of the Spanish National Health Service. To have a systematic analysis of the quality indicators of the SS of the Spanish National Health Service performed, including the set of recommended indicators. To have studied the possibility of adopting a more specific classification of surgery according to its urgency than the one in use nowadays in Spain (NCEPOD or similar) The Spanish Society of Anaesthesiology and Resuscitation (SEDAR in its Spanish acronym) will suggest a codification of the different types of anaesthesia which would allow the standardization of the anaesthetic procedures within the Spanish National Health Service. SURGICAL SUITE. STANDARDS AND RECOMMENDATIONS 19

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25 1. Introduction Surgery is the only reason for hospital admittance to many patients in Spain and in Western developed countries. According to the Statistics of Hospitals published by the Spanish Ministry of Health and Social Affairs 1, in surgical acts were performed. The frequency of surgery in Spain in 2005 was 95 7 per one thousand people, being 49 6 for surgical procedures which required admission and 22 7 for Day Surgery (DS) procedures. The importance of the surgical activity both on its rate of performance and on its quality, the need to review and update some practices which, even though they are usual, are no longer recommended, the clear diversity and dispersion of the regulations concerning operating theatres, and the advisability to update the management and design criteria of surgical suites make SS the main target for the establishment of quality and safety criteria within the aims and actions observed at the Quality Plan of the Spanish National Health Service 2. Law 16/2003, (May 28th), Cohesión y Calidad del Sistema Nacional de Salud (Cohesion and Quality of the National Health System) states on chapters 27, 28 and 29 the need to settle safety and quality guarantees which, once agreed at the Interterritorial Council of the Spanish National Health Service, should be compulsory for the regional regulation and authorization of the opening and bringing into operation of healthcaring centres, services and institutions. The Royal Decree 1277/2003, (October 10th), por el que se establecen las bases generales sobre autorización de centros, servicios y establecimientos sanitarios (establishing the general basis for the authorization of healthcare centres, services and institutions) defines and relates the healthcaring centres and services which must settle the requirements which will guarantee their safety and quality. The classification of healthcaring centres and services was modified by the Ministerial Order 1741/2006. Chapter 5. section 1. marks those units listed on the Royal Decree 1277/2003 (modified by means of the Ministerial Order 1741/2006) which have a broader relationship with the SS. The main objective of the Strategy 7 of the Quality Plan of the Spanish National Health Service is to settle the basic requirements and the safety and quality guarantees that have to be observed before the opening and operation of healthcare services which belong to the Spanish National Health Service. As an example of similar procedures, on 2007, the Spanish Ministry of Health and Social Policy worked on the publication of the safety and quality standards and recommendations, reviewing and updating those relating SURGICAL SUITE. STANDARDS AND RECOMMENDATIONS 21

26 to DS 3 and publishing those concerned with Day and Onco-haematologic Hospital Units 4. The aim of this Guide is to provide public health administrators, managers of both public and private centres, and healthcare professionals with in-depth knowledge for the management of this unit, allowing improving safety and quality conditions at service provision, design and equipment. Therefore, the Guide includes aspects relating to: a) Patients Rights and guarantees. b) Patient s safety. c) Organization and management of the SS. d) Physical structure and material resources of the SS. e) Human resources. f) Quality. g) Criteria for the reviewing and monitoring the SS standards and recommendations. This document is not a legal document and does not settle the minimum requirements for the opening and working conditions of the SS, or the standards for their accreditation. The Directorate of the Spanish National Health System Quality Agency has monitored the setting up of these standards and recommendations within the frame settled by the Quality Plan of the National Health System. This document has been written by a group of experts selected by the Quality Agency on the basis of their experience and knowledge of the aspects covered in this Guide. They have also been appointed -under the same criteria- by Scientific Societies and Professional Associations. The team work has been coordinated by Dr. Jordi Colomer, as scientific coordinator appointed by the Spanish National Health System Quality Agency. Furthermore, a technical support group has assisted the experts in the development of the project, making follow-ups, providing technical assistance at meetings, conducting analysis of current situation, proofreading the documents written by the experts and analyzed evidence and collaborating with the Quality Agency on the successive drafts and on the final document. Throughout the document, several bibliographic references considered relevant are provided. Moreover some strong recommendations are highlighted, either because they are supported by legal requirements or because they are based, according to the group of experts involved on this writing, on sufficiently sound evidence. These cases will be introduced by the word recommendation and highlighted in bold. 22 REPORTS, STUDIES AND RESEARCH

27 2. Current situation The SS is, on the one side, the area in which all operating theatres are sited, with the necessary equipment and characteristics to perform any surgical procedure 5,6. On the other side, the SS is an organizational structure, that is to say: a healthca ring professional organization which provides multidisciplinary healthcaring surgery in a specific functional area which holds the necessary theatres, supply rooms and facilities and which complies with the specific structural and functional means and resources to ensure efficiency, high quality and a safe environment. The SS is an intermediate unit which carries out its activity for final health services (those that discharge patients) which generally correspond to the surgery specialities services or units. On accounting terms, the SS invoices the final units. The Quality Agency of the Spanish Ministry of Health, Social Policy and Equality has recently published a guide on the standards and recommendations for Day Surgery 2. Irrespective whether the operating theatres of the DS Unit are integrated within the hospital SS or not, the document issued by the Spanish Ministry of Health, Social Policy and Equality recommends autonomous DSU, organized independently and, if the volume of activity allows it, architectonically separated from the hospital. This document does not provide the standards and recommendations for other units or for anaesthesia and recovery units, which include, among their activities, some which are not directly related with the SS such as pain management, assistance to diagnosis and treatment investigation units, to E&R units, to conventional hospitalization nursing units or to intensive care units. These units will all be dealt with on future guides on standards and recommendations of the Quality Agency of the Spanish Ministry of Health, Social Policy and Equality. It is not included within the SS office-based surgery or the procedures performed at minor surgery rooms, nor at the medical investigation units for endoscopies or at the units for haemodynamic or electrophysiology procedures. The SS includes the premises in which the surgical procedure is accomplished (operating theatre and the post anaesthesia care unit) and its utility rooms Standards and recommendations in Spain Authorization and registration Both the State and all the regional governments have issued legislation on the authorization and registration of healthcare centres. Regulations may SURGICAL SUITE. STANDARDS AND RECOMMENDATIONS 23

28 be divided into two types: those on authorization and registration, which assess healthcare centres before they come into operation, and those on accreditation, for the evaluation of operational centres Authorization All regional governments have issued legislation on the authorization of healthcare centres. Since the publication of the RD 1277/2003, 10 regional governments have modified their legislation in order to adapt it to the new regulations, while 7 governments have not updated theirs. Though there are several common contents, relevant differences regarding the criteria for the authorization / registration may be appreciated. Some even have issued specific regulation on surgery centres and services (15, 16). Moreover, concerning the authorization and registration regulations for healthcaring centres issued by the regional governments there are some specific references to the SS (17,18,19,20,21,22), which may be considered as a minimum. (1) Aragón, March 8th, Regional gazette nº 36, 03/27/2006. (2) Castilla-La Mancha, Order, Regional Gazette, July, 12 th, (3) Balearic Islands. Order february, 20 th, 2004 mitjançant la qual es modifica l.ordre de la mateixa Conselleria de 19 de desembre de 2000, per la qual s.estableixen les condicions, els requisits tècnics i el procediment d.autorització per a la creació, modificació, trasllat i tancament d.hospitals. (which modifies the order of the same regional government issued on December, 19 th, 2000, which establishes the conditions, the technical requirements and the authorization procedures for the authorization, modification, transfer and closure of hospitals). Regional Health and Consumer Affairs Authority. (4) Canary Islands. Order June, 15th, 2000 por la que se establecen las condiciones mínimas que deben cumplir los centros hospitalarios de la Comunidad Autónoma de Canarias (Regional Gazette nº107, August, 16 th, 2000) (which settles the minimun conditions that have to be observed at healthcaring institutions of the Canary Island Region). Regional Health and Consumer Affairs Authority. (5) Order July, 10th, 1991, per la qual es regula l acreditació dels centres hospitalaris (which regulates the accreditation of healthcaring institutions). (Regional Gazette of Catalonia, nº 1477, August, 7 th, 1991). (6) Galicia. Order, September 24 th, 1986, po la que se fixan os requisitos e condicións necesarias para a autorización dos centros de asistencia hospitalaria na Comunidade Autónoma de Galicia (which settles the necessary requirements and conditions for the authorization of healthcaring centres of the Regional Government of Galicia.) (7) Order February 11 th, 1986 por la que desarrolla el Decreto 12 diciembre 1985 (LCM 1986\321), en lo relativo a requisitos para creación, modificación o supresión de centros, servicios y establecimientos sanitarios (which settles the basis for the Decree, December 12 th, 1985 (Regulation of the Regional Government of Madrid 1986/321) regulating the creation, alteration or closure of healthcaring centres, services and instutions). (8) Basque Country. Order February 29 th, 1996 issued by the Regional Health Authority por la que se regulan las autorizaciones de creación, de realización de modificaciones y de funcionamiento de los hospitales de la Comunidad Autónoma del País Vasco, 24 REPORTS, STUDIES AND RESEARCH

29 Accreditation Accreditation is a voluntary process by which a healthcare centre undergoes external assessment which establishes its level in accordance to a set of standards previously settled, agreed by a group of experts and adequate to the reference area. Experience of accreditation of healthcare centres and services is still very limited in Spain. Only four regions (Andalusia, Catalonia, Galicia and Extremadura) have legislation and official programmes for the accreditation of healthcare centres based on voluntary external assessment. Some regions have accreditation programmes for specific types of centres, services or activities (i.e., organ transplants, assisted reproduction, haemotherapy, etc.) Andalusia bases its accreditation system on the Program for the accreditation of centres belonging to the Andalusian (9) Health Service. The program is based on a reference criterion which includes a series of characteristic standards of the Andalusian Public Health Service. Catalonia was the first region to develop an official procedure for the accreditation of healthcare centres. The current system is the third that has been developed (there have been two former procedures in 1981 and 1983). Decree 5/2006 (230) rules the accreditation of acute healthcare centres and the authorizing procedures for the evaluation bodies. It additionally provides two accreditation guides which include the settled standards 7,8. Specific standards for surgical healthcare are gathered under the paragraph surgical healthcare, within the chapter 5.b: production, distribution and service of healthcare products and services. The region of Galicia settled in 2001 an accreditation system for hospitals, ruled by Decree (11), which may be applied to all the hospitals which belong to the healthcare system of the Galician Health Service and to any other which may have subscribed or want to subscribe an agreement with them, for which they must obtain accreditation. It also settles a set of requirements for the surgical and anaesthetic areas. (which regulates the authorizations for the opening, changes and operation of healthcare institutions). (9) Resolution July 24th 2003 of the General Directorate for Evaluation and Training, por la que se establece el sistema de acreditación de la calidad de los centros y unidades sanitarias del Sistema Sanitario Público de Andalucía, de acuerdo con el modelo de calidad del sistema sanitario de Andalucía. (establishing the quality accreditation program for healthcare centres and units of the Andalusian Public Health Service, in accordance with the quality model of the Andalusian Health Service. Ministry of Health for the Andalusian Health Service). (10) Decreee 5/2006, January 17 th, Catalonian Autonomous Region. (11) Galicia. Decree 52/2001, February 22nd. SURGICAL SUITE. STANDARDS AND RECOMMENDATIONS 25

30 In a similar way to the models suggested by Andalusia and Galicia, the system of centre accreditation of Extremadura is focused on inpatient and outpatient centres and does not deal with the requirements and standards of SS. It is ruled by Decree and by a subsequent order which develops it (12) Unit guides Both the Spanish Ministry of Health, Social Policy and Equality and the regional departments have published guides for some units which, though they are not legal documents, they try to settle the standards and recommendations. Among those guides, those related to DS 3,9,10, which at the same time refer to the SS, should be pointed out. The former Spanish Health Institute (INSALUD on its Spainsh acronym) issued in 1996 a Practical guide for air conditioning design and maintenance in operating theatres 11 ; this institution also published a guide for the management of surgery waiting lists 12. The Andalusian Health Department has issued a guide on SS Healthcare Support Process 13. The Health Department of Castilla la Mancha has written a document on SS design Standards and recommendations in other countries United States The Joint Commission (JC) has issued a general rule for hospitals 14. It is an extensive document which takes into account the objectives for national quality and patients safety (Inpatient Quality Indicators) 15, and which includes two types of requirements and standards: patient focused activities and management activities. The JC standards are limited to the processes and do not include aspects related to the structure, design, sizing, equipment and facilities programme. The Commission has also published a guide on SS safety 16. Inpatient Quality Indicators 16, issued by the Agency for Healthcare Research and Quality (AHRQ) from the United States Health Department are a set of measures which may be obtained from the discharge reports to provide an outlook of the quality of the centres. It meets the following criteria: Volume of activity. Mortality related to procedures. (12) Extremadura. Decree 227/2005, September 27th. Order July 18th, REPORTS, STUDIES AND RESEARCH

31 Mortality related to processes. Usage. Rate of attendance. Several of these indicators are related to processes and surgical procedures United Kingdom The National Health Service (NHS) published in 1991 a SS17 Note within the Health Building Notes series, dealing with the functional programme and design of this area. The Healthcare Commission is a public non-governmental organization whose aim is to promote quality improvements at healthcare assistance and public health in England and Wales. It is responsible for the audits to, among other institutions, hospitals that belong to the NHS (Anual health check. NHS performance ratings)18. The basic topics for this evaluation are19: How do hospitals comply with the basic standards settled by the Department of Health and with the national objectives settled for NHS suppliers. How resources are managed according to the criteria established by state agencies (Audit Commission and Monitor). The domains settled for reviewing and evaluating if hospitals meet the basic standards established by the Health Department are: safety; clinical and cost effectiveness; governance; patient focus; accessible and responsive care; care environment and amenities; and public health. They do not deal specifically with the SS though many standards may apply to its management and functioning. The audit carried out on hospitals by the Healthcare Commission is based on a broad variety of standards and recommendations settled by the Health Department and agencies as the National Institute for Health and Clinical Excellence (NICE) 20,21,22,23. The Scottish Intercollegiate Guidelines Network (SIGN) has issued several guides related with the SS 24,25 activities Experience in Spain and abroad In surgical acts were performed at Spanish hospitals1; (85,9%) had been previously scheduled. 51,8% of surgical procedures implied hospitalization ( procedures) which meant 40,32% of the total number of admissions SURGICAL SUITE. STANDARDS AND RECOMMENDATIONS 27

32 inpatient surgical procedures (23,3% of the total number of inpatient surgical procedures) were urgent procedures1. 23,7% of surgical procedures were performed at DS (243). 24,4% of the other surgical procedures respond to office-based procedures. In 2005 the surgery rate of attendance in Spain reached 95,7 per one thousand people (14) ; inpatient surgical procedures extended to 49,6 per one thousand people and day unit procedures to 22,7 per one thousand people. The inpatient surgery rate of attendance is lower in Spain than in other countries within the same setting (EU 15) 26 : Table 1.1. Surgical procedures with hospitalization per people /2001 Year Austria 131, ,7% Belgium 63,5 62,1-2,2% 2004 Denmark 72,7 75,9 4,4% Finland 56,1 62,6 11,6% France n.d. n.d. Germany 98,1 79,4-19,1% 2004 Greece 47,1 n.d Ireland 31,9 30,3-5,0% Italy 56,8 53,3-6,2% 2004 Luxembourg 128,3 136,7 6,5% Netherlands 37,3 39,4 5,6% Portugal 49,7 50,9 2,4% Spain 52,4 50,8-3,1% 2004 Sweden 54,7 63,5 16,1% United Kingdom 63,2 63,8 0,9% Source: OECD 2007 (13) Do not confuse with the Substitution Index which is worked out as the percentage of surgery at DS in relation to potential office-based surgery 4. (14) Our estimate. Total amount of surgical acts (Statistics of Hospitals, 2005)/Population on (INE, 28 REPORTS, STUDIES AND RESEARCH

33 Table 1.2. DS surgery procedures per people /2001 Year Austria n.d. Belgium 37,1 45,7 23,2% 2004 Denmark 57,8 72,5 25,4% Finland 32 40,3 25,9% France n.d. Germany 15, Greece n.d. Ireland 12,4 12,7 2,4% Italy 18,1 28,5 57,5% 2004 Luxembourg 83,9 70,7-15,7% Netherlands 34,5 37,9 9,9% Portugal 3,8 8,6 126,3% Spain 17,3 21,8 26,0% Sweden n.d. United Kingdom 73 80,3 10,0% Source: OECD There are differences on the type of procedures included. 60% of all surgical procedures performed in Spain take place at the Spanish National Health Service. The same rate may be applied to inpatient surgical procedures. DS rates at Spanish hospitals are increasing in relation to the international standards 3. The guide on DS standards and recommendations issued by the Spanish Ministry of Health, Social Policy and Equality points out that 3 experience and progress on surgical and anaesthetic techniques led to a change on the point of view of DS, from the classical approach is the patient liable to undergo DS procedures? to a current one is there any reason for this patient to be admitted into hospital?. DS should be considered as the standard and first healthcare option for patients who must undergo surgery procedures gathered on lists A and B of the above mentioned guide 3. The NHS Modernisation agency gives a broader recommendation: to consider DS as the rule for scheduled surgery 27 instead of conventional inpatient surgery. In Spain there are operating theatres which are mainly placed in general and acute hospitals (3.651 theatres). The rate of theatres in Spain is 84 theatres per one million people. SURGICAL SUITE. STANDARDS AND RECOMMENDATIONS 29

34 Both the Spanish Society of Surgeons (Asociación Española de Cirujanos, AEC in its Spanish acronym) and the Spanish Society of Anaesthesiology and Resuscitation (Sociedad Española de Anestesiología y Reanimación, SEDAR in its Spanish acronym) have published guides and sets of criteria regarding the SS. The most remarkable study might probably be the publication of the Spanish Society of Surgeons on surgical clinical management 6 and which includes a section on SS. Gómez-Arnau and González 28 have issued a paper in which the SS is considered as a unit. Nurse managers who work at the same hospital as the authors have published an essay on SS management as a nurse unit 29. The Spanish Society of Anaesthesiology and Resuscitation (255) has issued several documents on relevant aspects of the organization and management of the SS (documentation and register; preoperative studies; basic intraoperative monitoring; postanaesthesic care; recommendations for checking the anaesthetic systems). Moreover, the Spanish Society of Surgeons (16) and the Spanish Society of Anaesthesiology and Resuscitation have issued a consensus document on additional preoperative studies 30. On International grounds it should be pointed out the forerunning job of Laufman who in the eighties settled the design recommendations for the SS and for other hospital units and which are nowadays still useful 31. The organization and management of the British National Health Service, backed by the job made by the regulating and evaluating agencies, provide a huge number of studies on SS design, organization and management which may be of interest for setting the standards and recommendations in Spain. Some have been mentioned on section The NHS Modernization Agency has published a guide for improving the SS 32 output. The Audit Commission, an independent institution responsible for assuring that public resources are efficiently used, published in 2003 a review on surgical suite work in England and Wales 33. The NCEPOD (17), an organization which works under the NICE issued a report on perioperative death 34. The Association of Anaesthetists of Great Britain and Ireland and the Royal College of Anaesthetists (18) have both published a set of recommendations to enhance safety, quality and efficiency of anaesthesia and surgery 35,36,37,38,39,40,41,42,43. In the United States the Surgical Care Improvement Project (19) is an initiative to improve surgical care quality in the United States by reducing (15) (16) (17) (18) (19) 30 REPORTS, STUDIES AND RESEARCH

35 postoperative surgical complications. Its goal is to save lives by means of the reduction on the incidence of surgical complications by 25 per cent by the year Research shows that a significant percentage of nearly 30 million operations performed in the United States (whose rate of inpatient surgery is substantially higher than in the European Union 89,9 people a year) results in preventable complications. A 2003 study published in the Journal of the American Medical Association 44 found that postoperative complications accounted for up to 22 per cent of preventable deaths among patients. In this respect, the aim of this document on SS standards and recommendations is to identify those actions that may limit and prevent the complications that may arise in this type of units due to the importance of the surgical processes considering both the rate and quality of healthcare in any healthcaring centre. The same study found unnecessary overstays which accounted for 2.4 million additional hospital days and 9.3 billion dollars in additional charges each year. Both the American Society of Anesthesiologists 45,46,47,48,49,50,51,52,53 and the American College of Surgeons 54,55,56 have published several statements related to different activities linked to surgical activity. SURGICAL SUITE. STANDARDS AND RECOMMENDATIONS 31

36

37 3. Patient s rights and guarantees Healthcare centres must observe and respect all the rights granted to patients and relatives in existing healthcare legislation. This chapter deals in detail with aspects related to the information that has to be provided to patients and relatives at the SS and, in general, with other legislative aspects to be taken into account in these units and, where appropriate, in the corresponding healthcare centres. The hospital must guarantee all patients the right to surgical or anaesthetic assistance according to updated procedures and social needs. It must also manage all processes, evaluate the result, and ensure that they have followed all rules and protocols established in accordance with common ethical principles: autonomy, information confidence, fidelity, justice, prevention, respect for life, people and truth (common ethical principles). Since the patient arrival at the SS it will be guaranteed: 1. Respect to his/her privacy. 2. Humane treatment. 3. Psychological support. 4. Detailed information of all the procedures that will be performed during the surgical process (pre-anaesthesia, surgery, postoperative, etc.) Information to patients and relatives The information that has to be provided to patients at the SS will take into account the following aspects 21 : Details of the procedure they are going to undergo. Expected benefits of the surgical procedure and possible risks. Approximate stay at the operating theatre. Possible schedule of the recovery process, including when the patient would usually be expected to be able to drink, eat, move; when he/she will be probably discharged and able to resume everyday activities. Predictable level of pain and its treatment (for example, details of epidural anaesthesia or patient controlled analgesia). Approximate time of sick leave. SURGICAL SUITE. STANDARDS AND RECOMMENDATIONS 33

38 Ask the patient to notify if: He/she cannot attend. There have been important changes on his/her clinical situation. His/her medication has changed. He/she needs some advice. Ask the patient if he/she have signed an advanced directive (20). Let the patient know what he/she must bring on admission day (medication, for example) Map showing entrance to hospital, parking, public transport. Escorts and visits policy. Fasting times and other aspects relative to preoperative preparation. Moreover, relatives should be informed once the procedure has finished and at the immediate postoperative period and on discharge Information on the genera characteristics of the unit It is highly recommended that welcoming information (leaflet, booklet) should include, at least, a description of the different stages the patient will go through as well as special recommendations and warnings. Inclusion of pictures of the SS may help patients understand and accept the healthcare process Detailed information about the surgical procedure. The information provided to patients should be procedure-specific and should consider his/her psychological, cultural and social aspects. It is recommended that it should include: Basic information about the surgical pathology. Basic information about the surgery. (20) Sect Act 41/2002, November 14th, ruling Autonomía del Paciente y de Derechos y Obligaciones en Materia de Información y Documentación Clínica (Patient Autonomy and Rights and Obligations regarding Clinical Documentation and Information). 34 REPORTS, STUDIES AND RESEARCH

39 Informed consent 57 It will be a written document in the following cases: surgery, invasive diagnostic or therapeutic procedures and, in general, in all procedures that may imply risks or inconveniences which may have a clear and predictable negative effect on the patient s health (21). Any therapeutic procedure that implies any risk must be accompanied with the necessary information so that the patient may be aware of the risks and of the consequences of not taking them. The informed consent is ruled in Spain by Act 41/2002, November 14th, ruling patient autonomy, rights and obligations regarding clinical documentation and information (Official State Gazette 274, November 15th, 2002). The act defines it at the free, voluntary and conscious patient s consent, issued in full possession of his/her faculties and in possession of all relevant facts so that a procedure affecting his/her health may be performed. Hospitals must have an informed consent form for each procedure and speciality included in its service portfolio. At a surgical level, the informed consent should include specific aspects relating to the surgical procedure and the healthcare modality (inpatient/ outpatient), including some minimums (22) : Patient identity; identity of the doctor who recommends and asks for the informed consent and identification of the procedures that will be performed. Name, description and aims of the surgical procedure. General and specific risks. Expected benefits and possible surgical options. The patient has to be informed that he/she has the right to accept or reject any suggested option or to withdraw the informed consent. He/she also has to be informed of the right to settle the limits that he/she may consider appropriate (as blood transfusion or complete mastectomy). Annex 1 provides a sample of an informed consent for surgery rejecting blood transfusion (23). Confidentiality and data management. Date of the consent. (21) Section law 88/2002, November 14th, ruling Autonomía del Paciente y de Derechos y Obligaciones en Materia de Información y Documentación Clínica (Patient Autonomy, Rights and Obligations regarding Clinical Documentation and Information). (22) Bioethics committee of Cataluña. Guía sobre el consentimiento informado. October 2002; Pajuelo A. Bloque Quirúrgico. Proceso de Soporte. Health Department Annex 1. (23) The annex may also be used as a model for an informed consent deleting the section which specifically refers to the refusal to blood transfusion. SURGICAL SUITE. STANDARDS AND RECOMMENDATIONS 35

40 Specific section for the legal representative consent. Declarations and signatures (patient and doctor). The document will be provided in duplicate. The patient will have at his/her disposal a doctor or a member of the staff to clear any doubts and to broaden the information. Procedures implying anaesthetic treatment require a specific informed consent. This consent will be obtained once the anaesthetist has valued the specific circumstances of the patient which may increase the risk, based, when appropriate, on additional general or specific tests, having informed the patient about the possible anaesthetic techniques which she/he may undergo and explaining the preferred procedure and the alternative ones, the risks that each technique implies and if those risks could increase according to the circumstances of the patient. The informed consent for the anaesthetic procedure may include information regarding the risks of a blood transfusion and the patient s acceptance or refusal of this procedure Instructions and recommendations The patient should be provided with the following written information: Instructions for the day before the procedure. Checklist prior to arriving at the SS and undergoing surgery (24). Instructions for the immediate post-operative stage. Post-discharge instructions: they must be procedure-specific. The information must include all the possible incidences the patient may experience at home. It must be accompanied by the medication/care procedures that have to be administered and by a contact phone number to solve any doubt. Data on access to continued care resources connected to the hospital Ensuring patients rights. Healthcare centres that have a SS should keep the following documentation, in addition to the more specific aspects included in section 3.1. (25) : (24) Patients cared at the surgical suite may be inpatients from conventional hospitalization, patients coming from the E&R services or, if surgery has been previously scheduled, they may come from home even though after surgery they will be admitted in hospital. This last group of patients should be considered as the patients that attend DSU3 and thus they must be provided with written instructions prior to arriving to hospital. (25) Draft of Royal Decree which settles the minimum safety and quality minimum guarantees that centres, services and institutions must obey for their authorization and operating. October, REPORTS, STUDIES AND RESEARCH

41 a) Service portfolio. b) Reception programme. c) Code of ethics. d) Clinical practice guides, pathways or protocols. e) Written clinical trial procedures. f) Price list, when appropriate. g) Clinical record. h) Medical discharge reports. i) Protocols ensuring safety, confidentiality and legal access to patient data. j) Complaints and suggestions forms. k) Liability insurance policy. l) Policies and certificates archive. Patients should have guaranteed access to these documents in accordance with the corresponding legislation, except for those indicated points d), e) and j). Below there is more detailed information on some aspects of these documents. Points a) service portfolio, f) medical records and h) medical discharge report are discussed in chapter 5 Organization and Management Reception programme Hospitals should have a reception programme for inpatients. Surgical services must have a reception programme for their patients which will include the general information included in sections 3.1. as well as the information included on the above mentioned list of patients rights and obligations Code of ethics Healthcare centres should have a specific code of ethics that will include the rules and principles to guide their activity in line with professional deontology Clinical practice guides, pathways and protocols Surgical and anaesthetic services will have demonstrable documented record of the clinical practice guides, pathways and protocols used, together with the evaluations and, when appropriate, modifications and adaptations. SURGICAL SUITE. STANDARDS AND RECOMMENDATIONS 37

42 Clinical trial procedures All clinical trials must comply with the conditions and guarantees established in their correspondent legislation Price list All healthcare centres with SS must have price lists available to users; this information must also be notified to the competent authorities in accordance with the applicable legislation on this matter Complaints and suggestions 1. Healthcare centres that have SS will have complaints and suggestions forms available to allow users to record any complaints, claims, initiatives or suggestions they may wish to communicate in connection with the operation of the suite. 2. The existence of these forms will be clearly signalled and the forms will be easily available to allow their identification and use. 3. Users of healthcare centres are entitled to receive written replies from the manager or any other authorized person to the complaints posted, besides their referral to the competent authority in accordance with the provisions of regional applicable legislation. 4. Complaints, claims, initiatives and suggestions should be periodically reviewed Liability insurance policy 1. All healthcare professionals working in the private sector and all private bodies or corporate persons providing healthcare services of any kind must have the mandatory liability insurance or financial guarantee to meet any compensation claims that may derive from eventual harm caused to persons as a result of these services (26). 2. Private healthcare centres that have a SS must have the necessary liability insurance policy to cover any possible compensation to harm caused to patients. 3. (26) Public administrations are considered vicariously responsible of public healthcare centres practice. 38 REPORTS, STUDIES AND RESEARCH

43 Policies and certificates archive Centres and, where appropriate, independent healthcare professionals should keep a copy of the documents which certify the mandatory liability guarantees. SURGICAL SUITE. STANDARDS AND RECOMMENDATIONS 39

44

45 4. Patient s safety 17 This chapter deals with the criteria and guidance related to patients safety during their stay at the SS. The WHO has issued a guide for the implementation of the Surgical Safety Checklist (Annex 2) (27). The checklist divides the surgical process in three stages, each corresponding to a specific time period in the normal flow of the procedure: The period before induction of anaesthesia (Sign in), the period after induction of anaesthesia and before skin incision (Time out) and the wound closure (Sing Out). In each stage, the checklist coordinator (generally a circulating nurse, though it can be any healthcare professional) must confirm that all the members of the team have completed their tasks before the procedure goes any further. As operating teams become familiar with the checklist, they can integrate it into their familiar working patterns and verbalize the completion of each step without the explicit intervention of the checklist coordinator. Each team should seek to incorporate the checklist into their job with maximum efficiency and minimum disruption, accomplishing the steps effectively. One of the objectives of this document on SS standards and recommendations is to point out the importance of following a method on everyday work in order to prevent work from turning into a routine. Working with clearly established processes under continuous assessment guarantees safety. This continuous assessment, ordered and sequential, allows processes to be traced, incidences identified and, at the same time, a continuous improvement capacity developed Efficient communication in the theatre Efficient structural communication is a key element to guarantee safety at the operating theatre. Organizational culture must focus on team work and replace hierarchic relationships with leadership. To make teamwork easier, organizations must follow a series of actions: To use structural communication tools. (Annex 3) To promote feedback by gathering information from multiple sources, including patients, relatives and healthcare staff opinion surveys, from focus group, from direct observation and from patients and staff complaints. (27) SURGICAL SUITE. STANDARDS AND RECOMMENDATIONS 41

46 To provide team training, highlighting the value of teamwork to attend patients, preparing staff for teamwork, and paying special attention to body language, to solving problems techniques and to learn to communicate in an efficient and respectful way. To fight disruptive behaviour (which affects the steady flow of the work of the team at the operating theatre), promoting conflict resolution and putting into practice zero tolerance policies towards this kind of behaviour Error prevention on determining the surgical site, the type of procedure and patient identification Probabilities of making mistakes when determining the surgical site, the type of procedure and the identity of the patient increase when communication between the members of the team is inappropriate or inefficient, when the patient is not involved in marking the site and when there is a lack of procedures when checking the site. Some elements of risk include: Inappropriate evaluation of the patient. Inappropriate review of the clinical records. Non-inclusion of some members of the surgery team in the verification process. A culture which does not provide open communication between the members of the team and which contributes to the belief that doctors are always right and their decisions are never discussed. Problems related to unreadable handwriting. Usage of abbreviations related to the type of procedure, the site or the side of the body. More than one surgeon involved, either because surgery implies multiple procedures or because the case is transferred to other surgeon. Time pressure (duration of the procedure; emergency surgery). Non habitual characteristics of the patient, such as great deformity or obesity. Changes on the scheduled surgical order. The anaesthetic procedure begins before the surgeon makes the compulsory verifications on the patient and on the planned procedure. 42 REPORTS, STUDIES AND RESEARCH

