1. Auditing Homecare Suppliers Trevor Munton Regional QA Pharmacist

2. Auditing Homecare Suppliers background NHMC asked for representation from the NHSPQA for input of QA matters Audit was seen as a priority Regional QA Pharmacists already perform audits of traditional suppliers and NHS production units

3. Auditing Homecare Suppliers why audit Lack of available formal audit reports from NHS pharmacy which covered all aspects of service provision National accreditations etc are useful but rather distant and black / white Gain information for realistic contracting agreements, develop pragmatic standards to audit against Transparency, comfort factor, two way learning

4. Auditing Homecare Suppliers some practicalities National audit tool developed and implemented Agreed with companies via NAHC Audits carried out by local QA Pharmacist to national standard Results of audit always agreed with the company prior to circulation Circulation is to Regional QA and Procurement Pharmacists Confidentiality is emphasised

5. Auditing Homecare Suppliers the audit topics General administration, conduct of audit Business matters Participating organisations Prescription management Compounding / manufacture – additional audit tool used Quality Assurance Training Delivery Patient experience

6. Auditing Homecare suppliers audit topic – general administration Make arrangements Review previous reports and information Meet with key personnel and obtain overview of activity Use nationally agreed format Discuss points during the audit Closing meeting Write report, facts mutually agreed

7. Auditing Homecare Suppliers audit topic – business matters Contracts in place Clear management structure Robust invoice procedure Defined person for product quality Senior management involved in QMS Insurance Contingency plans Separation of medicine costs from service costs

8. Auditing Homecare Suppliers audit topic – participating organisations Names of sub-contractors Appropriate licences Professional supervision Audit reports on sub-contractors Technical agreements Clear lines of responsibility Source of products

9. Auditing Homecare Suppliers audit topic – prescription management Clear audit trail of prescription Transcriptions Clinical checks Timeliness of transmission Stability / technical checks Database of patients prescriptions Pharmacist interventions recorded and analysed

10. Auditing Homecare Suppliers audit topic – quality assurance Accreditations etc held MHRA licence RPSGB registration Satisfaction surveys Product recall Evidence of product quality up to time of administration QMS Product returns Documentation system Complaints file

11. Auditing Homecare Suppliers audit topic – quality assurance ( continued ) Internal audit Clear responsibilities Deviation reporting Records of dispensing errors and near misses

12. Auditing Homecare Suppliers audit topic - training Clinical staff Non clinical staff Qualifications / experience Competency assessment Training records Use of temporary staff Police check Training programme, induction programme

13. Auditing Homecare Suppliers audit topic - delivery Method of delivery, vehicle type, contractor Timeliness, reliability, records, Cold chain Waste management Audit trail Product protection Geographical coverage Emergency supplies

14. Auditing Homecare Companies audit topic – patient experience Contact with patient, information on service Patient / carer consent Notification of delivery time Convenient for patient Product presentation, ease of use Monitoring equipment in homes Discretion of delivery All consumables provided Telephone help line

15. Auditing Homecare Companies audit topic – patient experience ( continued ) Clinical governance lead in company Waste management

16. Auditing Homecare Suppliers general observations from the audits Experience to date is good, companies offer a comprehensive patient orientated service Not difficult to agree on final audit report Companies welcoming and transparent Audit reports useful to procurement Anecdotal evidence should be ignored Focus on auditing company’s QA systems and evidence of compliance with their own systems

17. Auditing Homecare Suppliers specific minor observations from the audits Quality management systems can be patchy eg change control, CAPA formal systems Performance indicators present but can be difficult to locate the evidence in support of them Use of external compounding companies was not necessarily tightly controlled eg audit, licensed status, contract. The use of these companies could be opaque Patient notes, variable systems from good database to informal notes Out of hours patient contact line can be less than robust

18. Auditing Homecare Suppliers specific minor observations from the audits Delivery only service, clarity required on which organisation offers patient advice Contracts not always in place, continuation from in patient treatment Cold chain, look for the evidence not the method.