Policies and Protocols for the Management of Recombinant and Coagulation Products in Scotland

Transcription

1 Policies and Protocols for the Management of Recombinant and Coagulation Products in Scotland Version 2.0 Updated: October 2012 Next Review: August 2014 Haemophilia Centre Protocol v2.0 1

2 Table of contents 1. Protocol for Home Delivery of Factor Concentrates in Scotland...4 A National Guideline for Haemophilia Centres...4 Appendix 1: New Patient Criteria Checklist (Home Delivery of Factor Concentrates in Scotland)... 8 Appendix 2: Patient Acknowledgement (Home Delivery of Factor Concentrates in Scotland)... 9 Appendix 3: Patient Information Sheet Appendix 4: Performance Indicator Home Delivery within Haemophilia Centre (Home Delivery of Factor Concentrates in Scotland) Data Management Guidelines...16 Data Recording...16 Treatment issued within the Hospital setting (Hospital issues)...16 Wastage...17 Deliveries by the Home Care Provider...18 Reporting and Reconciliation...19 Appendix 5: Example of stock control ledger (Data Management Guidelines) Appendix 6: Spreadsheet for reconciliation of home delivery products (Data Management Guidelines) 24 Appendix 7: Scottish Haemophilia Coagulation Factor Request/Issue Sheet (Data Management Guidelines) Appendix 8: Cummulative total spread sheet (Data Management Guidelines) Appendix 9: Data required for all Centres for monthly NSD report (Data Management Guidelines) Guidelines for Stock Management of Coagulation Factor Concentrates within the Hospital Setting.29 Procedure for Ordering, Receipt and Storage of Coagulation Factor Concentrate...29 Appendix 11: Example of list of Coagulation Factor Concentrates held (Recombinant Policies and Procedures) Appendix 12: Example of Coagulation Factor Concentrate Minimum Stock Levels (Recombinant Policies and Procedures) Appendix 13: Example Purchase Order Form (Recombinant Policies and Procedures) Appendix 14: Storage Guidance of Coagulation Factor Concentrate (Recombinant Policies and Procedures) Appendix 15: Example of Coagulation Factor Concentrate Fridges Alarm Protocol (Recombinant Policies and Procedures) Appendix 16: Example of Blood Fridges Daily Checks (Recombinant Policies and Procedures) Appendix 17: Sample: Product Wastage/Non Infused Factor Form (Recombinant Policies and Procedures) Procedure for Issuing of Coagulation Factor Concentrate...40 Issues of Home Treatment Supply from Hospital...40 Appendix 18: Example Coagulation Factor Issue Record Sheet (Recombinant Policies and Procedures) Appendix 19i & 19ii) Sample Home Treatment Record Sheet (Recombinant Policies and Procedures) 42 Protocol for Supplying Coagulation Factor to Outreach Areas...44 Procedure for the Return of Coagulation Factor Concentrate...45 Appendix 20: Sample Product Return Form (Recombinant Policies and Procedures) Procedure for the Documentation of Coagulation Factor Concentrate Wastage...47 Procedure for Withdrawal of Coagulation Factor Concentrate Product Administration...49 Guideline for Administration of Factor Replacement Products within the Hospital Setting throughout Scotland...49 Haemophilia Centre Protocol v2.0 2

3 Introduction This policies and protocols document has been compiled in conjunction with the six haemophilia centres in Scotland to ensure good practice operational guidelines and standardised protocols are followed across Scotland in relation to: - Home delivery of factor concentrates - Data Management Guidelines - Stock management within hospital setting - Product administration procedures All six centres have signed up to following the protocols to ensure a consistent approach across Scotland in relation to the stock management of recombinant and coagulation products and to reduce the risk of waste. The document will be review biennially. Haemophilia Centre Protocol v2.0 3

4 1. Protocol for Home Delivery of Factor Concentrates in Scotland A National Guideline for Haemophilia Centres a) Background In Scotland factor concentrates for persons with haemophilia who use prophylaxis and /or home treatment can be delivered directly to the patient. The principal aim of the service is to provide a sensitive and personal home delivery service to haemophilia patients and their families to improve the quality of care to patients at home who require to administer clotting factor on a regular basis thus enabling these patients and their families to lead as normal and active lives as possible. Home delivery has been offered since 2007 and has been implemented by all haemophilia centres. Approximately 170 patients across Scotland benefit from this service, with deliveries per annum. National Procurement with input from the haemophilia centres hold and organise the specification and oversee the acknowledgement and procurement of this service. b) Aim of Protocol The aim of the protocol is to: To set national agreed terms of reference in relation to home delivery within all haemophilia centres. To be used as a tool to enhance home delivery service within a haemophilia centre c) Selection of patient for home delivery It is important to choose the patients who may benefit and comply with home delivery. Many factors have to be taken into consideration to allow home treatment to be undertaken safely eg reconstitution of products, venepuncture, hygiene, safe disposal of sharps and medicines. In addition the patient / carer must understand the importance and increasing necessity and requirement demanded of the haemophilia teams to provide accurate factor usage information. To assist the teams to assess, record and manage home treatment the following documentation can be completed by all teams and copies held in patients notes. i) New Patient Criteria Checklist (Appendix 1) ii) Patient Acknowledgement (Appendix 2) iii) Patient information(appendix 3) d) Managing Home delivery within the Haemophilia Centre The centres haemophilia nurse and data manager will be primarily responsible for the daily management of the home delivery service to the local population and an example flowchart is available to assist teams with the organisation of home delivery within their centre. Prescriptions will be provided by the designated medic or independent nurse prescriber in keeping with the Medicines Act 1968 and the Misuse of Drugs Act The centre will check and provide prescriptions as necessary, the provision of which will be decided by the prescriber as each patient may have varied needs and change of dose. A log of each patient prescription should be held within the haemophilia centre and a copy held and filed within the patients case notes. The centre has responsibility to inform the designated home delivery company of any change of prescription or circumstances. The full home delivery specification is available and has previously been agreed but will require review when new contracts are negotiated, this is available from NHS National Procurement (NP). Haemophilia Centre Protocol v2.0 4

