Standard No.:	GB/Z 43281-2023
English Name:	Guidance for supervisors and operators of point-of-care testing(POCT) devices
Chinese Name:	即时检验（POCT）设备监督员和操作员指南
Chinese Classification:	C30    Medical apparatus and devices in general
Professional Classification:	GB    National Standard
Issued by:	SAMR; SAC
Issued on:	2023-11-27
Implemented on:	2024-6-1
Status:	valid
Language:	English
File Format:	PDF
Word Count:	16500 words
Price(USD):	495.0
Delivery:	via email in 1~3 business day

GB/Z 43281-2023 Guidance for supervisors and operators of point-of-care testing (POCT) devices 1 Scope This document gives guidance for supervisors and operators of point-of-care testing (POCT) services where POCT is performed without medical laboratory training, supervision or support. It includes the key components that should be considered to provide safe and reliable POCT results. Self-testing is excluded from this document. 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 analyte item that is being measured, tested or calculated Example: Glucose, troponin, concaine, HIV antibodies. 3.2 biological reference interval reference range normal range normal value specified interval of the distribution of values taken from a biological reference population Note 1: A reference interval is composed of the values or range for an analyte (3.1) that are expected for a “healthy person”. They are sometimes called "normal" values. Whilst “normal” ranges can give an indication about the wellbeing of a patient (3.10), things which should be considered are that a result within the “normal” range does not necessarily mean the patient (3.10) is healthy, or a result outside of the “normal” range does not necessarily mean the patient (3.10) is unhealthy. It is also important to note that “normal ranges” can differ from equipment (3.6) to equipment and population to population. Note 2: In some cases, such as drugs of abuse testing the normal value should be negative or not detected. [SOURCE: GB/T 22576.1-2018, 3.4, modified.] 3.3 clinical handover patient handover handover transfer of professional responsibility and accountability for some or all aspects of care for a patient (3.10) to another person or professional group on a temporary or permanent basis Note 1: Transferring all or part of a patient’s (3.10) care between healthcare providers or locations is a high-risk situation and a failure in clinical handover is a major source in preventable patient (3.10) harm. Note 2: Effective clinical handover, which is structured and standardised, can reduce communication errors and improve patient (3.10) safety. Note 3: A simple example: of clinical handover is ensuring critical result notification to an appropriate person is performed in a timely manner to minimise harm to the patient (3.10). 3.4 competence demonstrated ability to apply knowledge and skills to produce an accurate POCT result [SOURCE: GB/T 22576.1-2018, 3.5, modified.] 3.5 critical results results outside defined limits which may indicate a life-threatening situation and require immediate notification of the referring doctor 3.6 equipment any device or apparatus which can be used to perform a POCT (3.11) Note 1: Examples include simple colour changing urine test strips for glucose to more complex electronic hand held or bench top analysers such as glucometers, lipid analysers and alcoholmeters. Note 2: For the purposes of this document equipment includes any reagents or consumables required to perform the test. 3.7 external quality assessment (EQA) proficiency testing (PT) process where samples (3.13) of known values are tested periodically and the results are not known to the operator at the time of testing Note 1: The results obtained are then compared against others testing the same sample (3.13) with the same POCT (3.11) equipment (3.6) type giving the participant the ability to evaluate their performance against others. Note 2: Commercially available EQA programmes are recommended but are not always available. Where these are not available manufacturers and/or laboratories may be able to offer assistance with sample (3.13) exchange programs. 3.8 interference factors a substance or process which falsely alters a test result Note 1: Interference can be significant. Note 2: Interfering substances can be endogenous (substances found naturally in the patient (3.10) sample (3.13) such as lipids, proteins, antibodies) or exogenous (substances not naturally found in the patient’s sample such as drugs, poisons or medications). Note 3: The most common interfering factors are haemolysis (the rupturing of red blood cells and the release of their contents into surrounding fluid (e.g. blood plasma/serum), hyperbilirubinemia (a yellow or green pigmentation of the blood plasma/serum due to high bilirubin) and lipaemia (an abnormally high concentration of lipids in the blood, characteristically the blood plasma can appear white or milky in colour due to the presence of fat). Note 4: The type of collection tube can also cause test interference as these often contain additive components. 3.9 internal quality control (IQC) quality control (QC) internal procedure which monitors the testing process to decide if the system is working correctly and gives confidence that the results are reliable enough to be released Note: IQC samples (3.13) have known quantities of the analyte (3.1) being tested. The result obtained is expected to be close to the known value and within an acceptable range. Where results fall outside the acceptable range action to rectify the issue needs to occur before patients (3.10) are tested. 3.10 patient individual undergoing POCT (3.11) Note 1: For this document the term patient has been used for consistency. Note 2: It should be noted that an individual who undergoes POCT (3.11) may not have an ongoing disease and therefore may not be a patient as such. They can be clients or employees being tested for reasons other than to receive medical care, such as community screening, pre-employment testing or assessing the use of performance-enhancing drugs or chemicals. 3.11 point-of-care testing; POCT near-patient testing testing that is performed near or at the site of a patient (3.10) 3.12 point of care testing service provider POCT service provider individual or organisation responsible for providing POCT (3.11) 3.13 sample primary sample specimen discrete portion of a body fluid (e.g. blood, urine, saliva), breath, hair or tissue taken from the human body for POCT (3.11) which is assumed to represent the whole patient Note 1: In some countries, the terms “specimen” or “primary sample’ are used instead of sample. For the purpose of this document the terms “sample”, “primary sample” and “specimen” should be considered interchangeable Note 2: The source of blood samples (whether arterial, venous or capillary) is another important consideration as POCT results for capillary specimens may differ from arterial, venous values for certain tests and in certain circumstances. 3.14 urgent results results needed for the care management of a patient within a minimal time period 3.15 validation process of establishing the performance characteristics and limitations of POCT (3.11) equipment (3.6) and the identification of the influences which can change these characteristics and to what extent Note 1: Which analytes (3.1) it can measure and in which sample (3.13) type (blood arterial, venous or capillary), plasma, urine) in the presence of which interferences (3.8) are important considerations. Note 2: The process for confirming that a method is fit for purpose (is appropriate for its intended use). 3.16 verification process of demonstrating the performance criteria to which the method has been validated have been met by the POCT Service provider (3.12) prior to introducing into routine use 4 Personnel 4.1 Supervisor There shall be an appointed person(s) (supervisor) who has the authority and takes responsibility for, the quality of the service and is competent to supervise the testing provided. The supervisor is responsible for the quality, timeliness, accuracy and safe delivery of the POCT which includes hazard analysis (See 9.2.5). The supervisor shall define the roles and responsibilities of POCT operators. The supervisor shall ensure implementation of the following: ——selection of appropriate tests in consultation with a medical professional, when indicated; ——maintaining privacy, safety and confidentiality of personal information and test results of patients undergoing testing; ——availability of appropriate result interpretation; ——access to advisory services; ——confirmatory testing and/or referral for appropriate or necessary additional testing; ——selection of suitable testing equipment; ——identification and adherence to applicable guidelines; ——performance and review of quality control with corrective actions; ——establishment and maintenance of internal instructions or processes; ——operator training and competency assessment; ——appropriate environment for testing; ——inventory control management processes; ——appropriate and effective clinical handover; and ——appropriate biosafety and infection control procedures. The supervisor shall ensure procedures are in place and appropriate for the POCT service provided and that operators adhere to all instructions and procedures relating to POCT.