Cumbria Internal Audit & Counter Fraud Consortium

Transcription

1 Cumbria Internal Audit & North Cumbria University Hospitals Final Report Distribution List: Executive, Carole Heatly Director of Finance, Jonathan Wood Deputy Executive, Kevin Clarkson Company Secretary, Paul Mavin, Bill Glendinning Audit Committee Chair, Michael Bonner External Audit Manager, Angela Stubbs Sue Turner, Auditor Cheryl McAdams, Internal Auditor November 2008 Cumberland House, Carleton Clinic, Cumwhinton Drive, Carlisle, CA1 3SX Tel: Fax:

2 INTRODUCTION 1. North Cumbria University Hospitals has an annual drugs budget of 11.2m. It has two main pharmacies one on each Hospital site (Cumberland Infirmary Carlisle and West Cumberland Hospital in Whitehaven) and a smaller pharmacy at Carleton Clinic supporting Cumbria Partnership Foundation Trust. The total budget for Pharmacy services net of income is 13.5m. 2. including the safe handling and administration of drugs has been the subject of legislation and Department of Health reports in recent years, and falls within the clinical governance arrangements within the Trust. 3. Previous audits have reviewed the computer ordering and stock control system (Aposyst) within Pharmacy; the purpose of this audit is to review the basic procedures and practices in place from the ordering of medicines in the Pharmacy dept. through to the administration of medicines to patients. 4. The Pharmacy is preparing for a new system Ascribe to go live in January This has been seen as an opportunity to standardise the procedures across the Trust, where working practices have been similar but not uniform across the sites since the Trust was reconfigured in SCOPE 5. The audit examines the policies and procedures in place and through a sample of visits to clinical areas, assesses compliance in practice. The work of the Drugs and Therapeutics Committee was be examined in respect of new guidance, alerts received, risk management and governance arrangements. The procedures for managing risk and reporting and learning from adverse incidents were reviewed. The procedures for evidencing compliance with Health Care Standard 4d was also reviewed. OBJECTIVES 6. To provide assurance that the Trust has in place policies and procedures to ensure that medicines management conforms to legal requirements and best practice as outlined in Department of Health reports in respect of prescriptions, supply and administration of medicines including controlled drugs METHODOLOGY 7. The audit was conducted by a series of interviews with Pharmacy staff and observing procedures. Visits were made to a sample of wards across both sites and involved nursing and Pharmacy staff. In addition minutes from the Drugs and Therapeutics Committee, Risk Management and Clinical Governance Committees were examined. Records from Risk Management of incident reporting were extracted from the Ulysses system from April 2008 to date. OPINION 8. There is overall Significant assurance that the procedures for the safe handling of medicines within the Pharmacy Department are in place with only minor areas requiring improvement and these will be addressed when the new system in introduced. Cumbria Internal Audit & 1

3 9. There is Limited assurance that the Wards are fully up to date with the policy on the Storage and safe handling of medicines and controlled drugs, as each ward has different procedures and differing levels of compliance. 10. There is Limited assurance that the Trust has set up a committee structure to monitor medicines management and report on assurance. There is some weakness in the reporting of incidents which the Trust has recognised is low and needs to be further addressed. The assurances received by the Board could be strengthened by the introduction of key performance indicators benchmarking medicines management against external and internal standards. 11. There is Limited assurance that the Trust is covering income due on prescriptions dispensed at either pharmacy. There is an unofficial arrangement not to ask for payment in some cases, and an attempt to recover some income which is incomplete and does not follow through. Whilst Internal Audit can understand why this is so and the amount in involved is not material, the law in unequivocal. REVIEW FINDINGS System of Board accountability and assurance 12. Executive Director responsibility for lies with the Deputy Executive who is also the Accountable Officer in respect of Controlled Drugs. The is directly accountable to him and there are regular meetings discussing objectives and progress. 13. The is a member of The Drugs and Therapeutics Committee, his deputy is a member of the Clinical Audit and Effectiveness Group and a non core member of the Risk Management Committee. The is invited to attend the Governance Committee as required, but is not a standing member, in the last year he has attended twice, in November 2007 to present the annual update on assurance and again in April 2008 to advise on progress against plans. The is not a member of the Risk Management Committee, the link from Risk Management to the Drugs and Therapeutics committee is the Risk Manager who attends both. There is therefore, no automatic pharmacy input to the Governance Committee. 14. The current reporting structure is being reviewed as the Medical Director is considering whether the reporting of Pharmacy services to the Board should be via the Clinical Policy Group, on which the sits. Moreover, this group reports directly to the Board. The disadvantage of this arrangement is that this would by pass the Governance Committee which has the role of assessing the level of assurance that the Board can place in systems and controls which includes medicines management. 15. Under the main committee structure there are other groups that support medicines management, notably the Safe Medicines Practice Group. This group is responsible for responding to National Patient Safety Alerts (NPSA) regarding medicines. The group is also working on the introduction of Standard Operating Procedures (SOPs) for example in the handling of controlled drugs on ward areas, which was approved during this audit. 16. Within the Pharmacy department there is a transparent reporting arrangement between the Pharmacy Steering Group and the Senior Managers meetings held at the West Cumberland Hospital and Cumberland Infirmary. The minutes and Cumbria Internal Audit & 2

