EU Directive on Blood Safety and Quality Education

EU Directive on Blood Safety and Quality Education and training implications Adrian Copplestone Derriford Hospital, Plymouth 20. 7. 05

Is there a difference between education and training?

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

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.

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

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

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.

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]

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 )

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

Are these rules new?

Standards A ORGANISATION AND QUALITY MANAGEMENT SYSTEM A 1 Organisation and management A 1. 3 The laboratory shall have: a) personnel with the authority, training and resources to carry out their duties

B PERSONNEL B 2 Staffing B 2. 1 Laboratory management shall ensure that there appropriate numbers of staff, with the required education and training, to meet the demands of the service and appropriate national legislation and regulations.

B 2. 3 The staffing shall include an individual(s) with the following roles: a) quality management (A 7) b) training and education (B 9) c) health and safety (C 5).

B 3. 1 Laboratory management shall ensure that procedure(s) for personnel management include: g) staff training and education (B 9)

B 6 Staff records B 6. 2 Staff records shall include: g) a record of education and training including continuing professional development

B 7 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

B 9 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.

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.

B 9. 4 Records shall be kept of all training and education (B 6). B 9. 5 Laboratory management shall appoint a training officer (B 2).

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

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. 8 m)

CNST: Transfusion Standard 7 - Clinical Care 7. 1. 2 There appropriate systems in place for the request, safe storage, collection and administration of human blood and blood products Level 1 standard

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

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.

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.

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.

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).

Transfusion training in NHS hospitals (2004) n=106 Induction Annual Update Doctors Nurses Phlebotomists Porters www. blood. co. uk/hospitals C Howell & M Murphy BBT 2 Questionnaire 83% 75% 59% 32% 43% 46%

So what’s the problem? Massif Mt Blanc

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?

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

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)

Knowledge • Information – 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

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

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

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

Help!!! • Local – Transfusion Team Cons / BMS / SPOT – Transfusion Committee members – Link Nurses – Risk Management – Personnel (Induction & SUET / A 4 C KSF ) – Clinical Governance Director (Dr & Trust Bd) – Medical Director – Finance – Management for new posts

Help!! • Regional – Regional Transfusion Committee – Local BB managers meetings – NBS Liaison Transfusion Nurses

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

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