NOTTINGHAM UNIVERSITY HOSPITALS NHS TRUST
Documentation Control
SAMPLE ACCEPTANCE IN PATHOLOGY LABORATORIES PROCEDURE
Reference
Approving Body
Date Approved
Implementation Date
Version
Summary of Changes from
Previous Version
Supersedes
Consultation Undertaken
Date of Completion of
Equality Impact Assessment
Date of Completion of We
Are Here for You
Assessment
Date of Environmental
Impact Assessment (if
applicable)
Legal and/or Accreditation
Implications
CL/CGP/049
Directors’ Group
16 May 2013
16 May 2013
2
Includes reference to new standards and
general update of information
CL/CGP/049 Sample Acceptance For
Pathology Laboratories Procedure Version 1
(September 2009)
Pathology Health & Governance Group
Directorate Governance Group
March 2013
March 2013
March 2013
Clinical Pathology Accreditation (UK) Ltd
(CPA) system which is owned by The
United Kingdom Accreditation Service
(UKAS)
The British Committee for Standards in
Haematology
Target Audience
All requesters of Pathology Services
Review Date
March 2016
Lead Executive
Medical Director
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Author/Lead Manager
Name Ian Harris
Job title Deputy Head of Pathology Services
Extension 61184
Further Guidance/Information Name Liz Bakowski
Job title Pathology Quality Manager
Extension 62538
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CONTENTS
Paragraph
Title
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
Introduction
Executive Summary
Policy Statement
Definitions (including Glossary as needed)
Roles and Responsibilities
Policy and/or Procedural Requirements
Training, Implementation and Resources
Impact Assessments
Monitoring Matrix
Relevant Legislation, National Guidance
and Associated NUH Documents
Flow charts relating to section 6
Equality Impact Assessment
Environmental Impact Assessment
Here For You Assessment
Certification Of Employee Awareness
Appendix (1)
Appendix (2)
Appendix (3)
Appendix (4)
Appendix (5)
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3
1.0
Introduction
1.1
This document is intended to provide additional supporting
information on the procedure that Pathology will adopt in dealing with
specimens and requests that do not comply with the Trust’s policy on
Request and Specimen Labelling Policy - CL/CGP/018.
This document should be read in conjunction with Request and
Specimen Labelling Policy - CL/CGP/018
2.0
Executive Summary
2.1
This procedure details the acceptance criteria for labelling Pathology
samples and associated request forms to enable accurate
registration of samples in Pathology.
This is a requirement in order to ensure that the correct diagnostic
result is distributed for the correct patient
In addition this document contains the procedure for dealing with
non-compliant requests and samples throughout Nottingham
University Hospitals NHS Trust. In the interests of patient safety
and diagnostic management it is essential that both request forms
and samples contain an adequate amount of information to
ensure unequivocal identification of the patient.
It is essential that the person requesting and collecting the
sample ensure that they have correctly identified the patient, prior
to collection, by asking the patient for his/her name and date of
birth and/or confirmation either by a separate form of identification
or via a wristband as appropriate. Samples must be labelled at
the time of collection not prior to, or remotely from the patient
after collection in accordance with Request and Specimen
Labelling Policy - CL/CGP/018
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3.0
Policy Statement
3.1
NUH is committed to providing the highest possible standard of care
for patients requiring diagnostic results.
All patient information provided on request forms, whether written or
electronic, should be clear, unambiguous and allow for unequivocal
identification of the patient, the requesting clinician, patient location,
Clinical details and investigations required. The use of Electronic
Requesting systems will ensure compliance with the Request and
Specimen Labelling Policy – CL/CGP/018 and minimise rejections.
All requesters of diagnostic pathology tests are responsible for
ensuring full and accurate completion of request forms and sample
labels.
Requesters of diagnostic pathology tests must be aware of the
potential for sample rejection if samples or request forms are not fully
and accurately labelled with the required patient details.
