Pathology Quality Manual
Pathology Quality Manual
Pathology Quality Manual
QMn-GEN-0001 Page 1 of 82
Rev. No. 18 Quality Manual Effective Date:
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Author: Kathleen Callan Authoriser: Dr Su Maung
QUALITY MANUAL
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Contents
1. INTRODUCTION .......................................................................................................................... 3
1.1 Purpose .................................................................................................................................. 3
1.2 Overview of Our Lady’s Hospital ......................................................................................... 4
1.3 Overview of Department of Pathology ................................................................................. 5
2. QUALITY MANAGEMENT SYSTEM ...................................................................................... 5
3. TERMS AND CONDITIONS ...................................................................................................... 5
4. MANAGEMENT REQUIREMENTS.......................................................................................... 6
4.1 Organisation and Management Responsibility...................................................................... 6
4.2 Quality Management System .............................................................................................. 17
4.3 Document Control ............................................................................................................... 20
4.5 Examination by Referral Laboratories ................................................................................ 24
4.6 External Services and Supplies ........................................................................................... 26
4.7 Advisory Services................................................................................................................ 28
4.8 Resolution of Complaints .................................................................................................... 29
4.9 Identification and Control of Non-Conformances............................................................... 29
4.10 Corrective Action............................................................................................................. 31
4.11 Preventative Action ......................................................................................................... 32
4.12 Continual Improvement ................................................................................................... 33
4.13 Control of Records ........................................................................................................... 33
4.14 Evaluation and Audits...................................................................................................... 36
4.15 Management Review ....................................................................................................... 39
5. TECHNICAL REQUIREMENTS .............................................................................................. 41
5.1 Personnel ............................................................................................................................. 41
Table 5. Responsibilities of Personnel.......................................................................................... 43
5.2 Accommodation and Environmental Conditions ................................................................ 48
5.3 Laboratory Equipment, Reagents and Consumables ........................................................... 52
Table 6: Equipment Records ......................................................................................................... 57
5.4 Pre-examination Procedures ................................................................................................ 59
5.5 Examination Procedures ...................................................................................................... 66
5.6 Ensuring Quality of Examination Results ........................................................................... 71
5.7 Post-Examination Processes ................................................................................................ 75
5.8 Reporting of Results ............................................................................................................ 75
5.9 Release of Results ............................................................................................................... 78
5.10 Laboratory Information Management.............................................................................. 79
6. APPENDICES ............................................................................................................................ 82
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Author: Kathleen Callan Authoriser: Dr Su Maung
1. INTRODUCTION
1.1 Purpose
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Governance Background
Our Lady’s Hospital, Navan is part of the Ireland East Hospital Group (IEHG).
This group also includes the Mater Misericordiae University Hospital, St Vincent’s
University Hospital, Midland Regional Hospital, Mullingar, St Luke’s Hospital,
Kilkenny, Wexford General Hospital, National Maternity Hospital, St Columcille’s
Hospital, St Michael’s Hospital, Dun Laoghaire, Cappagh National Orthopaedic
Hospital and the Royal Victoria Eye and Ear Hospital. The Academic Partner
nominated is University College, Dublin.
Capacity
Services Provided
Our Lady’s Hospital, Navan provides a general acute hospital service to the
catchment area of Meath and an orthopaedic service to the region as a whole.
Services provided at the hospital are detailed in Table 1. Services Provided at Our
Lady’s Hospital
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Ray O’Hare the Chief Medical Scientist is responsible for the Day to day operations in the
Laboratory including responsibility for Scientific and Administration Issues and he reports
directly the General Manager.
All personnel are required to follow these lines of communication and authority without
exception.
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4. MANAGEMENT REQUIREMENTS
The Blood Bank in Our Lady’s Hospital, Navan has been accredited to ISO
15189 since 17th February 2009. The scope of the accreditation is detailed in
Registration Number 215MT. All work relevant to the scope of ISO 15189
(current version) accreditation is carried out in the permanent facility.
LF-BT-0111 Schedule of Testing for Blood Transfusion includes a list of the tests
that are included in the scope of ISO15189 accreditation for the Blood Bank in
Our Lady’s Hospital, Navan.
The Haematology and Biochemistry Departments have been accredited since 2016
following initial inspection in October 2015. QF-HAEM-0004 Schedule of Testing
for the Haematology Department and QF-BIO-0007 Schedule of Testing for the
Biochemistry Department include a list of the tests that are included in the scope
of ISO15189 accreditation for Haematology and Biochemistry respectively.
Extension to scope for Microbiology was awarded in October 2018 following the
initial inspection in April 2018. Ref.: QF-MIC-0012 Schedule of Testing for
Microbiology.
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Navan,
Co. Meath.
C15 RK7Y
Telephone: Hospital Switchboard 046 9021210
Laboratory Office 0469078701
Blood Bank 046 9078573
Haematology 0469078575
Biochemistry 0469078574
Fax: Laboratory Office 046 9098016
b) Management and personnel are free from any undue internal and external
commercial, financial or other pressures and influences that may adversely
affect the quality of their work. This is implemented through adequate
provision of resources as defined in MP-GEN-0001 Management of the
Laboratory and MP-GEN-0026 Code of Conduct for Laboratory Personnel
& Confidentiality Statement.
d) There are appropriate procedures to ensure that staff treats human samples,
tissues or remains according to relevant legal requirements.
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The duties and responsibilities of the Laboratory Director are documented in MI-
GEN-0006 Laboratory Director Roles & Responsibilities in Our Lady’s Hospital,
Navan.
The Laboratory Director has the necessary competence, authority and resources to
fulfil the requirements of ISO15189.
c) To ensure that there are appropriate numbers of staff with the required
education, training and competence to provide medical laboratory services
that meet the needs and requirements of the users described according to
MP-GEN-0017 Pathology Training Policy;
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b) Establishing the quality policy ensuring the quality objectives and planning
are established;
g) Ensuring that all personnel are competent to perform their assigned activities
according to the MP-GEN-0017 Pathology Training Policy;
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Our Lady’s Hospital Navan plays an important role in the provision of health services in the
North East region. The Department of Pathology is committed to providing a service of the
highest quality and shall be aware and take in to consideration the needs and requirements of its
users.
The Mission Statement of the Department of Pathology is:
‘Our purpose is to contribute to improvement of the health and well-being of the people in
the North-East’
In order to ensure that the needs and requirements of users are met, the Department of
Pathology implements the Quality Policy by:
Ensuring the policy is appropriate to the purpose of the organisation;
Including a commitment to good professional practice, examinations that are fit for
intended use, compliance with the requirements of ISO 15189 and continual improvement
of the quality of the laboratory services;
Providing a framework for establishing and reviewing quality objectives;
Ensuring that the policy is communicated and understood within the organisation;
Treating Health and Safety as a prime focus for users and staff of the Department of
Pathology;
Upholding professional values and good professional practice through the provision of
continuing education, training and professional development;
Recruiting of staff, training and development at all levels to provide an effective and
efficient service to its users;
Providing and managing resources to ensure that laboratory examinations are processed to
produce the highest quality results possible;
Reporting results in ways which are timely, confidential, accurate and are supported by
clinical advice and interpretation when required;
Implementation of internal quality control, external quality assessment, audit and
assessment of user satisfaction to continuously improve the quality of the service.
