EU Directive on Blood Safety and Quality

Education and training implications

 Adrian CopplestoneDerriford 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

• 8th February 2005• Amended 8th April 2005• Fully in force 8th

November 2005• Competent Authority:

Medicine and Healthcare Products Regulatory Authority (MHRA)

Blood Safety & Quality Regulations

Hospital blood bank requirements9.- (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?

A ORGANISATION AND QUALITY MANAGEMENT SYSTEM

A1 Organisation and managementA 1.3 The laboratory shall have:a) personnel with the authority,

training and resources to carry out their duties

Standards

B PERSONNELB2 StaffingB 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.

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).

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

B6 Staff recordsB 6.2 Staff records shall include:

g) a record of education and training including continuing professional development

B7 Staff annual joint reviewB 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 memberd) training and development needs of the staff member

B9 Staff training and educationB 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 bodiesb) 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 servicesb) access to a conveniently situated quiet room for private studyc) staff attendance at meetings and conferencesd) financial support.

B 9.4 Records shall be kept of all training and education (B6).

B 9.5 Laboratory management shall appoint a training officer (B2).

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 1995Contributions depend on type of trust,

specialities and number of WTEsDiscount for levels of Risk ManagementLevel 1: 10%, 2: 20%, 3: 30% (£3.8m)

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

CNST: TransfusionGuidance

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: TransfusionGuidance

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: TransfusionGuidance

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: TransfusionGuidance

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 83% 32%Nurses 75% 32%Phlebotomists 75% 43%Porters 59% 46%www.blood.co.uk/hospitalsC Howell & M MurphyBBT2 Questionnaire

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

www.transfusionguidelines.org.uk

Completion Date: Annual Review Date:

Skills and Knowledge Framework for staff involved in the Blood Transfusion Care Pathway

K = Knowledge and/or Information at induction only S = Skills requiring top-up / regular training /

assessment of competency Leave blank if you feel this area is not applicable to the group of people within your Trust This will only apply if staff are actually involved in performing a task ie. Nurses collecting blood will need K&S but if they

are not involved in collection may only need K BMS MLA Phlebotomist Nursing /

midwifery Medical ODA/

ODP Hospital Support Worker

Perfusionist Other e.g. ATO

Phlebotomy Pre-transfusion sampling

Requesting

Pre transfusion testing

Issue of components

Collection of components

Bedside checking

Observations

Documentation

Transfusion Reactions

Note: This is a guidance document and can be modified at Trust level to accommodate different roles & activities undertaking tasks

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” questionswritten, 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

Generic procedure

An observational assessment should be per formed to assess the training procedure. Procedure assessment Did the candidate:

? or X Ensure that the f ollowing was correctly completed on the request f orm

a. Full name b. Date of Birth c. Hospital number / other number 1st line address d. Signature of person and contact details

Bleed only one patient at a time Ask the patient to state their

a. Full name, b. DOB c. Address

I npatient - Check the details on the wristband or other attached identifier were correct

Did unconscious patients have an attached ident ifi er with minimum inf ormation

Did the neonate have an attached identifi er with minimum inf ormation Was the sample handwritten beside the patient Was the minimum inf ormation on the sample:

a. Full name, b. DOB c. Hospital No./ 1st line of address d. Date e. S ignature

You may wish to also complete the knowledge assessment (this is optional)

Medical staff assessment criteria Blood Transf usion

Name of student: Name of assessor: Pass Pass with instruction Fail I s aware of appropriate handwashing technique? I s patient correctly identified? Has patient assessment been performed and consent gained? Has reason f or transf usion been legibly documented in patients’ notes?

Correctly take a blood sample and order a group & save or a blood product f or transf usion

I s aware of the safe & correct prescribing of blood and blood products: Transfusion triggers I ndications f or transf usion Special requirements

Demonstrate the correct checking procedure and safely administering a blood transf usion

Can recognise and act appropriately on a transfusion reaction S igned (Student): Comments: ……………………………………………………………………………………………………………………………………………………………………………………………… Signed (Assessor): Comments: ………………………………………………………………………………………………………………………………………………………………………………………………

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 / A4C 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