Compliance & Regulation

The Clinical Laboratory Improvements Act of 1988 (CLIA ’88) set certain conditions that medical laboratories must meet in order to perform testing on human specimens for the diagnosis of disease or determination of the health status human beings. The Act categorizes testing into the following sections: waived complexity, moderate complexity, a subset of moderate complexity testing; provider performed microscopy (PPM) or high complexity testing.

Waived testing is usually associated with physician office laboratories or hospital nursing units. CLIA designates waived methodology as meeting the following criteria:

• Test is cleared by the FDA for home use; and
• Employs methodologies that are so simple and accurate as to render the likelihood of erroneous results negligible; or
• Poses no reasonable risk of harm to the patient if the test is performed incorrectly.

An example of a waived test would be a urine pregnancy test, glucometer glucose check or a urinalysis chemical dipstick test. As long as a laboratory or facility restricts its testing to what CLIA considers waived and follows the manufactures instructions for testing, they will meet the eligibility requirement to be granted a Certificate of Waiver. A list of test kits, platforms and/or devices that have been categorized by CLIA as meeting waived criteria is available at TESTS GRANTED WAIVED STATUS UNDER CLIA. Testing that does not appear on this list of tests that have been granted waived status by CLIA must be considered moderately or highly complex.

PPM testing is also something usually associated with a physician’s office laboratory or hospital unit. PPM is considered a subset of moderately complex testing. Examples of PPM testing are urine sediment examinations, fern testing or nasal smears for granulocytes. For a test to be considered PPM, the criteria to be met are:

• The testing can only be performed by the physician; during the patient’s visit, a mid-level practitioner supervised by a physician, or a dentist.
• The primary instrument for performing the test is the microscope, limited to bright-field or phase-contrast microscopy.
• The specimen is labile or delay in performing the test could compromise the accuracy of the test result.
• Control materials are not available to monitor the entire testing process.
• The procedure must be categorized as moderately complex and limited specimen handling must occur.

If all of these criteria are met the laboratory or facility would be eligible to be granted a Certificate for PPM procedures.

Moderately and highly complex tests are usually associated with a hospital laboratory or reference laboratories. In order to qualify for either of these certificates much stricter requirements must be met such as participating in proficiency testing, performing a quality check system and meeting personnel testing requirements according to CLIA ’88.

All healthcare organizations, including laboratories, in order to qualify for payment from Medicare or Medicaid programs, must participate in an accreditation process that confirms the healthcare organizations compliance with federal regulations. This accreditation or certification process is conducted by a state agency representing the Center for Medicare and Medicaid Services (CMS). Any accrediting organization that exists which meets or exceeds CMS accreditation requirements can be considered deemed by CMS to conduct accreditations. Laboratory deemed status accreditation providers include Joint Commission, College of American Pathology (CAP) and COLA. In addition to the accreditation survey, CMS conducts validation surveys on an unannounced and random basis to validate an organization's accreditation process. These surveys occur on a random sampling of facilitates or sometimes are conducted based upon a report of non-compliance observed within the organization.

Quality compliance and meeting regulations is a continuous process for the clinical laboratory and inspections are a necessary part of the compliance procedure. Typically an inspection by an outside source will happen every couple of years (with interim self inspections performed in the off year). If there are complaints against a laboratory, inspections can be more frequent. Some of the things inspections will cover are maintenance and function checks, calibration and calibration verification procedures, or the quality control system. The tier or responsibilities necessary to meet compliance minimums are: follow manufacturer instructions or provide documentation to expand beyond manufacturer claims, follow regulatory guidelines, follow your own organization’s policy and procedure. The laboratory or organization is held to all of these standards and must demonstrate compliance for a successful accreditation outcome.

For a complete review of the CLIA regulation you can access the entire code at the Centers for Disease Control and Prevention. (www.cdc.gov/clia/regs/toc.aspx).