The Clinical Laboratory Improvement Amendments of 1988 and their associated regulations require laboratories performing moderate- or high-complexity testing to enroll in an approved proficiency-testing (PT) program “for each specialty, subspecialty, and analyte or test for which the laboratory is certified under CLIA.” These regulations were most-recently amended in 2012, and as of January 2017 there were 36,777 laboratories required to enroll in such a program. CMS is proposing to again modify these requirements, as laboratory testing has changed significantly since 1992 and many of the analytes now commonly-tested were not in existence at the time of the initial regulations. This proposed rule implements many of the recommendations of the Clinical Laboratory Improvement Advisory Committee over the past ten years, in collaboration with the Centers for Disease Control and Prevention (CDC). On average, CMS expects these new requirements will cost laboratories between $721 and $3,218 per laboratory.
CMS will accept comments on these proposed regulations until April 5, 2019.
Microbiology requirements to be more generalized and retain some flexibility
Current CLIA regulations include PT requirements for each subspecialty of microbiology, but do not specify required analytes. CLIAC recommended four categories of testing for each subspecialty: stains, susceptibility and resistance testing, antigen and/or toxin detection, and microbial identification or detection. However, CMS found that not all of these exist for each subspecialty and is therefore proposing to add specific requirements for each of bacteriology, mycobacteriology, mycology, parasitology, and virology. These requirements will be modified as additional PT becomes available. Additionally, CMS is proposing to remove the specific lists of microorganisms in each of these categories and replacing these with general lists of the types of organisms included in each. Proficiency testing results for microbiology organism detection will be required to be reported to the highest level reported on patient specimens. In addition, CMS is proposing to require at least two PT samples per event for susceptibility and resistance testing.
Non-microbiology analytes added to PT regulations, but others proposed for removal
In order to determine which analytes to propose for the addition of PT requirements, CMS used a four-criteria process based on current availability of PT materials, volume of patient testing, impact on patient/public health, and cost and feasibility of implementation. Based on these criteria, CMS is proposing the following analytes for addition to the PT requirement regulations:
| CLIA Regulation | Analytes |
| General Immunology §493.927 | Anti-HBs Anti-HCV C-reactive protein (high sensitivity) |
| Routine Chemistry §493.931 | B-natriuretic peptide (BNP) ProBNP Cancer antigen (CA) 125 Carbon dioxide Carcinoembryonic antigen Cholesterol, low density lipoprotein Ferritin Gamma glutamyl transferase Hemoglobin A1c Phosphorus Prostate specific antigen, total Total iron binding capacity Troponin I Troponin T |
| Endocrinology §493.933 | Estradiol Folate, serum Follicle stimulating hormone Luteinizing hormone Progesterone Prolactin Parathyroid hormone Testosterone Vitamin B12 |
| Toxicology §493.937 | Acetaminophen, serum Salicylate Vancomycin |
CMS estimates that the additional costs of PT testing for these additional analytes will generally not exceed $5. Based on the same criteria, CMS proposes to eliminate LDH isoenzymes, ethosuximide, quinidine, primidone, and procainamide from the proficiency testing regulations. In addition, for certain analytes, CMS is changing the methodology for determining certain acceptance limits, which vary based on the analyte, and tightening the satisfactory performance criteria for a number of tests.
Miscellaneous changes
CMS is proposing to require that each PT program have ten laboratory participants before offering any PT analyte, in order to reduce burden on labs that pay for testing but do not receive a score. CMS also proposes to limit the number of online submissions of PT data to create an audit trail in PT referral investigations. HHS will be allowed to perform on-site visits to PT program applicants and approved programs and may require re-application in the event that widespread problems are found in a program. Additional tweaks are included in response to CLIAC recommendations, feedback from stakeholders, and to correct historical errors.