Clinical. Clozapine PocHi clinic Standard Operating Procedure. Document Control Summary

Transcription

1 Clinical Clozapine PocHi clinic Standard Operating Procedure Document Control Summary Status: Version: Author/Owner: Approved by: Ratified: Related Trust Strategy and/or Strategic Aims Implementation Date: Review Date: Key Words: Associated Policy or Standard Operating Procedures New 1.3 Date: December 2017 Mo Azar Deputy Director of Pharmacy Joan Eccles Lead Nurse, Clozapine Clinic Project Manager Policy and Procedures Committee Date: 18 January 2018 Policy and Procedures Committee Date: 18 January 2018 Medicines Optimisation Strategy : Making the Most of Medicines September 2017 September 2020 Quality Assurance, Quality Control, NEQAS, Blood Test, Monitoring, CPMS, Sysmex, Pharmacy, CMHT Trust Medicines Code Clozapine Policy

2 Contents 1. Introduction Purpose Scope Patient Procedure Activating Procedure for PocHi Machines Analysing Blood Samples Quality Assurance Potential PocHi Machine Problems Regular Maintenance and stock Medication End of Clinic Appendix 1: Certified and Registered PocHi Machine Operators Appendix 2: CLOZAPINE CLINIC DAILY LOG SHEET Appendix 3: Quick Guide to Recording External learning on ESR Change Control Amendment History Version Dates Amendments 1.0 June 2016 New Document in draft 1.1 November 2016 Reformatted to Trust s standard policy template 1.2 Aug 2017 Updated to include ESR recording of Pochi 100i operator training (Certified or Registered)-section 2. Quick Guide to Recording External Learning in ESR shown in Appendix 3(Pages 20-22). Changes in recording physical health outcomes in RIO-section 5 ECG recording and monitoring-section 5 to advise regarding Pochi 100i stand-alone process if internet is down- section 10 and to show revised ordering practice for 50L sealed units(now 60L units) following changes in waste disposal company service- section Dec 2017 Quarantined medication update(section 12) 2

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4 1.0 Introduction In order to enable the provision of a modern and efficient clozapine service, the Trust has established One-Stop Clozapine Clinics in a number of CMHTs and inpatient areas with high numbers of service users prescribed this treatment. To support these clinics, Point of Care Haematology (PocHi) Analysers have been installed and these will enable service users to receive the results of their blood test and their medication supply at the same appointment as their blood sample is taken. Clozapine clinics have been developed to monitor patients who are prescribed the atypical antipsychotic clozapine. The clinics will monitor patients who require weekly, fortnightly or 4- weekly full blood counts as well as review their mental state, vital signs and carry out an annual ECG. Clinic staff will liaise with the prescriber, care co-ordinator/ inpatient ward staff as well as the patient s GP, to ensure any concerns are communicated and actioned appropriately. 2. Purpose In order to provide governance for these clinics, this document sets out the procedural information required to enable the PocHi machine to be set up and calibrated correctly for each clinic session. It also details some of the mandatory quality assurance and maintenance tasks as well as how to report and rectify problems. Much of the information for this document has been provided by the PocHi machine s manufacturer (Sysmex) and the Clozapine Patient Monitoring Service and further information and operating manuals can be obtained from these sources. 3. Scope Clozapine clinics will be led by a nurse and they will be responsible for the provision and coordination of care during the clinic s session. As a clinic co-ordinator, they will be trained to strictly operate the PocHi machines in accordance with these procedures; they are accountable for the safe operation of the machine and the continuance of the quality assurance standards. The clinic co-ordinator and other named operator of the PocHi machine must undertake training provided and certified by Sysmex. Other users may be trained by a certified operator in the Trust and become a registered operator. All operators, whether certified or registered, must hold an up to date certificate of competence from Sysmex UK Ltd. This certificate will be renewed annually after successful completion of an online test. All operators must update their individual ESR record of this training annually via an external learning link within ESR and their line manager will automatically be asked to verify. A Quick Guide to Recording External learning in ESR is shown in Appendix 3(Pages 20-22). Any operator who no-longer holds a valid certificate will be removed from the register by Mylan and their line manager informed. They will no-longer have access to the Pochi 100i machine thereafter. All operators must adhere to the Trust s Infection Control Procedures. 4. Roles and Responsibilities 4.1 Lead Clinic Nurse The nominated nurse leading the clinic service will: Follow this protocol. Advise on baseline measurements that need to be done. Provide information on clozapine to the patients who attend the clinic, including side effects, how to manage them, and when to seek medical attention. 4

