1. Dr Mairiead MacLennan Quality and Training Manager, Medical Microbiology NHS Fife

2. Background and Experience  ONC Multidisciplinary  HNC Histopathology & Cytology  State Registered (CPSM)  Career break  Multidisciplinary major in Microbiology (Veterinary)  Training/Education interest  Gazette article (1990)  BSc Biomed Sci  Mphil…..Phd  Functional Manager in SACVS (Quality Environment Training / Education)  Extended Practice Certificate Quality  Extended Practice Certificate Training  Certificate in Counselling Skills (work in progress)  SQMDG Committee & IBMS Scotland Training Forum

3. Practical Experience of UKAS Assessments SACVS now SRUC Working towards accreditation 1997 Standardisation across all 8 Veterinary laboratories Far North to the Borders 2000 to 2008 2004 to 2010 attended each visit

4. Process To establish a robust QMS To demonstrate that the organisation did what is said it was doing To establish parameters for and demonstrate competence To ensure compliance with ISO 17025

5. Compare ISO 15189 with CPA ISO15189 4 Management requirements 4.1Organisation and Management responsibility 4.1.1.4 Laboratory Director CPA B1 Professional Direction B1.1 & B1.2

6. Compare ISO 15189 with CPA ISO 15189 5.1 Personnel 5.1.2 Qualifications 5.1.3 Job Description 5.1.4 Personnel Introduction to organisational environment 5.1.5 Training 5.1.6 Competence Assessment 5.1.7 Performance reviews 5.1.8 CPD 5.1.9 Personnel records CPA B3 B 6.2h B5.1 B4 B9 ??? B7 B9 B6

7. ISO 15189 what is the requirement? 5.1.1 General Documented procedure for personnel management..records..indicate compliance with requirements 5.1.2 Document..qualifications for each position reflecting education training experience skills appropriate to tasks performed 5.13 Job descriptions: responsibilities authorities and tasks 5.1.4 Induction, T &Cs,facilities, H & S, occupational health

8. Definitions Competency: the quality o f being adequately or well qualified physically and intellectually Plural : Competencies Competence: The ability to do something successfully or efficiently Plural :Competences

9. ISO 15189 what does it mean? 5.1.5 Training Details provision of training QMS, work processes & procedures, LIMS, H & S, ethics, confidentiality Supervised at all times Effectiveness of training; programmed reviewed regularly

10. ISO 15189 what does it mean? 5.1.6 Competence Assessment Following appropriate training, the laboratory shall assess the competence of each person to perform assigned managerial or technical tasks according to established criteria. Reassessment shall take place at regular intervals. Retraining shall occur when necessary Note 1 –competence assessed by variety of methods Note 2-professional judgement specific and FFP

11. Which means ? Training Records Can be either paper or electronic however MUST be accessible whether the operator is on site or not during the assessment Evidence:-If the assessor can’t see it- it didn’t happen

12. Records 5.1.9 CV a, c Organisational Diagram (4.1.2.5) Job Description d HCPC registration b Personal development plan/review i List of expected competences for the assigned grade f List of competences assessed/signed off f g List of training courses attended g Evidence of Induction e CPD f & 5.1.8 Certificates etc f g

13. Competence Assessment Note 1 Competence can be assessed by using any combination of a number of approaches under the same conditions as the working laboratory. Direct observation of tasks undertaken Monitoring quality/standard of work output Review of work records Assessment of problem solving skills EQA/IQA

14. Competence Assessment Direct observation-audit (Method Witness) What do you audit against? Set the acceptance criteria (specify in QMS) What must an operator be able to do/know before you think they are sufficiently safe, qualified, knowledgeable, skilled and efficient to undertake a process or procedure unsupervised. How do you check that? (specify in QMS)

15. Evidence=Training Records CV Competency Records Equipment training Records Course Attendance Lunchtime meetings All forms of CPD Audits HCPC registration Portfolio etc Q Pulse records Reflective Practice Training Delivery Presentations Validations Evaluations

16. Compliance The QMS must state what is expected Each post holder must demonstrate they meet that Responsibility lies with individual Department must ensure that the expectations are clear and understood Quality Manager ensures that the line managers know what is required and that the process is audited for compliance

17. Questions/comments

18. And finally… Former colleagues in Veterinary Services Current colleagues in NHS Fife