ISO/FDIS 20364

ISO/TC 304
Secretariat: KATS
Date: 2025-12-04
Healthcare organization management — Pandemic response —
Requirements for surging diagnostic demand
FDIS stage
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ii © ISO #### 2025 – All rights reserved
ii
Contents
Foreword . iv
Introduction . v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Mitigating threats encountered in providing diagnostic services . 5
4.1 Threats encountered . 5
4.2 Supply chain disruption of resources for diagnostic testing . 6
4.3 Shortage of laboratory personnel . 7
4.4 Health and safety of healthcare workers . 7
5 Quality assurance . 8
5.1 Responsibility . 8
5.2 Collaborative response with the stakeholders . 9
5.3 Advisory committee . 10
5.4 Emergency-use IVD medical devices . 12
6 Response to the surge in diagnostic demand . 14
6.1 Strategy to maximize the workforce . 14
6.2 Strategy to maximize capacity to conduct diagnostic tests . 14
Bibliography . 16

iii
Foreword
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iv © ISO #### 2025 – All rights reserved
iv
Introduction
Diagnostic testing plays a critical role in triaging patients, making informed treatment decisions, enabling
contact tracing, and carrying out epidemiological studies for policy making. During the mid to later phases
ofDuring the COVID-19 pandemic, the demand for diagnostic testing increased with the reopening of
[1][1]
economies and businesses when large-scale testing of the asymptomatic population was required. .
The surging demand for diagnostic testing in a pandemic poseposes challenges in human resourcesresource
capacity and supply chain management, not only within diagnostic laboratories but also within entire
healthcare organizations. Healthcare organizations haveThe increased workload on existing limited numbers
of laboratory personnel and skilled laboratory professionals for performingto perform diagnostic testing
which can lead to staff burn-out related to the delivery of diagnostic services (e.g., specimen collection,
examination, interpretation). The overworking and burn-out of staff, which can also impact the accuracy of
testing and the turn-around time (TAT) of test results.
Lengthy TAT, in turn, leads to overcrowding in units for persons under evaluation for highly infectious
diseases, as well as. Similarly, this generates significant delays in patient care for patients who need emergency
care for patients with infectious pandemic symptoms and patients under investigation for non-pandemic-
[2,3] [2,3]
related symptoms (e.g.,. acute stroke care, and emergency operation). ) . Moreover, increased TAT for the
pandemic infectious agent can also impact the performance and TAT of other routine laboratory functions,
[4][4]
including the testing of critically ill patients. . Accurate test results with rapid TAT are crucial for successful
[5][5]
intervention and care within a pandemic response. . All of these factors can contribute to global disruption
in the provision of healthcare services and patient flow within a healthcare organization, leading to patient
overload in the emergency department and intensive care unit and subsequently prolonging the length of
[3] [3]
hospital stay. stays .
The solution to the above challenges normally should be to increase laboratory capacity. However, increasing
the laboratory capacity abruptly is not feasible within a short timeframe, leadingtime frame, which can lead
to a more challenging situation. Healthcare organizations need to find alternative solutions to address the
surging diagnostic demand by optimizing available resources and overcoming the limitations set by
laboratory capacity.
This document aims to strengthen the capabilities for responding to surging diagnostic demand in upcoming
pandemics. The standardThis document is based on the experiences of different countries in previous
pandemics –, particularly, COVID-19 –, including lessons learnedlearnt. It suggests innovative approaches to
meet the surging demand for medical testing services that maycan occur in any future pandemic. A
standardized framework for healthcare organizations to follow during a pandemic can facilitate a more
effective pandemic response and may engendercan enhance public trust in healthcare organizations’ response
to the pandemic. In any future pandemic, healthcare organizations may need to modify the requirement
specified in this document based on policy and reporting directives of jurisdictional authorities responsible
for pandemic response management.
v
Final draft International Standard ISO/FDIS 20364:2025(en)

Healthcare organization management — Pandemic response —
Requirements for surging diagnostic demand
1 Scope
This document provides guidance and considerationsoutlines requirements for healthcare organizations to
deliver diagnostic tests timely and accurately in a pandemic by leveraging innovative approaches to overcome
the limitations of laboratory capacity as follows:
— — mitigation of threats encountered in providing diagnostic services during a pandemic;
— — consideration for quality assurance of diagnostic service provision in a pandemic context;
— — possible response measures to the surge in diagnostic demand.