5 Check patient details at each attendance. Ensure correct patient identity and check sensitivities and allergies are discussed and checked on a regular basis. Monitor physical health in accordance with the Lester tool recommendations and prescribing guidance, and record in the patient s physical health assessment record in RIO. Over and above monitoring for side effects, health monitoring will cover the person s weight, blood pressure, lifestyle (smoking, alcohol, diet, activity, drug use), cholesterol and blood glucose levels. Trust staff are expected to provide brief health advice and referral on as appropriate. Advise and monitor in respect of side effects from the medication (GAS/ LUNSERS) and inform relevant medical staff (either primary or secondary care) of any concerns. For patients who do not have a Care Co-ordinator the clinic staff will inform the appropriate consultant psychiatrist (or deputy) or duty care worker, depending on who is most appropriate. Monitor patient s mental state and inform the care coordinator and consultant psychiatrist of any concerns. Undertake/participate in any required audit work Provide local induction to any new staff in the clinic Report any adverse events through the Trust s electronic incident reporting system Safeguard and to MHRA (yellow card reporting system) Identify any training needs and report these to appropriate line manager. Attend any training which is provided to enable them to fulfill their duties within the clinic safely. 4.2 Care Coordinator Care coordination remains the responsibility of the allocated Care Coordinator or Lead Professional The patients Care Co-ordinator will be responsible for: Supporting the patient in their attendance at the clinic. Following up any patients who do not attend their appointment. Highlight any concerns raised by the patient to the clinic 4.3 Consultant Psychiatrist (or nominated deputy) or main prescriber It is the responsibility of the Consultant Psychiatrist (or deputy) to register the patient with the relevant clozapine monitoring service and then refer them to the clozapine clinic. If the clinic has a NMP (Non-Medical Prescriber), the consultant should liaise with the NMP in order to avoid duplication of prescribing. It should be agreed who will take responsibility for regular prescribing and this should be clearly documented in Rio notes and communicated. If the clinic does not have a NMP then the consultant (or deputy) is responsible for: Prescribing the patient s clozapine on an ongoing basis (maximum validity is six months for a repeat clozapine prescription). Informing clinic staff, care coordinator, supplying pharmacy and GP of any dose changes Referring to primary care any concerns regarding the patient s physical health 4.4 Supplying Pharmacy The supplying pharmacies are responsible for:. Informing the clinic staff of any problems in respect of the dispensing of clozapine Providing advice on pharmaceutical matters as requested by the clinic staff Arranging for alterations of their previous supplies (where appropriate) for example if patients have missed their clinic appointment, are planning a holiday, or have confirmed that they have been advised to take a different dose to the one that is prescribed (and this is approved by the clinical team). 5

6 5. Managing Clinic Appointments NB: Refer to other policies/procedures that cover routine appointment management and communication. This section only details the specific issues relating to the clozapine clinic. Patients treated with clozapine will be required to attend for FBC tests on either a weekly, fortnightly or four-weekly schedule as stipulated by the CPMS/DMS. Unless special protocols are in place, the usual schedule is: Weekly for the first 18 weeks of starting clozapine Fortnightly between weeks 19 and 52 Four-weekly from the first year of treatment onwards In the event of treatment breaks, CPMS must be informed with the details of the non-concordance and will usually require weekly monitoring for six or 18 weeks depending on the duration of time since clozapine was last taken and how long the patient had been on it previously. Inpatients If the patient is an inpatient at The Redwoods Centre or St George s Hospital, contact staff on the relevant ward and arrange a time for the sample to be taken during the clinic session. If it is not possible for the patient to attend, or the sample is required outside of the clinic s opening time, request that the ward s doctor completes a phlebotomy request form for a FBC and arrange for the sample to be analyzed at the local general hospital s laboratory. Outpatients Arrange a time for them to attend the clinic for a blood sample to be taken An entry to this effect is to be made in the patient s clinical record Action if unable to contact an outpatient If you are unable to contact the patient inform their Care Coordinator and continue to attempt to make contact on subsequent days. If there is no CCO, liaise with the patient s lead professional or care home manager if a resident of such a place. All attempts to contact the patient are to be recorded in the clinical record. If the sample is urgent arrangements are to be made for staff in the Crisis Team to continue further attempts to contact the person outside office hours. Inform the relevant Consultant Psychiatrist of any repeated non-attendance or difficulty in contacting the patient. Urgent samples outside of clinic opening times should be sent to the local general hospital s laboratory for analysis. Inform the supplying pharmacy of any delays encountered with obtaining blood results. Lloyds (Dawley): Tel: Fax: High Street, Dawley, Telford, TF4 2EX Lloyds (Hednesford): Tel: Fax: Market Street, Hednesford, Staffordshire, WS12 1AH St George s Hospital: The Redwoods Centre: NB: Only the pharmacy that is listed on a patient s CPMS/DMS file can dispense for that patient. The results for any samples arranged at a local hospital will need to be obtained and inputted onto CPMS by the clinic staff (not the pharmacy). 6

