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Identified By

CPA Standard Lab Area* Conform Y/N Nature of Non Compliance Comments
(initials)

A ORGANISATION AND MANAGEMENT


Organisation and Quality
A1
Management
Laboratory management demonstrates
its commitment to fulfilling the needs
and requirements of its users by clearly
defining the way in which the laboratory
is organised and managed.
The laboratory, or the parent
organisation of which it is a part, shall
A1.1
be an entity that can be held legally
responsible.
The laboratory, or the parent
organisation of which it is a part, shall
A1.2 This is a repeat of A1.1
be an entity that can be held legally
responsible.
A1.3 The laboratory shall have:
personnel with the authority, training
a)
and resources to carry out their duties
arrangements to ensure that the quality
of work is not adversely affected by any
b)
improper internal or external
commercial, financial or other pressures
arrangements that ensure the
c) protection of its users' confidential
information and proprietary rights
arrangements that address any
d) activities that would diminish
confidence in its impartiality or integrity.
Laboratory management shall, with the
A1.4
aid of organisational charts:
define the organisation and
a) management of the laboratory and its
place in a parent organisation
specify the responsibility, authority and
b)
interrelationships of all personnel.
Laboratory management shall have
regular meetings. Records shall be kept
and agreed action points noted.
A1.5
Laboratory management shall ensure
that actions are discharged within an
appropriate and agreed timescale.
NEEDS AND REQUIREMENTS OF
A2
USERS
It is an essential prerequisite of a
quality service that the organisation and
management of the laboratory relates
to the needs and requirements of its
users.
Laboratory management shall
determine the needs and requirements
A2.1 with users (E1) and specify them as
objectives for the organisation and
management of the laboratory.
Laboratory management shall
A2.3 demonstrate its commitment to users
by:
a) establishing a quality policy (A3)
establishing a quality management
b)
system (A4)
establishing quality objectives and plans
c)
(A5)
d) performing management reviews (A11)
ensuring the availability of necessary
e)
resources (Standards in B,C and D).
A3 QUALITY POLICY
A quality policy provides the basis for
running a laboratory in a manner that
will fulfil the needs and requirements of
its users.
Laboratory management shall establish
A3.1 a quality policy [NOTE 1] that includes
the following:
a statement of the laboratory's intention
with respect to the standard of services,
a)
including a commitment to meet the
needs and requirements of users
a statement of the purpose of the
quality management system (A4)
b) including a commitment to set quality
objectives (A5) and to achieve continual
quality improvement (H6)
a requirement that personnel are
familiar with the contents of the quality
c)
manual and all procedures relevant to
their work
commitment to good professional
d)
practice
a commitment to the health, safety and
e) welfare of all staff and visitors to the
laboratory
a commitment to comply with relevant
f)
environmental legislation
a commitment to continuing compliance
g) with CPA(UK)Ltd accreditation
standards.
Where the laboratory is part of a larger
Notes organisation its quality policy should be
1 consistent with other policies in the
organisation.
Laboratory management shall ensure
A3.2
that the quality policy is:
signed and issued by a person with
a)
appropriate authority
communicated, understood, available
b) and implemented throughout the
laboratory
reviewed for suitability and
c) effectiveness at the annual
management review (A11).
A4 QUALITY MANAGEMENT SYSTEM

A quality management system provides


the integration of organisational
structure, processes, procedures and
resources needed to fulfil a quality
policy and thus meet the needs and
requirements of users.
Laboratory management shall establish
A4.1
a quality management system.
Roles, responsibilities and authority of
all personnel shall be defined to ensure
A4.2 the establishment, implementation and
maintenance of the quality
management system.
Laboratory management shall be
A4.3
responsible for:
setting quality objectives and
a)
undertaking quality planning (A5)
b) preparing a quality manual (A6)
appointing a quality manager (however
c)
named) (A7)
d) establishing a procedure for
d)
document control (A8)
establishing a procedure for control of
e)
process and quality records (A9)
establishing a procedure for control of
f)
clinical material (A10)
conducting a management review
g)
(A11).
A5 QUALITY OBJECTIVES AND PLANS

Implementation of a quality policy


requires the establishment of quality
objectives and plans.
Laboratory management shall establish
written quality objectives that shall be
A5.1
consistent with the quality policy and
regularly reviewed (A3).
Laboratory management shall have
A5.2 plans to achieve and maintain its quality
objectives.
A6 QUALITY MANUAL