Complying with all environmental legislation;
Complying with all regulatory standards including ISO 15189, EU Directive 2002/98/EC,
AML-BB including Article 14 and 15, INAB Regulations for the services and tests defined
in the Quality Manual;
Reviewing for continuing suitability
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The Chief Medical Scientist reports to the General Manager on governance issues
and operational issues. The Chief Medical Scientist reports to the Laboratory
Director of the Department of Pathology and the relevant Laboratory Consultants on
clinical matters.
Consultants
Chief Medical Scientist
Quality Co-ordinator
Medical Scientist Representatives (if required)
IT Co-ordinator (if required)
Senior Phlebotomist (if required)
Haemovigilance Officer (Blood Transfusion)
The Consultants are responsible for:
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4.1.2.6 Communication
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Records are kept in hard copy of items discussed in communications and meetings
and managed by the Quality Co-ordinator.
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Senior Medical Manage technical matters on a Ensure adherence to the Quality Management Medical Scientist
Scientist daily basis as directed by the System by all staff
Chief Medical Scientist
Quality Co-ordinator Fulfils the roles and Development & implementation and Chief Medical
responsibilities of a quality maintenance of the QMS. Scientist
manager. Is responsible for the
overall management of the Quality
Management System
Medical Scientist Day to Day work-load Adheres to the Quality Management System. Medical Scientist
IT Co-ordinator Manages the Laboratory Ensure that all requirements of Annex B of Chief Medical
Information System and any IT ISO 15189 are met Scientist
Issues.
Laboratory Aides Specimen reception and any other Adheres to the Quality Management System. Medical Scientist
duties specified by the Chief
Medical Scientist
Haemovigilance Haemovigilance/Traceability Ensures compliance with AML-GEN, Articles Senior Medical
Officer 14 & 15. Scientist Blood Bank
Surveillance Scientist Manages the collection, analysis To fully implement all the requirements of the Senior Medical
and dissemination of all HIQA National Standards for the Prevention Scientist in
Healthcare Associated Infection and Control of Healthcare Associated Infection Microbiology,
data in the Our Lady’s Hospital, for Surveillance and provide a link between the
Pathology Laboratory, Public Health and the Infection Prevention
Navan and the surrounding & Control Nurse,
community. Health Protection Surveillance Centre in
relation to the surveillance and reporting of Antimicrobial
infectious diseases and antimicrobial resistance Pharmacist,
via CIDR and EARS-Net. Be responsible for Chief Medical
the development, co-ordination and Scientist
implementation of quality processes within
Pathology and for all documentation required
for Surveillance of pathogens and antimicrobial
resistance patterns on direction of the Chief
Medical Scientist, HPSC and Consultant
Microbiologist
Senior Phlebotomist Manages the phlebotomy service Specimen collection and dispatch of samples to Phlebotomist
the laboratory.
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The Quality Co-ordinator fulfils the roles and responsibilities of the Quality Manager
in Our Lady’s Hospital, Navan. The Quality Co-ordinator is responsible for ensuring
that processes needed for the quality management system are established,
implemented and maintained across the Department of Pathology.
The Quality Co-ordinator reports directly to the Chief Medical Scientist who has the
authority to make or recommend changes on policy and resources, in conjunction
with the Director of the Department of Pathology.
The Quality Co-ordinator ensures the promotion of awareness of users’ needs and
requirements throughout the laboratory organisation.
The quality management system provides for the integration of all processes required
to fulfil its quality policy and objectives and meet the needs and requirements of the
users. The interaction of all pre-examination, examination and post examination
activities is illustrated in QF-GEN-0063 Process Flow for the Quality Management
System. Resources such as staff, facilities, equipment, process management (quality
control, change control) materials, information technology, and techniques/methods
are considered as part of the input resources. Also included, are strategic processes
including the mission statement, leadership review and resource management.
Participation in External Quality Assurance Schemes, internal audits and external
assessments and monitoring quality indicators are systems used to support the output
of test results.
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b) Monitors and evaluates the criteria and methods needed to ensure that both
the operation and control of pre-examination, examination and post-examination
processes for the quality management system are established, implemented and
maintained. The Department of Pathology has an adequate internal quality control
procedure in place LM-BT-0001 Reagent Quality Control. They also participate in
External Quality Assurance (EQA) Schemes which is implemented through the
procedure for External Quality Assurance as per QP-GEN-0003 External Quality
Assessment. They are also monitored through tracking and trending non-
conformances, internal and external audit and risk assessments. Preventive actions
are put in place as required.
c) Determines criteria and methods needed to ensure that both the operation and
control of these processes are effective as per MP-GEN-0001 Management of the
Laboratory. Actions are implemented as necessary to achieve planned results and
continual improvement of these processes. A list of quality objectives is compiled at
the beginning of each year to present to the Annual Management Review as the list
of goals for the forthcoming year.
4.2.2.1 General
b) The Quality Manual which describes the operation and management of the
quality management system
The documentation is in both paper and electronic format and is readily accessible
and protected from unauthorised changes and undue deterioration. The electronic
format is available in Q-Pulse. Controlled hard copy Standard Operating
Procedures are used in the laboratory as a source of information. LP-GEN-0007
User Manual is available on the J drive.
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The laboratory has established and maintains a Quality Manual which includes:
IS
ISO 15189
AML-BB
Quality Manual
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e) The documented policies established for the quality management system and
reference to the managerial and technical activities that support them. The
Department of Pathology management implements plans and procedures which
regularly monitor and demonstrate proper calibration and function of
instruments, reagents and analytical systems.
All personnel have access and are instructed on the use and application of the Quality
Manual, all referenced documents and the requirements for their implementation.
The laboratory controls documents required by the quality management system and
ensures that unintended use of any obsolete documents is prevented.
Documents considered for control are those that may vary based on changes in
versions or time. Examples include policy statements, instructions for use, flow
charts, procedures, specifications, forms, calibration tables, biological reference
intervals and their origins, charts, posters, notices, memoranda, software
documentation, drawings, plans, agreements and documents of external origin such
as regulations, standards and text books from which examination procedures are
taken.
The Document Control System is an electronic system i.e. Q-Pulse. Where there is a
requirement for a change to a document due to a change in practice, procedure,
material, and equipment etc., the change is requested, assessed, approved and
authorised as per MP-GEN-0019 Management of Change Control.
All documents are retained for a defined period. The retention period meet minimum
requirements of the Royal College of Pathologists.
Master copies of documents are maintained as hardcopies or on Q-Pulse.
a) All documents issued as part of the Quality Management System are reviewed
and approved by authorized personnel prior to issue.
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The first unit describes the procedural activity and document type
The second unit defines the department to which the document applies.
The third unit defines the actual number of the document. This number is
composed of four digits, starting with 0001.
Document Title
Document unique identifier on each page
Source identification – The source is identifiable from the unique
Management Procedure MP
Management Form MF
Quality Manual QMn
Quality Procedure QP
Quality Form QF
Laboratory Procedure LP
Laboratory Form LF
Laboratory Instruction LI
Haemovigilance Procedure HP
Laboratory Manual LMn
External Document ED
Effective Date
Page number to total number of pages [e.g. page 1 of 5]
Personnel responsible for approval of document
Revision Number
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g) Documents remain legible from revision to revision and the review history is
stored in Q-Pulse.
h) All documents are reviewed at least every two years for adequacy and revised
when necessary. All revisions are authorised prior to implementation.
i) Obsolete controlled documents are placed in the obsolete file on Q-Pulse. Hard
copies are destroyed and information is recorded on Q-Pulse.
