NIHR / Wellcome King s Clinical Research Facility. CRF User Induction Pack

Transcription

1 NIHR / Wellcome King s Clinical Research Facility Page 1 of 25

2 1.0 Introduction 1.1 Introduction to the Clinical Research Facility The King s Clinical Research Facility (CRF) is a specialist unit for clinical research within King s College Hospital NHS Foundation Trust (KCH), South London and Maudsley (SLaM), King s College London (KCL), and Guy s and St Thomas NHS Trust (GSTT). KCH is part of King s Health Partners Academic Health Science Centre (AHSC). The CRF comprises the following sub units: Clinical Trials Facility (CTF), Experimental Medicine Facility (EMF) (which includes the MRI suite) and the Cell Therapy Unit (CTU). Please refer to the appendices for CRF floor plans. This induction document is relevant to users of the CTF and EMF only. The CTU conducts a separate induction for users of this facility to ensure users are compliant with local policies and procedures and Good Manufacturing Practice (GMP). This document is designed for all users of the EMF and CTF, including Principal and Co- Investigators, Research Nurses, Trial Co-ordinators, Radiographers, Psychiatrists, and Scientists (this list is not exhaustive). It helps to enable all users to look after their study subjects in a safe and comfortable environment. It also helps to promote the smooth running of research projects in the CRF, whilst achieving the needs and objectives of the Trust and the wider research community. The study/trial you are working on must have all the necessary approvals in place prior to participant booking. CRF personnel are here to assist you with your research, to ensure it is completed to the highest possible quality and safety standards. All CRF staff have attended Good Clinical Practice training and attend mandatory Trust training sessions in line with the Trust s clinical and governance arrangements. It is expected that all visiting trial-related staff are also appropriately qualified and trained to look after participants in this environment. 1.2 Instructions for Use of Induction Pack The document is split into five main sections: Introduction Personnel General Information (for all CRF Users) Layout and Resources of Clinical Trials Facility (CTF) Layout and Resources of Experimental Medicine Facility (EMF) Page 2 of 25

3 2.0 Personnel CRF personnel can be contacted via the CRF Reception on /1852 (internal extension: 31851/31852). 2.1 CRF Personnel (EMF & CTF) Role CRF Director PA to Director CRF Manager CRF Facilities Manager CRF Quality Assurance Manager CRF Lead Research Nurse CRF Research Nurses CRF Research Coordinators CRF Research Technician CRF Data Analyst CRF Administrator CRF Administrator / PPI Lead CTF Security CTF Housekeeper CTU Quality Director CTU GMP Laboratory Technicians Name Professor Peter Goadsby Alison Worth Elka Giemza Peter Bishai Georgia Bullock Noah Yogo Asha Mathews Efisia Sais George Brown Kristina Posadas Darwin Matila Chifundo Stubbs John Lord Villajin Louisa Green Olabisi Awogbemila Stewart Lee Loong Adebukola Shopade Stephanie David Dennis Myers Tina Odlum Tamara Geach Penny Bligh and Frank Alves 2.2 MRI Personnel (staff working in EMF MRI area only) Role Name Professor of MRI, Department of Professor Gareth Barker Neuroimaging, Institute of Psychiatry, KCL (CRF MRI Safety Advisor) Superintendent Radiographer, (CRF MRI Mark Allin Responsible Person) Professor of Neuroimaging, Head of Professor Steven Williams Department, Department of Neuroimaging MRI Physicist Karlene Fraser 3.0 General Information (for ALL CRF Users) 3.1 General Office Conduct The general office is a working environment. No meetings which are likely to disrupt the work of others are permitted. Any conversations should be kept professional and must not breach patient confidentiality in line with KCH policy. Whilst light snacks are permitted at your desk, please eat meals in the appropriate tea point or recreation areas. We operate a clear desk policy. Ensure your desk is clear once you have finished working. Please also bear in mind that we have a number of visitors to the Page 3 of 25