This document does not cover the specific procedures involved in providing pandemic-response medical tests,
such as the specimen collection protocols in the specimen collection units or screening stations (e.g.,. walk-
through or drive-through), experimental procedures, and the quality management systems of medical
laboratories. Furthermore, this document omitsdoes not address the pandemic responses related to the
medical treatment of infected patients in care units (e.g.,. emergency unit, and in-patient unit) and the
transferring of confirmed patients within the healthcare organization during a pandemic.
2 Normative references
There are no normative references in this document.
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 following terms and definitions 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
accuracy
closeness of agreement between a measured quantity value and a true quantity value of the measurand
Note 1 to entry: The concept “measurement accuracy” is not a quantity and is not given a numerical quantity value. A
measurement is said to be more accurate when it offers a smaller measurement error.
Note 2 to entry: The term “measurement accuracy” should not be used for measurement trueness and the term
“measurement precision” should not be used for measurement accuracy, which, however, is related to both these
concepts.
Note 3 to entry: Measurement accuracy is sometimes understood as closeness of agreement between measured quantity
values that are being attributed to a measurand.
[SOURCE: ISO 18113-1:2022, 3.2.27, modified — The preferred term "“measurement accuracy"” and Note 4
to entry have been deleted.]
3.2
adverse event
any untoward medical occurrence, inappropriate patient management decision, unintended disease or injury,
or untoward clinical signs in subjects, users, or other persons, with any connection to study related activities,
whether or not related to the in vitro diagnostic (IVD) medical device under investigation
Note 1 to entry: Adverse events can be caused by, for instance, insufficient or inadequate instructions for use,
deployment, installation, operation, or any malfunction of the IVD medical device under investigation.
Note 2 to entry: This definition includes the malfunction or deterioration of a device which has not yet caused death or
serious injury, but which could lead to death or serious injury.
Note 3 to entry: This definition is not intended to be used in determining whether an event is reportable to a regulatory
authority.
Note 4 to entry: For users or other persons, this definition is restricted to events related to investigational (IVD) medical
devices.
Note 5 to entry: False negative or false-positive results are not considered an adverse event unless in an interventional
study, inappropriate patient management decisions are made based on those false results.
[SOURCE: ISO 20916:2019, 3.2, modified — The abbreviation "abbreviated term “AE"” has been removed
fromdeleted as the preferred term.]
3.3
emergency-use in vitro diagnostic medical devices
emergency-use -IVD medical device
in vitro diagnostic medical device(s) (3.6)(3.6) which are urgently permitted to introducebe introduced or use
(used in) the market under minimum requirements or fast audit programprograms in disaster situations, such
as pandemic (3.9)(3.9) infectious diseases
3.4
external quality assessment
EQA
proficiency testing
PT
international, national or local program designed to provide regular, external, independent quality assessment
of a medical laboratory’s analytical performance, and assist in detecting bias of reported results compared to
other laboratories
Note 1 to entry: Also known as Proficiency Testing (PT).
Note 2 to entry: EQA is the term used in this document.
[SOURCE: ISO/TS 20914:2019, 3.10], modified —The admitted terms "proficiency testing" and "PT" have been
added and notes to entry deleted.]
3.5
false-negative result
negative result by the tested method that is actually confirmed as a positive result
[SOURCE: ISO 16140-1:2016, 2.23]
3.6
in vitro diagnostic medical device
IVD medical device
medical device, whether used alone or in combination, intended by the manufacturer for the in vitro
examination of specimens derived from the human body solely or principally to provide information for
diagnostic, monitoring or compatibility purposes
Note 1 to entry: IVD medical devices include reagents, calibrators, control materials, specimen receptacles, software, and
related instruments or apparatus, or other articles and are used, for example, for the following test purposes: diagnosis,
aid to diagnosis, screening, monitoring, predisposition, prognosis, prediction, determination of physiological state.
Note 2 to entry: In some jurisdictions, certain IVD medical devices can be covered by other regulations.
[SORUCESOURCE: ISO 18113-1:2022,3.1.33]
3.7
internal quality control
IQC
set of procedures and specified materials used by laboratory staff for the repetitive monitoring of analytical
performance of measuring systems
[SOURCE: ISO/TS 20914:2019, 3.13]
3.8
medical laboratory
laboratory
entity for the examination of materials derived from the human body for the purpose of providing information
for the diagnosis, monitoring, management, prevention and treatment of disease, or assessment of health
Note 1 to entry: The laboratory can also provide advice covering all aspects of examinations including appropriate
selection, the interpretation of results and advice on further examinations.