7 Action to be taken if a patient fails to attend their appointment at the Clinic Inpatients In the event that an inpatient fails to attend their appointment, the clinic staff should contact the ward and request that if possible the patient attend clinic prior to closure. In the event that the patient is not able to attend the clinic that day, ward staff are to be instructed to obtain a sample which is to be brought either to the clinic prior to closing or if later, to send to the local general hospital s laboratory for analysis. The clinic staff should endeavor to obtain the result and input onto CPMS. Outpatients In the event that an outpatient fails to attend their appointment clinic staff will: Attempt to contact the patient by phone to make an alternative appointment for them to have their blood sampling done. If the patient is not able to attend the clinic later that day, the CCO must be contacted to facilitate a blood test as soon as possible this sample should be sent to the CPMS Laboratory in the post (using their phlebotomy kit) or if urgent, taken to be analyzed at the local general hospital s laboratory. In the event that no contact can be made with the patient, the CCO should attempt to establish contact through the patient s relative/carer (if prior consent granted) or through the patient s GP. In the case of repeated non-attendance or difficulty in contacting the patient for a sample the following are to be informed: o Patient s Consultant Psychiatrist o The supplying pharmacy service Depending upon the frequency of testing required for individual patients, an extra three day (weekly monitored) or seven day (fortnightly and monthly monitored) supply of clozapine may be authorised in order to facilitate continued clozapine therapy. This must be arranged with the local supplying pharmacy for it to be prepared. The additional medication will be sent to the clinic on the next scheduled delivery or may be collected by the patient, CCO or clinic staff from the pharmacy. Secondary dispensing of previously dispensed clozapine by clinic staff or doctors is NOT permitted. The item must be processed at the original supplying pharmacy. For dispensing efficiency, it may be appropriate to dispense the remaining four/seven days or three weeks at the time of the adjusted supply so that the clinic may issue this remainder to the patient at the next clinic (depending on a satisfactory blood test. This will enable the patient to remain on their original four weekly appointment schedule and avoid recurrent shifts to the clinic schedule. The original full supply can remain secure at the clinic base until the next routine appointment or can be returned to the pharmacy. If the patient fails to have a blood test within the valid period, they will become prohibited on the monitoring system and will not be able to continue treatment until active registration is restored. This may involve a treatment break and re-titration; liaise with the CPMS/DMS, Consultant Psychiatrist and supplying pharmacy where this occurs. 7

