ISO 15189:2022 Checklist

This ISO 15189:2022 Checklist can be used for internal audits, to assess compliance with requirements for quality and competence in medical laboratories.

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ISO 15189:2022 Checklist



7.2.6.1 Sample Receipt Procedure

1. 7.2.6.1.a - Does the laboratory have a procedure for sample receipt that includes the unequivocal traceability of samples by request and labeling, to a uniquely identified patient and, when applicable, the anatomical site?


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2. 7.2.6.1.b - Does the laboratory have a procedure for sample receipt that includes criteria for the acceptance and rejection of samples?


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3. 7.2.6.1.c - Does the laboratory have a procedure for sample receipt that includes recording the date and time of receipt of the sample, when relevant?


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4. 7.2.6.1.d - Does the laboratory have a procedure for sample receipt that includes recording the identity of the person receiving the sample, when relevant?


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5. 7.2.6.1.e - Does the laboratory have a procedure for sample receipt that includes evaluation of received samples by authorized personnel to ensure compliance with acceptability criteria relevant to the requested examination(s)?


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6. 7.2.6.1.f - Does the laboratory have a procedure for sample receipt that includes instructions for samples specifically marked as urgent, including details of special labeling, transport, rapid processing methods, turnaround times, and special reporting criteria to be followed?


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7. 7.2.6.1.g - Does the laboratory have a procedure for sample receipt that ensures all portions of the sample are unequivocally traceable to the original sample?


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7.2.6.2 Sample Acceptance Exceptions

1. 7.2.6.2.a.1 - Does the laboratory have a process that considers the best interests of the patient in receiving care when a sample has been compromised due to incorrect patient or sample identification?


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2. 7.2.6.2.a.2 - Does the laboratory have a process that considers the best interests of the patient in receiving care when a sample has been compromised due to sample instability, such as delays in transport?


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3. 7.2.6.2.a.3 - Does the laboratory have a process that considers the best interests of the patient in receiving care when a sample has been compromised due to incorrect storage or handling temperature?


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4. 7.2.6.2.a.4 - Does the laboratory have a process that considers the best interests of the patient in receiving care when a sample has been compromised due to the use of inappropriate container(s)?


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5. 7.2.6.2.a.5 - Does the laboratory have a process that considers the best interests of the patient in receiving care when a sample has been compromised due to insufficient sample volume?


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6. 7.2.6.2.b - When a compromised clinically critical or irreplaceable sample is accepted, after consideration of the risk to patient safety, does the final report indicate the nature of the problem and where applicable, advising caution when interpreting results that can be affected?


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8.8.1 General

1. Does the laboratory conduct evaluations at planned intervals to demonstrate that management, support, and pre-examination, examination, and post-examination processes meet the needs and requirements of patients and laboratory users, and to ensure conformity to the requirements of this document?


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8.8.2 Quality Indicators

1. Is the process of monitoring quality indicators [see 5.5 d)] planned, which includes establishing the objectives, methodology, interpretation, limits, action plan, and duration of monitoring? Are the indicators periodically reviewed to ensure continued appropriateness?


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8.8.3 Internal Audits

1. 8.8.3.1.a - Does the laboratory conduct internal audits at planned intervals to provide information on whether the management system conforms to the laboratory’s own requirements for its management system, including the laboratory activities?


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2. 8.8.3.1.b - Does the laboratory conduct internal audits at planned intervals to provide information on whether the management system conforms to the requirements of this document?


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3. 8.8.3.1.c - Does the laboratory conduct internal audits at planned intervals to provide information on whether the management system is effectively implemented and maintained?


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4. 8.8.3.2.a - Does the laboratory plan, establish, implement, and maintain an internal audit program that gives priority to risks to patients from laboratory activities?


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5. 8.8.3.2.b - Does the laboratory plan, establish, implement, and maintain an internal audit program with a schedule that considers identified risks, the outcomes of both external evaluations and previous internal audits, the occurrence of nonconformities, incidents, and complaints, and changes affecting the laboratory activities?


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6. 8.8.3.2.c - Does the laboratory plan, establish, implement, and maintain an internal audit program that specifies audit objectives, criteria, and scope for each audit?


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7. 8.8.3.2.d - Does the laboratory plan, establish, implement, and maintain an internal audit program that includes the selection of auditors who are trained, qualified, and authorized to assess the performance of the laboratory's management system, and, whenever resources permit, are independent of the activity to be audited?


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8. 8.8.3.2.e - Does the laboratory plan, establish, implement, and maintain an internal audit program that ensures objectivity and impartiality of the audit process?


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9. 8.8.3.2.f - Does the laboratory plan, establish, implement, and maintain an internal audit program that ensures the results of the audits are reported to relevant personnel?


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10. 8.8.3.2.g - Does the laboratory plan, establish, implement, and maintain an internal audit program that ensures the implementation of appropriate correction and corrective actions without undue delay?


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11. 8.8.3.2.h - Does the laboratory plan, establish, implement, and maintain an internal audit program that retains records as evidence of the implementation of the audit program and audit results?


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5.4.1 General

1. 5.4.1.a - Does the laboratory define its organizational and management structure, its place within any parent organization, and the relationships between management, technical operations, and support services?


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2. 5.4.1.b - Does the laboratory specify the responsibilities, authority, lines of communication, and interrelationships of all personnel who manage, perform, or verify work affecting the results of laboratory activities?


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3. 5.4.1.c - Does the laboratory specify its procedures to the extent necessary to ensure the consistent application of its activities and the validity of the results?


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5.4.2 Quality Management

1. 5.4.2.a - Does the laboratory have personnel who, irrespective of other responsibilities, possess the authority and resources needed to carry out their duties, including the implementation, maintenance, and improvement of the management system?


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2. 5.4.2.b - Does the laboratory have personnel who, irrespective of other responsibilities, possess the authority and resources needed to identify deviations from the management system or procedures for performing laboratory activities?


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3. 5.4.2.c - Does the laboratory have personnel who, irrespective of other responsibilities, possess the authority and resources needed to initiate actions to prevent or minimize such deviations?


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4. 5.4.2.d - Does the laboratory have personnel who, irrespective of other responsibilities, possess the authority and resources needed to report to management on the performance of the management system and any need for improvement?


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5. 5.4.2.e - Does the laboratory have personnel who, irrespective of other responsibilities, possess the authority and resources needed to ensure the effectiveness of laboratory activities?


