Point-of-Care Testing (POCT) Checklist for CLIA, CAP and COLA

A note on the CAP point-of-care testing checklist

Laboratories accredited by the College of American Pathologists are inspected against CAP's own checklists, including a point-of-care testing checklist. Those checklists are copyrighted and CAP makes them available to its participants through cap.org. If your program is CAP-accredited, download the current edition there and use it as the standard for your inspection. COLA-accredited laboratories work from COLA's criteria in the same way.

This page is not a copy or summary of any accreditor's checklist. It is SLC's independent checklist built on the federal floor: 42 CFR Part 493 and CMS's published guidance. Accreditation standards must be at least equivalent to CLIA, so a program that meets the items below has a solid base for any accreditor's requirements.

1. Program governance and the POC coordinator

Most POCT failures come from unclear ownership rather than bad devices. Testing happens on nursing units, in clinics and in pharmacies, often by staff who do not report to the laboratory. A good program makes the chain of responsibility explicit.

• Identify the laboratory director named on each CLIA certificate. The director is responsible for the testing performed under that certificate, even where duties are delegated.

• Designate a POC coordinator in writing and define what they do: device approval, training, competency tracking, QC review, PT, and corrective action.

• Set up a POCT committee or a regular review that includes laboratory, nursing, clinical leadership and IT.

• Keep a written policy that no new test or device goes into use without laboratory approval.

• Maintain an inventory of every testing location, device (with serial number), test and certificate.

If you need a qualified director for one or several POC sites, see our laboratory director services.

2. Test menu and complexity

CLIA sorts tests into waived, moderate complexity and high complexity (42 CFR 493.5). Your certificate type and every downstream requirement depend on this category, so confirm it for each test.

• Look up each test system in the FDA CLIA database by manufacturer, model and analyte.

• Confirm the specimen type you use is the one categorized. A waived test run on an unapproved specimen type, or with a modified procedure, is no longer treated as waived.

• Record the complexity for each test on your menu and recheck when kits, models or package inserts change.

• Flag provider-performed microscopy (PPM) procedures separately; they require a PPM certificate or a higher one.

3. Certificate and site licensure

• Hold the correct CLIA certificate for the highest complexity you perform: Certificate of Waiver (42 CFR 493.35), PPM, Registration and Compliance (42 CFR 493.43), or Accreditation (42 CFR 493.55).

• Confirm whether your sites operate under one certificate or several, and that addresses, the director and the test menu on file are current.

• Notify CMS or your state agency of changes in director, ownership, location or test complexity within the required timeframes.

• Check state requirements. Some states license laboratories or personnel in addition to CLIA.

• Waived sites: 42 CFR 493.15 requires you to follow the manufacturer's instructions and permit announced or unannounced inspections.

Our clinical lab setup checklist covers certificate applications in more detail.

4. Device selection and verification

• Choose devices with the laboratory involved, considering complexity, connectivity, operator lockout, QC options and specimen type.

• For nonwaived tests, verify performance specifications before reporting patient results, as required by 42 CFR 493.1253: accuracy, precision and reportable range, and confirm the manufacturer's reference intervals fit your population.

• Where the same test is run on more than one device or method, compare results at least twice a year (42 CFR 493.1281).

• Keep the verification study, director approval and date placed into use with the device file.

• For waived tests, document that you follow the current package insert and keep a copy at each site.

5. Operator training and competency

42 CFR 493.1235 requires the laboratory to have policies for assessing personnel competency. For moderate complexity the technical consultant (42 CFR 493.1413) carries this responsibility; for high complexity it falls to the technical supervisor (42 CFR 493.1451). For nonwaived testing, 42 CFR 493.1413(b)(9) and 493.1451(b)(9) require each operator's performance to be evaluated at least semiannually during the first year they test patient specimens, at least annually after that, and again before reporting patient results when test methodology or instrumentation changes. The evaluation must include the six elements listed in 493.1413(b)(8) and 493.1451(b)(8):

1. Direct observation of routine patient testing, including patient preparation if applicable, and specimen handling, processing and testing.