Agreements to provide medical laboratory services take into account the request, the
examination and the report. The agreement specifies the information needed on the
request to ensure appropriate examination and result interpretation.
Only requests on the official request forms are accepted by the Department of
Pathology. The acceptance of a contract is based on the incoming inspection
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process. Checks are performed upon receipt of specimens and there are mandatory
requirements which the specimens must meet in order to be successfully processed.
If incoming inspection process fails i.e. if sufficient requirements are not met, the
customer is informed by phone and a repeat specimen may be requested. All rejected
contracts are documented on the non-conformance register.
d) Appropriate procedures selected are able to meet the contract requirements and
clinical needs (section 5.5) of the customer.
e) Customers and users are informed of deviations from the agreement that impact
upon the examination results.
Any deviation from the agreed service to be provided will be reported and
investigated as a non-conformance or reported as a ‘Planned Deviation’ through
QP-GEN-0005 Control of Non-Conformances. Affected users will be informed
by way of a memo. The document number of the memo will be referenced on
the non-conformance pertaining to the deviation.
Where a change to the contract between the Department of Pathology and the
Referral Laboratory affects the service provided, users will be informed of the
change, prior to implementation, as described in MP-GEN-0019 Management of
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Records of reviews including any significant changes and pertinent discussions are
maintained and include:
Minutes of Meetings
Customer Satisfaction Survey data and reports
Customer Complaints
Change Request on Q-Pulse
Laboratory Test Request Forms
The laboratory does not enter into financial arrangements with referring practitioners
or funding agencies where those arrangements act as an inducement for the referral
of examinations or patients or interfere with the practitioner’s independent
assessment of what is best for the patient.
User satisfaction surveys which are carried out annually are used as a forum to
review the contract. Review and changes may be made following discussion at the
Quality Meetings and/or the Pathology Governance Meetings.
MP-GEN-0016 Management and Review of Contracts describes the system in use for
evaluating, selecting and using referral laboratories.
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quality of the performance and ensuring that the referral laboratories are
competent to perform the requested examinations.
e) Requests and results of all samples are kept for a pre-defined period.
Unless otherwise specified in the agreement, the laboratory (and not the referral
laboratory) is responsible for ensuring that examination results of the referral
laboratory are provided to the person making the request. As described in MP-GEN-
0014 Reporting of Results, it is the policy of the Department of Pathology to ensure
that results, (specifically all essential elements of results) are returned to the
requesting clinician.
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The name and address of the referral laboratory responsible for the examination
result is clearly indicated on the result report. Results from the referral laboratory
are issued directly to the requesting clinician. The comment ‘Results received from
referral laboratory’ is entered on the LIS to confirm receipt of reports.
The laboratory adopts the most appropriate means of reporting referral laboratory
results, taking into account turnaround times, measurement accuracy, transcription
processes and interpretative skill requirements. In cases where the correct
interpretation and application of examination results needs collaboration between
clinicians and specialists from both the referring and the referral laboratories, this
process is not hindered by commercial or financial considerations.
A Service Level Agreement is set-up for the use of the referral laboratories. An
annual Quality Assessment Confirmation LF-GEN-0002 Quality Assessment
Confirmation Form is sent annually to the referral laboratories for completion.
The procedures for the selection and purchasing of external services, equipment,
reagents, consumable supplies and off-site archiving that affect the quality of
services provided by the Department of Pathology are defined through the following
procedures:
The Quality Co-ordinator maintains a list of equipment in use for Blood Bank,
Haematology, Biochemistry and Microbiology, in the Asset Module in Q-Pulse. This
list identifies at a minimum the following:
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A log of reagents and consumables in use are also retained in each department.
The laboratory selects and approves suppliers annually based on their ability to
supply external services, equipment, reagents and consumable supplies in
accordance with the laboratory’s requirements; however, it may be necessary to
collaborate with other organizational departments or functions to fulfil this
requirement. All suppliers who supply external services, equipment, reagents and
consumables that affect the quality of service are required to complete MF-GEN-
0035 Supplier Questionnaire. All information obtained through supplier postal
audits is reviewed on MF-GEN-0049 Evaluation of Supplier Form and retained.
Suppliers are listed in the Suppliers module in Q-Pulse. Documentation that confirms
the suppliers conformance with its quality management system, SLAs/contracts are
maintained in Q-Pulse. The laboratory monitors the performance of suppliers to
ensure that purchased services or items consistently meet the stated criteria.
Ref.: MF-GEN-0049 Evaluation of Supplier Form.
Purchased equipment that affects the quality of service are not used until they have
been verified as complying with requirements defined in VMP-GEN-0001 Validation
Master Plan for the Pathology Laboratory. The schedule and status of Preventative
Maintenance for all items of equipment is logged in the Assets module in Q-Pulse.+
Reagents and consumables that affect the quality of the service are only used when
expected results are achieved, as defined in the procedure LP-BT-0002 Monitoring of
Materials in Blood Transfusion, LP-BIO-0007 Batch Acceptance of Reagents,
Calibrators, Q.C. and Consumables, LP-HAEM-0012 Batch Acceptance of Reagents
in Haematology and LP-MIC-0065 Batch Acceptance in Microbiology.
Non-conforming external services and supplies are reported and investigated through
QP-GEN-0005 Control of Non-Conformances and discussed as required at Quality
Meetings as described in MP-GEN-0021 Quality Meetings.
Postal Audits have been carried out on key suppliers in order to obtain
documentation of conformance with their quality management system.
There is an inventory control system for supplies. Appropriate quality records of
external services, supplies and purchased products are established and maintained for
a period of time, as defined in the Quality Management System. This system includes
the recording of lot numbers of all relevant reagents, control materials and
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calibrators, the date of receipt and the date the material is placed in service. All of
these quality records are available for management review. This is implemented
through the procedure LP-BT-0002 Monitoring of Materials in Blood Transfusion,
LP-BIO-0007 Batch Acceptance of Reagents, Calibrators, Q.C. and Consumables,
LP-HAEM-0012 Batch Acceptance of Reagents in Haematology and LP-MIC-0065
Batch Acceptance in Microbiology.
In order to meet the needs of patients and all clinical personnel responsible for
patient care, the Department of Pathology provides advisory services as required to
all users, as described in QP-GEN-0007 Advisory Services.
The laboratory has arrangements for communicating with users on the following:
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All complaints and user feedback are discussed at Quality Meetings as described in
MP-GEN-0021 Quality Meetings.
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Non-Conformances can occur in many different areas and can be identified in many
different ways such as quality control indicators, instrument calibrations, checking of
consumable materials, staff comments, reporting and certificate checking, audits,
complaints etc.
The Quality Co-ordinator is responsible for implementing and managing the Non-
Conformance System which is managed through Q-Pulse.
d) When a non-conformance has been identified which may impact upon other
specimens being processed, examinations are halted and reports withheld as
necessary. The responsibility for the halting of laboratory examinations lies
with the Chief Medical Scientist. All affected clinicians / users of the service
are informed of the halting and subsequent resumption of examinations by
Chief Medical Scientist/Consultant as deemed appropriate. Corrective action is
taken as soon as possible upon detection of the non-conformance. The
timeframe for execution of corrective action is cognisant of the urgency of the
incident. The target close out for non-conformances is up to 90 days depending
on the nature of the non-conformance.
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a) Reviews non-conformances
d) The nature of the corrective action depends on the classification of the non-
conformance and of its potential risk to the patient. This also applies to
Haemovigilance & Traceability and Phlebotomy activities. Any changes
required resulting from corrective action investigations are documented and
implemented as described in QP-GEN-0019 Management of Change Control.