A quality manual describes the quality


management system of a laboratory
and includes the quality policy and
arrangements for its implementation.
Laboratory management shall be
A6.1 responsible for the preparation of a
quality manual.
A6.2 The quality manual shall include:
a) a quality policy
a description of the quality
b)
management system
a presentation of the organisational
c)
structure
an outline of the structure of the
d) documentation used in the quality
management system [NOTE 1].
Personnel shall be familiar with and
work to current versions of the quality
A6.3
manual and all referenced
documentation.
The quality manual shall be reviewed
regularly, updated as required and any
A6.4
changes communicated to all personnel
concerned.
The outline should refer to procedures
for the management of resources
(sections B, C and D), pre examination,
Notes
examination and post examination
1
processes (sections E, F and G) and the
quality management system evaluation
(H).
A7 QUALITY MANAGER
The quality manager is the individual
who ensures, on behalf of laboratory
management, that the quality
management system functions
correctly.
Laboratory management or
management of the parent organization
A7.1
shall appoint a quality manager [NOTE
1].
The quality manager’s reporting
arrangements shall be agreed between
A7.2
laboratory management and
management of the parent organisation.
The quality manager, irrespective of
A7.3 other responsibilities [NOTE 2], shall
have defined authority for:
ensuring the quality management
a)
system is implemented and maintained
reporting to laboratory management on
b) the functioning and effectiveness of the
quality management system
coordinating awareness of the needs
c)
and requirements of users.
The quality manager should have
responsibility for the implementation
and maintenance of the quality
Notes management system but not for
1 undertaking all the tasks involved. The
term quality manager is comparable
with management representative (as
described in ISO 9001:2000 para 5.5.2)
The quality manager may be engaged
full time or part time on quality
Notes
management. They may or may not
2
have other responsibilities in the parent
organisation or the laboratory.
A8 DOCUMENT CONTROL
Document control is an essential part of
a quality management system.
Laboratory management shall establish
a procedure to control all documents
(internally generated and from external
A8.1
sources) [NOTE 1] required for the
quality management system. This
procedure shall ensure that:
documents are approved for use by
a)
authorised personnel prior to issue
documents are uniquely identified; the
identification shall include the date of
b)
issue, revision version, the total number
of pages and the authorising signatories
there is a readily accessible master list
or equivalent document control
procedure. This identifies the current
c)
revision status and distribution of
documents in order to prevent the use
of invalid and/or obsolete documents
ocuments shall be legible, readily
d)
identifiable and retrievable
documents shall be regularly reviewed
e)
and updated as required.
Only current versions of documents
A8.2 shall be available at the appropriate
locations.
Laboratory management shall
determine, with regard to current
A8.3 legislation, regulations and guidelines,
the appropriate retention times for
documents removed from current use.
Documents may be on various media,
Notes whether hard copy or electronic and
1 may be digital, analog, photographic or
written.
CONTROL OF PROCESS AND
A9
QUALITY RECORDS
The control of process and quality
records is an essential part of a quality
management system.
Laboratory management shall establish
a procedure(s) for controlling process
A9.1
records [NOTE 1] and quality records
[NOTE 2], that includes:
a) identification and indexing
b) security
c) retention
d) storage and retrieval
e) disposal
Laboratory management shall
determine which process and quality
records (including quality records of
A9.2 external origin [NOTE 3]) are to be
retained and for how long. Notice shall
be taken of current legislation,
regulations and guidelines.
Quality records shall be readily available
to demonstrate compliance with the
A9.3
requirements and operation of the
quality management system (section H).
Process records shall be readily
A9.4 available in order to reconstruct the
process of any examination.
Process records should include records
made during pre examination,
Notes
examination and post examination
1
processes (sections E, F, and G) and
include internal quality control records.
Quality records should include records
Notes
made during quality evaluation
2
procedures (section H)
Records of external origin should include
Notes accreditation visit reports, external
3 quality assessment reports, health and
safety reports.
A10 CONTROL OF CLINICAL MATERIAL
The control of clinical material is an
essential part of a quality management
system
Laboratory management shall establish
A10.1 a procedure(s) for controlling clinical
material [NOTE 1] that includes:
a) identification and indexing
b) security
c) retention
d) storage and retrieval
e) disposal
Laboratory management shall
determine the clinical material to be
A10.2 retained and for how long. Notice shall
be taken of current legislation,
regulations and guidelines.
Retained clinical material shall be stored
A10.3 in a way that ensures the validity of a
repeat examination.
Clinical material includes any primary
Notes specimens/samples and relevant
1 preparations made in the course of
examination.
A11 MANAGEMENT REVIEW
A management review of the quality
management system serves to identify
any changes required, to meet the
needs and requirements of users, and
any action needed to ensure the
continuation of the service.
Laboratory management shall conduct
an annual review of the laboratory's
A11.1
quality management system and all its
services. The review shall include:
reports from managerial and
a)
supervisory personnel
assessment of user satisfaction and
b)
complaints (H2)
internal audit of quality management
c)
system (H3)
internal audit of examination processes
d)
(H4)
external quality assessment reports
e)
(H5)
reports of assessments by outside
f)
bodies
status of preventive, corrective and
g)
improvement actions (H6)
major changes in organisation and
h) management, resource (including
staffing) or process.
Findings of the management review and
the actions to be taken shall be
recorded. Laboratory management shall
A11.2
ensure that actions are discharged
within an appropriate and agreed
timescale.
The management review shall contain
A11.3 an executive summary, a copy of which
shall be sent to CPA(UK) Ltd.
B PERSONNEL
B1 Professional Direction
Professional direction is essential for the
proper performance of a laboratory.
Each discipline shall be professionally
directed by a consultant pathologist or
B1.1 clinical scientist of equivalent status.
Competence shall be demonstrated in
the following ways :

