ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence
Clause 7: Process requirements – ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence
ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence 7.3.7.3: External quality assessment
What does 7.3.7.3 require?
Performance shall be checked against other laboratories by taking part in external quality assessment (EQA) programmes that fit the laboratory's examinations and interpretations, POCT included, under a procedure for enrolment, participation and performance. EQA samples shall be handled by the staff who normally do the work. As far as possible, programmes shall test every phase from before examination through to after it, use samples resembling patient samples and conform to ISO/IEC 17043, with attention to the type of target value. Where no suitable programme exists, the laboratory shall use justified alternatives backed by evidence that they work, such as exchanging samples with other laboratories, comparing IQC across laboratories, testing different calibrator lots, split-sample testing, commutable reference materials, clinical correlation or repository materials. EQA results shall be reviewed regularly against acceptance criteria. Results outside the criteria shall trigger action, including an assessment of clinical significance and, where significant, a review of the patient results affected and advice to users.
This control maps to 7 controls across 2 other frameworks. If you already hold one of them, the evidence you collected for it is the starting point here rather than new work.
1236 Review and evaluate all proficiency testing results, verify the accuracy of any unscored or unevaluated analyte, and at least twice a year verify the accuracy of every test not covered by an approved PT program, documenting all evaluation and verification
801(a) Enrol in a CMS-approved proficiency testing program for every specialty, subspecialty and regulated analyte the laboratory is certified to perform, designate the program used for each, stay with it for a year before changing, and authorise release of PT data to HHS
801(b) Test proficiency testing samples exactly as patient specimens, within the routine workload by the staff who normally test, the same number of times, with no inter-laboratory communication or referral of PT samples before the reporting deadline, with the analyst and director attesting to routine integration and all records kept for two years
803-807 Participate successfully in proficiency testing for each specialty, subspecialty and analyte certified, take remedial action when an individual fails gynecologic cytology, and, after a failure-based suspension or withdrawal, demonstrate satisfactory performance on two consecutive events before reinstatement
10.10 External quality assurance programs: participate in EQA for the preanalytical, analytical and postanalytical phases of every test or test group with an available program, assess program suitability against predefined criteria including ISO 17043, keep the supervising medical practitioner in oversight, test and report EQA material like routine specimens wherever possible, document acceptable performance criteria, review results for acceptability against the practice's risk analysis, investigate discordance promptly and assess and correct any impact on patient results, and notify the designated person of serious and persistent poor performance
10.11 Morphological external quality assurance: ensure every workforce member involved in morphological diagnosis takes part in at least one relevant EQA program a year, retain individual participation records, review results and follow up discordance, and state clearly where submissions are collegiate
10.12 Internal quality assurance: where no suitable EQA exists, use alternative internal quality assurance for the preanalytical, analytical and postanalytical phases, addressing high-risk collection and testing areas through comparison with other accredited laboratories, demonstrating result validity through reference material or interlaboratory comparison such as sample exchange, and using peer review through formal sample exchange, formal second opinion or informal second opinion to compare diagnoses