47 In order to help hospitals to minimize the number of mistakes relating to the patient, the site or the procedure, the Joint Commission has issued a universal protocol (28), which includes the following items: To conduct a pre-procedure verification process. To mark the procedure site to identify it without ambiguity. To conduct a final verification assessment immediately before starting the procedure. The National Patient Safety Agency (NPSA) and the Royal College of Surgeons of England recommend marking the site before identifying the intended site for the scheduled procedure. Annex 4 includes the NPSA recommendations in marking the surgical site. Recommendations to prevent site, procedure or patient errors are the following: 1. At healthcare centres there would be a reliable, unequivocal, universal and unique system of patient identification. Since admission into hospital, patients must have an identification (bracelet, wristband). It is important to have a patient traceability protocol: Reception Hospital admittance Preoperative area Operating theatre Post anaesthesia recovery (PACU) Intensive Care Unit (ICU) (when needed) Hospitalization Discharge 2. This system must allow checking patients identity before any diagnostic procedure and, obviously, before performing any riskimplying procedure or administering any drugs or blood products. 3. Centres which carry out surgical procedures will have a protocol for error prevention on the identification of the patient, the procedure or the site Fire safety Regardless the information provided on Chapter 7 (Facilities) which refers to fire safety, fires at the SS, though unusual, may bring about serious consequences for the patient, the staff and the equipment. The three sides of the fire triangle 17 are a fuel agent, an oxidizing agent and a heat agent. Fuel agents are: Alcohol based agents. Breathing circuits. Surgery mats. Ointments. (28) SURGICAL SUITE. STANDARDS AND RECOMMENDATIONS 43

48 Surgical equipment and supplies. Gastrointestinal and bladder gases. Blood pressure cuffs. Anaesthesia vaporizers. Povidone-iodine solution. Synthetic suture. Human tissue. Textile. Tracheal tube. Body hair. Heat agents: Drills and saws. Defibrillator. Optical fibre light sources and cables. Laser. Halogen light. Electric scalpels or electric cauterization units. Many surgical procedures take place on rich oxygen environments (oxygen concentration level higher to 23,5%). The higher the oxygen concentration, the higher the risk of fire is. Risks related to the fire triangle must be minimized by means of patient adequate preparation (protecting body hair that is close to the surgical site with water soluble gel; covering eyes with sodium chloride (29) soaked cotton balls on some face procedures; drying completely the site covering it with non inflammable pads; etc.), adequate equipment maintenance; and engaging staff on the fire protection process. Even though fire may break out in several places, the Joint Commission suggests the following reactions when fire occurs on the surgical wound or in the respiratory tract: Fire on the surgical wound Close medical gases. Pour saline solution on the site. Throw surgical pads and any other material that may have been burning on the floor. Look for and extinguish any remaining flame. If there is smoke in the theatre, determine when it is necessary to evacuate. Keep all the material for further investigation. (29) Eye protection does not necessary imply soaked cotton. There are specific eye protectors and, what is more, closing the eye and keeping it closed would be enough. 44 REPORTS, STUDIES AND RESEARCH

49 Fire on the respiratory tract Disconnect the tracheal tube from the ventilation circuit. Remove the tracheal tube and devote one of the members of the surgery team to put the fire out. Remove any other section of the tube that may be burnt and any other cuff protective device that may still be in the area. Re-establish the respiratory tract device and reassume air ventilation until it may be confirmed that there is no fire or combustion on the tract. Examine the respiratory tract to evaluate damage. Keep all the material for further investigation. A specific fire plan for the SS (especially for the theatre) must be drawn up, setting the specific responsibilities of each of the members of the surgery team Nosocomial infection prevention Recommendations on this aspect of patient s safety are the following: 1. Healthcares centres with SS shall have an infection control and prevention programme adapted to its specific characteristics and activities. The programme will ensure that patients at risk and risky procedures are identified and that the necessary information is provided to the corresponding authorities in accordance with all applicable legislation. 2. To such effects, a protocol shall be set up, which will include aspects related to hand hygiene, use of alcohol-based hand cleansers, antiseptics, antibiotic prophylaxis, prevention and handling of incidents related to blood exposure; patients health; types of preventive measures, and infection risks at invasive procedures. 3. Healthcare centres must be able to demonstrate that they have the necessary resources to comply effectively with this obligation. Surgical site infections mean 14% of nosocomial infections 58. The NICE has recently published a guide 59 for the prevention of surgical site infections which is summarized in chapter 5. There are provided below some items related to this part of patient s safety which deal with surgery team hygiene (focussing mainly on hand washing), environmental items (including an especial reference to air conditioning) hair removal and antibiotic prophylaxis. SURGICAL SUITE. STANDARDS AND RECOMMENDATIONS 45

50 Surgery team hygiene The basic rules to keep surgical asepsis, which are recommended by the Association of Perioperative Registered Nurses (AORN), are a set of rules that have to be put into practice at the SS. It is the first strategy that tries to establish an acceptable infection control as it settles some basic hygienic principles to avoid microorganism transmission. To wear correctly gown, cap, mask and shoes. It is advisable that the uniforms used at the theatre would be different from those used in other wards of the hospital. The same practice should be adopted for the shoes (clogs) used at the theatre; the hospital should be responsible for cleaning them. People belonging to the surgery team should not use shoe covers to protect street shoes. Hand washing before and after coming into contact with the patient or his/her environment. Hand scrub of the surgery team, surgeons and surgery nurse. Artificial nails and nail polish should be removed before operations. Any piece of equipment used at the surgical site should be sterile; contact at any point with non sterile objects contaminates it. Gowns, sheets and surgical table covers should be sterile. Elements used on a sterile site should be manipulated in such a way that its sterility and the integrity of the sterile site are kept. The site has to be preserved from non sterile objects; packaging and sterile material boxes make circulation possible from one site to another without becoming contaminated. Movement around the sterile site should not contaminate it. During the procedure there should not be any change either of the furniture or of the equipment until the wound dressing is placed. Particles that may have settled down on any surface should not be removed as they may fall into the sterile site. The sterile site should be checked and preserved constantly; any item whose sterility might be put into question, should not be considered sterile. Policies regarding this topic include aspects such as SS staff health, injuries or diseases suffered by any of the surgery team members which may put patients at risk; waste management; cleaning and disinfection of the area and all surfaces; sterilization methods; maintenance and storage, and type of clothes used, either textile or disposable. Surgical staff has the responsibility to follow tight aseptic principles in order to minimize risks and to obey the established protocols. However, the 46 REPORTS, STUDIES AND RESEARCH

51 control, the evaluation and the registry of sterile material and the cleaning and disinfection of the SS is competence only of surgical nursing (30). Singleuse materials should never be sterilized and/or re-sterilized Surgical hand wash Recent evidence shows that hand wash without scrubbing may be as or even more effective than the traditional scrubbing 17. This is an important recommendation as the lack of skin integrity may enhance the possibilities of bacterial colonization which may bring up infection. The following steps illustrate the hand washing process without scrubbing. 1. Use a nail stick for cleaning the nails. Dispose the stick and wash hands and arms with water. 2. Dispense the antiseptic product that does not require scrubbing by means of a foot or elbow pump. 3. Rub hands together and then rub up the arms, higher than elbows. Rub hands and arms for 90 seconds. 4. Rinse hands and arms completely. 5. Repeat steps 2 to 4 for a second time. 6. Dry hands by means of an aseptic technique. The Spanish Ministry of Health, Social Policy and Equality has issued a guide which summarizes the WHO guidelines on hand hygiene at healthcare atte n tion 60. Annex 6 illustrates the steps for hand hygiene with alcohol-based cleanser Environmental factors As to the environmental factors, the most important items are: Air quality and ventilation. Theatre cleanness. Equipment cleanness. Uniform cleanness. Cleanness and sterilization will be dealt with in chapter 8 and those aspects relating to air conditioning in chapter 7. In this section some aspects of air conditioning that are closely related to infection control will be dealt with. There are three points of the air system that are directly related to infection control. Pressure rates. Pressurization of the SS area must ensure that air movement goes from the cleanest locations to those that are not (30) Surgical nursing refers to the nursing staff involved on the nursing care process of the SS patient. SURGICAL SUITE. STANDARDS AND RECOMMENDATIONS 47

52 as clean. For example, positive pressure at the theatre room may guarantee clean air at all times. Air change rates. Bacterial count is proportional to the volume of air administered. Filter efficiency. Chapter 7 includes the Spanish standards for infection control and ventilation at operating theatres. Patient hypothermia should be avoided during surgery. It has been proved that hypothermia increases the risk of infections 61, of myocardial ischemia 62 events, of blood loss and thus the need for transfusions 63. A habitual control criteria of the anaesthetic/surgical procedure is the maintenance of normothermia Air removal Several investigations have proved that the rate of infection is lower in patients whose hair has not been removed 17. If an institution establishes a policy on hair removal, it must be put into practice only when necessary. Razors should not be used, and they should disappear from healthcare centres. Institutions should train their staff on the importance on cutting hair instead of shaving it and coach them on the adequate use of electric clippers Antibiotic and bacterial endocarditis prophylaxis The CDC have published a set of guidelines to prevent nosocomial64 infection. The effectiveness of the use of antibiotics depends on three critical factors: 1. Adequate selection of the antibiotic. Surgical protocols must study, together with the department of microbiology and, when needed, with the preventive medicine unit or department, the appropriate selection of the antibiotic, the type of antibiotic and an adequate alternative treatment should an allergy break out. 2. The appropriate time to start the prophylaxis. Ideally, the first dose should be administered before the incision though never more than minutes before. 3. The appropriate time to interrupt prophylaxis, which should also be included in the protocol. Studies have reported the effectiveness of antibiotic single doses (single-dose) for surgical prophylaxis of the surgical wound (cephalosporin, 48 REPORTS, STUDIES AND RESEARCH

53 mainly) for biliary, gastric and transurethral surgery, caesarean section and hysterectomies 65. The recently published SIGN guide also recommends single-dose 66 antibiotics. In relation with bacterial endocarditis prophylaxis the NICE has published a guide in which it recommends its administration in patients suffering from valvepathies or with a valve prosthesis, from structural congenital cardiopathy (excluding interauricular communication, interventricular communication closed by means of surgery and closed ductus arteriosus) with history of infective endocarditis or from hypertrophic cardiomyopathy Epidemiological alerts Healthcare centres with SS shall have epidemiological alert systems connected to the adequate health authorities, in accordance with present legislation. An epidemiological alert is a set of events that have a potential risk for the population and/or that have a certain social significance which require urgent and efficient public health actions. It can be considered as an alert: Sudden outbreak of risks that require immediate public health services involvement. Outbreak of epidemics regardless their type or origin as, for example, legionella or nosocomial infections at intensive care units. Detection of a case of a disease that has to be urgently and compulsory made public Deep vein thrombosis and management of anticoagulation/antiplatelet prevention The NICE has recently (2007) published a guide which recommends that those patients with risk factors should undergo mechanic prevention procedures combined with low molecular weight heparine 24. There should be a protocol on perisurgical management of antiplatelet 67 and anticoagulant drugs, as it is one of the problems which brings up more negative events and which is generally the reason for surgery cancellations (see ). SURGICAL SUITE. STANDARDS AND RECOMMENDATIONS 49

54 4.6. Drugs and fluids management. Medication error prevention. The Joint Commission has settled the following standards to prevent errors on medication. To label drugs, drug containers and other solutions inside and outside the sterile site. To use of at least two methods for identifying patients (being none of them the room number) when drugs or blood products are administered, samples for laboratory study taken or when any other treatment or procedure is performed. To unify in the centre the Minimum Basic Data Set, the terminology, the definitions, the classifications, the vocabulary and the nomenclature, including abbreviations, acronyms and symbols. To guarantee that drugs are properly and safely stored.to settle and to review, at least once a year, the list of drugs whose name or appearance may be mistaken and to establish actions to prevent errors in their handling (in these cases, it is advisable to use different types of packaging; when impossible, keep the clearly separated in the storing places). To reduce the number of verbal or telephone orders. When impossible, the complete order or the result of the procedure should be checked by making the person who receives the order or the result read it from top to bottom. The centre must have an active policy on drugs adverse effects, either confirmed or potential and it should take part on pharmacovigilance programmes of the regional governments (yellow card programme and others). To transmit the complete list of drugs a patient is taking to the new supplier when the patient is referred to or transferred to any other healthcare centre, doctor or level of care inside or outside the organization. Nearly all the standards issued for drug management can be applied to fluid management. Potassium based solutions and hyper or hypotonic solutions should not be stored at the SS. These solutions should be kept at the pharmacy unit or service and should be required on individual basis. The recommendations regarding this type of patient safety are the following: 1. Centres would have list of standards on drug storing, labelling, identification, handling and prescription, paying special attention 50 REPORTS, STUDIES AND RESEARCH

55 to the handling and administration of high risk drugs and to the use-by date. 2. SS healthcare centres would follow the specific obligations settled by the drug law. 3. There would be specific rules for toxics safekeeping at the SS Blood products management The recommendations regarding this type of patient safety are the following: 1. Management and safe storing of blood products is competence of the transfusion service of the centre, which must have an accreditation for that purpose (31). 2. Identity of the receptor should be unmistakably guaranteed prior to sample taking and blood and blood product transfusion. 3. The traceability of the transfusion process should be guaranteed and accountability settled for the blood product perfusion between the blood bank and at the different healthcaring units Anaesthetic and intraoperative risk prevention Anaesthesia at extreme ages There should be a protocol on the attention to extreme age patients as the special characteristics of elderly people and children make the attention to this range of population be guided by specific criteria to avoid complications to which they are particularly sensitive Intraoperative awareness prevention An estimated 0,1% - 0,2% of patients that undergo general anaesthesia go through some kind of intraoperative awareness (they are aware up to a certain degree, they can hear, they feel pain, etc). It is more frequent at cardiac surgery, obstetric surgery and severe trauma surgery as the level of hypnoses reached is usually lower and it may not be deep enough to prevent (31) RD 1.088/2005, September 16 which settles the requisitos técnicos y condiciones mínimas de la hemodonación y de los centros y servicios de transfusión (technical requirements and minimum conditions for blood product donation and for the transfusion centres and services). SURGICAL SUITE. STANDARDS AND RECOMMENDATIONS 51

56 memories. Moreover, when muscular relaxant drugs are used in surgery, they may mask the fact that the anaesthesia is not deep enough. This may also happen at specific stages of the surgical process, when there are greater stimuli on the patient, as intubation, incision or stages in which anaesthetic drugs administration is interrupted. On the other hand, there can also be patients who may have a tendency to intraoperative awareness, such as young patients, women and maybe chronic drug and alcohol abusers. Other reasons for the awareness may be the misuse of anaesthetic equipment, the excessive use of neuromuscular blocking drugs, a lack of surveillance from the anaesthetist or the intended low use of anaesthetic drugs to allow a faster recovery. Intraoperative awareness typical symptoms include arterial hypertension, tachycardia, haemodynamic changes and movements which, even though they are specific signs for alert or suspicion, do no necessary imply that the patient is awake and aware. Neuromuscular blocking drugs, beta blockers and calcium antagonist drugs may mask some of the symptoms. The ASA and the American Association of Nurse Anaesthetists have issued some guidelines to reduce the frequency of intraoperative awareness: To consider premedication with amnesic drugs such as benzodiazepine or scopolamine, especially if light anaesthesia is foreseen. To administer more than a sleep dose of induction agent when it is immediately followed by intratracheal intubation. To avoid muscular paralysis unless it is absolutely necessary and even on such case avoid total paralysis. To solve this problem, healthcare centres should develop a set of rules based on: Identifying patients at risk. Monitoring muscular relaxation. Using a monitor of hypnosis (of anaesthetic depth ). Performing a structured postoperative interview in case of suspicion. Writing down in the clinical record the information related to this event. Keeping equipment in suitable conditions. Reacting to these events in the appropriate way. Training staff about this problem Malignant hyperthermia At all centres in which general anaesthesia is used, there should be a deposit of liposoluble hydantoin for treating malignant hyperthermia. Moreover, at all SS there should be a protocol for treating this condition. 52 REPORTS, STUDIES AND RESEARCH

57 Hypothermia prevention Hypothermia is a habitual and important complication, mainly in surgery procedures which take more than 90 minutes. Centres should thus have the material to avoid this condition (air blankets, fluid heaters, inhalation gas warmers, etc.) and avoid temperature dropping under the strictly necessary level Difficult respiratory tract management Specific protocols and training programmes should be established to treat this contingency, The necessary equipment ( difficult intubation cart ) with specific storing conditions should be available Pre-anaesthesia check of the anaesthetic equipment. It is compulsory to carry out a previous structured check of the anaesthetic material prior to each procedure, including the ventilator. This checking procedure has proved useful to avoid anaesthetic adverse events 68. At some hospitals the electromedicine services perform a routine check up in the early morning, before the clinical activity of the equipment begins. This check up is advisable for safety reasons as well as for management ones so as to avoid problems at the beginning of the day. Moreover, the anaesthetic equipment must have undergone the compulsory check ups as indicated in its operating manuals How to proceed on a cardiopulmonary arrest To deal with this contingency, protocols should be settled and specific training developed. Moreover, the necessary equipment needs to be available and the cardiac arrest cart specifically stored 69. This Should be identical to the other cardio respiratory arrest carts both about contents and distribution throughout the centre. It must have an steady location at the SS. It must be sealed and a protocol for its breaking and closing should be established. There should be a detailed list of the material and resuscitation drugs for regular checking. It should be checked once a week (this applies to units such as the SS in which the equipment is rarely used). Checking will imply a check-out procedure of the defibrillator. SURGICAL SUITE. STANDARDS AND RECOMMENDATIONS 53

58 Prevention of postural injuries. SS must have specific necessary protective equipment and must train staff on it: nurses, assistants and orderlies Prevention of retained bodies The AORN recommended practices for the count of gauze sponges, needles and surgical instruments and the statement on the prevention of retained bodies after surgery made by the American College of Surgeons (ACS) should be taken into account to prevent mistakes: Which articles should be counted. When articles should be counted. How counting should be carried out. Which information has to be documented. Gauzes should be counted in those procedures in which any may have been left. They should be counted by two nurses. Needles, cotton pads and other objects should be counted in all procedures. Instruments should be counted in all procedures in which an instrument may have been left. Count should be done before starting the procedure to establish a starting point, before closing any wound and at the end of the procedure. It should also be performed if a nurse or any member of the cleaning staff is substituted Counts should figure out on the intraoperative record of the patient. To that effect, The New England Journal of Medicine published in 2003 a research which points out that patients with higher risks of retaining foreign bodies are 70 : Patients that undergo emergency surgery. Patients that suffer an unpredicted alteration in the surgical procedure. Patients with high body mass index (BMI) (10% for every one-unit increment of BMI). Circulating nurses state that distractions may also be considered as risk factors: Frequent phone calls. Substitutions at breakfast stops or shift changes. Tiredness. Tasks that have to be performed while the counting is being done. 54 REPORTS, STUDIES AND RESEARCH

59 Rigid staff policies and inappropriate equipment for the procedures (operating theatres are standardized while procedures are not). Hierarchical organization of the SS staff relationship to the detriment of team work. Training policies that may be improved on the importance of specific knowledge, information and experience in areas such as the SS Mobile phones at the SS There should be a control on the use of mobile phones at the SS to avoid distractions and make the patient feel a lack of interest towards himself/ herself, apart from the possible interferences that may come up with electromedicine devices. It is recommended to keep mobile phones a metre away from electromedical equipments and systems. There should be an area at the SS for non restricted use of mobile phones Patient s safety and healthcare risk management. Adverse events related to the surgical process are 40% of all the informed inhospital adverse ones 72. Among the measures aimed at reducing the number of adverse events are gathering together specific difficult surgery procedures at hospitals with high levels of activity, having emergency surgery teams or preventing surgery based infections. Some of these measures are included on this document of standards and recommendations. Good practices on patient s safety imply an organization for safety management. Healthcare centres must develop efficient systems that guarantee, through the clinical direction, safe healthcare and a learning process from their own and others practice. Key points to this policy are risk management processes, including the review of cultural organization, risk assessment, training, protocols, communication, audits and learning from adverse events and complaints. At healthcare centres classified as hospitals (RD 1277/2003) and dependent from the direction board, there will be a commission or a unit, when needed, which will identify and register the adverse events that may come up as a result of the care provided, and which will work on the settlement and assessment of improvement actions resulted from those events. At SS, risk management has to be supervised and coordinated by a management team which belongs to the suite, headed by a senior doctor SURGICAL SUITE. STANDARDS AND RECOMMENDATIONS 55

60 and made up of members of several disciplines, and which should meet regularly (at least every six months). The team should be sufficiently trained to put into practice the different tools required for safety management and should transmit this sensation on to the SS staff. Risk management procedures must be written down, including the sentinel events that have to be acknowledged and their revision. Risk management multidisciplinary training should be encouraged. There must be a proactive and continuous risk assessment at the SS and a formal one which should be carried out at least every two years. An occurrence registry should stem from the assessments which will include the acknowledged and studied events, the tasks performed and the measures taken as well as the outcome analysis, guaranteeing the strictest confidence of the data. When adverse events occur, healthcare centres should study the causes and consequences of the identified problems. The appropriate analysis of the underlying problems should be performed with a suitable action plan which must be part of the training and change implementation process. Frequent audits of surgical adverse events should be performed. Meetings to analyze adverse events are part of the risk management system and to the training process at the SS. Good communication among the professionals involved on an occurrence is an important mechanism to prevent adverse events from happening again. Training results should be utterly transparent by setting multidisciplinary meetings and providing feedback by means of digital or paper printed documents. While many reviews will identify the need of some changes on practices and systems which will improve the results without having to raise costs, some may require some actions that may imply higher assets. People in charge of the administration and management of centres must be informed of these requirements. Having the support of the centre directors and of the managers of the SS is a determining factor to make the safety management strategy effective. Standards and results rules should be adopted, audited and published as a yearly report in line with the best practice on an online document which would include best practices. Doctors should document adequately the occurrences including date and place. Improving clinical practice is crucial to have a system for documenting and recording clinical decisions and occurrences. Data archive is vital. A member of the SS, the risk manager if possible, should be responsible for guaranteeing that the appropriate methods are taken. There are several SS safety management tools which are mainly part of the quality programmes. Department systems for communicating and analysing occurrences (considering occurrence as the event that puts or may put at risk the patient s safety) have proved useful 73, 74. In the same way, the occurrence notifications systems, the risk analysis and assessment techniques, 56 REPORTS, STUDIES AND RESEARCH

61 the Design Failure Mode Effects Analysis (DFMEA), the Root Cause Analysis and other techniques (such as briefings, etc.) have proved useful in risk management. A common taxonomy on healthcare safety should be established and notifying systems and occurrence assessment systems at national level implemented. Occurrences could be gathered according to their origin: pre, intra or postoperative; anaesthetic, surgical, drug related, etc. Legal confidentiality on the identification and signing of the notification should be promoted Patient s engagement on their safety Patients should play an active role in their safety improvement, obtaining the information they need, taking part in their care procedures and contributing on the decisions regarding their treatments 75, (32). In this respect, one of the challenges the WHO has established in relation with patients safety is their participation. The London Declaration: Patients for Patient Safety (January, 2006) settles a series of collaboration commitments and establishes certain requirements for healthcare systems in terms of honesty, safety and transparency to reduce healthcare errors as a basic human right to preserve life. Another initiative for the active participation of patients is the Speak Up campaign developed by the Joint Commission which stresses patients rights to ask and be informed about their diagnosis, tests, treatment and care procedures. Other campaigns have produced leaflets which encourage patients to take an active role on their safety before a surgical procedure is performed 76,77,78. They focus mainly on: Recommending patients to play an active role, to place questions to their doctors and nurses and to make sure that they do not have any doubts either before nor after undergoing surgery about The procedure, its risks, its benefits and possible alternatives. The anaesthetic expected to be used and possible alternatives. Getting ready for surgery (which drugs may the patient take and which may avoid; if the patient may eat or drink before admittance; etc.) The procedures that will be performed once the patient is admitted to guarantee his/her safety (wristbands or bracelets, (32) See, for example, the leaflets Mejoramos juntos ( Improving together ) issued by the Madrid Regional Government rtalsalud%2fpáginae%2fptsa_pintarcontenidofinal&vest= SURGICAL SUITE. STANDARDS AND RECOMMENDATIONS 57

62 checking the patient s information several times, marking the area that the patient is to be operated on). Post surgery care (which drugs are administered and if there are any side-effects, for example). Encouraging the patient to involve a relative or a friend in his caring process, someone who may know his/her health problem and who may stay with the patient and help him/her ask questions, understand instructions and make the patient s preferences be heard. Recommending patients to ask for a second opinion if they consider it necessary. Recommending smoking patients to quit a month before the procedure Self-protection plan There are specific risks for operating theatre related staff, as fires, ionizing radiation, infection or stab wounds, which may be a vehicle for infectious contamination. The ACS 55 estimates that in 1% to 15% of all surgical procedures, wounds with stabbing objects occur. There are some measures which may prevent this situation from happening: Usage of safety devices such as protected scalpels or blunt suture needles (33). Development of safety practices to reduce risks: Neutral zones (34) (recommended by the ACS and the AORN). Double gloving. Regular glove change. Avoid interferences in the incision site and the suture site. There are also other important occupational hazards for the staff that works at the SS: exposure to ionizing radiation, exposure to inhaled anaesthetic agents, and exposure to chemotherapeutic agents. Protection and safety rules should be applied in accordance with the applicable legislation. Recommendations regarding this aspect of safety at the SS are the following: 1. Healthcare centres with SS will have a self-protection plan implemented which will settle the arrangement of human and (33) The ACS recommends this type of sutures for fascia suturing 55. (34) Zone established by the surgery team on the sterile site for pick up or release of sharp instruments to ensure no direct handoff of sharp instruments between team members REPORTS, STUDIES AND RESEARCH

63 equipment resources available for fire prevention or for other equivalent risks, for guaranteeing evacuation and the immediate intervention in any possible catastrophe, either internal or external. There should also be an action protocol in the event of a biological accident at the SS. 2. The self-protection plan will include the assessment of SS specific risks, protective measures, the emergency plan and the implementation and updating of measures. SURGICAL SUITE. STANDARDS AND RECOMMENDATIONS 59

64

65 5. Organization and management The SS is, on the hand, the area in which all the operating theatres are settled with the different characteristics and equipments necessary to perform the surgical procedures scheduled 6 and, on the other hand, -as it has been stated before- it is an organizational unit, that is to say, an organization of healthcare professionals which provides multidisciplinary healthcare to different procedures by means of surgery, in a specific functional area which gathers the operating theatres, the utility rooms and the necessary facilities and which obeys to functional, structural and management requirements so that the appropriate safety, quality and efficiency conditions are observed on the fulfilment of this activity. This chapter is dedicated to the criteria and guidance related to the different characteristics of the SS if considered as an organization: relation of the SS with other hospital units, service portfolio, SS organization and management and other aspects related to patient management Relation of the SS with other units The SS is an intermediate unit that renders service to final surgery services mainly; its final clients. However, DS Units3 work as final units as they discharge the patients they take care of. The following units may be clients of the SS: U.21 Paediatric Surgery U.26 Gynaecology U.34 Voluntary interruption of pregnancy U.39 Angiology and vascular surgery U.40 Cardiac surgery U.42 Thoracic surgery U.43 General surgery and digestive surgery U.45 Maxillofacial surgery U.46 Plastic and reconstructive surgery U.47 Cosmetic surgery SURGICAL SUITE. STANDARDS AND RECOMMENDATIONS 61

66 U.49 Neurosurgery U.50 Ophthalmology U.51 Refractive surgery U.52 Otolaryngology U.53 Urology U.55 Orthopaedic and trauma surgery At times, it can render service to other final units as: U.7 Cardiology U.8 Dermatology U.25 Obstetrics U.36 Pain unit U.93 Organ recovery U.94 Organ transplantation U.95 Tissue recovery U.96 Tissue transplantation At the same time the SS is itself a client of several other structural and intermediate units of the centre, external or not, as Storeroom Pathologic anatomy Blood/tissue bank Image diagnosis Sterilization Pharmacy Patient management Waste management Laboratories Laundry and linen Cleaning Maintenance Preventive care The SS should be near to the critical care unit, be easily accessible either from the E&R service and from polyvalent hospitalization units allocated to different surgery services and should have appropriate communication 62 REPORTS, STUDIES AND RESEARCH

67 means (telematic, pneumatic tube, etc.) with the pathology anatomy and image diagnosis services and with the laboratories Service portfolio Service portfolio is defined as the set of techniques, technologies and procedures, considering such as each of the methods, activities and resources based on knowledge and scientific experimentation, which make effective healthcare services (35). A way of approaching the service portfolio of a hospital unit is to define the procedures it deals with, in accordance with the diagnosis and procedures codification of the International Classification of Diseases 9, Clinical modification, 5th edition (ICD 9) and the whole of them making use of the APDRG version SS service portfolio is made of the surgery procedures that are performed in this unit, which belong to the healthcare process of the patients cared at the final services and units Criteria for patient admission The criteria for patient admission and the circuits studied in this document on standards and recommendations usually refer to the patients that require conventional hospitalization. The guide on DSU should be looked up for information on patients admitted in this type of healthcare3. Patients admitted to the SS must Be prescribed for a surgical procedure by a specialist surgeon (who will preferably be later in charge of the surgery). Have provided their written consent after having been appropriately informed or, when needed, their relatives or escorts (see annex 1 and 7) (36). Have attended anaesthetist consultation at which anaesthetic risk would be evaluated, the anaesthetic technique studied and its consent (37) obtained, after the patient has been appropriately (35) RD 1030/2006, September 15th, por el que se establece la cartera de servicios comunes del Sistema Nacional de Salud y el procedimiento para su actualización (which settles the common service portfolio of the Spanish National Health Service and its procedure for updating). (36) The creation of an informed consent document for each type of surgery or anaesthetic procedure is recommended. Vital urgency procedures are excluded; those cases will be ruled by section 9.2b from the Act 41/2002. (37) For patients with scheduled surgery. SURGICAL SUITE. STANDARDS AND RECOMMENDATIONS 63

68 informed or, when needed, his/her relatives or escorts, or in case of patients under 18, his/her guardian. Have admission scheduled; the procedure must be included in the agenda for specific surgery and a bed at conventional (38) hospitalization must be available and, in those cases where it can be necessary, a bed at the CCU. Have followed the preoperative protocol and undergone the additional tests whose results should be checked prior to setting in the agenda the date for the procedure Structure and typologies (39),18 As it has been stated before, the SS is the area which includes all the operating theatres with the different characteristics and equipments necessary to perform all the surgery procedures scheduled. It is also an organizational unit. The physical structure of the SS premises may determine to a great extent the organization and management of surgical activity 29. The need to make an efficient use of all the available resources has promoted the centralization of the SS in two different ways; a) gathering theatres in an unique SS to make the most of equipments and to avoid doubling staff and b) unifying operating theatres management to optimize the use of equipments, the allocation of staff and to plan global aims in the long term 79. It is recommended that if structural conditions, the volume of activity and the organization and management (including staff management) allow it, the SS should be independent from DSUs (autonomous DSUs) 3. Usually, some operating theatres are kept for specific procedures, being the most common services (40) : Any speciality. Urgent trauma. E&R. Radiosurgery. (38) For patients with scheduled surgery at conventional hospitalization. The lack of beds is a frequent reason for non-medical cancelations. Beds at conventional hospitalization are generally available by the second hour of the morning, once the discharges have been carried out. Efficiency may be improved by admitting patients at the preoperative are on the same day of the procedure. This area may be incorporated into the preoperative assessment area to facilitate the use of trained staff and the transfer to the operating theatre 36. (39) The diagrams of corridors and their relations with the operating room that appear on this section are based on Department. HBN 26. NHS Estates. HMSO (40) The following information has been adapted from Operating Theatres. Review of national findings. Audit Commission REPORTS, STUDIES AND RESEARCH