4.0
Definitions
4.1
GUM = Genito urinary Medicine
CSF = Cerebrospinal fluid
5.0
Roles and Responsibilities
5.1
Committees
5.1.1Pathology Health & Governance Group
Meet monthly to identify and consider all local risks relating to the
number of rejections received in the department due to incomplete/
incorrect completion of request forms and or sample labels.
Any such issues which cannot be managed at a departmental level
will be escalated as required to the Directorate Governance Forum.
through membership
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5.1.2 Hospital Transfusion Committee
Monitor frequency of rejections via the incident reporting process on
a quarterly basis.
5.1.3 Directorate Governance Group
Meet monthly to monitor delivery of local action, agree and
implement Directorate actions, or (if the risk cannot or should not be
managed within the Directorate) pass it on to the appropriate SubCommittee of QUOG. The Directorate Governance Forum will ensure
that all types of risk facing the Directorate / Corporate Function are
identified, assessed, managed or escalated as required.
5.2
Individual Officers
5.2.1 Chief Operating Officer
The Chief Operating Officer has delegated responsibility for the
strategic development, implementation and monitoring of risk in
relation to;
 Operational performance across clinical services in the Trust.
 The management, strategic development and professional
leadership of the Trust’s information, management, analysis,
presentation and clinical coding services.
5.2.2 Clinical Directors
Responsible for the implementation and monitoring of policies and
procedures within their areas of responsibility
5.2.3 Heads of Service
Heads of Service report to their relevant Director and are responsible
for implementing policies and procedures at a local level.
Raising the profile, awareness and understanding of this procedure
within their areas of responsibility and control
Ensuring that staff receive regular feedback on actions taken to
reduce risks associated with this procedure
Ensuring that staff are made aware of risks and their personal
responsibilities as part of their induction and in-service ongoing
training
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5.2.4 Pathology General Manager
Responsible for defining and communicating the criteria for
acceptance and rejection of diagnostic dsamples and providing
information on correct completion and labelling of request forms and
samples
Responsible for ensuring feedback on sample rejection is
communicated to service users and escalating issues through
appropriate groups if a risk is identified.
5.2.5 Employees responsibilities
All staff must be aware that they have a duty under Health and Safety
legislation to take reasonable care for their own safety and for the
safety of others who may be affected by the Trust’s activities
All staff requesting pathology diagnostic tests must comply with this ,
procedure and associated policy and guidance and attend relevant
education and training events
All staff receiving pathology samples must take comply with this
procedure in acceptance and rejection of samples.
U
U
6.0
Policy and/or Procedural Requirements
6.1
6.1.1 Repeatable samples that do not meet the standard
requirements (Not Blood Transfusion*)
Laboratories will not process unlabelled or mislabelled samples.
The requesting clinician will be advised that repeat request form
and sample collections are necessary. Exceptions to this may
apply in the case of unrepeatable samples (see section 3 of this
document)
* For regulations applying to Blood Transfusion samples please
refer to the Blood Transfusion Policy.
6.1.2 Acceptance Criteria
Requests/Samples will not be accepted if any of these criteria are
not met:



There is no unique identifier quoted on the request form1
If any of the following are missing or incorrect
Full name - Surname and Forename (in full and not initials) 2
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 Date of Birth
 The sample or request form is illegible or unclear.
 There is discrepancy between the details provided on the
request card and sample
1
Except in the case where the unique identifier is not known, for
example Transients or asylum seekers
2
Except in the case of Genito urinary medicine (GUM) samples
Requests/Samples will not be accepted if:
 For certain requests the site of specimen is not given
 No Clinician or location is given to send a report.
In exceptional circumstances and with the authorisation of
Consultant or Senior Laboratory Management staff the laboratory
may call upon the person that collected the specimen to attend
the laboratory in order that the missing information can be added.
If this is not possible then a repeat sample will be requested.
6.1.3 Laboratory procedure when acceptance criteria are not
met
The laboratory will,
 Inform a senior member of laboratory staff.
