Counting Tests

6140.1 - Counting Tests (Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) Total annual volume for waived tests, if any, should be recorded on the CLIA application (Form CMS-116) in the waived testing section. The total annual volume for nonwaived tests, including PPM procedures, should be reported on the form in the Nonwaived Testing section by specialty and subspecialty. Only tests that are ordered and reported should be included in the laboratory’s test volume(s). Calculations (e.g., A/G ratio, MCH, MCHC, HCT, and T7), QC tests, and PT assays should not be counted. • For chemistry tests, each non-calculated analyte is counted separately (e.g., Lipid Panel consisting of a total cholesterol, HDL cholesterol, LDL cholesterol and triglycerides equals 4 tests). • For complete blood counts, each measured individual analyte that is ordered and reported is counted separately. Differentials count as one test. • For urinalysis, microscopic and macroscopic examinations each count as one test. Macroscopics (dipsticks) are counted as one test regardless of the number of reagent pads on the strip. For screening drug tests (e.g. dipsticks, cups, cards) count as one test regardless of the number of drugs tested. • For microbiology, susceptibility testing is counted as one test per group of antibiotics used to determine sensitivity for one organism. Cultures are counted as one per test request from each specimen regardless of the extent of identification, number of organisms isolated, and number of tests/procedures required for identification. Each gram stain or acid-fast bacteria (AFB) smear requested from the primary source is counted as one. For example, if a sputum specimen has a routine bacteriology culture and gram stain, a mycology test, and an AFB smear and culture ordered, this would be counted as five tests. For parasitology, the direct smear and the concentration and prepared slide are counted as one test. • For allergy testing, each allergen is counted as one test. • For flow cytometry, each measured individual analyte (e.g. T cells, B cells, CD4, etc.) that is ordered and reported should be counted separately. • For manual gynecologic and nongynecologic cytology, each slide (not case) is counted as one test. Refer to D5643 for counting non-gynecological slide preparations using liquid-based slide preparatory techniques. Refer to D5665 for counting gynecologic cytology slide preparations when using automated and semi-automated screening devices. • For immunohematology, each ABO, Rh, antibody screen, cross match, or antibody identification is counted as one test. • For histocompatibility, each HLA typing (including disease associated antigens) is counted as one test, each HLA antibody screen is counted as one test and each HLA cross match is counted as one test. For example, a B-cell, a T-cell, and an auto-crossmatch between the same donor and recipient pair would be counted as 3 tests. • For histopathology, each block (not slide) is counted as one test. Autopsy services are not included. For those laboratories that perform special stains on histology slides, the test volume is determined by adding the number of special stains, including immunohistochemistry, performed on slides to the total number of specimen blocks prepared by the laboratory. • For cytogenetics, the number of tests is determined by the number of specimen types processed on each patient (e.g., a bone marrow and a venous blood specimen received on one patient are counted as two tests). NOTE: For all other genetic tests, the number of tests is determined by the number of results reported in the final report. • Genetics tests should be placed in the specialty or subspecialty where they fit best, according to the methodology of the test.