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5.5 Objectives And Policies

1. 5.5.a.1 - Does laboratory management establish and maintain objectives and policies to meet the needs and requirements of its patients and users?


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2. 5.5.a.2 - Does laboratory management establish and maintain objectives and policies to commit to good professional practice?


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3. 5.5.a.3 - Does laboratory management establish and maintain objectives and policies to provide examinations that fulfill their intended use?


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4. 5.5.a.4 - Does laboratory management establish and maintain objectives and policies to conform to this document?


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5. 5.5.b - Does the laboratory ensure that the objectives and policies are implemented at all levels of the laboratory organization, measurable, and consistent with policies?


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6. 5.5.c - Does laboratory management ensure that the integrity of the management system is maintained when changes to the management system are planned and implemented?


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7. 5.5.d - Does the laboratory establish quality indicators to evaluate performance throughout key aspects of pre-examination, examination, and post-examination processes and monitor performance in relation to objectives (see 8.8.2)?


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7.2.7.1 Sample Protection

1. Does the laboratory have procedures and appropriate facilities for securing patient samples, ensuring sample integrity, and preventing loss or damage during, handling, preparation, and storage?


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7.2.7.2 Criteria For Additional Examination Requests

1. Do laboratory procedures include time limits for requesting additional examinations on the same sample?


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7.2.7.3 Sample Stability

1. Considering the stability of the analyte in a primary sample, is the time between sample collection and performing the examination specified and monitored where relevant?


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8.9.1 General

1. Does laboratory management review its management system at planned intervals to ensure its continuing suitability, adequacy, and effectiveness, including the stated policies and objectives related to the fulfillment of this document?


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8.9.2 Review Input

1. 8.9.2.a - Are the inputs to management review recorded and do they include evaluations of the status of actions from previous management reviews, internal and external changes to the management system, changes in the volume and type of laboratory activities, and the adequacy of resources?


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2. 8.9.2.b - Are the inputs to management review recorded and do they include evaluations of the fulfillment of objectives and the suitability of policies and procedures?


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3. 8.9.2.c - Are the inputs to management review recorded and do they include evaluations of the outcomes of recent evaluations, process monitoring using quality indicators, internal audits, analysis of non-conformities, corrective actions, and assessments by external bodies?


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4. 8.9.2.d - Are the inputs to management review recorded and do they include evaluations of patient, user, and personnel feedback and complaints?


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5. 8.9.2.e - Are the inputs to management review recorded and do they include evaluations of the quality assurance of result validity?


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6. 8.9.2.f - Are the inputs to management review recorded and do they include evaluations of the effectiveness of any implemented improvements and actions taken to address risks and opportunities for improvement?


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7. 8.9.2.g - Are the inputs to management review recorded and do they include evaluations of the performance of external providers?


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8. 8.9.2.h - Are the inputs to management review recorded and do they include evaluations of the results of participation in interlaboratory comparison programs?


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9. 8.9.2.i - Are the inputs to management review recorded and do they include evaluations of POCT (Point-of-Care Testing) activities?


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10. 8.9.2.j - Are the inputs to management review recorded and do they include evaluations of other relevant factors, such as monitoring activities and training?


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8.9.3 Review Output

1. 8.9.3.a - Is the output from the management review a record of decisions and actions related to the effectiveness of the management system and its processes?


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2. 8.9.3.b - Is the output from the management review a record of decisions and actions related to the improvement of the laboratory activities in relation to the fulfillment of the requirements of this document?


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3. 8.9.3.c - Is the output from the management review a record of decisions and actions related to the provision of required resources?


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4. 8.9.3.d - Is the output from the management review a record of decisions and actions related to the improvement of services to patients and users?


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5. 8.9.3.e - Is the output from the management review a record of decisions and actions related to any need for change?


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6. Does laboratory management ensure that actions arising from management review are completed within a specified time frame?


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7. Are conclusions and actions arising from management reviews communicated to laboratory personnel?


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5.6 Risk Management

1. 5.6.a - Does laboratory management establish, implement, and maintain processes for identifying risks of harm to patients and opportunities for improved patient care associated with its examinations and activities, and develop actions to address both risks and opportunities for improvement (see 8.5)?


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2. 5.6.b - Does the laboratory director ensure that these processes are evaluated for effectiveness and modified when identified as being ineffective?


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7.3.1 General

1. 7.3.1.a Does the laboratory select and use examination methods that have been validated for their intended use to assure the clinical accuracy of the examination for patient testing?


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2. 7.3.1.b Do the performance specifications for each examination method relate to the intended use of that examination and its impact on patient care?


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3. 7.3.1.c Are all procedures and supporting documentation, such as instructions, standards, manuals, and reference data relevant to the laboratory activities, kept up to date and readily available to personnel (see 8.3)?


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4. 7.3.1.d Do personnel follow established procedures and the identity of persons performing significant activities in examination processes be recorded, including POCT operators?


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5. 7.3.1.e Do authorized personnel periodically evaluate the examination methods provided by the laboratory to ensure they are clinically appropriate for the requests received?


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7.3.2 Verification Of Examination Methods

1. 7.3.2.a Does the laboratory have a procedure to verify that it can properly perform examination methods before introducing them into use, by ensuring that the required performance, as specified by the manufacturer or method, can be achieved?


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2. 7.3.2.b Are the performance specifications for the examination method confirmed during the verification process relevant to the intended use of the examination results?


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3. 7.3.2.c Does the laboratory ensure the extent of the verification of examination methods is sufficient to ensure the validity of results pertinent to clinical decision-making?


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4. 7.3.2.d Do personnel with the appropriate authorization and competence review the verification results and record whether the results meet the specified requirements?


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5. 7.3.2.e If a method is revised by the issuing body, does the laboratory repeat verification to the extent necessary?


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6. 7.3.2.f.1 - Are records of verification retained for the performance specifications to be achieved?


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7. 7.3.2.f.2 - Are records of verification retained for the results obtained?


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8. 7.3.2.f.3 - Are records of verification retained for a statement of whether the performance specifications were achieved, and if not, what action was taken?


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7.3.3 Validation Of Examination Methods

1. 7.3.3.a.1 - Does the laboratory validate examination methods that are derived from laboratory-designed or developed methods?


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2. 7.3.3.a.2 - Does the laboratory validate examination methods that are used outside their originally intended scope, such as outside of the manufacturer's instructions for use, or original validated measurement range, or when third-party reagents are used on instruments other than the intended instruments and where no validation data are available?


