CLIA and Point-of-Care Testing (POCT): How to Stay Compliant When Testing at the Bedside (42 CFR § 493.15)

Point-of-care testing has become a core feature of small practice care, especially for rapid flu, COVID-19, strep, glucose, and pregnancy tests performed in exam rooms or at the bedside. Under CLIA, however, any facility that performs testing on human specimens for diagnosis, prevention, or treatment of disease must hold an appropriate CLIA certificate and comply with the applicable requirements, even when those tests are waived and performed at the point of care.

42 CFR 493.15 sets out which laboratories performing only waived tests may obtain a certificate of waiver and which conditions apply, forming the legal foundation for much of physician-office POCT. When practices treat bedside testing casually, assume CLIA does not apply, or ignore manufacturer instructions, they expose themselves to enforcement actions that can include sanctions against the CLIA certificate and limits on the ability to bill Medicare and Medicaid for lab services.

For a small practice with limited staff and budget, the key is to treat bedside testing as a small, distributed laboratory, with simple but reliable structures for training, documentation, quality checks, and oversight anchored in CLIA’s requirements. By understanding how 42 CFR 493.15 fits into the broader CLIA framework and implementing a focused operational playbook, even the leanest clinic can deliver fast POCT results while staying firmly inside the regulatory lines.

Many small practices adopted point-of-care testing to reduce turnaround time and improve patient satisfaction. A rapid strep or flu result in a few minutes can transform a visit, support evidence-based prescribing, and avoid a trip to an off-site laboratory. Yet the informality that often surrounds POCT can hide a serious compliance risk: every bedside test that produces a patient-specific result is regulated under CLIA.

CLIA does not distinguish between a large independent laboratory and a two-exam-room family clinic in how it defines a “laboratory.” If your practice performs testing on human specimens to provide information for diagnosis, prevention, or treatment, you are a laboratory for CLIA purposes and must hold a CLIA certificate. For clinics that perform only waived tests, 42 CFR 493.15 allows operation under a certificate of waiver, but this status carries responsibilities, not a free pass.

This article explains how the CLIA framework applies specifically to point-of-care testing in small practices, with 42 CFR 493.15 as the central regulatory reference. It then outlines enforcement structures, an operational playbook for bedside testing, and governance practices that can keep POCT fast and clinically useful while minimizing the risk of CLIA citations, sanctions, and reimbursement problems.

Understanding Legal Framework & Scope Under 42 CFR 493.15

The CLIA statute, at 42 U.S.C. 263a, authorizes the Secretary of Health and Human Services to regulate all laboratory testing performed on human specimens for the purpose of providing information for the diagnosis, prevention, or treatment of disease, or for health assessment. The implementing regulations at 42 CFR part 493 categorize tests by complexity (waived, moderate, and high), and link each category to specific certificate types and regulatory obligations.

Waived testing and certificates of waiver

42 CFR 493.15 deals with laboratories that perform only waived tests. These are tests that the Food and Drug Administration has determined to be simple and to carry a low risk of an incorrect result, such as many rapid strep, influenza, HIV screening, and pregnancy tests when used strictly according to the manufacturer’s instructions.

Under 42 CFR 493.15, laboratories that limit their activities to waived tests may apply for and operate under a CLIA certificate of waiver. This certificate type has a lighter regulatory burden than certificates for non-waived testing. However, the regulation makes clear that waived laboratories must:

• Perform only tests that are categorized as waived for CLIA purposes and are cleared for home or simple use.

• Follow the manufacturer’s instructions precisely for each test system, including storage, specimen handling, timing, interpretation, and quality controls.

• Comply with other applicable provisions in part 493, such as the requirement for a CLIA certificate, fees, and inspections when there is evidence of noncompliance or complaints.

Point-of-care testing in small practices often falls into this waived category, but that does not mean it is unregulated. The location of the test at the bedside or in the exam room is operationally convenient; legally, it remains a CLIA laboratory activity that must be covered under the practice’s CLIA certificate and subject to the conditions of 42 CFR 493.15.

Scope and limits for POCT under 42 CFR 493.15

For POCT, the scope of 42 CFR 493.15 can be summarized as follows:

• If a test is CLIA-waived and performed according to the manufacturer’s instructions, it can be performed under a certificate of waiver.

• If your practice performs any non-waived (moderate or high complexity) tests, you cannot rely solely on a certificate of waiver; you must obtain the appropriate higher-level certificate and comply with more extensive requirements in part 493.