2. Monitoring the recording and reporting of test results.

3. Review of intermediate results or worksheets, QC records, PT results and preventive maintenance records.

4. Direct observation of instrument maintenance and function checks.

5. Assessment of performance using previously analyzed specimens, internal blind samples or external PT samples.

6. Assessment of problem-solving skills.

• Assess competency for each test system the operator uses, not once per person.

• Confirm personnel qualifications for nonwaived testing and keep evidence (diplomas, licenses) on file.

• For waived testing, CLIA does not prescribe the six-element assessment. The CDC Ready? Set? Test! booklet, written for sites testing under a Certificate of Waiver, sets out recommended good testing practices, and accreditors may set their own training and competency requirements.

• Remove device access for operators whose competency lapses.

Many POC programs track hundreds of operators. mylabcompliance.io can help manage documents, training records, competency assessments and PT scheduling and records.

6. Quality control

• Waived tests: perform QC as the manufacturer instructs, including the stated frequency. The CDC Ready? Set? Test! booklet gives recommended practices, forms and examples for waived testing sites.

• Nonwaived tests: 42 CFR 493.1256 sets the default of at least two levels of control material each day of testing for quantitative tests (493.1256(d)(3)(i)), and a negative and a positive control for qualitative tests (493.1256(d)(3)(ii)), unless CMS approves an equivalent procedure, such as an IQCP, or a specialty requirement says otherwise.

• IQCP: CMS allows an Individualized Quality Control Plan for eligible nonwaived test systems. It requires a documented risk assessment, a quality control plan approved by the director and ongoing quality assessment. IQCP does not apply to waived tests.

• Define acceptable QC ranges, who reviews QC, and what operators do when QC fails, including not reporting patient results.

• Track reagent and control lot numbers, expiration dates, and storage temperatures.

• Document corrective action for every QC failure.

7. Connectivity and the result record

• Interface devices to the LIS or EHR where possible so results, operator ID, device ID and time are captured automatically.

• Use operator lockout so only competent, current users can run tests, and QC lockout where devices support it.

• Verify that results, units, reference intervals and flags display correctly in the patient record before go-live and after updates.

• For manual entry, define a transcription check and audit it.

• Make sure the test report identifies the testing location and meets CLIA test report requirements.

• Retain records for the periods CLIA requires. Under 42 CFR 493.1105(a), test requisitions, QC records and patient test records must be kept for at least 2 years, and test procedures for at least 2 years after they are discontinued. Some record types and state rules require longer.

8. Proficiency testing or alternate assessment

• Enroll each regulated analyte performed at moderate or high complexity in a CMS-approved PT program (Subpart H, beginning at 42 CFR 493.801).

• Test PT samples the same way as patient samples, by the operators who normally test, and do not refer them to another lab or communicate about results before the deadline.

• Review every PT result, investigate unacceptable scores and document corrective action.

• For nonwaived tests not listed in Subpart I, or for which no CMS-approved PT program offers compatible samples, verify accuracy at least twice a year as required by 42 CFR 493.1236(c), for example by split-sample comparison with the main laboratory.

• Rotate PT among sites and operators where one certificate covers several locations.

9. Inspection readiness

• Know your inspector: CMS or state agency surveyors, COLA, CAP or another accreditor, and whether inspections are announced.

• Keep a current binder or electronic folder per site: certificate, procedures, package inserts, verification, competency, QC, PT, maintenance and corrective action.

• Run internal audits at each location and trace a patient result back to operator, device, QC and lot.

• Review open corrective actions and repeat findings from past surveys.

• For CAP-accredited sites, work through the current CAP point-of-care checklist obtained from cap.org.

For help preparing, see our CLIA consultant services.

Printable POCT checklist

Print this page or copy the list into your own audit form. Mark each item Yes, No or N/A.

