Managing CLIA-waived testing across multiple locations

What CLIA-waived testing is

The Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulate all laboratory testing on human specimens in the United States, other than research. The rules are at 42 CFR Part 493 and are administered by the Centers for Medicare and Medicaid Services (CMS), with the Food and Drug Administration (FDA) categorizing tests by complexity. Every test is waived, moderate complexity or high complexity; the last two together are called non-waived.

A waived test is one the FDA has determined is simple enough, with a low enough risk of an erroneous result, to be performed outside the full laboratory framework. Examples include glucose meters, urine dipsticks, rapid strep and influenza antigen tests, pregnancy tests, some HbA1c and lipid analyzers, handheld INR meters and several molecular respiratory tests on platforms such as the Abbott ID NOW and the Roche cobas Liat. Whether a specific test is waived depends on the exact product and specimen type; the FDA's CLIA test categorization database is the place to check.

A site that performs only waived tests applies to CMS, through its state agency on form CMS-116, for a Certificate of Waiver, valid for two years. Holding it commits the site to a short list: enroll and pay the fee, follow the manufacturer's current instructions for each test, and allow CMS or the state agency to inspect. The personnel, proficiency testing (PT) and quality control (QC) requirements of 42 CFR Part 493 apply to non-waived testing and are not imposed on a waived-only site. The moment a site runs even one non-waived test, for example a moderate complexity hematology analyzer, it needs a different certificate and the fuller rules apply.

What changes when waived testing runs at many sites

One clinic with a glucose meter, a urinalysis reader and a rapid strep test is easy to run well: the practice manager knows the two medical assistants who test, and the QC log is on the counter. The same testing across 12, 40 or 200 sites is a different operation, and the difference is not the tests.

• Urgent care networks run the same waived menu at every site, with high staff turnover, extended hours and results that have to be in the chart before the patient leaves.
• Physician office laboratories (POLs) in a multi-site medical group often grew up independently, each with a different meter, a different log format and a different idea of what "QC" means.
• Multi-site medical groups and health systems mix waived clinics with moderate complexity sites and a central laboratory. The point-of-care coordinator, if there is one, sits in the central laboratory and cannot be in 30 clinics.
• Employer and occupational health programs run screening at worksites and mobile events, sometimes under the rules for non-fixed locations, with staff who may test only during a campaign.

What changes is that the things a single site does informally now need a system: who is allowed to test, where each device is, which lot is in it, whether QC was done today at site 27, whether the certificate at site 9 expires next month, and how a recall is traced across the network. None of that is required by a Certificate of Waiver. All of it is what an inspector or accreditor asks for after something goes wrong.

The CLIA obligations that still apply with a Certificate of Waiver

"Waived" is not "exempt". The following still apply to every Certificate of Waiver site.

Follow the manufacturer's instructions, exactly. This is the central condition of the waiver, stated at 42 CFR 493.15. The package insert defines the specimen type, storage temperatures, QC frequency, how to read the result and what to do when QC fails. A site that stores strips outside the labeled temperature range, skips the QC the insert requires or uses a specimen type the insert does not list is performing a modified test, which CLIA treats as high complexity: testing the site holds no certificate for.

A certificate for each location. CLIA certificates are issued to a laboratory at a specific address, and the default rule is a separate certificate for each site where testing is performed. The regulation (42 CFR 493.35 for Certificates of Waiver) allows a few exceptions, which should be checked with your state agency before relying on them: laboratories not at a fixed location, such as mobile units and temporary testing sites, can operate under the certificate of a designated primary site; certain not-for-profit or government public health laboratories with a limited menu can file a single application; and hospital laboratories in contiguous buildings on one campus under common direction can be covered together. A chain of urgent care clinics at separate addresses needs a certificate per clinic.

Keep the certificate current and accurate. Renew every two years, pay the fee, and notify the state agency within the period the regulation sets when the director, name, address or ownership changes, and when the site adds testing that changes its certificate type. Adding a moderate complexity test to a waived site is the most common way a certificate silently becomes the wrong one.