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Action taken at the time of the non-conformance to mitigate its immediate effects is
considered “immediate” action. Only action taken to remove the root cause of the
problem that is causing the nonconformities is considered “corrective” action.
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All personnel involved in the delivery of services have access to suitable education
and training opportunities, as described in MP-GEN-0001 Management of the
Laboratory, and QP-GEN-0004 Continual Improvement.
Retention and storage of pathological records and specimens are in accordance with
the recommendations of the Royal College of Pathologists as they apply to the
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retention and storage of pathological records and specimens and also the INAB
Regulations.
Records are created concurrently with performance of each activity that affects the
quality of the examination.
All personnel involved in the delivery of services are required to read and sign off on
MP-GEN-0002 Management of Documentation, Preparation and Control which
stipulates that all records must be completed in a legible manner.
Records are stored on hard copy and by electronic means. The Department of
Pathology take all possible steps to ensure that technical records are stored in an
environment that prevents damage, deterioration or unauthorised access. Access to
both the Laboratory Information System and Q-Pulse are password protected.
For some records, especially those stored electronically, the safest storage may be on
secure media and an offsite location.
a) Supplier selection and performance and changes to the approved supplier list
c) Request forms (including the patient chart or medical record only if used as the
request form)
f) Laboratory work-books/work-sheets
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u) Minutes of meetings that record decisions made about the laboratory’s quality
management activities
All of these quality and technical records are available for laboratory management
review. A list of authorising signatures and the name printed in capitals allows
traceability of the requesting clinician. Storage of Quality and Technical Record hard
copies are externally contracted to Iron Mountain. There is a Service Level
Agreement in place with Iron Mountain and Our Lady’s Hospital, Navan.
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Table 4 List of Blood Transfusion Records and their Associated Minimum Retention Times
4.14.1 General
The Internal Audit Schedule is prepared by the Quality Co-ordinator and indicates
the area to be audited, the month the audit is to take place, the auditor assigned.
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All elements of the Quality Management System are subject to internal audit once
every twelve months.
Audits are performed by designated personnel who have undergone auditor training.
Where possible, personnel do not audit their own activities. Auditors review the
examinations provided by the laboratory to ensure that they are clinically appropriate
for the requests received.
The laboratory conducts internal audits at planned intervals to determine whether all
activities in the quality management system including pre-examination, examination
and post-examination:
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Selection of auditors and conduct of audits ensure objectivity and impartiality of the
audit process. Auditors are, wherever resources permit, independent of the activity
to be audited.
All elements of ISO 15189 as they relate to the services are audited at least once
annually. The internal audit programme progressively addresses all aspects of the
services. A horizontal audit is a detailed check of the efficacy of implementation of
a particular aspect of the ISO15189 and AML-BB standards.
In addition, vertical audits are carried out periodically during the year. A vertical
audit of a request is a detailed check that all the elements associated with a chosen
examination are implemented (e.g. select a particular request form and audit its trail
as follows: reprint the request form, locate the specimen, check IQC & EQA details,
instrument maintenance, the report, interpretation etc).
The Laboratory has a documented procedure which defines the responsibilities and
requirements for planning and conducting audits and for reporting and maintaining
records QP-GEN-0002 Evaluation and Audits. All Audit documentation is retained
by the Quality Co-ordinator and they are responsible for the area being audited to
ensure that appropriate action is promptly undertaken when non-conformances are
identified. Corrective action is taken without undue delay to eliminate the causes of
the detected non-conformances.
The results of internal audit are regularly evaluated by the Quality Co-ordinator and
the decisions taken are documented, monitored, reviewed and acted upon. Any non-
conformance detected through auditing is investigated as described in QP-GEN-0005
Control of Non-Conformances. The results of internal audits are discussed at the
Quality Meetings and Management Reviews as described in MP-GEN-0021 Quality
Meetings and MP-GEN-0020 Management Review Procedure, respectively.
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The laboratory evaluates the impact of work processes and potential failures on
examination results as they affect patient safety and modifies processes to reduce or
eliminate the identified risks and document decisions and actions taken. Risk
assessments are carried out on key areas of the pre-examination, examination and
post examination processes to identify possible risks and to put controls in place to
support potential vulnerable areas. All risk assessments are recorded on Q-Pulse.
The process of monitoring quality indicators is planned and includes establishing the
objectives, methodology, interpretation, limits, action plan and duration of
measurement.
Quality indicators are established through discussion at Quality meetings and the
Annual Management review meeting. The indicators are reviewed bi-annually to
ensure their continued appropriateness on QF-GEN-0071 Quality Indicators Bi-
Annual Audit
The laboratory, in consultation with the users, establishes turnaround times for each
of its examinations that reflect clinical needs. Turnaround times for all tests are
included in LP-GEN-0007 User Manual. The laboratory periodically evaluates
whether or not it is meeting the established turnaround times.
All services are subject to annual review. The Annual Management Review,
described in MP-GEN-0001 Management of the Laboratory, examines the
continuing suitability and adequacy of services and their effectiveness and support of
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patient care. The need to introduce any necessary changes or improvements may also
be identified.
In addition, Quality meetings, as described in MP-GEN-0021 Quality Meetings, are
held to address individual aspects of the Quality Management System on an on-
going basis.
c) Staff suggestions
e) Risk management
n) Changes in the volume and scope of work, personnel and premises that could
affect the quality management system
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The various meetings analyse the input information for causes of nonconformities,
trends and patterns that indicate process problems. It also includes assessing these
opportunities for improvement and the need for changes to the quality management
system, including the quality policy and quality objectives.
Minutes of the findings and actions from all meetings are documented. The minutes
document:
c) Resource needs
Findings and actions are implemented within the appropriate and agreed upon
timeframes and are available for review by laboratory staff.
5. TECHNICAL REQUIREMENTS
5.1 Personnel
5.1.1 General
The laboratory has documented procedures for personnel management and maintains
records for all personnel to indicate compliance with requirements. These include
MP-GEN-0005 Management of Personnel and MP-GEN-0011 Management of Data
and Information.
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The reporting and working relationships are demonstrated through the Appendix 1
QF-GEN-0060 Department of Pathology Organisation Chart for Our Lady’s
Hospital, Navan.
The Chief Medical Scientist ensures that sufficient resources are available to meet
the requirements of the Quality Management System. This includes a commitment to
ensuring that staff resources are adequate for the work performed including
Haemovigilance and Traceability.
The Human Resources Department at Our Lady’s Hospital ensure that all personnel
working in the hospital, including personnel working within the Department of
Pathology have the required qualifications (in accordance with national guidelines and
regulations) and experience to carry out the duties relevant to their post within the
organisation. See Table 5. Responsibilities of Personnel outlines the personnel
responsible for the discharge of key tasks.
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*The Department of Pathology Management Team consists of the Laboratory Director of the
Department of Pathology, Laboratory Consultants, the hospital General Manager and the
Chief Medial Scientist.
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e) All qualifications or licenses are current and up to date, and are obtained
by the HR personnel prior to the person taking up the post. This is
implemented through the Public Service Management (Recruitments and
Appointments) Act 2004.
Job descriptions are in place for all staff and retained in individual training folders.