5 e) Setting up Home Delivery Within the haemophilia centre Each haemophilia centre is staffed and manages their service independently. How home delivery is set up within a centre is and should be the responsibility of the haemophilia team. However the following flowcharts may be of use to teams to organise there practice. Flowchart for Home Delivery Set up for all Scottish Haemophilia Centres Patient currently on Home Treatment and meeting criteria for Home Delivery Service New Patient Criteria Checklist completed Write to patients introducing new delivery method to patients Content of letter Patients informed of delivery service and requirement of regular clinical review and completion of home treatment records Patient discussion on next visit to Centre to explain service Patient signs patient acknowledgement Patient Acknowledgement See Appendix 2 Spend 30 minutes discussing new service on next visit Patient Referral to Home Delivery Company Patient Registration form completed and sent to home delivery company 6 or 12 month prescription issued by consultant / nurse Patient Registration Form completed Prescription to provide details of projected delivery quantities and frequency Ancillary items will be based on a standard list with variations for individuals Ordering Order prepared according to the process for each Haemophilia Centre Refer to separate ordering and invoicing flowchart. To be completed Haemophilia Centre Protocol v2.0 5

6 Flow Chart for Home delivery Ordering and Invoicing carried out by Comprehensive Care Centre Delivery Home delivery company prepares delivery timetable for year Telephones patient to confirm next delivery Checks current stock levels and delivery requirements Delivers Clotting Factor Signed Delivery Notes are copied/sent to Centre Patients may identify an alternative delivery address (which may include the Haemophilia Centre) Home Delivery Company requires informing the Centre of delivery levels +/-20% of prescription levels Deliveries should be processed according to local health board finance instruction. To include reconciliation, invoice reporting and payment. Haemophilia Centre Protocol v2.0 6

7 e) Patient Information An agreed patient information leaflet (see Appendix 3) will be provided to all haemophilia or inherited bleeding disorder patients who are considered for home delivery in Scotland. This hopes to provide information to the patient or carer of the service and to clarify the responsibilities of the centre and patient. This will promote the need for home treatment records to be returned to the centre and stipulates that the centre has increasing demands to supply such information to National Services Division. How the bleed or treatment history is recorded will remain under the control of each haemophilia centre as the various needs of the patient and carers will have to be assessed e.g. does every patient have access to IT / PC, can all patients read / write? However it should be stressed that some form of record will be returned and held within the haemophilia centre. Home delivery does give the option if the patient cannot take receipt of their delivery at home for deliveries to be made to the haemophilia centre for safe storage until the patient can collect. This arrangement will continue and will be the responsibility of each haemophilia centre to organise dependent on storage facilities. f) Audit of Performance of home delivery service within haemophilia centre All centres will be expected to audit patient satisfaction in relation to the home delivery service. A patient survey will be developed and collated by all Scottish haemophilia centres with patient representation on an annual basis. g) Performance indicator development A PID can be developed to audit practice and measure quality of service for home delivery. See example Appendix 4. Haemophilia Centre Protocol v2.0 7

8 Appendix 1: New Patient Criteria Checklist (Home Delivery of Factor Concentrates in Scotland) To be completed by haemophilia nurse or haematologist. If a patient answers no to any of following questions they should not be considered for home delivery. Please delete as necessary, sign and date. This should be reviewed by prescriber at patient review. 1. Has patient or carer been assessed by nurse or medic as competent to reconstitute factor concentrates YES / NO Date Signature of assessor 2. Has patient completed home treatment education pack YES/ NO 3. Does patient return treatment records at present YES / NO 4. Has patient agreed and signed Patient Acknowledgement which outlines agreed terms and specific terms of when home treatment will cease or be withdrawn by haemophilia centre YES/ NO 5. Does the patient attend for regular review at the haemophilia centre YES/ NO 6.Has all documentation been provided and completed to allow home delivery to take place YES/ NO 7.Has factor usage treatment record been agreed and signed by patient / carer YES/ NO Haemophilia Centre Protocol v2.0 8

