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US Clinical Laboratory Improvement Amendments (CLIA) Regulations (42 CFR Part 493)
United States (federal)
v42 CFR Part 493 as codified in the eCFR at the 2026-10-15 issue date (incorporating the CLIA fees, histocompatibility, personnel and alternative sanctions final rule of 28 December 2023, effective 27 December 2024); fetched 2026-10-18
8 domains
47 controls
The CLIA laboratory requirements in 42 CFR Part 493: certificates and notifications, proficiency testing, facility administration and record retention, the quality system for nonwaived testing across all phases, personnel qualifications and responsibilities, and inspection, as a CLIA-certified laboratory must meet them for certification and Medicare approval.
Verified
US Clinical Laboratory Improvement Amendments (CLIA) Regulations (42 CFR Part 493) is a compliance framework from United States (federal) with 8 domains and 47 controls that map to 1 other frameworks. The largest domains are Subpart K: quality system, analytic systems (sections 493.1250 to 493.1289) – US Clinical Laboratory Improvement Amendments (CLIA) Regulations (42 CFR Part 493) (16 controls), Subpart K: quality system for nonwaived testing, general laboratory and preanalytic systems (sections 493.1200 to 493.1249) – US Clinical Laboratory Improvement Amendments (CLIA) Regulations (42 CFR Part 493) (11 controls), Subpart M: personnel for nonwaived testing, qualifications and responsibilities (sections 493.1351 to 493.1495) – US Clinical Laboratory Improvement Amendments (CLIA) Regulations (42 CFR Part 493) (7 controls). Every control below carries what it requires and what an assessor expects to see.
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Framework Domains (8)
Subpart H: participation in proficiency testing for nonwaived testing (sections 493.801 to 493.865), with Subpart I program approval as context – US Clinical Laboratory Improvement Amendments (CLIA) Regulations (42 CFR Part 493)
4 controls
| Code | Title |
|---|---|
| us-clinical-laboratory-improvement-amendments-clia-regulations-42-cfr-part-493::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 |
| us-clinical-laboratory-improvement-amendments-clia-regulations-42-cfr-part-493::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 |
| us-clinical-laboratory-improvement-amendments-clia-regulations-42-cfr-part-493::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 |
| us-clinical-laboratory-improvement-amendments-clia-regulations-42-cfr-part-493::821-865 | Meet the specialty and subspecialty proficiency testing criteria: for each microbiology, immunology, chemistry, hematology, gynecologic cytology and immunohematology event, the laboratory must identify or quantify the challenges to the program's target within the stated acceptance limits, and unsuccessful performance in two of three consecutive events is unsuccessful participation |
Subpart J: facility administration for nonwaived testing (sections 493.1100 to 493.1105) – US Clinical Laboratory Improvement Amendments (CLIA) Regulations (42 CFR Part 493)
3 controls
| Code | Title |
|---|---|
| us-clinical-laboratory-improvement-amendments-clia-regulations-42-cfr-part-493::1101 | Keep the laboratory constructed, arranged and maintained with adequate space, ventilation and utilities, contamination minimised, uni-directional workflow for open molecular amplification, sufficient equipment and supplies, compliance with federal, State and local laboratory laws, observed safety procedures, and records and slides stored to preserve them |
| us-clinical-laboratory-improvement-amendments-clia-regulations-42-cfr-part-493::1103 | Where transfusion services are provided, hold an approved transfusion service agreement, provide prompt ABO grouping, D typing, antibody detection, compatibility testing and transfusion reaction investigation through a CLIA-certified laboratory, store blood under appropriate conditions, positively identify the recipient, and investigate and report transfusion reactions |
| us-clinical-laboratory-improvement-amendments-clia-regulations-42-cfr-part-493::1105 | Retain records for the CLIA minimum periods: requisitions, procedures, analytic and quality control records, PT records, quality assessment records and test reports for two years, pathology reports and histopathology slides for ten years, cytology slides for five years, blocks for two years, tissue until diagnosis, with provisions made for retention if the laboratory closes |
Subpart K: quality system for nonwaived testing, general laboratory and preanalytic systems (sections 493.1200 to 493.1249) – US Clinical Laboratory Improvement Amendments (CLIA) Regulations (42 CFR Part 493)
11 controls
| Code | Title |
|---|---|
| us-clinical-laboratory-improvement-amendments-clia-regulations-42-cfr-part-493::1200 | Establish and maintain written policies and procedures implementing and monitoring a quality system across the general laboratory, preanalytic, analytic and postanalytic phases, with a quality assessment component that identifies, evaluates and resolves problems and drives continuous improvement, scaled to the specialties, services and clients served |
| us-clinical-laboratory-improvement-amendments-clia-regulations-42-cfr-part-493::1231 | Ensure confidentiality of patient information throughout every phase of the total testing process under the laboratory's control |
