ISO/TS 23824:2024

Technical
Specification
ISO/TS 23824
First edition
Medical laboratories — Guidance
2024-05
on application of ISO 15189 in
anatomic pathology
Laboratoires médicaux — Recommandations pour l'application
de l'ISO 15189 en anatomopathologie
Reference number
© ISO 2024
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ii
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 General requirements . 3
4.1 Anatomic pathology (AP) laboratory .3
4.2 Examples of process actions and risks for general requirements of ISO 15189 .4
5 Structural and governance requirements . 5
5.1 Structure of a management system .5
5.2 Examples of process actions and risks for structural and governance requirements of
ISO 15189.6
6 Resource requirements . 8
6.1 Managing personnel in anatomic pathology (AP) .8
6.2 Examples of process actions and risks for resource requirements of ISO 15189:2022 .9
7 Process requirements .15
7.1 Managing processes in anatomic pathology (AP) . 15
7.2 Examples of process actions and risks for the process requirements of ISO 15189:2022.16
8 Management system requirements .25
8.1 Managing risk in anatomic pathology (AP) . 25
8.2 Managing nonconforming work in anatomic pathology (AP). 26
Bibliography .31

iii
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
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This document was prepared by Technical Committee ISO/TC 212, Medical laboratories and in vitro diagnostic
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Any feedback or questions on this document should be directed to the user’s national standards body. A
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iv
Introduction
Anatomic pathology (AP) is the branch of medicine that examines tissue samples and cells by microscopy
and other methods. AP seeks to answer clinical questions (e.g. Is it neoplastic? Is it malignant? Where does
it arise? How can it be treated?) by rendering a diagnosis that allows the patient’s caregiver to treat the
patient’s condition, predict the condition’s response to treatment and make a judgement about the condition’s
prognosis.
AP comprises three activities: examination of tissue obtained from the body by biopsy, surgery or autopsy;
examining exfoliated or aspirated single cells, circulating tumour cells, or groups of cells whose architectural
context is often lost; and examination of deceased persons, usually to confirm or document a cause of death,
or the extent of known or previously undiagnosed conditions.
Ancillary techniques such as immunohistochemical stains, (fluorescence) in-situ hybridization studies,
molecular testing and advanced genomic and proteomic studies (e.g. next-generation sequencing, mass
spectrometry) have complemented or even been incorporated into AP. The arrival of image analysis tools,
machine learning algorithms and artificial intelligence systems will introduce new examinations to AP
laboratories with a new set of risks and opportunities (e.g. automated quality control).
AP is different from other laboratory medicine specialties such as chemistry, microbiology, or haematology
in several aspects. First, samples submitted for evaluation are often solid and, in many instances, unique
(i.e. if the sample is exhausted or lost, it cannot be replaced by another sample) and indivisible (i.e. a part
taken from the primary sample cannot be expected to have the same properties as the primary sample).
Second, the structural integrity at the macroscopic scale determines diagnostic features such as margins
status or orientation. Third, the examination process almost always requires at least two separate activities,
macroscopic and microscopic examination, that occur at different times. Fourth, processing the sample
involves many, often unrepeatable, manual steps, that introduce several risk points along the process.
Finally, the analytical examination process is interpretive, performed by humans with intra- and inter-
observer variability, and with no universally accepted biological reference intervals.
ISO 15189, can be applied to, and encompasses AP. This document provides guidance for AP laboratories on
how the requirements contained in ISO 15189 can be met. Like ISO 15189, this document applies to both the
resource and process aspects as well as the governance and management aspects of AP. ISO 15189 defines
medical laboratory as an entity performing examinations of materials derived from the human body for the
purpose of providing information for a diagnosis.
In AP, examination is not synonymous with diagnosis. An examination has the objective of determining the
value or characteristics of a property. The result of an examination in AP can influence, and even be the
sole determinant, of a diagnosis. In many instances, however, a diagnosis rests not only on the result of
the AP examination but also the clinical setting and results of other examinations (e.g. medical laboratory,
imaging). Rendering a diagnosis constitutes practice of medicine. While this document must not infringe
on the practice of medicine, it reminds users that the practice of AP is inseparable from the activities and
requirements addressed by ISO 15189 and strives to promote the welfare of patients.
This document does not impose new or more stringent requirements than ISO 15189. Instead, this document