69 Below, it will be analysed the advisability to keep operating theatres devoted to urgent procedures, either general or trauma, to scheduled urgent surgery. Multifunctionality of operating theatres should be maximized. There are two main reasons to justify specialized operating theatres: a) specific equipment that cannot be moved or that is too expensive to be provided at all operating theatres and b) prevention of cross contamination. However, the reasoning of the equipment does not prevent other services which may easily fit their equipment from using an operating room which has been specifically endowed. It is recommended that operating theatres would not be allotted generally to a speciality, distributing thus the sessions according to the scheduling criteria that are provided below (5.5.2). Aspects of microbiological safety have prevailed on the design and management of the SS. The requirements of a clean corridor and a dirty (41) one based on theories lacking scientific evidence should not be a requirement 18,32,80. Nowadays, it is considered that separating the clean and dirty corridor should not be a requirement on its own. Staff movement control at the suite should not be settled on a double corridor system. Avoiding the circulation of staff and material from the dirty areas to the clean ones should not be underestimated as working criteria. People, when they move around, are the main source of microorganisms. The bacterial load decreases by reducing the amount of people and their movements, assuring, thus, an adequate flow and air renewal. Air pollution is high when patients enter or exit the room; therefore at that precise moment sterile boxes should not be manipulated. Sterile carts should be arranged at a nearby premise, adjacent to the operating theatre, with direct access. The doors at this preparation area should be kept closed until the following patient enters the room (42). Access to the different areas of the SS should be restricted and traffic elements within the SS separated. According to access restrictions, four different areas at the SS can be settled: General access area. There are no restrictions for the people that have been granted admittance to the SS (patients reception area, administrative area of the unit, staff changing room and toilets and staff room) (41) These requirements are considered on some of the regulations required by regions for the opening authorization of healthcare centres. (42) The arrangement of the surgery table is made at the operating theatre once the patient is anaesthetized. SURGICAL SUITE. STANDARDS AND RECOMMENDATIONS 65

70 Limited access areas. Only people who have to reach the adjacent premises to the restricted access areas or the surgery areas (storeroom, PACU). Restricted access areas. Only the people who have to get to the surgery area are admitted. They should be appropriately authorized (surgery cleaning area, preanaesthesia, dirty room). Surgery areas. Operating theatre and area for the preparation of sterile carts. Traffic elements that have to be separated are: Patients. Staff. Supplies. Waste. Corridors should allow easy and economic circulation. Among all possibilities, unique corridor design is generally the easiest and most economic possibility. Figure 5.1. shows four distributions for the corridor system corresponding to four different organizations of the areas which have a direct relation with the operating room (figure 5.2.). Patient transportation from conventional hospitalization to the operating room and back to the hospitalization area must keep patient s discomfort to the minimum, must avoid interference with clinical activities and must not imply an additional physical effort for the staff. There are several transportations means, some based on the clear difference of a clean and a dirty corridor; other systems allow taking the bed from conventional hospitalization to the pre-anaesthesia area and even to the operating theatre, reducing, thus, the number of transfers and keeping the patient most of the time at his/her bed. If the bed used for hospitalization is carried to the operating room, it must fit the corridor, have adjustable height so that it can be regulated to fit the operating table requirements, and the linen must have been changed just before the transfer. It should be considered the need to have enough room for the beds or the gurneys while the patient is being operated or recovering from the anaesthesia. 66 REPORTS, STUDIES AND RESEARCH

71 Figure 5.1. Corridor organization at the SS (43) (43) Adapted from: Operating Department. HBN 26. NHS Estates. HMSO Illustration SURGICAL SUITE. STANDARDS AND RECOMMENDATIONS 67

72 Figure 5.2. Relation between operating theatres and traffic division policies (44) (44) Adapted from: Operating Department. HBN 26. NHS Estates. HMSO Illustration REPORTS, STUDIES AND RESEARCH

73 5.5. Management and operation of the SS The organization of the SS is drawn in relation with the process which implies all the healthcaring and support activities aimed at performing a surgery procedure, since the moment when the patient arrives to the reception area of the SS until the immediate postoperative recovery (Post Anaesthesia Care Unit PACU). On this document DS patients are not considered; please check bibliographical reference nº 4. 14, (45) Patient care process at the SS Access to the SS Patients that attend the SS may come from the hospitalization area, from their private home, from an alternative accommodation (it is advisable to have an appropriate program to avoid unnecessary waiting times and to have available a waiting area specifically designed) or from the E&R service. A circulation patient protocol should be drawn up at the SS (there are two examples at annexes 8 and 9). Transfer to the preoperative area may be made by means of a wheelchair, a gurney or a conventional hospitalization bed. Whichever the origin of the patient might be, before his/her arrival to the preoperative area or once he/she is there, the responsible surgeon would have: Requested in advance to the head of the surgery nurse service the necessary material for surgery (prostheses, etc.) Requested in advance (at least 24 hours) to the head of the surgery nurse service the use of a portable radiodiagnosis monitor, if needed. Checked that the patient or an appropriate person have signed the informed consent for surgery. Scheduled the cooperation of other doctors (endoscopist, radiologist, pathologist, etc.) or of other necessary technicians for surgery. Provided the appropriate medical instructions for preparing the patient according to the protocols and the prototypes settled (fast, antibiotic and deep vein thrombosis prophylaxis, preparation of the surgical site, etc.). The main tasks of the anaesthetist in charge are: Identifying the patient and checking that the scheduled surgery instructions agree with the clinical record. (45) Other sources used in this section are González Arévalo, Gómez Arnau and García del Valle 79 and Operating Theatre Standards of the University Hospital Fundación Alcorcón. SURGICAL SUITE. STANDARDS AND RECOMMENDATIONS 69

74 Checking that the clinical situation of the patient and his/her preoperative evolution are appropriate to the scheduled procedure. Requesting and checking that the patient or an appropriate person has signed the informed consent for the anaesthesia. Requesting and checking that the necessary blood products are available according to the protocols settled by the blood bank and the anaesthesia service. Checking that, if needed, a bed at the postoperative critical care unit might be available. Requesting in advance the head of the surgery nurse service the necessary material for anaesthesia. Checking the availability of other doctors necessary for the intraoperative handling. Nurse activities for inpatients or for those patients that came directly from their homes or from the preoperative reception area: Identifying the patient appropriately Checking: Additional tests that may have been performed at preoperative consultations (Annex 10 includes the recommendations of the Spanish Association of Surgeons and of the Spanish Society of Anaesthesiology and Resuscitation in relation with additional preoperative tests). The patient has signed the informed consent(s). There have been observed the protocols of fasting (46),81, prophylaxis (antibiotic, anti-thrombosis), when needed, and other additional instructions that may have been provided by the surgeon and/or the anaesthetist at preoperative consultation. The necessary blood products are available according to the protocols settled by the blood bank and the anaesthesia service. The surgery site has been prepared and marked appropriately. Any metal object, hair pins and other hair accessories, dental prostheses, glasses or contact lenses have been removed. The patient is not allergic to latex. The patient wears clean hospital clothes (open gown). The patient is not wearing make up or nail polish. Taking down patient s vital signs. If patient s preparation is not complete it will be communicated to the surgeon or the anaesthetist in charge and it will be written down on the clinical record. (46) The Royal College of Nursing has issued a guide backed by other professional associations such as the Royal College of Anaesthetists, on fast in relation with surgery for adults and kids. Reference also appears on annex B of reference nº REPORTS, STUDIES AND RESEARCH

75 Preoperative preparation area At the preoperative preparation area the surgical care plan is drawn up and started. The following activities are performed: 1. Patient reception protocol would be observed; it will include checking the patient s identity (id. bracelet: patient personal information, diagnosis and surgery procedure), and the review of the complete clinical record and of the additional tests. Within this area, the following activities belong to the nurse service: a) Introducing and identifying himself/herself to the patient. b) Checking the patient s healthcare supplier, as well as the diagnoses and the procedure. c) Checking the patient s general condition: catheter, drainage, tractions d) Checking preoperative tests. e) Asking for known allergies (especially latex). f) Checking informed consents on the clinical record. g) Checking that dental prostheses, hearing aids, contact lenses and other personal objects have been removed. h) Checking fast instructions. i) Checking that nail polish and make up have been removed. j) Checking, when needed, that hair has been removed and the habitual hygienic measures taken. k) Venoclysis or checking vein permeability. l) Antibiotic prophylaxis administration according to the protocol, making clear the doses, the channel and the time. m) Checking and/or administering prophylaxis to prevent thromboembolisms, when needed. n) Making clear concepts or any possible doubts that may arise with regard to the surgery environment or the surgery procedure so as to reduce anxiety. o) Checking the availability of crossed blood, if needed. p) Collaborating with the anaesthetist on the anaesthetic techniques that may be performed at the preoperative preparation (47). q) Activities registry and evaluation. r) In coordination with the anaesthetist, communicate the assistant staff the patient s transfer to the operating theatre. (47) At the preoperative preparation area just some anaesthetic techniques area performed: blocks for eye surgery, peripheral nerve block, etc. At the anaesthetic room adjacent to the operating theatre which some SS have, any type of anaesthetic procedure may be performed. In Spain, most anaesthetic techniques are habitually performed at the operating theatre. SURGICAL SUITE. STANDARDS AND RECOMMENDATIONS 71

76 s) In coordination with the anaesthetist, communicate the assistant staff and the reception unit the transfer of the patient: PACU, CCU. 2. Fulfilment of the specific elements of the area on the CR/SR which would reflect all the circumstances and controls that the patient has undergone Anaesthetic induction Anaesthesia will be performed according to the type of organization chosen (anaesthetic room, theatre room, etc.). The general trend is to perform induction at the theatre room being thus unnecessary to have an anaesthetic room available. The anaesthetist will be present, according to the protocol and to the specific risk characteristics: At all cases in which local anaesthesia is provided together with some sedation/analgesia, to point out or to apply the necessary medicines for such sedation being the only responsible for taking the essential cardiopulmonary resuscitation measures and to indicate the most appropriate monitoring measures. At endovenous, inhaled or mixed general anaesthetic, he/she will be in charged of performing the technical procedure. At procedures performed by means of nervous blockade, he/she will be in charged of performing the technical procedure. The anaesthetist would be in charge of fulfilling the registry of anaesthesia (48) (Annex 11), which will gather, among other information 82 : Type of procedure. Doctors involved on the surgery and anaesthetic procedure. Type of anaesthesia (local plus sedation, loco-regional or general) (49) Control devices of the air tract used (face mask, laryngeal mask, orotracheal intubation, double intubation, or other). Invasivity level and type of monitoring used (haemodynamic, of the respiratory rate, of the neuromuscular function, of the neurophysiological function or other). Channels for the administration of the induction drug (inhaled, intramuscular, endovenous) and the dose administered. (48) Anaesthesia chart or anaesthesia sheet. (49) There is not and accepted coding on the types of anaesthesia. It should be advisable to propose one which would allow the standardization of the anaesthetic procedures. It would be a proposal from the Spanish Society of Anaesthesiology and Resuscitation. 72 REPORTS, STUDIES AND RESEARCH

77 Channels for drug administration during the regression stage and doses administered. Incidences at the anaesthetic induction, maintenance and regression. Electrolytic and blood product fluids balance. Possible perianaesthetic complications which may require subsequent control. Final anaesthetic comment Surgery procedure. Operating room The surgeon will carry out the surgical protocol. The procedure will depend on the degree of invasivity and on the need of hospital care. Depending in the characteristics of the procedure, the necessary number of surgeons with the required qualification will take part in it. Surgery nurses will be previously informed of the procedure by means of the surgery report which should be available at least 24 hours prior to the procedure and will have the necessary specific qualification. Surgery nurse applies, develops and adapts the care plan to the patient, following the basic principles of hygiene, asepsis and sterilization, as well as all the safety principles inherent to the environment and to the surgery procedure. She will perform and document all the care activities by means of the systematic application of protocols and will assess the results. The nurse will write down the perioperative circumstances and the controls at the CR/SR. She will identify and handle intraoperative biological samples for later clinical analysis and would separate and process all material that may be reimplanted. There would be a register that would ease the information and control of important material that each patient may require during his/her procedure. The traceability of sterile material should be guaranteed. The scrub nurse, once the procedure has been completed, will check the totality of the surgery material that has been used and would control the processing of non disposable material, assuring its sterility and its traceability. Surgery nurse is responsible for counting the number of gauzes, sponges, etc End of the anaesthesia at the operating theatre The end of the anaesthetic procedures at the operating room and the exit of the patient will depend on the anaesthetist opinion who will command the regression or not of the general anaesthesia and the transfer of the patient to other postoperative unit according to the patient s situation and to the procedure performed. SURGICAL SUITE. STANDARDS AND RECOMMENDATIONS 73

78 The anaesthetist would write down all the information he/she may consider important at the anaesthesia record (annexes 11 and 12), as well as the type of anaesthesia and the technique used. The nurse will write down the circumstances of the regression on the CR/SR for the follow up Recovery. Post anaesthesia care unit (PACU) The anaesthetist of any patient that has undergone an anaesthetic procedure must have previously planned: a) Destination area after the procedure. b) Specific protocol for anaesthetic recovery. It is important that the patient should be transferred to a unit where he/she can get the appropriate care regarding his/her situation and the procedure he/she has undergone to avoid later transfers and to manage that longer stays in a unit do not imply preventing other patients from attending it or calling off surgery procedures. Transfer to the PACU should be done in decubitus position accompanied by the nurse and the anaesthetist. The later would provide the criteria for monitoring and the oxygen therapy to be followed. The clinical records will always be included at all transfers. The activities to be followed at the PACU are: 1. Assessment of the patient in accordance with the admittance protocol at the PACU (Annex 13). 2. Monitoring of the patient according to the monitoring protocol (Annex 13). 3. Care plan according to the protocols settled at the PACU (Annex 13). Actions will be taken depending on the clinical situation of the patient. 4. Review and writing up of the CR/SR Discharge from the SS The anaesthetist will command the patient s discharge when he/she may follow the criteria established at the PACU, considering too the characteristics of the centre (care level of the different units of the centre) (50). (50) From: Pajuelo A (Coord.). Bloque Quirúrgico. Proceso de Soporte. Department of Health Guidance criteria for discharge at the PACU: Aldrete score 9. Appropriate and enough ventilation (deep ventilation excursion with a frequency of >= 10 /min). Bilateral auscultation clear. 74 REPORTS, STUDIES AND RESEARCH

79 The appropriate medical care will be prescribed according to the procedure performed and to the patient s clinical condition. The discharge record will be handled to the surgeon and to the anaesthetist and the nursing record will be handled when discharged so that the appropriate follow up of the patient may be carried on until his/her surgery process is settled at the hospitalization ward. All the necessary information for the operating theatre registry and the MBDS will be gathered. The Guide of the Scottish Intercollegiate Guidelines Network (SIGN) 83 stratifies the care provided to patients discharged at the SS in different levels, depending if the patient that has undergone surgery is transferred to day hospitalization at a DHU 4, to a conventional hospitalization ward or to a critical care unit. Conventional hospitalization units and critical care units are not considered in this document on standards and recommendations and will be the object of a specific document in an immediate future. If the patient does not observe the criteria for the discharge and, if it were the case, the working hours of the PACU (51) are over, it should be considered the possibility of transferring the patient to a level III care (intensive) 84 unit. Intensive care units must have consensual admission and discharge protocols to prevent beds from being blocked. A system for booking beds for scheduled admissions should be foreseen though bed availability should be checked before starting scheduled surgery Surgery scheduling 79 Operating room scheduling is one of the most important aspects of SS management as it has important consequences over the hospital, the staff and the patients. The way the scheduling is done determines the operation of other areas of the hospitals: office workers in charge of appointing to Able to keep airway permeability. Awake and oriented. Vital signs stable similar to preoperative. Appropriate muscular tone. SpO2 > 95% (Except from lower previous figures). Appropriate pain control (51) PACU working times will adjust to the specific characteristics of the SS according to the number of patients, its opening hours and the type of care needs, avoiding that the PACU occupation may block the admittance and discharge of patients of the SS. As a general rule a patient must not stay at the PACU for more than 6 hours; if longer care is required it should be assessed whether if he/she requires a higher level of care III (intensive). SURGICAL SUITE. STANDARDS AND RECOMMENDATIONS 75

80 patients, admission services and services in charge of preparing patients for surgery, postoperative recovery units, catering services, etc. Among the main priorities that should be taken into account when setting the schedule should be patient s and staff s satisfaction, though always taking into account that the resources available should be efficiently used. An operating theatre for scheduled procedures should be used at morning and afternoon sessions to make profitable its expensive facilities, equipment and maintenance. To do so it is necessary that the surgery team as well as the staff and the hospital resources should be available. The review of the Audit Commission at NHS34 hospitals proved that there is a usage rate of 41 hours per operating theatre a week. A reasonable use rate aim for the scheduled operating theatres should be, at least, 10 hours every working day and 7 hours on Fridays which means 47 hours a week per theatre. Some hospitals that belong to the Spanish National Health Service already use this resource more intensively and thus, once the staff, resources and hospital services requirements are fulfilled and whenever there is enough demand, the scheduled weekly use of the operating room can be considerably higher. Several stages can be set apart on the scheduling. First, the surgeon prescribes surgery for the patient and settles the priority for the procedure (emerging, urgent, urgent deferred or scheduled) (52). Then surgery time has to be settled among the surgery services and surgeons. And last, it should be established the order in which the patients from an specific surgery session will be scheduled Scheduled surgery Operating theatre available time for scheduled surgery may be distributed on different ways among the surgery services: Open scheduling: time is booked on demand by surgery services. The only priority criteria is booking order regardless the service or the type of operating theatre required ( First come/first served ). It is an inefficient scheduling system from the surgeons point of view as, unless there are enough cases to schedule in advance, as a given surgery service or a given surgeon may have several cases throughout the day at different operating theatres with idle times among each. Moreover, surgery services that may (52) Emergency categories of the National Confidential Enquiry into Preoperative Deaths (NCPOD), 42 : 1. Emergency. Procedures must be performed within an hour. 2. Urgent. Procedures must be performed within 24 hours. 3. Scheduled. Procedures must be performed within 3 weeks. 4. Elective. Procedures are agreed between patients and surgical services. 76 REPORTS, STUDIES AND RESEARCH

81 schedule most of their procedures well in advance monopolize the best time line which may cause services whose main cases are urgent or semi-urgent have problems to schedule. Block scheduling: it lies on ascribing to a surgery service or to a surgeon a specific operating theatre time which allows dealing with cases as they appear. This system permits surgeon or service continuity on healthcaring procedures without idle times though it has the inconvenience that much time of the operating theatre availability may be lost if the allotted time blocks are not occupied with any activity. This type of scheduling generally brings up conflict on block and time distribution and length of the period. If block division is established for the first time on a centre which was previously arranged on an open scheduling basis, it must be based on analysing how different services or different surgeons use the operating room in the previous period and on the periodic review of the allotted times and of the time out of theatres 85. The most profitable way to ascribe times is to allot them to a surgery service of a specific speciality; therefore a highest usage rate of the operating theatre may be obtained. Then the surgery service may allot times among surgeons on an open basis or even, and more profitably, on a block basis. What is more, this type of scheduling is more appropriate for surgeons as it allows them to plan their surgery days and the days dedicated to other tasks. Moreover, it is the basis which permits a better use of operating theatres as changing times are smaller if the procedures (previous and following) are performed by the same surgeon or at least by the same team 86. It also prevents delays due to the fact that a surgeon cannot begin a procedure because he/she is still at another operating theatre. At the Spanish National Health Service this is the most common scheduling basis as all services have wait lists long enough to manage the allotted time. Combined scheduling: block scheduling has the disadvantage that as it has to be settled well in advance it is difficult to plan those cases of relative emergency that may require surgery within one or two days and those cases which involve the assistance of several teams. These problems may be avoided by booking a certain amount of time on an open schedule. Time on an open schedule may be previously settled or left unlocked from block scheduling. In this case, surgeons settle times within their blocks and the hours left free are available for the first person who needs them ( release time ). The amount of time that must be kept for open scheduling will depend on the release time of the block and on how profitable the release time may be. Once scheduling is settled the release time may be a source for conflict. It is advisable and feasible to have settled the schedule a week in SURGICAL SUITE. STANDARDS AND RECOMMENDATIONS 77

82 advance though it is habitually established 48 hours before surgery. From the surgeons point of view setting time lines should be as closer to surgery as possible. However, if the main objective is to reach a good optimization of the operating theatre, the sooner the release time is settled the more possibilities there are for a surgeon to occupy that time. If release time is too close to surgery there is a high risk that it may be left unoccupied; if it is too long it would be difficult to schedule semi-urgent surgery procedures. However, scheduling closing time does not have to be the same at all operating theatres and it can be closer to surgery on those operating theatres which service deals with urgent cases such as cardiac surgery or vascular surgery. Operating theatres are generally polyvalent and according to their characteristics and to the availability of human and technical resources its usage should not be separated attending to speciality reasons and thus the totality of the surgery services of the centre should be offered. Operating theatres are rented by the services to fulfil their activity promises and in this sense if there are any idle periods of time left setting an auction system is way of showing up the interest to improve the efficiency of a resource that is limited on its own. It is obvious that a good planning, compromise, being predisposed and goodwill are key aspects to make compatible service needs and the proper work of operating theatres. Once operating theatre times have been allotted, the surgeon or the surgery team will schedule their procedures. Scheduling on a specific day for a specific operating room must take into account the following circumstances: If the first scheduled case is the longest and the shortest ones are left for later, starting times for the shortest ones may vary substantially which implies that patients have to be admitted well in advance and they possibly would have to wait before being transferred to the operating room. As a result, the occupation rate of preoperative beds increases (53). Moreover, the postoperative care unit would have low occupancy rates at the early hours of the day and, by the end of the day, patients which require a higher level of care will mix up with those who do not require such specific attention. This scheduling reduces the number of extended cases as it would be easier to change the operating theatre allotted to shorter procedures if the first case of the day lasts more than expected; however, it is more difficult to foresee the starting time of the following cases (53) This could be avoided by admitting patients to the preoperative area on the same day as the procedure. This area may be integrated with the preoperative assessment area to ease the use by trained staff and to facilitate transfer to the operating theatre REPORTS, STUDIES AND RESEARCH

83 which may be an inconvenience for the surgeons who will take part on them if they are not the same that participated in the first procedures. If scheduling is open, the same specialities would nearly always be scheduled at the first hours of the day. On the other hand, this system of scheduling allows increasing the use of the operating theatres and avoiding cancelations due to lack of time or having to compensate economically the staff who works overtime to complete the surgical report but it implies allotting changes on the last cases of the day. The opposite system, scheduling first the shorter cases, allows a better use of the postoperative recovery beds avoiding low occupation periods at the first hours of the day. In any case, and whenever possible, children and diabetic patients should be scheduled at the early hours of the day to avoid long periods of fast due to lengthening of the procedures that come before. The development of autonomous 4 DSU allows scheduling of the most difficult cases on operating theatres devoted for conventional hospitalization. Foreseeing in the most accurate way the length of the surgery procedures is one of the most important facts of scheduling as it improves operating theatre utilization and may save money to the hospital. Calculation of the length of a procedure may be made by analysing the previous cases with the same diagnosis and procedure. Those cases in which the scheduled procedure was performed should be utterly differentiated as some scheduled cases for a specific procedure may experiment some complications and thus imply different procedures. It should also be taken into account that the more cases used for the estimation of the length of procedure the more precise the result would be and that there should not be used a lot of data as the first data collected may reach back to some time ago when other techniques or instruments were used. Nowadays, most healthcare centres have different information in the shape of uncollected data (ICD, DRG, ASA, surgery times, etc.) which can be intermingled, for example, with the clinical record. By crossing information any centre has the possibility to know the average times for most of its surgery procedures. In this sense, for the different specialities a reduced number of procedures means 80% of the speciality. Therefore centres have the appropriate information available to make a good management of its surgery scheduling. Introducing the calculation of the length of a procedure on the estimation of the surgeon from his/her average time in similar procedures and taking into account the complexity of a specific case, improves calculation87. If there is not software to review the allotment of resources in accordance with the scheduled surgery procedures, the operating theatre SURGICAL SUITE. STANDARDS AND RECOMMENDATIONS 79

84 coordinator should review all the circumstances that may interfere with the scheduling as radiodiagnosis material, endoscopy material accessibility, the availability of hospital beds, etc. Each centre must settle its own scheduling programme so as to adjust better to its circumstances Cancellations A cancellation is the procedure that appears on the definite surgery record and that it is not performed 88. Cancellations may be due to clinical and to non-clinical reasons. Lack of beds and, in the second place, the inappropriate preoperative preparation of the patient are the most common reasons for cancellations for procedures scheduled for conventional hospitalization surgery, according to Association of Anaesthetists of Great Britain and Ireland 36. This source, which collects information from the experience of the NHS, also points out that the most frequent reasons for DS cancellations are the fact that the patient does not show up, the lack of adequate preoperative preparation and the cancellations made by the patient (non-suitable appointment or unnecessary procedure). Cancellation rate may be reduced by using an appropriate preoperative protocol 21,43, in which the adequate information to the patient has a key role, scheduling on a realistic basis the use of the operating theatre times, considering urgent procedures, etc., developing a comprehensive management of the procedure, incorporating all the concerned parties and providing a preoperative preparation area for the admissions made on the same day as the procedure. If the procedure is cancelled it has to be re-programmed with the patient on a date that is most suitable for him/her Urgent procedures Setting apart operating theatres to perform urgent procedures will depend on the number of urgent procedures the centre deals with and on the characteristics of the procedures. Emergency surgery does not generally need immediate care at the operating theatre. The NCEPOD has issued a report that states that there is a higher risk of peri-operative deaths if patients have undergone night surgery (after 21:00) and recommends, when possible, to delay the procedure until the first 24 hours of the day (urgent procedure). The reports of the NCEPOD, backed up by the Department of Health of the United Kingdom, recommend devoting operating theatres to emergency surgery 89. The Royal College of Surgeons of England proposed (1997) that emergency surgery services 80 REPORTS, STUDIES AND RESEARCH

85 would be more centralized, reaching a higher scope of the population, and that an emergency reference service with operating room available 24 hours for emergency procedures should be accessible 90. In the working hours of operating theatres with scheduled surgery, booking an operating theatre and a nurse and anaesthesia team for urgent procedures would depend on the type and number of procedures that the hospital receives and the time it will take to have an operating room available if all are performing scheduled surgery Delays in emergency surgery The Association of Anaesthetists of Great Britain and Ireland points out some measures to reduce delays in emergency surgery and to prevent it from interfering with scheduled surgery 36 : 80% of emergency surgery procedures may be taken care of during a common working day provided that there are surgery sessions, staff and equipment specially allotted to this activity. Moreover, the association states that the benefits of scheduling emergency procedures during the morning and afternoon reduces staff requirements once the last shift has been completed and the need to call anaesthetists and surgeons on-call duty. Surgery sessions must be organized and equipped with staff anaesthetist and surgeons working on scheduled sessions and with the only duty to attend the operating theatre. Anaesthetists, surgeons and managers must establish the organization and management of emergency (54),91 admissions and procedures. To avoid setting waiting lists it might be necessary to call an adjudicator for the operating theatres who may settle priorities. Many patients who require immediate admission to the E&R may be scheduled for surgery for the following day. The less urgent cases may be discharged to their homes with written information to come back in the following day, maybe to a DSU, for a scheduled procedure. An action plan on the clinical record of the patient should be opened and the preoperative requirements started. Many scheduled trauma procedures to adults are called off due to inappropriate preparation. A preoperative evaluation of these (54) For example, work team constituted by The Royal College of Surgeons of England, The Royal College of Physicians, the Faculty of Accident and Emergency Medicine and the British Association for Emergency Medicine, together with the Department of Health s National Clinical Director for Emergency Access 91. SURGICAL SUITE. STANDARDS AND RECOMMENDATIONS 81

86 patients that would include the anaesthetist, the surgeons and the specialist could reduce this problem 41,92,(55). The information available on trauma surgery in elderly patients recommend that procedures should be performed within the first hours and that they should not be delayed for non-clinical reasons 92, SS management structure. Organization requirements 79 The SS is an intermediate management unit which provides services (surgery procedures) to the final services, mainly surgery specialities 29. According to the needs derived from the care procedure at the SS, the following organization is recommended Medical coordinator of the SS. Nursing supervisor of the SS. Operating theatre committee Medical coordinator of the SS The role of the medical coordinator of the SS (56) implies managing and planning. He/she must be a reference and an adjudicator to the other professionals that work at the SS (anaesthetist, surgeons, nurses, auxiliaries, technicians, etc) and a link between them and the directors of the centre. Regardless his/her origin (anaesthetist, surgeon, etc) he/she must intercede on an equity basis in all conflicts that may arise among the different working groups of the operating theatres and who may have opposed interests being the safeguard of the patients interests his/her main objective. The main task of a coordinator is to provide an organization where professionals offer efficiently their best. To do so it is necessary to have a clear vision of the organization and of job allotment. A coordinator must have command of management, ability to listen and to value work as well as the capacity to encourage teamwork. If the SS is considered as a management unit, the director of the SS (57) must have authority and responsibility over the budget, and an adequate (55) A habitual problem is hip fracture at people under anticoagulant agents. The Scottish Intercollegiate Guidelines Network recommends performing surgery within the first 24 hours, on day time, including weekends 92. (56) At autonomous DSU it is recommended a DSU coordinator independent from the SS medical coordinator 4. (57) The term director is used to denote the executive role of the post at a SS understood as a management unit. Functions have been adopted from the Association of Anaesthetists of 82 REPORTS, STUDIES AND RESEARCH

87 remuneration. The director will be in charge of its management and will have the appropriate IT systems and administrative support available. The medical coordinator of the SS must be part of the operating theatre committee being, generally, its president. As such, he/she must encourage the committee to deal with those matters that are really important for the work at the operating room and must take care that all the decisions that are adopted by the committee are put into practice. The medical coordinator of the SS must be concerned with the performance of the operating theatres as a whole and not with the specific worries of a group or of a specific surgery speciality Nursing supervisor of the SS The nursing supervisor of the SS is generally the operative responsible of the SS. This does not only imply supervising the nursing, auxiliary and technician staff that work at the operating theatres, it means having the executive capacity to assign and distribute the scheduled procedures at the convenient theatres. It is a job of key importance for the functioning of the SS and implies being in charge of the operational management of the SS. The person in charge must have broad experience in surgery, conversation and bargaining power, fit for team work and have management abilities. He/she is generally a member of the operating room committee providing information about human and equipment resources, operations, deficiencies and possible working conflicts Operating theatre committee The operating theatre committee must be responsible for the strategic organization, monitoring and efficiency management of operating theatres (58). It is a plural arrangement, that is to say, apart from the people responsible for the planning and the functional characteristics (coordinator and supervisor) there should also be a person responsible for the patient s admission and a representative of each of the surgery specialities. The committee may and must adapt to the different realities taking into account the size of the centre and its organization model. The committee must make clear its objectives both regarding its activities and its technical and perceived quality. In those cases in which Great Britain and Ireland 36. The Director of the SS should be part of the Board of Directors of the centre. (58) Taken from the Modernization Agency of the NHS (Step Guide to Improving Operating Theatre Performance. NHS Modernisation Agency. June 2002), which may be adapted to the Spanish Health Service, especially to hospitals of the Spanish National Health Service 33. SURGICAL SUITE. STANDARDS AND RECOMMENDATIONS 83

88 institutions work on a objective based payment policy, objectives must respond to this reality being allotted collectively and individually. Meetings should be settled on a weekly basis to schedule procedures well in advance, to optimize time, to study incidences and to set up policies and actions for continuous improvement. All the participation mechanisms that may add value to everyday work, regardless the level of responsibility within the SS, should be added. The operating theatre committee is responsible for the agreement, implementation and update of the planning, monitoring and management policies of the SS. The Modernization Agency recommends putting into practice the following standards for the SS (59) : Standards for making up surgery reports: Procedures to make up the surgery reports. Procedures to relay surgery reports to operating theatres and wards. Deadline to receive the surgery reports at the operating theatres and wards. Procedures to inform pertinent people of any change on the surgery report. Scheduling of the beginning and end of the surgery session. Standards for the cancellation and the reallocation of surgery sessions: Procedure for the reallocation of sessions. Designation of the person in charge (i.e.: operating room coordinator) of reallocating the called off sessions. Designation of the person in charge of distributing information about the called off sessions. Standards for the control of emergency and urgent trauma surgery (according to the NECPOD (60) classification; annex 18), including a specific protocol for emergency procedures after 21:00, including a protocol for procedures NCEPOD 1 after 21:00. Standards for elective surgery (NECPOD 3; annex 18) Organization and operation manual The SS should have an organization and operation manual including: (59) Section relating to standards when authorization or absence has been omitted from reference. (60) NCEPOD: National Confidential Enquiry into Peri-Operative Deaths. 84 REPORTS, STUDIES AND RESEARCH

