National Accreditation Policy for Health Care Facilities 2016

National Accreditation Policy for Health Care Facilities 2016

TABLE OF CONTENTS Section 1: INTRODUCTION 1.1 About NHRA... 4 1.2 The purpose of NHRA accreditation... 4 1.3 The benefits of NHRA accreditation... 5 Section 2: THE ACCREDITATION PROCESS 2.1 Introduction... 6 2.2 Steps involved in the accreditation process... 6 2.3 Accreditation Standards..... 7 2.4 Categorization of Accredited Health Care Facilities.. 7 2.5 The Accreditation Cycle..8 2.6 Fees associated with accreditation..... 8 Section 3: APPLICATION 3.1 Applying for accreditation... 9 3.2 Application review... 9 3.3 Self- assessment report... 10 3.4 Re- accreditation applications... 10 Section 4: ACCREDITATION VISIT 4.1 The visit process... 11 4.2 Selecting the survey team... 11 4.3 Preparing for the visit... 12 4.4 Facilities to be provided during the visit... 12 4.5 Making changes to a visit date or surveyors... 12 Section 5: REPORTING ON THE ACCREDITATION VISIT 5.1 The report format... 13 5.2 Summary of compliance in the visited areas... 13 5.3 Reviewing the reports... 14 2 Health care Facilities National Accredition Policy

Section 6: THE AWARD OF ACCREDITATION 6.1 Decisions on the award of accreditation... 15 6.2 Award of accreditation... 15 6.3 Conditional accreditation... 15 6.4 Refusal, suspension or withdrawal of accreditation... 16 Section 7: AFTER ACCREDITATION HAS BEEN AWARDED 7.1 Maintaining accreditation... 17 7.2 Quality Improvement Plan... 17 7.3 Mid- term Self- Assessment Report... 17 7.5 Annual Inspection... 18 7.6 The re- accreditation process... 18 7.7 Withdrawal and suspension of accreditation... 18 7.8 Statement of accreditation... 19 8. APPEALS 8.1 Lodging an appeal... 20 8.2 Grounds for an appeal... 20 8.3 The appeals process... 21 8.4 Additional procedures for appeals... 21 8.5 Recommendations on appeals... 21 8.6 After the appeal hearing... 21 9. Appendix 9.1 Accreditation pathway... 22 9.2 Application form... 23 9.3 Self assessment form... 27 9.4 Supporting documents... 28 Version 1 December 3

1. INTRODUCTION TO THE ACCREDITATION FRAMEWORK 1.1. About the National Health Regulatory Authority (NHRA) The National Health Regulatory Authority (NHRA) is an independent regulatory body established in 2010 under Law No. 38 of 2009. NHRA s mission is to regulate the provision of healthcare in Bahrain and ensure appropriateness, continuity, efficiency and safety in delivering health services, both in the governmental and private sector. It will be based on the best scientific evidence and healthcare best practices, in accordance to international standards. The vision of NHRA is to ensure a Safe and High quality in the delivery of health care. We aim to achieve our vision through three strategic action lines: Regulated and accountable healthcare facilities: We ensure that all health care facilities meet the required standards for licensing. Safe and trusted health services: We are committed to continuously monitor the quality of the provision of health services to ensure compliance with evidence-based practices and accreditation standards. Preserved patients health rights and guarantee patient safety: we will act to protect the rights and the safety of all people using the health care facilities. 1.2 The purpose of NHRA accreditation Accreditation is a self-assessment and external peer review process used by healthcare organizations to accurately assess their level of performance in relation to established standards and to implement ways to continuously improve the healthcare system ISQua (Intenational Society for Quality in Health care) definition. Federation Operating Rules 1998 According to the World Health Organization (WHO), Accreditation can be the single most important approach for improving the quality of health care structures. Accreditation is not an end in itself, but rather a means to improve quality. The accreditation movement is gaining prominence due to globalization and especially the global expansion of trade in health services. It will eventually become a tool for international categorization and recognition of hospitals. Law no. (21) of 2015 regarding private health care facilities, indicates in article (19) NHRA s responsibility for evaluating health services provided in all facilities in order to ensure quality and high performance of those services, and ensure compliance with regulations and standards related to patient safety, clinical performance, infection control, medication management, continuity of care, risk management and other technical standards. In order to implement the above article, the Supreme Council of Health issued decision no. (7) Of 2016 specifying the required NHRA standards, and article no. (26) Of 2016 regarding accreditation of hospitals. 4 Health care Facilities National Accredition Policy