4 CRF and that a tidy work space conveys a good impression of the CRF. To ensure safety of your valuables, do not leave unattended wallets/bags/phones on your desk and utilise the staff lockers provided in both the CTF and EMF. 3.2 Daily Checks In order to comply with KCH policy and expected safety, quality and assurance standards, a list of regular medical equipment checks is completed within the CTF and EMF. These are important background checks to enable your studies to run both smoothly and safely. This is the responsibility of the CRF clinical staff. Regular checks conducted include: the cardiac arrest trolley, glucometer, walled and portable suction, O2 and air points, nurse call and emergency alarms, pharmacy drugs (including controlled drugs), linen, sharps bins and consumable stocks. Please note that if you are using the CTF or EMF for 24hr periods (for studies that require participants to stay overnight) or more, these checks are your responsibility for the period in which your study is being conducted within these areas. CRF clinical staff will also conduct weekly tidiness checks of the unit and regular audits will be conducted by the Quality Assurance (QA) Manager to ensure compliance with internal SOPs. If cardiac arrest trolley items are used by a study team they must be replaced by contacting the resuscitation department on ext (located in Golden Jubilee Wing 1 st floor, near the X-ray department). Please also inform a member of CRF clinical staff if the cardiac arrest trolley has been used. For replacement of crash trolley items out-of-hours, please bleep 333; Bleep format extn no. The emergency resuscitation items store is situated on the ground floor of Cheyne Wing, in between RD Lawrence Ward and the lift (yellow door).the emergency pharmacy store is situated on Cheyne Wing 1 st floor, opposite Lister Ward. 3.3 Training Records of Training / Induction All users of the CRF are required to undergo an induction to the CRF prior to commencing work on a study. You will be trained in local procedures, health and safety and also on the use of relevant equipment, as required. Induction documentation will be signed off by the QA Manager or their delegate. You must provide all documents / certificates requested by the QA Manager at induction or as soon as possible following induction. All CRF users must also complete the relevant statutory/mandatory training for their role. All CRF users will have to complete their substantive employer s mandatory training and, in addition, CRF users who are non-kch staff should attend one of the KCH fire evacuation training sessions to familiarise themselves with fire evacuation procedures. The CRF will advise you on what mandatory training you are expected to have done relevant to your role within the CRF. Relevant mandatory training undergone by users from institutions outside KCH will be accepted as part of CRF induction. CRF users who do not have a contract with an NHS Trust, and therefore cannot currently access NHS statutory/mandatory training (e.g. Safeguarding of Adults/Children, Information Governance), may be able to access relevant KCH training courses upon acceptance of their study within the CRF and after being issued with a KHP Research Passport. The QA Manager will discuss this with you at induction. Users of the CRF are responsible for maintaining their own training records and undertaking delegated activities only for that in which they can demonstrate training and qualification, in accordance with KCH policy and Professional Licence. The CRF will hold records of training undergone by users of the CRF that is conducted within the CRF only. The CRF team will Page 4 of 25

5 support users by providing training on specific CRF equipment and procedures where applicable Procedure-Specific Training At induction it will be assessed what procedures you will be conducting within the CRF and what equipment you will be using. Your training needs will be assessed and training can be arranged for any unfamiliar procedures or equipment, eg: sample processing, use of the centrifuges Training on CRF SOPs / Policies At induction, the QA Manager or their delegate will advise you as to which CRF SOPs (Standard Operating Procedures) you need to read. Some CRF SOPs and Policies can be found on the King s CRF website here: CRF SOPs/Policies. Any other relevant SOPs will be provided by after induction, as well as an SOP Training Log. Once the relevant SOPs have been read and understood, this Log should be signed off and returned to the QA Manager, ideally within 3 weeks following the induction. If you return to the CRF at a later date to conduct a new study, it is important to ensure that you have read the current versions of the SOPs and any others which are relevant to your new study. The QA Manager can advise on this as necessary. 3.4 Consumables The CRF can supply some consumables for studies if agreed with the CRF Manager. However users of the CRF will usually bring their own consumables into the CTF/EMF. This may include phlebotomy/cannulation equipment, IV fluids/giving sets etc. CRF users are also expected to bring along their own supplies of stationery, eg: Patient Information Sheets, prescription forms, history sheets etc. Storage space for study consumables should be agreed with the CRF Manager or a member of the clinical team prior to the study commencing. Please be aware that storage space is limited within the CRF. 3.5 Pharmacy The Trust Pharmacy is situated on the ground floor of Cheyne Wing and it is open from 09:00-17:30. If you are collecting prescriptions from Pharmacy, you must wear your ID badge as the prescription will not be released to you without it. For studies where an IMP is required to be dispensed out of hours, prior arrangements must be put in place with Pharmacy and the CRF. 3.6 Personal Property Responsibility It is your responsibility to keep all personal valuables with you if they are not secured in a staff locker. If you see anyone acting suspiciously around the department, please report them to Security immediately. Likewise, do not allow anyone who does not have a valid ID badge to enter the department. 3.7 ID Badges All staff members working in the CRF MUST wear their staff ID badge at all times (including all non-kch members of staff, eg: KCL, SLaM). Non-KCH staff may be entitled to obtain a KCH ID badge once they have completed an induction to the CRF and this will allow access to the relevant areas of the EMF. CRF users requiring access to the CTF will require a KCL ID badge. All queries regarding ID badges for both the EMF and CTF should be directed to the QA Manager or CRF Manager. Any members of staff not wearing their ID badge will be challenged and could be refused entry to the CRF. All members of staff wishing to visit the CRF without their staff ID, must sign in and out and be supervised by another member of staff at all times. Page 5 of 25

