Recent CMS/CLIA Changes to Proficiency Testing Requirements

07/18/2024

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On July 11, 2024, revisions that impact PT requirements of some clinical laboratories went into effect. These revisions include the addition of 29 newly regulated analytes (Table 1), the removal of five previously regulated analytes (Table 2), and changes to the grading and reporting of PT challenges (Table 3). The changes cover regulations §§ 493.2 and 493.801 through 493.959 and are based on a Centers for Medicare & Medicaid Services (CMS) Proficiency Testing Final Rule (CMS-3355-F). Based on this rule, other changes will take place in 2025, and some changes took place on August 10, 2022 (Table 4). This is the first update to the CLIA 1988 PT regulations since its inception in 1992. For greater detail, please refer to the CMS rule, published on 7/11/22.

Table 1. Twenty-nine newly regulated analytes

CLIA Regulation	Analytes Affected
General Immunology §493.927	Anti-HBs Anti-HCV C-reactive protein (high sensitivity)
Routine Chemistry §493.931	B-natriuretic peptide (BNP) Pro-BNP Cancer antigen (CA) 125 Carbon dioxide Carcinoembryonic antigen (CEA) Cholesterol, Low Density Lipoprotein (LDL), direct measurement Ferritin Gamma glutamyl transferase (GGT) Hemoglobin A1C Phosphorus Prostate specific antigen, total (PSA) Total iron binding capacity (TIBC), direct measurement Troponin I Troponin T
Endocrinology §493.933	Estradiol Folate, serum Follicle stimulating hormone (FSH) Luteinizing hormone (LH) Progesterone Parathyroid hormone (PTH) Testosterone Vitamin B12
Toxicology §493.937	Acetaminophen, serum Salicylate Vancomycin

Table 2. Five analytes removed from Subpart I.

LDH isoenzymes

Ethosuximide

Quinidine

Primidone

Procainamide (and its metabolite, N acetyl procainamide)

Table 3. Criteria for Acceptable Performance.

Most limits were changed from standard deviations to percentage-based limits

Fixed concentration units were added to fixed percentage units to address lower concentrations. For example:

Bilirubin, total – ±20% or ±0.4 mg/dL
Thyroid-stimulating hormone – ±20% or ±0.2 mIU/L
Lithium – ±15% or ±0.3 mmol/L

Table 4. Key Dates for Some Laboratories.

January 1, 2025: Implementation date for the PT requirements for both PT vendors and laboratories.

July 11, 2024: Effective date for the PT requirement revisions that include the additions of 29 new regulated analytes, the removals of five regulated analytes, and changes to grading and reporting. (Regulations §§ 493.2 and 493.801 through 493.959.)

August 10, 2022: CMS clarified that PT referral regulations apply to waived testing as well as non-waived testing when a moderate- and high-complexity laboratory chooses to perform PT for waived tests. (Regulations §§ 493.20 and 493.25.)

FDA Imposes New Regulations on Laboratory Developed Tests ⇒