GB/T 43278-2023 Medical laboratories - Application of risk management to medical laboratories
1 Scope
This document specifies a process for a medical laboratory to identify and manage the risks to patients, laboratory workers and service providers that are associated with medical laboratory examinations. The process includes identifying, estimating, evaluating, controlling and monitoring the risks.
The requirements of this document are applicable to all aspects of the examinations and services of a medical laboratory, including the pre-examination and post-examination aspects, examinations, accurate transmission of test results into the electronic medical record and other technical and management processes described in ISO 15189.
This document does not specify acceptable levels of risk.
This document does not apply to risks from post-examination clinical decisions made by
healthcare providers.
This document does not apply to the management of risks affecting medical laboratory enterprises that are addressed by ISO 31000, such as business, economic, legal, and regulatory risks.
2 Normative references
There are no normative references in this document.
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
——ISO Online browsing platform: available at https://www.iso.org/obp
——IEC Electropedia: available at http://www.electropedia.org/
3.1
benefit
impact or desirable outcome of a process (3.19), procedure (3.17) or the use of a medical device on the health of an individual or a positive impact on patient management or public health
Note: Benefits include prolongation of life, reduction of pain, (relief of symptoms), improvement in function, or an increased sense of well-being.
3.2
event
occurrence or change of a particular set of circumstances
Note 1: An event can be one or more occurrences, and can have several causes.
Note 2: An event can consist of something not happening.
Note 3: An event can sometimes be referred to as an “incident” or “accident”.
Note 4: An event without consequences can also be referred to as a “near miss”, “incident”, “near hit” or “close call”.
[SOURCE: GB/T 23694-2013, 4.5.1.3]
3.3
examination
set of operations having the object of determining the value or characteristics of a property
Note 1: In some disciplines (e.g., microbiology) an examination is the total activity of a number of tests, observations or measurements.
Note 2: Laboratory examinations that determine a value of a property are called quantitative examinations; those that determine the characteristics of a property are called qualitative examinations.
Note 3: Laboratory examinations are also often called assays or tests.
[SOURCE: GB/T 22576.1-2018, 3.7]
3.4
frequency
number of events (3.2) or outcomes per defined unit of time
Note: Frequency can be applied to past events (3.2) or to potential future events (3.2), where it can be used as a measure of likelihood or probability (3.18)
[SOURCE: GB/T 23694-2013, 4.6.1.5]
3.5
harm
injury or damage to the health of people, or damage to property or the environment
[SOURCE: ISO/IEC Guide 51:2014, 3.1]
3.6
hazard
source of potential harm (3.5)
[SOURCE: GB/T 23694-2013, 4.5.1.4]
3.7
hazardous situation
circumstance in which people, property, or the environment are exposed to one or more hazard(s) (3.6)
[SOURCE: ISO/IEC Guide 51:2014, 3.4]
3.8
healthcare provider
individual authorized to deliver health services to a patient
EXAMPLE: Physician, nurse, ambulance attendant, dentist, diabetes educator, laboratory technician, laboratory technologist, biomedical laboratory scientist medical assistant, medical specialist, respiratory care practitioner.
[SOURCE: GB/T 29791.1-2013, 3.23]
3.9
in vitro diagnostic manufacturer
IVD manufacturer
natural or legal person with responsibility for the design, manufacture, packaging, or labelling (3.12) of an IVD medical device (3.10), assembling a system, or adapting an IVD medical device (3.10)before it is placed on the market or put into service, regardless of whether these operations are carried out by that person or on that person's behalf by a third party
Note: Provisions of national or regional regulations can apply to the definition of manufacturer.
[SOURCE: YY/T 0316-2016, 2.8, modified – “manufacturer” has been changed to “in vitro diagnostic manufacturer”.“A medical device” has been changed to “an IVD medical device” (3.10). “Attention is drawn to the fact that” has been deleted in Note 1. In addition, Note 2 has been deleted.]
3.10
in vitro diagnostic medical device
IVD medical device
device, whether used alone or in combination, intended by the manufacturer for the in vitro examination (3.3) of specimens derived from the human body solely or principally to provide information for diagnostic, monitoring or compatibility purposes and including reagents, calibrators, control materials, specimen receptacles, software, and related instruments or apparatus or other articles
[SOURCE: GB/T 29791.1-2013, 3.27]
3.11
in vitro diagnostic instrument
IVD instrument
equipment or apparatus intended by a manufacturer to be used as an IVD medical device
[SOURCE: GB/T 29791.1-2013, 3.26]
3.12
information supplied by the manufacturer
labelling
written, printed or graphic matter
——affixed to an IVD medical device or any of its containers or wrappers or
——provided for use with an IVD medical device (3.10),
related to identification and use, and giving a technical description, of the IVD medical device, but excluding shipping documents
EXAMPLE: Labels, instructions for use (3.13).
Note 1: In IEC standards, documents provided with a medical device and containing important information for the responsible organization or operator, particularly regarding safety, are called “accompanying documents”.
Note 2: Catalogues and material safety data sheets are not considered labelling of IVD medical devices (3.10).
[SOURCE: GB/T 29791.1-2013, 3.29]
3.13
instructions for use
information supplied by the manufacturer to enable the safe and proper use of an IVD medical device (3.10)
Note: Includes the directions supplied by the manufacturer for the use, maintenance, troubleshooting and disposal of an IVD medical device (3.10), as well as warnings and precautions.
[SOURCE: GB/T 29791.1-2013, 3.30]
Standard
GB/T 43278-2023 Medical laboratories—Application of risk management to medical laboratories (English Version)
Standard No.