89 a) Organizational chart of the unit. b) Service portfolio. c) Details of the physical layout of the unit and its structural resources and equipment. d) Regulations and operation manual: The manual must have an implementation spatial limit (area), must state the staff to which it is addressed and the timeline in which it should be put into practice. It will define patients, staff and equipment circulation flows according to the design of the SS in which it is put into practice. Rules according to staff and patient safety (radiological protection, infection protection, environmental pollution in the operating theatre, electrical safety, catastrophes, etc.) should be part of the manual. The manual should be open and subject to review and update, incorporating any changes made in the service portfolio or, when required, any structural and functional changes. A. Organizational chart Director or medical coordinator of the SS. Nursing supervisor of the SS. Operating theatre committee. Responsibilities, hierarchies, tasks and competences of each of the SS staff members should be clearly defined. B. Service portfolio The service portfolio of the SS will include all the surgery procedures and all the anaesthetic techniques offered. C. Physical layout of the unit. The organization and operation manual should include: The physical layout of the SS and its relationship with other areas of the hospital. The structural resources available at the SS and the equipment available. The different areas of the SS and the patient, staff, supplies and waste circuits. D. Regulations manual The SS must have a regulations manual adapted to their organizational requisites that orderly describes each stage of the care process, the necessary protocols, the point of introduction on the circuit and the reporting chains in each action of the healthcare process. SURGICAL SUITE. STANDARDS AND RECOMMENDATIONS 85

90 Below are provided the structural and organization requisites and the protocols that take part on the care process following the patient flow scheme described in section 5.5.1: Table 5.1. SS healthcare regulations. Part of the process Access Reception Preoperative area Action Patient reception at hospital. Go with patient and relatives to the SS / Transfer from hospitalization Ward / Transfer from E&R. Reception at the SS. Patient identification. CR/SR opening. Patient evaluation. Fulfilling CR/SR. Structural requisites Reception area. General waiting area (comfortable and separate from hospitalization area). Office for information to relatives. Computers. Computer net. Common CR. Direct phone. Intercom with on duty staff. At the SS, within the non restricted area for open circulation. Toilet and changing room. Lockers for personal belongings. Protocols Admission Clinical record. Assessment and preoperative preparation protocols followed. Surgery scheduling. Operating room arrangement. Patient identification protocol. Global preanaesthesia evaluation (Anaesthesia registry). Specific preparation protocol (when needed) Technical anaesthesia protocol (when needed). CR/SR. Staff Porter. Administrative assistant. Nursing staff. Anaesthetist. Surgeon. Administrative assistant. Nursing staff. Nurse. Anaesthetist. Surgeon. Porter. 86 REPORTS, STUDIES AND RESEARCH

91 Part of the process Action Structural requisites Protocols Staff Operating theatre Anaesthesia. Protocols for specific surgery procedures. Operating room. CR/SR. Anaesthesia registry. Anaesthesia procedures protocols. Patient safety procedure (anaesthesia equipment check up, operating theatre communication, etc.) Surgery procedures. Nurse. Auxiliary nurse. Surgeon/s. Anaesthetist. Other specialist doctors or technicians (i.e.: radiology technician). Postanaesthesia recovery Admission. Patient evaluation. Discharge, operating theatre data registry and MBDS. At the SS, within the unrestricted area for general circulation. PACU admission protocol. CR/SR. Anaesthesia registry. Monitoring protocol. Care plan. Aldrete score Þ Discharge to hospitalization ward or to CCU. Anaesthetist. Nurse. Porter. TO: conventional hospitalization / CCU 5.8. Patient management Admission Admission will be part of the general admission procedures of the centre. However, activities and functions related to it should be, ideally, performed by the administrative support units of the SS. All aspects relating to the clinical records, discharge report and data protection belong to the general hospital the SS is related to. SURGICAL SUITE. STANDARDS AND RECOMMENDATIONS 87

92 Documentation and clinical record. Clinical documentation refers to the documents resultant from the care process, regardless their format or medium. Clinical documentation will be handled by the admission and clinical documentation unit or equivalent. Handling will involve creation, safekeeping, lending, copying, follow-up and processing of any clinical document. Clinical documentation must be kept so as to ensure correct and safe conditions for an appropriate period of time, and at least for five years from the date of completion of the corresponding care process Clinical records Each patient must have and individual clinical record which would be shared between medical staff, healthcare centres and healthcare units. Moreover, it should respond to the technical compatibility requirements established by each regional health authority. Clinical records may be in paper, digital, electronic or telematic format; they must guarantee complete access to all information at all times. As far as the design, minimum content, requisites, guarantees and uses of clinical records are concerned, the provisions of the Act 41/2002 (November 14th) on Autonomía del Paciente y de Derechos y Obligaciones en Materia de Información de Documentación Clínica (Patient Autonomy Rights and Obligations regarding Clinical Documentation and Information) shall apply. Each healthcare centre must have a unique clinical record register which will centralize all the data of the activities conducted at the centre. This register will be managed in accordance with a protocol that guarantees that the information can be traced and located, and that it includes written criteria on document filing, safekeeping and access Circulating record/surgery record (CR/SR) The CR/SR is a characteristic document of the SS. It may be in paper or in digital format and it designed to cover all the surgery process from the arrival of the patient to the SS to the end of it is at the PACU, even though some other criteria more restrictive or more broadening may be established and regardless more specific documents of the different surgery services. The CR/SR settles those key stages that guarantee quality on the surgery procedure and on each situation as they have to be signed by the person in charge. In different and clearly defined areas the following information appears neatly and organized: 88 REPORTS, STUDIES AND RESEARCH

93 Administrative information. Diagnosis Procedures scheduled. Scheduled date for the procedure. Level of anaesthesia. Type of anaesthesia. Known allergies. Habitual medication (especially anticoagulants, etc.). Transfusion prevision. Specific surgical instruments available. Fast reminder before the procedure. Marking of the affected member. Gauze count. Criteria for discharge. The CR/SR should be written out taking into account all the elements that take part on the surgery procedure: outpatient consultation, hospitalization, E&R, SS and patient management. Thus it is the result of a careful consideration process of doctors, nurses and administrative and management staff who take part on those areas aiming to settle a process, to avoid mistakes and to provide safety, taking into account quality sentinel tags. It is an instrument that aims that all parts have a whole view of the process. An exhaustive character of the CR/SR should be avoided (introducing information less relevant that is already included in other systems) as the main objective may be diverted: little information, time and stage arranged and related to the procedure. Annex 14 includes a sample of a CR/SR Discharge report Upon completion of the care process or transfer to another healthcare centre, patients are entitled to receive the medical discharge report contemplated in the Ley reguladora de la autonomía del paciente y de derechos y obligaciones en materia de información y documentación clínica (61) (Act on Patient Autonomy Rights and Obligations regarding Clinical Documentation and Information). (61) Single transitory provision. Discharge report. El informe de alta se regirá por lo dispuesto en la Orden del Ministerio de Sanidad, de 6 de septiembre de 1984, mientras no se desarrolle legalmente lo dispuesto en el artículo 20 de esta ley. (Discharge reports shall be governed by the provisions of the Ministerial Order of the Ministry of Health of September 6th 1984, until the provisions of article 20 of the present law are developed. SURGICAL SUITE. STANDARDS AND RECOMMENDATIONS 89

94 Health data protection Obligations and rights Personal data related to patient health are classified as special protected data in contemplation of the Organic Law 15/1999, December 13th on Protección de Datos de Carácter Personal, LOPD (Persona Data Protection). Healthcare centres shall take all the organization, procedural and technical measures necessary to guarantee the safety, confidentiality and integrity of all data regarding patient health and to facilitate the exercise of the right to access, rectification and cancellation of such information File manager Centres and institutions shall ensure that all files, automated or not, are kept safely and in good condition. All healthcare centres shall designate a file manager to be in charge of files, appointment which will be notified to the corresponding authorities. The file manager as well as those involved at any point with the processing of patient data shall comply with the professional secrecy rule Data confidentiality All patients are entitled to confidentiality about their health state according to the provisions of the Ley Reguladora de la Autonomía del Paciente y de Derechos y Obligaciones en Materia de Información y Documentación Clínica (Act on Patient Autonomy Rights and Obligations regarding Clinical Documentation and Information) Data transfer Any transfer of patient data needs the express content of the people involved with the exemptions contained in the health and data protection legislation IT system IT system will be part of the hospital general IT system and it should meet the SS requirements: Patient management: Type of insurance. Appointment. Admission. 90 REPORTS, STUDIES AND RESEARCH

95 Discharge and codification. Clinical record management. Clinical workstation: Electronic patient record. Operating theatre management. Department applications (laboratory, image diagnosis...). Economic and administrative general services management (62) : Storeroom (supply agreements, inventory management, purchase orders, etc.). Pharmacy (Electronic prescription system; unit-doses; conciliation system). Accounting. Sterilization. HR management (short-term disabilities, incidents, leaves, substitutions, etc.). Assessment (management): Costs per procedure (cost accounting). Satisfaction surveys. Activity indicators. Quality indicators (chapter 10). Performance indicators Procedural times 79 One of the main problems found when analysing operating room working information relies on the fact that professionals who work in them do not accept the results as they do not agree with the way in which the data has been gathered or analyzed. In that respect, a pragmatic point of view would be recommended: a reduced number of relevant data gathered automatically will be more useful than a lot of information obtained manually or from making a huge effort to get a lot of information by means of an IT system specifically designed. It may be more difficult if data from two different centres are to be merged, as if it has not been previously agreed upon, the same name may be used for two different things. To avoid these problems, the American Association of Anaesthesia Clinical Directors has made up a glossary 94 so as to have a common taxonomy available for data collection. Proposed (63) definitions may be used for time data collection of diagnostic and therapeutic (62) Economic and administrative management will be centralized, though some administrative procedures will be carried out at the SS. (63) The aim of this list is not gathering all the information but having the appropriate vocabulary available. SURGICAL SUITE. STANDARDS AND RECOMMENDATIONS 91

96 procedures and allows unifying programming, usage and efficiency analysis criteria. This glossary has been approved by the ASA (American Association of Anaesthetists), the ACS (American College of Surgeons) and the AORN (Association of Operating Room Nurses).This glossary is aimed at United States healthcare institutions and thus may not adjust to other centres that respond to a different healthcare pattern; in any case, each institution must select the data it records according to its characteristics and needs. It is recommended that a work team from the Spanish National Health System will write down the definitions for those data which, as the procedural times, may allow evaluation and comparison among healthcare centres which belong to the National Health System Performance information 79 To manage a good operating theatre performance it is important that the first case of the day starts on due time, that time between cases would be as short as possible, that the cancellation rate would be low, that scheduling mistakes would be scarce and that scheduling would be well adjusted. To do so, it should be registered the delays on schedule and the reasons why, surgery cancellations and its reasons and the alterations on the foreseen length of the procedure and the real one. These data should be summed up and presented in such a way that it may be interpreted, to extract conclusion from them and to allow activity follow up from those interested. Information registry must be performed in such a way that its analysis might detect the moments when maladjustments or delays take place: as a lengthy Room gap due to inappropriately trained or inadequate cleaning staff, to bad schedule planning which may imply a transfer or having to prepare a great amount of equipment between procedures or a inadequate admission planning or operating room patient transfer. Objectives for all the staff should be specifically settled as for surgery performance standards (start time, operating theatre use, overrun hours), there should be determined the means that are going to be put into practice to get them, review their fulfilment periodically, analyze mistakes if they have not be attained, establish new measures, modify objectives if previous where unattainable or if circumstances have changed. The objective of these analyses is not showing up those who have not reached the aims but developing a training system in which those who managed to reach them may expose the way they did it and those who did not, may let know the measures they are going to take or the possibilities they consider appropriate. As in other continuous improvement programs, strategies must be proactive and never punitive. Moreover, it is more important to reach moderate objectives than taking the risk of, after having settled unattainable objectives, part 92 REPORTS, STUDIES AND RESEARCH

97 of the team may want give up the whole process for not being able to get it. What is more, it should be taken into account that an extra pressure to improve efficiency standards may take to non safety practices towards the patient. On the analysis of the operating room utilization, the two standards most frequently used are the percent utilization and the raw utilization (see annex 19). Percent utilization: can be calculated either globally or a time a speciality utilizes it. In this case: (Effective block time + Average operating theatre turnover time of the speciality on each analyzed date) / Allotted surgery hours to the speciality x100. It may be over 100% if operating theatre time has extended. Raw utilization: can be calculated on a global or on a speciality basis. For the global calculation: ( Procedural time / Available hours of the operating theatre) x100 For the service calculation: ( Procedural time / Operating theatre hours allotted to a speciality) x100 The preparation and clean up time of the operating theatre is not taken into account and thus the higher the number of procedures performed the lower the usage rate would be as operating theatres turnovers will increase. Performance standards used by the Audit Commission 34 are the following: Cancelled scheduled lists. Cancelled operations. Utilisation of scheduled theatre hours. Review of list starting and finishing times. Number of patients operated on compared with planned numbers. Incidence of out of hours operating. Theatre incident (adverse events) rates and patterns. It is very important that when these standards are used all the people involved know exactly their meaning and to understand that when the information is completed with data obtained from the intuitive interpretation of the information mistakes may appear; a high rate of utilization may be due to a scheduling that includes more cases than those which can be performed on the allotted times and this brings out: a) out of hours work at the theatre and b) cancellations of some operations as they cannot be performed in the scheduled time. There is not a universal agreement on the ideal level of operating theatre utilization. References propose a range of 75% to 90%. The Audit SURGICAL SUITE. STANDARDS AND RECOMMENDATIONS 93

98 Commission 34 on the review of the Operating theatres of the British National Health Services found out the following performances and proposed the following aims: Table 5.2. Proposal objectives of the British National Health Service. Type of procedure Theatre raw utilization National rate Aim Scheduled 65,6-80,8 77% Trauma 58,9-86,4 77% Emergency 38,4-62,7 60% Source: Operating Theatres. Review of national findings. Audit Commission Procedural times definition. Annex 18. Terms and definitions glossary. The main aspects that must be taken into account to settle the utilization objectives of the centre are the type of scheduling and the basis for staff reward. On an open scheduling it is difficult to get utilization rates as high as on the block scheduling. On combined scheduling high utilization rates would possibly imply a low proportion of open scheduling possibilities which would cause troubles when having to schedule semi-urgent procedures. This is important as having difficulties to schedule procedures which even though they are not urgent have to be performed in a short period of time may lengthen patient stays and thus increase costs and have possible clinical aftermaths. 94 REPORTS, STUDIES AND RESEARCH

99 6. Physical structure and material resources This chapter deals with the criteria and recommendations related to the structural and functional conditions of the general SS, equipment and facilities. Annexes 15 and 16 provide information in direct relation with this chapter: resource sizing (annex 15) and a sample of a functional design programme for a surgical suite with twelve operating theatres (annex 16) 6.1. Functional design programme Each surgical suite must define its functional programme and its organizational structure. The functional programme would take into account the following criteria: Demographic analysis of the surrounding area (with special reference to the patient source area and patient selection criteria) or a market research study in the case of private organizations. Study of a theoretical demand of surgery procedures (scheduled with previous hospitalization and urgent) according to the volume of procedures included in this kind of healthcare and the surgery attendance rates. It should be taken into account the unit s market penetration capacity once it is fully operational. Analysis of the production capacity in different scenarios: working hours, performances, procedural times for different services and different types of procedures. Study of the SS staff and equipment requirement depending on the demand, on the estimated activity and on service portfolio of the centre. Definition of the number of operating theatres, units at the PACU as well as the unit main premises based of previous analysis. Development of the functional requirements of each area of the unit as well as the development of the premises with the necessary equipment to perform any scheduled activity. The functional programme would be adapted to the specific characteristics of each healthcare organization. To settle the functional programme it will be necessary to analyze the different activities and functions performed by the different users of the unit: patients, surgeons, SURGICAL SUITE. STANDARDS AND RECOMMENDATIONS 95

100 anaesthetist, nursing service, preventive medicine, maintenance staff, cleaning staff, etc. The functional programme will include the type of relation and how it is arranged between the SS and the other hospital healthcaring units. The unit will describe its working operations based on the regulations manual and on the protocols for prevention of nosocomial infections at the unit; it will have patient, staff, relatives and supplies circulation schemes. This can be launched by means of an area and premises graphic diagram (64) providing the relation among them and the connexions and circulation of the different users at the hospital: patient, staff, supplies and materials used. This graphic scheme of circulations and relations among the different areas and premises of the unit is previous to the design programme necessary on a later stage of the design of the unit. Setting up a general circulation scheme inside the unit is really important. The unit will carry a viability study including the budget essential for infrastructure, equipment, staff and maintenance and the economic and healthcare impact of the unit s activities on the healthcare organization on which it depends Structural aspects of the general SS unit Changes and trends on surgery In the last years, surgery has gone through some changes derived from the application of technological innovations which have taken procedures which were previously performed at operating theatres to treatment and medical investigation units at day hospital units. Breakthroughs at IT and communication systems are also allowing the introduction of robots at theatres as well as the possibility of performing teaching out of them. An important aspect in the changes of surgery activity is derived from the demographic variations as the average age of the patient who undergoes procedures has risen, which implies new situations concerning his/her safety. Surgery frequentation rates have risen in Spain substantially for the past two decades with the consequent impact in the necessary resources which have also been affected by the progressive development of Day Surgery which still is to develop. These changes on the request and on the (64) Interesting to recall here the innovative performance of the block diagrams of surgical developed by architect Paul Nelson in collaboration with the surgical staff during the period between the great wars of the twentieth century 96 REPORTS, STUDIES AND RESEARCH

101 apparition of new types of healthcare make clear some of the relevant changes that have taken place on the configuration of the model of current hospitals. Processes of functional programming and design of SS units must take into account these trends and changes on the request of surgery activity taking the necessary precautionary measures on aspects relating to functional design programme which may allow the introduction of new technologic improvements SS resource sizing and effects on the design programme. Annex 15 of this document on standards and recommendations provides an example of the resource sizing criteria for a SS unit. For the resource sizing, the following factors should be considered: Surgery frequentation (procedures per 1000 people a year), different procedural varieties: scheduled with hospitalization, scheduled at DS and urgent. Performance of surgery activity according to theatres depending on hospital and unit organization, service schedule and type of the procedure performed. In this respect, the evolution of the hospital and of similar ones will serve to settle activity and performance objectives. Calculations regarding the number of operating theatres must be made taking into account that the total number of procedures trends will grow as a result of technologic improvements and clinical advances (anaesthesia, prostheses, etc.) and which allow performing higher number of procedures in elderly people as well as responding to a higher demand. Moreover, technological and clinical advances allow greater numbers of non-invasive acts (haemodynamic procedures, interventionist radiology, laparoscopy, endoscopies, arthroscopic surgery, etc). What is more, advances in anaesthesia permit faster and better patient recovery and so the global increase in the number of procedures will refer mainly to DS. Different resource sizing criteria will take into account the average operating theatre time according to services and type of procedure, and the performance of the operating theatre depending on the time line and the type of healthcare provided: scheduled surgery with hospitalization, urgent surgery or Day Surgery. According to the hospital service portfolio, there would be operating theatres for transplants, paediatric surgery and other SURGICAL SUITE. STANDARDS AND RECOMMENDATIONS 97

102 reference services so that their activity does not affect the operation of scheduled surgery, which has the highest volume of activity. For the resource sizing at the PACU, it is considered that there should be beds for each operating room considering that at the PACU there are not postoperative CCU functions performed and thus patients stay at this area of the suite should not be, generally, over 6 hours. Final resource sizing of the suite must take into account, apart from the variables previously pointed out, factors related with the criteria of the physical organization of the unit and the minimum and maximum gathering that may be considered appropriate for the efficient working of the total amount of the resources of the unit. Two operating theatres together on each ward in single block hospitals devised to make a direct connection with surgery hospitalization unit is obsolete; general SSs must have at least four operating theatres. In the same way, resource sizing must consider current gathering and design criteria according to the estimated number of operating theatres. In this sense, the trend is to create cluster or group designs, mainly when the number of operating theatres makes it difficult for a linear design Location of the unit within the hospital and spatial relations with other units. This unit is considered as a central and internal unit of the hospital. The general SS should be nearby and with the specific communication systems to allow internal communication of the hospital with the critical care unit or units (preferably if they are at the same level), E&R, hospitalization units, pathologic anatomy services and clinical analysis services (by means of pneumatic tube), sterilization and supplies and when needed with other units (neurophysiology, teaching ) whose relation may settled by means of IT systems. The location of each SS in relation with the global design of the hospital is directly related with the functional characteristics of the surgery activity (introduction of the DSU on the general suite or existence of and autonomous DSU) as well as with the functional programme of the other healthcaring units of the hospital. 98 REPORTS, STUDIES AND RESEARCH

103 Relation of the internal circulation at the surgical suite and its ventilation in the control of nosocomial infections. Surgical suite design has been based on the need to have a clean circulation and a dirty circulation, relying on a theoretical basis which from a long time ago 32 has been proved beyond all scientific evidence. Most surgery infections are caused by the patient s own microbiota (on the skin or in other polluted organs such as the intestinal tract). In these cases, the air quality of the operating theatre is secondary. However, equipment sterilization and avoiding air pollution are needs of modern surgery procedures even in intestinal procedures. In the section concerning patient s safety of this document on standards and recommendations there are described the variables that affect the development of nosocomial infections and the measures that have to be settled to reduce them to a greater extent. Circulation separation does not reduce the risk of infection and it is generally based on management reasons, on simplifying staff discipline, on distributing the unit interior circulation according to fire protection (65) measures, or on habit. Single corridor circulation design for the different traffic routes of the unit (patients, staff, sterile material and dirty instrument) is a proved solution with high levels of satisfaction among users. It does not encourage mistakes or ambiguous working situations, even though it requires training and discipline from the unit staff required in any other design. Air at the theatre may have microorganisms, dust, aerosol, squamous epithelium cells, microscopic drops from respiration. The microbial load of the theatre air is on a direct proportion to the number of people who have gone through it 95. Research has proved lower infection rates caused by coagulase negative staphylococcus when there was a limited number of people going through the theatre while the procedure 96, and thus it is recommended that the traffic should be as limited as possible, even though the importance of the existence of bacteria by the surgery site on the development of the nosocomial infection has not been completely proved 97. Optimal ventilation, humidity (<68%) and temperature conditions are required for staff comfort but also to avoid environmental conditions which may enable growth and transmission of microorganisms 98. Operating theatres should be kept at positive pressure in relation to the corridors and the adjacent areas 99. The usage of laminar flow air has been suggested as an accessory means to reduce the risk of nosocomial infection; however its efficiency 100,101, has not been proved, nor the usage of ultraviolet light (66). (65) In Spain, Technical Building Code (Código Técnico de la Edificación), DB-SI. (66) Taylor GD, Bannister GC, Leeming JP. Wound disinfection with ultraviolet radiation. J Hosp Infect 1995;30: SURGICAL SUITE. STANDARDS AND RECOMMENDATIONS 99

104 In patients suffering from active tuberculosis scheduled procedures must be called off until they have followed an appropriate drug treatment. If they require urgent procedures, taking additional specific air tract transmitted infection control is recommended Physical structure of the surgical suite: unit areas and premises General SS requires a series of structural and equipment resources which are directly related with the characteristics of the scheduled surgery activity. It is important to point out that apart from the criteria explained in this document on standards and recommendations, the functional programme and the resource sizing criteria of the unit must adapt to each specific reality and particularly depend on the decisions that the managers have adopted in relation to the units, the human resources and on the definition of the operating processes and protocols, together with the specific conditions of each situation. The structure of a SS obeys to the main functions that are performed on it and has the following areas: 1) Admittance and reception area. 2) Logistics area. 3) Preoperative preparation area. 4) Operative area. 5) Post-operative area. 6) Anaesthesia and surgery staff area. Below there is a description of the main functions and characteristics of each of the areas that belong to a general SS according to the design concerns indicated above. Annex 16 provides a functional design programme for a SS with 12 operating theatres. 1) Admittance and reception areas 1.a. Entrance, admission and patient transfer Access to the general SS must be made through a hospital internal circulation corridor (patients in bed, staff and supplies) which has to be well communicated mainly with the CCU, E&R and the hospitalization units. It should be desirable that the suite would have a unique access so that the different circulation flows could be controlled within the unit. Unique access allows controlling safety inside the unit. There are several criteria that recommend transfering the patient in bed to the operating table and thus it should be defined in each case the 100 REPORTS, STUDIES AND RESEARCH

105 transfer protocol that has to be applied to each patient. In practice, many of the mechanisms implemented for patient transfer in this area, which acts as a barrier between the entrance and the corridor that joins the surgery area, have never been used. This fact should be discussed with the staff before introducing this transfer system. The sizing of the admission area is related to the predicted circulation flows (patients in bed, staff towards changing room, supplies), to the sizing of the SS, to the transportation system and to the possibilities of making patient transfers from their beds to the suite. There should be enough space to accommodate the beds once the patient is transferred to the operation area. The SS should be located on the upper floor of the hospital, on a floor allotted to treatment and diagnosis so that the facilities, mainly those air treatment terminal units which have a specific place and are directly connected to the operating theatres and to the other areas of the suite, to undergo maintenance procedures without interfering with the unit activity in an well-equipped area for carrying out this activity. It is also advisable that the SS would be located in the same floor as the critical care unit(s). 1.b. Reception and control From the reception desk, there would be a good visual control of the entrance and of the circulation flows of the area. Figure 6.1. Admission to the SS and control desk. SURGICAL SUITE. STANDARDS AND RECOMMENDATIONS 101

106 1.c. Control office It is necessary to have an office for the organization of the unit internal activity, for controlling patients circulation and for setting communication with other hospital units (pathologic anatomy laboratory, pharmacy, sterilization, etc). It will have a pneumatic tube terminal; it would be well communicated with the unit reception and with the circulation flow associated to the operating theatre entrance. However, this office may be located at the control or alarm desk of the SS. 1.d. Information office An information office is required to provide information in the appropriate private and environmental conditions to relatives and/or escorts of the patient. The office should be part of the suite and be close to the waiting areas or to family and escorts resting rooms. Figure 6.2. Relatives information office. 1.e. Common waiting room Common waiting room for relatives and escorts located outside of the SS in an area closed to the entrance and to the information office and to the PACU. 102 REPORTS, STUDIES AND RESEARCH

107 The sizing of the waiting room will depend on the foreseen surgery activity and on the socio-cultural characteristics of the population. Under normal circumstances there should be 1.5 comfortable chairs (waiting times may be lengthy) for each patient that might be treated at the unit. Environmental conditions of the waiting rooms must take into account the anxiety and distress situations that people who are at it may undergo. The room will also have adapted toilets for relatives and/or escorts. The room will be provided with phone connections and with vending machines with cold food and drinks and a cold water fountain. Taking into account the size of vending machines, it is advisable that they should be placed apart so that their installation does not interfere with the operation and capacity of the room. Figure 6.3. Common waiting room. 1.f. Patient changing rooms Toilets and changing rooms for patients with scheduled procedures that are admitted into the Surgical Suite from outside the hospital and thus are not previously admitted into a hospitalization unit. There will be separate changing rooms for men and women and will have the sufficient space for lockers where patients may leave their clothes and personal belongings. There will be basins, toilets (one for every 10 patients) and showers. The following table brings in the main functions and characteristics of the premises of the preoperative area. SURGICAL SUITE. STANDARDS AND RECOMMENDATIONS 103

108 Table 6.1. Structural characteristics of the preoperative area. Area Purpose Structural characteristics Entrance, admission and patient transfer Reception and control Reception Staff control office Information office Common waiting room Patient changing room Unique entrance to the unit. Patient transfer to the Operative Area. Control desk. Patients attention during the admission process. Unit control. Relation and communications with other units. Unit alarm desk. Information to relatives and/or escorts. Waiting and resting area for patients and relatives. Patient preparation for procedure at the operative area. Appropriate signposting. Size adapted to circulation flow needs (patients in beds, staff and supplies) and with enough place for storing beds once the patient has been transferred. Patient and staff circulation towards changing rooms must be clearly seen from the unit admission control desk. Reception will have a good visual control from the entrance and the circulation flows of the area. Computer and telephone connections. Adequate equipment: office and computer equipment, telephone, answering machine, fax, etc. Storage and specific document filing space. Office for the organization of the internal activity of the unit, for controlling patients transfers and setting relations with other hospital units (pathologic anatomy laboratory, pharmacy, sterilization ). Pneumatic tube. In constant communication with the unit admission and with the circulation flow system related to access to operating theatres. Control desk and SS alarm desk. For informing relatives. Computer and telephone connections. Comfortable (lengthy waits possible). 1.5 comfortable chair for each patient in any of the premises of the unit. Adapted toilets. Telephone, television / video (optional) Drinks/food vending machine and cold water fountain. Patient preparation. Admission filters to clean areas for patients. Airlocks from the outside area of the suite to the inside circulation flow. Area with toilet, basin and shower. Sizing according to surgery activity and to admission service organization. 104 REPORTS, STUDIES AND RESEARCH

109 2) Logistics area 2.a. Staff changing rooms and toilets Premises for surgery staff to prepare, with access from the main entrance of the SS. Changing rooms will have a preparation area prior to the entrance to the operation area. It will be designed to work as a lock from the outside of the suite in relation with the internal staff circulation. It will also have a hygiene previous area with basin, toilet and shower. Each of the premises holds people and it is better to have several premises for this objective so that it may adapt to the changing conditions of the activity within the unit and to any possible staff changes. Figure 6.4. Changing rooms, toilets and staff preparation. 2.b. Cleaning staff changing rooms. It is advisable to have specific changing rooms for the staff in charge of the basic cleaning tasks. It will work as an airlock from the outside of the suite in relation with the internal staff circulation. It will also have a hygiene previous area with basin, toilet and shower. SURGICAL SUITE. STANDARDS AND RECOMMENDATIONS 105

110 2.c. Resting room Common and resting room that includes an area for the staff who works at the unit to eat. 2.d. Sterile supplies store room Figure 6.5. Staff resting room. For sterile supplies, surgery equipment, prostheses and disposable material. With positive pressure and air conditioning system with absolute filters. Number, size and location are settled according to the layout of the operating theatres within the unit and the surgery procedures scheduled. Sterile supplies store rooms must be close to the operating theatres. The sizing of these premises is also in relation with the supplies distribution management, frequency and store room control. An efficient supplies control does not only reduce costs but also improves supplies safety and quality. Figure 6.6. Sterile supplies store room. 106 REPORTS, STUDIES AND RESEARCH

111 2.e. Sterilization sub-unit Supplies sterilization at the SS is made outside the suite, at the sterilization unit. The sterilization unit is usually distant from the SS and it can even be a unit placed outside the hospital. Thus it is advisable to have a small sub-unit for urgent equipment sterilization. The room must be equipped with the necessary installations for the unit operation: cover for the sterilizer (autoclave), power point, compressed air inlets and pressure water inlets. The sterilization sub-unit may be associated to a sterile supplies store room and connected to the arrival of sterile material from the central sterilization unit. Figure 6.7. Sterilization sub-unit. 2.f. Supplies store room Room for storing supplies from the pharmacy and disposable material. Number and size of the store rooms are settled according to the total sizing of the SS, the layout of the operating theatres within the unit and the surgery procedures scheduled. SURGICAL SUITE. STANDARDS AND RECOMMENDATIONS 107

112 Figure 6.8. Supplies store room. 2.g. Anaesthesia supplies room Area for storing the SS anaesthesia supplies. In direct relation with the area or areas for patient preparation and PACU. Its size and number will depend on the size, design and activity of the SS. 2.h. Equipment store room Room for storing portable radiodiagnosis equipment and image intensifiers, surgical laser, ventilator, portable lamps, etc. With power points for equipment check up. The functional design programme of these premises allows circulations free of obstacles and appropriate maintenance and cleaning in an appropriate room. Its number, layout and size are related with the scheduled surgery activity, with the sizing and design of the suite and with the type of service procedures. Figure 6.9. Portable equipment store room. Figure Defibrillator. 108 REPORTS, STUDIES AND RESEARCH