 Notify the requesting Clinician or deputy and/or,
 Issue a report to the requesting Clinician
6.1.4 Unrepeatable samples that do not meet the standard
requirements (Not Blood Transfusion*)
In a number of circumstances, it would not be possible to repeat
the collection of the sample. The laboratory would classify these
as ‘Unrepeatable samples’ or unique specimens. Please note in
general that specimens of Blood would not normally be classified
as ‘Unrepeatable’.
* For regulations applying to Blood Transfusion samples please
refer to the Trust Blood Transfusion Policy.
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Examples of unrepeatable samples would include:
 All histology and non-gynae cytology samples.
 Bone marrow, CSF samples, tissues and other fluids obtained
by invasive procedures (NOT blood samples).
 Samples where re-collection presents a risk to the patient.
 Dynamic function test samples.
 Post mortem samples where re-collection is not possible
 Samples collected in an acute situation where the clinical
status of the patient may have changed e.g. drug overdose,
hypoglycaemic episode.
 Samples for culture from normally sterile sites where antibiotic
therapy has been subsequently started e.g. blood cultures
This list is not intended to be exhaustive.
6.1.5 Laboratory procedure when acceptance criteria are not
met in the case of unrepeatable samples.
A senior member of the laboratory staff will,
 Contact the Clinician (or responsible deputy) in charge of the
patient.
 Discuss the circumstances of sample collection and labelling
with the Clinician (or responsible deputy)
 Decide whether or not to process the sample(s) based on all
the information available and bearing in mind the potential risk to
the patient
 Complete a log of the event and where appropriate complete
an incident report
 Where an incident report is completed record the decisions
made and issue a copy of the incident report to the requesting
Clinician
 Patient reports will be identified clearly with the noncompliance and that correct patient identification cannot be
guaranteed.
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7.0
Training and Implementation
7.1
Training
Training for this procedure will be provided as part of the general
Pathology training
7.2
Implementation
Non-compliance with this policy will result in requests being delayed
or rejected.
The immediate implementation of this policy will be the responsibility
of the Clinical Directors and Clinical Leads.
The policy will be distributed via the Trust and Pathology websites.
7.3
Resources
No additional resources are required.
8.0
Trust Impact Assessments
8.1
Equality Impact Assessment
An equality impact assessment has been undertaken on this draft
and has not indicated that any additional considerations are
necessary.
The procedure applies equally to all samples.
(see appendix 2).
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8.2
Environmental Impact Assessment
An environmental impact assessment has been undertaken on this
draft and has not indicated that any additional considerations are
necessary.
(see appendix 3)
8.3
Here For You Assessment
A Here For You assessment has been undertaken on this document
and has indicated the need for additional considerations which have
been duly incorporated.
(see appendix 4)
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9.0
Policy / Procedure Monitoring Matrix
Minimum
requirement
to be
monitored
Responsible
individual/
group/
committee
Process
for
monitoring
e.g. audit
Undertake
risk
assessment
Pathology
General
Manager
Monitoring of Formal
Risk Register review
annually
Samples
meet
standard
requirements
Laboratory
Managers
Audit
Annually
Error Log
monitoring
Laboratory
Managers
Audit/
Monthly
review
Monthly
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Frequency
of
monitoring
Responsible
individual/
group/
committee for
review of
results
Responsible
individual/
group/
committee
for development
of action plan
Responsible
individual/
group/
committee
for
monitoring
of action plan
Monitoring biDirectorate
Directorate
monthly via ORC
Governance
Governance
Forum
Forum / ORC
quarterly
Pathology Health Directorate
Directorate
& Governance
Governance
Governance
Group
Forum
Forum/
Appropriate
QUOG sub
committee
Specialty based
Specialty based
Pathology
Quality Groups in Quality Groups in Health &
Cellular pathology, Cellular pathology, Governance
Microbiology and
Microbiology and
Group
Clinical Pathology Clinical Pathology
12
10.0
Relevant Legislation, National Guidance and Associated NUH
Documents
10.1
Request and Specimen Labelling Policy CLCGP018
Standards for the Medical Laboratory – Clinical Pathology
Accreditation (UK) Ltd - September 2007
Safety in Health Service Laboratories: The labelling, transport and
reception of samples 1986; Health Services Advisory Committee.