8 6. Additional Monitoring In addition to the FBC monitoring, one-stop clozapine clinics will also: Record BP, pulse, temperature and weight at each outpatient appointment Take U&Es, lipids, LFTs, Glucose, Prolactin at baseline then every three months (on a rolling schedule) for the first year. The GP should then be asked to follow these up annually thereafter. These blood tests should be collected in a gold top sample tube and sent to the local general hospital laboratory for analysis. Calculate the Body Mass Index (BMI) every three months and record in RIO.A BMI calculator link is available within the new physical health assessment document in RIO. Measure the abdominal girth every three months. Complete an annual review of Lifestyle factors, more frequently if indicated. To include- smoking status, alcohol use, drug use, activity, diet. ECGs should be completed annually but more frequently if the patient is on two antipsychotics or on clozapine above BNF limits as per the High Dose Antipsychotic Procedure. If required, ECGs can be ordered by clinic staff as a 12-lead ECG with the results to be returned to the clinic. Either the patient or clinic staff can arrange the appointment with the local ECG service. Alternatively some clozapine clinics may be able to be set up to carry out their own ECGs. Clozapine Plasma Levels can also be taken if requested by the Consultant Psychiatrist, NMP or lead prescriber. There is no set frequency for these tests; refer to the Trust s Clozapine Policy for more details. The results of all of these tests should be reviewed by the clinic s NMP or Consultant Psychiatrist (or deputy) or junior doctor assigned to the team. Once signed off, the results should be scanned into the patient s RiO notes and where necessary forwarded to the GP for information or action. Clinic appointments will also be an opportunity to discuss a patient s general physical and mental wellbeing. The patient s views on clozapine treatment can also be assessed to identify any possible signs of non-concordance and alterations made to their dose. The presence and impact of side effects from clozapine can be assessed using the established tools using the Clozapine clinic side-effect monitoring form found on RiO. Service users should also be given an opportunity to regularly feedback their view/ opinions about the service offered in the one-stop Clozapine clinic. Clinic survey forms should be available at each clinic. All feedback data must be inputted in to the Trust intranet survey, for evaluation. 7. Patient Procedure Patient attends Clozapine Clinic as per appointment The clinic nurse will review the patient s mental and physical state, side effects discussed and a routine blood sample will be taken for processing in the PocHi machine Patients may be asked to stay until their blood results are available to enable medication to be issued following a valid blood result The patient will be advised of the date of their next appointment 8

9 8. Activating Procedure for PocHi Machines At the start of each clinic day, a background check runs automatically immediately upon switching on the PocHi machine. After this, the internal quality control process must be run. A satisfactory (i.e. valid) quality control test is required prior to the testing of patient blood samples with the PocHi machine. The entire start-up procedure should take a total of thirty minutes. x1 Take the correct week s QC sample from the clinic fridge (Eightcheck 3 WPL Low Level) Bring the sample to room temperature (at least 15 minutes out of the fridge) Mix the control sample for 2 minutes at 10 RPM in the rotary mixer just prior to analysis If the QC result is rejected by CPMS, or if the result has any incorrect values, the process should be repeated Perform the QC test in the machine and check the computer to confirm result transferred to CPMS If the second QC result is rejected using two separate control samples: Call CPMS PocHi Helpdesk No incorrect values a valid QC result: The PocHi is ready for use and the QC sample should be returned to the clinic fridge If the QC result is within the limits of the QC target result: The computer will display the following messages: Quality Check successfully completed PocHi 100i ready for use If the QC result is outside the limits of the QC target result: The PocHi indicates the incorrect values on the PocHi display and the printout The computer will display the following messages: QC failed: result does not match reference values Please perform Quality Check Repeat the above process one additional time. If following the second attempt the result from the QC tests fails: 9

10 The computer will display the following messages: QC failed (2): result does not match reference values PocHi has been disabled, please contact CPMS Call the CPMS helpdesk on If you have two consecutive failed QC tests, CPMS and Sysmex will be informed automatically. You will however need to contact CPMS to initiate the process of problem solving with your PocHi as the cause of the repeated QC failure must be investigated. If necessary, CPMS will consult Sysmex for advice to solve the problem. Once the problem is solved, CPMS will re-set the PocHi software and request a further repeat QC test, if applicable. Possible reasons for QC failure: Commonly: The sample has not been warmed or mixed sufficiently Less commonly: PocHi fails the PocHi machine needs repair or replacement Sample corrupted repeat the QC test with another sample QC lot expired QC lot not recognised Internet communication failure All QC check results should be recorded in the Sysmex PocHi Analyser daily log sheet. (Appendix 2) For information, Sysmex have a website which can be accessed via the following link: They also run a PocHi-100i Hotline for product support:

11 9. Analysing Blood Samples Blood samples must be labelled with a CPMS sticker and analysed as soon as possible after they are taken - always within 8 hours. Samples must be kept in the refrigerator if it is expected that analysis will be more than 4 hours from sampling bring to room temperature before testing Insert a valid CPMS User ID card in the card reader and log on (if applicable) The computer should display the message: PocHi-100i ready for use On the PocHi: Select WB (whole blood) analysis mode Scan the Patient s CPMS number using barcode Ensure that the computer with the PocHi software is connected to the internet and the PocHi PC software is running Mix blood sample for two minutes on the rotary mixer at 10 RPM Then put into the PocHi Visually confirm the PIN numbers match on the screen and the sample Press Run on the screen. Analysis takes approximately two minutes The result is visible on the PocHi Display and automatically transferred to CPMS If the patient result has been accepted by CPMS, the computer displays the message: Result transferred to CPMS database The CPMS website classifies the result instantly Amber Result Green Result Red Result CPMS will start amber alert procedure Refer to the Clozapine Issuing Protocol Valid Result Refer to the Clozapine Issuing Protocol Contact CPMS: Commence Red Result Procedure as per CPMS advice and Trust Clozapine Policy. Liaise with the supplying pharmacy. Refer sample to local laboratory for re-testing Ensure medication is removed from patient 11