by evidence of training and experience


in a pathology specialty as normally
exemplified, in the United Kingdom, by
membership of the Royal College of
Pathologists or its equivalent.
Appointment as a consultant, or
equivalent, by a properly constituted
a)
Advisory Appointments Committee, is
an acceptable alternative OR if the
laboratory is providing a limited range
of specialized tests it shall be directed
by an appropriately trained consultant
with special qualifications or skills in the
area of these tests.

by evidence of continuing practice and


experience in the specialty, with
b)
participation in appropriate continuing
professional development.
by recorded attendance at regular
departmental meetings to review
c)
service issues and to set quality
objectives.
In a laboratory without on site
consultants in each discipline,
B1.2 professional direction by the off site
consultant shall also satisfy the
following criteria:
provision of a written statement of the
sessional input for each consultant
a)
sufficient to meet the needs of the
service
regular on site laboratory attendance as
b) needed to match the needs of the
service; normally at least weekly
B2 STAFFING
The staff are the single most important
asset in any laboratory.
Laboratory management shall ensure
that there are appropriate numbers of
staff, with the required education and
B2.1
training, to meet the demands of the
service and appropriate national
legislation and regulations.
Registration of staff shall be in
B2.2 accordance with current national
legislation and regulations.
The staffing shall include an
B2.3 individual(s) [NOTE 1] with the following
roles:
a) quality manager (A7)
b) training officer (B9)
c) health and safety officer (C5).
These individuals may be engaged full
time or part time with regard to these
Notes
specific responsibilities and may or may
1
not have other responsibilities in the
parent organisation or the laboratory.
B3 PERSONNEL MANAGEMENT
Personnel management ensures that
staff contribute fully and effectively to
the service, while receiving fair and
consistent treatment from laboratory
management.
Laboratory management shall ensure
B3.1 that procedure(s) for personnel
management [NOTE 1] include:
a) staff recruitment and selection
b) staff orientation and induction (B4)
c) job descriptions and contracts (B5)
d) staff records (B6)
e) staff annual joint review (B7)
f) staff meetings and communication (B8)
g) staff training and education (B9)
grievance procedures and staff
h)
disciplinary action.
If the laboratory is part of a parent
organisation, reference shall be made in
Notes the procedure for personnel
1 management to those procedures
undertaken by management in the
parent organisation.
STAFF ORIENTATION AND
B4
INDUCTION
A comprehensive orientation and
induction programme is an important
element in the introduction of new
members of staff.
Laboratory management shall ensure
that all staff participate in a staff
B4.1
induction programme that includes
information on:
the laboratory and, if applicable, its
a)
parent organisation
b) terms and conditions of employment
c) patient confidentiality and data
c)
protection
d) health and safety
e) occupational health services
job description including an
f)
organisational chart
g) salaries and wages
h) staff facilities.
A record shall be kept of participation in
B4.2
the induction programme [NOTE 1](B6).
JOB DESCRIPTIONS AND
B5
CONTRACTS
Written job descriptions and contracts
enable staff to know their duties,
responsibilities and rights.
Laboratory management shall ensure
B5.1 that all staff shall have job descriptions
that include:
a) a job title
b) the location within the organisation
c) accountability
d) the main purpose of the job
e) the main duties and responsibilities
f) the staff annual joint review.
All staff should have contracts of
employment which are in compliance
B5.2
with current legislation and provide
clear terms and conditions of service.
B6 STAFF RECORDS
Maintenance of accurate staff records is
an essential part of personnel
management.
Laboratory management shall ensure
confidentiality of staff records in
B6.1
accordance with local guidelines and
national legislation.
B6.2 Staff records [NOTE 1] shall include:
a) personal details
b) employment details
c) job description
d) terms and conditions of employment
a record of staff induction and
e)
orientation
f) a record of attendance at fire lectures
a record of education and training
g) including continuing professional
development
relevant educational and professional
h)
qualifications
I) certificate of registration, if relevant
j) absence record
k) accident record
a record of staff annual joint reviews
l)
[NOTE 2]
m) occupational health record
n) record of disciplinary action.
If the laboratory is part of a larger
organisation staff records may be held
Notes
by the parent organisation but should be
1
available for inspection on an
accreditation visit if requested.
With respect to items B6.2 (l,m,n) the
Notes
inspectors should seek assurance that
2
they exist.
B7 STAFF ANNUAL JOINT REVIEW
Achievement of laboratory and personal
objectives is facilitated by regular staff
appraisal.
Laboratory management shall ensure
that all staff participate in an annual
B7.1
joint review that includes consideration
of the:
stated objectives and plans (A5) of the
a)
laboratory
b) job description of the staff member
c) personal objectives of the staff member
training and development needs of the
d)
staff member
All staff performing annual joint reviews
shall have received training and those
B7.2
staff participating shall have had a full
explanation of the process.
Records shall be kept of all staff joint
B7.3
reviews (B6).
B8 STAFF MEETINGS
Regular staff meetings are a mechanism
for maintaining good communications
and disseminating information on all
