ISO 22367:2020 pdf download Medical laboratories — Application of risk management to medical laboratories
5.3 Intended medical laboratory use and reasonably foreseeable misuses For the particular examination or service being considered, the laboratory shall document the intended medical laboratory uses and any reasonably foreseeable misuses. NOTE Misuse is intended to mean incorrect or improper performance of an examination, procedure or any procedure critical for patient safety.
5.4 Identification of characteristics related to safety For the particular examination being considered, the laboratory shall identify and document those qualitative and quantitative characteristics that could affect the safety of the patient, and where appropriate, their defined limits. EXAMPLES diagnostic specificity, diagnostic sensitivity, measurement specificity, measurement precision, measurement bias, analytical interference, reagent stability, analyte stability, sterility (for phlebotomy services), biological reference intervals. NOTE Annex D, contains a series of questions that can serve as a guide in identifying the characteristics of the examination and any IVD medical devices involved that could have an impact on safety.
5.5 Identification of hazards
The laboratory shall identify and document known and foreseeable hazards associated with the examination and other critical processes and their causes (e.g., potential failure modes and use errors). Hazards in both normal use (i.e., correct use and use errors),reasonably foreseeable misuse and fault conditions shall be addressed. For examinations involving the use of an IVD medical device, the laboratory may obtain information from the IVD manufacturer about potential hazards that were identified but not fully eliminated during the manufacturer’s risk management process. NOTE 1 The most common hazards to patients from medical laboratory examinations are incorrect results, misidentified results and delayed results. The examples of possible hazards in Annex E can be used as guidance when identifying hazards to laboratory workers, service personnel and other persons. NOTE 2 Annex F can be used to obtain information on the different steps where nonconformities can lead to errors in different steps (pre-examination, examination and post-examination) and for different medical laboratory disciplines.
NOTE3 Sources that can help identify the potential causes of hazards include laboratory investigationsof complaints，nonconformities,use errors and incidents, as well as the IVD manufacturer involved.IVDmanufacturers that follow IS0 14971 are required to disclose significant residual risks to laboratory users.
5.6ldentification of potentially hazardous situations
Reasonably foreseeable sequences or combinations of events that can lead to a hazardous situationshall be considered and the resulting hazardous situation(s) shall be recorded.The decision regardingwhich event in the sequence of events exposes a patient to the possibility of harm (i.e., a hazardoussituation) should be made by the laboratory to suit the risk analysis.
NOTE1 Sources of information about potential hazardous situations associated with medical laboratoryexaminations or services include the manufacturer(s) of any medical device used, the medical and scientificliterature, experience with similar examinations, expert medical or scientific opinion, and consensus positionsof medical laboratory associations.Refer to Annexes E and F for guidance for developing the list of hazardoussituations.
NOTE2 An incorrect result received by a healthcare provider can be considered the event that creates ahazardous situation for a patient, since subsequent medical decisions and actions that could harm the patientare beyond any reasonable means of risk control by the laboratory. Examples of other hazardous situations areprovided in Annex E.
NOTE3 Hazardous situations can arise from use errors in the performance of laboratory examinations,eitherfrom a laboratory worker choosing to do something or failing to do something.Refer to AnnexH for guidance onidentifying and classifying use errors for risk analysis.
5.7 ldentification of foreseeable patient harms
Reasonably foreseeable harms that could result from each hazardous situation shall be identifiedand classified along with the severity of each harm. This process and the identified harms, shall bedocumented.
NOTE Sources of information about foreseeable patient harms that could be caused by incorrect or delayedexamination results include medical literature, experience with similar examinations, expert medical opinionand consensus positions of professional medical societies.Refer to AnnexE for guidance for developing the list offoreseeable patient harms.
5.8 Estimation of the risk(s) for each hazardous situation
For each identified hazardous situation,the associated risk(s) shall be estimated using availableinformation or data.Risk estimation may be quantitative or qualitative and will need to focus on thewhole process rather than individual components of the situation.
NOTE1 Methods of risk estimation,including those resulting from systematic faults, are described inAnnex I, which gives examples of probability and severity scales based on quantitative, semi-quantitative orqualitative levels.
lf the likelihood of the occurrence of harm cannot be estimated, for example in the case of softwaredefects or other systemic faults, the possible consequences should be listed for use in risk evaluationand risk control.ISO 22367:2020 pdf download