attempts to clarify the requirements by providing examples of process actions and risks, using language and
concepts familiar to the AP laboratory. The left column in each table refers to the subclauses in ISO 15189
for which guidance is offered. Not every subclause of ISO 15189 is addressed, only the subclauses for which
clarification or guidance was thought to be of benefit. The tables in this document are not comprehensive
lists of actions and risks. They are examples of actions and risks, and conformance with every item in these
tables does not imply conformance with ISO 15189.
This document is aligned with ISO 15189 and assumes basic familiarity with central themes of ISO 15189,
including process and risk management, corrective action for nonconforming work, internal auditing, and
effective management reviews.
v
Technical Specification ISO/TS 23824:2024(en)
Medical laboratories — Guidance on application of ISO 15189
in anatomic pathology
1 Scope
This document provides guidance to anatomic pathology (AP) laboratories on implementing a management
system to meet requirements for quality and competence of ISO 15189.
NOTE International, national, or regional regulations or requirements can also apply to specific topics covered in
this document.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content constitutes
requirements of this document. For dated references, only the edition cited applies. For undated references,
the latest edition of the referenced document (including any amendments) applies.
ISO 15189:2022, Medical laboratories — Requirements for quality and competence
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 15189 and the following apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/
3.1
anatomic pathology
AP
branch of medicine that evaluates tissue and cellular samples
Note 1 to entry: This branch of medicine is also referred to as histopathology or cellular pathology.
3.2
cytopathology
subspecialty of anatomic pathology (AP) (3.1) that evaluates features at the cellular level
3.3
diagnosis
identification of a health or disease state
Note 1 to entry: A diagnosis can be based on examination results and the disease state’s signs or symptoms. A diagnosis
typically classifies the disease state into separate and distinct categories or subclasses that allow medical decisions
about treatment and prognosis to be made.
Note 2 to entry: Diagnosis is not synonymous with examination.
Note 3 to entry: A diagnosis is rendered by a trained, competent and authorized person. In most instances, this person
is a pathologist.
3.4
examination
set of operations having the objective of determining the numerical value, text value or characteristics of a
property
Note 1 to entry: An examination may be the total of a number of activities, observations or measurements required to
determine a value or characteristic (e.g. dissection, microscopic examination and immunohistochemical stains can be
necessary to determine whether a neoplasm extends to the margin of a surgical specimen).
Note 2 to entry: Laboratory examinations that determine a numerical value of a property are called “quantitative
examinations”; those that determine the characteristics of a property are called “qualitative examinations”.
[SOURCE: ISO 15189:2022, 3.8, modified — Note 1 to entry has been modified; Note 3 to entry has been
removed.]
3.5
frozen section
intra-operative consultation
rapid examination (3.4) of a tissue sample during surgery to help with intra-operative decision making
3.6
laboratory user
individual or entity requesting services of the medical laboratory
Note 1 to entry: Laboratory user can include patients, clinicians, surgeons, practitioners, requestors and other
persons, laboratories or institutions that send samples for examination.
[SOURCE: ISO 15189:2022, 3.16, modified — Note 1 to entry has been modified.]
3.7
gross examination
macroscopic examination
examination (3.4) to determine and record the characteristics and features of a tissue sample, and
includes dissection of a tissue sample, often performed to select samples for microscopic evaluation from
a primary sample
Note 1 to entry: Features of a tissue sample can include size, weight, visual description and lesions, such as tumours.
Note 2 to entry: Gross examination includes tissue transfer of small biopsies not needing dissection due to size.
3.8
pathologist
medical doctor practicing pathology
Note 1 to entry: Pathologists include general and specialized pathologists (e.g. cytopathologist) who perform
examinations, render diagnoses and provide advisory services to laboratory users.
Note 2 to entry: In some countries, settings or situations, individuals other than pathologists can perform
examinations, render diagnoses and provide advisory services to laboratory users (e.g. cytotechnologists, biomedical
scientists).
3.9
primary sample
specimen
discrete portion of a body fluid or tissue or other sample associated with the human body taken for
examination (3.4), study or analysis of one or more quantities or characteristics to determine the character
of the whole
Note 1 to entry: The International Medical Device Regulators Forum (IMDRF) uses the term specimen in its harmonized
guidance documents to mean a sample of biological origin intended for examination by a medical laboratory.