Not only must an accredited facility meet the specific standards listed for each of the visited areas at the time of the visit, but it must also demonstrate to the survey team that it has effective policies and systems in place to ensure that the standards continue to be met throughout the accreditation period. NHRA accreditation visits are conducted by highly experienced surveyors certified by the Saudi Central Board for Accreditation of Health Care institutions (CBHAI) and they can provide invaluable advice on quality assurance processes through the accreditation process and share best international practice. 1.3 The benefits of NHRA accreditation Implementing the accreditation framework, demonstrate the commitment of NHRA to ensure the quality of health services provided, and that these services are rigorously inspected and continuously monitored so as to establish and maintain public confidence in Bahrain, locally, regionally, nationally and internationally. The health facility will be able to demonstrate that it has undergone a rigorous process underpinned by internationally recognized standards. It shows a commitment to providing a quality learning experience, which places the patient at the heart of health care in the Kingdom. Accreditation will provide: An on-going monitoring and evaluation system, which complements the licensing process, as accreditation will be mandatory for a license to remain in operation. Assurance of the good standing of a facility to all stakeholders, especially patients, families and employers, as the facilities will be assessed against international norms and in case there is a cause for complaint, a rigorous and comprehensive policy and process is in place to effectively deal with it. Version 1 December 5

2.1 Introduction 2. THE ACCREDITATION PROCESS Accreditation is based on a visit of a survey team to all facility services. Evidence is required that the facility maintains acceptable standards and complies with its legal obligations to NHRA licensing requirements during the period of accreditation. The facility must complete a self-assessment report before undergoing the accreditation visit. Once this is completed, NHRA will conduct a rigorous process, to assess the facility s provision against the standards. A report of this visit is then considered by the NHRA s accreditation committee, which can recommend the award, conditional or refusal of accreditation, based on the evidence of whether all standards have been met. In addition, specific recommendations will be made in order to rectify the identified inefficiencies and the facility is expected to implement them within a reasonable timeframe that will be agreed. 2.2 Steps involved in the accreditation process 1. The facility completes and submits its application for accreditation with the supporting documents and self-assessment report to NHRA CEO 2. NHRA accreditation committee reviews the application form and supporting documentation 3. Accreditation committee will assign the surveyors and arrange visit in consultation with the facility 4. The visit is conducted by NHRA surveyors team 5. The surveyors team will prepare a report 6. The report is reviewed and edited by the NHRA surveyors team and sent to the facility for a factual accuracy check 7. The final report is considered by the NHRA Accreditation Committee which makes recommendations on the award of accreditation, along with the specific recommendations that will be made by the survey team and the Accreditation Committee and raise the recommendation to the CEO. 8. NHRA notifies the institution of the final decision through an official letter. It can be seen from the above that NHRA accreditation is a rigorous process, involving several stages before successful completion and therefore it is likely to be several months between the date of application and the award of accreditation. The time it takes to reach the survey team visit stage is dependent largely on the quality of the facility s initial application and the response time to queries and requests for further information. However, timescales are influenced by many factors and subject to constraints, some of which are outside NHRA s control. NHRA will endeavour to provide the applying facility with provisional dates throughout the accreditation processes. Please refer to (Annex 1) for accreditation pathway. 6 Health care Facilities National Accredition Policy

2.3 Accreditation Standards NHRA has developed standards for each type of health care facility. Those standards address the care of individuals in the facility environment and are designed to facilitate the effective provision of safe care. The intent of the standards is to keep them relevant and adaptable to all facilities licensed in the Kingdom, regardless of their size and governance arrangements. The standards identify core elements that are applicable to all facilities. In addition to, support elements and facility s specific elements. All facilities are assessed against all core elements of the standard. The specific elements are assessed as being applicable or not applicable and assessed accordingly, and the facility specific elements are only assessed in the facilities that provide the service/s identified. Each type of facility, whether a hospital, a medical centre, or a clinic, has specific standards to it that are published on NHRA web page: WWW.NHRA.BH 2.4 Categorization of accredited Health Care Facilities Based on the accreditation awarded, the facility will be categorized by NHRA into one of the following categories: Diamond: for facilities which achieve 95% or more of standards evaluation. Platinum: for facilities which achieve not less than 90% and not more than 95% of standards evaluation. Gold : for facilities which achieve not less than 80% and not more than 90% of standards evaluation Silver : for facilities which achieve not less than 70% and not more than 80% of standards evaluation The categories will be allocated according to the judgments made for each standard in a particular area, which are, in turn, based on the evidence available during the visit as to how the facility performs against the key indicators. The survey team will decide on one of the following four judgments, when considering the level of compliance in each standard: Fully met Partially met Not met Version 1 December 7

2.5 The accreditation cycle Successful applicants for facility accreditation are usually awarded accreditation for three years. NHRA will conduct annual inspection visits to ensure continuous compliance of the achieved standards and follow up of planned activities related to each recommendation. The facility will be required to submit a midyear self-assessment report showing achievements in the partially or non-met standards. The facility must apply for re-accreditation six months prior to the accreditation expiry date. All facilities applying for renewal of licence must undergo a new round of a full accreditation process. In considering a report on an accredited facility, NHRA may either recommend awarding reaccreditation for three years, change the category of accreditation, or withdrawing accreditation from the facility should it fail to maintain the standards required or implement the agreed upon recommendations. Any facility which has been unsuccessful in either gaining or retaining accreditation or awarded a score between (70% to 80%), may appeal against the decision of NHRA (see section 8 of this policy). Any facility, which fails to achieve the accreditation award after the appeal, or the appeal is dismissed by NHRA, will not be licensed to practice. As per decision no () for 2016, the facility will be suspended and given a period of 6 months to implement improvement and raise its standard and re submit to be evaluated again by NHRA. Failure to achieve 70% score after the second attempt will result in permanent closure of the facility. 2.6 Fees associated with accreditation Accreditation fees are issued by the Minister of Health in decree no (20) of 2016 specifying the fees for private facilities, as follows: Facility Type BD Annual Fees Hospitals Less than 50 beds 51 to 100 beds More than 100 beds 5000 7000 10000 Centres 2 to 5 clinics 6 to 10 clinics More than 10 clinics 500 1000 1500 Clinics - 300 The above fees must be submitted with the application form. The facility must submit the fees annually to be able to maintain its accreditation. 8 Health care Facilities National Accredition Policy

