Transcript EU Directive on Blood Safety and Quality Education and

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
• 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 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
A1 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
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.
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 records
B 6.2 Staff records shall include:
g) a record of education and training
including continuing professional
development
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
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.
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 (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 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)
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: 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
BBT2 Questionnaire
83%
75%
75%
59%
32%
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
www.transfusionguidelines.org.uk
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 / 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