113 2.i. Cleaning equipment room Room for storing cleaning equipment and products. With water intake and waste disposal unit. Its number and location will depend on the dimension of the SS and the procedures scheduled in the unit. As stated in section 6.5. cleaning is an important factor for infection prevention at the unit and thus this function must have the necessary utility room for the proper development of this activity. Cleaning staff are some of the unit s users whose work is not generally recognized with the sufficient premises. Figure Cleaning equipment room. 2.j. Dirty utility room Room for storing dirty linen and waste material carried by means of carts or containers distributed by the waste management unit. It must have a water intake and enough room for making an advanced waste classification. The room must be related with the circulation that connects the exit of dirty material from the operating theatre and the transfer (and/or exit of the SS) towards the sterilization unit and the hospital central waste unit, generally located in a floor where other general hospital services are placed. The number and sizing of the store room for dirty linen and waste depends on the surgery activity within the unit and on the frequency with which the carts are disposed. Waste has to be perfectly identifiable and clearly classified in special containers according to the waste treatment procedure that they will afterwards undergo. SURGICAL SUITE. STANDARDS AND RECOMMENDATIONS 109

114 Figure Dirty utiliy room and waste management. 2.k. Work room Room for surgeons and anaesthetists for writing reports of the procedures. It must have computer and telematic facilities. Size and number of office for professional staff at the SS is directly related with the scheduled activity of the suite. 2.l. Unit manager office Office for the person in charge of the management and appropriate organization of the SS. With computer and telephonic connections. 2.m. Reading room Office for analyzing images obtained at radiological operating theatres. It must have computer and telephonic connections. 2.n. Technological room Room that accommodates the electric equipment, including the switchboard, the isolation boards and the Uninterruptible Power Supply (UPS) in an specific area which had been planned on the initial stages of the sizing of the 110 REPORTS, STUDIES AND RESEARCH

115 SS. This room needs high volume ventilation or air conditioning due to the heat that the equipment gives off. Its size, number and place depend on the sizing of the unit and on the layout of the operating theatres. Figure Technical room with electric safety equipment. The following table describes the functions and characteristics of the main premises of the logistics area. Table 6.2. Characteristics of the logistics area. Area Purpose Characteristics Staff changing rooms and toilets Cleaning staff changing rooms Staff preparation for surgery at the operative area. Cleaning staff preparation. Surgery staff preparation. Access filters to the clean area for surgery staff. Airlock design from the outside of the suite in relation with the internal circulation on staff within it. Hygiene previous area with basin, toilet and shower. Sizing according to the surgery activity and the type of staff. Airlock design from the outside of the suite in relation with the internal circulation on staff within it. Hygiene previous area with basin, toilet and shower. Access filters to the clean area for auxiliary and cleaning staff. SURGICAL SUITE. STANDARDS AND RECOMMENDATIONS 111

116 Table 6.2. Characteristics of the logistics area. Resting room Area Purpose Characteristics Sterile supplies store room Staff rest and relaxation. Sterile supplies storing for scheduled procedures. It includes an equipped area with facilities and equipment for office work and breaks. Sizing and number of rooms will depend on the sizing and scheduled activities of the unit. For sterile supplies, surgery equipment, prostheses, disposable material. With positive pressure and air conditioning with absolute filters. Sterilization subunit Supplies store room Anaesthesia supplies room Equipment store room Cleaning equipment room Dirty utility room Work room For urgent sterilization. Pharmacy and disposable supplies store room. Anaesthesia supplies store room. Portable equipment store room. Cleaning equipment and supplies store room. Dirty linen and waste store room. Reports of surgery procedures. Equipment sterilization is made out of the unit. There would be a small sub-unit for urgent equipment sterilization. With the necessary installations for the unit operation. Cover for the sterilizer. Power points and water inlets. Compressed air inlets. Pressure water inlets. Pharmacy and disposable supplies. Anaesthesia supplies. Room for storing portable radiodiagnosis equipment and image intensifiers, surgical laser, ventilator, portable lamps, etc. With power points for equipment check up. For cleaning supplies and products. With water inlet. Related with the circulation that connects the dirty disposal of operating theatres. Dirty linen and waste store room. Water inlet. Includes enough room for advance waste classification. Surgeons and anaesthetist procedures report writing. With computer and telematic connections. 112 REPORTS, STUDIES AND RESEARCH

117 Area Purpose Characteristics Unit manager office Reading room Technological room Organization and adequate management of the SS. Radiological image reading. Safety electric appliances. With computer and telephone connections. For radiologic operating theatres. With computer and telephone connections. UPS and electric appliances (isolation boards). 3) Preoperative preparation area 3.a. Pre-operative preparation ward Common ward or ward distributed on the basis of the design and the organization of the SS where patient reception protocol is performed. In this area staff confirm the procedure to be performed, check that the patient has fulfilled pre-operative instructions, the anaesthesia assessment is carried out together with the specific preparation (venoclysis, etc.). In those patients that do not come from previous hospitalization units, access from the changing rooms must follow transfer and circulation requirements. 4) Operative area 4.a. Surgery team preparation: hand washing Room related to the operating theatre for disinfection and for putting on masks. It will be by the operating theatre and it will be away from the general SS patient circulation. There will be at least two water inlets for each operating theatre, with non hand operation surgical taps, antiseptics dispensers, automatic hand dryers and a clock. At university hospitals this area will be wider as surgery teams are bigger. This area may be shared by two operating theatres. From the hand washing area, it would be possible to see the operating theatre in order to allow staff to control activity at the theatre. It will have shelves with the equipment (caps, mask) and dispensers as well as a paper covers collection system. SURGICAL SUITE. STANDARDS AND RECOMMENDATIONS 113

118 Figure Area for staff preparation: hand washing. 4.b. Operating theatre Room where the surgery procedure is performed and in which the different circulation flows meet (patient, staff, sterile supplies and waste). The main unit premises would be set out according to the related circulations (changing rooms, waste circulation, and PACU). The minimum service surface of each operating theatre is 40m2, with a minimum free height (floor - false ceiling) of 3 metres and with measurements that would allow to make a 6 metre diameter circle around the operating table. Walls and ceiling will be made of hard, nonporous, waterproof, washable and fire-resistant materials; they would not have cracks, and they would be continuous and without gloss. There will be neither rails nor elements which could gather dirt and wall elements will be built-in. The floor will be antielectrostatic, conductive and earth wired. The operating theatre would have an entrance (airtight automatic sliding doors) from the staff preparation area communicated with the staff circulation flow (changing rooms), patient circulation flow (PACU) and another one, when needed, for the waste disposal of the theatre. Technical characteristics of the facilities are dealt with at chapter 7. There would be preferably used swivel articulated arms for anaesthesia and surgery. Hooks for lamps and other equipment, by means of plates forged on the top placed (recommended) on the rectangle corners associated to the surgery table. Computer and telephonic connections. 114 REPORTS, STUDIES AND RESEARCH

119 Figure Operating theatre: switchboard. Figure Operating equipment arrangement (1). Figure Operating theatre: equipment arrangement (2). Figure Operating theatre: equipment arrangement (3). SURGICAL SUITE. STANDARDS AND RECOMMENDATIONS 115

120 Figure Operating theatre: equipment arrangement. Figure Operating equipment arrangement. Figure Operating theatre: equipment arrangement. 116 REPORTS, STUDIES AND RESEARCH

121 Figure Operating theatre: equipment arrangement. Figure Operating theatre: equipment arrangement. SURGICAL SUITE. STANDARDS AND RECOMMENDATIONS 117

122 Figure Operating theatre: equipment arrangement. Figure Operating theatre entrance corridor. Figure Operating theatre entrance corridor. 118 REPORTS, STUDIES AND RESEARCH

123 Figure Surgical suite roof. The following table introduces the main functions and characteristics of the premises of the operative area. Table 6.3. Operative area structural characteristics. Area Purpose Structural characteristics Surgery team preparation: hand washing Surgery team preparation. Disinfection and hand washing. By the operating theatre and separated from the general SS patient circulation flow. There will be at least two water inlets for each operating theatre, with non hand operation surgical taps, antiseptics dispensers, automatic hand dryers and a clock. This area may be shared by two operating theatres. From the hand washing area, it would be possible to see the operating theatre in order to allow staff to control activity at the theatre. It will have shelves with the equipment (caps, mask) and dispensers as well as a paper covers collection system. SURGICAL SUITE. STANDARDS AND RECOMMENDATIONS 119

124 Area Purpose Structural characteristics Operating theatre Room where the surgery procedure is performed. The minimum service surface of each operating theatre is 40m2, with a minimum free height (floor - false ceiling) of 3 metres and with measures that would allow to make a 6 metre diameter circle around the operating table. Walls and ceiling will be made of hard, nonporous, waterproof, washable and fire-resistant materials; they would not have cracks, and they would be continuous and without gloss. There will be neither rails nor elements which could gather dirt and wall elements will be built-in. The operating theatre would have an entrance (airtight automatic sliding doors) from the staff preparation area communicated with the staff circulation flow (changing rooms), patient circulation flow (PACU) and another one, when needed, for the waste disposal of the theatre. Technical characteristics of the facilities are dealt with in the appropriate chapter of this document. There would be preferably used swivel articulated arms for anaesthesia and surgery. Hooks for lamps and other equipment, by means of plates forged on the top placed (recommended) on the rectangle corners associated to the surgery table. Computer and telephonic connections. 5) Postoperative area 5.a. Post-Anaesthesia Care Unit (PACU) Ward with cubicles for each operating theatre. Each cubicle will have 12 m 2 service surface. The PACU does not work as a post-operative CCU. Space in this ward will be open and with natural light. 120 REPORTS, STUDIES AND RESEARCH

125 Figure Post Anaesthesia Care Unit - PACU. Figure Post Anaesthesia Care Unit - PACU. 5.b. Nurse control Situated in a central position within the area. It must allow direct observation of all cublicles in the common ward. The nurse control must have a patient/nurse communication device by means of an acoustic and light system. Pneumatic tube terminal for sample transfer. Safety and fire protection system control, gas alarm board. Computer and telephonic connections. Figure PACU nurse control and utility rooms. SURGICAL SUITE. STANDARDS AND RECOMMENDATIONS 121

126 Figure PACU nurse control and utility rooms. Figure PACU nurse control and utility rooms. 5.c. Common store room PACU linen storage in carts as well as other disposable material. 5.d. Clean utility room Room directly related with the nurse control for drug preparation. 122 REPORTS, STUDIES AND RESEARCH

127 5.e. Dirty utility room Room for storing dirty linen and waste for their transport in carts or containers distributed for waste management. It must have a water inlet and enough room for advanced waste classification. Waste produced in this area must be properly identifiable and clearly classified in special containers according to the procedure to be followed after treatment. 5.f. Equipment store room Room for storing portable equipment used for resuscitation / awakening (ventilators, CPR, etc). With power points for equipment check up. The functional design programme of these premises allows circulations free of obstacles and appropriate maintenance and cleanness in an adequate room. 5.g. Cleaning equipment store room Room for storing cleaning equipment and products. With water intake and waste disposal unit. As stated on section 6.5. cleaning is an important factor for infection prevention at the unit and thus this function must have the necessary utility room for the proper development of this activity. Cleaning staff are some of the unit s users whose work is not generally recognized with the sufficient premises. The following table introduces the main functions and characteristics of the premises of the post-operative area. Table 6.4. Structural characteristics of the post-operative area. Pacu Area Purpose Structural characteristics Vital signs recovery. Surgeon or anaesthetist assessment. There would be cubicles of 12 m 2 each per working operating theatre. The PACU will not function as a post-operative CCU. With a nurse control and its utility rooms. SURGICAL SUITE. STANDARDS AND RECOMMENDATIONS 123

128 Nurse control Area Purpose Structural characteristics Post - operative care. In a central place of the area. It must allow direct observation of all the beds in the common ward. Patient / nurse communication by means of an acoustic and light system. Pneumatic tube installation for sample transfer. Safety and fire protection system control, gas alarm board. Computer and telephonic connections. Common store room Linen store room. Linen carts store room. Clean utility room Drug preparation. Drug storing and preparation. Dirty utility room Equipment store room Cleaning equipment store room PACU waste store room. Resuscitation portable equipment store room. Cleaning supplies and equipment store room. Dirty utility and waste classification unit. Waste disposal system. Room for storing portable equipment used for resuscitation / awakening (ventilators, CPR, etc). With power points for equipment check up. For cleaning supplies and equipment. With water inlet. 6) Anaesthesia, surgery and nurse staff area This area, which includes the working area (management, clinical sessions, teaching and training) for the SS staff is placed outside the suite but it should be nearby. 6.a. Staff offices Rooms for staff management and work distributed according to the management structure of the unit. With computer and telematic connections. There should be an office for the coordinator of the operating theatre. 124 REPORTS, STUDIES AND RESEARCH

129 6.b. Meeting room Multi-purpose room provided with computer and telematic equipment for the surgery team to work. It will have enough room for clinical sessions, for teaching and training and will have the necessary equipment for telemedicine (videoconference, image connection with the operating theatres, etc.). The number of multi-purpose premises and their size is directly related with the size of the unit and the training and teaching characteristics of the hospital. Figure Multi-purpose meeting room. 6.c. Secretary s office Office for the unit administrative work. It will be provided with computer and telematic connections. 6.d. Resting room Common and resting room that includes an area for the staff who works at the unit to eat. 6.e. Staff toilets and changing rooms Premises allocated for toilets and changing rooms for the surgery team and situated outside the unit but near it. Its sizing is related with the sizing and characteristics of the surgery activity and with the active protocols, for example those related to the use of clothes (white, green) when entering a specific area of the unit. SURGICAL SUITE. STANDARDS AND RECOMMENDATIONS 125

130 The following table provides the main functions and characteristics of the premises allotted to the anaesthesia, surgery and nurse staff area. Table 6.5. Structural characteristics of the anaesthesia, surgery and nurse staff area. Area Purpose Structural characteristics Staff offices Surgery team work. Unit staff management and work. With computer and telematic connections. Meeting rooms Multi-purpose meeting room for surgery team. Multi purpose room with computer and telematic equipment. With enough room for clinical sessions and for teaching and training. Secretary s office Administrative tasks. Unit administrative work. Resting room Staff toilets and changing rooms Staff common and resting room. Staff toilets and changing rooms. Includes area for staff to eat. Staff changing rooms and toilets placed outside the SS. The functional design programme, with an account of the areas and premises of a general SS (an exact example for a 12 operating theatres in ass is included in annex 16) will include: Table 6.6. Structural characteristics of the anaesthesia, surgery and nurse staff area. Area Premises n.º Admittance and reception area 1. Entrance, admission and patient transfer. 2. Reception and control. 3. Control office. 4. Information office. 5. Common waiting room. 6. Public toilet. 7. Adapted toilet. 8. Patient changing rooms. Floor surface (m 2 ) Total m REPORTS, STUDIES AND RESEARCH

131 Logistics area Area Premises n.º 1. Staff changing rooms and toilets. 2. Cleaning staff changing rooms. 3. Resting room. 4. Sterile supplies store room. 5. Sterilization sub-unit. 6. Supplies store room. 7. Anaesthesia supplies room. 8. Equipment store room. 9. Cleaning equipment room. 10. Dirty utility room. 11. Work room. 12. Unit manager office. 13. Reading room. 14. Technological room. Floor surface (m 2 ) Total m 2 Pre-operative area Operative area Post-operative area Anaesthesia and surgery staff area 15. Patient preparation. 16. Surgery team preparation: hand washing. 17. Operating theatre. 18. PACU. 19. Nurse control. 20. Common store room. 21. Clean utility room. 22. Dirty utility room. 23. Equipment store room. 24. Cleaning equipment store room. 25. Operating theatre coordinator office. 26. Staff offices. 27. Meeting rooms. 28. Secretary s office. 29. Resting room. 30. Staff toilets and changing rooms Equipment and facilities Facilities requirements of a general SS are included in chapter 7. Annex 15 of this document on Standards and Recommendations describes the resource sizing criteria and annex 16 the functional programme, including the premises, the characteristics of the facilities and the equipment for a general SS with twelve operating theatres. The criteria and recommendations included in both annexes can help when planning the equipment for a general SS as the one included in chapter 17. SURGICAL SUITE. STANDARDS AND RECOMMENDATIONS 127

132 6.3. Medical supplies. Sterilization All healthcare centres should exercise strict control over the storage and distribution of medical supplies and equipment, with special attention to expiry dates. Healthcare centres must have safe areas for the correct storage of medical supplies and equipment, with the appropriate capacity in accordance with its needs and which may allow its classification and control. Healthcare centres must ensure that sterile equipment is used correctly. Single-use supplies should be disposed of after each use and must not, under any circumstances, be re-used. Sterile equipment packaging must always indicate that the date on which the equipment was sterilized and the use-by date. Whenever necessary, staff and patients will be equipped with the appropriate personal protection Cleaning protocols Cleaning of the operating theatre is a key factor to minimize and prevent nosocomial infections both in the unit, patient-staff infection, and in other areas outside the suite. Cleaning is essential for the operation of a theatre and, in general, of a SS. For its appropriate performance the unit must have the adequate physical and material resources (specific clothing, store room, utility room) and the required times for its right execution should be considered in the work schedule of the SS. Cleaning staff of this unit will have the appropriate training so that their tasks are efficiently and tidily carried out. Equipment and covering material finish characteristics, together with the structural solutions of the premises of the unit, should allow high standing cleaning results. As it has been stated before, there are clinical and environmental variables that affect the safety at the SS. Among the environmental factors, apart from air quality and premises air conditioning, are: 1. Operating theatre cleanness. 2. Medical supplies cleanness. 3. Linen cleanness. Below are provided the recommended criteria for each of the outnumbered factors Operating theatre cleanness 102 The operating theatre has to be one of the cleanest areas or even the cleanest of all the premises in a healthcare centre, being the SS considered as an area with a very high risk. 128 REPORTS, STUDIES AND RESEARCH

133 The Centres for Disease Control (CDC) recommend a comprehensive cleaning of the operating theatre every 24 hours, even if the theatre has not been used. This cleaning may help to reduce the microorganisms and the risk of antibiotic resistant bacteria contamination which may also help to control the scope of patient infection. This comprehensive cleaning must be done in the operating theatres, hand washing areas and the utility rooms that have a connection with th e theatres. The following theatre equipment should be cleaned: Surgery lamps. Furniture. Medical supplies. Door handles. Ventilation grille. Horizontal surfaces. Complete floor surface. Hand basin. There should be a list for each operating theatre of the elements that have to be completely cleaned so that a specific cleaning pattern for this premise is settled Medical supplies cleaning Surgery equipment and supplies (endoscopes, bronchoscopes, etc) if they are not appropriately cleaned may transfer infections patient to patient or patient to staff or staff to patient. Healthcare centres must put into practice policies and procedures as these below: Specify clearly the equipment and the supplies that have to be cleaned up /disinfected / sterilized and those that are disposable. Specify when those equipments and supplies have to be cleaned. Specify how frequently they have to be cleaned. Specify how they have to be cleaned. Medical supplies should be cleaned up (cleaned, disinfected, sterilized...) before and after being used with a patient and whenever they are passed from one unit to another one. There are four types of cleaning which may remove dirt and pathogens from medical supplies: Cleaning. It removes visible dust, residues and any other visible material in which microorganisms may live and grow. Hot water and detergent cleaning is generally enough for this kind of cleaning. SURGICAL SUITE. STANDARDS AND RECOMMENDATIONS 129

134 Decontamination. It eliminates the organisms that bring up diseases and makes using the equipment safe. Disinfection. It destroys most of the organisms that bring up diseases except for the sporulated forms. There are three levels of disinfection: a) High. It destroys all the organisms but for the bacterial spores. b) Medium. It destroys most of the bacteria and the viruses except for the Mycobacteria. c) Low. It destroys some viruses and bacteria. Sterilization. It destroys all types of microbacterian life including bacteria, virus, spore and fungi. There are several techniques as the ethylene oxide, ozone, steam, plasma, etc Linen cleaning Operating theatres bring up a great demand of linen cleaning and treatment. Centres must separate appropriately dirty linen from the clean one and specify which of the linen is disposable at the SS. To destroy pathogens dirty clothes should be washed for at least 25 minutes at 60ºC in a bleach solution. When dirty linen and supplies are stored, they should be kept at least 15 centimetres from the floor even if they are in a closed plastic bag. It is assumed that all healthcare centres keep ideal cleaning and hygiene conditions in all its healthcare premises, facilities, equipment, supplies and instruments. There would be a cleaning protocol that would respond to specific situations and whose drawing up will be part of the quality control system of the preventive care service. Moreover, there should be a protocol for the cleaning, disinfection and, when needed, sterilization of non disposable medical equipment, supplies and instruments Waste management Healthcare centres are obliged to identify and classify hospital waste assuring that is properly removed and disposed of103. To comply with this obligation they must have a protocol for the identification, classification and handling of hospital waste that obeys current legislation and which should be acknowledged and followed by the staff of the general SS. 130 REPORTS, STUDIES AND RESEARCH

135 7. Systems (67) In the same way as in other buildings, in a hospital, a group of systems provide the environmental conditions, the energy and the necessary fluids to perform the activities the building was designed for. However, for carrying out the healthcare practice, hospitals need specific systems, as medical gases, that are not generally used in other places. Healthcare activity implies that systems are designed obeying to specific requirements: patient s safety, infection control, supplies safety conditions, etc. Moreover, at areas of critical hospital areas, in which the SS is located, the working demands of the system are at its highest level. At the SS system must, mostly, work continuously, without any interruptions and with 100% work guarantees as any malfunction may bring up safety and health risks for patients and workers. Therefore, special emphasis on the design, execution, practice and maintenance of the systems should be placed. As far as design is concerned, it is important to have a person in charge who will channel all the needs, uses and requirements of each space, mainly in the operating theatre areas, by means of a comprehensive description of the minimum basic elements to be installed, uses of each operating theatre and space so as to, according to this information, establish the design of the different systems. This chapter reviews the most important aspects, including regulations, of the complex SS systems: electric supply system, air-conditioning, mechanical systems, operation systems and system maintenance Electricity Regulations Regulations that must be complied with Reglamento Electrotécnico para Baja Tensión, REBT (Electrotechnical Regulations for Low Voltage) (RD 842/2002, August, 2nd); mainly the following technical regulations: (67) Written by Francisco López Cano, Intallations engineer, in collaboration with Ángel Sánchez, José Quian, Isabel Pacheco, Jaume Cera and Marc Blasco. Grupo JG. SURGICAL SUITE. STANDARDS AND RECOMMENDATIONS 131

136 ITC-BT-28. Instalaciones en locales de pública concurrencia (Systems in premises with public concurrence). ITC-BT-38. Requisitos particulares para la instalación eléctrica en quirófanos y salas de intervención (Specific requirements for the electric supply system at operating theatres and procedure rooms). UNE standard Instalaciones eléctricas en los edificios. Reglas para las instalaciones y emplazamientos especiales. Locales de uso médico (Electric supply system for buildings. Regulations for the installations and special locations. Medical premises). Código Técnico de la Edificación, CTE (Technical building code) (RD 314/2006, de 17 de Marzo). Section SU4 Seguridad frente al riesgo causado por iluminación inadecuada (Safety protection against inadequate lighting). Section HE 3 Eficiencia energética de las instalaciones de iluminación (Energetic efficiency of the lighting system). UNE-EN : Iluminación de los lugares de trabajo. Parte I: Lugares de trabajo en interiores (Lighting of working premises. Part I: Working indoors) Functions of the electric supply system Introduction Healthcare infrastructure has, in general, specific determining factors for the electric system and in areas such as the surgical suite the requirements are higher. This is due to the demands of the activities performed and to the critic condition of the patients. The electric supply system must contribute to guarantee at the SS the following: General lighting. Emergency/stand by lighting. Electric supply. Personal safety. Within the SS there are especially sensible areas, the operating theatres and the procedure rooms. The concept of procedure room needs a more detailed explanation as it would be mentioned in further sections Operating theatre The Reglamento Electrotécnico para Baja Tensión, REBT (Electrotechnical Regulations for Low Voltage) points out at instruction ITC-BT-38 the specific 132 REPORTS, STUDIES AND RESEARCH

137 requirement for the electric system of operating theatres and procedure rooms though it does not define at any time what may be understood as procedure room. Theses Regulations establish the connection to the metal masses of the invasive receptors to a common equipotentiality sealing. It also settles that they should be fed by means of separator transformers. It provides a definition for invasive receptors. An electrically invasive receptor is the receptor that from an electric point of view enters a body either through a body hole or through the surface of the body. That is to say, those products which due to their endocavitary use may bring up some risk of micro-shock to the patient, as electric scalpels, cardiovascular radiology equipment, some types of monitors. Invasive receptors should be connected to the power supply system by means of an isolation transformer. Moreover, the instruction ITC-BT-38 is binding on the use of isolation transformers at operating theatres and procedure rooms on the equipment in which an interruption of the power supply may imply some type of risk, direct or indirect, for the patient, the staff and in order to limit any current leakage that may occur. The standard UNE casts some light on the term procedure room. The standard classifies medical premises in three groups: group 0, group 1 and group 2. Within type 1 there are included those medical premises in which there may be used pieces of electro-medicine equipment connected to the general supply power system. Pieces applied on the outside Pieces applied to body fluids but not directly to the heart. Within group 2 there are included those medical premises in which there may be used pieces of electro-medicine equipment connected to the general supply power system applied to or at the heart in intracardiac procedures. In these premises it is used an IT system (an isolated neutral point with an isolation transformer). The standard shows that the classification of premises is related to the type of contact between a piece and the patient. The classification should be made in accordance with the medical corps or with the organization responsible for the healthcare. The standard also provides premises classification tables as examples, without intending to make a comprehensive study. From all these it could be derived that premises named within groups 1 and 2 of the standard should be considered as procedure room at the Reglamento Electrotécnico para Baja Tensión, REBT (Electrotechnical Regulations for Low Voltage). It would be used the definition of group SURGICAL SUITE. STANDARDS AND RECOMMENDATIONS 133

138 rooms 1 and 2 and of invasive receptor to consider a premise as a procedure room. According to the standard, group premises 2 are the operating theatres and the preoperative areas and group premises 1 are the anaesthesia room and the post operative recovery rooms General lighting The lighting system at the SS should be designed according to the Código Técnico de la Edificación, CTE (Technical building code). There are two sections that deal with different aspects of lighting: Sección SU4: seguridad frente al riesgo de iluminación inadecuado (Safety protection against inadequate lighting). Sección HE3: eficiencia energética en instalaciones de iluminación (Energetic efficiency of the lighting system). The main objective of section SU4 is to reduce to acceptable limits the risks of suffering immediate damage during the foreseen usage of the buildings and settles the minimum values of the lighting levels. It only deals with safety aspects. Section HE3 establishes the facilities calculation parameters and criteria so that the lighting may be efficient from an energetic point of view and appropriate to the needs according to the premises and to the task to be performed. An energetic efficiency index is defined and the need of turning on lighting on an area based system and the control and regulation of lighting according to natural light. It refers to standard UNE for other parameters. The index that measures energetic efficiency is the value of energy efficiency of the installation. It determines the need of electric power supply for a reference figure of 1 m² and 100 lux. The higher the index the highest the electric consumption and thus the least efficient the system would be. There are maximum acceptable levels of the value of energy efficiency settled according to the area, classifying it into two different groups: Group 1: non-representation areas. Technical criteria are put before design, image or state of mind criteria. Group 2: representation areas. Design, image or state of mind criteria that are to be shown to the user are put before energetic efficiency criteria. An example of diagnosis rooms included in room 1 would be examination cabinets. There would be excluded from the above mentioned classification procedure rooms, operating theatres and those rooms that can be considered as special. 134 REPORTS, STUDIES AND RESEARCH

139 Common areas, as corridors, could be introduced either is type 1 or 2. The clean corridor and the post operative recovery area could be included within type 2 in an attempt to improve the positive and relaxed state of mind of the patient. However, the dirty corridor could be included in group 1 according to strictly functional criteria. The standard UNE classifies the different inside areas and settles the lighting requirements for each of them including the minimum values for the following parameters: Maintained illuminance (Em) expressed in lux. In areas where different tasks could be performed, it would be appropriate if the system could be adjustable to convey flexibility. Unified Glare Index (UGI). Excessive glare causes visual stress and makes working conditions of healthcare staff difficult. Colour Rendering Index (CRI). Colour reproduction in the most accurate way is a key condition at operating theatres and theatres and at preoperative and post operative rooms where are minimum values of 90 over 100. Moreover, it is considered the relation between the lighting in the area where the task is performed and the surrounding area to avoid fatigue due to excessive contrast and in order to ease accommodation. Operating theatres require from to lux at the surgery area and 500 lux lighting in the surrounding areas. The standard includes a specific table for healthcare centres (table 5.7.); table 5.1. should be considered for those areas which are not included in table 5.7., traffic areas and common areas within the buildings. Recommendations: Increase lighting levels of ambient lighting at operating theatres on lux so as to reduce the difference with the surgery lamp. Low lighting levels at laparoscopic surgery operating theatres Adjustable lighting. It makes premises flexible. Adjustable reactance is recommended with minimum regulations values settled around 1%, as DALI reactance. Establish in the project the lamp colour performance and guarantee that it is carried out. Ra 90. Usage of electronic reactance. They prevent flickering and improve energetic efficiency. Establish in the project the glaring and efficiency index of the luminaire and guarantee that it is carried out. Limited Unified Glare Rating 19. Installation of sterile luminaires with high Protection Index (PI) in aseptic areas. Common values are PI 54 or PI 65. SURGICAL SUITE. STANDARDS AND RECOMMENDATIONS 135

140 Trends: Lighting points to efficient and long life light sources. Nowadays, LED technology is improving its lighting fulfilment and it is belief that in a close future it will substitute current lights in some uses within the healthcare field Emergency lighting In case of failure of the general lighting there should be an emergency lighting foreseen. Characteristics of the emergency lighting: Automatic switch on within a maximum of 0.5 s. Types of emergency lighting: Safety lighting: Evacuation lighting: it allows identifying and using the evacuation ways or routes. Open air or anti-panic lighting: it prevents panic as it identifies access to the evacuation routes and points out obstacles. High-risk areas lighting: it allows a safe interruption of any potentially dangerous task or of any task that is performed at a dangerous environment. Substitution lighting: lighting which allows keeping on with usual activities. Safety lighting range: 1 hour in general areas. 2 hours in hospitalization areas. Substitution lighting at procedure rooms and at those rooms appointed for intensive care, minor procedure rooms, delivery rooms and emergency rooms: 2 hour range Illuminance level is the same as general lighting. A solution widely employed at safety lighting is the use of autonomous units; thus the same equipment could be used for different types of safety lighting as evacuation and anti-panic, for example. 136 REPORTS, STUDIES AND RESEARCH

141 Recommendations: 2 hour range of the safety lighting in the SS. Use of Uninterrupted Power Supply Systems (UPS) to guarantee substitution lighting. Cable and wire network should be fire resistant as in this case the luminaries would perform safety services (ITC- BT-28). Use of a surgery lamp with a 2 hour range battery and an independent transformer Supply guarantee Introduction Taking into account the constant use of electromedical equipment in life support systems, it is of key importance the guarantee of electric supply. The supply system of the SS has to be conceived within the healthcare centre from which it depends. A hospital with a properly designed system from the point of view of the electric supply is basic so that it may be guaranteed at the SS. According to the Electrotechnical Regulations for Low Voltage healthcare centres are centres of public concurrence and as such they must obey certain supply safety regulations and, what is more, operating theatres and procedure rooms have to obey additional rules. There can be distinguished: Supply guarantee for public concurrence premises. Supply guarantee for operating theatres and procedure rooms Supply guarantee for public concurrence premises According to the Reglamento Electrotécnico para Baja Tensión, REBT (Electrotechnical Regulations for Low Voltage), instruction ITC-BT-28, healthcare centres are centres considered as public concurrence premises. As such they must guarantee electric supply to safety services should the habitual supply system fail. To fulfil so they must have an additional supply system, complementary to the habitual system. According to the percentage of complementary supply in relation to the habitual supply, it could be settled, as a general rate: Emergency supply: 15% of average power. Reserve supply: 25% of average power. SURGICAL SUITE. STANDARDS AND RECOMMENDATIONS 137

142 Those systems that may have a complementary supply system are: Taps isolated from the supply circuit, independent from the common power supply system. Generators. Accumulator batteries. It is important to take into account that in those cases in which there is a unique supply for the emergency services, it could not be used as a replacement supply, that is to say, to feed equipment that is not safety equipment. This is an important aspect when establishing the number of generators. Common solutions: Double connection made by the power supply company. Generators Supply guarantee for operating theatres and procedure wards. According to the Reglamento Electrotécnico para Baja Tensión, REBT (Electrotechnical Regulations for Low Voltage), instruction ITC-BT-28 binds healthcare centres to have a complementary especial supply system for operating theatres and procedure rooms. Characteristics: It should switch on automatically within 0.5 s. It must hold the lamps of the operating theatre or of the procedure room and the life support equipment. 2 hour minimum range. This supply system is independent from the complementary supply system bound by the ITC-BT-28. The complementary supply system cannot be used not even to guarantee the switching time or its time range. The fact that action time is rather short makes it necessary to have an Uninterruptible Power Supply (UPS) system. Types of UPS: Static UPS: electric system that storages energy in batteries. Dynamic UPS: mechanical system with the enough inertia to avoid a supply failure and which is connected to a fuel fed generator. From now on, references would be made to static UPS as they are the most broadly used. 138 REPORTS, STUDIES AND RESEARCH