| us-clinical-laboratory-improvement-amendments-clia-regulations-42-cfr-part-493::1232 | Establish and follow written policies and procedures that ensure positive identification and optimum integrity of each patient specimen from collection or receipt through testing and reporting |
| us-clinical-laboratory-improvement-amendments-clia-regulations-42-cfr-part-493::1233 | Operate a system that documents every complaint and problem reported to the laboratory and investigates complaints where appropriate |
| us-clinical-laboratory-improvement-amendments-clia-regulations-42-cfr-part-493::1234 | Identify and document problems arising from breakdowns in communication between the laboratory and the authorised persons who order or receive test results |
| us-clinical-laboratory-improvement-amendments-clia-regulations-42-cfr-part-493::1235 | Establish and follow written policies and procedures to assess the competency of employees and, where applicable, consultants, as the Subpart M personnel responsibilities require |
| us-clinical-laboratory-improvement-amendments-clia-regulations-42-cfr-part-493::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 |
| us-clinical-laboratory-improvement-amendments-clia-regulations-42-cfr-part-493::1239 | Run an ongoing, documented general laboratory systems quality assessment that monitors, assesses and corrects problems in confidentiality, specimen identification, complaints, communications, competency and PT evaluation, reviews the effectiveness of corrective actions, revises procedures to prevent recurrence and discusses the reviews with staff |
| us-clinical-laboratory-improvement-amendments-clia-regulations-42-cfr-part-493::1241 | Accept testing only on a written or electronic request from an authorised person (or an oral request followed within 30 days by written authorisation), ensure the requisition solicits the required patient, requester, test, specimen source and collection information, and transcribe requisition data accurately |
| us-clinical-laboratory-improvement-amendments-clia-regulations-42-cfr-part-493::1242 | Establish and follow written procedures for patient preparation, specimen collection, labelling, storage and preservation, transport, processing, acceptability and rejection, and referral; record the date and time of receipt; refer specimens only to CLIA-certified laboratories; and give clients written submission instructions |
| us-clinical-laboratory-improvement-amendments-clia-regulations-42-cfr-part-493::1249 | Run an ongoing, documented preanalytic systems quality assessment covering test requests and specimen submission, handling and referral, with effectiveness review of corrective actions, procedure revision to prevent recurrence and discussion with staff |
Subpart K: quality system, analytic systems (sections 493.1250 to 493.1289) – US Clinical Laboratory Improvement Amendments (CLIA) Regulations (42 CFR Part 493)
16 controls
| Code | Title |
|---|---|
| us-clinical-laboratory-improvement-amendments-clia-regulations-42-cfr-part-493::1251 | Maintain a written procedure manual for every test, assay and examination, followed by staff, containing the fourteen required elements where applicable, approved, signed and dated by the current director before use and on every change, with retired procedures kept with their dates of use |
| us-clinical-laboratory-improvement-amendments-clia-regulations-42-cfr-part-493::1252 | Select test systems and perform testing to the manufacturer's instructions within the laboratory's stated performance specifications; define, monitor and document the storage and operating conditions essential to reliable testing (water quality, temperature, humidity, power protection); label reagents and materials with identity, strength, storage, preparation and expiry; never use expired, deteriorated or substandard materials; and do not mix kit components across lots unless the manufacturer allows |
| us-clinical-laboratory-improvement-amendments-clia-regulations-42-cfr-part-493::1253 | Before reporting patient results on an unmodified FDA-cleared or approved test system, verify accuracy, precision and reportable range and confirm the manufacturer's reference intervals suit the patient population; for a modified, in-house or non-FDA test system, establish accuracy, precision, analytical sensitivity and specificity including interferences, reportable range, reference intervals and any other needed characteristic; set calibration and control procedures from those specifications; and document everything |
| us-clinical-laboratory-improvement-amendments-clia-regulations-42-cfr-part-493::1254 | Perform and document maintenance and function checks for unmodified manufacturer systems as the manufacturer defines and at least as often as specified, with function checks within the manufacturer's limits before patient testing; for in-house, modified or unspecified systems, establish and follow a maintenance protocol and a function check protocol (including background or baseline checks) that ensure reliable results |