12 If the patient s result is not accepted by CPMS: The following are possible reasons: CPMS PIN of the patient is not recognised Invalid patient identifier used Patient not registered with CPMS / or the PocHi machine A second result for the same patient is submitted on the same day. The sample has an invalid particle distribution: The sample is not sufficiently mixed The sample has clotted There is no sample tube in the PocHi during analysis The sample tube is empty or filled with watery fluid Values outside acceptable ranges Internet communication failure Other reasons may arise which will need to be discussed with CPMS Patients Blood Samples: Following analysis of the sample, it should be stored in a specimen fridge. All samples from the week s clinics are to be kept for 24 hours Samples tested on two occasions that have failed due to an invalid result reported as invalid particle distribution should be sent to the local laboratory for analysis; alternatively a second sample can be taken and run through the PocHi machine. Used/analysed blood samples/tubes are disposed of in plastic orange-lidded burn bins as advised by the Trust s Facilities and Estates Department. 12

13 10. Quality Assurance 10.1 Internal Quality Control Samples The type of Quality Control (QC) blood samples used for the internal Quality Control of the PocHi is Eightcheck 3 WPL (Low Level). The CPMS has a standing order with Sysmex on behalf of the Trust for delivery of new QC samples every three months. Every three months, a new pack of QC samples are delivered to PocHi clinic sites. These will be delivered to the clinic site and the clinic co-ordinator will be informed of arrival. The pack of QC samples must immediately be stored in the sample fridge. Upon receipt the delivery must be checked to ensure the correct type of QC samples Eightcheck 3 WPL (Low Level) with red tops and within date have been received. If no new QC samples have been received a week before the expiry date of the batch in use, the CPMS Helpdesk must be contacted. The QC samples should be stored in a locked fridge at a temperature of between 2-8 degrees centigrade; staff are required to keep ongoing records of fridge temperatures for audit purposes. The new pack of QC samples must only be used once the previous pack has expired. Prior to the use of the new QC pack, the batch number, expiry date and reference values should be entered into the PocHi machine (using the barcode scanner). A QC sample that is to be used should have two dates inserted on the tube label, one date when the sample is first used and the second date being the discard date one week later PocHi External Quality Assurance (NEQAS) CPMS have registered the PocHi machine with the National External Quality Assurance Scheme. The clinic is required to participate in the External Quality Control process on a monthly basis in order to keep the PocHi service operational. At the beginning of each month, a set of NEQAS samples will be delivered to PocHi clinic sites. These will be delivered to the clinic site and the clinic co-ordinator will be informed of arrival. The NEQAS samples must be tested (as if they were patient samples) and the result returned to NEQAS within the indicated timeframe on the enclosed instruction sheet. The NEQAS samples must be kept in the sample fridge until they are being tested. Instructions for testing are available with each set of NEQAS samples. If no new NEQAS samples have been received by the second half of the month, the CPMS Helpdesk must be contacted Record keeping / file maintenance Keep temperature log: Every day the PocHi Clozapine Clinic is in operation, the temperature of the fridge that stores the QC samples should be recorded to confirm that the samples are appropriately stored. Record the results on the temperature log (date and signature); see Trust Medicines Code. Training records: keep training records (Appendix 1) for all trained operators. Quality records: Maintain Daily Log Sheet (Appendix 2) with relevant information for each day that the PocHi machine is in operation. 13