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3. 7.3.3.a.3 - Does the laboratory validate examination methods that are derived from validated methods that have been subsequently modified?


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4. Is the validation as extensive as is necessary and confirms through the provision of objective evidence in the form of performance specifications, that the specific requirements for the intended use of the examination have been fulfilled?


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5. 7.3.3.b Does the laboratory ensure that the extent of validation of an examination method is sufficient to ensure the validity of results pertinent to clinical decision-making?


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6. 7.3.3.c Do personnel with the appropriate authorization and competence review the validation results and record whether the results meet the specified requirements?


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7. 7.3.3.d When changes are proposed to a validated examination method, is the clinical impact reviewed, and a decision made as to whether to implement the modified method?


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8. 7.3.3.e.1 - Are records of the validation procedure used retained?


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9. 7.3.3.e.2 - Are records of the specific requirements for the intended use retained?


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10. 7.3.3.e.3 - Are records of the determination of the performance specifications of the method retained?


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11. 7.3.3.e.4 - Are records of the results obtained during validation retained?


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12. 7.3.3.e.5 - Are records retained that include a statement on the validity of the method, detailing its fitness for the intended use?


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7.3.4 Evaluation Of Measurement Uncertainty (Mu)

1. 7.3.4.a Is the MU of measured quantity values evaluated and maintained for its intended use, where relevant? Is the MU compared against performance specifications and documented?


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2. 7.3.4.b Are MU evaluations regularly reviewed?


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3. 7.3.4.c For examination procedures where the evaluation of MU is not possible or relevant, is the rationale for exclusion from MU estimation documented?


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4. 7.3.4.d Is MU information made available to laboratory users on request?


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5. 7.3.4.e When users have inquiries on MU, does the laboratory’s response take into account other sources of uncertainty, such as, but not limited to biological variation?


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6. 7.3.4.f If the qualitative result of an examination relies on a test that produces quantitative output data and is specified as positive or negative, based on a threshold, is MU in the output quantity estimated using representative positive and negative samples?


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7. 7.3.4.g For examinations with qualitative results, is the MU in intermediate measurement steps or IQC results that produce quantitative data considered for key (high-risk) parts of the process?


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8. 7.3.4.h Is MU taken into consideration when performing verification or validation of a method, when relevant?


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7.3.5 Biological Reference Intervals And Clinical Decision Limits

1. Are biological reference intervals and clinical decision limits, when needed for interpretation of examination results, defined and communicated to users? 


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2. 7.3.5.a Are biological reference intervals and clinical decision limits defined, and their basis recorded, to reflect the patient population served by the laboratory, while considering the risk to patients? 


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3. 7.3.5.b Are biological reference intervals and clinical decision limits periodically reviewed, and any changes communicated to users? 


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4. 7.3.5.c When changes are made to an examination or pre-examination method, does the laboratory review the impact on associated biological reference intervals and clinical decision limits and communicate to the users when applicable? 


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5. 7.3.5.d For examinations that identify the presence or absence of a characteristic, is the biological reference interval the characteristic to be identified (e.g., genetic examinations)? 


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7.3.6 Documentation Of Examination Procedures

1. 7.3.6.a Does the laboratory document its examination procedures to the extent necessary to ensure the consistent application of its activities and the validity of its results? 


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2. 7.3.6.b Are procedures written in a language understood by laboratory personnel and available in appropriate locations? 


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3. 7.3.6.c Does any abbreviated document content correspond to the procedure? 


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4. 7.3.6.d Is information from product instructions for use, that contain sufficient information, incorporated into procedures by reference?


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5. 7.3.6.e When the laboratory makes a validated change to an examination procedure that could affect the interpretation of results, are the implications of this explained to users? 


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6. 7.3.6.f Are all documents associated with the examination process subject to document control (see 8.3)?


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6.1 General

1. 6.1.1 Does the laboratory have available the personnel, facilities, equipment, systems, and support services necessary to manage and perform its laboratory activities? 


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6.2 Personnel

1. 6.2.1.a - Does the laboratory have access to a sufficient number of competent persons to perform its activities?


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2. 6.2.1.b - Do all personnel of the laboratory, either internal or external, that could influence the laboratory activities act impartially, and ethically, be competent and work in accordance with the laboratory’s management system?


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3. 6.2.1.c - Does the laboratory communicate to laboratory personnel the importance of meeting the needs and requirements of users as well as the requirements of this document?


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4. 6.2.1.d - Does the laboratory have a program to introduce personnel to the organization, the department or area in which the person will work, the terms and conditions of employment, staff facilities, health and safety requirements, and occupational health services?


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6.2.2 Competence Requirements

1. 6.2.2.a - Does the laboratory specify the competence requirements for each function influencing the results of laboratory activities, including requirements for education, qualification, training, retraining, technical knowledge, skills, and experience?


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2. 6.2.2.b - Does the laboratory ensure all personnel have the competence to perform laboratory activities for which they are responsible?


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3. 6.2.2.c - Does the laboratory have a process for managing the competence of its personnel that includes requirements for frequency of competence assessment?


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4. 6.2.2.d - Does the laboratory have documented information demonstrating the competence of its personnel?


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6.2.3 Authorization

1. 6.2.3.a - Does the laboratory authorize personnel to perform specific laboratory activities, including but not limited to, selection, development, modification, validation, and verification of methods?


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2. 6.2.3.b - Does the laboratory authorize personnel to perform specific laboratory activities, including but not limited to review, release, and reporting of results?


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3. 6.2.3.c - Does the laboratory authorize personnel to perform specific laboratory activities, including but not limited to the use of laboratory information systems, in particular: accessing patient data and information, entering patient data and examination results, changing patient data or examination results?


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6.2.4 Continuing Education And Professional Development

1. Is a continuing education program available to personnel who participate in managerial and technical processes?


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2. Do all personnel participate in continuing education and regular professional development, or other professional liaison activities?


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3. Is the suitability of the programs and activities periodically reviewed?


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7.3.7.1 General

1. Does the laboratory have a procedure for monitoring the validity of results? 


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2. Is the resulting data recorded in such a way that trends and shifts are detectable and, where practicable, statistical techniques are applied to review the results? Is this monitoring planned and reviewed?


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7.3.7.2 Internal Quality Control (IQC)

1. 7.3.7.2.a Does the laboratory have an IQC procedure for monitoring the ongoing validity of examination results, according to specified criteria, that verifies the attainment of the intended quality and ensures validity pertinent to clinical decision-making?