• “Point of care” is not a regulatory category; it simply describes where the testing takes place. Complexity status and CLIA obligations remain exactly the same regardless of location.

Understanding this framework helps a small practice avoid two common traps: assuming waived POCT is “too simple to be regulated,” and quietly adopting new POCT devices that are not in fact waived under CLIA. Both missteps can convert routine bedside testing into a compliance gap that becomes visible at the next survey or in the wake of a complaint.

CLIA is administered at the federal level by the Centers for Medicare & Medicaid Services, which issues CLIA certificates, collects fees, and oversees compliance and enforcement. State survey agencies or accrediting organizations act on behalf of CMS to conduct inspections and investigations, even of waived laboratories, when there is evidence of serious problems or complaints.

Who enforces POCT compliance

For point-of-care testing under 42 CFR 493.15, key enforcement players are:

• CMS’s Center for Clinical Standards and Quality, which sets policy, issues interpretive guidelines, and makes sanction decisions under CLIA.

• State survey agencies, which conduct on-site CLIA surveys and complaint investigations, including in physician offices, urgent care centers, and other small practices when indicated.

• In CLIA-exempt states, state programs that meet or exceed CLIA requirements may perform parallel oversight for certain laboratories.

Common triggers for scrutiny of POCT

Several scenarios tend to draw enforcement attention to bedside testing:

• A complaint alleging inaccurate POCT results contributed to patient harm.

• Surveyors observing bedside testing during a broader CLIA or facility survey and noting lack of documentation, training, or adherence to instructions.

• CMS data showing inconsistent or implausible billing patterns for tests that should be performed under a certificate of waiver or higher certificate.

• Reports of testing performed on patients without the laboratory holding any CLIA certificate at all, which is a fundamental violation of 42 U.S.C. 263a.

When deficiencies are cited, CMS may require a plan of correction, conduct follow-up surveys, impose civil monetary penalties, or in severe cases suspend, limit, or revoke the CLIA certificate, which affects the ability to perform and bill for tests. For a small practice, these consequences can be existential.

Even though this section heading refers to HIPAA, the practical focus here is CLIA compliance for POCT under 42 CFR 493.15. For small practices, survival depends on a concise set of controls that can be maintained with minimal extra headcount.

1. Confirm the correct CLIA certificate and test menu

The first step is to make sure your CLIA certificate actually covers the tests being performed at the bedside. Under 42 CFR 493.15, a certificate of waiver is valid only if the laboratory performs tests that are categorized as waived and meets the related conditions.

• Implementation: Create a one-page test menu listing each POCT device or kit, its CLIA complexity category, and the certificate type under which it is performed. Only include waived tests on the menu if you hold a certificate of waiver.

• Evidence to retain: Copy of the current CLIA certificate, the test menu with effective dates, and the manufacturer or FDA documentation indicating the test’s CLIA category.

• Low-cost method: Use a simple shared spreadsheet or a printed binder kept at the nursing station or POCT cart and updated annually or when tests change.

This control ensures a traceable link between what is actually done at the bedside and what is permitted under 42 CFR 493.15, reducing the risk that a surveyor finds unapproved testing during a walk-through.

2. Standardize manufacturer instructions at the point of use

Certificates of waiver are granted on the assumption that the laboratory faithfully follows manufacturer instructions for waived tests. In practice, bedside staff often rely on memory or informal “cheat sheets.”

• Implementation: For each POCT system, place a clean, current copy of the manufacturer’s instructions at the exact location where testing occurs, and require staff to reference it whenever performing a test that they do not do daily.

• Evidence to retain: A master list showing where each set of instructions is stored, plus outdated copies in a historical file showing that updates were recognized and implemented.

• Low-cost method: Print and laminate key pages with step-by-step procedures and interpretation charts, while maintaining full package inserts in a central binder.

By tying every bedside test run back to the manufacturer’s instructions, the practice demonstrates that it is operating within the conditions of 42 CFR 493.15 for waived tests rather than improvising.

3. Basic quality checks for waived POCT

Although CLIA does not impose the full quality control requirements for waived tests that it does for moderate and high complexity testing, CMS guidance emphasizes that waived laboratories must still perform tests correctly and take steps to ensure reliable results.

• Implementation: For each POCT device, define simple, device-appropriate checks, such as monitoring built-in controls, documenting lot numbers and expiration dates, and logging any failed tests or control failures.

• Evidence to retain: A small logbook or electronic record for each device showing daily or per-use quality checks, including who performed them and any corrective action taken.

• Low-cost method: Add a one-page QC log to the front of each POCT supply bin that staff complete by hand, then scan or file monthly.