6 3.8 Infection Control Hand Hygiene Hospitals are places where infected patients and those vulnerable to infection are brought together. King s CRF is no exception to this. A variety of participants visit the CRF, many of whom may be carrying or be vulnerable to infections. In order to minimise Health Care Associated Infections (HCAI) all staff must adopt a positive approach to infection control by following best practice and being familiar with KCH requirements. There are five key moments ( Your 5 moments for hand hygiene ) during patient care when hands must be decontaminated: 1. Before patient contact 2. Before a clean/aseptic procedure 3. After body fluid exposure risk 4. After patient contact 5. After contact with patient surroundings In addition hands should be decontaminated: If moving from a contaminated body site to another body site during care of the same patient Before and after using personal protective equipment When hands are visibly dirty or visibly soiled with blood or body fluid After using the toilet Before handling food Before handling medication After handling waste and used laundry On entry and on leaving the CRF When advised by the Infection Control team Please also use the hand sanitising foam attached to the wall in the EMF and in all clinical areas in the CTF when entering or leaving the CRF areas. When coming into contact with a participant, use the hand gel provided, after and between patient contact and observe the bare below the elbows principle, ie: short sleeves or sleeves rolled up above the elbow. No watches, bracelets or any other jewellery below the elbow are permitted. One plain wedding ring is allowed but nothing else. Use soap to wash your hands, which is available at every sink in the CRF. Please refer to the KCH guidelines for correct hand washing technique (see the diagrams below). Hand gel is available at the sink area in each room Hand Hygiene Audit In compliance with the KCH clinical audit and infection control policies, regular hand hygiene conducts will be conducted using the Lewisham Hand Hygiene Observation Tool. Users of the CRF are advised that they are obligated to comply with local KCH Infection Control policies. Page 6 of 25

7 Hand Cleaning Techniques (Soap and Water) Page 7 of 25

8 Hand Cleaning Technique- Alcohol Page 8 of 25

9 3.9 Needlestick Injuries In the event of any needlestick injury obtained within the CRF, please alert a member of clinical CRF staff and follow the following procedure: First Aid Measures Immediately wash the exposed site with soap or chlorhexidine and water Do not scrub or suck the area Free bleeding of the area should be gently encouraged If the mouth or eyes are involved wash thoroughly with water (before and after removing contact lenses) Collect Source Details Collection of information relevant to possible carriage of a blood borne virus (BBV) should be carried out to aid in the risk assessment of possible transmission. This should include: Name, hospital number, age and sex Location of patient (e.g. ward, outpatients) Whether known to be infected with a BBV If not known to be infected, identification of any known risk factors for the source patient Complete Incident Form The relevant form is the Adverse Incident form accessible on the KCH intranet: A member of CRF staff can complete the form for you if you are not familiar with the Datix system. Please see section 3.11 for detailed guidance on completing adverse incident forms Contact OH or ED Departments Within the hours of Monday to Friday (excluding public holidays) exposed individuals should immediately contact the Department of Occupational Health and Wellbeing (DOHW) on extension for subsequent risk assessment, advice and management. Exposed individuals can be seen on a walk in basis and whilst it may help to let the department know in advance of arrival, there is no need to arrange an appointment in advance. Outside of these hours exposed individuals should attend the Emergency Department (ED), on extension 32401, and seek OH follow up at the earliest opportunity. Particularly if there are concerns that an exposure may be significant, virology can be contacted by ED (or DOHW) for advice. There is a reciprocal arrangement between the occupational health departments at King s College and Guy s / St Thomas Hospitals such that, for those who work close to one of these sites but have their occupational health provided for at the other site, they may attend the closest department for their first assessment. Subsequent follow up will then be with their usual DOHW. Page 9 of 25

10 3.10 Environment All CRF users are responsible for leaving their area of work clean and tidy. This includes wiping down equipment and couches with the available Clinell wipes and applying a green Clinell label, as well as making used beds, placing used cups/utensils in the available dishwashers and returning furniture and equipment to its original location Incident Reporting Principal Investigators (PIs) and study teams are responsible for ensuring that all Adverse Events (AEs), Serious Adverse Events (SAEs) and Suspected Unexpected Serious Adverse Reactions (SUSARs) that occur within the CRF are recorded and reported in compliance with the study protocol, Sponsor requirements and regulatory requirements. All Adverse Incidents (eg: accidents, injuries, medication errors, information security breaches) and any near misses that occur within the CRF must be reported to KCH using the KCH online Datix reporting form, available on the KCH intranet. CRF staff can assist with this if you are unfamiliar with the Datix system. Please note that some SAEs and SUSARs that occur within the CRF will also need to be reported to KCH as an adverse incident as well as to the Sponsor, if they meet the KCH criteria for an adverse incident. Please ensure that when completing an Adverse Incident form on Datix that you accurately complete all the required fields and assign the incident to an appropriate Division and Speciality (eg: Clinical Research Facility) to investigate and follow-up the incident. Please remember that if you are not employed by KCH, the adverse incident may also need to be reported to your employer Administration / Booking CRF Facilities The CRF s administration team can assist you in your application to use the CRF and advise on booking study participants into the CRF and obtaining a KCH hospital number if they are new to KCH. To book facilities for your study please send your request to kingscrf@kcl.ac.uk with the following details: Name of study Date and time of booking Duration of booking Preferred location (ie: EMF or CTF) Type of facility required (eg: clinical room, research chair, interview room) Subject/Screening ID number or the subject s initials Subject s date-of-birth (if known) The visit number (eg: Screening, Visit 1, Follow-up) Whether the subject is a patient or a healthy volunteer Please note: identifiable personal information should only be sent via secure nhs.net addresses. If this is not possible, any identifiable information should be omitted from the request and provided when the subject attends the CRF for a study visit Health Care Records Each study participant attending the CTF or EMF will be given a KCH hospital number. All patients health care records are tracked through the KCH patient administration system, PiMS, at reception and kept in a secure, locked filing cabinet on site in the Nurses Station in Page 10 of 25