14 11. Potential PocHi Machine Problems PocHi Failure In the event of PocHi failure, CPMS must be informed. If the problem cannot be solved by CPMS, the patients blood samples will need to be tested at the local hospital laboratory. CPMS will ensure that the PocHi machine is repaired or replaced within three working days; usually the next working day. PocHi Software / Internet Communication Failure When the PocHi software or the internet communication fails, the PocHi results will not be transferred to CPMS; CPMS must be contacted with the fault and results. If the QC check has already been performed that day, and the result is valid (accepted by CPMS), the PocHi can still be used for analysis of patients samples. If the QC has not been performed for that day, CPMS must be informed for resolution of the problem. If the problem cannot be resolved, the patients blood samples will need to be tested in the local hospital laboratory. CPMS will attempt to ensure that the problems with the PocHi software are solved within three working days; usually the next working day in liaison with the Trust s Health Informatics Service where necessary. In the event of a temporary internet communication failure, the PocHi software will continue to transfer the most recent results to CPMS for the next three hours. This result will be transferred to CPMS upon restoration of the internet communication. The 100 last results are stored in the PocHi. If necessary/applicable the stored results can be submitted to CPMS through the CPMS PocHi software. Use of PocHI Standalone Please note that the PocHi can be used as a standalone machine to enable clinics to be run if there is a computer failure with the local internet or if the results cannot be transmitted to the computer. In this event clinic staff must phone CPMS to report the problem and CPMS will then instigate an IT support call to investigate the issue. CPMS may give temporary access to PocHI standalone laboratory to input patient results if required. Clinic staff must initially fax or a printout of the daily QC result to CPMS. CPMS will confirm if this result is valid. No patient samples should be run until CPMS have confirmed a valid QC result. Once the QC is deemed valid by CPMS patient samples can be run via the PocHI. Clinic staff must either fax or any patient result printouts to CPMS for entry on to ecpms, or alternatively enter results on to ecpms themselves, choosing PocHI standalone as the laboratory. Staff should follow the guidelines outlined in Quick Guide 13-PocHi Standalone when entering results manually as any results with any blank parameters or flags on them must not be entered on ecpms and staff must follow procedure as if the result was an error. 14

15 12. Regular Maintenance and stock Clozapine PocHi clinic SOP, version 1.2 PocHi Reagents and Fluids A stock of PocHi Pack 65 and Cell Clean, the cleaning agent, must be kept in a locked cupboard at all times in the Clozapine Clinic at ambient temperature. To re-order reagents (Cell Clean or PocHi Pack 65) CPMS using the following link: cpms@mylan.co.uk and quote the relevant product codes. Ordering should be performed as the stock level decreases to a (recommended) one week s supply of PocHi Pack 65 and Cell Clean. Protective goggles, gloves and plastic aprons should be worn when changing and handling reagents. All spillages must be cleaned according to the Trust s Health and Safety procedures. The PocHi Pack 65 reagents box when ready for disposal must be wrapped in an orange waste disposal bag, secured with hazard tape and then placed in a special 60L sharp safe- box. The latter is ordered via e procurement in packs of 10 as follows: Product Description: Sharp safe 60 Litres x pack of 10 Product Code: FSL2011A Supplier Ref: Once the 60L sharp safe box is full, place the lid on and put the sealed unit in the usual clinical waste storage area but not in a yellow clinical waste bin. Note that once the lid has been firmly closed on the 60L unit it cannot be removed. All clinical waste will be collected by the clinical waste collection service at regular monthly intervals. Replacement 60L units will need to be reordered via e procurement as required in packs of 10. Changing Reagents The PocHi prompts that reagents need changing or change is deemed necessary by the operator PocHi Prompt: Press Execute Operator Decision: Press Menu Select Chg. Reag Press Execute Scan in or manually enter the Lot number, expiry date and serial number of the new pack Replace the pack to be changed 15

16 Transducer Cleaning prompted automatically Performed every two weeks or after 150 blood samples Add 1ml of Cell Clean to an empty sample tube Put the tube, without cap, in position in the PocHi machine PocHi Prompt: Press Execute The process will take approximately 10 minutes Operator Decision: Press Menu Select Maint. Press Execute The process will take approximately 10 minutes Waste Chamber Cleaning prompted automatically Performed every three months or after 1500 samples Add 1ml of Cell Clean to an empty sample tube Put the tube, without cap, in position in the PocHi machine PocHi Prompt: Press Execute The process will take approximately 15 minutes Operator Decision: Press Menu Select Clean W. Chamber Press Execute The process will take approximately 15 minutes 16