Written job descriptions are in place for all grades of personnel including:
Laboratory Director
Consultants
Chief Medical Scientist
Quality Co-ordinator
Senior Medical Scientists
Medical Scientists
Haemovigilance Officer
Phlebotomists
Clerical
The laboratory has a programme to introduce new staff to the organisation, the
department or area in which the person will work the terms and conditions of
employment and staff facilities as per MF-GEN-0044 Laboratory Staff Induction
Checklist for all new staff members
5.1.5 Training
Only staff that hold the required qualifications, the applicable theoretical and
practical background, recent experience and suitable training are authorised to make
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The laboratory provides training for all personnel in areas that are relevant to their
position. These include:
Ethics
Personnel that are undergoing training are supervised at all times. The effectiveness
of the training is periodically reviewed.
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A comprehensive Training and Competency programme for all staff ensures that
personnel are competent to perform their tasks. Competency testing is carried out on
an on-going basis, as described in MP-GEN-0017 Pathology Training Policy,
MP-GEN-0005 Management of Personnel and HP-GEN-0008 Haemovigilance
Training. Competency training plans ensure that the competency of each member of
routine and on-call staff will be assessed at least once annually, thus ensuring that
they are competent to perform individual tasks. Refer to LF-BT-0016 Competency
Review for Rotating Blood Transfusion Laboratory Scientist, MF-BIO-0006
Biochemistry Training and Competency Programme for Non-Biochemistry On-call
Staff, MF-BIO-0017 Biochemistry Certificate of Competency. LF-HAEM-0019
Annual Competency Review for Haematology Laboratory Scientists, LF-HAEM-
0067 Haematology Tests Performance and Authorization: Competency Testing, LF-
HAEM-0073 Interpretation of Data for Proficiency Testing, LF-HAEM-0096
Competency Assessment Questionnaire Haematology and LF-MIC-0012 Annual
Competency in Gram Staining in Microbiology for On-call Medical Scientists.
In addition, retraining is carried out when a member of staff returns from a leave of
absence of greater than one year.
There is a plan in place for Internal & External Training and for On-going
Competency Assessment of Laboratory Personnel. This is implemented through
MP-GEN-0017 Pathology Training Policy and MP-GEN-0005 Management of
Personnel. All training is documented and records retained in individual training
folders for each laboratory staff member.
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5.2.1 General
The laboratory evaluates and determines the sufficiency and adequacy of the space
allocated for the performance of the work.
The design and environment of the Department of Pathology is suitable for the tasks
carried out therein. The environments in which the primary sample collection and
examination / testing are performed is controlled so that samples taken or results of
testing performed are valid and not adversely affected in quality.
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Adequate lighting
Adequate ventilation
Adequate heating
Adequate water supply
Adequate waste and refuse disposal
Controlled environmental conditions.
The Department of Pathology has procedures for checking that the environment does
not adversely affect the performance of specimen collection and equipment.
Attention is paid to overall cleanliness and temperatures relevant to the technical
activities concerned. Environmental conditions are routinely monitored either
manually or by the Rees temperature monitoring system. This is implemented
through MP-GEN-0025 Facilities in the Department of Pathology. Environmental
conditions are also assessed through regular audits.
d) Communication systems within the laboratory are appropriate to the size and
complexity of the facility to ensure the efficient transfer of information and
implemented through MP-GEN-0025 Facilities in the Department of
Pathology.
These include:
E-mail
Meetings (all minuted)
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Notice Boards/Memos
Message Logs
Handover Logs
e) Safety facilities and devices are provided where appropriate and their
functioning regularly verified.
Storage space and conditions are provided that ensure the continuing integrity of
sample materials, documents, equipment, reagents, consumables, records, results and
any other items that could affect the quality of examination results.
Storage and disposable facilities for dangerous materials are appropriate to the
hazards of the materials and as specified by applicable requirements.
Appropriate Safety signage is used where there are potential hazards. Hazardous
chemicals are stored in the chemical cabinets. The fume cupboard is used to
dispense hazardous materials and to minimise the risk of inhalation of vapours or
particles. All hazardous chemicals are clearly labelled. MP-GEN-0007 Staff Health
and Safety Manual is available for consultation by all staff.
The laboratory provides space for staff activities such as meetings and quiet study
and a rest area.
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wards and clinics ensure privacy, comfort and adequate space for the taking of blood
samples.
Facilities at which patient sample collection procedures are performed enable the
sample collection to be undertaken in a manner that does not invalidate the results or
adversely affect the quality of the examination.
The sample collection facility has and maintains first aid materials for both patient
and staff needs.
All work areas within the Department of Pathology are kept clean and well
maintained. It is the responsibility of the Chief Medical Scientist to ensure that all
maintenance requirements relating to work areas are communicated to the General
Manager and the Maintenance Department as required.
The temperature of fridges, freezers, cold rooms and the room temperature are
monitored either manually or by the Rees Centron Environmental Monitoring
System, as defined in MP-GEN-0010 Management of the Rees Monitoring System.
The system records temperatures at defined intervals, alerting where temperatures
detected are beyond defined limits. Any deviation is investigated as non-conformity,
as described in QP-GEN-0005 Control of Non-Conformances.
Environmental conditions are also assessed through the Audit Procedure, as defined
in QP-GEN-0002 Evaluation and Audits.
In the laboratory, work is carried out at designated work stations.
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5.3.1 Equipment
5.3.1.1 General
The Department of Pathology is furnished with all items of equipment required for
the provision of service, including primary sample collection, sample preparation,
sample processing, examination and storage. Equipment is procured and managed as
described in MP-GEN-0009 Procurement and Management of Equipment and
MP-GEN-0016 Management and Review of Contracts.
In cases where the laboratory needs to use equipment outside its permanent control,
laboratory management ensures that the requirements of ISO 15189 are met.
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details the use of the main analyser in the Biochemistry Department. QF-MIC-0002
Microbiology Instrumentation Index details the equipment used in the Microbiology
Department.
Once an item of equipment has been decommissioned, the equipment file relating to it is
sent to Iron Mountain for storage and retained as defined in MP-GEN-0002
Management of Documentation, Preparation and Control.
The equipment asset number and all data relating to calibration/maintenance of the item
of equipment are defined on LF-BT-0006 Biannual/Annual Maintenance Form and LF-
BT-0005 As Required Maintenance Form, LF-HAEM-0005 Haematology
Instrumentation Index, LP-BIO-0001 Operation and Maintenance of the Abbott
Architect CI8200 Analyser and QF-MIC-0002 Microbiology Instrumentation Index
details the equipment used in the Microbiology Department.
.
Equipment may only be used by trained and authorised personnel. The operation and
maintenance of each piece of equipment is detailed in the relevant standard operating
procedure which is available at point of use. Standard Operating Procedures and/or
user manuals define the safety precautions to be adhered to when using equipment.
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The laboratory has procedures for safe handling, transport, storage and use of
equipment to prevent its contamination or deterioration.
Any item of equipment that has to be calibrated by the Medical Scientist is detailed
in the relevant SOP. A print out of all calibration/correction factors are maintained
and are checked for correctness after each change is made.
e) Ensuring that, where calibration gives rise to a set of correction factors, the
previous calibration factors are correctly updated
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0051 Out of Service Equipment Form is completed. The laboratory examines the
effect of any defects on previous examinations and institutes immediate action or
corrective action. These records are filed in the individual Equipment File, as
described in MP-GEN-0009 Procurement and Management of Equipment.