143 The 2 hour range requirement poses the question on what is understood as life support equipment. The UPS must feed a separator transformer of a specific power. It will seem unreasonable to consider the transformer power as the power to be fed for two hours, due to the great volume and expense of the necessary batteries. It is very important that during the design of the project the person in charge would specify the power necessary for the equipments, even approximately. UPS configuration: Distributed UPS. There is an independent UPS in each room. Centralized UPS. There is a UPS to feed a group of rooms. Centralized redundant UPS. The centralized UPS has two units, each of them can stand the necessary power. Combination of the previous. Advantages of the distributed UPS: The UPS is close to the power intake and thus the number of elements that are liable to fail is reduced. Advantages of centralized UPS: The room in which it is accommodated must follow certain requirements, mainly temperature requirements, being this a critical determining factor for batteries. Only maintenance staff may enter the room, different to the other small units placed at the dirty corridors. Design recommendations: The UPS will stand the power connection of the transformer it feeds. The nominal power of the UPS would need to have the capacity to feed the nominal power of the transformer. The two hour range will keep part of the nominal power of the UPS depending on the life support equipment and lamp power requirements. Use of an RF cable for centralized UPS People safety Introduction A patient with undermined physical strength suffers to a greater extent the effects of the electric power system. Moreover, it must be taken into account SURGICAL SUITE. STANDARDS AND RECOMMENDATIONS 139

144 that the skin acts as an intensity limiter of the electric supply. If the skin is wet or if incisions have been made on it, the value of the power supply would be higher if contact should occur. The patient is connected to life support equipment which should be always fed; supply interruption is not advisable. According to the ITC-BT-38, in order to minimize risks, to provide electric supply to equipment which may put at risk patients or staff if service is interrupted there should be used a system that obeys the following conditions: Limit the current leakage. Avoid supply interruptions. The system used in that equipment is the isolated neutral (IT) which implies: Separator transformer which will provide supply to that equipment, placed at the switchboard. Line isolation monitor at the switchboard. The switchboard must be placed outside and near the room, and should be easily accessed. Line isolation repeater, placed at the operating theatre or at the procedure room. Equipotential bonding in the room to avoid potential differences between the metal masses. Operation: When a first failure occurs the current has an inconsiderable value and the protections are not activated. The line isolation monitor shows that there has been a failure. The line isolation monitor repeater shows in the room where the failure has taken place so that medical staff may notice. A second failure may cause an amplification of the current and thus make the protections activate; the equipment supply is interrupted. It may be pointed out that medical staff should warn urgently and immediately hospital maintenance staff so that they may solve the problem before the second failure, which could be fatal, occurs. Conditions for the appropriate implementation: Strict values of the equipotential connection in the room according to the Reglamento Electrotécnico para Baja Tensión, REBT (Electrotechnical Regulations for Low Voltage). Appropriate protection of the transformer against over-currents. Protection coordination (selectivity) of the exit circuits of the transformers in relation to the entrance protection. This implies 140 REPORTS, STUDIES AND RESEARCH

145 the selection of the appropriate protection and of the specific characteristics of the transformer. The ITC-BT-38 points out that the equipment supplied by means of an isolation transformer must not be protected by means of differential controllers at the primary or the secondary circuits of the transformers. The protections to be installed are generally automatic switches. There is equipment at the operating theatre or at the procedure room such as the x ray equipment which require more than 5 kva and that does not require to be supplied by means of the separator transformer. This equipment should be protected by type A differential switches. Within the equipment that should be fed by a separator transformer it should be included the monitoring systems at the preanaesthesia and at the post operative recovery rooms Isolation transformer The characteristics of the transformer should obey the Spanish standard UNE , as binds the Reglamento Electrotécnico para Baja Tensión, REBT (Electrotechnical Regulations for Low Voltage) Recommendations: Use of transformers with Vcc (common collector voltage) with a value ranking between 5% and 10% to settle the appropriate selectivity between protections. Use of three-phase transformers for high supply powers with a triangle secondary circuit, which reduces instabilities in the supply system. Protection of the primary circuit of the transformer with omnipolar automatic switches of nominal current adjusted to the current of the transformer. It is not appropriate to double or triple protection of the nominal current as some manufacturers recommend. Protection of circuits that depend from the secondary transformer with automatic switches selective over the protection of the primary circuit of the transformer. E.g. A three-phase 7,5 kva transformer with a transforming range of 400/230 V, with automatic 16A three phase switch in the primary circuit and 16A bipolar switches in the secondary circuit would be appropriately protected. It should be taken into account that the 16A power supply of the secondary circuit is seen from the primary circuit as a 9.2A power supply. It will be equal to having upwards a 16A switch and a 9.2A switch downwards. Control of the temperature of the transformer. SURGICAL SUITE. STANDARDS AND RECOMMENDATIONS 141

146 Line isolation monitor The characteristics of the line isolation monitor must obey the standard UNE , according to the Reglamento Electrotécnico para Baja Tensión, REBT (Electrotechnical Regulations for Low Voltage). Recommendations: Internal resistance not smaller to 5 MΩ. It reduces current leakage that the equipment causes. Alarm alert should the earth ground or the connection cable be interrupted. The circuit identifies individually the failures, reducing intervention time. Alarms are centralized in an IT system. Failures and their exact time of occurrence are stored Air conditioning Regulations RD1027/2007, July 20th, which passes the Reglamento de instalaciones térmicas en los edificios (Regulations of Thermal Installations in buildings) and its additional Technical Instructions and settles an advising commission for the thermal installation in buildings. RD correction 1027/2007. RD 47/2007, January 19th, 2007, which passes the procedure for the certification of energetic efficiency in newly-built buildings. This requirement derives from Regulation 2002/91/CE. RD 314/2006, March 17th, which passes the Código Técnico de la Edificación (Technical Building Code) (BOE [Spanish National Gazette] nº 74, 28/03/2006). Section 14. Basic legislation on noise protection (HR). RD correction 1371/2007, October 19th, which passes the core document «DB-HR Protección frente al ruido» (Core document - HR Noise Protection) of the Código Técnico de la Edificación (Technical Building Code) and modifies the RD 314/2006, March 17th, which passes the Código Técnico de la Edificación (Technical Building Code). Noise Act 37/2003 development, referring to acoustic zoning, quality aims and acoustic emissions according to RD 1.367/2007 October, 19 th, REPORTS, STUDIES AND RESEARCH

147 Act 34/2007, November 15th, on air quality and protection of the atmosphere (BOE [Spanish National Gazette] nº 275, 16/11/2007). Hygiene and healthcare criteria for the prevention and control of legionellosis. RD 865/2003, July, 4th (BOE [Spanish National Gazette] nº 171, 18/07/2003). General regulation on safety and hygiene at work: Order from March, 9th, 1971, Spanish Department for Work (BOE [Spanish National Gazette] Nº 64 y 65, 16/03/1971) and further corrections. Act 31/1995, November 8th, from the head of the State (BOE [Spanish National Gazette] Nº 269, 10/11/1995). Corrected, Act 50/1998, de December, 30th, on legal, administrative and social regulations (BOE [Spanish National Gazette] Nº ). Minimum safety and health regulations at work. RD 486/1997, April 14, Spanish Department of Work and Social Affairs (BOE [Spanish National Gazette] Nº 97, 23/04/1997). UNE standards quoted in the acts and regulations. All the equipment and components of the facilities that are part of this project will comply with the corresponding specific legislation apart from the rules provided by the additional Technical Instructions and those derived from the implementation and development of the RD 1630/1992. *Correction. RD 1328/1995 (BOE [Spanish national Gazette] Nº ) Functions of the air conditioning system. As in other buildings and premises of the hospital, the main function of the air conditioning system is to provide an acceptable quality of interior air by means of adequate ventilation and filtering levels and comfortable environmental conditions keeping a pre-established temperature and relative humidity range. The standard UNE Instalaciones de aire en hospitales (Air conditioning systems at hospitals) should be obeyed as it is the only Spanish reference Regulation and the RITE (Regulations of Thermal Installations in buildings) shows that its values are appropriate. This standard establishes from an hygienic point of view two types of premises: Premise type I: Very high requirements. Three filtering levels. Premise type II: Common requirements. Two filtering levels. SURGICAL SUITE. STANDARDS AND RECOMMENDATIONS 143

148 The area of the operating theatres, the corridors, the storage rooms, the sterile supplies rooms, the admission and the discharge area and the recovery area are considered within type I. The other areas of the SS should be included within type II and thus should have an air conditioning system similar to other hospital areas, with two filtering levels. Special attention should be paid to the control of pressure levels to prevent air from the dirtiest premises to flow to the cleanest ones. At the SS comfort criteria are more specific and must observe particular requirements to guarantee temperature comfort of the team work and patients safety. Temperature at the operating theatre must range between 22 and 26ºC and relative humidity between 45 and 55% according to the Spanish standard UNE At high performance operating theatres (type A) there are some heart procedures in which temperature could lower to 17ºC. Due to the inherent use of the operating theatre (surgery procedures mainly in which the patient, due to the procedure, is exposed to pathogenic agents) the possibility of an air-acquired infection should be reduced and one of the main agents responsible for reducing these possibilities is the air conditioning system. Several factors must concur for the patient to acquire an infection: the rate of infection particles must be high, the exposure time sufficient and the defences of the patient low. The air conditioning system must work in such a way that the doses or the rate of particles in a square metre should be lower than those values considered as infectious or that may cause an infection as well as the exposure time to them. To do so, a system made up of three filtering levels would be installed. It guarantees that all the air that goes into the premises bears the maximum acceptable level of particles. However, and due to the fact that healthcaring staff and equipment are constantly entering and leaving the operating theatre, some contamination of the nearby areas which do not have this type of filtering may occur. So as to reduce risk, the air conditioning system should provide the operating theatre with plenum conditions in relation to the nearby premises and thus avoid that when the door opens air enters the theatre. For a valid plenum the operating theatre must work as an air-tight chamber: any hole, stand, equipment or pipe must be utterly sealed; doors both at the clean and at the dirty side must be air-tight. It is advisable to have airlocks in those areas that do not belong to type I so as to guarantee that plenum is maintained in those areas even though doors are opened. Several studies in Fluid Dynamics show that even though there may be plenum at type I areas in relation to surrounding areas, when a door opens there are air flows that go from the dirty area to the clean one. 144 REPORTS, STUDIES AND RESEARCH

149 Being the surgery staff at the operating theatre there are more different air flow movements, air may stagnate in some areas and there may be a higher contamination due to the in and out movements and to the contribution these people make. Therefore one of the most determining contamination factors of the operating theatre relies on the number of people that are at the operating theatre. Thus it should be limited. To limit the contamination level of an operating theatre to the acceptable values settled by the UNE there should be a minimum flow of m3/h (667 l/s) per operating theatre with at least 20 movements per hour. Another task of the air conditioning system is diluting the gases or the contaminating agents that may exist within the operating theatre as anaesthetic gases, medical gases or any other type of contamination agent. To comply with this section, the Spanish standard UNE settles that a minimum of m3/h (333 l/s) outside air should enter the operating theatre though it is advisable that all the air flow that gets in the theatre would come from the outside (at least in type B operating theatres) which is also recommended by the Spanish standard UNE With this air volume, it is proved for the Reglamento Electrotécnico para Baja Tensión, REBT (Electrotechnical Regulations for Low Voltage) that there is no need to consider the environment as an explosive atmosphere as the anaesthetic gases are conveniently diluted. Regarding the post operative area (PACU) the RITE (Regulations of Thermal Installations in buildings) also points at the Spanish standard UNE which establishes the minimum ventilation level in 30 m3/h x (8,33 l/s x m2) and 15 m3/h x m2 (4,16 l/s x m2) at the other areas of the SS. The range of temperature and relative humidity is the same as for any other area: ºC and 45-55% RH This Spanish standard also settles the level of sound pressure at 40 db(a) for the SS but for the postoperative recovery area where the level is set at 35 db(a) Air conditioning systems at operating theatres. From the air conditioning point of view there are 3 different types of operating theatres: A, B and C Type C operating theatres They are operating theatres that are not included in the SS and thus are not dealt with in this document. SURGICAL SUITE. STANDARDS AND RECOMMENDATIONS 145

150 Type B operating theatres They are the most common operating theatres. Within this type there can be included those that are within the SS and which cannot be considered as type A operating theatres. Air diffusion is made in laminar or turbulent regime. The former consists on a flow powered by a diffuser placed on the ceiling which provides a mixture with environment air by means of induction and thus dilutes contaminants and obtains the homogeneity of temperature and of relative humidity. The return conduits are placed on the wall, if possible on the four walls and corners (at least it is recommended that it should be placed in two opposite walls) and with 1200 m3/h of flow evacuated through the grille placed on the lower part of the wall, 15 cm from the floor. The rest of the flow is extracted from the upper part of the wall. Thus a recirculation of the air is obtained avoiding air stagnation. Moreover, inflammable gases (heavier than air) would be removed as they gather in the lower part of the theatre Type A operating theatres They are specialized operating theatres with an air conditioning system whose installation and usage involve high costs. Therefore it is recommended in high performance operating theatres (heart surgery, organ transplantation, neurosurgery, trauma surgery and implant vascular surgery) that require the most sterile environment as possible as any infection could bring about serious consequences. This is achieved by means of a laminar flow diffusion system accommodated in the room. The volume of air to be propelled is increased so that on the concerned area (the area closed to the surgery table) the volume of air is such that it may displace all the air of the area and prevent air from the nearby areas to enter the area surrounding the patient. It works as a piston pump that moves a huge air flow. To reach this desired effect it is necessary to have 80 to 150 air flows per hour and renew at least 20 times per hour the air with air from the outside. Return would be similar to that of type B operating theatres Post operative recovery area (PACU) The system most commonly used at the post operative recovery area consists on an air conditioning system independent from the other areas with a distribution air system with three filtering levels which includes and air diffusion system with turbulent regime by means of diffusers with absolute filters in the suspended ceiling of the room. 146 REPORTS, STUDIES AND RESEARCH

151 In this case, as no inflammable anaesthetic gases are used, there is no need to have return conduits on the lower part of the wall and thus they can be placed in the ceiling Air conditioning components Supply It is advisable that an autonomous emergency supply would be guaranteed in the SS area, in case of a continuous supply system failure of the company (failure of the sub-unit, of the switching station, of the company line) the procedures that have already been started could be finished and the future urgent performed. Thus, one cold production equipment and one heat production one, as well as the pumping equipment, the air conditioning equipment and the management system should obtain supply from an auxiliary supply unit Air conditioner To guarantee an appropriate regulation and that the maintenance works of an operating theatre do not affect another one it is compulsory to have independent air conditioners on each operating theatres. It is advisable to place the operating theatre air conditioners near the SS. Each unit will be placed the closer as possible to the room to aircondition so as to limit to a higher extent the distances between the conduits and thus the risk of gathering dirt and organic remains in them. It is advisable to accommodate the air conditioners in a roofed technical gallery, which would facilitate maintenance tasks of the equipments, will extend the life of the equipments and would contaminate less inside areas. According to the Spanish standard UNE : Air intake would be placed at 2.5 m. from the roof and the ground and at 10 m from those areas where cars pass. Air discharge would be placed at least from 7.0 m to 0.5 m from the air intake depending on the air flow and on the contamination level of the discharge air. It is advisable that the air conditioner would obbey with the Spanish standard UNE-EN 1886 Ventilación de edificios. Unidades de tratamiento de aire. Rendimiento mecánico (Air circulation in buildings. Air treatment units. Mechanical performance) regarding the level of stagnation and isolation. It is also advisable that the equipment should follow the following requirements: SURGICAL SUITE. STANDARDS AND RECOMMENDATIONS 147

152 Smooth inside walls without any sharp items and projections with stainless steel finish. Air lock filter support casing. Fans directly connected to the engine (without any belts). Jet blade fans, as they are more stable to flow variations. Independent frequency variator engines. Batteries accessible from both sides with a maximum of 4 row per battery. If more than four are necessary (for cold, for example), batteries would be double, each with its own dampers. Condensation tray made of stainless steel and with a certain slope to avoid stagnated water. Water siphon for the battery recovery system would be smaller than 5 cm. Emergency location between the extraction fan and the impulsion fan so in case the impulsion fan stops the extraction one stops too. Should a silencer be necessary it will be placed on the air conditioner before the second filtering level. It should be taken into account that the energetic expenditure of the air conditioning system implies 36 to 46% of the total energetic expenditure of a hospital and thus its use should be limited as much as possible. A measure that allows saving important amounts of energy is the use of energy recovery systems in the air conditioning unit. According to the RITE (Regulations of Thermal Installations in buildings) it is compulsory for those expulsion flows higher than 0.5 m3/s (500l/s). Even though our flow is smaller its usage is also advisable. The use of enthalpy recovery systems is inadvisable as their cleaning possibilities are very reduced. Other possibility to be considered so as to improve energy saving is to make operating theatres function in a stand-by mode. The operating theatre will receive 25% of its flow but will keep the necessary plenum. Operating theatres may be under this system when they are not used. Both for cleaning and maintenance the theatre should work in normal mode. The air conditioning system of the operating theatres should never stop. If an emergency or maintenance stop occurs monitored airlocks should be placed on the conduit system. Regarding type A operating theatres where it may be necessary to lower temperatures to 17ºC during a procedure, this process may be obtained with two cold batteries. One of them should be of water which would allow us to reduce temperature to 20ºC and the other one would be a direct expansion battery which will permit to lower temperature to 17ºC. Appropriate humidity levels are necessary to guarantee comfort and to reduce the number of static currents which could bring up explosions should 148 REPORTS, STUDIES AND RESEARCH

153 they combine with inflammable anaesthetic gases. To reach the adequate level in most cases there would be necessary to install humidification systems. It is advisable to install autonomous steam humidifiers. Even though the electric consumption is higher than in other systems, its hygiene level is clearly superior. Other option could be the centralized system of steam production in boilers which would be distributed to each air conditioner. It should be taken into account that both the boilers and the pipes should not give off any substance that could contaminate this water steam. A possible air conditioning configuration could be the following: Figure 7.1. Possible configuration of air conditioning. SURGICAL SUITE. STANDARDS AND RECOMMENDATIONS 149

154 Figure 7.2. Legends and symbols. [limit switch, air conduits temperature probe; outside air temperature probe; air speed probe; air conduit relative humidity probe; immersion temperature water pipe probe; water flow switch; carbonic anhydride probe; two way proportional action valve; three way proportional action valve; absolute pressure air conduit probe; air conduit pressure switch; differential pressure air conduits probe; proportional airlocks actuator; analogical liquid level probe; pulse emitting flowmeter; digital outlet electric switchboard contactor; operation status; thermal operation status; frequency variator operation status; analogical intake; digital intake; analogical outlet; digital outlet; cold water pulse circuit; cold water return circuit; hot water pulse circuit; hot water return circuit; expansion circuit; full-way valve; air-stop valve; check valve; two-way mechanical valve; three-way mechanical 150 REPORTS, STUDIES AND RESEARCH

155 valve; outlet valve; three-way outlet valve expansion vase; safety valve; balance valve; pressure stabilizer valve; damper; water filter; manometer; thermometer; water meter.] Conduits The role of conduits is to take already treated air from the air conditioner to the room diffuser, maintaining the flow, the temperature, the humidity level and the hygiene conditions. Therefore, and as it has been stated before, it is recommended that the net of conduits would be as shorter as possible as it is a probable place for dirt accumulation. Conduits must have a degree of roughness lower to 0.3 μm. Under no circumstances fibre conduits or conduits with interior insulation systems should be used. It is recommended that conduits would be made of METU type galvanized metal sheet as it allows dismounting all parts of the conduit and a level of air tightness higher to those that have an interlocked gasket system. To guarantee air tightness all gaskets of the conduit systems would be sealed. The air tightness recommended level is level C. Cleaning airlocks should be mounted according to the Spanish standard UNE-ENV always by the regulation and fire-break airlocks. Round conduits are preferable to rectangular ones as they are easier to clean and offer better air tightness. Under no circumstances flexible conduits would be installed at type I areas as they cannot be cleaned Diffusion Pulse elements will have absolute filters in those cases in which there are three levels of filtering. It is advisable that the air speed at the exit of the laminar diffuser would be around 0,15 and 0,18 m/s. In turbulent regimes the diffusion should be settled in such a way that the medium speed in the occupied area would be lower to 0,15 m/s. It is advisable to install a smoke extraction system for the electromedical equipment that may cause some kind of smoke, gas, etc, as the electric scalpel Filtering In order to fulfil the required filtering standard, three filtering levels are required. SURGICAL SUITE. STANDARDS AND RECOMMENDATIONS 151

156 The first one is a F7 efficiency flat filter according to the RITE (Regulations of Thermal Installations in buildings) placed at the air intake of the air conditioner with a protection filter. The second one will be a F9 bag filter according to the RITE (Regulations of Thermal Installations in buildings) placed at the last unit of the air conditioner. If it were necessary to install a silencer, the filter should be placed before the second filtering level. The third filter would be a H13 efficiency absolute filter installed at the air diffuser of the room which has to be conditioned according to the Spanish standard UNE It is advisable to mount a pressure measure point before the absolute filter to check the flow that gets into the room and a differential pressure probe to control the level of dirt. At the air extraction point of the room there would be at least a G4 filter placed before the fan according to the RITE (Regulations of Thermal Installations in buildings). The recovery area will have the protection of at least a F6 filter, according to the RITE (Regulations of Thermal Installations in buildings). If there were contaminating gases in the outside, gas filters or chemical filters should be installed Adjustment The system should be controlled and adjusted by a centralized management system made by independent controllers, autonomous from the bus and the central computer so that it may work even though the central computer or the communication bus are out of order. It is advisable that the system should be provided with an auxiliary supply unit and a UPS. At operating theatres the same air flow should always be pulsed to guarantee the required air renovations. The impulsion fan should have a frequency variator which will alter the fan turning speed as the filter gets dirtier. The variator would be directed by a air flow probe placed at the impulsion conduction. To obtain plenum in the room it is advisable that the return flow would be a 15% lower than the impulsion flow. The return fan should have another frequency variator to guarantee the plenum of the room. A differential pressure probe would be placed between the operating theatre and the clean corridor and there would be another one between the operating theatre and the dirty corridor managed by this 152 REPORTS, STUDIES AND RESEARCH

157 variator so that if the plenum is not achieved the flow of the fan may be reduced. It is advisable to keep at least 5 Pa of pressure difference between the operating theatre and the clean corridor and 15 Pa between the theatre and the dirty corridor. There should also be at the procedure room a device that would indicate the flow level, the temperature, the relative humidity level and the pressure at the operating theatre and that device should also allow modifying those values and setting the operating theatre in stand-by mode. It is also advisable that the device would be accommodated in the switchboard. There should be capillary tubes to control the differential pressure with a portable differential pressure probe with the doors and the airlocks closed. These capillary tubes should be placed between the operating theatre and the clean corridor and between the theatre and the dirty corridor. It is advisable that the temperature and relative humidity probe would be at room temperature Performance As it has been stated before it should be thoroughly planned all the tasks that have to be performed at the SS as they imply great difficulty, and there is a great number of utility rooms, of people working on it and their hygiene requirements are the highest. It is advisable that due to all the dust produced, the works (including brickwork, drills, hollows, etc; but for the false ceiling) should be completely finished before the systems are installed, mainly the air conditioning conduits. It is important to guarantee that in the whole process from the factory, the transportations, the unloading and mainly the gathering and the installation, the conduits are closed and cannot gather under any circumstance environmental dust or dirt. At the end of the day they should be covered (either with plastic or board) the conduits that are opened. As far as the dampers is concerned, there is no need to plan a damper within the operating theatre and thus those devices that require them should be placed in nearby areas; if the SS is designed on a double corridor pattern, it would be preferable placed in the dirty corridor. It should be taken into account the necessary height within the false ceilings. Heights lower to 80 cm and t-beams are inadvisable. SURGICAL SUITE. STANDARDS AND RECOMMENDATIONS 153

158 7.3. Mechanical systems Regulations Mechanical systems must comply with the following regulations: RD 314/2006, March 17th, which passes the Código Técnico de la Edificación (Technical Building Code). Spanish Ministry of Housing. B.O.E (Spanish National Gazette). Nº 74, March 28, Basic Decree SI Seguridad en caso de incendio (Safety in case of fire) and RD 1371/2007 October 19th, which passes the Basic Decree DB-HR Protecciones contra el ruido del Código Técnico de la Edificación (Noise protection of the Technical Building Code) and which modifies the RD 314/2006, March 17th which passes the Código Técnico de la Edificación (Technical Building Code). Spanish Ministry of Housing. B.O.E. (Spanish National Gazette) Nº 254, October, 23rd, RD 1942/1993, November 5th which passes the Reglamento de Instalaciones de Protección Contra Incendios (Regulations of Fire Protection Systems), Spanish Ministry of Industry and Energy. B.O.E. (Spanish National Gazette), December 14th, 1993 and further Order April 16th, 1998 on procedure and development regulations of the RD 1942/1993, November 5th, which passes the Reglamento de Instalaciones de Protección Contra Incendios (Regulations of Fire Protection Systems) and which reviews annex 1 and the appendix. Spanish Ministry of Industry and Energy. B.O.E. (Spanish National Gazette), April, 28th, RD 393/2007, March 23rd, which passes the Norma Básica de Autoprotección (Basic Self-Protection Regulation) of centres, institutions and premises whose activities may bring about emergency situations. Spanish Ministry of Home Affairs. B.O.E. (Spanish National Gazette) Nº 72, March 24th, P RD 314/2006, March 17th, which passes the Código Técnico de la Edificación (Technical Building Code). Spanish Ministry of Housing. B.O.E. (Spanish National Gazette) Nº 74, March 28th, Basic Document HS 4. Water supplies. March 17th, which passes the Código Técnico de la Edificación (Technical Building Code). Spanish Ministry of Housing. B.O.E. (Spanish National Gazette) Nº 74, March 28th, Basic Document HS 5. Waste water management Spanish Standard UNE-EN-ISO Medical gases channelling system. Part 1: Channelling systems for compressed medical gases 154 REPORTS, STUDIES AND RESEARCH

159 and vacuum. November (Its implementation is not compulsory but advisable). Spanish Standard UNE-EN-ISO Medical gases channelling system. Part 2: Final waste systems of anaesthetic gases. (Its implementation is not compulsory but advisable) Medical gases and vacuum system There is not a specific and compulsory Spanish standard for the medical gases and the vacuum at the SS and thus the international ISO standards are used a reference as they have been adapted to European standards and to Spanish (UNE) standards. At the SS, these systems include the oxygen supply system, the breathable compressed air, high pressure compressed air or as an option nitrogen gas, nitrogen protoxide and those for the vacuum and for the extraction of anaesthetic gases. In relation to the establishment of a centralized CO2 system it should be taken into account the cost-benefit relation in accordance with the number of operating theatres devoted to or specialized in laparoscopic procedures (with devoted laparoscopy equipment) or in surgical suites or operating theatres in which it may be foreseen a high rate of medical specialities such a general surgery procedures, gynaecology or urology where a great extent of the procedures may be laparoscopic Supplies The medical gases and vacuum supplies of the SS must be independent from the other hospital supplies, i.e., must be direct from the gas supply unit and double, with a double supply line so as to guarantee supply even in those cases in which a line fails or is under maintenance conditions. At the entrance of each operating theatre or in the connection of each equipment tower there should be cut valves to make a theatre or a tower independent in case of breakdown Gas and vacuum conduits At the operating theatre gas intakes are generally placed at the anaesthetist and surgeon equipment towers to prevent having tubes in the floor around the surgery table. In the anaesthetist equipment tower there are generally two oxygen intakes, two vacuum intakes, one breathable compressed air and one nitrogen protoxide intake. SURGICAL SUITE. STANDARDS AND RECOMMENDATIONS 155

160 In the surgeon equipment tower there are generally an oxygen intake, two vacuum intakes, one breathable compressed air intake, one nitrogen protoxide intake and another one of carbon dioxide used for laparoscopic procedures. On that same tower there is a high pressure compressed air intake for the operation of the medical equipment. This gas may be substituted by nitrogen gas but it is much more expensive. Intakes distributions in the towers allow the people who take part on the surgery procedure to change their places according to the area in which the procedure is performed. Apart from the gas and vacuum intake that are placed in the towers, some hospitals have intakes placed in the walls of the operating theatre or in a switchboard. The extraction intakes placed at the anaesthetist towers are connected to a compressed air ejector which expels to the outside of the building. At the preanaesthesia area there is an oxygen intake, a vacuum intake, a breathable compressed air intake and a nitrogen protoxide at the headboard of each bed. At the PACU there would be an oxygen intake, a vacuum intake, a breathable compressed air intake and a nitrogen protoxide intake for each bed placed at a system rail Alarms There should be optic and acoustic alarms so that it may be immediately noticed if there is a pressure drop of any of the gases or vacuum. These alarms may be placed within the operating theatre, at the switchboard or centralized in the area of the operating theatre manager or at the PACU control Plumbing Plumbing systems and sanitary fittings are complementary for the SS. They must comply with the Código Técnico de la Edificación (Technical Building Code). Water pipes will feed the basins placed in the areas prior to the operating theatres and in the pre-anaesthesia areas, the resting rooms, the clean and dirty utility rooms of the post-operative area, the waste collection unit of the dirty corridor and the common changing rooms of the SS. In each of the premises with water intakes there should be cutting valves to make an area independent should it be needed or if a failure occurs. 156 REPORTS, STUDIES AND RESEARCH

161 Cold water pipes should be insulated to avoid condensation and hot water pipes to avoid heat losses. Pipes distribution, without any recirculation section, would allow making all the necessary controls and periodic treatment to prevent legionella. Vertical drainpipes should be avoided in the operating theatres and vertical manifolds should not be placed in the false ceiling of the operating theatre. If this cannot be avoided, they should be insulated to avoid disturbing noises during the procedures Fire safety systems Fire safety at the SS is included within the fire safety regulations of the hospital. It must obey the SI document of the Código Técnico de la Edificación (Technical Building Code), the Reglamento de Instalaciones de Protección Contra Incendios (Regulations of Fire Protection Systems) and the Norma Básica de Autoprotección (Basic Self-Protection Regulations). The rate of small fires at the SS has substantially reduced in the last years due to the lower degree of inflammability of the anaesthetic gases which used to be the main source of fires. Nowadays, most fires are related with electrical risks of the switchboards and the electromedic equipment or to fumes coming from other areas of the hospital. Fire safety at the SS must be comprehensive and equilibrate in those aspects regarding passive safety, active safety and operative safety Passive safety Passive safety would prevent fire and fumes from spreading on the SS, it will isolate the area from other areas of the hospital and would allow the evacuation of the SS safely and orderly. It implies: Zoning. Sealing of pipe bays. Use of the appropriate finish materials. Evacuation and safe ways Zoning The SS, including the post-operative resuscitation area must create an independent fire area. At the same time it is also important that the SS would be divided in two independent fire areas so that a fire would not SURGICAL SUITE. STANDARDS AND RECOMMENDATIONS 157

162 collapse the activity of all the operating theatres. Area fire resistance would range between 60 to 120 minutes depending on the height of the building to be evacuated. Access to different areas should be made through fire lobbies with fire resistant officially approved doors. These doors may be generally held open with electromagnets to allow beds and gurneys going through. Air-conditioning conduits as they go through the walls or floors that separate the different areas must have automatic firebreak lock-gates activated by the automatic detection systems Sealing of pipe bays The pipe bays of the walls and floors that limit the different fire areas must be utterly sealed with fire resistant material to guarantee airlock conditions of the area against fumes Use of finish materials Finish materials of walls, floors and false ceilings of the premises of the SS should be self-extinguishable and difficult to burn, which would not contribute to fire spread and would not give off neither fumes nor toxic gas in case of fire. Ceilings and walls should be B-s1, do and floors C FL -s1; they would have the certificates of the officially approved trials that prove that they respond to these category and they have been adequately installed Evacuation and safe ways The SS should have at least two safe, alternative, fume-free evacuation ways aiming towards two protected stairs to allow evacuation in case of fire within or outside the SS. The SS should never be located under the first basement floor as upwards evacuation is always slower and more difficult than downwards Active safety Active safety includes fire protection systems which would allow locating quickly the fire, transmitting the information provided by the alarm and fighting the fire with their own means until the arrival of the fire brigades. It implies: Fire detection. Alarm transmission. Fire fighting. 158 REPORTS, STUDIES AND RESEARCH