Note 2 to entry: Sample, according to ISO 15189, refers to one or more parts taken from a primary sample. Both
definitions apply to anatomic pathology (AP), but primary sample and sample are often used synonymously. Users
may use the specific term, especially when that distinction is required. Using specimen instead of primary sample or
sample is acceptable.
Note 3 to entry: In AP, a sample is often called a specimen and these words can be considered synonymous.
[SOURCE: ISO 15189:2022, 3.25, modified —Notes 2 and 3 to entry were added.]
4 General requirements
4.1 Anatomic pathology (AP) laboratory
An AP laboratory, like other sections of the medical laboratory, uses materials derived from the human
body for the purpose of providing information for the diagnosis, management, prevention, and treatment
of disease in, or assessing the health of, human beings. The AP laboratory also provides advisory services,
including the interpretation of results and offering advice on further examinations and other appropriate
actions.
AP operates in close association with surgeons and interventionalists who perform operations and obtain
biopsy samples. Surgeons and interventionalists are technical experts who obtain tissue for diagnostic
purposes, but treatment decisions are often made by other members of the healthcare team. Thus, AP has
several users: the patient, the person obtaining the tissue and the person using the tissue examination
results to direct treatment.
The tissue obtained from patients can be used for rendering a diagnosis and also for biomedical research.
Therefore, addressing impartiality, confidentiality and patient needs in AP requires consideration of various
stakeholders (Figure 1). Several interests within and outside the AP laboratory deserve attention when
building the AP management system and risk management plan.
Figure 1 — Outside interests influencing anatomic pathology (AP) processes

4.2 Examples of process actions and risks for general requirements of ISO 15189
Table 1 shows examples of actions that can meet the ISO 15189:2022, Clause 4 requirements as applied to
the AP laboratory’s processes and also shows examples of risks in the AP laboratory for those processes.
NOTE 1 The actions and risks listed here are not comprehensive, but merely examples for guidance. Conformance
with every item in Table 1 does not imply conformance with ISO 15189.
NOTE 2 ISO 22367 provides details for managing risk in medical laboratories.
Table 1 — Examples of process actions and risks for ISO 15189:2022, Clause 4
Actions for process management to meet
ISO 15189:2022 Examples of risks
ISO 15189:2022 requirements
subclause in the AP laboratory
in the AP laboratory
4.1 Impartiality — Manage the professional and personal — Pathologists assuring impartiality can
relationships of personnel with themselves be subject to conflicts of
manufacturers and suppliers of interest.
instruments, reagents, antibodies,
— Research applications or
probes, etc.
methodologies that can
— Assess the influence of the several inappropriately influence patient care.
roles in an academic organization (e.g.
— Purchasing decisions driven by an
research, teaching, clinical care) or
individual instead of a group.
across several organizations on patient
care and take action to remove any
— Financial compensation for expert
conflicts of interest.
witness activity that provides an
incentive for one examination or
diagnosis over another.
— Not removing a pathologist from
a case or project if impartiality is
threatened.
4.2 Confidentiality — Know the contractual arrangements — Security of slide or tissue transport
that allow the laboratory to release between different sites.
confidential information and develop a
— Potential litigation from patient or
process for when and how to notify the
patient advocate when patient samples
patient.
are used without consent.
NOTE Contractual arrangements in AP can be
— Unintended release of patient
a formal or legal arrangement to share
information with research samples.
personal information with research
organizations, insurance companies,
— Consent not retrievable for use of
consultants or other third parties.
materials in the future.
— Remove patient identification from
— Cases or material taken out of
samples (paraffin blocks, slides) that are
the laboratory (e.g. for referral
used for research.
examinations or reporting at another
site or at home) can lead to inadvertent
breach of patient confidentiality if
materials are lost or stolen.
TTabablele 1 1 ((ccoonnttiinnueuedd))
Actions for process management to meet
ISO 15189:2022 Examples of risks
ISO 15189:2022 requirements
subclause in the AP laboratory
in the AP laboratory
4.3 Requirements — Specify who is responsible for acquiring — Prioritizing AP service to the
regarding patients informed consent for the use of samples submitting physician instead of
beyond routine laboratory examinations. service to the patient.
— Specifically include AP in a patient’s — Performance or selection of an
consent for research. examination based on cost or
payment.
— Establish a point of contact for patients
to communicate with AP. — Obtaining referral examinations based
on routines and traditions rather than
— When reviewing examinations for
what is best for the patient.
appropriateness and necessity, include
gross examination (e.g. sampling — Discrimination based on patient
protocols), microscopic examinations ability to pay for examinations.
(e.g. application of interpretive