| us-clinical-laboratory-improvement-amendments-clia-regulations-42-cfr-part-493::1255 | Calibrate each test system per the manufacturer's instructions and the laboratory's established criteria, with traceable materials where possible; verify calibration across the reportable range using at least a low, mid and high value at least every six months and after a complete reagent change, major maintenance or critical part replacement, or when control results trend or shift unexplained; recalibrate whenever calibration verification fails |
| us-clinical-laboratory-improvement-amendments-clia-regulations-42-cfr-part-493::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 |
| us-clinical-laboratory-improvement-amendments-clia-regulations-42-cfr-part-493::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 |
| us-clinical-laboratory-improvement-amendments-clia-regulations-42-cfr-part-493::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 |
| us-clinical-laboratory-improvement-amendments-clia-regulations-42-cfr-part-493::1271 | Meet the immunohematology requirements: perform ABO, D typing, antibody detection and identification and compatibility testing per the manufacturer and 21 CFR 606.151; confirm ABO with reverse grouping; comply with the FDA blood regulations for testing and distribution; store blood with an audible 24-hour temperature alarm that is inspected and documented; retain samples of transfused units; and promptly investigate transfusion reactions with documented remedial action |
| us-clinical-laboratory-improvement-amendments-clia-regulations-42-cfr-part-493::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 |
| us-clinical-laboratory-improvement-amendments-clia-regulations-42-cfr-part-493::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 |
| us-clinical-laboratory-improvement-amendments-clia-regulations-42-cfr-part-493::1276-1278 | Meet the clinical cytogenetics and histocompatibility requirements: specimen identification through accessioning, culture, imaging and reporting, records of media, cells counted and karyotyped, banding resolution and adequate karyotypes, sex by full chromosome analysis, ISCN reporting; continuous monitored specimen and reagent storage with alarm and emergency storage, cell exchange participation, WHO HLA nomenclature, written typing and crossmatch criteria, monthly recipient sera, transplant testing protocols and a day-of-transplant recipient specimen |
| us-clinical-laboratory-improvement-amendments-clia-regulations-42-cfr-part-493::1281 | Twice a year evaluate and define the relationship between results for the same test performed by different methods, instruments or sites, and maintain a system that flags patient results inconsistent with age, sex, diagnosis, result distribution or related parameters, documenting all comparison activity |
| us-clinical-laboratory-improvement-amendments-clia-regulations-42-cfr-part-493::1282 | Maintain and follow corrective action procedures, and document every corrective action taken when test systems fall outside established performance specifications, when calibration or control results fail (with evaluation of all patient results since the last acceptable run), or when reagent and specimen storage criteria are not met |
| us-clinical-laboratory-improvement-amendments-clia-regulations-42-cfr-part-493::1283 | Maintain a test record system that captures positive specimen identification, the date and time of receipt, the condition and disposition of unacceptable specimens, and the records and dates of all testing including who performed each test, and retain patient testing records including instrument printouts |
| us-clinical-laboratory-improvement-amendments-clia-regulations-42-cfr-part-493::1289 | Run an ongoing, documented analytic systems quality assessment covering the procedure manual, test systems, performance specifications, maintenance, calibration, controls, specialty requirements, comparisons, corrective actions and test records, with effectiveness review, procedure revision and staff discussion |
Subpart K: quality system, postanalytic systems (sections 493.1290 to 493.1299) – US Clinical Laboratory Improvement Amendments (CLIA) Regulations (42 CFR Part 493)
2 controls
| Code | Title |
|---|---|
| us-clinical-laboratory-improvement-amendments-clia-regulations-42-cfr-part-493::1291 | Report results through a system that transmits them accurately and timely from data entry to final destination; include patient identification, performing laboratory name and address, report date, test, specimen source, result with units or interpretation and specimen condition; make reference intervals, methods and interferences available to clients and update them on change; release results only to authorised persons (and to patients on request); immediately alert the requester to life-threatening or panic values; notify of delayed results; handle referred results without alteration and disclose the performing laboratory; keep reports retrievable; and on error notify promptly, issue corrected reports and keep both versions |
| us-clinical-laboratory-improvement-amendments-clia-regulations-42-cfr-part-493::1299 | Run an ongoing, documented postanalytic systems quality assessment of test reporting, with effectiveness review of corrective actions, procedure revision to prevent recurrence and discussion with staff |
Subpart M: personnel for nonwaived testing, qualifications and responsibilities (sections 493.1351 to 493.1495) – US Clinical Laboratory Improvement Amendments (CLIA) Regulations (42 CFR Part 493)