aspects of the laboratory service.
There shall be regular meetings open to
B8.1 all staff in order to provide the
opportunity for exchange of information.
Records shall be kept and made
B8.2
available to staff.
B9 STAFF TRAINING AND EDUCATION
Access to continuing education and
training is important for all grades of
laboratory staff and participation in
Continuing Professional Development
schemes is a method of achieving this
for relevant staff groups.
There shall be a training and education
B9.1 programme for all members of staff
governed by the following criteria:
training and education shall be in
accordance with guidelines from the
a)
relevant professional and registration
bodies
all staff shall be given the opportunity
for further education and training in
b)
relation to the needs of the service and
their professional development.
All trainee staff shall have a designated
B9.2
supervisor.
There shall be the resources for training
B9.3
and education, that includes:
access to library and information
a)
services
access to a conveniently situated quiet
b)
room for private study
staff attendance at meetings and
c)
conferences
d) financial support.
Records shall be kept of all training and
B9.4
education (B6).
Laboratory management shall appoint a
B9.5
training officer (B2).
C PREMISES AND ENVIRONMENT
C1 Premises and Environment
A department requires sufficient space
to ensure that work is performed safely
and efficiently.
The premises shall provide a working
environment in which staff can perform
C1.1
required functions in accordance with
national legislation and guidelines.
The premises shall have space for the
C1.2
following:
a) the functioning and use of all equipment
b) specimen reception (E5)
c) separation of incompatible activities
d) facilities for staff (C2)
e) facilities for patients (C3)
f) facilities for storage (C4).
Access to the premises shall be
C1.3
restricted to authorised personnel.
C2 Facilities for Staf
All staff need facilities, within the
department, to ensure personal safety,
comfort and hygiene.
The premises shall have staff facilities
C2.1
that are readily accessible and include:
a) sufficient toilet accommodation
b) shower facilities where required
c) a rest area
basic catering facilities and access to a
d)
supply of drinking water
a changing area and secure storage for
e)
personal effects
f) storage for protective clothing
g) safe and secure working arrangements.
There shall be overnight
C2.2 accommodation, when necessary, that
is conveniently sited and secure.
C3 Facilities for Patients
The facilities available for patients
should provide for privacy during
reception and sampling and be suitable
for the examination being performed.
Facilities for specimen collection and
C3.1
examination of patients shall include:
a waiting/reception area with suitable
a) facilities and access for disabled
persons
a phlebotomy area which offers privacy
b)
and recovery facilities
toilet facilities for patients separate
c)
from those provided for staff.
There shall be notices advising patients
C3.2 and visitors of health and safety
precautions.
C4 Facilities for Storage
The provision of sufficient storage
space, under the correct conditions, is
important in maintaining the integrity of
samples, reagents and records.
There shall be separate storage
C4.1
facilities, as required, for:
a) process and quality records (A9)
b) clinical material (A10)
c) blood and blood products
d) hazardous substances (C5)
e) drugs, vaccines and other therapeutics
f) reagents (D3).
The storage facilities shall be in
C4.2 accordance with national legislation,
regulations and guidelines.
C5 Health & Safety
A health and safety statement, and
procedures to implement it, are
required to ensure a safe environment
in the laboratory for staff, patients and
visitors.
Laboratory management shall be
C5.1
responsible for:
defining and implementing health and
a)
safety procedures
ensuring that there is a safe working
environment in accordance with current
b)
safety guidelines and legislation [NOTE
1]
c) providing personal protective equipment
delegating day to day management of
d) health and safety to the appointed
health and safety officer (B2)
providing model rules for staff and
e)
visitors to the laboratory
where applicable, nominating a
consultant microbiologist responsible for
f) infection control and regular reporting to
the Communicable Disease Surveillance
Centre.
All staff shall be aware of their
C5.2 responsibilities relating to health and
safety.
Laboratory management shall establish
C5.3 a health and safety procedure(s) that
includes: [NOTE 2]
a) action in the event of fire
action in the event of a major spillage of
b)
dangerous chemicals or clinical material
action in the event of inoculation
c)
accident
reporting and monitoring of accidents
d)
and incidents
e) COSHH/risk assessments
f) disinfection processes
g) decontamination of equipment (D1)
h) chemical handling (D3)
I) storage and disposal of waste
specimen collection and handling,
j) transportation, reception and referral to
other laboratories (E3-E6).
Laboratory containment facilities shall
conform to the requirements of the
C5.4
ACDP guidelines as appropriate to the
testing being performed.
There shall be sufficient safety notices
and labelling of the laboratory
C5.5
environment such that staff are aware of
the risks and safe practice required.
Work areas shall be clean, uncluttered
and well maintained and there shall be
C5.6
evidence of good housekeeping
procedures.
A copy of the latest Health & Safety
Notes
Executive inspector report shall be Unsure if this exists
1
available to inspectors.
This procedure(s) may be in the form of
Notes
a Health and Safety Handbook readily
2
available to staff.
EQUIPMENT, INFORMATION SYSTEMS AND
D
MATERIALS
Procurement and Management of
D1
Equipment
The proper procurement and