When equipment is removed from the direct control of the Department of Pathology
to be serviced or repaired, or is serviced or repaired on-site, the Department ensures
that the equipment is checked and shown to be functioning satisfactorily before
being returned to use, as described in MP-GEN-0009 Procurement and Management
of Equipment. This is done by carrying out quality control testing, or
maintenance/validation checks appropriate to the instrument, as described in the
standard operating procedure relevant to the piece of equipment.
Adverse incidents and accidents that can be attributed directly to specific equipment
is investigated and reported to the manufacturer and appropriate authorities as
required. Where equipment is found to be defective, the incident is reported as a
non-conformance and the effect of the defect on previous examinations is
investigated, as described in QP-GEN-0005 Control of Non-Conformances.
Equipment is labelled to indicate the status of calibration and maintenance and the
dates that recalibration and maintenance are due.
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Records are maintained for each item of equipment that contributes to the
performance of examinations. These equipment records includes, but not limited to
the following:
e) Location
g) Manufacturer’s Instructions
h) Records that Confirmed the Equipment’s Initial Acceptability for Use when
Equipment is Incorporated in the Laboratory
These records are maintained and are readily available for the lifespan of the
equipment and up to 30 years in storage.
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Table 6 - Equipment Records outlines the records maintained for equipment and their location.
Table 6: Equipment Records
Record ID Record Description Record Location
It is the responsibility of the Quality Co-ordinator and the Chief Medical Scientist to
ensure that all the relevant documentation is obtained and maintained for each piece
of equipment.
It is also the responsibility of the Quality Co-ordinator and Chief Medical Scientist to
ensure that validation, calibration and maintenance are kept up to date and carried out in
accordance with the relevant plan. This activity is aided through the use of LF-BT-0006
Biannual/Annual Maintenance Form, LF-HAEM-0005 Haematology Instrumentation
Index, QF-MIC-0002 Microbiology Instrumentation Index details the equipment used in
the Microbiology Department and in the case of Biochemistry they are stored on Q-
Pulse
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5.3.2.1 General
The laboratory is the sole receiving facility for reagents and consumables and it has
adequate storage and handling capabilities to maintain purchased items in a manner
that prevents damage or deterioration.
Consumables that can affect the quality of examinations are verified for performance
before use in examinations.
The laboratory has inventory control systems for reagents and consumables.
The systems for inventory control segregate uninspected and unacceptable reagents
and consumables from those that have been accepted for use as per MP-GEN-0013
Management of Materials.
Instructions for the use of reagents and consumables, including those provided by the
manufacturers are available to staff as required.
Adverse incidents and accidents that can be attributed directly to specific reagents or
consumables are investigated and reported to the manufacturer and appropriate
authorities, as required in accordance with QP-GEN-0008 Complaints Procedure.
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Records are maintained for each reagent and consumable that contributes to the
performance of examinations as per LP-BT-0002 Monitoring of Materials in Blood
Transfusion, LP-HAEM-0012 Batch Acceptance of Reagents in Haematology, LP-
BIO-0007 Batch Acceptance of Reagents, Calibrators, Q.C. and Consumables and
LP-MIC-0065 Batch Acceptance in Microbiology.
These records include but not limited to the following:
d) Date of receiving, the expiry date, date of entering into service and, where
applicable, the date the material was taken out of service
f) Manufacturer’s instructions
g) Records that confirmed the reagent’s or consumable’s initial acceptance for use
5.4.1 General
The Department of Pathology has information available for patients and users of the
laboratory services in LP-GEN-0007 User Manual. The information includes as
appropriate:
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The request forms allow spaces for the inclusion of, but not limited to, the following:
c) Type of primary sample and the anatomic site of origin, where appropriate
d) Examination(s) requested
f) Clinical relevant information about the patient for examination purposes and
interpretation purposes. This includes clinical details, antibiotic therapy, and
transfusion history.
The format of the request form (paper) and the manner in which requests are to be
communicated to the Department of Pathology are determined in discussion with the
users of the service and through reviews of the e.g Pathology Laboratory In-House
Satisfaction Surveys, Pathology Laboratory General Practitioner Satisfaction
Surveys.
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5.4.4.1 General
Specific instructions for the proper collection and handling of primary samples are
documented in LP-GEN-0007 User Manual are available to all users of the service.
All hard copies of LP-GEN-0007 User Manual are controlled through MP-GEN-
0002 Management of Documentation, Preparation and Control. The LP-GEN-0007
User Manual on J drive is updated on revision of the document.
All procedures carried out on a patient need the informed consent of the patient. For
most routine laboratory procedures, consent can be inferred when the patient
presents himself or herself at a laboratory with a request form and willingly submits
to the usual collecting procedure, for example, venepuncture. Patients in a hospital
bed are given the opportunity to refuse.
c) Type and amount of the primary sample to be collected with descriptions of the
primary sample containers and any necessary additives.
The current sample volumes required were determined with knowledge of sample
volume requirements for manual testing and for assurance that a sample will be
sufficient for further testing and investigations, e.g. antibody investigations and/or
crossmatching, as required. It is not expected that required volumes will change.
However, this will be reviewed periodically to ensure that neither insufficient nor
excessive amounts of sample are collected.
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f) Recording of the identity of the person collecting the primary sample and the
collection date, and when needed, recording of the collection time
b) Within a temperature interval specified for sample collection and handling and
with the designated preservatives to ensure the integrity of samples.
c) In a manner that ensures the integrity of the sample and the safety for the
carrier, the general public and the receiving laboratory, in compliance with
established requirements.
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It is the policy of the Department of Pathology to have a request form for every test
requested. However, where a sample is already in the department and a verbal
request is received, the testing may commence prior to receipt of the request form, as
described in LP-GEN-0007 User Manual. The lack of a request form does not
impede the processing of an urgent sample. Verbal requests for the Blood Bank are
recorded on the LF-BT-0012 Telephone Request Form. A completed request form is
requested for all additional requests in each department.
All samples received by the Department of Pathology must meet the acceptability
criteria. This ensures that primary samples are traceable to an identified individual.
Samples that do not meet acceptability criteria will result in a delay in processing or
rejection of the sample. These are communicated to the requesting clinician or area
to which the patient has presented. Rejected samples are recorded as per LP-BT-
0001 Specimen Handling in Blood Transfusion, LP-GEN-0003 Specimen Reception,
LP-GEN-0014 Specimen Handling in the Blood Sciences Laboratory and Lp-MIC-
0063 Specimen Reception in the Microbiology Laboratory.
If an amendment is made, the final report indicates the nature of the problem
and, where applicable, that caution is required when interpreting the result.
d) All primary samples received are recorded/logged onto the LIS as per
procedure. The date and time of receipt of samples, as well as the identity of
the receiving member of staff, are recorded.
In the Blood Bank, crossmatch requests that deviate from the HF-GEN-0003
OLH Maximum Blood Ordering Schedule are clarified by contacting the
requesting clinician, as described in LP-BT-0001 Specimen Handling in Blood
Transfusion. Requests for platelets, factor concentrates and plasma may be
checked with the Consultant Haematologist, to verify the appropriateness of
specific requests outside the HF-GEN-0069 Major Haemorrhage Protocol.
In the Haematology and Biochemistry Departments, requests that deviate from
LP-GEN-0014 Specimen Handling in the Blood Sciences Laboratory are
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f) Where relevant, there are instructions for the receipt, labelling, processing and
reporting of samples specifically marked as urgent. The instructions include
details of any special labelling of the request form and sample, the mechanism
of transfer of the sample to the examination area of the laboratory, any rapid
processing mode to be used and any special reporting criteria to be followed.