7 controls
| Code | Title |
|---|---|
| us-clinical-laboratory-improvement-amendments-clia-regulations-42-cfr-part-493::1355-1365 | For provider-performed microscopy procedures, have a qualified director (physician, independently practising midlevel practitioner or dentist, State-licensed where required) who directs no more than five laboratories, ensures each PPM procedure is personally performed by a qualified practitioner during the patient visit using a brightfield or phase contrast microscope and in line with Subparts H, J and K, and evaluates and documents testing personnel competency semiannually in the first year and annually thereafter |
| us-clinical-laboratory-improvement-amendments-clia-regulations-42-cfr-part-493::1405-1489 | Employ only personnel who meet the Subpart M qualification standards for their role and the complexity of testing: laboratory director, technical consultant, clinical consultant and testing personnel for moderate complexity, and laboratory director, technical supervisor (by specialty), clinical consultant, general supervisor, cytology general supervisor, cytotechnologist and testing personnel for high complexity, each with the State licence where required and the education, board certification, training and experience the sections specify, and keep the qualification evidence on file |
| us-clinical-laboratory-improvement-amendments-clia-regulations-42-cfr-part-493::1407-1445 | The laboratory director takes responsibility for overall operation and administration and for compliance, is onsite at least twice a year at least four months apart with documented visits and remains accessible, directs no more than five laboratories, and ensures quality testing across all three phases, a safe physical plant, adequate methods and verification, PT enrolment with timely results and reviewed reports and corrective action plans, quality control and assessment programs, analytical performance levels, documented remedial action with results withheld until the system works, interpretable reports, client consultation, sufficient qualified staff, training and demonstrated competence before testing, competency monitoring policies, an approved procedure manual, and written duties for every consultant, supervisor and testing person |
| us-clinical-laboratory-improvement-amendments-clia-regulations-42-cfr-part-493::1413-1451 | The technical consultant (moderate complexity) or technical supervisor (high complexity, by specialty) provides accessible technical and scientific oversight: method selection, verification of procedures and performance characteristics, PT enrolment and participation, the quality control program and performance parameters, resolution of technical problems and remedial action, no reporting until corrected, training needs and in-service education, competency evaluation using the six required methods, and documented performance evaluation semiannually in the first year then annually or on method change; in cytology the technical supervisor also sets and reassesses workload limits, performs the section 493.1274 reviews, ensures individual PT participation and records their own screening volumes |
| us-clinical-laboratory-improvement-amendments-clia-regulations-42-cfr-part-493::1419-1457 | The clinical consultant is available to advise the laboratory's clients on the appropriateness of tests ordered and the interpretation of results, and ensures reports carry the information needed for patient-specific interpretation and that consultation on result quality and interpretation is communicated to clients |
| us-clinical-laboratory-improvement-amendments-clia-regulations-42-cfr-part-493::1425-1495 | Testing personnel (and cytotechnologists) perform only the tests the director authorises and that match their skill; follow the laboratory's procedures for handling, testing, reporting and record keeping; keep records showing PT samples are tested like patient samples; adhere to quality control policies and document control, calibration and maintenance; follow corrective action procedures when systems are out of limits; identify and correct or escalate problems; document corrective actions; and, if qualified under the high school route, perform high complexity testing only under onsite direct general supervision; cytotechnologists document their interpretations, slide counts across employers and hours |
| us-clinical-laboratory-improvement-amendments-clia-regulations-42-cfr-part-493::1463-1471 | For high complexity testing the general supervisor is accessible to testing personnel whenever testing is performed, provides day-to-day supervision, is onsite to directly supervise individuals qualified under the high school route, monitors analyses and examinations for acceptable analytic performance and may carry delegated remedial action, result release, orientation and competency duties; the cytology general supervisor is accessible for technical problems and documents slide interpretations, slide counts across all employers and hours per 24-hour period |
Subparts B to F: certificates of waiver, registration, compliance and accreditation, deemed status, validation inspections and fees (sections 493.35 to 493.680) – US Clinical Laboratory Improvement Amendments (CLIA) Regulations (42 CFR Part 493)