Such basic logs give surveyors concrete evidence that the practice takes CLIA quality expectations seriously, even under the more flexible 42 CFR 493.15 framework.

4. Competency and training tailored to bedside testers

CLIA requires that testing personnel be appropriately trained and competent for the tests they perform, even in waived settings. In a small practice, that usually means nurses, medical assistants, or other clinical staff who are not laboratory professionals.

• Implementation: For each staff member who performs POCT, create a brief competency checklist covering specimen collection, timing, interpretation, documentation, and waste disposal for each device they use. Reassess competency at hire and at least annually, or when a new device is introduced.

• Evidence to retain: Signed and dated competency forms stored with HR or compliance records, plus any training materials or sign-in sheets.

• Low-cost method: Conduct short, focused huddle trainings led by the medical director or lead nurse, then complete competency checklists immediately afterward.

This makes the link between CLIA’s competency expectations and actual bedside practice visible and defensible during a survey.

5. Central oversight of distributed POCT locations

Many small practices provide testing in multiple exam rooms, a minor procedure room, or even a mobile unit, all under one CLIA certificate of waiver. Under CLIA, the certificate covers all testing sites that operate under a single federal tax identifier, so the practice must ensure consistent compliance at every location.

• Implementation: Assign a POCT coordinator (often the practice manager or lead nurse) who is responsible for maintaining the POCT test menu, training records, quality logs, and supply management across all sites.

• Evidence to retain: Job description or delegation memo naming the POCT coordinator, a simple POCT oversight plan, and evidence of periodic internal walk-throughs or spot checks.

• Low-cost method: Combine POCT oversight with an existing quality or infection control role instead of creating a new position, and add POCT checks to existing monthly safety rounds.

This structure reassures surveyors that someone is accountable for making sure 42 CFR 493.15 conditions are met in each room where testing occurs, not just on paper.

Together, these controls form a survival playbook for small practices: limited in number, inexpensive to maintain, and tightly aligned with CLIA’s requirements for waived POCT under 42 CFR 493.15.

Case Study

A three-provider family medicine clinic holds a CLIA certificate of waiver and performs rapid strep, influenza, COVID-19 antigen, and urine pregnancy tests in each exam room. Over time, the clinic stops keeping manufacturer instructions in the rooms and relies on staff memory. A new medical assistant, trained informally by a colleague, begins running rapid strep tests. She shortens the incubation time to “save a minute,” interpreting results at three minutes rather than the manufacturer’s required five.

One winter, a patient with severe sore throat and fever tests negative at three minutes and is discharged without antibiotics. A culture taken at a local reference lab later returns positive for group A strep. The patient’s symptoms worsen, and he is hospitalized with complications. His family files a complaint citing the “false negative” POCT result.

During the complaint investigation, state surveyors visit the practice under CLIA authority. They find:

• The test menu indicates waived tests only, consistent with a certificate of waiver, but it is outdated and does not show recent POCT additions.

• No current manufacturer instructions are available in exam rooms or at the nurses’ station.

• Staff describe various timing and interpretation practices that do not match the package insert.

• No logs exist for quality checks, lot numbers, or expired tests.

Surveyors cite the practice for failing to perform waived tests according to the manufacturer’s instructions and not meeting the conditions for laboratories operating under 42 CFR 493.15. CMS requires a plan of correction that includes updated procedures, training, and documentation. The clinic must suspend certain POCT activities until it can demonstrate compliance, causing disruptions in patient flow and revenue.

If the clinic had implemented the operational playbook described above, the outcome likely would have been different. Correct timing would have been reinforced by exam-room instructions and competency checklists; built-in quality checks and lot tracking would be documented; and a named POCT coordinator would be able to show surveyors an organized structure for compliance under 42 CFR 493.15.

Using this table as a living document helps a small practice turn the abstract requirements of 42 CFR 493.15 into a concrete, auditable routine that can be shown to surveyors at any time.

Common Audit Pitfalls to Avoid Under 42 CFR 493.15

When CLIA surveyors focus on point-of-care testing, they often encounter the same types of problems. Addressing these proactively can significantly reduce risk.

• Treating bedside testing as “nursing activity” instead of laboratory testing, leading to the mistaken belief that CLIA does not apply to POCT, which puts the practice in violation of 42 U.S.C. 263a’s basic requirement for a CLIA certificate. Consequence: potential sanctions for operating an unlicensed laboratory.

