Urgent message: Most of the laboratory testing that occurs in urgent care consists of simple, on-site tests that are “waived” from federal CLIA regulations—but urgent care centers must still comply with standards affecting their CLIA waiver.
All facilities in the United States that perform laboratory testing on human specimens for health assessment or the diagnosis, prevention, or treatment of disease are regulated under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). CLIA requires laboratories to be certificated by individual states as well as by the Centers for Medicare & Medicaid Services (CMS). Laboratories must comply with regulations jointly administered by CMS, the FDA, and the CDC, who together oversee all aspects of the CLIA program.
Because of the low- to moderate-acuity level of medical conditions typically treated in urgent care, the on-demand nature of urgent care services requiring an immediate diagnosis, and the fact that the top 10 diagnoses constitute 80% or more of urgent care visits, urgent care centers typically do not conduct complex labs that require expensive equipment and a dedicated technician. Rather, they use various “instant” (nonautomated) lab tests that provide fast and accurate diagnoses for simple presentations. Common tests in urgent care include urine pregnancy tests, dipstick urinalysis tests, rapid strep and flu tests, blood glucose tests, and urine tests for marijuana and other substances. If more complicated testing is needed, most urgent care centers do a “collect” and send out to a full-service reference lab, such as LabCorp or Quest, which would be fully compliant with CLIA.
Because the instant tests used in urgent care have been proven so simple and accurate that it’s virtually impossible to produce an incorrect result when conducting them, CLIA provides a “waiver” for medical practices that perform only these types of tests. The rapid availability of results for immediate patient follow-up, combined with the ability to be administered with minimum training, makes CLIA-waived tests an indispensable tool for urgent care. However, this type of testing still requires a certificate of CLIA waiver regardless of how many tests the center performs and even if the center does not charge the patient or bill Medicare or other insurance plans for lab services.
Even with a waiver, compliance inspections by one of the aforementioned CLIA governing bodies can and do occur—either at random, or to investigate a patient or employee complaint. Penalties for not meeting CLIA-waived test standards depend on the level of the violation:
- Lower-level or nonimmediate jeopardy issues can result in fines ranging from $50 to $3,000 per day, whereas…
- Violations that could cause false point-of-care results—primarily due to improper quality proceduresor those that could cause patient harm can result in significantly higher fines, exclusion from federal programs, suspension or revocation of your CLIA-waived certificate, or in extreme cases, prison time.
Clearly, any type of CLIA-waived test violation has the potential to disrupt your patient care and business overall. Hence, you should take the following seven steps to prevent CLIA-waived test violations and avoid penalties, especially when electronic devices (such as a Piccolo or iStat) are used to administer the test.
- Create a CLIA-waived test quality control overview. It’s a best practice to have a summary or overview of all quality control requirements for all of your CLIA-waived devices on hand. Required controls are typically detailed by the test manufacturer or vendor. Creating a summary of controls aids in the accurate auditing of control logs, creates a ready catalogue of all your CLIA-waived devices, and provides an orientation tool for new clinicians and staff.
- Log and document all quality controls. While some tests require that a quality control test occur before each administration, others require daily quality control tests, or a test with each new package of test devices. In either case, all quality control activity should be documented.
- Log and document staff orientation to CLIA-waived devices. The entire clinical staff, including providers, should be oriented to the performance and function of each CLIA-waived test device. Document the orientation by having each staff member sign off on a checklist that attests to their ability to use and perform quality controls on the device.
- Maintain an equipment maintenance log. As some devices must be inspected and recalibrated at regular intervals—which is typically performed by a biomedical equipment maintenance vendor—it’s important to maintain a log documenting said maintenance. Items to be documented include device name, serial number, schedule, and maintenance activity.
- Monitor test kit expiration dates. Make sure that your staff highlights or circles all expiration dates on culture media, reagents, kits, controls, and calibrators. If not clearly and prominently displayed, manually write expiration dates on the box in large print using a black marker.
- Remove unused equipment from service. Properly label all equipment that is either not in use, or not on the CLIA application. Place unused equipment in storage with an affixed label denoting it as such, or remove it from the premises.
- Review your CLIA-waived certificate at regular intervals. As some state agencies directly regulate CLIA-waived activities for medical facilities, ensure that your device list corresponds with the application. If you add a new device or test, keep your list current by immediately amending your application. Also, closely track your expiration date and renewal at least 3 months in advance.
As CLIA-waived tests themselves are nearly error-proof and require minimal training, it’s the issues around quality controls that can be problematic if handled improperly. You certainly don’t want the fines, publicity, or service interruptions associated with a negative, unexpected CLIA audit. By ensuring quality through documentation of devices and controls along with regular audits, you can keep your CLIA program running smoothly and ready to withstand regulatory scrutiny.
Alan A. Ayers, MBA, MAcc is Chief Executive Officer of Velocity Urgent Care, LLC and is Practice Management Editor of The Journal of Urgent Care Medicine.
