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

6.5.1 General

6.5.2 Equipment Calibration

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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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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7.7.1 Process

7.7.2 Receipt Of Complaint

7.7.3 Resolution Of Complaint

6.6.1 General

6.6.2 Reagents And Consumables â€” Receipt And Storage

6.6.3 Reagents And Consumables â€” Acceptance Testing

6.6.4 Reagents And Consumables â€” Inventory Management

6.6.5 Reagents And Consumables â€” Instructions For Use

6.6.6 Reagents And Consumables â€” Adverse Incident Reporting

6.6.7 Reagents And Consumables â€” Records

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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6.7.1 Agreements With Laboratory Users

6.7.2 Agreements With POCT Operators

8.1 General Requirements - 8.1.1 General

8.1.2 Fulfillment Of Management System Requirements

8.1.3 General

6.8.1 General

6.8.2 Referral Laboratories And Consultants

6.8.3 Review And Approval Of Externally Provided Products And Services

4. 6.8.3.d - Does the laboratory have procedures and retain records for ensuring that externally provided products and services conform to the laboratory's established requirements, or where applicable, to the relevant requirements of this document before they are used or directly provided to the user?

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8.2.1 General

1. Does the laboratory management establish, document, and maintain objectives and policies for the fulfillment of the purposes of this document and ensure that the objectives and policies are acknowledged and implemented at all levels of the laboratory organization?

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8.2.2 Competence And Quality

8.2.3 Evidence Of Commitment

8.2.4 Documentation

8.2.5 Personnel Access

4.1 Impartiality

7.1 General

1. Does the laboratory identify potential risks to patient care in the pre-examination, examination, and post-examination processes? Are these risks assessed and mitigated to the extent possible? Is the residual risk communicated to users as appropriate?

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8.3.1 General

8.3.2 Control Of Documents

4.2.1 Management Of Information

3. Is all other information, except for information that the user and/or the patient makes publicly available, or when agreed between the laboratory and the patient (e.g., for the purpose of responding to complaints), considered proprietary information and regarded as confidential?

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4.2.2. Release Of Information

2. Is information about the patient from a source other than the patient (e.g., complainant, regulator) kept confidential by the laboratory? Is the identity of the source kept confidential by the laboratory and not shared with the patient, unless agreed by the source?

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4.2.3 Personnel Responsibility

1. Do personnel, including any committee members, contractors, personnel of external bodies, or individuals with access to laboratory information acting on the laboratory’s behalf, keep confidential all information obtained or created during the performance of laboratory activities?

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7.2.1 General

7.2.2 Laboratory Information For Patients And Users

1. Does the laboratory have appropriate information available for its users and patients? Is the information sufficiently detailed to provide laboratory users with a comprehensive understanding of the laboratory's scope of activities and requirements?

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8.4.1 Creation Of Records

8.4.2 Amendment Of Records

8.4.3 Retention Of Records

4.3 Requirements Regarding Patients

5. 4.3.d - Does the laboratory establish and implement, where appropriate, the disclosure of incidents that resulted or could have resulted in patient harm to patients, users, and other relevant persons, along with records of actions taken to mitigate those harms?

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7.2.3.1 General

7.2.3.2 Oral Requests

8.5.1 Identification Of Risks And Opportunities For Improvement

8.5.2 Acting On Risks And Opportunities For Improvement

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7.2.4.1 General

3. Does the laboratory periodically review requirements for sample volume, collection device, and preservatives for all sample types, as applicable, to ensure that neither insufficient nor excessive amounts of sample are collected, and samples are properly collected to preserve the analyte?

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7.2.4.2 Information For Pre-collection Activities

6. 7.2.4.2.e - Does this include sample labeling for unequivocal identification of the patient, as well as the source and site of the sample, and labeling when several samples from the same patient are to be collected, including multiple pieces of tissue or slides?

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7.2.4.2 Patient Consent

7.2.4.4 Instructions For Collection Activities

2. 7.2.4.4.b - To ensure safe, accurate, and clinically appropriate sample collection and pre-examination storage, does the laboratory provide instructions for verifying and, when relevant, recording that the patient meets pre-examination requirements (e.g., fasting status, medication status, sample collection at predetermined times or intervals)?

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3. 7.2.4.4.c - To ensure safe, accurate, and clinically appropriate sample collection and pre-examination storage, does the laboratory provide instructions for the collection of primary samples, including descriptions of the primary sample containers, any necessary additives, and, where relevant, the order of sample collection?

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4. 7.2.4.4.d - To ensure safe, accurate, and clinically appropriate sample collection and pre-examination storage, does the laboratory provide instructions for the labeling of primary samples in a manner that provides an unequivocal link with the patients from whom they are collected?

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5. 7.2.4.4.e - To ensure safe, accurate, and clinically appropriate sample collection and pre-examination storage, does the laboratory provide instructions for recording the identity of the person collecting the primary sample, the collection date, and, when relevant, the collection time?

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7. 7.2.4.4.g - To ensure safe, accurate, and clinically appropriate sample collection and pre-examination storage, does the laboratory provide instructions for the stabilization and proper storage conditions before collected samples are delivered to the laboratory?

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8.6.1 Continual Improvement

2. 8.6.1.b - Does the laboratory identify and select opportunities for improvement and develop, document, and implement any necessary actions? Are improvement activities directed at areas of highest priority based on risk assessments and the opportunities identified?