4 reports including action plans and progress are available on the intranet. At the last Pharmacy Steering Group it was agreed that the department would establish a Commissioning Audit Group with the specific remit of checking compliance with various standards including the Health Care Commission. Data relating to evidence would be on the shared drive for all pharmacy staff to access. This group is to report to the Clinical Effectiveness and Audit Group and could play a key role in embedding a culture of assurance within the department. Recommendations: 1. The representation of Pharmacy services on the Governance/ and Risk Management committees needs to be reviewed as the current arrangements are not comprehensive enough to ensure that gaps in assurance identified, can be effectively reported. 2. Ensure that the Commissioning Audit Group is used to embed a culture of assurance within the department. Principles of Safe handing of Medicines 17. The Duthie Report (1988) set the standard for medicines management. The key up dates since the Duthie Report have been: a. Building a safer NHS for patients: improving medication safety (Report of Pharmaceutical Officer 2004) b. The Safe Handling of Medicines, a Team Approach (2005) c. Safety in Doses (NPSA 2007) d. Controlled Drugs (supervision and management) Regulations 2006 The key principles of the Duthie report and subsequent reviews has been that there should be an auditable trail to be established for the procurement, ordering, delivery, storage, distribution, dispensing and issue, supply, administration and disposal of medicines and at each step where a medicine changes hands there should be clear procedures which document: Where responsibility lies, whether it may be delegated and how far it extends What should be recorded where, by whom and how long records should be kept How often stock reconciliation should take place and who should undertake the task 18. The current system used in the Pharmacy department is out of date and is being replaced in January One of the key weaknesses in the existing system is that it does not record any patient history of medicines. The new system does and will facilitate s dispensing medicines by interfacing with the Patient Administration System (PAS) to see a medicines history when dispensing new prescriptions. 19. The Trust has in place a policy entitled The Control, Storage and Administration of Medicines in Trust Premises. This makes reference to national guidance and was ratified by the Trust Board in June All Pharmacy staff interviewed during the audit were aware of it and its main contents. On the four wards visited where the nurse in charge was interviewed, three were aware it was on the intranet, two confirmed they had read it (and were able to make reference to Cumbria Internal Audit & 3