guidelines and reporting schemes),

and other examinations (e.g. predictive

marker or genomic testing).
— Decide when it is appropriate to disclose
to patients any incidents that resulted or
could have resulted in patient harm.
— Provide reports for patients who have
died since the sample was obtained.
— Share any ethical considerations with
patients.
5 Structural and governance requirements
5.1 Structure of a management system
Two kinds of structures are implied in the management system requirements of ISO 15189:
a) the laboratory’s organizational structure (e.g. leadership, laboratory sections);
b) the structure of the management system.
Organizational structure is often displayed graphically, such as in an organizational chart that shows people
and laboratories connected by lines in a hierarchy.
Management system structure comprises mission and vision statements, policies, objectives, processes, and
procedures. Laboratory management defines the goals in a set of policies. Processes transform the intent
of the policies into actions for the work needed to achieve the objectives. The laboratory’s stated objectives
typically measure progress towards goals to achieve and are the “outcome measures” of laboratory
processes and procedures. Records can provide evidence of whether processes have been implemented and
are effective.
The laboratory can use two kinds of metrics. First, measuring whether the objectives were met indicates the
overall success of the process, but does not detail its functionality. An objective can be met by chance with a
non-functioning process or by process errors that cancel each other. Second, measuring quality indicators at
different stages of the process provides information about process performance.
EXAMPLE Showing that every report includes all immunohistochemical stains performed can tell the laboratory
that the objective was met. However, also showing that half the reports were revised by the pathologist to add missing
stains, shows that the reporting process is flawed, and the reporting of stains is easily missed, resulting in extra work
for the pathologist and introducing unnecessary risks, such as overworked pathologists and inaccurate charging.

Figure 2 shows the hierarchy and relationship between management system components.
Key
process improvement
Figure 2 — Relationship of management system components
5.2 Examples of process actions and risks for structural and governance requirements of
ISO 15189
Table 2 shows examples of actions that would meet the ISO 15189:2022, Clause 5 requirements as applied
to the AP laboratory’s processes and also shows examples of risks in the AP laboratory for those processes.
NOTE 1 The actions and risks listed here are not comprehensive, but merely examples for guidance. Conformance
with every item in Table 2 does not imply conformance with ISO 15189.
NOTE 2 ISO 22367 provides details for managing risk in medical laboratories.

Table 2 — Process actions and risk examples for ISO 15189:2022, Clause 5
Actions for process management to meet
ISO 15189:2022 Examples of risks
ISO 15189:2022 requirements
subclause in the AP laboratory
in the AP laboratory
5.1 Legal entity — Clarify legal responsibilities and — Inaccurate scope stated in the AP
liabilities, including the applicability and license.
extent of the legal relationship of the AP
— Insufficient understanding of AP legal
laboratory with any medical laboratory
responsibilities and liabilities.
or the wider organization.
NOTE  Specifying the intersections of AP
laboratory processes with those of the
hospital or wider organization in legal
relationships and contracts can help
delineate the activities for which the AP
laboratory can be held accountable and
responsible.
5.2 Laboratory — Ensure that the person directing AP — A person without AP education,
director has the appropriate AP education, certification, licensure, or experience
certification, and experience for the AP directing AP services and, therefore,
services provided. potentially not understanding AP
processes or AP risks, process
— Define who is responsible for verifying
problems, and issues.
the personnel qualifications for positions
in histopathology, molecular pathology, — Non-AP laboratory director managing
autopsy, etc. AP personnel without proper
authorization or involvement in
— The laboratory director may delegate the
laboratory operations.
AP service to a qualified and competent
person.
5.3 Laboratory — In the list of provided services, — Potential AP users not aware of
activities include not only general services (e.g. limitations of AP services provided.
examinations, diagnosis, advising
— Not being able to acquire needed
clinicians, treatment planning, test
advisory or interpretive AP services
utilization) but also any specific AP
when timely examination, diagnosis or
specialty services (e.g. neuropathology,
treatment is needed for the patient.
paediatric pathology).
5.4.2 Quality — Document the description of the — Separate, different, and possibly
management structure and management of AP erroneous understandings of AP
services (e.g. in an organization chart). processes.
— Quality management personnel not
given the resources and authority to
change processes.
5.5 Objectives and — Establish who are the users of the — Inability to identify, monitor and
policies AP laboratory: patients, physicians, assess trends in nonconformities that
researchers, screening programs, impact patient safety.
the judicial system, law enforcement,
— Making changes to processes or
insurance companies, businesses
resources that affect other processes
(e.g. for pre-employment testing).
or resources that impact laboratory
— Determine how to handle requests activities and subsequent patient care.
for examinations that do not have a
generally accepted intended use (e.g.
immunohistochemical stains that have
shown a correlation in a retrospective
study but have not been evaluated in a
clinical trial).
— Establish rules for research on archived
samples
TTabablele 2 2 ((ccoonnttiinnueuedd))
Actions for process management to meet
ISO 15189:2022 Examples of risks
ISO 15189:2022 requirements
subclause in the AP laboratory
in the AP laboratory
5.6 Risk management — Apply risk management aligned with the — Risk management that focuses on
principles of ISO 22367. liability and legal complaints following