As part of HF-GEN-0019 Acute Massive Blood Loss all users of the Blood Bank are
advised to telephone in advance of sending urgent samples to ensure that they are
received and prioritised. It is also recommended that urgent samples are hand-
delivered to a Medical Scientist in the Blood Bank by the sample taker, to ensure that
acceptability criteria can be checked in the presence of the sample taker to minimise
delay in processing the sample.
Aliquots of samples frozen for future testing are labelled with permanent marker to
include the primary sample ID number and the patient’s name, date of birth and
medical record number, and date of freezing, thus ensuring that sample portions are
traceable to the original primary sample.
The Department of Pathology has procedures and appropriate facilities for securing
patient samples and avoiding deterioration, loss or damage during pre-examination
activities and during handling, preparation and storage.
Samples are stored for a specified time, under conditions ensuring stability of sample
properties, to enable repetition of the examination after reporting of the result or for
additional examinations that may be requested (as long as time requirements are
met). LP-BT-0001 Specimen Handling in Blood Transfusion and LP-GEN-0003
Specimen Reception, LP-GEN-0014 Specimen Handling in the Blood Sciences
Laboratory and LP-MIC-0063 Specimen Reception in Microbiology.
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5.5.1.1 General
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Validation is completed on
b) Non-standard methods
c) Laboratory designed and developed methods
d) Standard methods used outside their intended scope
e) Validated methods subsequently modified
The laboratory documents the procedure used for the validation and record the
results obtained. Staff with the authority reviews the validation results and record
the review.
When changes are made to a validated examination procedure, the influence of such
changes is documented and, where appropriate, a new validation is carried out.
The relevant uncertainty components are those associated with the actual
measurement process, commencing with the presentation of the sample to the
measurement procedure and ending with the output of the measured value.
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Sampling
Sample preparation
Sample portion selection
Calibrators
Reference materials
Input quantities
Equipment used
Environmental conditions
The laboratory defines the biological reference intervals or clinical decision values,
documents the basis for the reference intervals or decision values and communicates
this information to users via the report form.
Biological reference intervals are periodically reviewed at quality meetings for their
appropriateness. A review of biological reference intervals also takes place when
there is a change in any pre-examination or examination procedure. All changes are
managed using MP-GEN-0019 Management of Change Control.
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The testing procedures are based on instructions for use from the manufacturer. All
additional information required to perform the test is documented in the technical
procedure for the test method(s).
All test procedures are reviewed every 2 years or before that if a major amendment is
required. These reviews are documented.
e) Patient preparation
j) Procedural steps
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p) Instructions for determining quantitative results when a result is not within the
measurement interval
t) References
The Chief Medical Scientist is responsible for ensuring that the contents of
examination procedures are complete, current and reviewed by the Consultant.
All changes to test/ examination procedures are processed through the MP-GEN-
0019 Management of Change Control and the MP-GEN-0002 Management of
Documentation Preparation and Control.
The Department of Pathology provides users of the service with a list of current
examination procedures, including primary sample requirements and relevant
performance specifications and requirements, on request. This is implemented
through the LP-GEN-0007 User Manual.
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Reagent Logs in the Department of Pathology list all reagents in use, the revision
number of the package insert of the batch in current use. Current product inserts for
each reagent are retained. On receipt of reagents, the revision number of product
inserts is checked to be current as part of the incoming inspection process, as
described in LP-BT-0002 Monitoring of Materials in Blood Transfusion, LP-HAEM-
0012 Batch Acceptance of Reagents in Haematology, LP-BIO-0007 Batch
Acceptance of Reagents, Calibrators, Q.C. and Consumables and LP-MIC-0065
Batch Acceptance in Microbiology.
5.6.1 General
The laboratory ensures the quality of examinations by performing them under
defined conditions. Appropriate pre and post examination processes are
implemented. The laboratory does not fabricate any results.
5.6.2.1 General
Staff are required to sign off on the Internal Quality Assurance procedure having
read and fully understood all aspects therein. This ensures that staff members
understand the Internal QC system as a basis for technical and related medical
decisions.
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The Department of Pathology uses quality control material that reacts to the
examining system in a manner as close as possible to patient samples.
Quality control materials are periodically examined with a frequency that is based on
the stability of the procedure and the risk of harm to the patient from an erroneous
result.
Use of independent third party control materials are considered, either instead of, or
in addition to, any control materials supplied by the reagent or instrument
manufacturer.
The Department of Pathology has procedures to prevent the release of patient results
in the event of quality control failure.
When the quality control rules are violated and indicate that examination results are
likely to contain clinically significant errors, the results are rejected and relevant
patient samples are re-examined after the error condition has been corrected and
within specification performance is verified. The laboratory also evaluates the
results from patient samples that were examined after the last successful quality
control event.
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Statistical and non-statistical techniques for process are used wherever possible to
continuously monitor examination system performance.
5.6.3.1 Participation
The results of external quality assessments are monitored and any failures are
documented, investigated and resolved as per the non-conformance system,
QP-GEN-0005 Control of Non-Conformances. The results of the assessments are
reviewed and signed-off by the Consultant, Chief Medical Scientist and Senior
Medical Scientist. In addition they are discussed at the Quality Meetings with the
Consultant. A review of these results is presented at the Annual Management Review
Meeting.
There are External Quality Assurance Programmes available for the tests listed on
the scope of ISO 15189 accreditation in the Blood Bank and for the tests proposed
for extension to scope of ISO 15189 accreditation by Haematology and Biochemistry
Departments. There is no need for alternative approaches to be taken.
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The laboratory does not communicate with other participants in the interlaboratory
comparison programme about sample data until after the date for submission of the
data.
The laboratory does not refer interlaboratory comparison samples for confirmatory
examinations before submission of the data, although this would be routinely done
with patient samples.
When predetermined performance criteria are not fulfilled (i.e. non-conformances are
present), staff participate in the implementation and recording of corrective action.
The effectiveness of corrective action is monitored. The returned results are
evaluated for trends that indicate potential non-conformances and preventive action
is taken.
There are defined means of comparing procedures, equipment and methods used and
establishing the comparability of results for patient samples throughout the clinically
appropriate intervals. This is applicable to the same or different procedures,
equipment, different sites, or all of these.
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Only authorized trained personnel review the results of examinations, evaluate them
in conformance with the clinical information available regarding the patient and
authorize the release of the results. The procedure to be applied to the review and
release of results, including urgent results is defined in individual departmental
procedures.
The procedures also describe that the authorised personnel ensures review of the
results of examinations before release and evaluates them against internal quality
control and, as appropriate, available clinical information and previous examination
results.
When the procedure for reviewing results involves automatic selection and reporting,
review criteria is established, approved and documented.
The Blood Bank has documented procedures for the identification, collection,
retention, indexing, access, storage, maintenance and safe disposal of clinical
samples.
The laboratory defines the length of time, clinical samples are to be retained.
Retention times are defined by the nature of the sample, the examination and any
applicable requirements.
All clinical material i.e. primary samples are retained and stored in accordance with
the requirements, thus ensuring the validity of a repeat examination, if required.
Samples are finally disposed of in accordance with the ED-GEN-0035 Guidelines for
Management of Healthcare Waste 2010 and MP-GEN-0007 Staff Health and Safety
Manual.
Safe disposal of samples no longer required for examination are carried out in
accordance with the ED-GEN-0035 Guidelines for Management of Healthcare Waste
2010 and MP-GEN-0007 Staff Health and Safety Manual.