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2. 7.3.7.2.a.1 Is the intended clinical application of the examination should be considered, as the performance specifications for the same measurand can differ in different clinical settings?


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3. 7.3.7.2.a.2 Does the procedure also allow for the detection of either lot-to-lot reagent or calibrator variation, or both, of the examination method? To enable this, does the laboratory procedure avoid lot change in IQC material on the same day/run as either lot-to-lot reagent or calibrator change, or both?


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4. 7.3.7.2.a.3 Is the use of third-party IQC material considered, either as an alternative to or in addition to, control material supplied by the reagent or instrument manufacturer?


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5. Does the laboratory select IQC material that is fit for its intended purpose?


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6. 7.3.7.2.b.1 - When selecting IQC material, is stability with regard to the properties of interest considered?


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7. 7.3.7.2.b.2 - When selecting IQC material, is the matrix as close as possible to that of patient samples?


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8. 7.3.7.2.b.3 - When selecting IQC material, does the IQC material react to the examination method in a manner as close as possible to patient samples?


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9. 7.3.7.2.b.4 - When selecting IQC material, does the IQC material provide a clinically relevant challenge to the examination method, with concentration levels at or near clinical decision limits, and when possible, cover the measurement range of the examination method?


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10. 7.3.7.2.c - If appropriate IQC material is not available, does the laboratory consider the use of other methods for IQC?


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11. 7.3.7.2.c.1 - Does the laboratory consider trend analysis of patient results, e.g., with moving averages of patient results, or percentages, as an alternative IQC method?


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12. 7.3.7.2.c.2 - Does the laboratory consider the comparison of results for patient samples on a specified schedule to results for patient samples as an alternative IQC method?


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13. 7.3.7.2.c.3 - Does the laboratory consider retesting of retained patient samples as an alternative IQC method?


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14. 7.3.7.2.d - Is IQC performed at a frequency that is based on the stability and robustness of the examination method and the risk of harm to the patient from an erroneous result?


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15. 7.3.7.2.e - Are the resulting data recorded in such a way that trends and shifts are detectable and where practicable, statistical techniques applied to review the results?


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16. 7.3.7.2.f - Are IQC data reviewed with defined acceptability criteria at regular intervals, and in a  particular time frame that allows a meaningful indication of current performance?


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17. 7.3.7.2.g - Does the laboratory prevent the release of patient results in the event that IQC fails the defined criteria?


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18. 7.3.7.2.g.1 - When IQC-defined acceptability criteria are not fulfilled and indicate results are likely to contain clinically significant errors, are the results rejected and relevant patient samples re-examined after the error has been corrected?


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19. 7.3.7.2.g.2 - Are the results from patient samples that were examined after the last successful IQC event evaluated?


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7.3.7.3 External Quality Assessment (EQA)

1. 7.3.7.3.a - Does the laboratory monitor its performance of examination methods, by comparison with results of other laboratories? This includes participation in EQA programs appropriate to the examinations and interpretation of examination results, including POCT examination methods.


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2. 7.3.7.3.b - Does the laboratory establish a procedure for EQA enrollment, participation, and performance for examination methods used, where such programs are available?


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3. 7.3.7.3.c - Are EQA samples processed by personnel who routinely perform pre-examination, examination, and post-examination procedures?


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4. 7.3.7.3.d.1 - Do the EQA programs selected by the laboratory have the effect of checking pre-examination, examination, and post-examination processes?


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5. 7.3.7.3.d.2 - Do the EQA programs selected by the laboratory provide samples that mimic patient samples for clinically relevant challenges?


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6. 7.3.7.3.d.3 - Do the EQA programs selected by the laboratory fulfill ISO/IEC 17043 requirements?


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7. 7.3.7.3.e.1 - When selecting EQA programs, does the laboratory consider whether the target values are independently set by a reference method?


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8. 7.3.7.3.e.2 - When selecting EQA programs, does the laboratory consider whether the target values are set by overall consensus data?


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9. 7.3.7.3.e.3 -When selecting EQA programs, does the laboratory consider whether the target values are set by method peer group consensus data?


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10. 7.3.7.3.e.4 -When selecting EQA programs, does the laboratory consider whether the target values are set by a panel of experts?


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11. 7.3.7.3.f - When an EQA program is either not available, or not considered suitable, does the laboratory use alternative methodologies to monitor examination method performance? Does the laboratory justify the rationale for the chosen alternative and provide evidence of its effectiveness?


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12. 7.3.7.3.g - Are EQA data reviewed at regular intervals with specified acceptability criteria, in a time frame that allows for a meaningful indication of current performance?


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13. 7.3.7.3.h - Where EQA results fall outside specified acceptability criteria, is appropriate action taken (see 8.7), including an assessment of whether the non-conformance is clinically significant as it relates to patient samples?


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14. 7.3.7.3.i - Where it is determined that the impact is clinically significant, is a review of patient results that could have been affected and the need for amendment considered and users advised as appropriate?


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7.3.7.4 Comparability Of Examination Results

1. 7.3.7.4.a When either different methods or equipment, or both, are used for an examination, and/or the examination is performed at different sites, is a procedure for establishing the comparability of results for patient samples throughout the clinically significant intervals specified?


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2. 7.3.7.4.b Does the laboratory record the results of comparability performed and its acceptability?


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3. 7.3.7.4.c Does the laboratory periodically review the comparability of results?


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4. 7.3.7.4.d Where differences are identified, is the impact of those differences on biological reference intervals and clinical decision limits evaluated and acted upon?


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5. 7.3.7.4.e Does the laboratory inform users of any clinically significant differences in the comparability of results?


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6.3 Personnel Records

1. 6.2.5.a - Does the laboratory have procedures and retain records for determining the competence requirements specified in 6.2.2 a)?


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2. 6.2.5.b - Does the laboratory have procedures and retain records for position descriptions?


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3. 6.2.5.c - Does the laboratory have procedures and retain records for training and re-training?


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4. 6.2.5.d - Does the laboratory have procedures and retain records for authorization of personnel?


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5. 6.2.5.e - Does the laboratory have procedures and retain records for monitoring the competence of personnel?


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7.4.1 Reporting Of Results - 7.4.1.1 General

1. 7.4.1.1.a Are examination results reported accurately, clearly, unambiguously, and in accordance with any specific instructions in the examination procedure? Does the report include all available information necessary for the interpretation of the results?