Note 2 to entry: Laboratory activities include pre-examination, examination and post-examination processes.
Note 3 to entry: Materials for examination include but are not limited to, microbiological, immunological, biochemical,
immunohaematological, haematological, biophysical, cytological, tissue and cells, and genetic material.
[SOURCE: ISO 15189:2022, 3.20]
3.9
pandemic
worldwide spread of a disease
[SOURCE: ISO/PAS 45005:2020, 3.5]
3.10
point-of-care testing
POCT
examination performed near or at the site of a patient
[SOURCE: ISO 15189:2022, 3.22]
3.11
referral laboratory
external laboratory to which a sample or data is submitted for examination
Note 1 to entry: A referral laboratory is one to which laboratory management chooses to submit a sample or sub-sample
for examination, data for analysis or interpretation, or when routine examinations cannot be carried out.
Note 2 to entry: This differs from a laboratory to which submission of samples is required by regulation, or a so-called
reference laboratory, e.g.,. public health, forensic, tumour registry, or a central (parent) facility to which submission of
samples is required by structure.
[SOURCE: ISO 15189:2022, 3.27]
3.12
risk management
systematic application of management policies, procedures and practices to the tasks of analysing, evaluating,
controlling and monitoring risk
[SOURCE: ISO/IEC Guide 63:2019, 3.15]
3.13
specimen
discrete portion of a body fluid or tissue or other sample associated with the human body taken for
examination, 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 Forummedical 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.
[SOURCE: ISO 15198 15189:2022, 3.25, modified — the preferred term 'primary sample'"primary sample"
has been deleted.]
3.14
stakeholder
person or organization that can affect, be affected by, or perceive themselves to be affected by a decision or
activity
Note 1 to entry: A decision maker can be a stakeholder.
[SOURCE: ISO 22367:2020, 3.39]
3.15
turn-around time
TAT
time interval between the specimens receivedspecimen arrival in the laboratory to and the reporting of the
time of reports dispatched with verificationverified result
3.16
validation
verification (3.17)(3.17) that the specified requirements are adequate for an intended use
EXAMPLE : A measurement procedure for creatinine concentration in human serum can also be validated for the
measurement of creatinine concentration in human urine.
Note 1 to entry: ISO 9000:2015, definition 3.8.13, defines validation as confirmation, through the provision of objective
evidence that the requirements for a specific intended use or application have been fulfilled.
[SOURCE: ISO 18113-1:2022, 3.1.91]
3.17
verification
provision of objective evidence that a given item fulfils specified requirements
EXAMPLE 1 : Confirmation that a given reference material, as claimed, is homogeneous for the quantity value and
measurement procedure concerned, down to a measurement portion having a mass of 10 mg.
EXAMPLE 2 : Confirmation that performance properties or legal requirements of a measuring system are achieved.
EXAMPLE 3 : Confirmation that a target measurement uncertainty can be met.
Note 1 to entry: The item can be, e.g.,. a process, measurement procedure, material, compound or measuring system.
Note 2 to entry: The specified requirements can be, e.g.,. that a manufacturer’s claims or specifications are met.
Note 3 to entry: In legal metrology, verification pertains to the examination and marking, and/or the issuing of a
verification certificate for a measuring instrument, or any combination thereof.
Note 4 to entry: Verification should not be confused with calibration or validation (3.16).(3.16).
Note 5 to entry: In chemistry, the verification of the identity of the entity involved, or of the activity, requires a description
of the structure or properties of that entity or activity.
Note 6 to entry: ISO 9000:2015, 3.8.12, defines verification as confirmation, through the provision of objective evidence
that specified requirements have been fulfilled.
[SOURCE: ISO 18113-1:2022, 3.1.92] modified — “and/or” has been replaced with “or any combination
thereof” in Note 3 to entry, and the articles "the" have been added to Notes 3 and 5 to entry.]
4 Mitigating threats encountered in providing diagnostic services
4.1 Threats encountered
4.1.1 Identification of threats
The healthcare organization shall be aware of possible threats that can be encountered in the process of
providing diagnostic services during a pandemic.