11 either the CTF or EMF. On PiMS, the CRF is recorded as a ward. Once the study subject has been registered onto PiMS, medical notes will then be tracked into the CRF Study/Trial Files The Investigator Site File (ISF) is the responsibility of the Principal Investigator and should be held within their local department. In some circumstances, and only with the approval of the CRF Manager, the ISF can be stored in the CRF. The CRF will keep some approved essential documents. Please inform us if there have been any protocol amendments and provide us with copies of the most up-to-date documents Computerised Systems PCs are available throughout the EMF and CTF, with access to KCH and KCL networks. Wi-Fi (for KCH, KCL and SLaM) is available throughout the CRF. Please log in with your usual log-in credentials for your organisation. Non-KCH users can log into KCH PCs using the user name: kingsepr and password: denmarkhill which will allow access to EPR, Datix etc. There is an EPR label printer available in the Nurses Station on the 1 st floor of the EMF. Please inform a member of CRF staff if you require training to use EPR at KCH. Q-Pulse is the CRF s electronic quality management system where all CRF SOPs, Policies, forms and templates are stored. Access is currently granted to core CRF staff only. Please contact the QA Manager for more information on Q-Pulse if required. Tutela is the CRF s web-based temperature monitoring system for the laboratory/pharmacy fridges and freezers in the CTF and EMF. The fridges/freezers are monitored 24 hours a day by this system, to ensure that they are operating within the defined parameters. Temperature logs can be generated for Sponsors as required. Please contact the QA Manager or CRF Manager for more information. 4.0 Layout and Resources of Clinical Trials Facility (CTF) 4.1 Patient Accommodation Access to the CTF is via the ground floor entry of the Wellcome Foundation building and the CTF is staffed by housekeeping and security staff from The CTF has a patient lounge with television and magazines available for patients to relax between study procedures. There are male/female shower areas which are provided with disabled access WC s and showers and allow participants to change as required. Participant lockers for the storage of personal property are available the CTF and property must be stored in line with KCH policy. Please ask a CRF Nurse/CTF housekeeper to access the keys. Page 11 of 25

12 4.2 Clinical Accommodation Clinical accommodation in the CTF consists of examination/interview rooms, a quiet lounge, an open-plan ward area with research beds and chairs, an open-plan trial procedures area with research chairs (both areas have their own Nurses Station), a single-bedded quiet room, a sample processing area and a drug preparation and dispensing area. A drug cupboard is available in the Nurses Station in the open-plan ward area, and centrifuges, fridges, -20 C freezers and a -80 C freezer are available in the sample processing area for sample processing and storage. A Pharmacy fridge is also available in the trial procedures area. All participant areas are equipped with a telephone point, wash hand basin, wall mounted soap or gel dispensers, disposable gloves and aprons. 4.3 Staff Accommodation There are numerous PCs in the nursing station and clinical areas of the CTF for use by CRF users. There are male and female staff changing rooms in the ground floor of the CTF with toilets and showers available. Staff lockers on the ground floor of the CTF are available and are to be used for personal belongings only and not for storage of study-related materials. 4.4 Kitchens On the ground floor of the CTF, a nutritional kitchen comprising of fridge/freezers for storage of patient and staff food items, a cooker for preparation of patient food if necessary and tea/coffee making facilities are available. Study participants must not access the kitchen. Arrangements for any required patient meals are the responsibility of the CTF user. Meals can be ordered via KCH, ordered from an external supplier, or specialist items can be prepared by the trials team in the kitchen. The kitchen is equipped with a fridge/freezer and a separate fridge is provided for use of staff. Please ask a CRF member of staff if you are unsure how to operate kitchen equipment. The CTF also has a staff room located on the ground floor. Please ensure that you place all dirty crockery/cutlery into the dishwasher after use and leave the area clean and tidy after preparing food or drink for yourself or a participant. 5.5 Equipment Medical and sample processing equipment available for use in the CTF includes: Glucometers Stethoscopes Mobile neurological examination set Wall-mounted neurological examination sets IV stands 12-lead ECG machine Weighing scales/chairs Vital signs monitoring equipment Cardiac arrest trolleys* Centrifuges for spinning blood samples Pharmacy fridge for temporary storage of medication/imps Laboratory fridges for short-term storage of samples Laboratory freezers (-20 C and -80 C) for short-term storage of samples Page 12 of 25