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8.6.2 Laboratory Patients, User, And Personnel Feedback

5.2.1 Laboratory Director Competence

5.2.2 Laboratory Director Responsibilities

1. Is the laboratory director responsible for the implementation of the management system, including the application of risk management to all aspects of the laboratory operations so that risks to patient care and opportunities to improve are systematically identified and addressed?

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5.2.3 Delegation Of Duties

7.2.5 Sample Transportation

8.7.1 Actions When Nonconformity Occurs

8.7.2 Corrective Action Effectiveness

8.7.3 Records Of Nonconformities And Corrective Actions

5.3.1 General

5.3.2 Conformance With Requirements

5.3.3 Advisory Activities

2. 5.3.3 a - Does the laboratory establish arrangements for communicating with laboratory users, advising on the selection and use of examinations, including the required type of sample, clinical indications and limitations of examination methods, and the appropriate frequency for requesting the examination?

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7.2.6.1 Sample Receipt Procedure

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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7.2.6.2 Sample Acceptance Exceptions

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

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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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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5.4.1 General

5.4.2 Quality Management

7.2.7.1 Sample Protection

7.2.7.2 Criteria For Additional Examination Requests

7.2.7.3 Sample Stability

8.9.1 General

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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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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8.9.3 Review Output

5.5 Objectives And Policies

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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7.3.1 General

7.3.2 Verification Of Examination Methods

7.3.3 Validation Of Examination Methods

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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7.3.4 Evaluation Of Measurement Uncertainty (Mu)

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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7.3.5 Biological Reference Intervals And Clinical Decision Limits

7.3.6 Documentation Of Examination Procedures

6.1 General

6.2 Personnel

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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6.2.3 Authorization

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.

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

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

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?

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

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

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

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?

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

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

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?

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?

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?

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?

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

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?

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?

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

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

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

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)

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

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?

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

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?

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

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

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?

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?

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

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

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?

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

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.

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?

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

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

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

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

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?

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

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?

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

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?

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

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

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?

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

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

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

4. 6.7.1.c - When applicable, does the procedure ensure that the laboratory advises the user of the specific activities to be performed by referral laboratories and consultants?

5. Are laboratory users informed of any changes to an agreement that can affect examination results?

6. Are records of reviews, including any significant changes, retained?

1. Do service agreements between the laboratory and other parts of the organization using laboratory-supported POCT, ensure that respective responsibilities and authorities are specified and communicated?

1. Has the laboratory established, documented, implemented, and maintained a management system to support and demonstrate the consistent fulfillment of the requirements of this document?

2. Does the management system of the laboratory include responsibilities as outlined in section 8.1?

3. Does the management system of the laboratory include objectives and policies as outlined in section 8.2?

4. Does the management system of the laboratory include documented information as outlined in sections 8.2, 8.3, and 8.4?

5. Does the management system of the laboratory include actions to address risks and opportunities for improvement as outlined in section 8.5?

6. Does the management system of the laboratory include provisions for continual improvement as outlined in section 8.6?

7. Does the management system of the laboratory include corrective actions as outlined in section 8.7?

8. Does the management system of the laboratory include evaluations and internal audits as outlined in section 8.8?

9. Does the management system of the laboratory include management reviews as outlined in section 8.9?

1. Does the laboratory meet 8.1.1 by establishing, implementing, and maintaining a quality management system? (e.g., in accordance with the requirements of ISO 9001) (see Table B.1).

2. Does this quality management system support and demonstrate the consistent fulfillment of the requirements of Clauses 4 to 7 and the requirements specified in 8.2 to 8.9?

1. 8.1.3.a - Does the laboratory ensure that persons doing work under the laboratory’s control are aware of relevant objectives and policies?

2. 8.1.3.b - Does the laboratory ensure that persons doing work under the laboratory’s control are aware of their contribution to the effectiveness of the management system, including the benefits of improved performance?

3. 8.1.3.c - Does the laboratory ensure that persons doing work under the laboratory’s control are aware of the consequences of not conforming with the management system requirements?

1. 6.8.1.a - Does the laboratory ensure that externally provided products and services intended for incorporation into the laboratory's own activities are suitable?

2. 6.8.1.b - Does the laboratory ensure that externally provided products and services, which are provided in part or in full directly to the user by the laboratory as received from the external provider, are suitable?

3. 6.8.1.c - Does the laboratory ensure that externally provided products and services used to support the operation of the laboratory are suitable?

1. 6.8.2.a - Does the laboratory communicate its requirements to referral laboratories and consultants for the procedures, examinations, reports, and consulting activities to be provided?

2. 6.8.2.b - Does the laboratory communicate its requirements to referral laboratories and consultants for the management of critical results?

3. 6.8.2.c - Does the laboratory communicate its requirements to referral laboratories and consultants regarding any required personnel qualifications and demonstration of competence?

4. Unless otherwise specified in the agreement, is the referring laboratory (and not the referral laboratory) responsible for ensuring that the examination results of the referral laboratory are provided to the person making the request?

5. Is a list of all referral laboratories and consultants maintained?

1. 6.8.3.a - Does the laboratory have procedures and retain records for defining, reviewing, and approving the laboratory's requirements for all externally provided products and services?

2. 6.8.3.b - Does the laboratory have procedures and retain records for defining the criteria for qualification, selection, evaluation of performance, and re-evaluation of external providers?

3. 6.8.3.c - Does the laboratory have procedures and retain records for the referral of samples?