Expect the possibility of inspection. Waived sites are not on the routine two-year survey cycle, but CMS or the state agency may inspect a Certificate of Waiver site to check that it is following the manufacturer's instructions, to investigate a complaint, or as part of a sample of waived sites (42 CFR 493.1775). The CDC's published recommendations on good laboratory practices for waived testing sites list what inspectors kept finding: expired reagents, no QC, staff not following the insert, no record of who tested.

State variations: New York, Washington and others

CLIA is federal, but two states run their own laboratory programs that CMS has recognized as equal to or stricter than CLIA, and laboratories there are licensed by the state instead of being certified under CLIA. At the time of writing these CLIA-exempt states are New York, through the New York State Department of Health's Clinical Laboratory Evaluation Program, and Washington, through the Washington State Department of Health's Medical Test Site licensing program. A waived-only site in either state works with the state program, which may register some sites under a limited-service route while requiring others, such as independent physician office laboratories in New York, to obtain federal CLIA certification through the state; confirm the route with the state agency. In New York, sites performing only waived tests are handled through a registration route separate from the full laboratory permit; confirm the current requirements with the state directly.

Other states add requirements on top of CLIA rather than replacing it. California, for example, requires state registration of sites performing waived testing and has its own rules on who may perform tests; several other states license laboratory personnel or require state registration in addition to the federal certificate. Keep a table of each state's additional requirements, owned by one person and reviewed annually.

The program good organizations run anyway

This list mixes what a Certificate of Waiver obliges (following the manufacturer's instructions, including its quality control, and keeping the certificate current) with governance practices that CLIA leaves to the organization. All of it is required by common sense at scale, and most of it is what CAP, COLA and The Joint Commission look for when they accredit organizations that do point-of-care testing.

1. Documented procedures. One procedure per test, written from the current package insert, in the same format at every site, with a version and an approval date. When the insert changes, every site gets the new procedure.
2. Training and competency. Every person who tests is trained before their first patient, assessed after, and reassessed on a schedule. The six-element competency model used for non-waived testing (direct observation, review of results, review of QC and maintenance records, observation of maintenance, testing of known samples, and problem-solving) is a good template even where it is not required. Keep the record against the person, not the site.
3. Quality control per the manufacturer's instructions. Run external QC at the frequency the insert states, on new lots and shipments, after repairs and when results look wrong, and record the result, the lot and who ran it.
4. Lot tracking and inventory. Know which reagent and QC lots are at which site, their expiration dates and storage conditions. When a manufacturer issues a recall, you should be able to list the affected sites, devices and patient results within the hour.
5. Device inventory and maintenance. A register of every analyzer and meter by serial number, location, software version and service history.
6. Incident reporting and corrective action. A single route for reporting wrong-patient results, ignored QC failures, expired reagent use and device faults, with root cause and corrective action recorded, and a route to the FDA's MedWatch program where a device may have contributed to harm.
7. Certificate management. One list of every certificate, its type, director, expiration date and state, with reminders well ahead of renewal.
8. Periodic internal review. Someone visits, or remotely reviews, every site on a schedule and checks the above against what is actually on the counter.

Our guide to managing POCT across multiple sites covers who owns each piece.

What a CAP or COLA accredited site adds

CLIA does not require accreditation for a waived-only site. The College of American Pathologists (CAP) runs the Laboratory Accreditation Program, with checklists that include a Point-of-Care Testing Checklist, and inspects on a two-year cycle with peer inspectors. COLA accredits physician office and community laboratories with a program built around CLIA compliance and an educational inspection style. The Joint Commission accredits hospitals and ambulatory organizations and has laboratory and point-of-care standards of its own.

These programs are built around non-waived testing, because that is where CLIA allows accreditation to stand in for a CMS survey, so a site that performs only waived tests is not usually accredited on its own. In practice, waived testing performed under the umbrella of an accredited laboratory, for example a health system's point-of-care program, is inspected against the accreditor's checklist, which expects the things in the section above: procedures, competency, QC records, reagent labeling, result reporting and record retention, whether or not CLIA requires them for a waived test. Confirm the current scope with the accreditor, because the treatment of waived tests in each program is specific and changes. For a multi-site group, the practical effect is that the operational program stops being optional and starts being auditable.

Obligations across a network: what to standardize

Results into the EHR, and where software helps

A waived test result written on a sticky note and typed into the chart later has no operator, no lot, no device and a real chance of being wrong. Multiply by 40 sites and it is the biggest quality risk in the program. Connecting devices so results flow electronically into the electronic health record (EHR) removes the transcription step and attaches the evidence to the result.