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2. 7.4.1.1.b Does the laboratory have a procedure to notify users when examination results are delayed, based on the impact of the delay on the patient?


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3. 7.4.1.1.c Is all information associated with issued reports retained in accordance with management system requirements (see 8.4)?


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7.4.1.2 Result Review And Release

1. Are results reviewed and authorized prior to release?


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2. Does the laboratory ensure that authorized personnel review the results of examinations and evaluate them against IQC and, as appropriate, available clinical information and previous examination results?


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3. Are responsibilities and procedures for how examination results are released for reporting, including by whom and to whom, specified?


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7.4.1.3 Critical Result Reports

1. 7.4.1.3.a - When examination results fall within established critical decision limits, is the user or other authorized person notified as soon as relevant, based on clinical information available?


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2. 7.4.1.3.b - When examination results fall within established critical decision limits, are actions taken documented, including date, time, responsible person, person notified, results conveyed, verification of the accuracy of communication, and any difficulties encountered in notification?


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3. 7.4.1.3.c - When examination results fall within established critical decision limits, does the laboratory have an escalation procedure for laboratory personnel when a responsible person cannot be contacted?


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7.4.1.4 Special Considerations For Results

1. 7.4.1.4.a - When agreed with the user that the results will be reported in a simplified way, is any information listed in 7.4.1.6 and 7.4.1.7 that is not reported to the user readily available?


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2. 7.4.1.4.b - When results are transmitted as a preliminary report, is the final report always forwarded to the user?


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3. 7.4.1.4.c - Are records kept of all results that are provided orally, including details of verification of the accuracy of communication, as in 7.4.1.3 b)? Are such results always followed by a report?


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4. 7.4.1.4.d - If special counseling is needed for examination results with serious implications for the patient (e.g., for genetic or certain infectious diseases), does laboratory management ensure that these results are not communicated to the patient without the opportunity for adequate counseling?


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5. 7.4.1.4.e - If results of laboratory examinations that have been anonymized are used for such purposes as epidemiology, demography, or other statistical analyses, are all risks to patient privacy and confidentiality mitigated and in accordance with any legal or regulatory requirements?


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7.4.1.5 Automated Selection, Review, Release And Reporting Of Results

1. 7.4.1.5.a - When the laboratory implements a system for automated selection, review, release, and reporting of results, does it establish a procedure to ensure that the criteria for automated selection, review, and release are specified, approved, readily available, and understood by personnel responsible for authorizing the release of results?


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2. 7.4.1.5.b - Does the laboratory ensure that the criteria for automated selection, review, and release are validated and approved before use, regularly reviewed, and verified after changes to the reporting system that can affect their proper functioning and place patient care at risk?


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3. 7.4.1.5.c - Does the laboratory ensure that results selected by an automated reporting system for manual review are identifiable and that the date and time of selection and review, as well as the identity of the reviewer, are retrievable?


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4. 7.4.1.5.d - Does the laboratory have a procedure to apply rapid suspension of automated selection, review, release, and reporting when necessary?


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7.4.1.6 Requirements For Reports

1. 7.4.1.6.a - Does each report include unique patient identification, the date of primary sample collection, and the date of the issue of the report on each page of the report, unless the laboratory has documented reasons for omitting this information?


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2. 7.4.1.6.b - Does each report include the identification of the laboratory issuing the report, unless the laboratory has documented reasons for omitting this information?


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3. 7.4.1.6.c - Does each report include the name or other unique identifier of the user, unless the laboratory has documented reasons for omitting this information?


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4. 7.4.1.6.d - Does each report include the type of primary sample and any specific information necessary to describe the sample (e.g., source, site of specimen, macroscopic description), unless the laboratory has documented reasons for omitting this information?


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5. 7.4.1.6.e - Does each report include clear, unambiguous identification of the examinations performed, unless the laboratory has documented reasons for omitting this information?


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6. 7.4.1.6.f - Does each report include the identification of the examination method used, where relevant, including, where possible and necessary, harmonized (electronic) identification of the measurand and measurement principle, unless the laboratory has documented reasons for omitting this information?


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7. 7.4.1.6.g - Does each report include examination results with, where appropriate, the units of measurement, reported in SI units, units traceable to SI units, or other applicable units, unless the laboratory has documented reasons for omitting this information?


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8. 7.4.1.6.h - Does each report include biological reference intervals, clinical decision limits, likelihood ratios, or diagrams/nomograms supporting clinical decision limits as necessary, unless the laboratory has documented reasons for omitting this information?


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9. 7.4.1.6.i - Does each report include the identification of examinations undertaken as part of a research or development program and for which no specific claims on measurement performance are available, unless the laboratory has documented reasons for omitting this information?


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10. 7.4.1.6.j - Does each report include the identification of the person(s) reviewing the results and authorizing the release of the report, or is this information readily available when needed, unless the laboratory has documented reasons for omitting this information?


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11. 7.4.1.6.k - Does each report include the identification of any results that need to be considered as preliminary, unless the laboratory has documented reasons for omitting this information?


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12. 7.4.1.6.l - Does each report include indications of any critical results, unless the laboratory has documented reasons for omitting this information?


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13. 7.4.1.6.m - Does each report include unique identification that all its components are recognized as a portion of a complete report, and a clear identification of the end (e.g., page number to the total number of pages), unless the laboratory has documented reasons for omitting this information?


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7.4.1.7 Additional Information For Reports

1. 7.4.1.7.a - When necessary for patient care, is the time of primary sample collection included?


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2. 7.4.1.7.b - Is the time of report release, if not contained in the report, readily available when needed?


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3. 7.4.1.7.c - Is the identification of all examinations or parts of examinations performed by a referral laboratory included, along with information provided by consultants without alteration, as well as the name of the laboratory performing the examinations?


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4. 7.4.1.7.d.1 - When applicable, does a report include interpretation of results and comments on sample quality and suitability that can compromise the clinical value of examination results?


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5. 7.4.1.7.d.2 - When applicable, does a report include interpretation of results and comments on discrepancies when examinations are performed by different procedures (e.g., POCT) or in different locations?


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6. 7.4.1.7.d.3 - When applicable, does a report include interpretation of results and comments on the possible risk of misinterpretation when different units of measurement are in use regionally?


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7. 7.4.1.7.d.4 - When applicable, does a report include interpretation of results and comments on result trends or significant changes over time?