a nonconformity instead of proactive

NOTE 1  The laboratory director is
risk mitigation.
responsible for the application of

risk management to all aspects of the — Lack of risk management training
laboratory operations. for all personnel who design and

revise laboratory operational and

— Assess the risk of litigation that involves
management processes.
AP examinations and reports.
— Risk management delegated to
— Mitigate risks arising from the manual
personnel unfamiliar with AP
nature of many AP processes, such as
processes and practice who are unable
personnel distraction and tiredness.
to identify hazards or risks.
— Provide risk management training for all
— Leadership that does not emphasize
personnel.
the importance of risk management
and does not provide leadership
NOTE 2  The level of risk management
support for any issue that threatens
training can vary depending on the
effective risk management.
individual’s role and responsibilities.
— Define when a process is deemed
ineffective or improperly implemented.
6 Resource requirements
6.1 Managing personnel in anatomic pathology (AP)
A feature that distinguishes AP from most other medical laboratory disciplines is that examinations are
often performed by humans as opposed to instruments and can be interpretive in nature. Interpretations
entail an amount of subjectivity and variability. Although it is highly desirable (and true in many cases) that
all personnel performing examinations independently arrive at the same result when studying the same
glass slide or digital image, this is not true in a significant subset of samples because several conditions can
show overlapping macroscopic, histopathologic or cytopathologic features. Diagnoses are formulated based
on examination results. Many factors affect examination results and, therefore, also diagnoses, including
application and stringency of diagnostic criteria, training and experience, slide or image quality, availability
of ancillary examinations, clinical history, imaging findings, pre-test probability, current workload,
distractions (e.g. phone calls, frozen sections, colleague requesting consultation) and time of day (e.g. level
of exhaustion, rushing to get case done).
Considerations of workload limits, work environments, resources in the form of books, internet access
and other technologies, effective onboarding, allotting time for continuing education and interaction with
pathologists, technical staff and other colleagues cannot be neglected. The technical staff are responsible
for performing examinations correctly and competently in order to enable the pathologist to render and
report the correct diagnosis for each patient. This can only be achieved with high reliability and low risk in
the proper AP environment.
Figure 3 shows a generic example of how processes and procedures for personnel relate to policies.
NOTE Interpretive examination by a human is not unique to AP but is a feature of all branches of medicine and
is used in other areas of the medical laboratory (e.g. sediment examination in urinalysis, blood smear examination in
haematology, fungal morphology in microbiology).

Figure 3 — Examples of policies, processes and procedures for personnel
6.2 Examples of process actions and risks for resource requirements of ISO 15189:2022
Table 3 shows examples of actions that can meet the ISO 15189:2022, Clause 6 requirements as applied
to the AP laboratory’s processes and also shows examples of risks as they would apply to each respective
AP laboratory for those processes.
NOTE 1 The actions and risks listed here are not comprehensive but merely examples for guidance. Conformance
with every item in Table 3 does not imply conformance with ISO 15189:2022.
NOTE 2 ISO 22367 provides details for managing risk in medical laboratories.
NOTE 3 ISO 15190 provides details for facility and environmental conditions.