3.1 Applying for accreditation 3. APPLICATION All facilities licensed by NHRA applying for accreditation for the first time, are required to complete and submit a formal application for accreditation to NHRA CEO six months prior to renewal of their license. Along with the completed application form, a self-assessment report and supporting documentation as evidence of existing systems and processes linked to the accreditation standards and criteria will be submitted. From the submission of the application, a timeframe will be applied to the time taken by NHRA accreditation team to review the material and raise queries with the facility and the time allowed for the facility to submit any further complementary material. Applications will only be active for six months after submission. If the application is not considered complete by the end of the six months, the applicant will be required to re-submit the entire application to NHRA along with the required fees. The application for accreditation comprises: completed application form (annex 2) self -assessment report form (annex 3) required supporting documentation (annex 4) payment of required annual fees NHRA will not begin scrutiny of the facility application until all the required documentation has been received along with the full payment of the accreditation fees. 3.2 Application review The facilities will receive official letter from CEO confirming that its application has been received within five working days of submission, but the review of the facility s application will take up to three weeks to allow for proper scrutiny. This formal evaluation process is undertaken by the accreditation committee and will begin with a review of the application form and accompanying documentation, in order to ensure that the form has been completed in full and supporting documentation has been provided and adequate information is included. The accreditation committee will assign a dedicated facility coordinator from NHRA who will be the main point of contact with the facility. This member of NHRA staff will contact the facility to seek clarification or request additional documentation, in case the submission is incomplete, there are discrepancies in the information or elements of the facility s provision do not meet NHRA s requirements. There will be no further progress until these matters have been satisfactorily resolved. Once all the outstanding issues have been resolved, the complete application will be considered by the NHRA accreditation committee, the committee will assign a surveyor team to conduct the field survey and write the survey report. 3.3 Self-assessment report Version 1 December 9

3.3 Self-assessment report Facilities are required to complete and submit a self-assessment report assessing structural, and procedural elements that are in place and correspond them to all NHRA s standards prior to the actual visit of the survey team. The self-assessment report must be submitted in English. Facilities are advised to complete the self-assessment report form (annex 3) in as much detail as possible and to be completely transparent in their evaluation of their strengths, weaknesses and compliance with NHRA standards. Self-assessment is a very important tool in the quality assurance process and should be a built-in component of the facility s regular reviewing system. This particular exercise will effectively help the facility to be prepared in full for the visit and to ensure that evidence is available upon which the survey team can base their judgements. It is likely that in completing this exercise the facility will identify that further evidence, is needed and should make an action plan for ensuring that by the time of the visit, this evidence will be available. The self-assessment report form provides tables for the recording of the evidence and actions required. The self-assessment report must be completed and sent to NHRA at least two months before the start of the visit. 3.4 Re-accreditation applications NHRA accreditation is valid for three years; facilities must submit an application for reaccreditation and undergo a full re-accreditation process every three years. NHRA expects accredited facilities to develop and improve their quality improvement processes over the period of accreditation.. NHRA facility section will contact the facility six months before the facility s accreditation is due to expire, setting out the application procedure for re-accreditation and the application deadline. The deadline will normally be three months before the expiry date of the facility s current accreditation. To remain in accreditation, NHRA must receive the facility s application for re-accreditation by this deadline, comprising the following: Accreditation application form (annex 2) Self-assessment report form (annex 3) required supporting documentation (annex 4) Payment of required fees. The re-accreditation application form and guidance notes can be downloaded from the NHRA website. All pages of the application and supporting documentation should be stamped and signed. A re-accreditation process will be organized only if NHRA has received a completed application for re-accreditation along with full payment of the required annual fees by the deadline given. The facility that fails to undergo a re-accreditation process before its current accreditation expiry date and without having been granted an extension by the NHRA, the facility s accreditation will be withdrawn and license will be suspended. 10 Health care Facilities National Accredition Policy