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7.4.1.8 Amendments To Reported Results

1. 7.4.1.8.a - Does the procedure for issuing amended or revised results ensure that the reason for the change is recorded and included in the revised report, when relevant?


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2. 7.4.1.8.b - Does the procedure for issuing amended or revised results ensure that revised results are delivered only in the form of an additional document or data transfer, clearly identified as having been revised, with the date and patient's identity in the original report indicated?


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3. 7.4.1.8.c - Does the procedure for issuing amended or revised results ensure that the user is made aware of the revision?


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4. 7.4.1.8.d - Does the procedure for issuing amended or revised results ensure that when it is necessary to issue a completely new report, it is uniquely identified and contains a reference and traceability to the original report that it replaces?


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5. 7.4.1.8.e - When the reporting system cannot capture revisions, is a record of such revisions kept?


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7.4.2 Post-examination Handling Of Samples

1. Does the laboratory specify the length of time samples are to be retained following examination and the conditions under which samples are to be stored?


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2. 7.4.2.a - Does the laboratory ensure that after the examination, the patient and source identification of the sample is maintained?


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3. 7.4.2.b - Does the laboratory ensure that the suitability of the sample for additional examination is known?


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4. 7.4.2.c - Does the laboratory ensure that the sample is stored in a manner that optimally preserves its suitability for additional examination?


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5. 7.4.2.d - Does the laboratory ensure that the sample can be located and retrieved?


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6. 7.4.2.e - Does the laboratory ensure that the sample is discarded appropriately?


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6.3.1 General

1. Are facilities and environmental conditions suitable for the laboratory activities and not adversely affecting the validity of results, or the safety of patients, visitors, laboratory users, and personnel? Does this include pre-examination-related facilities and sites other than the main laboratory premises where examinations are performed, as well as POCT?


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6.3.2 Facility Controls

1. 6.3.2.a - Are facility controls implemented, recorded, monitored, and periodically reviewed to include access control, considering safety, confidentiality, quality, and the safeguarding of medical information and patient samples?


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2. 6.3.2.b - Are facility controls implemented, recorded, monitored, and periodically reviewed to prevent contamination, interference, or adverse influences on laboratory activities arising from energy sources, lighting, ventilation, noise, water, and waste disposal?


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3. 6.3.2.c - Are facility controls implemented, recorded, monitored, and periodically reviewed to address the prevention of cross-contamination where examination procedures pose a risk or where work could be affected by a lack of separation?


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4. 6.3.2.d - Are facility controls implemented, recorded, monitored, and periodically reviewed to ensure the provision and regular verification of safety facilities and devices, where applicable?


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5. 6.3.2.e - Are facility controls implemented, recorded, monitored, and periodically reviewed to maintain laboratory facilities in functional and reliable condition?


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6.3.3 Storage Facilities

1. 6.3.3.a - Is storage space, with conditions that ensure the continuing integrity of samples, equipment, reagents, consumables, documents, and records, provided?


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2. 6.3.3.b - Are patient samples and materials used in examination stored in a manner that prevents cross-contamination and deterioration?


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3. 6.3.3.c - Are storage and disposal facilities for hazardous materials and biological waste appropriate to the classification of the materials in the context of any statutory or regulatory requirements?


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6.3.4 Personnel Facilities

1. Is there adequate access to toilet facilities and a supply of drinking water, as well as facilities for storage of personal protective equipment and clothing?


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2. Is space for personnel activities, such as meetings, quiet study, and a rest area provided?


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6.3.5 Sample Collection Facilities

1. 6.3.5.a - Do sample collection facilities enable collection to be conducted in a manner that does not invalidate results or adversely affect the quality of examinations?


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2. 6.3.5.b - Do sample collection facilities consider the privacy, comfort, and needs of patients (e.g., disabled access, toilet facilities) and accommodate accompanying persons (e.g., guardian or interpreter) during collection?


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3. 6.3.5.c - Do sample collection facilities provide separate areas for patient reception and sample collection?


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4. 6.3.5.d - Do sample collection facilities maintain first aid materials for both patients and personnel?


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7.5 Nonconforming Work

1. Does the laboratory have a process for when any aspect of its laboratory activities or examination results do not conform to its own procedures, quality specifications, or user requirements (e.g., equipment or environmental conditions are out of specified limits, results of monitoring fail to meet specified criteria)?


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2. 7.5.a - Does the process ensure that the responsibilities and authorities for the management of nonconforming work are specified?


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3. 7.5.b - Does the process ensure that immediate and long-term actions are specified and based on the risk analysis process established by the laboratory?


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4. 7.5.c - Does the process ensure that examinations are halted, and reports are withheld when there is a risk of harm to patients?


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5. 7.5.d - Does the process ensure that an evaluation is made of the clinical significance of the nonconforming work, including an impact analysis on examination results which were or could have been released prior to identification of the non-conformance?


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6. 7.5.e - Does the process ensure that a decision is made on the acceptability of the nonconforming work?


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7. 7.5.f - Does the process ensure that when necessary, examination results are revised, and the user is notified?


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8. 7.5.g - Does the process ensure that the responsibility for authorizing the resumption of work is specified?


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9. Does the laboratory implement corrective action commensurate with the risk of recurrence of the nonconforming work (see 8.7)?


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10. Does the laboratory retain records of nonconforming work and actions as specified in 7.5 a) to g)?


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6.4.1 General

1. 6.4.1 - Does the laboratory have processes for the selection, procurement, installation, acceptance testing (including acceptability criteria), handling, transport, storage, use, maintenance, and decommissioning of equipment, in order to ensure proper functioning and to prevent contamination or deterioration?


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6.4.2 Equipment Requirements

1. 6.4.2.a - Does the laboratory have access to equipment required for the correct performance of laboratory activities?


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2. 6.4.2.b - Where the equipment is used outside the laboratory's permanent control, or equipment manufacturer's functional specification, does laboratory management ensure that the requirements of this document are met?


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3. 6.4.2.c - Is each item of equipment that can influence laboratory activities uniquely labeled, marked, or otherwise identified, and is a register maintained?


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4. 6.4.2.d - Does the laboratory maintain and replace equipment as needed to ensure the quality of examination results?


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6.4.3 Equipment Acceptance Procedure

1. Does the laboratory verify that the equipment conforms to specified acceptability criteria before being placed or returned into service?