5.8.1 General
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The laboratory defines the format and medium of the report (i.e. electronic or paper)
and the manner in which it is to be communicated from the laboratory.
The format of reports is decided by the Chief Medical Scientist with input from
Consultants, Scientific Staff and Laboratory IT Co-ordinator. Users may raise issues
relating to the quality of the results report through QF-GEN-0001 Pathology
Laboratory In-House Satisfaction Survey and QF-GEN-0002 Pathology Laboratory
General Practitioner Satisfaction Survey which are distributed and reviewed, or the
Complaints System, as described in QP-GEN-0001 User Satisfaction, QP-GEN-0008
Complaints Procedure.
Reports include the information necessary for the interpretation of the examination
results.
The Department of Pathology ensures that the following report attributes effectively
communicate laboratory results and meet the users’ needs:
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f) Date of primary sample collection and time when available and relevant to
patient care.
n) Identification of the person reviewing the results and authorising the release of
the report i.e. the individual identification of the Medical Scientist is printed
on the report (if not contained in the report, readily available when needed).
The initials of the Medical Scientist checking and releasing the report are
recorded on the report (Blood Bank).
o) Date of the report and time of release (if not contained in the report, readily
available when needed)
p) Page number of total number of pages (e.g. “Page 1 of 5”, Page 2 of 5”, etc)
The description of tests and results are presented in clear, unambiguous language,
using syntax as recommended by:
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The Department of Pathology has clearly documented procedures for the release of
examination results, including details of who may release results and to whom. The
procedures ensure release of results to requesting clinicians/clinical areas/hospital
staff only. The Laboratory policy on result reporting is that a result of an
examination/test is never issued directly to patients. This is implemented through
MP-GEN-0014 Reporting of Results.
a) When the quality of the primary sample received is unsuitable for examination,
or could have compromised the result, this is indicated in the report. The test
report indicates if the quality of the primary sample received was unsuitable for
examination or could have compromised the result e.g. haemolysis. It is
endeavoured to check samples conformance to defined acceptability criteria as
soon as possible upon receipt by the Department of Pathology. Where samples
do not meet acceptability criteria, this information is entered on the LIS and is
authorised immediately by a Medical Scientist to facilitate timely
communication to wards. In urgent cases, this information is also telephoned to
the requesting clinician.
Records are maintained of actions taken that document date, time, responsible
laboratory staff member, person notified and examination results conveyed and any
difficulties encountered in notifications.
d) When results are transmitted as an interim report, the final report is always
forwarded to the requester.
Results of laboratory examinations that have been separated from all patient
identification may be used for such purposes as epidemiology, demography or other
statistical analyses.
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Copies of all in-house generated results are retained electronically on the Laboratory
Information System (LIS). This ensures prompt retrieval of the information.
The Department of Pathology does not use any system for automation and reporting
of results.
When an original report is revised there are written instructions regarding the
revision so that:
c) The amended record shows the time and date of the change and the name of the
person responsible for the change. This is viewable in the audit trail and paper
copy of report.
d) The original report entries remain in the audit trail when amendments are made
5.10.1 General
There is a procedure in place to describe the Laboratory Information System (LIS)
used in the MP-GEN-0012 Management and Operation of Apex. Work undertaken
in the department is logged on Apex and reports are stored indefinitely in the system.
The laboratory has a documented procedure to ensure that the confidentiality of
patient information is maintained at all times. This is described in MP-GEN-0011
Management of Data and Information.
The central Apex main server is located at HSE DNE Headquarters, Kells, Co.
Meath and is managed by the ICT Department, Kells. The LIS database is backed up
nightly at 9.00pm and the whole system is backed up weekly on Wednesday
mornings at 5.30am. The back-up tapes are stored in a secure fire proof location in
the HSE DNE headquarters in Kells.
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The laboratory information system is described for the Department of Pathology and
Laboratory Medicine in MP-GEN-0012 Management and Operation of Apex, LP-
HAEM-0018 Operation of APEX in the Haematology Laboratory and in LP-BT-0003
Operation of Apex in Blood Transfusion, LP-MIC-0082 Microbiology Apex
Procedures. Apex is supplied by CSC and was upgraded to Version 6.0 in Jan 2019.
The main functions of the LIS are as follows:
To store patient, specimen and test details
To identify the status of tests
To enter results
To store test results in relation to patient details
To provide results enquiry options
To generate reports and labels of results and Blood Products respectively
To provide statistical information on laboratory throughput
Manage in part the traceability of Blood Products
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If a procedure requires alterations to reports, the LIS transition log defines the time,
date and name of person responsible for the change. An audit is maintained of
reports, which have been revised. The audit trail provides details of who made the
amendment(s), details of the amendment(s) and the date and time of all actions.
These reports are easily retrievable and available to relevant clinical personnel. This
is described in MP-GEN-0012 Management and Operation of Apex.
The Laboratory IT Co-ordinator and the Senior Medical Scientist manages the LIS
software application. They ensure that:
Computer software, including that built into equipment, is adequate for use in
the facility
Procedures are established and implemented for protecting the integrity of
data at all times
Computers are maintained to ensure proper functioning with environmental
and operating conditions necessary for maintaining the integrity of data.
Computer programmes and routines are adequately protected to prevent
access, alteration or destruction by casual or unauthorised persons.
Access to the LIS is password controlled and user security is set up and maintained
to ensure data integrity. External access to the LIS is read-only access to authorised
blood results. Haemovigilance records are stored in a password protected computer
in the Haemovigilance Office.
Q-Pulse
Q-Pulse is a tool which compromises a series of interacting modules designed to
streamline key quality management system functions. Modules in Q-Pulse include
Document Management for managing a document and change control of policies
and procedures; CA/PA Module for capturing and managing non-conformances and
complaints; and Audit Management for planning, scheduling and reporting on the
audit and verification activities. An overview of the system is described in
MP-GEN-0018 Management and Operation of Q-Pulse.
These systems are:
a) Validated by the supplier and verified for functioning by the laboratory before
introduction, with any changes to the system authorized, documented and
verified before implementation. For the Apex System see VMP-GEN-0001
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Validation Master Plan and IOQ-BT-0008 IOQ APEX 5.8. For the Electronic
Blood Track system see PQ-BT-001 Performance Qualification Protocol for
Electronic Blood Track System.
b) Documented and the documentation, including that for day to day functioning
of the system, readily available to authorized users.
f) Maintained in a manner that ensures the integrity of the data and information
and includes the recording of system failures and the appropriate immediate
and corrective actions.
The laboratory verifies that the results of examinations, associated information and
comments are accurately reproduced, electronically and in hard copy where relevant,
by the information systems external to the laboratory intended to directly receive the
information (e.g. computer systems, fax machines, e-mail, website, personal web
devices). When a new examination or automated comments are implemented, the
laboratory verifies that the changes are accurately reproduced by the information
systems external to the laboratory intended to directly receive information from the
laboratory.
The laboratory has a documented contingency plan to maintain services in the event
of failure or downtime in information systems that affects the laboratory’s ability to
provide service. This is described in LP-GEN-0015 Laboratory Contingency Plan.
The information systems are managed and maintained on-site and laboratory
management is responsible for ensuring that the operator of the system complies with
all applicable requirements of ISO 15189:2012. This is in accordance with MP-
GEN-0011 Management of Data and Information.
6. APPENDICES
Nil
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