4.1 The visit process 4. ACCREDITATION VISIT The accreditation process involves a rigorous on-site visit focusing on core and specific element standards. These elements can be built upon to create a comprehensive accreditation visit report, which is relevant to each facility that is licensed in the Kingdom. All facilities are assessed against all core elements of the standard. The support elements are assessed as being applicable or not applicable and assessed accordingly, and the facility specific elements are only assessed in the facilities that provide the service/s identified. The visit will include, in addition to a comprehensive documentation review: an introductory meeting with staff (at least members of the management team); a tour of the facility; a meeting with the CEO; a meeting with the President/Vice-President; a meeting with senior management team (Chief of medical staff, Nursing director, human resource director, quality officer); a meeting with a representative group of doctors, nurses or pharmacists; Field visits; a final meeting with the CEO and senior managers; 4.2 Selecting the survey team NHRA has a large pool of certified surveyors whom it can call on to conduct facility visit. The survey team will be carefully selected by NHRA, taking into account the experience, specialties, location, availability, and the nature of the facility and its services. The team will include sector experts (doctors, nurses, engineers, pharmacists, allied health professionals administrators) and subject specialists to ensure appropriate level of knowledge for each particular service. NHRA s surveyors are required to sign a declaration identifying any conflicts of interest. They are also required to inssure as to both the process and the outcome of the visit. The facility will be informed of the names of the surveyors before the visit and can make recommendations to NHRA if it is felt that there could be potential for a conflict of interest. The surveyor s team usually comprise: A lead surveyor, responsible for co-ordinating the survey team, arranging the visit timetable, managing any potential issues that may arise during the visit, compiling the report and ensuring that the visit is carried out according to published guidelines and covers all the standards. NHRA coordinator will be responsible for liaising with the facility A number of expert surveyors selected by the NHRA, based upon the facility size and services. Version 1 December 11

The visit timetable will be developed prior to the visit by the lead surveyor, in consultation with the facility through the NHRA coordinator. The facility will be required to facilitate this by providing adequate staff, information, and program timetables by suggesting the right timing at which key personnel will be available to meet with the surveyors. The lead surveyor is responsible for producing the visit timetable to ensure it is in accordance with other commitments and meets the needs of the survey team to effectively undertake the accreditation. 4.3 Preparing for the visit Once a visit has been organized, the facility will receive written confirmation from the accreditation committee regarding the dates, the names of the members of the survey team and details of the visit, including a list of premises to be visited. The facility should inform their staff that a visit will be taking place. It is the surveyors intention to avoid disruption of the facility s normal activities as far as possible during the visit. All documentation, which the surveyors will require will need to be gathered and collated before the visit electronically and preferably, in hard copies, too. 4.4 Facilities to be provided during the visit The survey team will be accompanied by an NHRA coordinator who will be the liaison person between the facility and the team for all administrative matters. The coordinator will facilitate the visit timetable and coordinate the meetings, which the team will hold with all stakeholders. A dedicated room must be available throughout the duration of the visit for the team to use. This should be located centrally in the facility, within close reach of the administration and CEO of the facility, if possible. It should offer privacy for internal discussions between the team members and they should be able to leave personal belongings in complete safety during the visit. The team may need the room to hold meetings with staff members. An internet access, whenever possible, should be available in the room. All documentation, which needs to be reviewed by the survey team must be placed in this room. This will include all the documentation sent in with the application form, all supplementary documentation providing evidence of the facility ability to meet the standards. 4.5 Making changes to the visit date or surveyors Rescheduling and Postponements of Survey by the facility may cause some difficulties in fulfilling this objective. Therefore, facilities are encouraged to adhere to the proposed date by NHRA. However, if rescheduling or postponement is needed, hospitals need to submit in writing their request, indicating their justification for the request. NHRA reserves the right to change the date of the visit or surveyors, prior to the commencement of the visit. NHRA would only make such changes once all other options have been exhausted and where it would be impossible or detrimental to go ahead with the visit as planned. Those alterations will be agreed by the facility prior of the visit. 12 Health care Facilities National Accredition Policy

5. REPORTING ON THE SURVEY FINDINGS Towards the end of the final day of the visit the team will meet to discuss findings and agree on judgments and action points. The lead surveyor will be responsible for producing the final facility report. The report is reviewed and edited by the NHRA survey team. The ratings and the comments will be notified to the facility staff at the end of the visit. However, specific recommendations and the final decision regarding the accreditation status of the organization will be given by the Accreditation Committee, on the basis of the ratings and the comments of the survey team. After that the report will be sent to the facility for a factual accuracy check. It should be noted that the facility will only be able to comment on the factual accuracy of the report and not on the judgments made. Once the factual accuracy checking with the facility is complete, a draft of the final version with the recommendations will be sent to the survey team members for their comments prior to being sent to NHRA. The final report is considered by the NHRA Accreditation Committee, which makes recommendations on the award of accreditation and raise the recommendation to the CEO. 5.1 The report format The facility report will include the following sections. Brief on the background to the facility and its scope of services Background and context for the visit process Areas visited Methodology and process Commentary on how the facility performs against each of the accreditation standards and key indicators Details of the evidence for judgments of partial compliance or non-compliance An overall judgment on the facility s compliance with the requirements for each of the visit areas reported as fully met, partially met or not met Recommendations for corrective action and if necessary a timeframe Summary of compliance 5.2 Summary of compliance in the visited areas The report will contain a summary of the judgments made by the survey team as to the overall achievement of the facility in the core standards and other specific elements according to facility s scope of services. It is these judgments, which will form the basis of the survey team recommendation to the NHRA, as well as the specific recommendations that the Accreditation Committee will make. The concluding section of the report normally contains a number of action points. These are categorized as being of high, medium or low priority. High priority - those which the surveyors consider necessary to action as a matter of urgency and which will normally prevent the immediate award of accreditation Medium priority - those which the surveyors have concerns about but which can be actioned in a longer time-frame. These action points could result in a recommendation to defer the decision on the award of accreditation Version 1 December 13