management of equipment ensures that
the laboratory can fulfil the needs and
requirements of users.
Laboratory management shall ensure
D1.1 that the equipment is sufficient and
appropriate to provide the service.
Laboratory management shall establish
a procedure(s) for the procurement and
D1.2
management of equipment, that
includes:
a) assessment and justification of need
b) selection
c) acceptance
d) training
e) maintenance, service and repair
f) decontamination
record of instrument failure and
g)
subsequent corrective action
h) planned replacement and disposal
I) adverse incident and vigilance reporting
There shall be an inventory of
D1.3
equipment that includes:
a) name of manufacturer
b) serial number
c) date of purchase or acquisition
d) record of contracted maintenance
e) record of equipment “downtime”.
Management of Data and
D2
Information
The proper management of data and
information in the laboratory is essential
for the provision of the service.
Laboratory management shall ensure
the availability of data and information
D2.1
required to provide a service that meets
the needs and requirements of users.
Laboratory management shall establish
D2.2 a procedure(s) for the management of
data and information, that includes:
a) security
b) access
c) confidentiality and data protection
d) backup systems
e) storage, archive and retrieval
f) secure disposal.
Laboratory management shall ensure
compliance with current national
D2.3
legislation and regulations in relation to
data protection.
D3 Management of Materials
It is essential to have proper
management of all the materials used in
the provision of the service.
Laboratory management shall ensure
the availability of reagents, calibration
D3.1 and quality control material required to
provide a service which meets the
needs and requirements of users.
Laboratory management shall establish
a procedure(s) for the management of
D3.2
reagents, calibration and quality control
material that includes:
a) selection, purchasing and ordering
b) assessment of suppliers
receipt and verification of identity and
c)
condition
d) issue and inventory management
risk assessment through classification of
hazard and exposure potential and
e)
assignment of handling precautions
when appropriate
Safe disposal of reagents is included in
individual SOPs where appropriate, but I
f) safe disposal. suggest that it could be summarised in
COSSH as a separate entry for each
reagent, for ease of reference.
Materials in use shall be correctly
D3.3 identified with the date of receipt, lot
numbers, first use and expiry.
E PRE EXAMINATONI PROCESS
E1 Information for Users and Patients
To facilitate proper use of the services,
departmental policies, procedures and
repertoire should be provided in a
readable and manageable form. Users
particularly require information about
the availability of clinical advice, as well
as the scope and limitations of the
service.
There shall be up to date information for
E1.1 users. This shall be prepared in
consultation with the users. (A2 and H2)
E1.2 The information for users shall include:
a) contact details of key members of staff
b) the location of the laboratory
c) times of opening of the laboratory
details of any out of hours service or
d)
shift system
instructions for completion of the
e)
request form
instructions for transportation of
f) samples, including any special handling
needs
availability of clinical advice and
g)
interpretation
the laboratory’s repertoire including
specimens required, sample volumes,
h)
special precautions, turnaround time
and reference ranges
a list of those key factors which are
I) known to affect the performance of the
test or the interpretation of the results.
There shall be up to date information for
patients. This shall be prepared in
E1.3
consultation with patients or
representative groups.
The information for patients shall
E1.4
include:
an explanation of any clinical procedure
a)
to be performed
instructions regarding preparation for
b)
the procedure.
E2 Request Form
Correctly designed and properly
completed request forms are essential
for the performance of all laboratory
tests to the benefit of the patient and
the satisfaction of the requesting
physician.
The design of the request form [NOTE 1]
E2.1 shall allow the inclusion of the following
items:
sufficient information to allow unique
a)
identity of the patient
dentification(s) and the location of the
b)
requesting individual
c) date and time of specimen collection
type of specimen and, where
d)
appropriate, anatomical site of origin
e) investigations requested
date and time of receipt of samples by
f)
the laboratory
g) relevant clinical information
h) identification of priority status
location(s) to which the results are to be
I)
sent
j) laboratory accession number.
The laboratory shall encourage the
E2.2
proper completion of request forms.
Notes The request form may be in paper or
1 electronic format.
E3 Specimen Collection and Handling
Proper preparation of the patient,
specimen collection and handling are
essential for the production of valid
results by a laboratory.
Laboratory management shall establish
E3.1 a procedure(s) for the specimen
collection and handling that includes:
checking the completion of the request
a) form and confirming the identity of the
patient
checking that the specimen container is
b)
labelled correctly
checking that the patient is
c)
appropriately prepared
ensuring that the specimen is collected
d)
correctly
minimising the risk of interchange of
e)
samples and sub samples
ensuring that environmental and
f)
storage conditions are fulfilled
ensuring the safe disposal of all
g)
materials used in specimen collection
ensuring that high risk specimens are
h)
identified and processed correctly
ensuring that all spillages and
I)
breakages are dealt with correctly