GB/T 43278-2023
Status
valid
Language
English
File Format
PDF
Word Count
33000 words
Price(USD)
990.0
Implemented on
2024-6-1
Delivery
via email in 1~3 business day
Detail of GB/T 43278-2023
Standard No.
GB/T 43278-2023
English Name
Medical laboratories—Application of risk management to medical laboratories
GB/T 43278-2023 Medical laboratories - Application of risk management to medical laboratories
1 Scope
This document specifies a process for a medical laboratory to identify and manage the risks to patients, laboratory workers and service providers that are associated with medical laboratory examinations. The process includes identifying, estimating, evaluating, controlling and monitoring the risks.
The requirements of this document are applicable to all aspects of the examinations and services of a medical laboratory, including the pre-examination and post-examination aspects, examinations, accurate transmission of test results into the electronic medical record and other technical and management processes described in ISO 15189.
This document does not specify acceptable levels of risk.
This document does not apply to risks from post-examination clinical decisions made by
healthcare providers.
This document does not apply to the management of risks affecting medical laboratory enterprises that are addressed by ISO 31000, such as business, economic, legal, and regulatory risks.
2 Normative references
There are no normative references in this document.
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
——ISO Online browsing platform: available at https://www.iso.org/obp
——IEC Electropedia: available at http://www.electropedia.org/
3.1
benefit
impact or desirable outcome of a process (3.19), procedure (3.17) or the use of a medical device on the health of an individual or a positive impact on patient management or public health
Note: Benefits include prolongation of life, reduction of pain, (relief of symptoms), improvement in function, or an increased sense of well-being.
3.2
event
occurrence or change of a particular set of circumstances
Note 1: An event can be one or more occurrences, and can have several causes.
Note 2: An event can consist of something not happening.
Note 3: An event can sometimes be referred to as an “incident” or “accident”.
Note 4: An event without consequences can also be referred to as a “near miss”, “incident”, “near hit” or “close call”.
[SOURCE: GB/T 23694-2013, 4.5.1.3]
3.3
examination
set of operations having the object of determining the value or characteristics of a property
Note 1: In some disciplines (e.g., microbiology) an examination is the total activity of a number of tests, observations or measurements.
Note 2: Laboratory examinations that determine a value of a property are called quantitative examinations; those that determine the characteristics of a property are called qualitative examinations.
Note 3: Laboratory examinations are also often called assays or tests.
[SOURCE: GB/T 22576.1-2018, 3.7]
3.4
frequency
number of events (3.2) or outcomes per defined unit of time
Note: Frequency can be applied to past events (3.2) or to potential future events (3.2), where it can be used as a measure of likelihood or probability (3.18)
[SOURCE: GB/T 23694-2013, 4.6.1.5]
3.5
harm
injury or damage to the health of people, or damage to property or the environment
[SOURCE: ISO/IEC Guide 51:2014, 3.1]
3.6
hazard
source of potential harm (3.5)
[SOURCE: GB/T 23694-2013, 4.5.1.4]
3.7
hazardous situation
circumstance in which people, property, or the environment are exposed to one or more hazard(s) (3.6)
[SOURCE: ISO/IEC Guide 51:2014, 3.4]
3.8
healthcare provider
individual authorized to deliver health services to a patient
EXAMPLE: Physician, nurse, ambulance attendant, dentist, diabetes educator, laboratory technician, laboratory technologist, biomedical laboratory scientist medical assistant, medical specialist, respiratory care practitioner.
[SOURCE: GB/T 29791.1-2013, 3.23]
3.9
in vitro diagnostic manufacturer
IVD manufacturer
natural or legal person with responsibility for the design, manufacture, packaging, or labelling (3.12) of an IVD medical device (3.10), assembling a system, or adapting an IVD medical device (3.10)before it is placed on the market or put into service, regardless of whether these operations are carried out by that person or on that person's behalf by a third party
Note: Provisions of national or regional regulations can apply to the definition of manufacturer.
[SOURCE: YY/T 0316-2016, 2.8, modified – “manufacturer” has been changed to “in vitro diagnostic manufacturer”.“A medical device” has been changed to “an IVD medical device” (3.10). “Attention is drawn to the fact that” has been deleted in Note 1. In addition, Note 2 has been deleted.]
3.10
in vitro diagnostic medical device
IVD medical device
device, whether used alone or in combination, intended by the manufacturer for the in vitro examination (3.3) of specimens derived from the human body solely or principally to provide information for diagnostic, monitoring or compatibility purposes and including reagents, calibrators, control materials, specimen receptacles, software, and related instruments or apparatus or other articles
[SOURCE: GB/T 29791.1-2013, 3.27]
3.11
in vitro diagnostic instrument
IVD instrument
equipment or apparatus intended by a manufacturer to be used as an IVD medical device
[SOURCE: GB/T 29791.1-2013, 3.26]
3.12
information supplied by the manufacturer
labelling
written, printed or graphic matter
——affixed to an IVD medical device or any of its containers or wrappers or
——provided for use with an IVD medical device (3.10),
related to identification and use, and giving a technical description, of the IVD medical device, but excluding shipping documents
EXAMPLE: Labels, instructions for use (3.13).
Note 1: In IEC standards, documents provided with a medical device and containing important information for the responsible organization or operator, particularly regarding safety, are called “accompanying documents”.
Note 2: Catalogues and material safety data sheets are not considered labelling of IVD medical devices (3.10).
[SOURCE: GB/T 29791.1-2013, 3.29]
3.13
instructions for use
information supplied by the manufacturer to enable the safe and proper use of an IVD medical device (3.10)
Note: Includes the directions supplied by the manufacturer for the use, maintenance, troubleshooting and disposal of an IVD medical device (3.10), as well as warnings and precautions.
[SOURCE: GB/T 29791.1-2013, 3.30]