13 *These are located in the open-plan ward (bed) area and trial procedures (chair) area. All users of the CRF must know where the cardiac arrest trolley is in the area in which they are working and be familiar with CRF emergency procedures. The trolley on the ward side only is a combined adult/paediatric trolley. Before using a piece of CRF equipment, you must have received the correct training to do so and have read any associated SOPs. CRF clinical staff can train you in any equipment that may be relevant for your study as part of the induction process. Manuals for equipment are available from the Nurses Station in the CTF. Copies of all CRF sample processing SOPs can be found in the sample processing areas of the CTF (and EMF) for reference. Please do not remove these SOPs from these areas. If you are bringing non-crf owned equipment into any area of the CRF you are responsible for ensuring that it is has had the appropriate electrical safety checks and required maintenance/service. 4.6 Medication Management Drug Preparation The drug preparation areas can be used as a clean utility for the preparation of all drugs. Drugs can be stored in the fridges situated in this area if required following agreement with the CRF Manager. In the CTF, all prescription and Controlled Drugs are kept in a locked drug cupboard situated in the Nurses Station of the open-plan ward area. Keys for this cupboard are accessible for authorised users through the locked and number coded key cupboard within the CTF. Users of the CRF are responsible for their own stock, including expiry checking Controlled Drugs (CDs) Access to the Controlled Drug cupboard is restricted to clinical staff only and staff must comply with the KCH policy on Controlled Drugs, located on the KCH intranet. 4.7 Health and Safety and Medical Emergency Procedures Medical Emergencies All users of the CRF must read the CRF SOP Management of Medical Emergencies in the King s CRF and sign off as having read and understood the procedures in this SOP prior to commencing work within the unit Medical Call Systems There are emergency alarms fitted in the following areas of the CTF: By each of the bed sides in the open-plan ward area (red push button and wall mounted) By each of the chair sides in the open-plan trial procedures area (red push button and wall mounted) Clinical examination rooms (red push button and wall mounted). Please note that there are no medical emergency alarms fitted in the CTF quiet lounge. When an alarm is activated in the CTF, a bell will sound on both sides of the CTF on the ground floor to alert other CTF staff and users. Page 13 of 25

14 4.7.3 PINPOINT To ensure the security of staff, there is an emergency security system (PINPOINT) installed throughout the CRF which immediately alerts KCH Security to your exact location. In the CTF, ID-style card alarm transmitters are available from the CTF staff. The PINPOINT system in the CTF is tested on a regular basis. Please read the CRF SOP Lone Working and Personal Security within the King s CRF for more information on the PINPOINT system and security in the CRF. Please DO NOT test or activate PINPOINT alarms if there is not a genuine immediate security risk. 4.8 BioHazard Spill Kits BioHazard spill kits are located in the sample processing area in the CTF. Please do not use these kits unless you have been trained in their use. In the event of any spillage of biological material within the CTF, please contact a member of core clinical CRF staff who will deal with the spillage safely. 4.9 First Aid Kits and Contacts First aid kits are located within the CTF at the Nurses Stations in both areas. The CRF Nurses are designated first aiders for the CTF, and the CRF Manager is designated first aid co-ordinator. Please report all incidents requiring first aid treatment to a CRF staff member and report as an adverse incident if appropriate (see section 3.11) Medical Gases Oxygen, air and suction are available on the wall of each clinical space and are checked and equipped according to the daily check folder. Portable oxygen is available on the cardiac arrest trolleys in the CTF. Portable suction is also available on the cardiac arrest trolleys Fire Evacuation Plans There are different evacuation plans for each floor of the CTF. The ground floor plans can be found on the main noticeboards on the chair side and bed side of the CTF for your information ID Badges Staff who do not have swipe-card access to the CTF can use a temporary swipe card which can be obtained from the CTF staff. These must be signed for and returned on departure from the CTF. Please be careful not to let tail-gaters enter the CTF and challenge anyone without an ID card Key Access System All keys for the CTF are held in the locked, number coded key cupboard in the Nurses Station of the ward area. The CRF manager (or delegate) will agree if appropriate for a CRF user to obtain the number-code for this key cupboard. Each member of staff taking a key out is responsible for its safe return Alarms The access codes for the alarms in both the CTF and EMF are confidential and thus out-ofhours access (early mornings, evenings and weekends) must be discussed and agreed with the CRF Manager in advance so that access can be arranged with Security. Page 14 of 25

