Seven steps to avoid CLIA-waived test violations

Clinical Laboratory Improvement Amendments (CLIA) inspections can be random or based on patient and employee complaints. Penalties for not meeting CLIA-waived test standards can range from $50 to $3,000 per day or violation for lower-level or nonimmediate jeopardy issues.

There are significantly higher fines, exclusion from federal programs and the possibility of prison for more serious violations that could cause patient harm. Suspension or revocation of your CLIA-waived certificate can lead to disruption of patient care and your business.

If you hire a new medical assistant who explains that he or she has never kept control logs for CLIA-waived tests, this is an indication that private practices may not be following CLIA regulations, particularly organizations that are not accredited. Tests not used for medical decision-making, such as drug screening, may not be subject to CLIA standards.

More important than penalties, false point-of-care (POC) test results — due to improper quality procedures — can lead to erroneous medical decisions and treatment.

Here are seven steps you can take to avoid penalties and improve patient safety:

• Ensure documentation of quality controls
  Some tests require that a quality control test be performed before each test on the patient, while others require control tests to be daily or with each new open package of test products. All quality control testing must follow manufacturer’s instructions. Standardization of devices is recommended, as different manufacturers for the same test may have different control documentation requirements. All quality control activity must be placed on a log, and each device should have its own log. Always perform a quality control test for each new user for each device.
   
• Establish a CLIA-waived test control schedule summary
  A summary of quality control requirements for all your devices is a best practice and aids in the accurate audit of quality control logs. It also provides an orientation tool for new staff and a reference for infrequently used devices. The summary should include all types of POC tests performed in the practice, the device manufacturer of each test and the quality control testing schedule. It outlines when each control needs to be conducted. For example, one manufacturer of a glucometer indicates testing high and low controls before using a new device, before using a new box of test strips or at least once per week. The same test with another manufacturer only requires testing if it is suspected that the meter is not working properly or test results do not match symptoms. Rapid lipids tests will typically require both an optics check and a control check at various frequencies.
   
• Document staff orientation to CLIA-waived devices
  All new clinical staff and medical providers should be oriented to the use of each CLIA-waived test device. Provide an orientation checklist itemizing each device, and have a supervisor or lead staff member sign off that the new operator has completed a return-demonstration on the use of each device and the quality controls. At any time, staff should be able to articulate the practice procedure of documenting and reporting CLIA lab results.
   
• Monitor test kit expiration dates
  It may be unpleasant if expired test supplies are found during an audit. Ensure that your staff circles all expiration dates on reagents, kits, culture media, controls, calibrators and other quality control products. As with medication and vaccines in your practice, ensure that staff circles them with red ink. It is sometimes necessary to write the expiration date on the box, if it is not immediately visible.
   
• Keep an equipment maintenance log
  Some devices are required to be inspected and calibrated on a regular basis, which is typically done by your biomedical equipment maintenance vendor. An equipment maintenance log can help leaders and staff plan for maintenance activities for all medical devices in the practice and document those activities. Include space to document the device name, serial number, schedule and the maintenance activity. Many practices keep their equipment maintenance logs in a single binder.
   
• Take unused equipment “out of service”
  Equipment not matching those listed on the CLIA application or in storage should have an affixed label stating, “not in use.” If you are not certified for microscopic examination, ask your providers to remove their personal microscopes, unless they are used for dry screen in cases not used for diagnosis and treatment decisions.
   
• Routinely review your CLIA-waived certificate
  Some state agencies directly regulate CLIA-waived activities and require a specific device list on the CLIA-waived application. Ensure that your devices match your application device list, or amend your application to keep the list current. Track your certificate expiration date and submit your renewal at least 90 days in advance of the expiration.

Quality control logs are a critical factor during a CLIA audit. If your practice has gaps, involve staff to create procedures and control logs using manufacturer’s instructions. To ensure consistent documentation, consider auditing control logs each quarter or more frequently if problems are observed. Also monitor lab cleanliness and ensure that staff are appropriately wearing gloves during lab procedures.

Tests not used for medical decision-making, such as drug screenings, may not be subject to CLIA standards.

CLIA-waived test devices in your practice may include:

Rapid A1c
Blood count
Fecal occult
Gastric pH
Glucometer
HIV
Influenza A and B
International normalized ratio (INR)
Rapid lipids
Ovulation
Strep A
Urinalysis
Urine test for pregnancy
Vaginal pathogens

Even home tests fall under the scope of CLIA regulations when performed in the office practice.