5 specific requirements), one wasn t sure where to find it on the intranet, and one had the 1994 policy on file. 20. Pharmacy procedures were reviewed on both sites from the ordering of medicines through to dispensing ward stocks and individual medicines. Generally, controls were good, but there is a potential weakness at the Cumberland Infirmary where the same staff are trained to order and receive/book in delivery of medicines (excluding controlled drugs). The system could potentially be open to abuse albeit on a small scale as a major discrepancy would stand out. At the West Cumberland Infirmary different staff deal with orders and receipts. The Pharmacy system is about to be replaced in the next few months and a better division of duties will be introduced. The pharmacy maintains documents of stock discrepancies against the system. From the records examined where these occurred they tended to be additional stock on the shelves which would be down to a booking in error. 21. The present Pharmacy system does not enable the booking in of deliveries checked against invoices to lead to automatic payment, and the invoices are sent to Finance to be entered on Integra for payment. All medicines are charged to stock. There is an interface which enables the picking lists for wards to credit the stock code and debit ward expenditure. Returns and write offs are not accounted for separately and once issued, medicines are deemed to have been used by the ward/department. 22. Ward top up stocks were made up from an agreed stock list devised by a and senior nurse on each ward. A Pharmacy Technician checks the stock and writes up the quantity of medicines on a pre printed sheet required for top up. In the Pharmacy this is input into the system, a picking list is produced and the medicines taken from the storage area into designated lockable boxes. Before dispatch each box is checked against the original top up order as a double check. Items to be kept refrigerated are clearly marked and not put in coxes until dispatch is due. The procedure for supplying community hospitals is the same. The transport of boxes has a signatory trail from the Pharmacy to the Ward. From the records examined, receipting of deliveries on the ward was not always recorded, particularly in the West Cumberland Hospital, breaking the audit trail. 23. Signatory lists of new junior doctors are kept on each site but they are incomplete. HR provide a list of the new starters but do not automatically ask them to sign. Signatory lists for permanent medical staff or nurse prescribers were not seen, and there is no system to update the records on a regular basis. This leaves a gap in assurance that all medicines have been prescribed by someone authorised to do so, but there is a range of mitigating procedures involving the dispensing technician and pharmacist which reduce the risk of the medicines causing harm to patients. 24. s and technicians are designated to cover specific ward areas and they dispense prescriptions from sub stores and from ward stocks to be stored in individual patient lockers/drawers (locked) by each bed. This avoids wherever possible charts being removed from the wards or transcribing the prescription (where errors could occur) to be made up in the pharmacy. On discharge, prescription may be dispensed by on the ward from the discharge letter, or the meds remaining in the patient s locker together with the discharge letter will be sent to Pharmacy for labelling and making up of any outstanding items. Only technicians who have undergone training are allowed to dispense/check medicines. In all cases medicines are checked after dispensing. Cumbria Internal Audit & 4

6 The discharge medications are stored in the patient s locker until the patient leaves with the exception of controlled drugs which are held in controlled drugs cupboards. All medicines dispensed and witnessed during the audit had two signatures/initials. 25. On wards, the security of storage was different in each location. Willow A did not lock the room where medicines were stored but all the cupboards were locked, Beech A had a locked storeroom with ward stocks on open shelving along with other supplies. Patterdale ward at West Cumberland had medicines in locked cupboards in a room were access was controlled by a swipe card held by each qualified nurse. On the Fairfield ward (Children s) in the west, medicines were locked in cupboards within the treatment room. Fridges were not always locked or lockable and monitoring of temperatures if there was a thermometer was inconsistent between wards. A summary of the visits is attached as Appendix 1. The Pharmacy has drawn up a detailed checking list to audit procedures on wards. This is being rolled out with the intention that all wards will have been reviewed by the end of December Internal audit would be able to offer support in facilitating better stock control on the wards if needed. 26. The current Strategy was drawn up in 2006 and the Deputy has linked it to the policies and procedures in the Trust, Governance framework and the Pharmacy Service objectives, including legislation, national guidance and risk management. The aim was to be able to link medicines management from strategic objectives to the evidence supporting compliance. This is a significant undertaking linking data bases and spreadsheets and whilst it provides a wealth of information and clear evidence that the Pharmacy department is cognisant with the current developments, it is not complete. With some in house support from IT this framework could be an excellent source of measuring performance and recording the evidence required by external agencies of compliance with standards. Recommendations: 3. Until the new system is introduced, the duties between ordering and booking in deliveries by the same person should be avoided wherever possible. As the new procedures will introduce this control, this will only have to be managed in the short term. 4. Consideration should be given to improve stock control of non controlled medicines on wards. Whilst it would be unworkable to account for each tablet, there should be some periodic check introduced to reconcile prescriptions to top up order levels within a given tolerance. The new system should facilitate better checks 5. Signatory lists should be completed and maintained for all those qualified to prescribe. New starters should complete specimen signatures on induction, and there should be a periodic review for all staff. 6. Once the Pharmacy audits of each area are completed they should be used to inform training needs. 7. Standard Operating Procedures are needed on wards to specify common standards, eg around checks and requirements for fridges re temperature and security. Cumbria Internal Audit & 5