17 13. Medication Clozapine PocHi clinic SOP, version 1.2 Medication will be delivered from the supplying pharmacy in a timely manner prior to clinic. All clinic medication will have a red sticker stating Quarantined and cannot be given to the service user until a satisfactory blood result is obtained in clinic that week. The medication must be checked against the delivery note and also checked that there is a supply of medication for each service user expected to be attending clinic that week; the delivery note should be signed accordingly. Medication must then to be stored in the clinic s locked medicines cupboard. The keys must be locked in the key cupboard located in the clinic room; this may only be accessed by a qualified nurse or nominated member of pharmacy staff. The room temperature of the clinic s medicines cupboard should be recorded each day the clinic is in operation. N/B: Please note that some clinics may not store quarantined medication for the clinic as the near-by hospital pharmacy may store these until collected by the service user following a satisfactory blood result in clinic. Provided the FBC that has been taken at the clinic is GREEN and that there are no other concerns with the patient s wellbeing and concordance with the prescribed dose, the clinic staff nurse may issue the pre-dispensed pack of medication to the patient. If there are any concerns regarding the medication provided, this should be discussed with the supplying pharmacy. Any errors identified or changes to be made to the supply will need to be carried out by the supplying pharmacy the clinic team may NOT attempt to issue part of the supply themselves. If an alteration is required, apologize to the patient for the inconvenience caused and arrange a time for when then amended supply will be available. Complete an incident form on the Safeguard system. Medication remaining at the clinic after finishing should be locked away securely. If necessary it may need to be returned back to the supplying pharmacy. Medication will be provided with a sheet attached and delivered in a locked box which will have a list of the patients for whom medication is available. Clinic staff should check this list to ensure that it matches the clinic schedule and discuss any issues with the supplying pharmacy. During the clinic, staff should sign off the packs from the contents sheet and ask the patient to sign the individual package sheets prior to issuing. The sheet should be removed and retained at the clinic. The contents sheet and package sheets should be returned to the supplying pharmacy to complete their audit trail that the supply process has been completed. When the clinic has finished, a copy of the delivery note needs to be returned to the supplying pharmacy for their records; the original delivery note should be filed correctly at the clinic. 14. End of Clinic At the end of each clinic session, ensure that: All contacts recorded and outcome on RiO All results and physical health observations have been recorded on RiO. Computers are shut down correctly The PocHi-100i machine is shut down correctly 17

18 Any remaining medication is returned to the medicines cupboard and reagents are stored away appropriately, filing is done and RiO entries completed Any items that require replenishing are ordered The details for the following clinic are confirmed within the team The medicines cupboard is locked and key placed back in the key cabinet Certified PocHi Operators (trained by CPMS/Sysmex) Trainer Date Treatment room windows and door is locked to restrict access Registered PocHi Operators (trained by SSSFT Certified Operator) Trainer Date Appendix 1: Certified and Registered PocHi Machine Operators Clozapine Clinic:.. 18

19 19 Clozapine PocHi clinic SOP, version 1.2

20 Appendix 2: CLOZAPINE CLINIC DAILY LOG SHEET SYSMEX POCHI ANALYSER Month/Year:.../... QC Check must be performed every day the PocHi is used The shutdown procedure must be done at the end of each working day the PocHi is used Change reagents must be done each time the machine prompts Number of tests must be recorded each working day NEQAS Check must be recorded each month Problems must be recorded as and when they happen in the problems section below Day: Change PocHi Pack 65 Shutdown Waste Chamber Clean Transducer Cleaning NEQAS (monthly) No. of Tests QC Check Initials: Date Problems: 20

21 Appendix 3 Quick Guide to Recording External Learning on ESR If you have undertaken learning with a provider external to the Trust you can record this on your learning history on ESR. You need to follow this process to record whether you are a Registered or Certified Pochi 100i Operator Access ESR and choose the role 301 Employee Self Service From the menu that appears select Learning Click on the External Learning Tab to view this section You will then be taken to your learner home screen which details information about all learning. Click on the Create Button to enter some new External Learning 21

22 You will then be taken to the External Learning Screen where you enter the relevant details. You are only required to complete the fields marked with an asterix as a minimum. For your Sysmex Training enter the following information: Title: Certified Pochi 100i operator training or Registered Pochi 100i operator training Date: This is the date you have passed your online test Supplier: Sysmex 22

23 Once you have entered the information Click on the Continue Button You will then be taken to the next screen where you can review your entry before you submit it to your line manager to confirm. Once you have reviewed your entry click on Submit Your manager will then receive a notification to let them know that they need to approve this entry. Until they do the learning will stay in the external learning record but you will see it in the section entitled External Learning Pending approval. Once approved, it will be moved to the historic external learning section. 23