15 4.15 Waste Stream Clinical and domestic waste within KCH is segregated into various types in order to comply with legislation. Orange bags: for all hazardous/infectious clinical waste. This waste must not be contaminated with pharmaceuticals/chemicals. Yellow sharps bins: for the disposal of sharps waste only. Sharps (eg: needles) must be disposed of at the point of use. Purple bags: for any cytotoxic/cytostatic waste (eg: the by-products of chemotherapy). Black and yellow bags: for offensive waste. Clear bags: for domestic waste. Please ensure that you dispose of all waste into the correct bag or bin. If you are unsure at any time as to where waste should be disposed of, please ask a member of CRF staff who will advise you. In the CTF, clinical waste management is the responsibility of the CRF clinical staff member who has been allocated to the area for the week. If there are any issues with waste collection, please inform a member of the CRF s clinical team or the CRF Manager Domestic Services There is a full-time housekeeper working within the CTF. The housekeeper within the CTF is not generally responsible for cleaning the kitchen or any cutlery and utensils left in any area or cleaning equipment or making beds. However, they may conduct some of these duties within reason Printing and Photocopying There is one combined scanner and printer located in the CTF. Due to the cost of operating these (particularly ink and paper), printing expenses and paper must be agreed at the feasibility stage for your study. Please discuss this with the CRF Manager Reporting Faults Maintenance in the CTF is managed by KCL. In the event of any fault in this area please report it to a CTF staff member in the first instance. If this is not possible, contact KCL estates on or online: Layout and Resources of Experimental Medicine Facility (EMF) 5.1 Patient Accommodation Access to the EMF is via the CRF Reception on the 1 st floor of Cheyne Wing. The EMF is staffed by a receptionist between 08:30 17:00 hrs. In the EMF there is a patient recreation area which comprises of a mixture of soft seating, coffee tables, magazines and a television to allow participants to relax, if allowed by the study protocol. Further tables and seating are provided outside, in a secure area. There is also a tea point for staff use only to provide refreshments to participants. Page 15 of 25

16 There are male/female shower areas which and disabled-access WC s which allow participants to change as required. Lockers for the storage of personal property are available and property must be stored in line with KCH policy. 5.2 Clinical Accommodation All participant areas are equipped with a telephone point, wash hand basin, wall mounted soap or gel dispensers, disposable gloves and aprons. Ground Floor: 4-bed Ward Area This comprises an open-plan room with 2 beds, a WC/shower room, a Nurses Station, and two individual single bed rooms. There is a workstation with computers and open storage cupboards for clinical supplies. ITU This comprises of two single-bedded ITU rooms, a Nurses Station and sluice. There is a workstation with a computer, storage and controlled drug cupboards for clinical supplies and a pharmacy fridge for temporary storage of drugs. MRI Suite This suite includes a waiting area for participants, clinical prep room, MRI equipment/plant, control room, image analysis room, and a research office for staff, and a 3T functional MRI scanner, with access for both ambulatory and non-ambulatory participants. In the clinical preparation room there is a centrifuge for spinning samples, a -20 C freezer for short-term storage of samples and an airway trolley. First Floor: VR / Group Interventions Room This room has potential for dual function, primarily as a Virtual Reality (VR) facility and also for round-table activities. Tables and chairs are available to furnish this room and these are held in a compact store area accessed from within the VR room. EEG Suite EEG room 1 is installed with supine EEG equipment and is furnished with a bed and EEG room 2 is installed with sitting EEG equipment and is furnished with a desk and chair. These rooms are separated by a common control room and hair-washing facilities are available for study subjects. Trial Procedures Room This is an open-plan trial procedures area complete with research chairs/couches to allow for the administration of trial medication and general trial procedures such as sample collection and ECGs. O 2 and suction supply are also available in this area as are vital signs monitoring equipment and mobile neurological examination equipment. There is also a sample processing area here which includes a pharmacy fridge for temporary storage of medication, two centrifuges (one is located just outside of the sample processing area) for spinning samples and a combined fridge and -20 C freezer for short-term storage of samples. Page 16 of 25

17 Interview Rooms 1, 2, 3, 4 and 5 These rooms provide space to allow researchers to conduct confidential interviews with study participants. Interview rooms 1, 4 and 5 are furnished with a desk and chairs and interview rooms 2 and 3 with several armchairs and a small table. All rooms can be filmed via CCTV to allow real-time or recorded footage to be used for teaching and research purposes. Clinical Examination Rooms 1 and 2 These are available for clinical examinations and contain an examination couch, desk and chair. Wall mounted neurological examination equipment is also available as is O 2 and suction supply. 5.3 Staff Accommodation There are numerous PCs in the Nurses Station and clinical areas of the EMF for use by CRF users. There are male and female staff changing rooms on the second floor of the EMF, (S42 and S44) toilets and showers are available in each. Staff lockers on the 2 nd floor of the EMF are available and are to be used for personal belongings only and are not for storage of studyrelated materials. 5.4 Kitchens In the EMF, a tea point area is available for staff use on the first floor of the EMF which is furnished with a microwave, fridge, freezer, kettle, dishwasher and tables and chairs. Please ask a CRF member of staff if you are unsure how to operate kitchen equipment. Please ensure that you place all dirty crockery/cutlery into the dishwasher after use and leave the area clean and tidy after preparing food or drink for yourself or a participant. 5.5 Equipment Medical and sample processing equipment available for use in the EMF includes: Glucometers Stethoscopes Mobile neurological examination set Wall-mounted neurological examination sets IV stands Virtual Reality equipment EEG machine 12 lead ECG machines Weighing scales Vital signs monitoring equipment Cardiac arrest trolleys* Centrifuges for spinning blood samples Pharmacy fridges for temporary storage of medication/imps Laboratory fridges for short-term storage of samples Laboratory freezers (-20 C) for short-term storage of samples *These are located on the ground floor (in the corridor near ITU) and on the first floor (next to the Nurses Station). An emergency airway trolley is also located in the MRI suite (in the clinical prep room). Page 17 of 25