7 8. Assistance should be sought and be available from IT to complete the database model of supporting the Strategy. Principles of Safe handing of Medicines- Controlled Drugs 27. The storage and administration of controlled drugs in each pharmacy was to a high standard. At the Cumberland infirmary controlled drugs are transported in separate lockable boxes for each ward and department. Order books and returns are delivered to the pharmacy, where medicines are dispensed by a qualified technician and put in each box to be checked by a pharmacist. In the West Cumberland Hospital, each order is put together on a work bench and when checked put into a tamper proof bag with an individual identity tag. In both cases record books of each drug dispensed and the stock level is recorded and checked by a pharmacist as each order is dispensed. Within the pharmacies there was evidence of weekly stock checks in all Controlled Drug Record books. Orders are completed by nursing staff on the ward and both pharmacies have an up to date list of authorised signatories which is kept on hand and was referred to when audit witnessed the dispensing procedure. In both cases the controlled drugs are in locked areas, alarmed and with restricted access. Order Books have provision for delivered stock to be signed for to complete the audit trail. In the books examined, the received had not always been completed, but on the sample of wards visited, requisition order numbers did cross check to the Controlled Drugs record book maintained on each ward with two signatories. 28. The quality of the controlled drugs record books on wards varied. It was evident that in two cases the stock check entries had been only recently introduced against each medicine (as required by the Controlled Drugs (Supervision and Management) Regulations 2006 rather than a generic sign off on the last page. Labels and instructions on the books by Pharmacy staff were present indicating that the improvement in recording had been initiated by the s on the wards. Patients own controlled drugs were written up either in a separate book or in the back pages. Evidence of stock checks was weaker and although the entries stated quantities returned to patients which left the stock at zero, stock levels were not always written down to zero. On Beech A there was a quantity of morphine for a patient who had been discharged a fortnight earlier and this needed to be written out and returned to pharmacy for destruction. 29. Controlled drugs must be stored securely in a metal cupboard, bolted to the floor or wall with two keys for entry. In the West Cumberland Hospital on both wards the cupboards were behind the nurses station, making access cramped. They were small and were designed as a metal cupboard inside a melamine faced wooden cupboard. This meant that the record book was stored in the outer area, although the order books were kept in the inner cupboard. Nursing staff on all wards were aware of requirement to keep Controlled Drug Record books for two years but limited space meant they were locked away elsewhere on the ward. Only on one ward was the controlled drugs cupboard found to contain other items which should not have been stored there. 30. In the West Cumberland Hospital on Patterdale Ward it is practice to keep codeine medicines in the outer part of the controlled drugs cupboard. This is as a result of a high use of codeine on some wards which had come to light and could not be accounted for (previous Internal Audit Report 2006/7). Cumbria Internal Audit & 6

8 31. Key security was good on most of the wards visited, and keys for controlled drugs were kept separate in all cases. 32. The disposal of controlled drugs returned to pharmacy as being out of date/patients own and no longer required is well managed within the department. The Pharmacy technician records all returns in a record for destruction book which is checked by a. The procedure is formal and a Business Manger is required to be an independent witness of the procedure to destroy the medication and render it harmless. The procedure is to check all the items against their record in the destruction book, recount the quantities and mix them altogether with a substance called DOOP which sets to a resin and renders any extraction of the drugs impossible. The Record of Destruction book is then signed by the Business manager and. As the process can be quite time consuming Pharmacy tries to arrange regular sessions to avoid a large quantity building up. It was noticed there was a quantity building up in the West, where the technician mistakenly believed the witness needed to be a member of the Board. Recommendations: 9. The Controlled Drugs stored at West Cumberland Infirmary should be destroyed as soon as possible. Income is properly recovered and accounted for 33. Prescriptions issued at outpatient clinics or A&E are on internal hospital forms. Patients eligible to pay charges are required to do so for such prescriptions unless exempt on national policy, eg <18, >60 or on income support etc. For each type of exemption there is a box to tick on the back of each form and in some cases additional details such as NI number are required. If the evidence for exemption is not seen by the dispensing pharmacist there is a space for them to initial this. Those exempt from charges (other than >60 with a printed label showing date of birth) are required to sign the prescription. Completion of these forms is poor, and a number had neither signature nor reasons for non charging. A sample from the Cumberland Infirmary suggested that in a two week period 65 prescriptions for 94 items were dispensed with no reason for not collecting the due charge amounting to At the West Cumberland Hospital, the pharmacy has a duplicate form which is given out where patients have not got the money on them to pay. This requests payment within 7 days. For the year to date the value of chits issued amounts to 5, with payments received 2, In both pharmacies there is an unofficial policy of not charging some patients based on the clinic they have attended (including day surgery)/the illness for which the medicines have been prescribed. Based on an extrapolation of the sample examined then the Trust is losing some 30,000 per annum. Given a 20% margin for genuine exemption/volume fluctuations the loss of income is probably between 25,000-36,000 p.a. Whilst audit has some sympathy for the staff in asking for payment from potentially seriously ill patients, the law is unequivocal, and the Trust has a legal obligation to collect income due. This was brought to the attention of senior Pharmacy staff during the audit and it was noted that patients were being asked to complete the reverse of their prescription forms whilst they Cumbria Internal Audit & 7