Low priority those which the surveyors consider that would benefit the facility, would enhance the quality of the services and foster best practice. These action points will not, on their own, normally affect the decision for the award of accreditation The final results will be weighed according to the judgments made for each standard in a particular area. Those, in turn, are based on the evidence provided during the visit as to how the facility performs against the key standards. The survey team will decide on one of the following four judgments when considering the level of compliance with NHRA accreditation requirements for each standard. Ø Not met when < 50 % compliance with the sub-standard Ø Partially met when 50 to < 80 % compliance with the sub-standard Ø Fully met when 80 % compliance with the sub-standard Ø Not Applicable indicates that the standard/sub-standard does not apply to the facility 5.3 Reviewing the reports The report once submitted by the lead surveyor will be reviewed and edited, if necessary, by the NHRA accreditation committee. Reviewers will consider a number of elements of the report including the following: The report has been completed according to established guidelines All sections have been completed fully and judgments made on all standards Action points are included for all standards which are judged to be partially met or not met The consistency of reporting including especially the comments that describe the inefficiencies found and that justify either partially met or unmet standards. Appropriateness of the language used The presentation of a clear evidence base for the report judgments. Following the review, which may involve the committee conacting the lead surveyor for further information or clarification, the committee, should decide on the award of accreditation and the specific recommendations that will be made 14 Health care Facilities National Accredition Policy

6. THE AWARD OF ACCREDITATION 6.1 Decisions on the award of accreditation The Accreditation Committee can recommend the award of accreditation, conditional accreditation, or refusal of accreditation or re-accreditation. In exceptional circumstances, suspension or withdrawal of a facility s accreditation may be recommended. The facility will be informed of the NHRA decision within one calendar month of the decision being made. NHRA will send the facility a copy of the report, along with an accreditation certificate if accreditation or re-accreditation has been awarded. 6.2 Award of accreditation Accreditation can be awarded following the full accreditation visit of an unaccredited facility Re-accreditation can be awarded following the full re-accreditation visit of an accredited facility. Accreditation or re-accreditation is awarded if NHRA is satisfied that the facility meets or exceeds standards in all areas of its provision. Accreditation or re-accreditation is awarded for a period of three years. The committee will grant the facility one of the following categorization: Diamond: for facilities which achieve 95% or more of standards evaluation. Platinum: for facilities which achieve not less than 90% and not more than 95% of standards evaluation. Gold: for facilities which achieve not less than 80% and not more than 90% of standards evaluation Silver: for facilities which achieve not less than 70% and not more than 80% of standards evaluation Upon completion of the Accreditation Committee process, the Committee's recommendations will be provided to the CEO for the final approval. 6.3 Conditional accreditation The Accreditation Committee may recommend conditional accreditation or reaccreditation if the visit report indicates that the facility overall scoring is between; 70% to 80%, and that the outstanding issues are such that they can be resolved easily within a short period of time. A decision can be deferred for up to six months if the surveyors have concerns about Medium priority issues - those that can be actioned in a longer time-frame. These action points could result in a recommendation to defer the decision on the award of accreditation During that time the facility must address the action points identified in the report and specifically raised by the Accreditation Committee. Version 1 December 15

The Accreditation Committee will require that, before the end of the deferral period, the facility either undergoes a supplementary visit or submits adequate documentary evidence that the outstanding requirements have been met or issues have been resolved. The supplementary visit report or documentary submission will be considered by the Accreditation Committee before the end of the deferral period, and a recommendation on accreditation or re-accreditation will then be made. If the supplementary visit report indicates significant concerns other than that led to the deferral, the Accreditation Committee may require an additional full visit before making a recommendation on accreditation or re-accreditation. If necessary, the deferral period may be extended to allow for this to take place. If the facility fails either to submit satisfactory documentary evidence or to undergo a supplementary visit before the end of the deferral period, the Accreditation Committee may recommend refusal or withdrawal of accreditation. 6.4 Refusal, suspension or withdrawal of accreditation The Accreditation Committee may recommend the refusal, suspension or withdrawal of accreditation, if the survey report indicates that the facility has failed to meet or maintain the standards required for accreditation and the overall scoring was less than 70%. If accreditation is refused or withdrawn, the reasons will be clearly explained in the report and the accompanying letter. Failing to achieve accreditation after expiry of deferred period will result in withdrawing the accreditation from the facility. The facility has the right to appeal against NHRA decision. See section 8. 16 Health care Facilities National Accredition Policy