• ☐ Governance: Laboratory director identified for each certificate

• ☐ Governance: POC coordinator designated in writing with defined duties

• ☐ Governance: Inventory of sites, devices, tests and certificates current

• ☐ Test menu: Each test system checked in the FDA CLIA database

• ☐ Test menu: Specimen types and procedures match the categorized system

• ☐ Certificate: Certificate type matches highest complexity performed

• ☐ Certificate: Director, address and menu on file are current; state licensure checked

• ☐ Devices: Performance verification on file for nonwaived tests

• ☐ Devices: Current package insert available at each site

• ☐ Devices: Comparison of results across devices twice a year

• ☐ Personnel: Training documented before testing

• ☐ Personnel: Six-element competency complete per test system on schedule

• ☐ Personnel: Qualifications on file for nonwaived testing personnel

• ☐ QC: Manufacturer QC followed for waived tests

• ☐ QC: QC meets 42 CFR 493.1256 or an approved IQCP

• ☐ QC: QC failures documented with corrective action

• ☐ QC: Lot numbers, expirations and storage temperatures recorded

• ☐ Records: Results, operator and device captured in the patient record

• ☐ Records: Operator lockout active; manual entries audited

• ☐ PT: Regulated analytes enrolled in approved PT

• ☐ PT: Twice-yearly accuracy verification for non-PT nonwaived tests (493.1236(c))

• ☐ PT: Unacceptable PT results investigated

• ☐ Readiness: Site documentation complete and current

• ☐ Readiness: Internal audit and result trace-back completed

• ☐ Readiness: Accreditor's current checklist reviewed (CAP sites: via cap.org)

Frequently asked questions

What is a point-of-care testing checklist?

A POCT checklist is a structured list of the governance, certificate, device, personnel, quality control, proficiency testing and record requirements a site must meet to run testing at or near the patient. SLC builds ours from 42 CFR Part 493 and CMS guidance.

Is this the same as the CAP point-of-care testing checklist?

No. The CAP checklist is a copyrighted document that CAP-accredited laboratories obtain from cap.org. This page is an independent checklist based on public CLIA regulations and CMS guidance. If you are CAP-accredited, use the current CAP checklist for your inspection.

Do waived point-of-care tests need a CLIA certificate?

Yes. Under 42 CFR 493.15, a site performing only waived tests must hold a Certificate of Waiver, follow the manufacturer's instructions and allow inspections.

How do I know the complexity of a POC test?

Look up the exact test system in the FDA CLIA database. Complexity is assigned to a specific system, so a different specimen type or a modified procedure can change it.

What are the six elements of competency assessment?

Direct observation of testing; monitoring of result recording and reporting; review of worksheets, QC, PT and maintenance records; direct observation of maintenance and function checks; testing previously analyzed or blind samples; and assessment of problem-solving skills (42 CFR 493.1413(b)(8) and 493.1451(b)(8)).

Can a POC device use manufacturer QC instead of two levels of external controls daily?

For nonwaived tests, 42 CFR 493.1256 sets the default frequency, and CMS allows an IQCP for eligible systems based on a documented risk assessment. For waived tests, follow the manufacturer's QC instructions.

Is proficiency testing required for point-of-care tests?

Regulated analytes at moderate or high complexity must be enrolled in approved PT under Subpart H. Other nonwaived tests need accuracy verification at least twice a year under 42 CFR 493.1236(c). Waived tests are not subject to CLIA PT, though accreditors may set their own expectations.

Who should be the POC coordinator?

Usually a laboratory professional designated by the laboratory director. The coordinator does not replace the director's responsibilities, so delegate duties in writing.

Get help with your POCT program

Sound Lab Consultants helps clinics, hospitals and multi-site organizations set up and maintain compliant point-of-care testing programs.

Sound Lab Consultants, PO Box 2135, Chandler, AZ 85244

This checklist is general information based on 42 CFR Part 493 and CMS guidance as of 2026 and is not legal advice. CAP and COLA are referenced only to identify accreditation programs; SLC is independent of both.