9 waited for their medicines. Internal Audit could review samples of prescriptions and follow them up as is the practice for such cases in the community but this may cause difficulties given that some patients will have become accustomed to free prescriptions. Recommendations: 10. The Trust needs to consider how it will meet its legal obligation to collect prescription income where it is due. Unlicensed aseptic dispensing 35. Aseptic pharmacy services are subject to external inspection by the Royal Pharamaceutical Society. Both visits within the last year highlighted minor areas to be addressed and rated both as low risk. Internal Audit has accepted this external evidence of compliance with standards. The staffing levels/workload in the Aseptic Suite has been on the Trust Risk Register since 20 th June The last update was on 15 th March 2008, where checking procedures are in place and a capacity plan has been developed. The score originally 20 has been reclassified as 12 which is reasonable given the control measures in place. Clinical Trials 36. There is a Standard Operating Procedure for Clinical Trials and storage of medicines complies with guidelines in that it is separate from general Pharmacy stock and kept in a secure part of the department which is alarmed out of hours. A lead is designated to manage clinical trials. There is a documented paper trail of all records associated with each trial. Once complete, records are stored for 15 years after the last entry. The usual practice is to send the file to the Principal Investigator (lead Consultant) but some are stored in Pharmacy. This area was not reviewed in depth but the principles of documenting the trials appear to be in place. Risk Management and Incident Reporting 37 There is evidence that risks in the Pharmacy Department including those of medicines management have been reviewed and assessed. The Trust Risk Register has 5 Pharmacy related risks including: a. IV medications Score 16 b. breakdown of the fridges Score 15 c. the layout of the West Cumberland Department Score 16 d. breakdown of the labelling equipment Score 9 e. Workload capacity of Aseptic Suites Score 12(see 30 above) These have all been revisited and have control measures in place. The labelling system will be removed when the new system is introduced in January 2009 as it has back up arrangements, which the existing one does not. 38. Standard Operating Procedures(SOPs) in the Pharmacy dated February 2007 were cited as evidence for compliance with Better Standards for Health 4d. There are 47 SOPs in total covering all aspects of dispensing within Pharmacy. Cumbria Internal Audit & 8

10 39 Following a review by the CNST the Trust is in the lower quartile of reporting medicines incidents. For the year to April to 10 th October 08 there have been 298 reported incidents. With a few exceptions the average per ward department is 4. The Pharmacy department has reservations with the recording of incidents as they are taken directly from the lilac forms and input onto the Ulysses data base for incident recording by staff who are not fully aware of some of the terms. Thus there is concern within the Pharmacy Department that the incidents may be mis-classified in regard of the type of medication error that has occurred. In the light of concern over incident reporting s have been asked to record on a data base interventions/errors. One has recorded 183 interventions for September alone classified as potentially moderate risk and 10 as potentially severe (level 5). The Pharmacy data base automatically highlights a level 5 in lilac, indicating that a form should be generated, but this is not standard procedure. There were a further 64 lower level potential procedure/discharge interventions in the same period. Whilst only one actual intervention scored high enough to have required actual intervention all the others having been prevented, there is no systematic procedure in place to record medication incidents consistently for national statistics. 40. Towards the end of the last financial year the Deputy asked staff to undertake risk assessments in their area. From the information on file this exercise was of limited scope and quality. The standard of completion in many cases was poor and a range of assessments anticipated the most extreme worst case scenarios resulting in scores of 25 (certain to happen with catastrophic outcomes) without taking account of the actual controls in place. These poor quality attempts could undermine the Department s efforts to maintain a quality process for assessing risk where the real risks are on the Trust Risk Register. What is missing in this process is evidence of risk reviews across the department s activities demonstrating where the risks are controlled and where they need to be highlighted at a corporate level. The introduction of the new system and the process maps being designed would provide an excellent platform on which to build up a departmental risk register. Recommendations: 11. The Trust should consider a procedure defining what the level of intervention is that requires a lilac form to be completed, and also how to record the near miss incidents which can be incorporated onto the Ulysses data base, but where the time spent on completing the lilac forms would be disproportionate. 12. Using the process maps for the new Pharmacy system as a starting point, draw up comprehensive risk assessments for the department which demonstrate a clear line of accountability up to the Trust Risk Register. Training 41. The Pharmacy department encourages training at all levels. There is a Centre for Postgraduate Pharmacy Education (CPPE) Learning at Lunch forum covering a wide range of topics on a regular basis with future sessions planned. The Department also supports technicians on external courses for (4 qualified) and Accuracy checking (6 qualified, 3 completing portfolios), and one about to start professional training. All non qualified staff undertake NVQ level 2 training. The Cumbria Internal Audit & 9