9 Appendix 2: Patient Acknowledgement (Home Delivery of Factor Concentrates in Scotland) Confidential Partnership Acknowledgement for Home Delivery Service Patient Name:.. Name of Parent or Carer (where appropriate): (where the patient is aged 0 to 16 years the parent/carer will be asked to help with this agreement) Hospital Number:.. Staff member name (member of staff who completed the agreement with patient/carer). Date this acknowledgement was discussed and agreed:. This acknowledgement is held between the patient, parent or carer and the Haemophilia Centre named below, and highlights the shared responsibilities that all parties have in relation to the Home Delivery Service. A copy will be held in the patient s notes and a copy given to the patient/parent / carer. Meeting these responsibilities will also help Centres to be fully aware of any haemophilia related issues that have occurred in the home setting and ensure that the clotting factor is being used appropriately and safely. If these responsibilities are not met home delivery may be withdrawn by the haemophilia centre. NHS National Services Scotland who commission haemophilia services request that all patients who receive home delivery must return on a monthly basis evidence of factor concentrate usage. In addition each Health Board requests that all patients within their area receiving home delivery must agree and return factor usage to their Haemophilia Centres who incorporate into reports for National Services Division. If treatment records are not received to the haemophilia centre home delivery may be withdrawn. Name of Centre: Haemophilia Centre Address of Centre: Telephone Number: Fax Number: Out of hours emergency contact details: Ask to speak to the on-call Haematologist Address if available: Haemophilia Centre Protocol v2.0 9

10 We the staff of the Haemophilia Centre at ensure the following: Ensure that your personal details are treated confidentially by all parties involved in the home delivery service. Continue to supply/stock appropriate treatments at the haemophilia centre to cover hospital/emergency treatments. Support your treatment in the home environment by providing telephone support and where/when possible visits by specialist nurses. Will be responsible for the provision of all aspects of haemophilia care and management. Name of member of staff:..... Position:.... Signature:.Date: (no legal status attached to signing) I,., agree the following: Ensure availability to receive my delivery of home treatment at the agreed time. Ensure rotation of stock (by expiry date) at/after each delivery. Use my treatment according to my prescription, and if I need to change it in any way, I will discuss this with Centre staff. Complete and return accurate home treatment records (or any others that apply to my treatment) on a monthly basis so that the Centre can accurately assess and monitor my haemophilia. Attend my pre-arranged appointment(s) and if the date and time are no longer suitable to me, contact the Centre to rearrange it. If I have any issues/concerns about the home delivery service, I will discuss these with the centre staff Name of patient/carer:.. Signature: Date:.. (No legal status attached by signing. If you do not want to sign this agreement this will in no way affect the care and treatment that you receive) A copy of this acknowledgement will be given to the patient with the original being kept in the patient s medical records. This Acknowledgement will be subject to regular review. PLEASE NOTE NON-COMPLIANCE WITH THE ABOVE WILL RESULT IN THE WITHDRAWAL OF THE HOME DELIVERY SERVICE Haemophilia Centre Protocol v2.0 10

11 Appendix 3: Patient Information Sheet Information for patients Home Delivery Service The company who delivers your home treatment is: (Company Name) (Company Address) Tel: Office hours Monday to Friday (insert opening hours) Your patient services co-ordinator for (insert company name) is: This leaflet contains everything you need to know about the service (Insert company name) will provide for you at home. Please read all the sections. Your patient services co-ordinator will be happy to answer any queries you may have. Please note: All your haemophilia medical and nursing care will continue to be provided from your Haemophilia Centre. Haemophilia Centre Protocol v2.0 11

12 Your consultant will continue to have overall clinical responsibility for your care. With this in mind, you should continue to contact your medical team with questions about your treatment, or to discuss any health problems. Frequency of deliveries The Clinical team at your hospital will prescribe your medication according to your individual needs and this will determine the frequency of your deliveries (for most patients this will either be once every 4 weeks or every 8 weeks). Your patient services co-ordinator will telephone you to make arrangements for your first and subsequent deliveries. Delivery Schedule The delivery dates are scheduled in advance. Your patient services co-ordinator will contact you in advance of your deliveries to: Confirm your next delivery date Confirm delivery address Check your current stock levels Advise you that your driver will be collecting and replacing your sharps bin. If due to unforeseen circumstances, you will not be in to receive your delivery, please contact your patient services co-ordinator as soon as possible (ideally hours pre delivery). If your details change Please let your patient services co-ordinator know as soon as possible if you: Wish to change your delivery schedule or any details of your delivery (at least 48 hours before your delivery is due). Move house Change your telephone number or mobile phone number. Change your GP or if their address or phone number changes. Upon delivery Deliveries are made in an unmarked van by a uniformed (insert company name) driver who will always carry a photographic identification card. The driver will ask you to check the delivery and sign the delivery note. If you are going to be out, please ensure that a responsible family member is available to receive and sign for the delivery. Under no circumstances will deliveries be left on your doorstep therefore, you may find it useful to provide (insert company name) with an alternative delivery address and details of a named person who will accept receipt of this. The delivery company will require appropriate advance notice from you in these circumstances. Haemophilia Centre Protocol v2.0 12