Most devices used in waived settings can send results over a standard interface. HL7 v2 (Health Level Seven, version 2) is the common language of clinical systems, POCT1-A2 was written by the Clinical and Laboratory Standards Institute (CLSI) specifically for point-of-care devices, and newer systems use FHIR (Fast Healthcare Interoperability Resources). Middleware receives results in whatever format each device produces, checks the operator and the patient, applies QC rules and forwards the result to the record. The EHRs common in urgent care and multi-site groups, for example Experity, athenahealth and eClinicalWorks, accept results over these standards; see the linked pages for how each is filed.

Beyond the interface, software for a multi-site waived program should give you:

• A single view of every site, device, operator and certificate, with expirations visible before they matter.
• Operator records that travel with the person and, where the device supports it, lockout of anyone not current.
• QC captured as it runs, with the failed run linked to the patient results around it, and a network-wide exception list.
• An unsent results queue per site and a store-and-forward gateway, so a network outage does not become a lost result.
• An audit trail of who did what, when, on which device, producible for an inspector on demand.

Catenix is built for this shape of organization: point-of-care middleware that has grown into a connected diagnostics platform, with multi-site administration, operator competency, QC, lot inventory and an audit trail in one place, designed and ready to connect to the EHRs above over open standards. It records and routes results; it does not interpret them.

Questions people ask

Do I need a separate CLIA certificate for each location?

Usually yes. CLIA certificates are issued per laboratory location, so an urgent care chain or medical group with clinics at different addresses generally needs a Certificate of Waiver for each. The regulation allows limited exceptions, for example mobile or temporary testing sites operating under a designated primary site's certificate. Confirm how the exceptions apply to your situation with your state survey agency before relying on one.

What are the requirements for a CLIA Certificate of Waiver?

A Certificate of Waiver site must enroll with CMS through its state agency, pay the certificate fee, renew every two years, perform only tests categorized as waived, follow the manufacturer's current instructions for each test, notify the state of changes in ownership, name, director, location or testing, and permit inspection by CMS or the state agency. CLIA's proficiency testing, personnel and quality control rules for non-waived testing do not apply, but state and accreditor rules may.

Can a CLIA-waived site be inspected?

Yes. Waived sites are not on the routine two-year survey cycle that applies to non-waived laboratories, but CMS and state agencies may inspect a Certificate of Waiver site at any time to confirm it is following manufacturer instructions, to investigate a complaint, or as part of a sample of waived sites. Inspectors typically check the certificate, the tests being performed, the package inserts, storage conditions, QC records and who is running the tests.

Is proficiency testing required for CLIA-waived tests?

Not by CLIA. Proficiency testing enrollment is a federal requirement for non-waived testing. Some states, and accreditors such as CAP, expect proficiency testing or an alternative performance assessment for waived tests where a program exists, and many multi-site organizations enroll anyway because it is the only external check that a site is getting the right answer. Check your state program and your accreditor's current requirements.

Which states have their own laboratory programs instead of CLIA?

At the time of writing, New York and Washington are the two CLIA-exempt states, meaning laboratories there are licensed under a state program that CMS has recognized in place of CLIA certification. Other states, such as California, add state registration or personnel requirements on top of the federal certificate. Requirements change, so confirm the current position with each state's laboratory program before opening a site there.

What happens if we run a waived test differently from the package insert?

A waived test is only waived when performed exactly as the manufacturer's instructions describe. Using a different specimen type, skipping the required QC, storing reagents outside the labeled conditions or changing the procedure means the test is modified, and CLIA treats a modified test as high complexity. The site would then be performing testing it is not certified for, which is a finding on inspection and a risk to patients.

Sources and further reading

• 42 CFR Part 493, Laboratory Requirements
• CMS, Clinical Laboratory Improvement Amendments (CLIA)
• CDC, Good Laboratory Practices for Waived Testing Sites, MMWR Recommendations and Reports (2005)
• FDA, CLIA Test Categorization Database
• CAP, Laboratory Accreditation Program
• CLSI POCT1-A2, Point-of-Care Connectivity