11 department has 2 student pharmacy technicians and one pre-registration pharmacy student. 42. training to nursing staff on the wards was more limited. All areas visited commented on the programme of training for IV fluids positively, but general updates were limited to the generic risk workbook completed by all staff and which qualified nursing staff said was not in depth enough for their needs. 43. The Training department are recording all training on IV fluids to update the Electronic Staff Record which is to be the central data base, but the application of the system is still embryonic, and Training have a backlog of data to enter. Eventually when self serve is introduced and managers can maintain their own department s training records this will be a very useful tool to monitor training. 44. There is a potential risk that with the high level support of Pharmacy staff on the wards that the nursing staff do not maintain the required knowledge of medicines management and place over reliance on pharmacy support. This would be borne out by the record keeping on controlled drugs for example where s have introduced tightened procedures 45. The Safe Handling of Medicines, a Team Approach (2005) states that it is the responsibility of the senior management within an organisation to ensure that systems and procedures are in place to ensure compliance with legislation, national guidance and manage risks to patients and staff of handling medicines. Training for Pharmacy staff appears to be extensive and high quality, but there is a gap in assurance that nursing staff receive updated training in medicines management. Recommendation 13. A medicines Management update Training should be introduced for all qualified Nursing staff and other professionals who may handle or administer medicines. The basis of this training will be compliance with the Standard Operating Procedures that are currently being put in place. Benchmarking and external assurance 46. The Trust has not developed internal benchmarking standards by which to compare performance of medicines management. The two pharmacies run by the Trust over its two sites still operate in many ways on historic procedures. The introduction of the new system, will mean that processes will be standardised across sites and the facilities of the new system will make it easier to introduce new controls which can be measured, for example, regular sample stock takes over a specific number of medicines. 47. Current arrangements for self assessment rely principally on compliance with Healthcare standards where a file of evidence is complied annually (electronically and hard copy) citing evidence of compliance with the standard C4d on medicines Management. The Trust declared itself as compliant for the year 07/08. From examination of the file there was clear evidence of the policies and SOPs in place and action plans and progress reviews on areas that needed addressing. Some of these areas are still being addressed in the current year. The Health Care Commission has not inspected the Trust on C4d. The evidence on file supports the declaration and there is evidence of action plans where weaknesses were identified. Training for nurses on wards on medicines management would strengthen the declaration in 08/09. Cumbria Internal Audit & 10

12 48. CNST feedback also provides some measures and the Trust is cited as low in the number of medicines management incidents it reports which is discussed in 37 above. Recommendation 14. The Trust should consider what key indicators would be helpful to benchmark the services of the Pharmacy Department. Resources and future developments 49. Recruitment of qualified staff has been difficult and there are approximately 9 vacancies in an establishment of wte. These break down into 3 s and 6 Technician posts. Consideration is being given to changing working practices as a way to deliver services and the possibility of introducing robotics is an option. The Director of Finance has requested a feasibility study into the costs. A basic system would be in the region of k, plus structural work. The complication of two sites and PFI at the CIC complicate the situation. The quid pro quo for any investment would be a review of the establishment but this work is at a very early stage. CONCLUSION 50. The Pharmacy Department is clearly endeavouring to improve standards and has addressed the risks that have been identified in the publications building on the principles of the Duthie Report. The Department is introducing a new system that will facilitate ordering and stock control and enable a link to PAS to provide patient histories of medicines prescribed. The new system is being introduced with process maps and a view to having one system of working throughout the department across both sites. There is evidence that s supporting role on wards is improving standards. 51. There is evidence that there are some weaknesses in assurance on medicines management at ward level. The Pharmacy is not unaware of the situation and is rolling out a system of ward checks to identify specific issues. If used to inform training and build up a programme of medicines management for all staff involved in the administration of medicines these gaps will be addressed. Sue Turner Principal Auditor November 2008 Cumbria Internal Audit & 11