Table 3 — Process actions and risks for ISO 15189:2022, Clause 6
Actions for process management to meet
ISO 15189:2022 Examples of risks
ISO 15189:2022 requirements
subclause in the AP laboratory
in the AP laboratory
6.2 Personnel — Clarify AP management and other AP — Lack of clarity for AP personnel
personnel’s availability. regarding their duties so that

important actions are overlooked or

— Ensure current position descriptions
otherwise failed to address.
for each AP position, including the

laboratory director. — Not having appropriate records

(including documented roles/
— Specify any formal arrangement of
responsibilities and training/
personnel who perform at locations
competency records) for all personnel,

other than the AP laboratory, e.g. via
if an examination or diagnostic error
digital pathology, and manage this
occur, or a legal challenge arises.
arrangement appropriately, including
specifying the equipment and IT
connectivity involved.
— Specify any formal arrangement (e.g.
contracts, documentation, logistical
protocols) for personnel who also work
for one or more other laboratories
to prevent risk to the laboratory’s
activities.
— Ensure that external or temporary
personnel also work in accordance with
management system requirements.
— Create a culture of process-based and
risk-based thinking in all AP personnel.
6.2.2 Competence — Ensure that all personnel performing — Incorrect diagnoses rendered from
examinations or rendering diagnoses anatomic and cytopathic examinations
are trained, competent and authorized when there is no means to assess
to perform examinations or render ongoing competence or unrecognized
diagnoses. deviations from the documented
competence requirements.
— Specify the required competence
levels of all AP personnel, including AP — Lack of cause analysis for examination
personnel who perform examinations on and diagnosis nonconformities that
AP and cytopathology samples and AP are attributed to individual personnel.
personnel who render diagnoses based
— Failure to include education and
on AP and cytopathology examinations.
training about the laboratory
— Assess and ensure the ongoing management system and quality
competence of all AP personnel, control processes in the onboarding
including AP personnel who perform process.
examinations on AP and cytopathology

samples and AP personnel who
render diagnoses based on AP and

cytopathology examinations.
TTabablele 3 3 ((ccoonnttiinnueuedd))
Actions for process management to meet
ISO 15189:2022 Examples of risks
ISO 15189:2022 requirements
subclause in the AP laboratory
in the AP laboratory
6.2.2 Competence — Document the plan of action for any
AP personnel, including AP personnel

who perform examinations on AP and

cytopathology samples and AP personnel

who render diagnoses based on AP and

cytopathology examinations, when
there are significant deviations from the
documented competence requirements.
— Consider not only technical competence
but also competence in meeting
management system requirements.
— Document the plan for action for any AP
personnel when there are significant
periods of time where an individual is
not practicing (e.g. maternity leave, long-
term sickness).
6.2.4 Continuing — Provide or allow for continuing — Lack of knowledge about or application
education and education and professional of new and emerging technologies
professional development of personnel performing and methods that would improve
development AP examinations and for personnel processes and services to patients or
rendering AP or cytopathology users.
diagnoses.
— No opportunities for continuing
NOTE  Continuing education can be obtained education for some personnel because
in person or virtually, when appropriate. others attend too often, or the budget
is distributed unequally.
— Not allowing for continuing education
and professional development
in quality management and risk
management for all personnel.
— Continuing education and professional
development programs not monitored
for effectiveness.
6.3 Facilities and — Provide designated areas for storage of — Inadequate separation of AP work
environmental samples pre- and post-dissection and areas causing cross-contaminations
conditions processing, gross dissection and tissue that can result in erroneous
processing. examinations and misdiagnoses.
— Separate the slide reading areas from — Distractions arising from inadequate
the technical processing areas. separation of microscope reading
areas from technical areas causing
— Establish control of access to
mis-readings that can generate
pathologists’ and other offices and slide
misdiagnoses.
and paraffin archives.
— Inappropriate access of personnel to
— Locate the morgue (mortuary) in an area
the morgue causing problems with
away from routine AP activities.
how remains are treated.
TTabablele 3 3 ((ccoonnttiinnueuedd))
Actions for process management to meet
ISO 15189:2022 Examples of risks
ISO 15189:2022 requirements
subclause in the AP laboratory
in the AP laboratory
6.3 Facilities and — Ensure access to the area for temporary — Proximity of morgue activities (e.g.
environmental storage of tissues removed during flow of removal of remains) causing
conditions surgery until transportation to the AP distractions to attention to the
laboratory only by authorized personnel technical work.
and ensure this area has the appropriate
— Inadequacies of temporary storage
environmental conditions and that these
areas causing:
conditions are monitored.
— Sample mishandling
— Provide guidance for those managing
temporary sample storage areas.
— Inadvertent or deliberate
adulteration
NOTE  Morgues can be considered
temporary storage areas.
— Storage conditions that affect
sample quality
— Monitor formalin, xylene and other
chemical exposure levels in the areas
— Sample loss
of highest exposure risk (e.g. dissection
room, tissue processing area, bulk
— Safety hazards causing either
chemical storage area).
personnel slips or falls, or both, when
working in the AP areas or walking
— Develop specific instructions for
through them.
cleaning laboratory areas that might
be contaminated with paraffin wax,
— Adverse health effects of aerosol
including the floors near tissue
inhalation.
processors, embedding stations and
microtomes.
— Adverse health effects of AP personnel
exposures to toxic chemicals (e.g.
— Ensure that AP waste management
staining chemicals, formalin, xylene),
follows required biohazard controls,
radiation and infectious agents.
including those for radioactive materials.
— Follow radiation control measures when
X-rays are used in the AP laboratory and