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2. Is the equipment used for measurement capable of achieving either measurement accuracy or measurement uncertainty, or both, required to provide a valid result (see 7.3.3 and 7.3.4 for details)?


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6.4.4 Equipment Instructions For Use

1. 6.4.4.a Does the laboratory have appropriate safeguards to prevent unintended adjustments of equipment that can invalidate examination results?


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2. 6.4.4.b Is equipment operated by trained, authorized, and competent personnel?


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3. 6.4.4.c Are instructions for the use of equipment, including those provided by the manufacturer, readily available?


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4. 6.4.4.d Is the equipment used as specified by the manufacturer, unless validated by the laboratory (see 7.3.3)?


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6.4.5 Equipment Maintenance And Repair

1. 6.4.5.a Does the laboratory have preventive maintenance programs, based on the manufacturer’s instructions?


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2. 6.4.5.a Are deviations from the manufacturer's schedules or instructions recorded?


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3. 6.4.5.b Is equipment maintained in a safe working condition and working order? Does this include electrical safety, any emergency stop devices, and the safe handling and disposal of hazardous materials by authorized personnel?


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4. 6.4.5.c Is equipment that is defective or outside specified requirements, taken out of service? Is it clearly labeled or marked as being out of service, until it has been verified to perform correctly?


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5. 6.4.5.c Does the laboratory examine the effect of the defect or deviation from specified requirements and initiate actions when non-conforming work occurs (see 7.5)?


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6. 6.4.5.d When applicable, does the laboratory decontaminate equipment before service, repair or decommissioning, provide suitable space for repairs, and provide appropriate personal protective equipment?


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6.4.6 Equipment Adverse Incident Reporting

1. Are adverse incidents and accidents that can be attributed directly to specific equipment investigated and reported to either the manufacturer or supplier, or both, and appropriate authorities, as required?


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2. Does the laboratory have procedures for responding to any manufacturer's recall or other notice, and taking actions recommended by the manufacturer?


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6.4.7 Equipment Records

1. Are records maintained for each item of equipment that influences the results of laboratory activities?


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2. 6.4.7.a - Do the records include manufacturer and supplier details, and sufficient information to uniquely identify each item of equipment, including software and firmware?


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3. 6.4.7.b - Do the records include dates of receipt, acceptance testing, and entering into service?


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4. 6.4.7.c - Do the records include evidence that equipment conforms to specified acceptability criteria?


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5. 6.4.7.d - Do the records include the current location of the equipment?


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6. 6.4.7.e - Do the records include the condition of the equipment when received (e.g., new, used, or reconditioned)?


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7. 6.4.7.f - Do the records include the manufacturer's instructions?


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8. 6.4.7.g - Do the records include the program for preventive maintenance?


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9. 6.4.7.h - Do the records include any maintenance activities performed by the laboratory or an approved external service provider?


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10. 6.4.7.i - Do the records include details of any damage to, malfunction, modification, or repair of the equipment?


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11. 6.4.7.j - Do the records include equipment performance records such as reports or certificates of calibration or verification, including dates, times, and results?


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12. 6.4.7.k - Do the records include the status of the equipment, such as active or in-service, out-of-service, quarantined, retired, or obsolete?


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13. Are these records maintained and readily available for the lifespan of the equipment or longer, as specified in 8.4.3?


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7.6.1 General

1. Does the laboratory have access to the data and information needed to perform laboratory activities?


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7.6.2 Authorities And Responsibilities For Information Management

1. Does the laboratory ensure that the authorities and responsibilities for the management of information systems are specified, including the maintenance and modification to the information systems that can affect patient care? Is the laboratory ultimately responsible for the laboratory information systems?


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7.6.3 Information Systems Management

1. 7.6.3.a - Are the system(s) used for the collection, processing, recording, reporting, storage, or retrieval of examination data and information validated by the supplier and verified for functionality by the laboratory before introduction, with any changes, including software configuration or modifications to commercial off-the-shelf software, authorized, documented, and validated before implementation?


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2. 7.6.3.b - Are the system(s) used for the collection, processing, recording, reporting, storage, or retrieval of examination data and information documented, with the documentation readily available to authorized users, including for the day-to-day functioning of the system?


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3. 7.6.3.c - Is the system(s) used for the collection, processing, recording, reporting, storage, or retrieval of examination data and information implemented with cybersecurity measures in place to protect the system from unauthorized access and to safeguard data against tampering or loss?


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4. 7.6.3.d - Are the system(s) used for the collection, processing, recording, reporting, storage, or retrieval of examination data and information operated in an environment that complies with supplier specifications or, in the case of noncomputerized systems, provides conditions that safeguard the accuracy of manual recording and transcription?


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5. 7.6.3.e - Are the system(s) used for the collection, processing, recording, reporting, storage, or retrieval of examination data and information maintained in a manner that ensures the integrity of the data and information, including the recording of system failures and the appropriate immediate and corrective actions?


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6. 7.6.3 - Are calculations and data transfers checked in an appropriate and systematic manner?


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7.6.4 Downtime Plans

1. Does the laboratory have planned processes to maintain operations in the event of failure or during downtime in information systems that affect the laboratory's activities? Does this include automated selection and reporting of results?


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7.6.5 Off Site Management

1. When the laboratory information system(s) are managed and maintained off-site or through an external provider, does the laboratory ensure that the provider or operator of the system complies with all applicable requirements of this document?


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6.5.1 General

1. Does the laboratory specify calibration and traceability requirements that are sufficient to maintain consistent reporting of examination results?


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2. For quantitative methods of a measured analyte, do specifications include calibration and metrological traceability requirements?


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3. Do qualitative methods and quantitative methods that measure characteristics rather than discrete analytes specify the characteristic being assessed and such requirements necessary for reproducibility over time?


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6.5.2 Equipment Calibration

1. Does the laboratory have procedures for the calibration of equipment that directly or indirectly affects examination results?


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2. 6.5.2.a - Do the procedures specify the conditions of use and the manufacturer's instructions for calibration?


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3. 6.5.2.b - Do the procedures specify the recording of metrological traceability?


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4. 6.5.2.c - Do the procedures specify the verification of required measurement accuracy and the functioning of the measuring system at specified intervals?


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5. 6.5.2.d - Do the procedures specify the recording of calibration status and the date of re-calibration?


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6. 6.5.2.e - Do the procedures ensure that, where correction factors are used, these are updated and recorded when recalibration occurs?