7. AFTER ACCREDITATION HAS BEEN AWARDED It is a condition of accreditation that certain basic information on accredited facility be published in the NHRA web page. Newly accredited facilities are added to NHRA directory of accredited facilities once the decision letter, accreditation report and accreditation certificate have been dispatched. Facilities whose accreditation has been withdrawn will remain in the site until the time allowed for lodging an appeal has expired and any subsequent appeal process has been exhausted. 7.1 Maintaining accreditation Gaining accreditation, although a major achievement for any health care facility, is not the end of the process. The accredited facility, have a continuing responsibility both to maintain the standards required for NHRA accreditation and to cooperate fully with NHRA in its monitoring of these standards. Specific duties arising from these responsibilities are listed below: Continue to comply with all relevant laws and regulations including those concerned with licensing Continue to maintain all the standards required for NHRA accreditation Work to meet the requirements set out in previous NHRA reports and implement the additional specific recommendations according the agreed upon timeframe Pay promptly the required annual fees Submit an application for re-accreditation and undergo a full re-accreditation visit before the expiry date of the facility s current accreditation. Failure of the facility to meet any of the above requirements may lead to the suspension or withdrawal of the facility s accreditation. 7.2 Quality improvement plan The facility will develop a quality improvement plan template, which summarizes the non-complaint standards and the action plan for all recommendations that were made. The facility is expected to fill in the template stating the proposed action and expected date to implement and the responsible personal to follow up implementation. The facility should submit the quality plan within 6 weeks of submitting accreditation report. This plan will be monitored during the annual inspection visits. 7.3 Mid-Term self-assessment report The facility should submit a follow up Mid-Term self-assessment report documenting the achievements made in the partially met or un-met standards. The facility should attach the supporting document or proof of this achievement. A delay in submitting the mid-term report by more than 60 days from due date without a justification acceptable to NHRA, may result in temporary suspension of accreditation, followed by revocation of accreditation if the total delay exceeds 90 days. Version 1 December 17

7.4 Annual inspections All accredited facilities are required to undergo an annual inspection as part of NHRA s quality monitoring process. The annual inspection will be conducted by NHRA inspectors over one day. This inspection will focus on areas that were partially achieved and un-met standards and the action plan related to the specific recommendations. The annual inspection report will be considered by the NHRA which will recommend either that accreditation should continue or that there are areas of concern, which require further action. The report will be sent to the facility with details of the recommendation and any further action, if required. Where an annual inspection report identifies significant problems or evidence that the facility is not meeting NHRA s standards, NHRA may require further action, such as: A further full or supplementary visit An unannounced spot check The submission of an action plan for addressing the issues identified The setting of a deadline for the submission of documentary evidence demonstrating that the issues identified have been resolved. 7.5 The re-accreditation process Accreditation is awarded for three years. To remain in accreditation, the facility must submit an application for re-accreditation and undergo a full re-accreditation visit before the facility s accreditation expires. Facilities will be notified by NHRA six months in advance of the need to apply for re-accreditation. Should the facility fail to undergo a reaccreditation visit before its current accreditation expiry date, the facility s accreditation will be withdrawn. The procedure for application for re-accreditation is set out in section 3.4 of this handbook. 7.6 Withdrawal and suspension of accreditation Occasionally, NHRA is required to suspend or withdraw accreditation from a health care facility because it has failed to meet the conditions for maintaining accreditation or because its provision no longer meets NHRA s standards. Suspension is a private arrangement between the facility and NHRA, and is usually accompanied by a set of requirements to be met by a stated deadline. The length of time given to meet requirements will be stipulated by the Accreditation Committee. Withdrawal of accreditation means that the organization is removed from the directory of accredited facilities and this will have an adverse effect on the facility s operating license. The facility may appeal against the withdrawal of accreditation, see section 8. 18 Health care Facilities National Accredition Policy

There are a number of reasons why accreditation can be suspended or withdrawn: Following an inspection NHRA may recommend withdrawing accreditation if the inspection report shows that the facility is failing to meet the standards required for accreditation. Failure to meet the requirements for continuing accreditation NHRA may recommend suspending or withdrawing accreditation if the facility fails to meet the requirements for continuing accreditation. Additional grounds for immediate suspension or withdrawal In addition to the above scenarios, the accreditation committee may recommend suspending or withdrawing the accreditation of the facility on the following grounds: Failure to comply with all relevant laws and regulations of NHRA Failure to apply for re-accreditation by the deadline given Failure to undergo a re-accreditation by the accreditation expiry date The submission of false or intentionally misleading statements on the forms or in associated documents of the application. Non-payment of required annual fees The Facility will continue to appear on the NHRA site of accredited health care facilities during any period of suspension, but will be removed if accreditation is subsequently withdrawn. 7.7 Statement of accreditation Following the award of accreditation, the facility is permitted to use the statement of accreditation, as well as being listed in the NHRA directory of accredited health care facilities on the NHRA website. The use of the statement in promotional materials is subject to certain conditions. Acceptable forms of the statement are: accredited by the National Health Regulatory Authority, Kingdom of Bahrain NHRA accredited. Version 1 December 19