when potentially radioactive samples

are received.
— Evaluate the risk of personnel attending
radiology procedures and being exposed
to radiation.
— Specify the storage and transport
requirements for paraffin blocks and
glass slides at off-site storage spaces.
— Establish the specific storage and
transport requirement for all samples,
including fresh and fixed tissue, cytology
fluid samples, and paraffin embedded
tissue (e.g. no shipping without ice to
high temperature environments).
— Conduct fine needle aspiration clinics for
accompanying care partners.
— Develop the process for managing
visits to the autopsy suite by family,
other persons with interest, and law
enforcement personnel.
TTabablele 3 3 ((ccoonnttiinnueuedd))
Actions for process management to meet
ISO 15189:2022 Examples of risks
ISO 15189:2022 requirements
subclause in the AP laboratory
in the AP laboratory
6.4 Equipment — Provide instructions and create — Improper equipment maintenance
records for installation, operational, leading to unavailability for AP

and performance qualifications of all procedures and services.

equipment, instruments, computer
— Inaccurate measurements of the tissue
systems (including digital pathology).

being examined from uncalibrated or

— Create schedules for, and records of, mis calibrated ocular micrometres (or
calibrations of measuring instruments mis calibrated microscope cameras if
as well as for in-house cleaning and measurements are done digitally).

externally provided preventive
— Contamination from wax trimmings
maintenance.
containing small amounts of tissue or
— Train all AP personnel on, and authorize cells.
their use of, AP equipment and
— Failure to consider computer software
instruments in their respective jobs.
as part of the equipment.
— Calibrate ocular micrometres used
on microscopes; ensure length
measurement using digital cameras or
on digital pathology slides are accurate
(e.g. for measuring depth of invasion).
— Ensure monitors used for digital
pathology slide review have suitable
display, resolution, brightness and
contrast, and that the AP laboratory is
aware of, and considers, any differences
between monitors used by different
personnel.
— Although AP testing might not allow
metrological traceability to reduce
between-method variability, be aware
of such variability and mitigate the risk
for patients and users arising from such
variability.
— Remove wax build-up from all
equipment, including histology
microtomes and microscopes.
— Remove mounting compound and tissue
shavings from cryostats and frozen
section area microscopes.
TTabablele 3 3 ((ccoonnttiinnueuedd))
Actions for process management to meet
ISO 15189:2022 Examples of risks
ISO 15189:2022 requirements
subclause in the AP laboratory
in the AP laboratory
6.6 Reagents and — Follow all specified manufacturer and — Selection of reagents based on price
consumables laboratory requirements for purchased without considering performance
and in-house prepared reagents and characteristics.
chemicals.
— Lack of complete records of reagent
— Verify the performance of each new management, resulting in inability
formulation or lot of reagents before to thoroughly investigate staining
use or before release
...