163 Detection It is really important for the SS that any fire should be detected as soon as possible so that it could be fought immediately with straightforward means preventing it to spread. All premises should have fire detection systems; they would preferably be individual optical smoke detectors. Link of the detectors with the control unit should be made through low fire risk areas of the hospital. Moreover, fire detection units of the SS should be placed closer than 25 metres to an alarm push button connected to the safety control unit of the hospital Alarm transmission When a fire detector or a push button of the SS goes off, the alarm should be transmitted from the control unit to external services (fire brigade), to the emergency intervention team of the hospital and to the people who are at the moment at the SS by means of sirens, the PA system and other communication means. At the same time from the control unit instructions will be provided to make a series of procedures which would allow the airtightness of the area (closure of firebreak airlocks of the air-conditioning system, closure of doors hold open by means of electromagnets) and its evacuations (change of the full play operating system of the elevators and service elevators to its operation with emergency key) Fire fighting The SS should have portable extinguishers and fire hoses (equipped hydrants). At the SS there must be a fire extinguisher every 15 metres. There would preferably be polyvalent, dry powder extinguishers which prevent the creation of embers for solid flammable materials or carbon dioxide, CO2 extinguishers for electric equipment or systems. Moreover, there should be a fire hose every 25 metres so that all points may be under its protections. Hydrants would be located by the access points and would be equipped with 25 mm semi-rigid hoses Operative safety In the self protection manual of the hospital there should be a specific section for the SS due to its particular characteristics in relation with other areas of the hospitals. In this document it should be included the arrangement of space and facilities, the identification, analysis and evaluation of the risks SURGICAL SUITE. STANDARDS AND RECOMMENDATIONS 159

164 that the activity generates on its own, a description of the self protection available measures and means, the rating of the emergency procedures according to the type of risk, the seriousness of the situation, the rate of occupancy and the available human resources, the emergency services that will take part, the response mechanisms to the emergency and the way the training and the implementation of the manual is made Setting into operation and maintaining operating theatres Operation Once the systems of the operating theatre are installed and before it is set into operation an appropriate start up should be made. There are provided below the minimum actions to be performed at the start up of the electric, mechanical, air-conditioning and medical gas systems Electric system At the beginning, and according to the Reglamento Electrotécnico de Baja Tensión REBT (Electrotechnical Regulation for Low Voltage) and to the Technical Complementary Instruction ITC-BT-38 the following check-ups and measurements should be made: Continuity of active connectors, of protection connectors and of the ground wire. Resistance of the insulation between the active connectors and the ground wire in each circuit. It should be over 0.5 Megaohm. Resistance of the ground wire. Operation of the additional supplies. Resistance of the protection and equipotentiality connectors. Antielectrostatic floor control. Operation of the protection measures. Moreover, the following check-ups should be made: Measure of the resistance level of the protection connectors. Measure of the resistance level of the equipotentiality connectors. Antielectrostatic floor control. Control of the equipment of the impedance leak detector. 160 REPORTS, STUDIES AND RESEARCH

165 Measure of the resistance level of the protection connectors. It should be guaranteed that the resistance of the earth wire between the intake and the protection sealing would be low so that a current leakage will not be dangerous. The maximum reference accepted value is 0.2 ohms Measure of the resistance level of the equipotentiality connectors. This measure pretends to guarantee that the resistance of the equipotentiality conductor between the conducting area surrounding the patient and the equipotentiality sealing is low so that a current leakage would not be dangerous. The maximum reference accepted value is 0.1 ohms Antielectrostatic floor control The aim of this measure is to check that the accumulation of static charges does not bring up any risk in the area where medical gases are used. Resistance between the earth wire and the triangular electrode is measured. The maximum reference accepted value is 1 megaohm even though it may admit up to 100 megaohms, whenever it is proved that this does not justify the accumulation of dangerous electrostatic charges (MI BT 025). Other standards (CEI 62 A ) establish 25 megaohms Check of the equipment of the impedance leak detector This check up is made to verify the correct working of the leak detector. The nominal set off reference value is 4 ma. The limit set off values are 4 to 4.4 ma Air conditioning mechanical systems Preliminary tasks Before setting into operation the air conditioning and ventilation systems, the following tasks should be performed in the air conditioning units: Clean the room where the air conditioner will be installed. Clean the outside air intake and the air conditioner prefilter. Clean the inside of the air conditioner unit. Clean the water filters placed before the motor valve. Check the operation of motor airlocks. Check the rotation direction of the fans. Check the estate and the cleanness of the condensation trays. Check the humectation. Water quality. SURGICAL SUITE. STANDARDS AND RECOMMENDATIONS 161

166 For the conduits and the additional elements, the following preliminary tasks will be performed: Check the cleanness of the inside by means of the dampers Check the correct placement of the measurement and control devices. Check the correct operation of the automatic airlocks and test its airtightness. Remove plastic protectors from the air units. First blow without absolute filter. Installation of absolute filtres. Turn on the humectation system. At operating theatres: Level of inside cleanness. Main inside elements placed. Automatic doors working. Check airtightness. Remove protection plastic from the air conditioning units. First blow of the air conditioner without absolute filter. Installation of the absolute filters. Turn on the humectation system Testing, adjusting and balancing Afterwards, the TAB (Testing; Adjusting and Balancing) will be performed. It is recommended: To have the technical information of the systems and equipments which provide the nominal parameters of each of the elements. To check the flow pulsed by each of the air conditioners, the flow outlet and the absolute filter to check the flows and detect any air leakage. To check the flow extracted in each of the rooms. To check the flow in each of the air outlet grille of the rooms. To check the airtightness of the operating theatre. To check air flows at the operating theatre. To check all the measures taken by the pressure, temperature and humidity probes. Check accuracy and time response. To check the leakage level of absolute filters. To check and adjust the pressure differences between adjacent rooms. If some type of adjustment has been made, then the pulsed flow would have to be measured again and extracted from the rooms until the flows and the pressure differences are within the standards established in the project. To check completely the centralized management system. 162 REPORTS, STUDIES AND RESEARCH

167 To check that in the operating theatre maximum and minimum temperatures and humidity levels are kept regardless the outside conditions and with the common interior heat sources of a procedure. All the testing and checking tasks should be made before taking any air sample to verify microbiological air quality of conduits and rooms. All measurements and check ups would be made with the system operating at nominal values and at stand-by mode Medical gases There are provided below all the tests to be made on the different medical gas systems of the operating theatres. Table 7.1. Compressed medical air system. Test The system will be subject to one and half times its operation pressure and to a minimum of 10 Kg./cm2. Once the previous test is made, the cut valves will be closed leaving one of the sides open for free outlet. Then a blow out test with gas is made through the source units to remove all solid particles that may have gathered. Increase conduit pressure to make safety valves go off. Once the central unit and the source unit are installed, make the whole equipment undergo one and half times its usage pressure and a minimum of 10 Kg./cm2. Check independently any of the systems. Isolate the medical gases conduits from the supply unit while safety valves are kept opened. Check that each gas goes off through its due outlet and not through other gases outlets. Check up to be made System airtightness. Airtightness of the cut valves. Removal of solid particles from conduits. Safety valves operation. Airtightness of the system. Checking that there are no crossed connection with other systems and outlet interchangeability. Nº of check ups The whole system. All the valves. All the intakes. All the valves. The whole system. All the outlets. Rejection parameters If after 12 hours there are some pressure changes due to reasons different to temperature changes. If there is some type of leakage in any valve after the first 15 minutes. There is no gas going out from the source units. The safety valves go off within the safety margins. If after 12 hours and when the pressure goes down there is some leakage detected by the manometer. No gas from the compressed air test goes off or it goes off through the outlets of other gases. SURGICAL SUITE. STANDARDS AND RECOMMENDATIONS 163

168 Test Check up to be made Nº of check ups Rejection parameters Check that it goes through this system and not through other. Cause a pressure drop in the system. Checking the change from the supply source to the emergency source. The whole system. There is no change to the emergency source. At the same time than in the previous test when the pressure drop takes place. Checking alarm systems. The whole system. No alert goes off. Simulate that there has been a power supply failure in the building. Checking the power supply/ emergency capacity The whole system. The system does not turn on. Air the system from the test gas and purge the oxygen system with enough time for a complete purge cycle. Purging the system. All the intakes and outlets. No pure compressed air goes off from any outlet. Table 7.2. Compressed medical air system. Check up to be Test made The system will be subject to one and half times its operation pressure and to a minimum of 10 Kg./cm2. Once the previous test is made, the cut valves will be closed leaving one of the sides open for free outlet. Then a blow out test with gas is made through the source units to remove all solid particles that may have gathered. Increase conduit pressure to make safety valves go off. Once the central unit and the source unit are installed, make the whole equipment undergo one and half times its usage pressure and a minimum of 10 Kg./cm 2. System airtightness. Airtightness of the cut valves. Removal of solid particles from conduits. Safety valves operation. Airtightness of the system. Check up to be made The whole system. All the valves. All the intakes. All the valves. The whole system. Rejection parameters If after 12 hours there are some pressure changes due to reasons different to temperature changes. If there is some type of leakage in any valve after the first 15 minutes. There is no gas going out from the source units. The safety valves go off within the safety margins. If after 12 hours and when the pressure goes down there is some leakage detected by the manometer 164 REPORTS, STUDIES AND RESEARCH

169 Test Check up to be made Check up to be made Rejection parameters Check independently any of the systems. Isolate the medical gases conduits from the supply unit while safety valves are kept opened. Check that each gas goes off through its due outlet and not through other gases outlets. Checking that there are no crossed connection with other systems and outlet interchangeability. All the outlets. No gas from the oxygen test goes off or it goes off through the outlets of other gases. Check that it goes through this system and not through other. Cause a pressure drop in the system. Checking the change from the supply source to the emergency source. The whole system. There is no change to the emergency source. At the same time than in the previous test when the pressure drop takes place. Checking alarm systems. The whole system. No alert goes off. Simulate that there has been a power supply failure in the building. Checking the power supply/emergency capacity The whole system. The system does not turn on. Air the system from the test gas and purge the oxygen system with enough time for a complete purge cycle. Purging the system. All the intakes and outlets. No pure oxygen goes off from any outlet. Table 7.3. Vacuum system. Test The test will be made prior to the installation of the intakes with the zoning valves opened and the sides of the conduits closed by means of plugs. The system will be subject to a pressure of 70 m.w.c. Once the previous text is done, and without removing the pressure from the conduits, the zoning valves of the by-passes will be closed leaving them thus, without any pressure. Once the airtightness of the bypass areas is checked-up, the valves of the columns will be closed removing pressure from them for check-up. Check up to be made Conduit airtightness. Zoning valves airtightness. Check up to be made The whole system. All the valves. Rejection parameters If after 12 hours a pressure loss to 1 w.m.c. occurs or there is some leakage during the test. There is a leakage in any valve 15 minutes after being under pressure. SURGICAL SUITE. STANDARDS AND RECOMMENDATIONS 165

170 Test Check up to be made Check up to be made Rejection parameters Once the intakes and outlets are installed, the system is subject to a pressure of 40 m.w.c. for 12 hours. Intake and outlet airtightness. All the intakes and outlets. There is a leakage at any intake or outlet during the test. Reduce the pressure of the system in 7 m.w.c. from air pressure; isolate the other medical gas conduits from the supply unit keeping all zoning valves open. Check that air flows from all vacuum outlets and not from any other. Checking that intakes and outlets are not connected to other conduits. All the valves. No air goes off from any of the vacuum outlets or from any of other gas outlets. Set the whole system in vacuum conditions with levels of 7480 m.w.c. Airtightness control under vacuum conditions. The whole system. 4 hours before, the low pressure has gone down more than 75 mm.w.c. It will be checked the rotation direction of the pumps, the absorbed current in full load and the device for its alternative operation. Operation of the mechanical and electrical system. The whole system. Any difference or deficiency from the specified characteristics. Unusual noises or vibrations. Table 7.4. Nitrogen protoxide system. Check up to be Test made The system will be subject to one and half times its operation pressure and to a minimum of 10 Kg./cm2. Then a blow out test with gas is made through the source units to remove all solid particles that may have gathered. Increase conduit pressure to make safety valves go off. System airtightness. Removal of solid particles from conduits. Safety valves operation. Check up to be made The whole system. All the intakes. All the valves. Rejection parameters If after 12 hours there are some pressure changes due to reasons different to temperature changes. There is no gas going out from the source units. The safety valves go off within the safety margins. 166 REPORTS, STUDIES AND RESEARCH

171 Test Check up to be made Check up to be made Rejection parameters Once the central unit and the source unit are installed, make the whole equipment undergo one and half times its usage pressure and a minimum of 10 Kg./cm 2. Airtightness of the system. The whole system. If after 12 hours and when the pressure goes down there is some leakage detected by the manometer. Check independently any of the systems. Isolate the medical gases conduits from the supply unit while safety valves are kept opened. Check that each gas goes off through its due outlet and not through other gases outlets. Checking that there are no crossed connection with other systems and outlet interchangeability. All the outlets. No gas from the nitrogen protoxide test goes off or it goes off through the outlets of other gases. Check that it goes through this system and not through other. Cause a pressure drop in the system. Checking the change from the supply source to the emergency source. The whole system. There is no change to the emergency source. At the same time than in the previous test when the pressure drop takes place. Checking alarm systems. The whole system. No alert goes off. Simulate that there has been a power supply failure in the building. Checking the power supply/ emergency capacity The whole system. The system does not turn on. Air the system from the test gas and purge the oxygen system with enough time for a complete purge cycle. Purging the system. All the intakes and outlets. No pure nitrogen protoxide goes off from any outlet Maintenance Specific maintenance of operating theatres is fundamental as it may affect their safety and the users safety. Systems may be divided in three: electric system, air conditioning mechanical system and medical gases system. The reference standard for maintaining these facilities is the following: Reglamento electrotécnico de baja tensión (Electrotechnical Regulations for Low Voltage). Reglamento de instalaciones térmicas en los edificios (Regulations of Thermal Installations in Buildings) The Spanish standard UNE :2005. SURGICAL SUITE. STANDARDS AND RECOMMENDATIONS 167

172 The Spanish standard UNE (Compulsory according to the Regulations of Thermal Installations in Buildings). The Spanish standard UNE :2006. The Spanish standard UNE :2005. As a general rule, there should be kept a registry of all the maintenance operation and former reports which could be easy to look up and available to the proper technical staff. Operations are classified in two levels: compulsory and common. Compulsory level means that it obeys an imposition of the Spanish current legislation. Common level means, that even though the procedure may not be compulsory as to the Spanish legislation, it is highly recommended by engineers, independent consultants, Spanish standards or manufacturers General aspects Maintenance staff must comply with the following requirements: There should be strictly devoted staff at critical areas. Maintenance programme should be exclusive. There should periodic internal controls and external controls regarding the maintenance. Maintenance should be done in accordance with cleaning staff and the person in charge of environmental control. Special attention should be paid to the air conditioning technical area. It should be kept perfectly clean. Quality conditions of the outside air intake should be checked up. The different sections of the air conditioning units should be periodically cleaned up. Special attention should be paid to the condensed battery. Conduits. The different filters of the air conditioners should be substituted. Periodic review of the humidifying units, its inside cleaning and the steam distribution system. At the operating theatre, special attention should be paid to: A strict scheme should be followed when performing the maintenance operations (waste, tools, spare parts, packing, etc.) Control of the dirt level of the absolute filters. Change filters. Periodic controls of the operation of control and measure devices. Keep airtightness conditions of the closing devices of the operating theatre. Check the historic records of the management system. 168 REPORTS, STUDIES AND RESEARCH

173 Below are provided the specific maintenance operations to be performed on the equipment and devices of the electric and air conditioning systems Electric system Equipment: The whole system Frequency: Weekly Level: Compulsory Legislation: Reglamento de Baja Tensión (Electrotechnical Regulation for Low Voltage). ITC-BT Check up of the isolation control system and of the protection systems Write down in the maintenance registry of the operating theatre. Any problem or anomaly would be informed to the operating theatre maintenance manager. Equipment: Uninterrupted Power Supply (UPS) Frequency: Fortnightly Level: Common 01.- Check the correct working and no power position of the alarms Check the correct load level of the batteries through the display Check the connection to life support systems. * The results of the check up will be written down in the maintenance book of the operating theatre. Equipment: The whole system Frequency: Monthly Level: Compulsory Legislation: Reglamento de Baja Tensión (Electrotechnical Regulation for Low Voltage). ITC-BT Perform insulation continuity and resistance measurements Write down in the maintenance registry of the operating theatre.. Any problem or anomaly would be informed to the operating theatre maintenance manager. SURGICAL SUITE. STANDARDS AND RECOMMENDATIONS 169

174 Equipment: The whole system Frequency: Yearly Level: Compulsory Legislation: Reglamento de Baja Tensión (Electrotechnical Regulation for Low Voltage). ITC-BT-38 Tasks to be performed by an officially authorized company: 01.- Check the correct operation of the protection measures Check the continuity of the active conductors, of the protection conductors and of the ground wire Check the resistance of the protection conductor connections and of the equipotentiality connections Check the isolation resistance between active conductors and ground wire in each circuit Check the resistance of the ground wire Check the isolation resistance of electrostatic floors Check the operation of all additional supplies. * The results of the check up will be written down in the maintenance book of the operating theatre Air conditioning system Equipment: Air conduits and additional elements Frequency: Annual Level: Common Legislation: Recommended by the Spanish standard UNE : Determine if there is a need of hygienization by assessing the hygienization state of the system by means of a visual analysis, a study of the surface state and an analysis of the quality of the ventilation air. If hygienization is necessary, it is advisable to follow the hygienization protocols established by the Spanish standard UNE :2005. Equipment: Air conduits and additional elements Frequency: Annual Level: Compulsory 170 REPORTS, STUDIES AND RESEARCH

175 Legislation: Spanish standard UNE (Compulsory according to the Reglamento de Instalaciones Térmicas en los Edificios [Regulations for Thermal Installations in buildings]) Check the state of the insulation Check the airtightness inspecting the gaskets and the connections Check the lack of vibrations Check, adjust and balance the flows Clean any part of a conduit that may be dirty. Equipment: Air conduits and additional elements Frequency: Annual Level: Common Legislation: Recommended by the Spanish standard UNE Check up of the outside condition: rusted parts, joints, detached adhesive tape, lack of isolation, coatings, etc. Mend all problems found Airtightness check up. Identification of air leaks in joints or junctions: joint sealing Check up of conduit strains: carry out repairs on strains or use braces Check up for any sign of humidity or water leaks over the conduits Check up for the existence of corrosion in metal conduits. Cleaning and protection of rusty areas Check up for the condition of the junctions Check up for the condition of the outer thermal insulation and of the anti-steam device. Repair all problems found Check up of all the yokes and flexible or elastic joints with machines: correct all the broken points and leakages Check up of all the supports: testing the spacing, the clamps, the fixations to the braces, the stoppers of the clamps and that there are no vibrations Inside check up: accumulated dirt, loosening of panels, deflectors, isolations, etc. Clean if necessary, according to the Spanish standard UNE Inside check up of fibre glass conduits: check up if there is no damage in the surfaces that are in contact with air or if the fibre glass is eroded. Repair if needed Check up of the state of excluders and of the joints of the damper and substitute when necessary Check up of the closure and adjustment of the flow regulation manual airlocks. SURGICAL SUITE. STANDARDS AND RECOMMENDATIONS 171

176 Silencers 01.- Airtightness inspection: repair any air leak Check up the joints and elastic junctions of conduits and machines. Fix any possible problems Measure flows in circulation and load losses and compare with the values stated in the design. Motor regulation airlocks 01.- Check up for the conditions of sheets and stand hinges. Clean all surfaces that are in contact with air. Oil hinges if necessary Check up of the position of the airlocks. Manual opening and closure Check up of the securing of the sheets. Verify that there are no noises or vibrations caused by the air flow during the normal operation. Make the required adjustment if needed Check up of all the mechanical operated systems: tighten screws and balancing arms, and oil yokes if needed Check the state and operation of the servomechanisms. Tighten the connections. Check the responses to control orders Verify the stroke of monitored airlocks. Final check ups. Make any adjustment if necessary. Difussion, return and air extraction elements Check up of the outer condition: clean the surfaces and the influence areas Verification of the state of the sheet clamps. Check that there are no noises or vibrations caused by the air flow during normal operation. Make the necessary adjustments when needed Check the state and operation of the flow regulation airlocks, either manual and automatic. Check free opening and closure. Make the necessary adjustments when needed Check up deflectors. Make the necessary corrections on the orientation when needed Measure air flows to get samples and to make comparisons with the values settled at the design project Check the condition and the solidity of the frames and securing devices Check the seals of the diffusers to conduits and walls. Make the necessary adjustments when needed. 172 REPORTS, STUDIES AND RESEARCH

177 Plenum airlock 01.- Inspection of the sheet stand. Verification that there are neither noises nor strange rattling during operation. Check up of the closure of the air ways in stand by mode Cleaning of the exterior surfaces. Equipment: Air conduits and additional elements Frequency: Every two years Level: Common Legislation: Recommended by the Spanish standard UNE :2006 Breakfire airlocks 01.- Operation check up: removal of any obstacles for its free closing and opening Check up of the mechanism of action and its responses to control orders Check up of fuses and electric connections. Tighten the connections Check up of the condition of the blanking plate and confirm that it is opened after the check up procedure. Equipment: Air treatment units (Air conditioners) Frequency: Monthly Level: Compulsory Legislation: Reglamento de Instalaciones Térmicas en los Edificios (Regulations for the Thermal Installations in Buildings) IT Check up and clean filters. Renew them when necessary Visual inspection for leaks in the press, in the union and in the joint of pipes and accessories. Equipment: Air treatment units (Air conditioners) Frequency: Bimonthly Level: Common Legislation: Recommended by the Spanish standard UNE : Take to pieces and clean the nozzle and the electrodes (selfgenerating) of the humidifier Take to pieces and clean the drain pump of the humidifier Check that fans are properly tightened Check the appropriate operation of the intake and outlet airlocks. SURGICAL SUITE. STANDARDS AND RECOMMENDATIONS 173

178 05.- Check the differential pressure switches at the control system For humidity sheets humidifiers, disinfect or substitute if needed. Equipment: Air treatment units (Air conditioners) Frequency: Six-monthly Level: Compulsory Legislation: Reglamento de Instalaciones Térmicas en los Edificios (Regulations for the Thermal Installations in Buildings) IT 3 and Spanish standard UNE Oil airlocks Check the appropriate operation of the condensed fluids drain Check that there are no vibrations or noises Oil rollers and any mobile elements Check braces Check and adjust fan belts Check for rust and apply anti-oxidizing agents if necessary Clean and check for stagnation at the tray for condensed liquids Check the airtightness conditions of the joints Control thermal insulation Control anti-vibration stands Verify and adjust probes and other field elements Verify that valves work adequately according to the control orders Verify and adjust action devices of the mechanized valves Check airtightness of interception valves Review and clean water filters Clean the outer cover and make a general review of the batteries. Check that there are no leaks. Equipment: Air treatment units (Air conditioners) Frequency: Six-monthly Level: Common Legislation: Recommendations of the Spanish standard UNE : Determine whether it is necessary to undergo any hygienization procedure by asessing the state of the system hygienization through a visual analysis, obtaining samples from the surfaces and analysing the quality of the ventilation air. It is advisable to follow the hygienization protocols established by the Spanish standard UNE : REPORTS, STUDIES AND RESEARCH

179 Equipment: Air treatment units (Air conditioners) Frequency: Annual Level: Compulsory Legislation: Reglamento de Instalaciones Térmicas en los Edificios (Regulations for the Thermal Installations in Buildings) IT Clean the outside and make a general review of the batteries and check that there are no leaks Check circulation within batteries; purge if necessary Verify that there are no leaks in the visible areas of the pipe system; check that distribution circuits are airtight. Equipment: Air treatment units (Air conditioners) Frequency: Annual Level: Common Legislation: Recommendations of the Spanish standard UNE :2006 IN 01.- Check up of the conditions of the outer surfaces, cleanness and rust removal Control de state of paint in the outside Check up of outside protection covers Check up door locks and dampers Mend and change (when needed) of excluders Clean inner surfaces of all sections and units State control and functionality of the anti-vibrations stands Check of the condition of surface sealing, joints and roofing felt. Repair if necessary Control unit union screws Replace rusty screws Check the condition of the inside thermoacoustic isolation system and repair if necessary Check the inside lighting circuit. Equipment: Filters Frequency: Monthly Level: Common Legislation: Recommendations of the Spanish standard UNE :2006 IN 01.- Check that there are no air leaks in panel joints, doors or dampers Verify the condition and the cleanness of the air filters. Clean or rather substitute when needed. SURGICAL SUITE. STANDARDS AND RECOMMENDATIONS 175

180 Equipment: Filters Frequency: Annual Level: Common Legislation: Recommendations of the Spanish standard UNE :2006 IN 01.- Check up of the conditions of the outer surfaces, cleanness and rust removal Control de state of paint in the outside Check up door locks and dampers. Mend and change (when needed) of excluders Control unit union screws. Replace rusty screws Clean the inner surfaces of the units and filtering sections Check the condition of the inside and outside thermoacoustic isolation system and repair if necessary Check of the airtight conditions of the frame holders and of the filter holder frames and repair if necessary. Equipment: Filters Frequency: Biyearly Level: Common Legislation: Recommendations of the Spanish standard UNE :2006 IN 01.- Check up of the condition and airtightness of the flexible joints in the flanges of conduits and repair if needed Verify the appropriate operation of the automatic alarm system for dirty filters. Equipment: The whole system Frequency: Annual Level: Common Legislation: Spanish standard UNE : Make hygiene analysis according to the protocol: A.- Measure airtightness between the joint of the filtering cellule and the airtightness profile of the standing casing. B.- Particle count: Particle count in type I premises will be directly made in the pulsed air flow. C.- Microorganism concentration measurement on air: measurement should be made in operating theatres and in the other type I premises in the pulsed air flow and behind the unit. 176 REPORTS, STUDIES AND RESEARCH

181 D.- Check up for the direction of the air flow: it should be done in a closed room by means of a smoke test Medical gases Equipment: Gases storage Frequency: Six-montly Level: Common 01.- Check the number of connected bottles and the number of stock bottles Change and put into operation stock bottles for a minimum of 10 minutes Check service pressure Verify that there are no leaks Verify that the optical and acoustic alarm switchboard works properly Verify that the hoses are in good condition. Equipment: Gas intake Frequency: Six-montly Level: Common 01.- Check that there are no leaks in the intakes Verify that the exit pressure is appropriate. Equipment: Pipes and additional elements. Frequency: Six-montly Level: Common 01.- Clean filters and drain-valves. Renew filters depending on usage rate Purge the circuit Verify that there are no leaks in joints and filters Verify that safety valves work properly Make a deep cleaning of all elements Check visually the outer conditions of the coils Check the use-by date of the flexible elements. SURGICAL SUITE. STANDARDS AND RECOMMENDATIONS 177

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183 8. Human resources This chapter is devoted to those criteria and recommendations related to human resources management, including administrative (register, qualifications, etc), training factors and guiding criteria which can help calculate the necessary resources Healthcare staff register Healthcare centres should have an update staff register whichever their contractual relationship with the centre, and the way or the place in which they render their services. This register will include the following information: registration number, full name, qualifications, professional category, speciality, function, nature of relationship with the centre or organization and, where appropriate, date of leaving, dismissal or retirement and, all the additional information required to comply with the general principles established by the Spanish National Health Interterritorial Board pursuant to all legislation on the medical profession. The staff register will be updated whenever there is any change on the staff and it will be reviewed at least once every three years, checking that all staff meets the necessary criteria for the exercise of their profession Personal file Healthcare centres will keep a personal file on each worker, retired employees too, including all documents relating to the qualification, specialized training, professional experience and work life. The people concerned will be entitled to access these files. Safety and confidentiality of all staff data will be guaranteed Qualifications Staff will work under the principles, the conditions and the requisites established in the medical profession law and in other legal and deontological ethic code applicable (68). The staff of the Surgical Suite will have the following functions and qualifications: (68) Act 44/2003, November, 21st, de ordenación de las profesiones sanitarias (on medical profession). SURGICAL SUITE. STANDARDS AND RECOMMENDATIONS 179

184 SS manager: He/she will be an anaesthetist or a surgeon of any of the services. He/she will be the head of the unit and thus will be, according to the management profile included in section 5.6.1, responsible for: Organizing a group of healthcare staff, from different medical services, under a protocolled and agreed consensus framework, making an appropriate use of the allocated resources to reach the unit objectives. Programming the unit, adapting demand to the resources available. Optimizing operating theatre usage, organizing processes to allow fulfilling the surgery schedule and adopting the necessary measures to begin sessions on time, to reduce idle times and to minimize avoidable cancellations. Carrying out the recommendations made by the operating theatre committee and watching over the standards on unit operation as well as assuring patients safety. Controlling the unit quality. The SS manager and the person responsible on his/her absence should be of public knowledge and, therefore, it must be indicated in the unit regulations. SS supervisor: he/she will be a registered nurse and will be, according to the management profile included in section , responsible for: Assigning and distributing scheduled surgery on the appropriate operating theatres, regarding the specific requirements of each procedure. Coordinating healthcare services according to the SS service portfolio. Programming the activities of the nursing staff. Controlling the adequacy and the availability of material resources and assuring that they are safely used. Surgeon: physician specialized in any of the services included in the SS. As a rule, and according to the procedure, there would be a head surgeon and a variable number of assistants. Anaesthetist: physician specialized in anaesthesiology and resuscitation. Registered nurse: he/she will be in charge of the surgery care at the operating theatre as surgery nurse, scrub nurse or at the PACU. Nursing assistant: at the operating theatre and at the PACU. Auxiliary staff: orderlies and cleaners. Administrative assistant: administrative and secretary work. 180 REPORTS, STUDIES AND RESEARCH

185 Staff ascribed to the SS will perform the duties attached to their professional status according to the working protocols and procedures included on the centre regulations and under the directions of the person in charge Identification and discrimination of staff members Healthcare centres will take the necessary measures to guarantee that patients and escorts can identify staff and distinguish the qualifications and the professional category of the people that are caring them. Healthcare staff are differentiated by their working categories and they would be identified by means of a personal ID tag which will clearly show the full name and the category. Healthcare staff are obliged to identify themselves when required by the patient or user, indicating their full name, their professional qualifications and their services, as well as the category and role whenever previously determined Documentation Healthcare centres with SSs will provide staff for the correct exercise of the profession and always according to their category, the following resources: a) Patient s clinical records. b) Healthcare and clinical practice guides, pathways and protocols. c) Internal regulations as well as the general objectives and functions of the healthcare unit. d) Healthcare, informative and statistical documents set by the centre. e) The procedures, reports, joint protocols or indicators that may help to guarantee continued patient care. f) DPA fulfilment Undergraduate and postgraduate training on health science Future aims In the upcoming years, teaching of medicine and specialist training should include not only new healthcare modalities but also current trends in SURGICAL SUITE. STANDARDS AND RECOMMENDATIONS 181

186 medicine, cost-effective use of technological advances, quality control, competence of service supplies, elaboration of clinical pathways and guides. Namely, it should adapt to clinical management techniques. The following aims should be met: 1. To take advantage of the large volume of surgery patients for the practical experience of medical students. 2. To train medical interns on the different functional elements of the SS. 3. To contribute on the promotion of the basic principles of managed healthcare, through the two previous aims Training for undergraduates and postgraduates Medical students and interns of family practice in general and specifically interns of SS services should be aware of the specific characteristics of this healthcare modality. Specialized training will adjust to the different programmes settled by the national commissions of the different specialities. Nurses will have to be trained on and be competent in this type of healthcare service before beginning the practice due to the high amount of patients and the diversity of procedures Continued training The SS unit will take the necessary measures to allow staff to receive continued training and to undergo research and training activities related to it. Training programmes to keep staff up to date on patients safety and quality should be provided, according to the unit characteristics Criteria for the calculation of staffing levels Staffing levels vary according to the service portfolio of the unit and to the organizational and management criteria of each individual unit. The criteria provided below are, therefore, purely illustrative, and would correspond to a Surgical Suite in a hospital operating with a fully computerized clinical record and administrative and clinical management system. 182 REPORTS, STUDIES AND RESEARCH

