Editor’s note: This is the first of a two-part series on billing for lab tests in physician offices.
The Clinical Laboratory Improvement Amendments (CLIA) program establishes quality standards for laboratory testing to ensure the accuracy, reliability and timeliness of patient test results. CLIA requires that any facility examining human specimens for diagnosis, prevention, treatment of a disease or for assessment of health must register with The Centers for Medicare & Medicaid Services and obtain CLIA certification.
CLIA was passed by Congress in 1988 to improve the quality of testing in all laboratories nationwide. These health assessment tests examine diagnoses, prevention and treatment of the human body. The basis of the complexity of CLIA tests are categorized into three levels: waived tests, moderate and high complexity.
Waived tests: Waived tests include any test listed in the regulation process of categorizing and re-categorizing of tests; any test in which the manufacturer’s instructions allow inspections and random compliance checks; and tests cleared by the FDA for home usage. When billing for waived tests approved on or after Jan. 23, 1996, laboratories must use the QW modifier. It is not mandatory for tests approved before Jan. 23, 1996.
The specified tests that are listed in the FDA regulation as waived are:
- Dipstick or tablet reagent urinalysis, nonautomated, for the following:
- Bilirubin
- Glucose
- Hemoglobin
- Ketone
- Leukocytes
- Nitritew
- pH
- Protein
- Specific gravity
- Urobilinogen
- Fecal occult blood
- Erythrocyte sedimentation rate—nonautomated
- Hemoglobin-copper sulfate—nonautomated
- Blood glucose by glucose monitoring devices cleared by the FDA specifically for home use
- Spun microhematocrit
- Added 1/19/93. Hemoglobin by single analyte instruments with self-contained or component features to perform specimen/reagent interaction, providing direct measurement and readout
- Moderate & high-complexity tests: Moderate- and high-complexity tests must meet requirements for proficiency testing, patient test management, quality assurance/control and personnel. Waived tests are exempted from these requirements.
Proficiency testing evaluates the laboratory’s performance mandated by CLIA. Moderate and high complexity tests are required to enroll in an approved PT program for specialties in which certification is sought. Regulations create rules for PT providers that include sample problem solving, distribution, preparation, result reporting and records.
Patient test management must maintain and establish a system to ensure identification and reliability of specimens during the testing process and correct handing of the results. Requirements for the submission and handling, specimen referral, test applications, test records and reports are stipulated by the regulations.
Quality assurance/control ensures that every laboratory create quality control procedures that oversee and assess every test technique to guarantee precise and dependable results. Each laboratory must ascertain written policies and procedures for a QA program intended to oversee and assess the complete testing process.