• Adding new POCT devices without verifying their CLIA complexity status or updating the test menu, which may mean performing non-waived tests under a certificate of waiver contrary to 42 CFR 493.15. Consequence: citations that can trigger corrective action plans and, in severe cases, certificate sanctions.

• Failing to follow manufacturer instructions for waived tests, for example by changing incubation times or specimen volumes, which conflicts with the conditions for waived testing under CLIA. Consequence: invalid test results, patient harm, and CLIA deficiencies.

• Neglecting basic documentation such as lot numbers, expiration dates, and built-in control results, even when devices provide them, undermining evidence that tests were performed correctly under 42 CFR 493.15. Consequence: surveyors may consider the laboratory out of control and require immediate corrective action.

• Allowing untrained or unassessed staff to perform POCT without documented competency, which runs counter to CLIA’s expectations that testing personnel be qualified for the testing performed. Consequence: surveyors may question all results generated by that staff group, increasing the scope of deficiencies.

By recognizing and correcting these pitfalls in advance, small practices can present a CLIA-compliant POCT program that aligns with 42 CFR 493.15 and withstands both routine and complaint-driven scrutiny.

A sustainable CLIA and POCT compliance program is not just a binder of policies; it is a set of habits embedded in daily workflows. For a small practice, the goal is a lean structure that clearly connects bedside testing to CLIA responsibilities without overwhelming staff.

• Staff training cadence: Integrate CLIA and POCT topics into regular clinical huddles, focusing on one device or risk area at a time, and anchor each discussion in a relevant part of CLIA such as the conditions for waived tests under 42 CFR 493.15.

• Policy ownership: Assign the medical director overall responsibility for CLIA compliance, with a designated POCT coordinator handling day-to-day tasks like logs, test menus, and training records. Document this delegation in writing.

• Leadership roles: Include POCT on the agenda of any quality or compliance committee, even if the “committee” is simply a brief monthly meeting between the physician lead and practice manager, and review any incidents or near misses involving bedside testing.

• Simple monitoring metrics: Track a few basic indicators, such as the percentage of staff with current POCT competency assessments, the number of expired reagents found during internal spot checks, and the timeliness of updating manufacturer instructions.

These elements help ensure that the clinical and administrative leaders of the practice see POCT as a regulated laboratory activity linked directly to 42 CFR 493.15, not an informal convenience at the edge of care.

CLIA applies to every point-of-care test that yields a patient-specific result, and 42 CFR 493.15 provides the framework that allows small practices to perform waived testing at the bedside under a certificate of waiver. The convenience and clinical value of POCT do not reduce regulatory responsibility; instead, they make it even more important to have a simple, disciplined approach to training, documentation, and oversight. By treating each exam room or bedside as part of a distributed laboratory and aligning everyday habits with CLIA expectations, small practices can protect patients, support accurate clinical decisions, and avoid disruptive enforcement actions.

Immediate next steps for a small clinic might include:

1. Pull your current CLIA certificate and create a one-page POCT test menu that lists each bedside test, its CLIA complexity, and confirms it is compatible with a certificate of waiver under 42 CFR 493.15.

2. Gather and standardize manufacturer instructions for each POCT device, placing copies at the locations where testing occurs and removing outdated versions.

3. Implement a basic QC and lot/expiration log for each POCT system, using a simple paper or electronic template that staff can complete with minimal effort.

4. Develop a short competency checklist for each type of POCT and complete initial and annual assessments for all staff who perform bedside testing.

5. Formally designate a POCT coordinator and schedule quarterly internal walk-throughs of all testing locations to verify adherence to CLIA requirements.

Recommended compliance tool: 

A single, shared “POCT Binder” or digital folder that combines the CLIA certificate, test menu, manufacturer instructions, QC logs, and competency records for all bedside testing.

Advice:

In the next week, perform a quick walk-through of every room where testing happens, and if a test is not on your CLIA-waived menu or lacks current instructions and logs, either fix it immediately or stop performing that test until it meets 42 CFR 493.15 conditions.

• 42 CFR Part 493 – Laboratory Requirements (CLIA Regulations)
  

• 42 CFR 493.15 – Laboratories Performing Waived Tests (Certificates of Waiver)
  

• 42 U.S.C. 263a – Clinical Laboratory Improvement Amendments Statute
  

• CMS CLIA Brochure – How to Obtain a CLIA Certificate of Waiver  CMS CLIA Overview – Roles of CMS, CDC, and FDA Under CLIA
  

• CMS and CLIA Survey and Certification Policy Materials (Sanctions and Enforcement Framework)