2 controls
| Code | Title |
|---|---|
| us-clinical-laboratory-improvement-amendments-clia-regulations-42-cfr-part-493::35-63 | Hold the CLIA certificate that matches the complexity of testing performed, apply and renew on the HHS form, and notify CMS within 30 days of any change of ownership, name, location or director and before adding tests or specialties outside the current certificate |
| us-clinical-laboratory-improvement-amendments-clia-regulations-42-cfr-part-493::551-567 | Deemed status through an approved accreditation organisation: obtain the certificate of accreditation, pay the fees, meet the proficiency testing subpart, authorise the PT program and the accreditation organisation to release results and adverse actions to CMS, and cooperate fully with any CMS validation inspection |
Subparts Q, R and T: inspection, enforcement procedures and the Clinical Laboratory Improvement Advisory Committee (sections 493.1771 to 493.2001) – US Clinical Laboratory Improvement Amendments (CLIA) Regulations (42 CFR Part 493)
2 controls
| Code | Title |
|---|---|
| us-clinical-laboratory-improvement-amendments-clia-regulations-42-cfr-part-493::1773 | Permit CMS or its agent to inspect, revisit and investigate complaints: allow testing of samples including PT samples, interviews of all personnel, observation of every phase of testing, access to all specimen, storage, testing and reporting areas, copies of all records and data, keep records accessible and retrievable within a reasonable time during the inspection, and provide all information needed to determine compliance; refusal leads to loss of Medicare and Medicaid participation and action against the certificate |
| us-clinical-laboratory-improvement-amendments-clia-regulations-42-cfr-part-493::1775-1780 | Accept the inspection regime for the certificate held: waived and PPM laboratories are inspected at any time to check for imminent risk, complaints, testing beyond the certificate or test appropriateness; registration and compliance laboratories undergo an initial inspection before the certificate of compliance and biennial or risk-based inspections thereafter; accredited and CLIA-exempt laboratories undergo validation and complaint inspections, with condition-level findings triggering full CMS review or State enforcement |
Maps to 1 other framework
47 total controls
ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence
39 source controls mapped|28 target controls covered
83%
Coverage is not the same as your position
This page shows what US Clinical Laboratory Improvement Amendments (CLIA) Regulations (42 CFR Part 493) overlaps with in general. Where your organisation actually stands, against the standard you are going for and the certifications you already hold, is a different question. Same graph and the same recorded refutations, scoped to you rather than to a pair.
The Compliance Position Diagnostic, $5,000 fixed, ten business daysWhat is US Clinical Laboratory Improvement Amendments (CLIA) Regulations (42 CFR Part 493) and who does it apply to?
US Clinical Laboratory Improvement Amendments (CLIA) Regulations (42 CFR Part 493) is a compliance framework from United States (federal) with 8 domains and 47 controls. The CLIA laboratory requirements in 42 CFR Part 493: certificates and notifications, proficiency testing, facility administration and record retention, the quality system for nonwaived testing across all phases, personnel qualifications and responsibilities, and inspection, as a CLIA-certified laboratory must meet them for certification and Medicare approval. It is used by organisations to establish and maintain compliance with industry standards and regulatory requirements.
What does US Clinical Laboratory Improvement Amendments (CLIA) Regulations (42 CFR Part 493) actually require?
US Clinical Laboratory Improvement Amendments (CLIA) Regulations (42 CFR Part 493) has 47 controls organised across 8 domains. The largest domains are Subpart K: quality system, analytic systems (sections 493.1250 to 493.1289) – US Clinical Laboratory Improvement Amendments (CLIA) Regulations (42 CFR Part 493) (16 controls), Subpart K: quality system for nonwaived testing, general laboratory and preanalytic systems (sections 493.1200 to 493.1249) – US Clinical Laboratory Improvement Amendments (CLIA) Regulations (42 CFR Part 493) (11 controls), Subpart M: personnel for nonwaived testing, qualifications and responsibilities (sections 493.1351 to 493.1495) – US Clinical Laboratory Improvement Amendments (CLIA) Regulations (42 CFR Part 493) (7 controls). Each control defines specific requirements that organisations must implement to achieve compliance.
If I already comply with another framework, how much of US Clinical Laboratory Improvement Amendments (CLIA) Regulations (42 CFR Part 493) do I already cover?
US Clinical Laboratory Improvement Amendments (CLIA) Regulations (42 CFR Part 493) maps to 1 other compliance frameworks. The top mapping partners are ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence (83% coverage). Use our comparison tool to explore control-level mappings between frameworks.
How do I implement US Clinical Laboratory Improvement Amendments (CLIA) Regulations (42 CFR Part 493)?
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