1. Sarah Smith Lothian Laboratory Training Manager

2. Overview of Lothian Laboratories Royal Infirmary of Edinburgh Microbiology; Haematology; Biochemistry; Pathology; Reproductive Medicine and NEQAS Royal Hospital for Sick Children Paediatric Haematology; Paediatric Biochemistry

3. Overview of Lothian Laboratories St Johns Hospital Microbiology; Haematology; Blood Bank; Biochemistry Western General Hospital Microbiology; Haematology; Biochemistry; Pathology; Blood Bank; Cytogenetics; Molecular genetics

4. Overview of Lothian Laboratories

5.   CPA Standards version 2.0 ~Sept 2007   First assessments against new standards ~April 2008.   All laboratories had to be compliant with the new standards by Sept 2008   Standards updated in March 09 CPA Standards – a recap!

6. Lothian….. Who deals with what?   Quality Manager~ Stds A, C-H   Training Manager ~ Std B but pitches in with other standards such as A, C & H

7. Standard B changes – a recap   Some major changes to standard B: B1 – Clinical Director B2 – Staffing B5 – Appraisals B6 – Proof of Competency B9 – Regular Reviews of Competency

8. Standard B1   Training Manager passes the buck!!!   Clinical Director / Consultant in Charge takes responsibility for Std B1

9. Standard B2 B2.1 Laboratory management shall ensure that there are appropriate numbers of staff, with the required education and training, to meet the demands of the service and appropriate national legislation and guidelines B2.2 Registration of staff shall be in accordance with current national legislation and regulations SOLUTION: Generic template for all disciplines to complete with staff lists outlining registration details and qualifications held. Registration should be in line with national legislation and professional guidelines such as IBMS, HPC & GMC Both lists should include ALL staff details

10. Standard B2 B2.3 The staffing shall include an individual with the following roles: *Quality Management *Training and Education *Health and Safety SOLUTION: Job Descriptions of Quality Manager/ Training Manager & H&S Officer.

11. Standard B5 B5.1f: a requirement for participation in staff annual joint review SOLUTION: Knowledge and Skills Framework Generic paperwork required to be completed Training Manager involved in the preparation of the paperwork so that all CPA standards are met.

12. Standard B9.1a Training and education shall be in accordance with the policies of the parent organisation and guidelines from the relevant professional and registration bodies SOLUTION: Evidence of Trust Learning and Development Plan Evidence that ALL staff have opportunities for further education in line with their professional bodies ~ Training Policy /Procedures

13. Standard B9.2 The training programme shall, as appropriate, include the following clauses: a) Assigned work processes and procedures b) The Quality Management System c) Applicable Computer Systems d) H&S including the prevention or containment of information e) The ethics and confidentiality of information SOLUTION: Elements should be included in the training records. Trainees also undertake a series of tutorials covering these elements for completion of the Registration Portfolio

14. Standard B6.2h & B9.3 Standard B6.2h:Staff records should contain records of competency Standard B9.3: Competency should be assessed following training and periodically thereafter. Retraining and reassessment shall occur when necessary. Records of competency assessment shall be kept

15. What is needed to cover B6.2h & B9.3?   Records that show individual Has an understanding of the underpinning knowledge of the tasks being carried out Can carry out task competently Has been reviewed in undertaking the task within a certain timeframe to ensure that they are still competent Has been retrained when appropriate   All records of competency and reviews should be kept in line with national guidance.

16. Oh *!*! My Reaction to these changes?

17. Our Solution? Only discipline within Lothian Laboratories regularly reviewing training were the Hospital Blood Bank Laboratories (WGH & St Johns) Requirement of Medicines and Healthcare Regulatory Authority (MHRA) Training records were produced to incorporate both CPA and MHRA requirements

18. Lothian Training Records  Training records encompass 4 different levels, each level increasing with complexity. Level 1: All staff. Covers basic laboratory tasks Level 2: Trainee BMS; BMS1; BMS2; BMS3 Level 3: BMS2; BMS3 Level 4: BMS3 All levels incorporates standard B9.2 Shows progression

19. Objectives are identified for each level specific to the discipline

20. Any Reviews of training are recorded

21. Each task is broken down and referenced to the standard operating procedure / reference documentation such as guidelines

22. The underpinning knowledge for the task is delivered and the task is observed and then performed under supervision.. When trainer and trainee are confident that task is being correctly undertaken, trainee is signed off.

23. Theory required for the task is evaluated with a series of questions. Opportunity for assessor to revisit areas that are not fully understood.

24. Once trainer happy with the evaluation of questions training record can be signed off.

25. Once evaluation complete both the SOP and Training Record are signed. Ensures that SOP is signed

26. Key result areas are identified in each task/ area and are assessed. Assessor uses own professional judgement when assessing.

27. Performed in each area of the laboratory. Individuals undertake review sessions three times a year Ensure that all SOPs have been read & signed and trainee is aware of any changes etc that have been made Allows individual to ask questions / clarify anything they may not understand. Identifies any retraining that is required REVIEW OF COMPETENCY

28. Current staff are “grand parented” through clause in policy Allows previous training records to stand. Current staff will continue to be assessed regularly Current Staff

29. Record in place for any training against new procedures / processes/ equipment Staff will be evaluated and assessed in the same way Once staff trained, level can be updated for new member of staff New Processes / Procedures?

30. Training Records Records show   Competency ~ Proof that trainee has accomplished skill   Knowledge ~ Underpinning knowledge of the tasks carried out   Review of training ~ identifies future learning and development requirements   Progression of knowledge and skills that is being learnt throughout the training process   Identifies where retraining is required.

31. Re-training (Standard B9.3)   Training Policy updated to reflect criteria when reassessment of competency is appropriate: Returning from long term absence ~ sickness / Maternity   Those individuals wishing to re register – training plans are used to ensure that they are competent and provides evidence to HPC

32. Retention of training documentation? NHS Code of Practice for Retention of Records: www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPol icyAndGuidance/DH_4131747 Code of Practice Part 2; Annex D2: Personnel / human resources records (include training records) 6 years after the individual leaves the service Following this, summary should be made of all records and be kept until individuals 70 th Birthday (or until 6years after cessation of employment if individual was aged over 70yrs at the time)

33. CPA visit results…. All Lothian laboratories have now been inspected against the new standards no non conformitiesin Standard B

34. However......  We can never sit still.  There will be more updates of the standards in the future  We must look beyond having the appropriate paperwork in place ~ its how we are using this paperwork and how its embedding into the system.

35. Many thanks for listening. Any Questions?