8. APPEALS A surveyed facility can appeal against the following accreditation decision: 1. Not accredited (denial of accreditation). 2. Revisit survey (when the overall score is between 70-79%). 3. Suspension/revocation of accreditation. The right of appeal is granted solely to provide the facility with the means of challenging either the assessment of the surveyors in the course of the visit or the judgement of the Accreditation Committee in coming to its recommendation. A facility has no right within this appeals procedure to challenge either the criteria assessed or standards required for accreditation or the general regulations that accredited facilities must follow. The right of the facility within this procedure is rather to challenge the application of these criteria, standards and regulations in its individual case. 8.1 Appeal submission If the facility is entitled to appeal and wishes to appeal a decision, it must submit a written letter of appeal to NHRA s CEO. This written letter must be received by NHRA within fifteen working days of the date of the letter that confirms the refusal or withdrawal of accreditation. For this purpose, each working day is held to end at 14.00. Any letter confirming the refusal or withdrawal of accreditation will be delivered to the facility s designated primary contact by registered post. The facility must ensure that any correspondence addressed to the facility s primary contact is opened and dealt with in their absence. NHRA should make a decision within 60 days of the date appeal submission 8.2 Grounds for an appeal The appeal submission against the accreditation decision must clearly state the grounds for the appeal, selecting one of the following grounds: 1. Relevant and significant information, which was available to the survey team was not considered in making of the accreditation decision. 2. The report of the surveyors was inconsistent with the information presented to the survey team. 3. Perceived bias of a surveyor(s) 4. Information provided by the survey team was not duly considered in the survey report. 5. The Accreditation Committee did not have all the relevant information available to it at the time. 6. The decision was not made in accordance with the procedures or criteria set out in the Accreditation policy. 20 Health care Facilities National Accredition Policy

8.4 The appeals process An appeal will be heard in 2 weeks time by an Appeal Committee, which is an unbiased body made up of one independent Chair, and surveyors who did not vote in the original recommendation of the Accreditation Committee. The appeal committee shall: 1. Consider the grounds for the appeal as alleged by the health care facility; 2. Study the evidence submitted by the facility in support of its allegation; 3. Consider the report of the survey team and other supporting statements and documents; 4. Consider whether the survey team and accreditation committee substantially followed stated policies and procedures; 5. Consider whether the survey team made substantially errors or omissions which affected the decision of the accreditation committee; 6. Consider whether the evidence at the time the accreditation decision was made, was wrongly assessed. 8.5 Additional procedures for appeals No appeal will be heard while the facility owes NHRA any fees. If the facility fails to settle all outstanding debts within ten working days of its notice of appeal, its right to appeal will expire. In the period between the notice of appeal and the outcome of the appeal, an accredited facility remains accredited and an unaccredited facility remains unaccredited. If the appeal is dismissed, NHRA decision will then be confirmed. A full new application will need to be submitted if the facility wishes to re-apply for NHRA accreditation, but this will not be considered until NHRA is first satisfied that all the requirements set out in the refusal/withdrawal letter have been or shortly will be met. 8.6 Recommendations on appeals At the end of the hearing, the Appeal Committee may make one of three recommendations: To dismiss the appeal To recommend a new visit To recommend that NHRA award or reinstate accreditation or re-accreditation. 8.7 After the appeal hearing The Chair of the Appeal Committee will make a written report to the NHRA s CEO, within 4 weeks time, setting out a final judgement, its grounds and, if appropriate, recommending changes in the accreditation process, at which point the procedure will be deemed to be exhausted. NHRA will inform the facility of its decision within 2 weeks. On completion, the appealing facility will have no further recourse to the appeals process. Version 1 December 21

Annex 1 Accreditation Pathway Application is not complete Facility submit request for accreditation 6 months prior to license expiry Accreditation Committee reviews application within 2 weeks of submission Assign a survey team and schedule a visit within 2 weeks 2 months Survey team conducts the survey and submits the report within 1 week for facility review and comment Further clarification needed from survey team Report final edit and submission to accreditation committee within 1 week Accreditation committee reviews report and submit decision within 2 week Facility appeal with 15 days of receiving decision Appeal committee review the appeal Within 2 weeks time of submission Facility informed of the decision within 1 week 6 weeks Appeal committee raise decision to CEO within 4 weeks 22 Health care Facilities National Accredition Policy

Tel: +973 17 11 33 33 Email: accreditation@nhra.bh P.O. Box: 11464, Manama Kingdom of Bahrain Website: www.nhra.bh Form 1 New Application Form for Hospital Accreditation IMPORTANT: Please fill in the required information completely. Failure to submit the necessary items/information will delay the processing of your application. You must complete and submit all of the requested information. Facility Title Facility Category Hospital Bed Capacity General Hospital Specialized Hospital Teaching Hospital Rehabilitation Hospital Day surgery Hospital Type A More than 100 Type B 50-100 Type C Less than 50 Address Tel. Contact Email Facility License Number Facility CEO CEO Tel. Contact CEO email Medical Director/COM COM Tel. contact COM email Version 1 December 23