HSE Books, Sudbury, UK
Medical Laboratories - Requirements for quality and competence.
BS EN ISO 15189:2012 5.4.3
Patient Sample and Request Form Identification Criteria - The
Institute of Biomedical Science British Committee for Standards in
Haematology
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Appendix 1
Patient Surname &
Forename in full
Date of Birth
If transient or
asylum seeker
please state on
form
Unique Identifier
 NHS Number
 Korner Number
 Hospital number
 GUM number
Details on form match
details on sample
Reject
Implement
appropriate
procedure for
repeatable or
non-repeatable
samples
Clinician in full or code if known
Location for report
Clear & legible
Accept
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APPENDIX 2
Insert templates of relevant impact assessments (page break after each)
Equality Impact Assessment (EQIA) Form (Please complete all sections)
Q1. Date of Assessment: March 2013
Q2. For the policy and its implementation answer the questions a – c below against each characteristic (if
relevant consider breaking the policy or implementation down into areas)
a) Using data and supporting
b) What is already in place in c) Please state any
Protected
information, what issues,
the policy or its
barriers that still need to
Characteristic
needs or barriers could the
implementation to address
be addressed and any
protected characteristic
any inequalities or barriers to proposed actions to
groups experience? i.e. are
access including under
eliminate inequality
there any known health
representation at clinics,
inequality or access issues to
screening
consider?
The area of policy or its implementation being assessed:
Race and
Ethnicity
Gender
No impact identified
No impact identified
No impact identified
No impact identified
No impact identified
No impact identified
Age
No impact identified
No impact identified
No impact identified
Religion
No impact identified
No impact identified
No impact identified
Disability
No impact identified
No impact identified
No impact identified
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Sexuality
No impact identified
No impact identified
No impact identified
Pregnancy and
Maternity
Gender
Reassignment
Marriage and
Civil Partnership
Socio-Economic
Factors (i.e.
living in a poorer
neighbour hood
/ social
deprivation)
No impact identified
No impact identified
No impact identified
No impact identified
No impact identified
No impact identified
No impact identified
No impact identified
No impact identified
No impact identified
No impact identified
No impact identified
Area of service/strategy/function
Q3. What consultation with protected characteristic groups inc. patient groups have you carried out?
Not applicable
Q4. What data or information did you use in support of this EQIA?
Not applicable
Q.5 As far as you are aware are there any Human Rights issues be taken into account such as arising from
surveys, questionnaires, comments, concerns, complaints or compliments?
None identified
Q.6 What future actions needed to be undertaken to meet the needs and overcome barriers of the groups
identified or to create confidence that the policy and its implementation is not discriminating against any
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groups
What
The procedure applies equally to all samples.
By Whom
All staff
By When
Immediately
Resources required
None
Q7. Review date
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Environmental Impact Assessment
APPENDIX 3
The purpose of an environmental impact assessment is to identify the environmental impact of policies, assess the
significance of the consequences and, if required, reduce and mitigate the effect by either, a) amend the policy b)
implement mitigating actions.
Area of
impact
Environmental Risk/Impacts to consider
Action Taken (where
necessary)
Waste and  Is the policy encouraging using more materials/supplies?
materials
No
 Is the policy likely to increase the waste produced?
No
 Does the policy fail to utilise opportunities for
introduction/replacement of materials that can be recycled?
No
Soil/Land  Is the policy likely to promote the use of substances
dangerous to the land if released (e.g. lubricants, liquid
chemicals)
No
 Does the policy fail to consider the need to provide adequate
containment for these substances? (e.g. bunded containers,
etc.)
No
Water
 Is the policy likely to result in an increase of water usage?
No
 Is the policy likely to result in water being polluted? (e.g.
dangerous chemicals being introduced in the water)
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
Air



Energy

Nuisances

No
Does the policy fail to include a mitigating procedure? (e.g.
modify procedure to prevent water from being polluted;
polluted water containment for adequate disposal)
No
Is the policy likely to result in the introduction of procedures
and equipment with resulting emissions to air? (e.g. use of a
furnaces; combustion of fuels, emission or particles to the
atmosphere, etc.)