13 Appendix 1 Ward Visits Willow A ( ) CIC Beech A ( ) CIC Patterdale ( ) WCH Fairfield ( ) WCH Policy on Meds Mngt held on Ward 1994 copy No but aware it is on intranet but asked auditor how to find it Yes aware on intranet no hard copy but referred to its contents demonstrating knowledge On notice Board. Showed awareness of content. Local operating procedures Records from 1995 No No No not written but have different procedures re paediatrics eg all meds admin must be checked and two signatures on charts Recording of incidents Said may get feedback from Risk Mngt if required did not keep log Recorded all incidents on file. Also evidence that discussed at ward team meetings but before last one was Jan 08. A risk assessment was on file after an incident reported Yes but file not accessible at visit. As ward has highest incident reporting of Trust clear awareness demonstrated. Frustration that feedback can be 2/3 months Yes keep copies on ward all discussed at team meetings.copy sent to Kathryn Ball Pharmacy. Record errors prompted by double check. Do not record where amended meds when seen error as part of supervision if incident is prevented Training IV training for all qualified staff. No other but general risk management acknowledged after prompt General training flyers and updates from on ward No meds Mngt referred to workbook but felt not detailed enough for qualified staff. Cited IV training with very positive feedback General training -updates from on ward No meds Mngt referred to workbook but felt not detailed enough for qualified staff General training updates from on ward Some staff have recently had updates on medicine management and also received IV Training for Hickman lines, Portacaths and general Ivs Cumbria Internal Audit & 1 Draft Report

14 Appendix 1 Fridge Unlocked temp gage and record of daily checks Lockable fridge, no temp gage and no checks made Fridge not lockable but has temp gage. Records of temp not kept/checked Two on ward, both locked and both have temperature gages. Only one is alarmed there is no logged check of temperatures Meds Cupboard Room not locked but meds in locked cupboards. Cupboards maintained on top up system by Pharmacy technician Room locked, meds on shelf with other supplies Meds stored in wall cupboards and stock charts on doors as used for top ups. Ward has a form to be completed when it supplies wards with meds from its own stock. Access to room via swipe card issued to all qualified staff. Kept in locked cupboards in treatment room. Cupboard contents on doors. Those seen were tidy. Delivery of meds usually unpacked and checked by night staff. Controlled Drugs 2 key lockable cupboard. Key security good. Cupboard contained small item if medical equipment and an envelope containing a penknife taken from a patient in Patients own meds on separate shelf and own record book. new to ward had improved stock checks in CDRBs to daily checks on each med witnessed, not generic sign off on last page of book. All records had two signatures. Old books for last 2 years in cupboard with Key security good two sets one for each time and master set for nurse un charge. Keep register since Patient meds on lower shelf with separate book. Page for each patient 35 entries and 2 lots of not recorded for patients who had left- register needs to be written up and meds returned to pharmacy for destruction. Remains of morphine syringes are emptied into sharps box. Ward stock dispensed is witnessed by two and book taken to Cupboard on wall behind nurses station one key for outer cupboard and another for inner cupboard. Record books and requisitions were in outer part of cupboard where codeine was stored. Although req book not signed as received on ward the records in CDRB confirmed and was witnessed with 2 signatures. Stock checks evidenced daily (nightshift duty) and separate for patients own cds Cupboard on wall behind nurses station one key for outer cupboard and another for inner cupboard. Cupboard is not metal and has no room to store controlled drugs record book, although would hold order book which was in Pharmacy (checked it was). Patients own cds in back of book. Although record said returned to Mum the stock level was not entered as 0. Cumbria Internal Audit & 2 Draft Report