Scope of services Please tick the appropriate service Please indicate the scope of services provided by your hospital Internal medicine Dermatology Neurology Rheumatology Endocrinology Cardiology Nephrology Hematology Family practice/gp Oncology Geriatric care Gastroenterology Rehabilitation Oncology Radiotherapy Dialyses Endoscopy Interventional Respiratory Interventional cardiology Surgery General surgery Orthopedic Urology Neurosurgery Cardiac Surgery Plastic Surgery Day surgery Maxillo- facial Gynecology & Obstetric Accident & Emergency ICU PICU Pediatrics Psychiatry Critical care NICU CCU Dental Ophthalmology Occupational Health Day care Complementary/Alternative medicine CAM Others(specify): ENT Nutrition Burn Unit IVF Home visits 24 Health care Facilities National Accredition Policy

Diagnostic/Supportive services Please tick the appropriate service Please indicate the scope of services provided by your hospital Radiology Services Conventional Radiology Ultrasound Mammography CT scan MRI Bone Density Interventional radiology practice/gp Laboratory Services Histopathology Chemistry hematology Microbiology Immunology/serology Cytogenetic Molecular pathology toxicology Blood bank Other(specify): pharmacy Laundry Ambulance services Kitchen Others (specify): Hospital Committees Please tick on the committees initiated in the hospital from the following list: o Pharmacy and Therapeutics. o Morbidity and Mortality o Infection Control and CSSD o Cardio Pulmonary Resuscitation (CPR) o Credentialing and Privileging. o Medical devices and equipment.- procurement and maintenance o Blood Utilization Review. o Quality, Risk and Safety areas o Medical/Nursing Record Review o Patient Rights/Patient Advocacy/Patient Care. o Facility operations and maintenance Version 1 December 25

Please indicate the number of staff in your hospital in each profession Consultants General Midwifes Administration Pathologists Specialist Nurses Pharmacists Radiologists Pharmacists Allied health (please list below) Safety Officer Infection Control Staff Other Staff Quality coordinator Others (please specify) Premises available Please give the number of each of the followings if available Outpatient Rooms Theater rooms Critical care Beds Administration Offices Delivery Rooms Wards Emergency Beds Isolation Rooms Maternity Beds Ambulances Others: Name.. Title Signature Date.. Contact Information: Tel. Email v Please submit the self-assessment Form 2 and the required documents 26 Health care Facilities National Accredition Policy

Tel: +973 17 11 33 33 Email: accreditation@nhra.bh P.O. Box: 11464, Manama Form 2 Self- Assessment Report Kingdom of Bahrain Please fill in the self- assessment report in relation to NHRA standards Applicable to your hospital by ticking the compliance status choosing one of the following: Fully met Partially Met Not Met NA(not applicable) Use the comment section to comment on any of the standards if you need to give further information. Your self- assessment should cover the following standards applicable to your scope of services 1 Governance, Management and Leadership 15 Emergency Care 2 Human Resource 16 Operating Theatre and Surgery Provision 3 Patient and Family Rights 17 Anesthesia and Sedation 4 Quality Management and Patient Safety 18 Intensive Care Units 5 Management of Information and Medical 19 Labour and delivery standard Records 6 Infection Prevention and Control 20 Outpatient Standards 7 Facility Management and Safety 21 Clinical Support Services 8 Health Promotion and Education 22 Fertility and Assisted Reproductive Technology 9 Provision of Care 23 Dental services 10 Medical 24 Optometry 11 Nursing 25 Hemodialysis 12 Radiology 26 Burns Care 13 Laboratory 27 Psychiatry 14 Pharmacy Version 1 December 27

Annex 4 Tel: +973 17 11 33 33 Email: accreditation@nhra.bh P.O. Box: 11464, Manama Kingdom of Bahrain Website: www.nhra.bh Form 4 Supporting Documents For office use application Number Please provide the following documents ( please indicate if any of the list below is not available) 1 Updated Management structure, and the names and titles of those responsible for management and leadership. 2 Facility strategic plan 3 Facility operational plan 4 Quality management plan 5 Evidence of Management meetings and issued Circulars and management and financial plans 6 Evidence of communication between management and staff through newsletters, meetings, training and education, notice boards, staff initiatives, etc. 7 Latest Annual Report Issued 8 Circular for establishing the following committees according to the hospital's scope of service Pharmacy and Therapeutics. Morbidity and Mortality Infection Control and CSSD Cardio Pulmonary Resuscitation (CPR) Credentialing and Privileging. Medical devices and equipment. - procurement and maintenance Blood Utilization Review. Quality, Risk and Safety areas Medical/Nursing Record Review Patient Rights/Patient Advocacy/Patient Care. Facility operations and maintenance Please provide example of committees meeting minutes 9 Written updated policy & procedures on transfer to another facility 10 Policy for handling staff complaints 11 Policy on Needle stick/sharps injury 12 Written policy and procedures on patient and family rights 13 The Infection control manual 14 Contracts for waste disposal 15 Latest report inspection by Environment Authority 16 Any other Contracts for outsourcing services in the hospital 28 Health care Facilities National Accredition Policy

Version 1 December 29