minimising the risk to ensure the safety
of the specimen collector, carrier, the
j)
general public and the receiving
laboratory.
These procedures shall be available to
users of the service and those who are
E3.2
responsible for specimen collection and
handling.
E4 Specimen Transportation
Specimen transportation systems need
to ensure the timely arrival of
specimens at the correct destination at
minimum risk to both laboratory and
non laboratory personnel.
Laboratory management shall establish
E4.1 a procedure(s) for the transportation of
specimens [NOTE 1], that includes:
ensuring the safety of the courier, the
a)
general public and receiving laboratory
b) packaging, labelling and despatch
protection of the specimens from
c)
deterioration
reporting incidents during transportation
d) that may affect the quality of the
specimen or the safety of personnel.
The procedures for the transportation of
E4.2 specimens shall meet all regulatory
requirements.
Where laboratory management do not
directly manage or control the transport
Notes of specimens, a system should be
1 established with consultation between
laboratory and hospital safety advisors
and be subject to safety audit.
E5 Speciment Reception
For examinations to be correctly
performed, specimens have to be
received into the laboratory efficiently
and safely.
Laboratory management shall establish
E5.1 a procedure(s) for specimen reception
that includes:
accurate identification of the request
a)
and specimen
recording of request form and specimen
b)
information [NOTE 1]
recording the date and time of receipt of
c)
specimens
d) handling urgent specimens
e) ensuring staff safety.
There shall be a procedure(s) for
E5.2
specimen rejection that includes:
a) the criteria for rejection of specimens
b) the recording of rejected specimens
notification of the user concerning
c)
rejected specimens
Notes The data may be recorded in paper or
1 electronic format.
E6 Referral to Other Laboratories
Procedures are required to ensure that
specimens/data sent to referral
laboratories, and to consultants for
second opinions in Histopathology and
Cytology, are efficiently handled.
Laboratory management shall establish
E6.1 a procedure(s) for the referral to other
laboratories that includes:
maintaining a record of all referral
a) laboratories [NOTE 1] and the relevant
repertoire
maintaining a record of all specimens
b)
referred
c) c) recording of dispatch dates
monitoring the return of reports from
d) the referral laboratory or referral
consultant
reviewing referral laboratories in terms
e) of EQA performance and turnaround
times.
Referral laboratories should where
possible, be accredited by CPA or
Notes
equivalent accreditation body or meet
1
the requirements of the sender’s quality
management system.
F EXAMINATION PROCESS
Selection and Validation of
F1
Examination Procedures
The selection of examination
procedures needs to be clear,
appropriate and subject to regular
evaluation with the users.
Examination procedures, including those
F1.1 for sampling, shall meet the needs and
requirements of users.
Examination procedures shall be
validated for their intended use prior to
F1.2
introduction, and the methods used and
results obtained, recorded.
When examination procedures are
changed so that results or their
interpretation may be significantly
F1.3 Not sure we do this
different, the implications shall be
explained to users, prior to the
introduction of the change.
F2 Eaxmination Procedures
Adherence to examination procedures is
essential to ensure a quality diagnostic
laboratory service.
There shall be procedures for the
conduct of all examinations that include
F2.1
and/or refer to, as applicable, the
following:
clinical relevance / purpose of
a)
examination
b) principle of examination
c) specimen requirements and means of
c)
identification
d) equipment and special supplies
reagents, standard or calibrants and
e)
internal control materials
instructions for the performance of the
f)
examination
limitations and pitfalls of the
g)
examination
h) recording and calculation of results
i) internal quality control procedures and
criteria against which examination
I)
processes (measurement and
observation) are judged
j) reporting reference limits
responsibilities of personnel in
k) authorising, reporting, and monitoring
reports
l) risk assessment
m) uncertainty of measurement .
All examination procedures shall be
F2.2 readily available in relevant sections of
the laboratory.
Assuring the Quality of
F3
Examinations
A comprehensive programme of internal
quality control is essential to ensure the
quality of all laboratory examinations.
There shall be procedures for internal
quality control (IQC) of all examinations
b)
which verify that the intended quality is
achieved. These shall include:
records of date, source and storage
a)
requirements of IQC material
the process of validation of IQC material
b)
prior to routine use
c) appropriate statistical procedures
where applicable, acceptance criteria
d) for results obtained on IQC material in
use.
All IQC results shall be regularly
F3.2 evaluated in staff meetings and actions
taken recorded.
G THE POST EXAMINATION PAHSE
G1 Reporting Results
The purpose of the laboratory is to
produce the results of examinations in
reports that are correct, timely,
unambiguous and clinically useful.
Laboratory management shall establish
G1.1 a procedure(s) for reporting results
which shall include:
a) the report (G2)
b) the telephoned report (G3)
c) the amended report (G4)
d) clinical advice and interpretation (G5).
G2 The Report
The main method of communicating the
results of examinations to the users of
the laboratory is by the production of a
report.
The report [NOTE 1] shall be clear,
unambiguous, and contain sufficient
G2.1
information to enable the user to
interpret the results.
The report shall be designed to comply