15 Appendix 1 requisition books bedside when administering. Keys No log Nurse in charge has cd keys Stock checks recorded daily on each page.since August. Previously not as frequent. Kept Log (recent) Kept log (longstanding) Qualified staff have keys, Nurse in charge has cd keys. No log on shift changes. Storage of meds makes up meds for each patient and hands to nurse for storage in locked locker by bedside. (CDs administered from CD cupboard) Allergy alert Box on prescription chart - not an issue staff feel completed appropriately Box on prescription chart - not an issue staff feel completed appropriately Nurses take packet from cupboard into lockable drawer by bedside. Pharm checks and orders any other meds on chart directly To write on patient bracelets red to alert but can be difficult to read as required to be hand written. Meds administered from either cupboard by nurs21se station or from treatment room. As procedure is two nurses sign off admin this makes where meds measured less important as always counter check on what is administered. Some CF patients may have meds in locked cupboard by bedside. On chart, has to be written before nurses will admin meds. Children also have to where allergy bracelets. As toddlers sometimes remove them and identity bracelets, these are double checked with parent on ward Cumbria Internal Audit & 3 Draft Report

16 Cumbria PCT Medical Agency 2008/09 ACTION PLAN MEDICINES MANAGEMENT REC. RESPONSIBLE TARGET No. DETAILS PRIORITY* MANAGEMENT RESPONSE The representation of Pharmacy services on the Governance/ and Risk Management committees needs to be reviewed as the current arrangements are not comprehensive enough to ensure that gaps in assurance identified, can be effectively reported. Ensure that the Commissioning Audit Group is used to embed a culture of assurance within the department. Until the new system is introduced, the duties between ordering and booking in deliveries by the same person should be avoided wherever possible. As the new procedures will introduce this control, this will only have to be managed in the short term. M Agreed H Agreed H Agreed and actioned immediately OFFICER Deputy Executive DATE Complete 4 5 Consideration should be given to improve stock control of non controlled medicines on wards. Whilst it would be unworkable to account for each tablet, there should be some periodic check introduced to reconcile prescriptions to top up order levels within a given tolerance. The new system should facilitate better checks. Signatory lists should be completed and maintained for all those qualified to prescribe. New starters should complete specimen signatures on induction, and there should be a periodic review for all staff M H Agreed as part of the 6 monthly medicines management check, following the introduction of the new system. Agreed, to be taken through the Medical Staffing Committee Deputy Executive *Priority Low = Opportunity for Improvement Cumbria Internal Audit & Medium = Risk of Loss or Misstatement High = Serious System Weakness

17 Cumbria PCT Medical Agency REC. RESPONSIBLE TARGET No. DETAILS PRIORITY* MANAGEMENT RESPONSE Once the Pharmacy audits of each area are completed they should be used to inform training needs. Standard Operating Procedures are needed on wards to specify common standards, eg around checks and requirements for fridges re temperature and security. Assistance should be sought and be available from IT to complete the database model of supporting the Strategy. The Controlled Drugs stored at West Cumberland Infirmary should be destroyed as soon as possible. The Trust needs to consider how it will meet its legal obligation to collect prescription income where it is due. The Trust should consider a procedure defining what the level of intervention is that requires a lilac form to be completed, and also how to record the near miss incidents which can be incorporated onto the Ulysses data base, but where the time spent on completing the lilac forms would be disproportionate. Using the process maps for the new Pharmacy system as a starting point, draw up comprehensive risk assessments for the department which demonstrate a clear line of accountability up to the Trust Risk Register. H Agreed H L Agreed H Agreed M H H Agreed Agreed to be taken forward in conjunction with the Director of Nursing Agreed. This has wider implications across the Trust eg in A&E and Day Services. A policy statement will be issued by the Director of Finance Agreed to define the level at which a lilac form needs to be completed OFFICER Director of Finance DATE *Priority Low = Opportunity for Improvement Cumbria Internal Audit & Medium = Risk of Loss or Misstatement High = Serious System Weakness

18 Cumbria PCT Medical Agency REC. RESPONSIBLE TARGET No. DETAILS PRIORITY* MANAGEMENT RESPONSE A medicines Management update Training should be introduced for all qualified Nursing staff and other professionals who may handle or administer medicines. The basis of this training will be compliance with the Standard Operating Procedures that are currently being put in place. The Trust should consider what key indicators would be helpful to benchmark the services of the Pharmacy Department. H Agreed. A timetable will need to be confirmed with the Education and Training Manager to fit in with the Training Programme Agreed that internal indicators be developed across the Trust s Pharmacies, eg on stock control. OFFICER DATE L Comparisons against other Trusts is a longer term issue as there are no national standards recorded on an on going basis. Development of indicators is an issue being discussed at regional networks and is a work in progress. *Priority Low = Opportunity for Improvement Cumbria Internal Audit & Medium = Risk of Loss or Misstatement High = Serious System Weakness