1. Adrian Copplestone Derriford Hospital, Plymouth 20.7.05
EU Directive on Blood Safety and Quality Education and training implications  
Adrian Copplestone
Derriford Hospital, Plymouth

2. Is there a difference between education and training?

3. educate
verb 1 give intellectual, moral, and social instruction to.
2 give training in or information on a particular subject

4. train
verb 1 teach (a person or animal) a particular skill or type of behaviour through regular practice and instruction.
2 be taught in such a way.

5. EU Directive / Blood Safety and Quality Regulations (2005)
What we must do?
How to go about the task

6. The Rules 8th February 2005 Amended 8th April 2005
Fully in force 8th November 2005
Competent Authority: Medicine and Healthcare Products Regulatory Authority (MHRA)

7. Blood Safety & Quality Regulations
Hospital blood bank requirements
9.- (1) the person responsible for the management of a hospital blood bank shall-
(a) ensure that personnel directly involved in the testing, storage and distribution of blood and components are qualified to perform those tasks and are provided with timely, relevant and regularly updated training.

8. Blood Safety & Quality Regulations
(b) Establish and maintain a quality system for the hospital blood bank which is based on principles of good practice;
(d) Maintain documentation on …training, … so they are readily available for inspection under section 15
[ Inspections, not less than every 2 years]

9. Quality Management System MHRA requirements
#3: Staff are provided with timely, relevant and regularly updated training including an induction programme. (OIG QMS 1.4)
#4: Document control system including
Training records (OIG QMS 3.1 )

10. Quality Management System MHRA requirements
Staff will need training in local systems for:
Traceability
Collection and Transport of blood
Notification of serious adverse events

11. Are these rules new?

12. Standards
A ORGANISATION AND QUALITY MANAGEMENT SYSTEM
A1 Organisation and management
A 1.3 The laboratory shall have:
a) personnel with the authority, training and resources to carry out their duties

13. B PERSONNEL
B2 Staffing
B 2.1 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 regulations.

14. B 2.3 The staffing shall include an individual(s) with the following roles:
a) quality management (A7)
b) training and education (B9)
c) health and safety (C5).

15. B 3.1 Laboratory management shall ensure that procedure(s) for personnel management include:
g) staff training and education (B9)

16. B6 Staff records
B 6.2 Staff records shall include:
g) a record of education and training including continuing professional development

17. B7 Staff annual joint review
B 7.1 Laboratory management shall ensure that all staff participate in an annual joint review that includes consideration of the:
c) personal objectives of the staff member
d) training and development needs of the staff member

18. B9 Staff training and education
B 9.1 There shall be a training and education programme for all members of staff governed by the following criteria:
a) training and education shall be in accordance with guidelines from the relevant professional and registration bodies
b) all staff shall be given the opportunity for further education and training in relation to the needs of the service and their professional development.

19. B 9.3 There shall be the resources for training and education, that includes:
a) access to reference material and information services
b) access to a conveniently situated quiet room for private study
c) staff attendance at meetings and conferences
d) financial support.

20. B 9.4 Records shall be kept of all training and education (B6).
B 9.5 Laboratory management shall appoint a training officer (B2).

21. All NHS laboratories have to be CPA registered
CPA covers the laboratory staff, but what about the ward staff?

22. NHS Litigation Authority Clinical Negligence Scheme for Trusts (CNST)
All clinical negligence claims since 1995
Contributions depend on type of trust, specialities and number of WTEs
Discount for levels of Risk Management
Level 1: 10%, 2: 20%, 3: 30% (£3.8m)

23. CNST: Transfusion Standard 7 - Clinical Care
7.1.2 There are appropriate systems in place for the request, safe storage, collection and administration of human blood and blood products
Level 1 standard

24. CNST: Transfusion Guidance
There is a widely disseminated Blood Transfusion Policy, which incorporates local protocols for the:
· Testing, request and collection of blood samples for pre-transfusion compatibility.
· Collection of blood or blood products and its delivery to the wards.
· Administration of blood and blood products including the prescription of blood and blood products Cont’d

25. CNST: Transfusion Guidance
There is a widely disseminated Blood Transfusion Policy, which incorporates local protocols for the:
· Care and monitoring of patients receiving transfusion.
· Process for reporting adverse events following transfusion.
· Guidelines, which define the responsibilities of each staff group.

26. CNST: Transfusion Guidance
The policy is supported by an annual in-house training programme for all staff involved in the prescription, collection and administration of blood and blood products, including the Maternity Services where applicable.
This will include both clinical and support staff, and should be incorporated into induction programmes for new staff and as part of the Trust’s regular training and risk management programme updates for existing staff.

27. CNST: Transfusion Guidance
Staff training records and competence should be maintained.
There is a Hospital Transfusion Committee that oversees all aspects of transfusion.
Autologous blood transfusions and the introduction of cell salvage should have been considered and, where appropriate, patients made aware of the options.
The Trust participates in the annual SHOT Enquiry, and also includes “near miss” reporting.
The Trust should consider the enquiry’s recommendations.

28. CNST: Transfusion Verification of Standard
7.1.2 Copy of the Trust protocols for handling blood products, Hospital Transfusion Committee minutes and evidence of submission to SHOT. Training registers for relevant staff should be available at the assessment (including the Maternity Services, where provided).

29. Transfusion training in NHS hospitals (2004)
n=106 Induction Annual Update
Doctors 83% 32%
Nurses 75% 32%
Phlebotomists 75% 43%
Porters 59% 46%
C Howell & M Murphy
BBT2 Questionnaire

30. So what’s the problem?
Massif Mt Blanc

31. An approach to the problem
Define the extent
Who are the people that need training?
Porters / Nurses / Doctors / ODAs / phlebotomists
What training do they require? When?
How to deliver training?
How to keep documentation?

32. Transfusion Guidelines website
Website contains links to many other sites providing education materials & specialist groups

34. What to teach? Importance of rules
Local systems for patient and blood identification
Collection and delivery of blood
Transport of blood
Documentation required (at relevant step)
How to recognise, (treat), and report adverse events (or near misses)

35. Knowledge Information Can be tested in “exam type” questions
Location of fridges, blood bank, wards
Blood groups and ABO compatibility
Your transfusion policy
Can be tested in “exam type” questions
written, spoken / paper or interactive IT

36. Skill Ability to perform task correctly
Positively identify patient
Checking procedures
Need to teach in steps with person performing the actions
Test by observing action
No guarantee that correct skills are used in workplace – eg handwashing

39. Top-up training Changes to local systems
Feedback on performance (incidents)
Further transfusion training – consent issues, alternatives, new information eg infection risk / new testing
Opportunity for testing of knowledge

40. Documentation Paper Electronic
Data entry
Swipe card
Readability?
Getting the system right in the first place

41. Help!!! Local Transfusion Team Cons / BMS / SPOT
Transfusion Committee members
Link Nurses
Risk Management
Personnel (Induction & SUET / A4C KSF )
Clinical Governance Director (Dr & Trust Bd)
Medical Director
Finance – Management for new posts

42. Help!! Regional Regional Transfusion Committee
Local BB managers meetings
NBS Liaison Transfusion Nurses

43. Help! National OIG website (www.transfusionguidelines.org.uk)
National Transfusion Committee (IT)
Lots of training materials (SNBS)

44. The first step is always the hardest
Mt Ruapehu from the Desert Rd