13 The driver will unpack the medication and remove the packaging for you if you so wish. However, if you unpack this yourself, please ensure you rotate your stock by putting the older medication in front so that it is used first. Also, please retain the package boxes until your next delivery when the driver will remove them for you. When your medication is delivered, always make sure your name appears correctly on the dispensing label. You should also check the expiry date of the medicines and their storage conditions. Sharps bins You will be supplied with sharps bins for disposal of needles and syringes. Please do not use the bin for the disposal of packaging. Ensure the sharps bin is firmly closed once full and give it to the (Insert company name) driver for return to (Insert company name) Prior to administration Please notify (Insert company name) immediately if: Your medication is damaged in any way or is leaking on delivery Your medication has become damaged or you are unable to use it for any reason. Your patient services co-ordinator will arrange for it s collection Always keep medicines and ancillaries out of the reach of children Frequently asked questions What time will my delivery arrive? (Insert company name) try to keep to the same route each time they make deliveries. However, this is not always possible, making it difficult for them to stick to an exact time. If you are concerned, please contact your patient services co-ordinator. BUPA Home Healthcare provide a text communication service prior to your delivery. This text can be sent to you after 3pm the day before your delivery is due and will confirm the 2 hour window when your delivery will arrive. If you wish to make use of this service, please discuss this with your patient services co-ordinator. If you do not have a mobile phone or do not wish to use this service, the patient services co-ordinator will call you on your preferred telephone number after 3pm the day before your delivery is due. How do I check my delivery? Each delivery comes with a delivery note. Make sure you have received all the items on this note. Please ensure to check that your name appears correctly on all labels and check the expiry date of medicines. If the delivery is correct sign the delivery note and hand it back to the driver. Haemophilia Centre Protocol v2.0 13

14 What do I do if I haven t received all of my delivery? If you have any concerns regarding the contents of your delivery, please contact the patient services co-ordinator or your local Haemophilia Centre. Who do I speak to if I am unhappy with (Insert company name) service? (Insert company name) take great care to provide a professional, high-quality service. However, if for any reason something does go wrong, your patient services co-ordinator will be able to correct most problems. If you wish to speak to someone other than your co-ordinator you may contact the Customer Services Manager (insert telephone number). If you are still not satisfied, you can call the Care Quality Commission directly on , who can provide advice and support on quality of care and safety issues. Customer Feedback Feedback from patients and carers is crucial in helping (Insert company name) provide the best quality care and service. They would like to hear from you at any time with your concerns, suggestions and comments favourable or otherwise. Please contact them via their website (insert website) or telephone (insert telephone number) Data protection (Insert company name) are committed to maintaining your personal data in accordance with the requirements of the Data Protection Act 1998 and will take all reasonable steps to ensure that your personal data is kept secure against unauthorised access, loss, disclosure or destruction. Haemophilia Centre Protocol v2.0 14

15 Appendix 4: Performance Indicator Home Delivery within Haemophilia Centre (Home Delivery of Factor Concentrates in Scotland) Performance indicator example Title: Evaluation of home delivery service within the haemophilia centre Aim: To audit practice and evaluate if agreed protocols are being followed within Haemophilia Centres Frequency of Audit: annually What is to be audited: Documentation in relation to home delivery for all patients. Number of patients currently on home delivery: Documentation to be audited 1. Patient checklist Has it been completed for all patients who use home delivery and logged in case notes 2. Prescriptions Is evidence of current prescription in patients case- notes 3. Patient consent/ agreement Is there copies of patient consent in patients case notes 4. Patient satisfaction Is there evidence of patients satisfaction survey been completed 5. Home treatment records Is there evidence of factor usage at home recorded and returned to centre 6. Complaints Number of complaints received in relation to home delivery Documentation Present (%) Documentation Not present Who will perform audit: Each haemophilia centre will designate appropriate staff to perform the audit. Information Sharing: Each haemophilia centre will be responsible for completing the audit on an annual basis and reporting this to their comprehensive care centre. This data will be fed back into the NSD reporting system. Haemophilia Centre Protocol v2.0 15