18 All users of the CRF must know where the cardiac arrest trolley is in the area in which they are working and be familiar with CRF emergency procedures. Before using a piece of CRF equipment, you must have received the correct training to do so and have read any associated SOPs. CRF clinical staff can train you in any equipment that may be relevant for your study as part of the induction process. Manuals for equipment are available from the Nurses Station in the EMF. Copies of all CRF sample processing SOPs can be found in the sample processing areas of the EMF (and CTF) for reference. Please do not remove these SOPs from these areas. If you are bringing non-crf owned equipment into any area of the CRF you are responsible for ensuring that it is has had the appropriate electrical safety checks and required maintenance/service. 5.6 Medication Management Drug Preparation Room The drug preparation area situated in the Trial Procedures Room of the EMF is used as a clean utility for the preparation of all drugs. Drugs can be stored in the pharmacy fridge situated in this area if required following agreement with the CRF Manager. In the EMF there are locked drug cupboards present in the first floor Nurses Station and the ITU ward on the ground floor. In the EMF keys for these cupboards are accessible for authorised users through the KeyTracker system (see section 5.13). Users of the CRF are responsible for their own stock, including the checking of expiry dates. 5.7 Health and Safety and Medical Emergency Procedures Medical Emergencies All users of the CRF must read the CRF SOP Management of Medical Emergencies in the King s CRF and sign off as having read and understood the procedures in this SOP prior to commencing work within the unit Medical Call Systems There are medical emergency alarms (red triangular pull buttons) fitted in the following areas of the EMF: Ground Floor: By each of the bed sides in the ITU (G29) and main ward (G20) areas (hand pull and wall mounted) En-suite toilet in ground floor ward (G32) (hand pull and wall mounted) MRI suite (G11) (hand pull and wall mounted) First Floor: By each of the chair sides in the trial procedures room (F20) (hand pull and wall mounted) Disabled toilet on first floor (F18) EEG control room (F26) (hand pull and wall mounted) Interview rooms 1, 2 and 3 (F09, F11 and F12) (hand pull and wall mounted) Clinical rooms 1 and 2 (F13 and F14) (hand pull and wall mounted) Patient recreation area (F15) (hand pull and wall mounted) Page 18 of 25

19 Second Floor: There are no medical emergency alarms as this is a non-patient area. When an alarm is activated in the EMF, an intermittent alarm sounds in the corridors of the EMF. The location of the emergency can be found by reading the alarm panel at the reception desk and by a light which will automatically switch on outside the door of the area where the alarm has been activated PINPOINT To ensure the security of staff, there is an emergency security system (PINPOINT) installed throughout the CRF which immediately alerts KCH Security to your exact location. On all floors of the EMF and CTU there are wall-mounted transmitters with orange call buttons that can be pushed in the event of an immediate security risk. There are call buttons present in the following areas: Ground Floor: Main Ward Area, ITU and MRI suite First Floor: Reception, Nurses Station, Interview Rooms, Trial Procedures Room and Clinical Rooms 1 and 2 Second Floor: Tea Point, QC Laboratory and Write-Up Room. No orange call buttons are located within the CTU laboratory areas Please read the CRF SOP Lone Working and Personal Security within the King s CRF for more information on the PINPOINT system and security in the CRF. Within the CTU, PINPOINT sensors are installed in the ceiling throughout the unit and are activated by a personal paging transmitter in the event of a man down. The transmitter can be worn clipped to a belt/pocket or placed on a desk next to the wearer. They have a motion sensor which can be set to a given time delay before activating an alarm. If you are working within the CTU you will receive training in the use of the personal paging transmitters at CTU induction. Please DO NOT test or activate PINPOINT alarms if there is not a genuine immediate security risk Liquid Nitrogen Liquid nitrogen is stored within the CTU and on the ground floor of the EMF in the cell/dewar store (G24) which has restricted access. 5.8 BioHazard Spill Kits BioHazard spill kits are located in the MRI suite, Trial Procedures Room and also in the QC Laboratory (on the 2 nd floor). Please do not use these kits unless you have been trained in their use. In the event of any spill of biological material within the EMF please contact a member of CRF clinical staff who will deal with the spillage safely. BioHazard spill kits are also located within the CTU and users of the CTU will be trained in their use as part of CTU induction. Page 19 of 25