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7. 6.5.2.f - Do the procedures specify the handling of situations when calibration is out of control, to minimize risk to service operations and patients?


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6.5.3 Metrological Traceability Of Measurement Results

1. 6.5.3.a - Does the laboratory establish and maintain metrological traceability of its measurement results through a documented, unbroken chain of calibrations, each contributing to the measurement uncertainty and linking them to an appropriate reference?


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2. 6.5.3.b.i - Does the laboratory ensure that measurement results are traceable to the highest possible level of traceability and to the International System of Units (SI) through calibration provided by a competent laboratory?


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3. 6.5.3.b.ii - Does the laboratory ensure that measurement results are traceable to the highest possible level of traceability and to the International System of Units (SI) through certified values of certified reference materials provided by a competent producer with stated metrological traceability to the SI?


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4. 6.5.3.c.i - Where it is not possible to provide traceability according to 6.5.3.a, does the laboratory apply other means to provide confidence in the results, such as the results of reference measurement procedures, specified methods, or consensus standards that are clearly described and accepted as providing measurement results fit for their intended use?


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5. 6.5.3.c.ii - Where it is not possible to provide traceability according to 6.5.3.a, does the laboratory apply other means to provide confidence in the results, such as the measurement of the calibrator by another procedure?


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6. 6.5.3.d - For genetic examinations, is traceability to genetic reference sequences established?


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7. 6.5.3.e - For qualitative methods, is traceability demonstrated by testing of known material or previous samples sufficient to show consistent identification and, when applicable, intensity of reaction?


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7.7.1 Process

1. 7.7.1.a - Does the laboratory have a process for handling complaints that include a description of the process for receiving, substantiating and investigating the complaint, and deciding what actions shall be taken in response?


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2. 7.7.1.b - Does the laboratory have a process for handling complaints that includes tracking and recording the complaint, including the actions undertaken to resolve it


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3. 7.7.1.c - Does the laboratory have a process for handling complaints that includes ensuring appropriate action is taken?


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4. 7.7.1 Is a description of the process for handling complaints publicly available?


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7.7.2 Receipt Of Complaint

1. 7.7.2.a Upon receipt of a complaint, does the laboratory confirm whether the complaint relates to laboratory activities that the laboratory is responsible for and, if so, resolve the complaint. (see 8.7.1)


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2. 7.7.2.b Is the laboratory receiving the complaint responsible for gathering all necessary information to determine whether the complaint is substantiated?


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3. 7.7.2.c Does the laboratory, whenever possible, acknowledge receipt of the complaint, and provide the complainant with the outcome and, if applicable, progress reports?


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7.7.3 Resolution Of Complaint

1. Do investigation and resolution of complaints result in any discriminatory actions?


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2. Is the resolution of complaints made by, or reviewed and approved by, persons not involved in the subject of the complaint in question? Where resources do not permit this, does any alternative approach compromise impartiality?


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6.6.1 General

1. Does the laboratory have processes for the selection, procurement, reception, storage, acceptance testing, and inventory management of reagents and consumables?


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6.6.2 Reagents And Consumables — Receipt And Storage

1. Does the laboratory store reagents and consumables according to manufacturers' specifications and monitor the environmental conditions where relevant?


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2. If the laboratory is not the receiving facility, does it verify that the receiving facility has adequate storage and handling capabilities to maintain supplies in a manner that prevents damage?


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6.6.3 Reagents And Consumables — Acceptance Testing

1. Is each reagent or new formulation of examination kits with changes in reagents or procedure, or a new lot or shipment, verified for performance before placing into use, or before the release of results, as appropriate?


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2. Are consumables that can affect the quality of examinations verified for performance before placing into use?


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6.6.4 Reagents And Consumables — Inventory Management

1. Has the laboratory established an inventory management system for reagents and consumables?


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2. Does the system for inventory management segregate reagents and consumables that have been accepted for use from those that have been neither inspected nor accepted for use?


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6.6.5 Reagents And Consumables — Instructions For Use

1. Are instructions for the use of reagents and consumables, including those provided by manufacturers, readily available?


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2. Are reagents and consumables used according to the manufacturer's specifications? If they are intended to be used for other purposes see 7.3.3.


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6.6.6 Reagents And Consumables — Adverse Incident Reporting

1. Are adverse incidents and accidents that can be attributed directly to specific reagents or consumables investigated and reported to either the manufacturer or supplier, or both, and appropriate authorities, as required?


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2. Does the laboratory have procedures for responding to any manufacturer's recall or other notice and taking actions recommended by the manufacturer?


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6.6.7 Reagents And Consumables — Records

1. Are records maintained for each reagent and consumable that contributes to the performance of examinations?


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2. 6.6.7.a - Do the records include the identity of the reagent or consumable?


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3. 6.6.7.b - Do the records include the manufacturer's information, including instructions, name, and batch code or lot number?


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4. 6.6.7.c - Do the records include the date of receipt, condition when received, expiry date, date of first use, and, where applicable, the date the reagent or consumable was taken out of service?


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5. 6.6.7.d - Do the records include documentation that confirms the reagent's or consumable's initial and ongoing acceptance for use?


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6. Where the laboratory uses reagents prepared, resuspended, or combined in-house, do the records include, in addition to the relevant information above, reference to the person or persons undertaking the preparation, as well as the dates of preparation and expiry?


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7.8 Continuity And Emergency Preparedness Planning

1. Does the laboratory ensure that risks associated with emergency situations or other conditions when laboratory activities are limited, or unavailable, have been identified, and that a coordinated strategy exists that involves plans, procedures, and technical measures to enable continued operations after a disruption?


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2. Are plans periodically tested and the planned response capability exercised, where practicable?


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3. 7.8.a - Does the laboratory establish a planned response to emergency situations, taking into account the needs and capabilities of all relevant laboratory personnel?


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4. 7.8.b - Does the laboratory provide information and training as appropriate to relevant laboratory personnel?


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5. 7.8.c - Does the laboratory respond to actual emergency situations?


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6. 7.8.d - Does the laboratory take action to prevent or mitigate the consequences of emergency situations, appropriate to the magnitude of the emergency and the potential impact?


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6.7.1 Agreements With Laboratory Users

1. Does the laboratory have a procedure to establish and periodically review agreements for providing laboratory activities?


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2. 6.7.1.a - Does the procedure ensure that the requirements are adequately specified?


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3. 6.7.1.b - Does the procedure ensure that the laboratory has the capability and resources to meet the requirements?


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