16 2. Data Management Guidelines On the recording and reporting of the use of recombinant and commercial blood products as per the National Recombinant Risk Share Review Meeting 20/11/2011 Ownership of these guidelines belongs to Scottish Haemophilia Data Managers who were in attendance at the above meeting. These guidelines are not self limiting and are subject to changes and additions at regular intervals. Data management is one of the most crucial elements of the Haemophilia Service. Annual Service Agreements and the management of the home delivery contract are dependant on robust and accurate data collection, recording and reporting in order to provide the facilities which ensure projected usage continues on track, financial forecasting is as accurate as possible and Health Boards are receiving value for money. Each Haemophilia Centre/Comprehensive Care Centre must have a good local database with the capabilities to produce the reports required by many stakeholders (Trust Finance Departments, National Services Division, National Procurement, National Haemophilia Database, Health Boards) with strong, dependable and accurate data. Ideally, each Centre should have in their employ, staff member(s) who is/are trained not only in data collation and entry but also who have the capabilities of producing reports to the standard required by the aforementioned stakeholders. Any education or training needs identified by these members of staff should be addressed in order that the data management of the service can continue to meet the standards required and the ever growing requirements. Data Recording Treatment issued within the Hospital setting (Hospital issues) When a patient contacts the Haemophilia Centre requesting or necessitating treatment, this should be prescribed by the Doctor or other prescribing practitioner and requested from the appropriate stock holding facility e.g. Blood Bank or Pharmacy. When the product is then delivered/received into the Haemophilia Centre, it should be accompanied by appropriate documentation which signs it out of the stock holding facility and which details the following patient identification: Patient Name, Date of Birth, Hospital Number (CRN) and CHI number Name of the Product (Refacto AF, Helixate NextGen, BeneFIX etc) Number of vials Vial size Batch Number Expiry Date This information should be checked upon receipt into the Centre and signed by a doctor or nurse at the time of hand over to the patient (if home treatment) or administration (if hospital treatment). A note should then be added to this document stating the reason for this treatment, e.g. home treatment, spontaneous bleed, pre/post surgery etc and in cases of a bleed, the site of the bleed. All this information should then be passed to the Data Manager for recording on the local database. Haemophilia Centre Protocol v2.0 16

17 The information then recorded on the local database should include but not be limited to: Patient I.D. Number/CRN/CHI Date product was issued/administered to patient Product Name Number of vials the patient actually received Size of vials actually received Batch number of vials Reason for issue/administration Any additional information e.g. administered in another area/hospital Wastage which may have occurred with this issue. Stock held within Haemophilia Centres In any Haemophilia Centre which holds stock on site, e.g. for emergency purposes, a stock control book must be held which has individual pages for each product and shows as Appendix 5. the date this stock was received to site from the stock holding facility the vial size batch numbers total amount of this product held with this product added on administration to a patient from this stock, the control book should show patient s name to whom product was administered the number of vials of each size issued the batch numbers issued the remaining total of this product after issue When product is administered to a patient from this stock, documentation in the same format as that supplied from the normal stock holding facility must be completed by the prescribing doctor or nurse and passed to the data management team. This should then be entered onto the local database in the normal manner and at the end of each month a report should be run from the local database and reconciled with the Stock Control Book. Any issues of product to patients should then be included in the normal monthly reporting system with other hospital issues. All information should be input to local databases on a daily basis in order that the database is kept in real time. Wastage Wastage can occur for many reasons and should always be recorded on the local database. The number of vials, the batch numbers and the reason for the wastage should always be recorded and any documentation which relates to this should be copied and retained on within the Haemophilia Centre for audit purposes. Wastage should always be highlighted and reported to National Services Division within required reporting facilities and therefore Haemophilia Centres should report this to the Comprehensive Care Centre with their monthly figures. Please refer to example Waste Form on the Stock Management Policies (appendix 17) N.B. The above guidelines apply to all Centres whether Haemophilia Centres or Comprehensive Care Centres Haemophilia Centre Protocol v2.0 17

18 Deliveries by the Home Care Provider In accordance with the Guidelines for Home Delivery, when product has been delivered to the patient s home address, the following data management procedures for recording information should take place. Sales Reports Every Monday, a Sales Report detailing all deliveries made to patients the previous week should be ed via nhs.net from the home care provider to the relevant Haemophilia Centre. Each Comprehensive Care Centre should also receive a copy of these for their own patients and for the Haemophilia Centres they oversee. Proof of Delivery Notes (POD) Every Wednesday, each Haemophilia Centre and Comprehensive Care Centre should receive by via nhs.net from the home care provider, a POD for every patient who received a delivery the previous week. Again, the Comprehensive Care Centre should also receive a copy of the POD for each delivery made to patients within the Haemophilia Centres which they oversee. Each individual Centre must reconcile these PODs with the Sales Report for their patients and ensure that the information on both agrees. Particular attention should be given to: o Correct patient information o Correct product has been delivered o The amount of product delivered is within the agreed prescribed amount o The POD has been signed by the patient or his/her representative and not by the home care provider personnel. Invoices Any discrepancies in either the Sales Report or the Proof of Delivery should be highlighted (to the Comprehensive Care Centre if a Haemophilia Centre) and reported to the home care provider through the appropriate procedures as detailed by National Procurement. When all the weekly data has been checked for accuracy, it must then be entered on to the local database. The product and reason for treatment in the case of home delivery should be highlighted as such. Products delivered through the home care method can be distinguished on the database from other products by adding HD after the product name e.g. Refacto AF HD, Advate HD, etc. When it has been ascertained that all weekly information is correct, the Comprehensive Care Centre can record this on a spreadsheet (see Appendix 6) which will include each individual Centre they oversee and at month end total this in preparation for receipt of the invoice from the home care provider. When this invoice is received (normally at the start of the following month) this should be easily reconciled with the spreadsheet allowing any discrepancies to be identified and rectified immediately. Local guidelines should then be followed in order that the invoice is sent to Finance Departments for payment within the agreed timeframe. All information for home care can then be combined with hospital issue data for reporting purposes. Copies of all documentation regarding issues to patients (hospital issue and home delivery) should be filed by each pertaining month and retained for audit purposes. Haemophilia Centre Protocol v2.0 18