20 5.9 First Aid Kits and Contacts First aid kits are located within the EMF on the ground floor in the MRI suite, on the 1 st Floor at Reception and in the sample processing area, and on the 2 nd Floor in the QC laboratory and the tea-point area. The CRF nurses are designated first aiders for the EMF and the CRF Manager is designated first aid co-ordinator. The CTU Quality Director and CRF Facilities Manager are designated first-aiders for the CTU. Please report all incidents requiring first aid treatment to a CRF staff member and report as adverse incident if appropriate (see section 3.11) Medical Gases Oxygen, air and suction are available on the wall of each clinical space and are checked according to the daily check folder. Portable oxygen is available on the cardiac arrest trolleys of the EMF (see section 5.5 for the location of the cardiac arrest trolleys). Portable suction is available on the resuscitation trolleys Fire Evacuation Plans There are different evacuation plans for each floor of the EMF. These are available on the main noticeboards on each floor for your information Security In the EMF, if there is an immediate security risk to you and/or a study participant the security team can be contacted by calling 2444 in an emergency or 4567 in a nonemergency. If required the PINPOINT system can also be activated to access Security in an emergency (see section 5.7.3) Signing-in All visitors to the EMF, who are not core members of staff, must sign in at reception in the EMF upon arrival. They must also sign out upon their departure. This is important in terms of both fire safety and security. Please be careful not to let tail-gaters enter the EMF and challenge anyone without an ID card KeyTracker System Keys for the EMF are kept in the KeyTracker which is a cabinet adjacent to the lift on the 1 st floor of the EMF. The cabinet is designed to restrict access to keys to authorised personnel only. It is swipe card operated (with a KCH ID badge) and it records a full audit trail of each key that has been removed and identifies the staff member who removed it. Each member of staff taking a key out is responsible for its safe return within the specified timeframe. The CRF Manager (or delegate) defines which keys each user can have access to and training will be provided in use of the KeyTracker system if required. Please contact the CRF Manager to be set up on the system if you need access Alarms The EMF is alarmed out of hours and there are motion sensors throughout the facility. The access codes for the alarms in the EMF are confidential and thus early, late or weekend access must be discussed and agreed with the CRF Manager in advance so that access can be arranged with Security Waste Stream Clinical and domestic waste within KCH is segregated into various types in order to comply with legislation. Page 20 of 25

21 Orange bags: for all hazardous/infectious clinical waste. This waste must not be contaminated with pharmaceuticals/chemicals. Yellow sharps bins: for the disposal of sharps waste only. Sharps (eg: needles) must be disposed of at the point of use. Purple bags: for any cytotoxic/cytostatic waste (eg: the by-products of chemotherapy). Black and yellow bags: for offensive waste. Clear bags: for domestic waste. Please ensure that you dispose of all waste into the correct bag or bin. If you are unsure at any time as to where waste should be disposed of, please ask a member of the CRF s clinical team who will advise you. In the EMF, all waste is processed by Medirest. Clinical and domestic waste is brought to the waste cupboard located on the ground floor by the domestic staff. Sharps bins, once full, should be signed and marked with the date of closing and the site it is from and brought to the ground floor waste cupboard. Recycling bins and confidential waste disposal boxes are located throughout the EMF. If there are any issues with waste collection, please inform a member of the clinical team, CRF Manager or contact the KCH Waste Management Team on ext Domestic Services King s CRF has a full-time domestic services team member working in the EMF. The domestic services staff are not responsible for cleaning the kitchen or any cutlery and utensils left in any area. They are also not responsible for cleaning equipment or making beds Printing and Photocopying There is one combined photocopier/fax/scanner in the EMF at the Reception. Due to the cost of operating these (particularly ink and paper), printing expenses and paper must be agreed at the feasibility stage for your study. Please discuss this with the CRF Manager Reporting Faults If you become aware of any faults while you are in any area of the EMF please notify a member of CRF staff who will report the fault to Estates and Facilities Area-Specific Training MRI Suite: If you require access to the CRF s MRI suite you are required to undergo specific MRI safety training with the Department of Neuroimaging at KCL. This can be booked by ing mri.booking@kcl.ac.uk. You must also complete a relevant safety screening questionnaire at the CRF Reception before entering the MRI suite. More information about these questionnaires and MRI access/safety can be found in the CRF SOP MRI Access Control and Safety Procedures in the King s CRF and this must be read prior to you working in the MRI suite. CTU: CRF users who wish to access or work in the CTU area will require separate training and induction prior to doing so. Please contact the CTU Quality Director or the CRF Facilities Manager to arrange this. Page 21 of 25

22 Appendix 1: Floor Plan of Clinical Trials Facility Page 22 of 25

23 Appendix 2: Floor Plan of Ground Floor EMF Page 23 of 25

24 Appendix 3- Floor Plan of 1 st Floor EMF Page 24 of 25

25 Appendix 4: Floor Plan of 2 nd Floor of CRF (Cellular Therapy Unit) Page 25 of 25