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 7.3.7.2: Internal quality control
What does 7.3.7.2 require?
An internal quality control (IQC) procedure shall confirm that intended quality is being achieved against set criteria. It shall take account of the clinical use of results, pick up variation between reagent or calibrator lots (IQC lots should not be changed in the same run as reagent or calibrator lots), and consider third-party control material. IQC material shall suit its purpose: stable, with a matrix and reactivity close to patient samples, and challenging the method in a clinically meaningful way at decision limits and across the measuring range; where no such material exists, other approaches shall be used, such as trend analysis of patient results, comparison with a traceable alternative method, or retesting of stored samples. How often IQC is run shall depend on how stable and robust the method is and how much harm a wrong result could cause. IQC data shall be recorded so trends show up and reviewed against defined acceptance criteria often enough to reflect current performance. When IQC fails, patient results shall be held back; results likely to carry clinically significant error shall be rejected and the samples re-examined once the fault is corrected, and results issued since the last acceptable IQC shall be assessed.
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.
1256 Operate control procedures for every test system that detect immediate errors and monitor accuracy and precision over time: at least daily two levels for quantitative tests, positive and negative for qualitative tests, graded or titered controls, extraction and inhibition controls for extraction and molecular amplification systems, specified controls for thin layer chromatography and electrophoresis, controls after reagent change or major maintenance, rotation among operators, controls tested like patients, established acceptability criteria and statistical parameters, reagent, stain and media checks, and no patient results released until controls are acceptable
1261-1265 Meet the microbiology specialty control requirements: reactivity checks of beta-lactamase, Gram stain, antisera and mycobacterial reagents at the stated frequencies; control organisms for each batch, lot and shipment of susceptibility media and agents with results within established limits before reporting; lactophenol cotton blue checks; a parasitology reference collection, calibrated ocular micrometer and monthly permanent stain checks; and uninoculated cell culture negative controls in virology
1267-1269 Meet the routine chemistry and hematology specialty control requirements: blood gas calibration or verification per the manufacturer, a low and high control each eight hours of testing and a control each run unless the analyser self-verifies calibration every 30 minutes; hemocytometer counts with one control each eight hours and duplicates; two coagulation control levels each eight hours and on reagent change, with duplicate manual coagulation testing
1273 Meet the histopathology requirements: control slides of known reactivity with each special stain and fluorescent and immunohistochemical stain checks each time of use, documented; retention of slides, blocks and tissue remnants until a qualified individual has made the diagnosis; tissue reports signed (or electronically authorised) by a qualified pathologist or an HHS-approved neuromuscular pathology trainee; and recognised disease nomenclature in reports
1274 Meet the cytology requirements: evaluate all slides on the premises of a cytology-certified laboratory; Papanicolaou staining and cross-contamination controls; a documented error-detection program with a 10 percent rescreen of negative gynecologic cases by a qualified reviewer before reporting, cytology-histology correlation, five-year lookback on new HSIL or malignancy, annual statistics and individual evaluation; technical supervisor-set workload limits reassessed every six months and never above 100 slides in no less than eight hours; technical supervisor confirmation of abnormal gynecologic and all nongynecologic preparations; narrative nomenclature; corrected reports stating the basis; and slide and record retention with loan documentation
10.05 Quality control process: the designated person oversees quality control, every assay has a documented quality control process assessing performance, the process specifies the criteria for control targets at clinical decision levels and acceptable results for patient testing and alternative mechanisms when internal controls are unavailable, a documented escalation procedure on control failure reviews specimens measured between the last successful and first failed control, performance is monitored with corrective action and reports, and control results are documented and retained per the relevant standards
10.06 Frequency of quality control testing: test control samples at a frequency based on the stability and robustness of the method and the risk of patient harm, and additionally when critical consumables change, when confidence in a result's reliability or accuracy is in question, and after substantial equipment maintenance or damage