19 Reporting and Reconciliation Monthly Local Reporting At the start of each month and once all data for product issues have been completed, all Haemophilia Data Managers should run 2 reports from their local database. Both reports should be within the dateline of the 1 st day of the month to the last day (e.g. 1 st to 30 th November). The first of these reports should include all patients who received treatment (hospital or home delivery) within this timeframe, the name of the product they received, the total amount they received and any wastage. The second report should show each product by name and a total amount for each product issued within the required timeframe. At the same time, the hospital stock holding facility (Blood Bank or Pharmacy) should also run 2 reports. The first showing details of every patient who was issued with product. This should include: o o o o o o o Patient demographics Where this product was issued to (e.g. Haemophilia Centre/Ward/Outlying Hospital) Name of product issued Number of vials issued Batch numbers of vials issued Total amount of product issued The second report should show the total amount for each product issued from this stockholding. The reports from the local database should then be reconciled with the reports from the stock holding facility and any discrepancies identified, discussed and resolved as quickly as possible. When reconciliation is agreed, Haemophilia Centres should via nhs.net, the required information to the Comprehensive Care Centre who report this data on their behalf. It is important that Comprehensive Care Centres receive in this information the following: o o o o Post Code Name of product Amount of Product Wastage details This information must be received by the Comprehensive Care Centre by the 7 th day of each month. When the Comprehensive Care Centre receives this required information from the Haemophilia Centre, the home delivery figures should be rechecked to ensure that they agree with the figures on Appendix 6 and therefore the total amount reconciled with the invoice. This also allows reconciliation with the Haemophilia Centre on their input of home delivery issues into their local database. Any discrepancies should be highlighted and discussed with the Haemophilia Centre, figures amended as necessary and reports resent. Product issued from or to outlying hospitals All products in outlying hospitals must be accounted for on a monthly basis. Product issued from a stock holding facility and sent to an outlying hospital on a named patient basis should have been picked up and reported on the monthly report from that facility. The outlying hospital must complete a form as in Appendix 7 and sent back to the haemophilia centre where the patient is registered as soon as the product has been administered. This information should then be entered on the local database and reported as per the normal reporting procedure. Product issued from emergency stock held within the outlying hospitals should also be reported using this form and recorded and reported in the same way. Haemophilia Centre Protocol v2.0 19

20 A stock check must be undertaken by outlying hospitals at the end of each month and forwarded to the appropriate Centre should reconcile any issues to patients and help identify any unaccounted for product or missing data. Once the Comprehensive Care Centre has checked and verified this information from the Haemophilia Centres and outlying hospitals, all data in their remit should be amalgamated in a suitable format as shown in Appendix 8. This shows total issues of each product against individual health boards for each reporting Centre and a final total of all issues. This then allows reconciliation when the Data Manager of the Comprehensive Care Centre completes the monthly report for National Services Division. Under Wave 2 of the new contract for the purchase of recombinant products, it is essential that all Centres monitor their usage of each product to ensure that agreed targets are being met and penalties for under usage are not incurred. It is useful if this is monitored monthly by Data Managers in order to identify and highlight to management and NSD at an early stage if problems are likely to occur. A simple method to facilitate this is shown in Appendix 8. This spreadsheet again also facilitates the reconciliation of other figures as well as an at a glance view of stock levels. National Services Division Report By the 14 th day of each month, NSD requires that the Comprehensive Care Centre completes a specific spreadsheet designed by them containing data they require for financial purposes and for reporting to Chief Executives of each Health Board. The data held within this sheet includes the units used of each product per Health Board and allows calculation of the cost of these products both for hospital and home delivery issues. This ensures accurate reimbursement to finance departments of Health Board areas who manage this contract i.e. NHS Greater Glasgow and Clyde and NHS Lothian. A spreadsheet should be designed as in Appendix 9 into which all data from all the Centres can be detailed by product and health board. This will allow calculation of both hospital issues and home delivery issues and can be used as a tool for reconciliation purposes by checking the final total column in this worksheet with the totals after completion of the NSD monthly report. Any discrepancies should be easily identifiable and corrected immediately. An exception report also forms part of the information on this spreadsheet and requires that NSD are notified of circumstances where patients may use an increased amount of product i.e. immune tolerance, pending elective surgeries etc. In circumstances where a patient has perhaps had a traumatic event, emergency surgery etc and has used exceptionally more product than normal, this must also be identified on the exception report. In all these exceptions, the patient s Health Board and a unique identifier (retaining patient confidentiality) must be provided and it is important that Haemophilia Centres report any exceptions to their Comprehensive Care Centre for inclusion in this report on a monthly basis. Once complete and all totals reconciled, this report must be ed to National Services Division with a copy to the local Finance Department to ensure reimbursement of costs. Stock Reports At each month end, every stock holding facility should conduct a stock check which is then sent to the Data Manager for that site. This should be reconciled against the previous month s stock levels taking into account all hospital issues to patients, outlying hospitals, emergency stock and any expired stock which would be considered as waste. Any deliveries received from the supplier should also be accounted for. Any discrepancies identified should be discussed and rectified immediately. Outlying hospitals would also be expected to complete and return a stock check of any stock they hold belonging to Haemophilia Centres/Comprehensive Care Centres. Haemophilia Centre Protocol v2.0 20