No
Does the policy fail to include a procedure to mitigate the
effects?
No
Does the policy fail to require compliance with the limits of
emission imposed by the relevant regulations?
No
Does the policy result in an increase in energy consumption
levels in the Trust? (estimate quantities)
No
Would the policy result in the creation of nuisances such as
noise or odour (for staff, patients, visitors, neighbours and
other relevant stakeholders)?
No
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We Are Here For You Policy and Trust-wide Procedure Compliance Toolkit
APPENDIX 4
The We Are Here For You service standards have been developed together with more than 1,000 staff and
patients. They can help us to be more consistent in what we do and say to help people to feel cared for, safe
and confident in their treatment. The standards apply to how we behave not only with patients and visitors, but
with all of our colleagues too. They apply to all of us, every day, in everything that we do. Therefore, their
inclusion in Policies and Trust-wide Procedures is essential to embed them in our organization.
Please rate each value from 1 – 3 (1 being not at all, 2 being affected and 3 being very affected)
Value
Score (13)
1.
Polite and Respectful
Whatever our role we are polite, welcoming and positive in the face of adversity, and are always
respectful of people’s individuality, privacy and dignity.
2.
Communicate and Listen
We take the time to listen, asking open questions, to hear what people say; and keep people
informed of what’s happening; providing smooth handovers.
3.
Helpful and Kind
All of us keep our ‘eyes open’ for (and don’t ‘avoid’) people who need help; we take ownership of
delivering the help and can be relied on.
4.
Vigilant (patients are safe)
Every one of us is vigilant across all aspects of safety, practices hand hygiene & demonstrates
attention to detail for a clean and tidy environment everywhere.
2
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2
3
20
5.
On Stage (patients feel safe)
We imagine anywhere that patients could see or hear us as a ‘stage’. Whenever we are ‘on stage’
we look and behave professionally, acting as an ambassador for the Trust, so patients, families and
carers feel safe, and are never unduly worried.
6.
Speak Up (patients stay safe)
We are confident to speak up if colleagues don’t meet these standards, we are appreciative when
they do, and are open to ‘positive challenge’ by colleagues
7.
Informative
We involve people as partners in their own care, helping them to be clear about their condition,
choices, care plan and how they might feel. We answer their questions without jargon. We do the
same when delivering services to colleagues.
8.
Timely
We appreciate that other people’s time is valuable, and offer a responsive service, to keep waiting to
a minimum, with convenient appointments, helping patients get better quicker and spend only
appropriate time in hospital.
9.
Compassionate
We understand the important role that patients’ and family’s feelings play in helping them feel better.
We are considerate of patients’ pain, and compassionate, gentle and reassuring with patients and
colleagues.
10. Accountable
Take responsibility for our own actions and results
11. Best Use of Time and Resources
Simplify processes and eliminate waste, while improving quality
12. Improve
Our best gets better. Working in teams to innovate and to solve patient frustrations
TOTAL
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3
3
3
3
3
3
3
32
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APPENDIX 5
CERTIFICATION OF EMPLOYEE AWARENESS
Document Title
Sample acceptance for pathology laboratories
procedure
Version (number)
Trust Secretary to insert
Version (date)
Trust Secretary to insert
I hereby certify that I have:
 Identified (by reference to the document control sheet of the above
policy/ procedure) the staff groups within my area of responsibility to
whom this policy / procedure applies.
 Made arrangements to ensure that such members of staff have the
opportunity to be aware of the existence of this document and have the
means to access, read and understand it.
Signature
Print name
Date
Directorate/
Department
The manager completing this certification should retain it for audit and/or other
purposes for a period of six years (even if subsequent versions of the
document are implemented). The suggested level of certification is;
 Clinical directorates - general manager
 Non clinical directorates - deputy director or equivalent.
The manager may, at their discretion, also require that subordinate levels of
their directorate / department utilize this form in a similar way, but this would
always be an additional (not replacement) action.
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