187 Each surgery team should have, at least, a surgeon and a number of assistants appropriate to the procedure, an anaesthetist, and two nurses, one acting as scrub nurse and the other one as a circulating nurse. As an aid to the surgery team, the unit will have the sufficient support staff (nurse assistants, porters, cleaners) to keep activity within schedule and, when needed, to make possible urgent procedures. As far as possible, and whenever the size and the volume of activity allow it, it is advisable that the activities of this staff should be scheduled so that they can assist at the highest number of operating theatres as possible in a situation that would be compatible with normal surgery activity. The post-anaesthesia recovery area should have a nurse and a nurse assistant available for every three patients that are being cared of at this area. The number of patients being cared of at the postanaesthesia recovery area may not necessary be the same to the number of patients that have undergone surgery, depending on the type of anaesthesia, the complexity of the surgery procedure and the care needs of the patients. Administrative assistant. At the SS there should be at least one administrative assistant. This number may vary according to the dimensions of the SS, if the centre is fully computerized or not and on the existence of a pre-operative reception area which may avoid unnecessary previous day admissions. It also depends on the distribution of administrative support and structural processes among the surgical suite and other hospital units. SURGICAL SUITE. STANDARDS AND RECOMMENDATIONS 183

188

189 9. Quality indicators Quality indicators must be followed by the management staff of the SS, including those relating to efficiency 6,29. However, most of the available indicators, including those of the AHRQ 16 or those for hospitals of the British del NHS 104, refer to final services and reflect the global functioning of the hospital. The Surgical Care Improvement Project (SCIP) has set up a group of measures and results which respond to the general operation of the hospital. It also uses a set of indicators that refer to processes and results which includes those indicators relative to nosocomial infections and to deep vein thrombosis 105. The Audit Commission used a set of indicators related to the operation of the SS 106, and the British NHS has prepared a set of key indicators for the operation of SS 33. According to the available information, a set of indicators has been selected related to the specific operation of the SS and which is included in the table below. Table 9.1. Quality indicators at the SS Quality dimension Scientifictechnical efficiency and quality of the SS. Usage Indicator 1. Cancellation of procedure. 2. Average pre-operative stay for scheduled surgery with conventional hospitalization. 3. Average pre-operative stay for urgent surgery with conventional hospitalization. 4. Intra-operative mortality. 5. Adverse events rate. 6. Raw utilization of the operating theatre. 7. % of cancelled procedures. Calculation % (cancellations / patients with appointments). Time (days) since admission till the surgery procedure. Time (days) since admission in the E&R service till the surgery procedure. Sentinel event. Nº of adverse procedures / Nº of procedures. % (å Procedural times / Operating theatre available hours). % (cancellations/ total number of scheduled procedures) (scheduled procedures). SURGICAL SUITE. STANDARDS AND RECOMMENDATIONS 185

190 Quality dimension Patient s safety Indicator 8. % of patients that receive antibiotic prophylaxis one hour before the surgery incision. 9. % of surgery patients that receive appropriate antibiotic prophylaxis according to current information. 10. % of surgery patients who have not received continuous antibiotic prophylaxis 24 hours after surgery (48 hours for heart patients). 11. % of surgery patients with appropriate hair removal. 12. % of surgery patients who need deep vein thrombosis prophylaxis and receive it. 13. % of surgery patients who need deep vein thrombosis prophylaxis 24 hours before and after surgery. Calculation % (patients that receive antibiotic prophylaxis and hour before surgery incision / total number of surgery patients). % (surgery patients that receive appropriate antibiotic prophylaxis according to current information / total number of surgery patients). % (of surgery patients who have not received continuous antibiotic prophylaxis 24 hours after surgery (48 hours for heart patients)/ total number of surgery patients). % (surgery patients with appropriate hair removal / total number of surgery patients). % (surgery patients who need deep vein thrombosis prophylaxis and receive it / surgery patients who need deep vein thrombosis prophylaxis). % (surgery patients who need deep vein thrombosis prophylaxis 24 hours before and after surgery / surgery patients who need deep vein thrombosis prophylaxis). Quality perceived by SS user 14. % of surgery related pulmonary thromboembolism. % (surgery related pulmonary thromboembolism / total number of surgery patients). 15. Satisfaction index. % in each response category. 186 REPORTS, STUDIES AND RESEARCH

191 10. Criteria for the review and follow up of the standards and recommendations It is predictable that there would be important changes in the organization and management of the SS thanks mainly to the technical-scientific advances as well as for the steps forwards taken on IT and communications in the management of healthcare services. Therefore, it is highly recommended that this report should be reviewed and updated within ten years at the most, though this period may be shorter if changes make it necessary to modify any important aspect and/or any of its strong recommendations. Throughout the setting up process of this report, some lacunae have been identified, particularly on the availability of the information and on the proven experience about how SSs work in the Spanish health service. In order to improve this knowledge as the source for setting up recommendations based on evidence, or at least, on experience, it is recommended that the next review should provide apart from the topics included in this document, the following: From the analysis of the legislation on the authorization and registry of SS that autonomous regions have developed it has been found out the underlying need to make a proposal for the review and the standardization of this legislation and its accommodation to the standards and recommendations included in this document, so as to base them in scientific evidence. An analysis of the whole surgery discharges, coded according to the MBDS and grouped according to processes / procedures (DRG or index used in the whole Spanish National Health Service), including private healthcare centres. A taxonomy or a safety glossary and a registry of adverse events for the communication and evaluation of adverse events which may be used in the whole Spanish National Health Service A research on procedural times according to processes / procedures in the Spanish National Health Service which may allow resource planning based on the case-mix and benchmarking of each hospital within the standard of the Spanish National Health Service. A common definition for the Spanish National Health Service of all the data, and the procedural times, which may allow evaluation and comparison among all centres of the Spanish National Health Service SURGICAL SUITE. STANDARDS AND RECOMMENDATIONS 187

192 A systematic analysis of the quality indicators of the SS of the Spanish National Health Service which will comprise the set of indicators recommended in chapter 8 of this document of Standards and Recommendations. An evaluation and a consensus in relation with adopting a more elaborate classification of surgery in relation with emergency procedures than the one that is currently used in Spain (NCEPOD or similar). A coding of anaesthesia types which may allow the standardization of the anaesthesia procedures for the whole Spanish National Health Service (as proposed by the Spanish Society of anaesthesiology and resuscitation). 188 REPORTS, STUDIES AND RESEARCH

193 Annex 1. Informed consent sample, including section for rejecting blood transfusion (69) at procedures LABEL (when needed, provide patient s name and location) Informed consent NAME:... AT (BED):... CRN: SERVICE: PROCEDURE: DATE:.../.../....GENDER:... Which procedure are you going to undergo? 1. Procedure description According to a diagnosis of we are going to perform a procedure which consists on: How it is performed La Paz University Hospital (Madrid). SURGICAL SUITE. STANDARDS AND RECOMMENDATIONS 189

194 How long does it take: Which are the objectives of the procedure: Are there any risks? 1. General risks: Frequent and not serious: Not frequent and serious: These complications are generally solved with medical care (drugs, solutions, etc.) but they can require a new operation procedure and may even bring up death risk. Moreover, unspecified complications may appear as in every procedure or at any postoperative period there can be unexpected problems and/or complications or even there may be necessary changes over the planned development of the procedure. 2. Other personal risks: Apart form the risks mentioned before due to the illness, there are other complications that may appear: PATIENTS SHOULD WARN IF THEY HAVE ANY DRUG ALLERGIES, COAGULATION DISORDERS, HEART AND LUNG DISSEASES, IF THEY HAVE ANY PROSTHESES, PACEMAKERS, UNDER WHICH MEDICATION ARE THEY AT THE MOMENT OR ANY OTHER DETAIL. 190 REPORTS, STUDIES AND RESEARCH

195 3. Benefits of the procedure in the short and medium term: Are there any other possibilities? Do you give us the authorization? We hereby request your authorization to perform the procedure and to use images and information from your clinical record with didactic and scientific purposes as you are being taken cared of at a university hospital. Your personal information will not be provided and you will remain anonymous. Statements and signatures Before signing the document, if you wish to receive further information or have any doubt regarding your disease, please do not hesitate to ask us. We would be delighted to help you. We hereby inform you that you have the right to revoke your decision and cancel your consent. In accordance with the Ley de Protección de Datos (Data Protection Act) 15/1999 from December 13 th we are pleased to inform you that your personal information will be processed and included in files with healthcaring, management and scientific investigation and teaching purposes. It could only be disclosed to authorized institutions. You have the right to access, block, remove and reject it at the Management Service to which the hospital belongs to. 1. Regarding the patient: Mr./Mrs..., I.D I have received enough information regarding the procedure I am going to undergo, I have been informed about the risks, the complications and the alternatives, I have understood it and I have had enough time to take and value my decision. Therefore, I am satisfied with the information I have received. Thus, I give my consent for the procedure to be performed by the responsible surgeon and/or an intern surgeon under the supervision of a specialized surgeon. I take this decision free and I can cancel this consent if I decide so. This decision will not have further consequences on future healthcare attentions. Due to my personal beliefs I DO NOT AUTHORIZE BLOOD OR BLOOD PRODUCTS PERFUSION before, during o after the procedure even though it should be necessary, even SURGICAL SUITE. STANDARDS AND RECOMMENDATIONS 191

196 in vital risk or death situations, assuming all the possible consequences that may derive from it. I know that I am being taken care of at a university hospital: I authorize YES NO the use of graphic or biologic material obtained from the procedure for didactic and scientific purposes.... This informed consent document should be handed duly fulfilled in order to begin the procedure, and thus you should not lose it nor leave it at home. Patient s signature Date: / / 2. Regarding the doctor that orders the procedure: Dr.... I have informed the patient and/or guardian and/or relatives of the purpose and type of the procedure that it is going to be performed, explaining clearly the risks, the complications and possible alternatives. Doctor s signature Date: / / 3. Regarding the doctor that performs the procedure: Dr.... I have informed the patient and/or guardian and or relatives of the purpose and type of the procedure that it is going to be performed, explaining clearly the risks, the complications and possible alternatives. Surgeon s signature Date: / / 4. Regarding relatives and guardians: Patient Mr/Mrs.... does not have the ability to take any decision at the moment. Mr. /Mrs.... I.D.nº.... and acting as... I have been sufficiently informed about the procedure that it is going to be performed. I therefore give my specific consent. I accept freely and thus I can cancel this consent whenever I consider it appropriate. Guardian or relative signature Date: / / 192 REPORTS, STUDIES AND RESEARCH

197 5. Consent cancellation: Mr./Mrs:... I.D. nº:.. I CANCEL the consent given before for the performance of this procedure of free will and I accept the consequences that may derive from it on the evolution of the disease I suffer from/ the patient suffers from. Patient s signature Date: /.../. SURGICAL SUITE. STANDARDS AND RECOMMENDATIONS 193

198

199 Annex 2. Surgical safety checklist (WHO, Spanish Surgeon Association) (70) BEFORE INDUCTION OF ANAESTHESIA: PATIENT HAS CONFIRMED: Identity Site Procedure Informed consent SITE MARKED / NOT APPLICABLE ANAESTHESIA SAFETY CHECK COMPLETED PULSE OXIMETER ON PATIENT AND FUNCTIONING DOES PATIENT HAVE A: Known allergy? NO YES Difficult airway / aspiration risk? NO YES Equipment/Assistance available Risk of > 500 ml blood loss (7 ml / kg in children) NO Adequate intravenous access and/or fluids planned NO YES YES BEFORE SKIN INCISION: CONFIRM ALL TEAM MEMBERS HAVE INTRODUCED THEMSELVES BY NAME AND ROLE SURGEON, ANAESTHETIST AND NURSE VERBALLY CONFIRM: PATIENT S IDENTITY SITE PROCEDURE 70 This is not a comprehensive list. Additions and modifications are recommended so that it can be adjusted to the centre practice. Source: WHO. Surgical Safety Checklist (First Edition): SURGICAL SUITE. STANDARDS AND RECOMMENDATIONS 195

200 1. ANTICIPATED CRITICAL EVENTS: SURGEON REVIEWS: WHAT ARE THE CRITICAL OR UNEXPECTED STEPS, OPERATIVE DURATION, ANTICIPATED BLOOD LOSS? ANAESTHESIA TEAM REVIEWS: ARE THERE ANY PATIENT-SPECIFIC CONCERNS? NURSING TEAM REVIEWS: HAS STERILITY (INCLUDING INDICATOR RESULTS) BEEN CONFIRMED? ARE THERE ANY EQUIPMENT ISSUED OR ANY CONCERNS? HAS ANTIBIOTI PROPHYLAXIS BEEN GIVIEN WITHIN THE LAST 60 MINUTES? YES NOT APPLICABLE IS ESSENTIAL IMAGING DISPLAYED? YES NOT APPLICABLE BEFORE PATIENT LEAVES OPERATING ROOM: NURSE VERBALLY CONFIRMS WITH THE TEAM: NAME OF THE PROCEDURE RECORDED THAT INSTRUMENT, GAUZE AND NEEDLE COUNTS ARE CORRECT (OR NOT APPLICABLE) HOW SPECIMEN/BIOPSIES IS LABELLED (INCLUDING PATIENT NAME) WHETHER THERE ARE ANY EQUIPMENT PROBLEMS TO BE ADDRESSED SURGEON, ANAESTHESIA PROFESSIONAL AND NURSE REVIEW THE KEY CONCERNS FOR RECOVERY AND MANAGEMENT OF THE PATIENT. 196 REPORTS, STUDIES AND RESEARCH

201 Annex 3. Communication system in the operating theatre (71) Problem analysis Communication problems have been the key source for adverse events at operating theatres as well as site and drug mistakes. Efficient communication must be an essential element in any team-based activity, mainly in relation to surgery procedures. Surgery teams Surgery teams are made up of a group of service purveyors that come from different services which may be, or not, acquainted with the other team members. At the same time, each purveyor has many specific priorities and restrictions on his/her field of work so that, many members rarely know important information regarding the patient when they arrive to the operating theatre. Objective of this system The purpose of this system is to provide a mean to communicate all surgery team members the necessary information for their efficient participation and to assure a safety and effective procedure. Who must use the system? Any member of the surgery team, usually the surgeon, may begin the information summary. However, surgery, anaesthesia and nursing members must share important information during this summary. When should be the instrument used? When all members of the surgery team are in the operating theatre and once the patient is anaesthetized (72). 71 Joint Commission on Accreditation of Health Care Organizations. Safety in the Operating Room. 2006, Figs. 1-1 and 1-2. taken from Johns Hopkins Medical Institutions. 72 The general opinion of a group of experts that has participated on the writing up of the Standards and Recommendations of the SS is that the system should be used before the patient is anaesthetized. SURGICAL SUITE. STANDARDS AND RECOMMENDATIONS 197

202 LIST OF TOPICS TO BE TACKLED This list helps to assure consistent and complete communication at the operating theatre. The surgeon is in charge of part I while all team members identify the relevant information in sections II and III. I. Name list and duties presentation, which are written down on the board (and introduced on the information system) II. Critical information review: Is the patient the right patient? Has the right site/side been marked? Has the procedure been previously determined? Has antibiotic prophylaxis been administered? III. Risk identification and reduction: Surgery: Describing critical moments. Providing the team with the relevant information, including the problems that may be found out. Ask the team: If something could go wrong on this procedure, which could it be and how could it be foreseen?: Risks during the procedures, as blood loss or other losses. The surgeon suggests: If somebody has a specific concern with this case, please, let me know Anaesthesia. Discuss the most relevant aspects: Comorbidity which may increase surgery risk such as the need of intravenous access. Blood and/or blood products availability. Procedures to prevent adverse events such as myocardial infarction of surgical wound infection. Nursing. Discuss the most relevant aspects: Is the necessary equipment available? Should be considered the need of special equipment? Plan shift changes (introducing oneself when taking over) 198 REPORTS, STUDIES AND RESEARCH

203 Annex 4. Surgery site marking recommendations (NPSA) (73) Pre-operative The National Patient Safety Agency (NPSA) and the Royal College of Surgeons of England (RCS) recommend pre-operative marking to show clearly the intended site for the surgery procedure. 1. How to mark An indelible marker pen should be used and an arrow drawn extending to or near to the incision site and remain visible after the application of skin preparation. It is desirable that the mark should remain visible after the application of surgery drapes. 2. Where to mark Surgical operations involving side (laterality) should be marked at, or near, the intended incision. For digits on the hand and foot, the mark should extend to the correct specific digit. The intended surgical site should be confirmed from reliable documentation and images. 3. Who marks Marking should be done by the surgeon or his/her assistant who will be present at the operating theatre during the procedure. 4. With whom Marking process must involve the patient and/or the relatives or the escort whenever possible. 5. Time and place The surgical site should ideally be marked on the hospitalization unit, on the pre-operative ward or at the day surgery unit, prior to patient transfer to the surgery suite. Marking should take place before pre-medication. 73 National Patient Safety Agency SURGICAL SUITE. STANDARDS AND RECOMMENDATIONS 199

204 6. Checking The surgical site mark should be checked before against reliable documentation to confirm if a) it is correctly located and b) it is still legible. This check up should be made after each care transfer of the patient and end with a check up previous to the start of the procedure. All team members should be involved in checking the mark. 200 REPORTS, STUDIES AND RESEARCH

205 Annex 5. Prevention of surgical site infection (74),107 Information for patients and carers. Provide patients and carers with clear, consistent and comprehensible information and advice through all the stages of the care process. The information must include: Risks of surgical site infections, how to prevent them and how to control them by means of an integrated care pathway. How to identify a surgical site infection and who to contact if they are worried. How to care for the wound after discharged. When do they have to receive antibiotics, before and after the procedure. Pre-operative stage Shower Advise patients to shower the day before or the day of the procedure. Hair removal Dot not remove hair routinely to reduce the risk of surgical site infection. When needed, use single-use head clippers on the day of the procedure. Do not use razors as they increase the risk of surgical site infection. Theatre wear Provide patients with theatre wear appropriate for the procedure. Patient s comfort and dignity should be considered. Staff should wear non-sterile theatre wear from a different colour from the wear they use in other areas of the hospital, and restrict their movements from inside and outside the suite to a minimum. Surgery team should remove artificial nails, nail polish and hand jewellery before operations. 74 Adapted from Leaper D. et al. Prevention and treatment of surgical site infection: summary of NICE guidance 107. SURGICAL SUITE. STANDARDS AND RECOMMENDATIONS 201

206 Nasal decontamination Do not use nasal decontamination with topical antimicrobial agents for eliminating Staphylococcus aureus routinely to reduce the risk of surgical site infection. Mechanical bowel preparation Do not use mechanical bowel preparation routinely to reduce the risk of surgical site infection. Antibiotic prophylaxis and treatment Give patients antibiotic prophylaxis before: - clean surgery involving prosthesis or implant; - clean-contaminated surgery; - contaminated surgery. Give antibiotic treatment (in addition to prophylaxis) to patients having surgery on a dirty or infected wound. Consider giving a single dose of antibiotic prophylaxis on starting the anaesthesia or earlier in those procedures in which a tourniquet is used. Give a repeat dose if the procedure is longer than the half-life of the antibiotic given. Do not use antibiotic prophylaxis routinely for clean, non-complicated, non-prosthetic procedures. Intraoperative stage Hand decontamination Before to the first operation, the surgery team should wash their hands with an antiseptic surgical solution using a pick for the nails. Team members must assure that hands and nails are visibly clean. Before the subsequent operations, hands should be washed using either a alcoholic hand rub or a antiseptic surgical solution. If hands are soiled, they should be washed again with an antiseptic surgical solution. Sterile gowns and gloves The surgery team should wear sterile gowns in the operating theatre during the operation. Consider wearing two pairs of sterile gloves when there is a high risk of glove perforation and the contamination consequences may be serious. 202 REPORTS, STUDIES AND RESEARCH

207 Incise drapes If incise drapes are requires, used iodophor-impregnated unless the patient has iodine allergy. Antiseptic skin preparation Prepare the skin at the surgical site immediately before the incision using and antiseptic preparation (chlorhexidine or povidone-iodine). Diathermy Do not use diathermy for surgical incision to reduce the risk of surgical site infection. Maintaining patient homeostasis Maintain optimal oxygenation, perfusion and temperature during the procedure. Do not give insulin routinely to patients who do not have diabetes to optimise blood glucose postoperatively as a means of reducing the risk of surgical site infection. Wound irrigation and intracavity lavage Do not use it as a means of reducing the risk of surgical site infection. There is no need of antiseptic or antimicrobial agents before wound closure. Wound dressing Cover incisions with an appropriate dressing at the end of the procedure. Post-operative stage Post-operative cleansing and dressings change. Advise patients that they may shower 48 hours after surgery. Use an aseptic non-touch technique for changing and removing surgical wound dressings. Use sterile saline for wound cleansing up to 48 hours after surgery. Then use tap water if the surgical wound has separated or if it has been surgically opened to drain pus. SURGICAL SUITE. STANDARDS AND RECOMMENDATIONS 203

208 Wound healing by primary intention. Do not use antimicrobial agents to reduce the risk of surgical site infection. Wound healing by secondary intention. Refer patient to a cosmetic surgery service for assessment on the appropriate use of Interactive dressing. Do not use chlorine solutions and gauze, moist cotton gauze or mercuric antiseptic solutions. Treatment of surgical site infection When surgical would infection is suspected, either de novo or because of treatment failure, use an antibiotic that covers the likely causative organisms, taking into account local resistance patterns and the results of microbiological tests. If debridement proves necessary, do not use chlorine solutions, gauzes, dextranomer or enzymatic treatments. Specialist care services. Provision of specialist wound care services (including pre-operative assessment to identify individuals with potential wound healing problems) is required in order to improve management of surgical wounds. 204 REPORTS, STUDIES AND RESEARCH

209 Annex 6. Pre-operative hand washing with alcohol based solution (75) Fig. A.6.1. Educational poster of handwashing 75 University Hospital La Paz (Madrid). The NICE guide (Annex 5) recommends that the first hand wash should be done with a surgical solution (chlorhexidine or povidone) while after the first procedure alcohol based hand rub is accepted. Alcohol based hand washing is accepted is hospitalization wards, investigation and treatment units, etc to avoid croosed infections 61. SURGICAL SUITE. STANDARDS AND RECOMMENDATIONS 205

210

211 Annex 7. Informed consent protocol (76) LABEL (When needed, provide patient s name and location) Name:... At (bed):... CRN:... Date:.../.../... Gender:... Informed consent Service: GENERAL ANAESTHESIA / LOCO REGIONAL / SEDATION Which procedure are you going to undergo? 1. Procedure description What does the procedure entail?: general anaesthesia implies losing consciousness and pain sensation. Since the beginning to the end of the anaesthesia you will feel quiet, in a condition similar to sleep. Loco-regional anaesthesia implies drug injection on the surgery sites which makes the area lose all feeling. Sedation means taking a drug that will relax and calm the patient down during the procedure. How it is made: the procedure begins with a preparation injection (pre-medication) which may be enough for short procedures. In longer operations, the pre-medication would be followed by drug vein perfusion or by the inhalation of gas by means of a mask or of a tube. In anaesthetic intubation, the patient will receive oxygen and anaesthetic gas by means of a tube that is introduced through the mouth once the patient is unconscious. Intubation provides high security breathing levels and protects lungs from the consequences of vomiting. Loco-regional anaesthesia is applied by means of an injection either on the lumbar area of the back or in an area closed to the surgery site. During the procedure, a specialist would control the patient and would value by different monitoring devices the anaesthetic requirements and the body response. 76 University Hospital La Paz (Madrid). SURGICAL SUITE. STANDARDS AND RECOMMENDATIONS 207

212 After the procedure the patient would be transferred to the post-anaesthesia care unit so that he/she may be under control until the complete recovery from anaesthesia. How long does it take: duration will depend on the procedure to be performed. 2. Which are the objectives of the procedure: to allow the performing the operation without suffering from any pain and in the best conditions for the doctor. Are there any risks? 1. General risks: The rate of complication appearance is rather low though no operation is risk-free. In general they are minor and can be solved, though there is a possibility of serious injuries in vital organs (1 each 10000). Common risks to the different types of anaesthesia: Allergies to the fluids or drugs used; they may occur even if there are no previous allergies known and can be minor or serious. Nausea, vomit, urinating difficulty and muscular pain on the days following the procedure. Phlebitis and/or trombophlebitis (inflammation of the veins). Skin burns or electrocution due to the usage of electric devices during the operation. Unexpected heart arrest with the result of death, comma, or irreversible brain damage. There is higher risk for patients suffering from heart diseases, elderly patients, on general anaesthesia procedures and on emergency surgery. General anaesthesia risks: Allergies to blood or blood products. Acute and serious non infectious fever reaction (malign hyperthermia) Breathing problems; patients suffering from breathing problems, obesity, face and neck anomalies or with muscular diseases. Neumothorax (air on the pleural cavity, which covers the lungs): it can be due to a central vein puncture (neck vein), to nerve blockade or to artificial breathing. Teeth break, moving or accidental extraction when intubation. Vocal cord suffering and eye wounds. Nervous postural affectation. Depression, nightmares or postanaesthesia neurosis. Risk of the epidural anaesthesia, rachianaesthesia and nervous blockade. Ecchymosis, haemorrhage or infection in the puncture area. Meningitis, at rachial punctures. Injuries of the anaesthetized nerves causing an alteration of the sensibility and/or paralysis of the anaesthetized members, which can be either partial or total and either transitorily or permanent. Headache and vision disorders. However, should any complication arise, be sure that all the resources of this hospital will be available to solve it.

213 2. Other specific risks: Apart form the risks mentioned before due to the illness, there are other complications that may appear 3. Benefits of the procedure in the short and medium term: It allows to perform the diagnosis procedure or the operation with a high level of wellness and safety. Are there any other possibilities? To perform your procedure, general, regional or local anaesthesia or sedation is necessary. Do you give us the authorization? We hereby request your authorization to perform the procedure and to use images and information from your clinical record with didactic and scientific purposes as you are being cared of at a university hospital. Your personal information will not be provided and you will remain anonymous. Statements and signatures Before signing the document, if you wish to receive further information or have any doubt regarding your disease, please do not hesitate to ask us. We would be delighted to help you. We hereby inform you that you have the right to revoke your decision and cancel your consent. In accordance with the Ley de Protección de Datos (Data Protection Act) 15/1999 from December 13th we are pleased to inform you that your personal information will be processed and included in files with healthcaring, management and scientific investigation and teaching purposes. It could only be disclosed to authorized institutions. You have the right to access, block, remove and reject at the Management Service to which the hospital belongs to. 1. Regarding the patient: Mr./Mrs..., I.D.... I have received enough information regarding the procedure I am going to undergo, I have been informed about the risks, the complications and the alternatives, I have understood it and I have had enough time to take and value my decision. Therefore, I am satisfied with the information I have received. Thus, I give my consent for the procedure to be performed by the responsible surgeon and/or an intern surgeon under the supervision of a specialized surgeon. I take this decision free and I can cancel this consent if I decide so. This decision will not have further consequences on future healthcare attentions....

214 I AUTHORIZE blood or blood product perfusion during the surgery procedure if it is necessary for treating my condition. I know that I am being taken care of at a university hospital: I authorize YES NO the use of graphic or biologic material obtained from the procedure with didactic and scientific purposes.... This informed consent document should be handed duly fulfilled in order to begin the procedure, and thus you should not lose it nor leave it at home. Patient s signature Date: / / 2. Regarding the doctor that orders the procedure: Dr... I have informed the patient and/or guardian and or relatives of the purpose and type of the procedure that it is going to be performed, explaining clearly the risks, the complications and possible alternatives. Doctor s signature Date: / / 3. Regarding the doctor that performs the procedure: Dr... I have informed the patient and/or guardian and or relatives of the purpose and type of the procedure that it is going to be performed, explaining clearly the risks, the complications and possible alternatives. Surgeon s signature Date: / / 4. Regarding relatives and guardians: Patient Mr/Mrs.... does not have the ability to take any decision at the moment. Mr. /Mrs.... I.D.nº.... Guardian or relative signature Date: / / 5. Consent cancellation: Mr./Mrs:... I.D. nº:... I CANCEL the consent given before for the performance of this procedure of free will and I accept the consequences that may derive from it on the evolution of the disease I suffer from / the patient suffers from. Patient s signature Date: /.../. 210 REPORTS, STUDIES AND RESEARCH

215 Annex 8. Patient circulation flow protocol at the SS (77) The operation area of a hospital is considered a special area due to the necessary defence against infections, compulsory at the surgery procedure. Zone division of the SS is settled in two main areas: highly restricted surgery area, and restricted surgery area. Recommendations concerning hospital clothes, patient and staff circulation flows and access restrictions are different for each area and they should be clearly signposted. Surgery area signposting There are four types of boards according to the place where they are located and the information they provide. a) Entrance to the restricted surgery area. b) Entrance to the highly restricted area. c) Operating theatres. d) Area for information to relatives. Fig. A.8.1. Surgery area signposting ÁREA QUIRÚRGICA 77 Pajuelo A (Coord.). Bloque Quirúrgico. Proceso de Soporte. Consejería de salud Annex 7. With permission. SURGICAL SUITE. STANDARDS AND RECOMMENDATIONS 211

216 Authorized relatives can only access the resuscitation area: Must wear previously: Disposable green gown. Disposable shoe covers. Staff access regulations Restricted surgery area (Area Quirúrgica Estricta) White clothes. Shoe covers or exclusive shoes of the area. Fig. A.8.2. Sign indicating highly restricted area of surgery Highly restricted surgery area access No admittance Limited access Operating theatre entrance regulations: COMPULSORY USE OF Surgery wear (green) Shoe covers or exclusive shoes of the area. Cap Mask Staff who does not belong to the surgery team will only enter the operating theatre on strictly justified reasons, trying to avoid it while there is a procedure going on. 212 REPORTS, STUDIES AND RESEARCH

217 Annex 9. SS sectoring and patient circulation flow (78) The SS is divided on the following areas (Figure 1): Non-restricted area (yellow): it includes the staff toilets, the patient reception area, the central control desk of the operating theatres, the SS secretary s office, the information office for relatives, the staff work room and the staff resting room. The staff who works at the SS wears blue clothes and blue clogs or shoe covers when needed. (figure 2). The staff that, coming directly from the outside of the SS may want to accede the offices, will wear hospital clothes. This area is separated from the semi-restricted area by the nurse control from the patient reception area. In this control the request and reception of patients is centralized. Semi-restricted area (purple): it includes the access corridor to operating theatres and supply rooms. Staff must wear surgery wear, with a cap covering all the hair and with shoes used exclusively at the surgery area (figure 2). Patients, that are transferred in their beds or in gurneys to the operating theatres will wear an open gown and a cap that will cover completely their hair. Bed linen will be clean. In this area, disposable and sterilized material reception is made and thus they should wear cap, shoe covers and gown. Restricted area - sterile- (green): it includes the operating theatres and the intermediate corridors where the toilets are located. Apart from the surgical wear, staff should wear a cap which will cover their hair completely and shoes exclusively used when they are at this area. At the theatre and/or when in presence of staff already washed for surgery or if sterile equipment is going to be opened, a mask that will cover completely the mouth and the nose should be worn (figure 2). It is not advisable that patients use mask as it 78 Taken from the regulations of the Surgical Suite of the University Hospital Fundación Alcorcón (With permission). SURGICAL SUITE. STANDARDS AND RECOMMENDATIONS 213

218 may difficult airway access; however, at the theatre there should be a barrier among the surgery area and the head of the table. There can be considered exceptions those cases indicated in the preventive medicine protocol on healthcare to immunosuppressed patients or those suffering from contagious diseases. Operating theatre doors should be kept closed but for the staff, patients and equipment circulation. Operating theatres allocation to services will be the responsibility of the manager of surgery and nursing of the SS aiming at getting a higher functionality and optimization of the resources. Dirty area (red): it includes the access corridor and four dirty locks among the operating theatres. It is the area through which waste and equipment is disposed of. Nurse assistant will put away dirty equipment in this in closed containers which will be collected by sterilization staff. Fig. A.9.1. Surgical clothes and circulation rules in surgery areas 214 REPORTS, STUDIES AND RESEARCH