21 Paperwork detailing stock checks and reconciliation should be retained for audit purposes. Quarterly National Haemophilia Database Each quarter, data should be extracted from the local database on the amount of product used for each individual patient and also a report on the total usage of each product for that timeframe. These quarters run on the calendar year and submission dates are as follows: Quarter 1: January 1 st to March 31 st Due by April 30 th Quarter 2: April 1 st to June 30 th Due by July 31 st Quarter 3: July 31 st to September 30 th Due by October 31 st Quarter 4: October 1 st to December 31 st Due by January 31st HCIS Users Centres who use the HCIS system should also run a report from the National Haemophilia Database and reconcile this with their own figures to ensure accuracy and that any waste which an individual patient has not actually received is not included in these totals. Please refer to National Haemophilia Database User Manual page 30, for information on how to view reports. Non-HCIS Users Centres not currently using the HCIS system should extract data from their local database and input this into the National Haemophilia Database via the website A report should then be extracted from the National Haemophilia Database (refer to User Manual as detailed for HCIS users) and reconciled against your own input figures to ensure 100% accuracy. All Centres should also ensure that the total amount for each product for the relevant quarter from their local database agrees with the National Haemophilia Database. When any discrepancies are corrected, the remainder of the required information should be completed and the National Haemophilia Database returns signed off for that particular quarter. Six Month Report to National Services Division (1 st April to 30 th September) Each Comprehensive Care Centre is required under the Service Agreement for Recombinant and Commercial Concentrates for Haemostasis Disorders to submit a 6 month report which incorporates information from all associated Haemophilia Centres. As such, all Haemophilia Centres should co-operate with the Comprehensive Care Centres in furnishing any information required for this report in an accurate and timely manner. This report requires to be submitted to National Services Division by 31 st October. Haemophilia Centre Protocol v2.0 21

22 Annual Report to National Services Division (1 st April to 31 st March) At the end of each financial year, National Services Division requires an annual report from both Comprehensive Care Centres on the previous year. This report is not confined to usage and cost but includes: Section A A General Description of Service/Programme to include: Title/Name of Service Programme/Year of Report Aim/Purpose/Mission Statement/Date of Designation Description of Patient Pathway Section B Quality Domains Efficient a) Actual v Planned Activity b) Resource use c) Finance & Workforce d) KPIs and HEAT Targets Effective a) Clinical Audit Programme b) Clinical outcomes/complication rates/external benchmarking c) Service improvement d) Research Safe a) Risk Register b) Clinical Governance c) Healthcare Associated Infection (HAI) & Scottish Patient Safety Programme (SPSP) d) Adverse Events e) Complaints & Compliments Timely a) Waiting/Response Times b) Review of Clinical Pathway Person Centred a) Patient/Carer/Public involvement b) Better Together Programme c) User Surveys/Action Plan Equitable a) Fair for All: Equity and Diversity b) Geographical Access Section C Section D Looking Ahead/Developments Summary of Highlights (Celebration and Risk) As this is the largest and most detailed report of the year, it is imperative that all Haemophilia and Comprehensive Care Centres work together to ensure information is reconciled allowing this report to be pulled together in a timely manner and submitted to National Services Division by the due date (31 st May). Haemophilia Centre Protocol v2.0 22

23 Appendix 5: Example of stock control ledger (Data Management Guidelines) Date Batch No No of vials Vial size Patient Name Product Name: Refacto AF No of vials issued Batch No Total Product Amount 01/11/ /11/ /11/2011 A.N. Other /11/ Haemophilia Centre Protocol v2.0 23

24 Appendix 6: Spreadsheet for reconciliation of home delivery products (Data Management Guidelines) Each product should have it s own worksheet (see Table 1 below) within the one Excel file with the final worksheet (see Table 2 below) being the total for all products and the final figure in the final column being that which should be reconciled with the monthly invoice from the home care provider. This final worksheet with the monthly invoice total can also carry a running total for reconciliation with the home care figures on the monthly NSD report. PRODUCT: Refacto AF Table 1 Month Centre Patient Name/ID Total Units Product Cost Delivery Cost Total Cost November A A.N Other , , J Bloggs , , Total for Centre A , , B M R Smith M S Smith Total for Centre B , , Grand Total , , Table 2 Month November Total Units Delivered Product Cost Delivery Cost Total Cost Product Helixate NextGen , , Kogenate Advate Refacto AF , , BeneFIX Haemate P Feiba TOTAL , , Haemophilia Centre Protocol v2.0 24

