Clia Urinalysis Tests in Physicians\' Offices Urinalysis

CLIA URINALYSIS TESTS IN PHYSICIANS' OFFICES

Urinalysis

CLIA Urinalysis Tests in Physicians' Offices

CLIA regulations cover all laboratory tests conducted medical purposes. Many of these tests no longer require intensive oversight procedures because manufacturers have designed them to be almost foolproof and safe to use. Waived urinalysis tests include those detecting illicit drug use, pregnancy, liver and kidney problems, and blood abnormalities. The ease and speed with which these tests can be performed, and the relatively relaxed CLIA regulations covering their use, are making them increasing popular for use in provider offices.

CLIA Urinalysis Tests in Physicians' Offices

All clinical laboratory services offered in the United States are regulated under the Clinical Laboratory Improvement Amendments (CLIA) of 1988 (Centers for Disease Control and Prevention [CDC], 2005, p. 2). The Centers for Medicare & Medicaid Services (CMS) administers the CLIA program and the CMS, CDC, and FDA are jointly responsible for implementing CLIA regulations.

Waived Laboratory Tests

CLIA regulations draw distinctions between high complexity, moderate complexity, and low complexity tests, due to how error-prone a given test might me and the associated safety concerns (CDC, 2005, p. 2). Low complexity tests are typically "waived" from CLIA oversight and personnel training requirements, which are required for moderate and high complexity tests. Waived tests are becoming more and more common, and error-free, and some can even be purchased over the counter in pharmacies for home use, e.g. pregnancy tests. For this reason, offering waived testing procedures in physician's offices is becoming more popular because of the convenience and speed with which test results can be obtained. All that's needed to begin is to obtain a Certificate of Waiver from CMS and pay the $150 biannual fee.

CLIA waived urinalysis tests are available for a large number of applications (for a complete list see: U.S. Food & Drug Administration, 2011) and include testing for illicit drug use, kidney and liver function, pregnancy, and blood problems. The most common format for these tests is test strips, which turn a specific color when exposed to the urine sample. The strips can be then graded by hand or by inserting into small automated strip readers. In terms of safety, the same biohazard precautions that a typical physician's office has in place are sufficient.

CLIA Regulations for Waived Tests

CLIA requires that the number of tests used be recorded and submitted on the CLIA application for waived testing Form CMS-116 (Centers for Medicar & Medicaid Services [CMS], 2004). Tests that are used for quality control testing or proficiency testing should not be included in the count, only those ordered and used for patient specimens. Dipsticks or strips are counted as one test, regardless of how many different reagent pads might be included on the stick or strip. CLIA regulations require laboratories operating under a Certificate of Waiver to follow the manufacturer's instructions when performing the test.

Laboratories that conduct non-waived tests must engage in a rigorous and ongoing self-assessment of performance. This includes proficiency testing of personnel, investigations of complaints, documentation of all methods, procedures, training, equipment calibration and maintenance, and remedial actions taken. Laboratories operating under a Certificate of Waiver are not required to perform the same oversight functions. Should the Regional CLIA Office receive a complaint, suspect the laboratory is performing non-waived tests, or are concerned about the safety or reliability of a waived test, then a survey could be conducted.

CLIA Regulations for PPM Procedures