with the needs of the users and with the
G2.2
requirements of the local medical
records system.
The report shall allow the inclusion of
G2.3
the following items:
a) the laboratory name
b) the unique identity of the patient
c) requester and/or address for delivery
type of specimen, date and time of
d)
collection
e) time and date of report
results, including reasons if no
f)
examination is performed (E5)
g) reference intervals as appropriate
h) interpretive comments as appropriate
I) highlighting of abnormal results ?How highlight
status of report as appropriate, eg,
j)
copy, interim or supplementary.
Reports or letters issued following
G2.4 receipt of the results from referral
laboratories shall additionally:
include the identity of the referral
a)
laboratory
b) include all the results
incorporate appropriate interpretive
c)
comments of the referral laboratory.
There shall be a mechanism for
G2.5 ensuring the reports are handled and
transmitted confidentially.
Notes The report may be in written or
1 electronic form.
G3 The Telephone Report
Laboratories are frequently required to
telephone reports to users. The method
by which this is done needs to be clearly
defined to minimise the risk of error.
Laboratory management shall establish
G3.1 a procedure(s) for giving reports by
telephone which includes:
a) the circumstances in which reports
a)
may be given
b) the nominated individuals who may
b)
give reports
c) the individuals who may receive
c)
reports
d) a method of mutual identification of
d) the patient between reporter and
receiver
e) a confirmation of correct transmission
f) the mechanism for recording the event
g) the maintenance of confidentiality
the process for sending a follow up
h)
report.
G4 The Amended Report
A process is required in the laboratory
to ensure that amended reports are
issued when necessary.
Laboratory management shall establish
G4.1 a procedure(s) for issuing amended
reports [NOTE 1] which shall include:
a) the criteria for issuing amended reports
the authorisation of staff able to amend
b)
reports
the identification to the user of
c)
amended reports
a process for recording the issue of
d)
amended reports
the reason for issuing an amended
e)
report
the instigation of preventive action, if
f)
required
g) a process for archiving amended results
An amended report is a report that is
Notes
changed in any way after the initial
1
report has been sent out.
G5 Clinical Advice and Interpretation
The provision of interpretive comments
on reports is an essential role of the
laboratory service. The frequency of
such comments may vary between
specialties.
Laboratory management shall ensure
that advice on examinations and the
G5.1 interpretation of results is available to
meet the needs and requirements of
users.
Interpretive comments on reports shall
G5.2
be clear, succinct and unambiguous.
Clinical advice and interpretive
comments shall only be provided by
G5.3
authorised personnel with appropriate
training.
EVALUATION AND QUALITY
H
ASSURANCE
Evaluation And Improvement
H1
Processes
Ongoing evaluation and improvement
processes are essential to ensure that
the service provided by the laboratory
meets the needs and requirements of
users.
Laboratory management shall establish
H1.1
a procedure(s) that includes:
Assessment of user satisfaction and
a)
complaints (H2)
Internal audit of quality management
b)
system [NOTE 1] (H3)
Internal audit of examination processes
c)
[NOTE 2] (H4)
d) External quality assessment (H5)
Reports from external assessment
e)
bodies
f) Quality improvement (H6).
The results of these evaluation and
improvement processes shall be made
H1.2
available to staff, and to users as
required.
Analysis, recording and interpretation of
H1.3 the evaluation data shall form part of
the management review (A11).
System performance relates to the
Notes organisation, quality management
1 system (section A) and associated
resources (sections B, C, D).
Process performance relates to pre
Notes examination, examination, and post
2 examination processes (sections E, F,
G).
Assessment of User Satisfaction
H2
and Complaints
The purpose of assessing user
satisfaction and monitoring complaints
is to establish that the service provided
by the laboratory meets the needs and
requirements of users.
H2.1 Laboratory management shall:
establish processes for obtaining and
monitoring data on user satisfaction and
a)
complaints. Users comments shall be
recorded, reviewed and acted upon.
meet performance targets (e.g.
b)
turnaround times) in all areas
assess the clinical relevance of
laboratory investigations performed and
c)
the reliability of interpretive reports in
conjunction with the users
participate in the evaluation of clinical
effectiveness, audit and risk
d)
management activities of the parent
organization or external bodies.
Internal Audit Of Quality
H3
Management System
Internal audit provides evidence to
demonstrate that the quality
management system has been
effectively established, implemented
and maintained.
Laboratory management shall establish
H3.1 an internal audit of the quality
management system.
H3.2 The internal audit process shall be
a) planned and scheduled
b) conducted against agreed criteria
carried out by personnel trained in
c)
internal audit [NOTE 1]
The record of internal audit shall
H3.3
include:
the activities, areas or items audited
any nonconformities [NOTE 2] or
deficiencies found
the recommendations and time scale for
corrective and preventive actions.
The results of internal audit shall be
regularly evaluated and the decisions
H3.4
taken documented, monitored, reviewed
and acted upon.
Where practicable internal audit should
be conducted by personnel who are
Notes independent of the work being audited,
1 e.g. personnel from one section of a
laboratory/department auditing another
section.