The threats shall include but are not limited toat least the following:
— — shortage of IVD medical devices including equipment, consumables and reagents;
— — shortage of personal protective equipment (PPE);
— — limited availability of skilled laboratory professionals;
— — deterioration of the accuracy and quality of test results due to overworking of healthcare workers;
— — prolonged turn-around time (TAT) of both pandemic and non-pandemic related medical tests;
— — infection of diagnostic service providers becoming infected bywith a pandemic disease leading to a
greater shortage of service providers.
4.1.2 Establishment of a threat mitigation plan
The healthcare organization shall develop a plan to mitigate possible threats.
The plan shall include but is not limited toat least the following:
— implementing measures to ensure the health and safety of workers and patients;
— providing training and education for workers to prepare and respond for a pandemic;
— developing strategies for stockpiling and emergency procurement of resources such as PPE and IVD
medical devices, including equipment, consumables and reagents;
— implementing quality assurance measures;
— maintaining the safety requirements of the medical laboratory and developing standard operating
procedures (SOPs) for managing the increased volume of hazardous and non-hazardous healthcare waste;
— developing effective communication strategies with external organizations.
NOTE 1 The healthcare organization can refer to ISO 15189 for information on continuity and emergency
[6]
preparedness planning in the medical laboratory. .
NOTE 2 The healthcare organization can refer to ISO 15190 for information on maintaining the safety requirements
[7][13]
of the medical laboratory. .
NOTE 3 The healthcare organization can refer to ISO 7101 for information on communication, risk management,
[8][14]
contingency planning and waste management processes. .
4.2 Supply chain disruption of resources for diagnostic testing
4.2.1 Supply chain integrity
The healthcare organization shall establish a plan to maintain the continuity of the diagnostic services.
The healthcare organization shall identify the stakeholders who need to cooperate outside the organization
(e.g.,. IVD manufacturers and suppliers) and review its supply chain's integrity to provide uninterrupted
pandemic-response medical tests.
NOTE 1 Surging diagnostic demands can exacerbate not only staffing shortages but also shortages of relevant medical
devices and PPE supplies.
NOTE 2 Strong, proactive collaboration between the healthcare organization and the manufacturers of various
products is needed proactivelycan help maintain supply chain integrity before the onset of a declared pandemic, as well
as during a pandemic crisis to maintain supply chain integrity.
4.2.2 Supply chain expansion
The healthcare organization shall identify additional relevant suppliers of IVD medical devices and PPE to
meet the surging demand of diagnostic testing.
NOTE During the diagnostic surge, usual suppliers of the healthcare organization cannot provide enough supply of
IVD medical devices and PPE. In this situation, the healthcare organization can purchase from additional relevant
suppliers.
4.2.3 Test reliability
The healthcare organization shall ensure that measures taken to maintain supply chain integrity do not harm
the reliability of diagnostic services.
4.3 Shortage of laboratory personnel
4.3.1 General
The healthcare organization shall address the possible shortage of laboratory personnel to provide diagnostic
tests for a pandemic in advance of pandemic onset.
NOTE The healthcare organization can consider cross-training staff to work in multiple departments to relieve the
shortage of laboratory personnel in a pandemic.
The healthcare organization shall ensure cross-trained staff are competent, qualified and have adequate
biosafety knowledge.
[6] [7][13]
NOTE The healthcare organization can refer to ISO 15189 and ISO 15190 for information on competence,
qualification and safety requirements in the medical laboratory.
4.3.2 Continuity of test service provision
The measures to maintain the continuity of diagnostic services for a pandemic disease shouldshall not hinder
the diagnostic services of other endemic diseases.
NOTE During surging diagnostic demand in a pandemic, allocating all laboratory personnel to performing pandemic-
response medical tests can cause a deterioration in diagnostic service delivery for other non-pandemic related tests.
4.3.3 Quality assurance
51 Quality assurance
The healthcare organization shall ensure that the increase in workload of laboratory personnel does not lead
to a decline in the quality of laboratory tests.
Contingency planning shall include but is not limited toat least the following:
— referring tests unrelated to the pandemic to referral laboratories (see 6.1.1); 6.1.1);
— reallocating tasks within the healthcare organization (see 6.1.2).6.1.2).
NOTE During a pandemic, healthcare organizations experience surging demand for pandemic-response medical
tests, which can lead to the burn-out of staff related todealing with diagnostic service delivery (e.g.,. specimen collection,
examination, and interpretation). The overworking of staff can affect not only the accuracy and TAT of test results but
also the mental and physical well-being of staff.
5.14.4 Health and safety of healthcare workers
...