25 Appendix 7: Scottish Haemophilia Coagulation Factor Request/Issue Sheet (Data Management Guidelines) Patient Details Patient Surname Patient Forename Patient DOB / CHI / Hospital number Patient Location i.e. Hospital and Ward Issuing Laboratory Details Hospital Location e.g. Blood Bank, Pharmacy etc Product Issue Details Product Name Batch Number Vial size No of vials issued Expiry Date Date of Issue Date of Infusion Time of Issue Time of Infusion Reason for Issue Issued By (Print Name) Additional Information: Issued By (Signature) Haemophilia Centre Protocol v2.0 25

26 Appendix 8: Cummulative total spread sheet (Data Management Guidelines) Actual Use & Stock levels (GRI + RHSC) 2011/2012 USE Usage Sept 10 to March 11 Apr10 May 10 June 10 July 10 Aug 10 Sept 10 Apr - Sept Total Product Total to Date April 11 to March 12 Total to date (Sept 11 to Aug 12) Projected outturn 2011/2012 as at April 2011 Advate 0 Advate Home Delivery Kogenate 0 Kogenate Home Delivery Refacto 0 Refacto Home Delivery Fanhdi 0 Fanhdi Home Delivery Helixate NexGen 0 Helixate nexgen HD Tot Recombinant STOCK Advate Kogenate Refacto Fandhi Helixate BeneFIX use BeneFIX Home Delivery TOTAL BeneFIX BeneFIX delivery BeneFIX stock GRI STOCK Advate Kogenate Refacto Fanhdi Helixate BeneFIX Haemophilia Centre Protocol v2.0 26

27 Appendix 9: Data required for all Centres for monthly NSD report (Data Management Guidelines) This spreadsheet would be made up of 3 identical worksheets (see spreadsheet below). One would be for Hospital Issues, one for Home Delivery issues and the final one for a total of both of these previous sheets. The total worksheet should be formatted in such a way that it adds the figures from both sheets together and automatically works them into individual totals. The figures on both the final column (headed Total ) on the hospital issue worksheet and the home delivery worksheet would be the figures used to be put into the NSD spreadsheet with the totals worksheet allowing reconciliation with the final totals on the NSD report. See enclosed Excel File (Appendix 10) as working example. Haemophilia Centre Protocol v2.0 27

28 Appendix 10: NSD Reporting Template completed by comprehensive care centre Health April May Board Product Units Units Health Board A Advate Benefix Kogenate Refacto Haemate P FEIBA Fibrogammin P Replenine Fanhdi Factor XI Haemocomplettan Atryn Kybernin P Alphanine Hexilate Nexgen Novoseven Antithrombin Berinert P Beriplex C1EBP BPL 8Y Spare Study Refacto AF - - Trial Drug B - - Trial Drug C Totals Support Costs Total Costs - - Haemophilia Centre Protocol v2.0 28

29 3. Guidelines for Stock Management of Coagulation Factor Concentrates within the Hospital Setting These guidelines have been produced with the collaboration of staff working within the combined Scottish Haemophilia Service. Creation of these guidelines were recommended within the outcomes from the National Services Division Report Report on Review of Recombinant Coagulation Risk Share Scheme 2011/12. The guidelines should be used alongside the Royal Pharmaceutical Society The Safe and Secure Handling of Medicines: A Team Approach March 2005 whose key principles are: Compliance with current legislation Adherence to guidance issued by the Health Departments for England, Wales, Scotland and Northern Ireland and other national guidance e.g. NPC Guide Management of the risks to patients and staff arising from the use of medicines. As defined in Chapter 4 of the Royal Pharmaceutical Society The Safe and Secure Handling of Medicines : A Team Approach March 2005, the medicines trail is a multistage process which needs the introduction of controlled links at the relevant stages from initiation of treatment through a prescription to the administration of the medicine and the disposal of any waste material. These guidelines highlight the local procedures required in the specialist treatment products, namely coagulation factor concentrates. Procedure for Ordering, Receipt and Storage of Coagulation Factor Concentrate A variety of coagulation concentrates are supplied for the Haemophilia Service (see example coagulation factor product list - appendix 11). The central store of these concentrates differs from Centre to Centre and may include pharmacy departments, the Blood Transfusion Service or the actual haemophilia centre itself. It is important that robust communication between the linked area of storage and the local Haemophilia Centre is maintained. Minimum stock levels for each product should be agreed with the local Haemophilia Centre and monitored regularly, according to usage patterns (see example minimum stock level template appendix 12) Routine frequency of stock checking should be agreed locally and may include daily/ weekly/ monthly checks. Hospital stock levels should sit between one month and three months issue volume. Ordering from Suppliers Frequent stock level checks will ensure triggering of the ordering process. Orders for product should ensure that stock of the coagulation factor concentrate are brought back to minimum levels required (taking into consideration any outpatient and inpatient treatment that may be required and any planned procedures or surgery). Storage personnel should liaise with Centre staff to ensure stocks are adequate. The order request is then processed and should include which coagulation factor is required, the amount and potency ( see example purchase order appendix 13) Haemophilia Centre Protocol v2.0 29