Identification of nonconforming work or


problems with the quality management
system or with examination procedures
can occur at various places within the
Notes quality system or examination
2 processes. Examples are customer
complaints, internal quality control,
instrument calibration, checking of
consumable materials, staff supervision,
reporting of results.
H4 Internal Audit of Examination Processes
Internal audit of pre examination,
examination and post examination
processes is required to ensure that
they are being conducted according to
agreed procedures. Internal quality
control helps to ensure that the
examinations are being correctly
performed.
There shall be internal audit of the pre
H4.1 examination, examination and post
examination processes.
H4.2 The internal audit process shall be
a) planned and scheduled
b) conducted against agreed criteria
carried out by personnel trained in
c)
internal audit [NOTE 1].
The record of internal audit shall
H4.3
include:
a) the activities, areas or items audited
any nonconformities or deficiencies
b)
found
the recommendations and time scale for
c)
corrective actions.
The results of internal audit shall be
regularly evaluated and the decisions
H4.4
taken documented, monitored and
communicated.
Where practicable internal audit should
be conducted by personnel who are
Notes independent of the work being audited,
1 i.e. personnel from one section of a
laboratory/department auditing another
section.
H5 External Quality Assessment
Participation in External Quality
Assessment (sometimes known as
Proficiency Testing) schemes is an
essential element in informing both
providers and users of the quality of the
service provided. Such schemes have a
major educational component and may
include either the analytical service of a
laboratory and/or the interpretations
provided by individual members of staff.
There shall be participation in approved
External Quality Assessment Scheme(s)
H5.1 [NOTES 1 and 2] appropriate to the
examinations and interpretations
provided.
A record of results against the agreed
H5.2 performance criteria in approved EQA
Schemes shall be maintained.
The record of the performance in EQA
shall be reviewed and communicated to
H5.3
staff and the decisions taken recorded,
monitored and acted upon [NOTE 3].
Approved EQA Schemes are Schemes
that are accredited by CPA (EQA) or by
another organisation accrediting to
standards based upon ISO Guide 43,
Notes
Parts 1 and 2. This should include an
1
appropriate scientific Steering
Committee and National Quality
Assurance Panel reporting
arrangements.
If such a Scheme(s) is not available for
all or part of the service(s) provided
Notes
then participation should be in a
2
professionally directed Scheme where
available.
H6 Quality Improvement
Continual quality improvement is an
essential part of maintaining and
improving laboratory services.
There shall be a process for continual
quality improvement. This shall include
H6.1
corrective action, preventive action and
improvement processes.
Corrective action shall be established
for identification and elimination of the
H6.2
causes of nonconformities. The process
shall include:
investigation of nonconformities and
a)
recording of results
determination of and responsibility for
b)
corrective action
implementation of corrective action
c)
within an agreed time scale
d) monitoring of corrective action taken.
Preventive action shall be taken to
H6.3 reduce nonconformities. The procedures
shall include:
investigation of the causes of potential
a)
nonconformities and recording of results
determination of and responsibility for
b)
preventive action
implementation of preventive action
c)
required and an agreed timescale
ensuring that the preventive action
d) taken is effective, recorded and
submitted for management review.
The results of the quality improvement
programme shall form a part of the
H6.4
development, training and education of
all staff.