Upcoming Important Changes to CLIA Proficiency Testing Requirements
The Centers for Medicare & Medicaid Services (CMS) published their final rule on July 2022 including Proficiency Testing (PT) revisions. PT revisions will go into effect January 1, 2025 and will include analytes that will be CMS regulated along with revised grading criteria for existing analytes. Please refer to this 2025 CLIA changes document for more information, including the effective date, and also the implementation date of the CMS final rule.
Most of the modules WSLH PT offers already meet these requirements. Where possible, WSLH PT will reassign laboratories using a non-waived method enrolled in a 3-sample PT module to a 5-sample PT module. Reassignments will be reflected on 2025 Enrollment Quotes sent out in September 2024. The tables below list new CMS regulated analytes with their corresponding modules and revised scoring criteria.
Further changes will be communicated closer to the implementation date of January 1, 2025. If you have any questions about the new requirements, please contact WSLH PT at 800-462-5261 or ptservice@slh.wisc.edu.
New CMS Regulated Analytes
| Analyte | WSLH Module | Current WSLH Criteria | New CMS Criteria |
|---|---|---|---|
| CHEMISTRY | |||
| BNP | 1260 | Target value ± 2.75 SD | Target value ± 30% |
| NT pro-BNP | 1260 | Target value ± 2.75 SD | Target value ± 30% |
| CO2, total | 1050, 1345, 1310-1322 | Target value ± 5 mmol/L | Target value ± 20% |
| Cholesterol, LDL measured | 1310-1322 | Target value ± 30% | Target value ± 20% |
| Ferritin | New 5-sample program pending | Target value ± 4.5 ng/mL or 30% (greater) | Target value ± 20% |
| GGT | 1310-1322 | Target value ± 20% | Target value ± 5 U/L or 15% (greater) |
| Hemoglobin A1c | 1524 | Target value ± 25% | Target value ± 8% |
| Phosphorus | 1310-1322 | Target value ± 0.5 mg/dL or 12% (greater) | Target value ± 0.3 mg/dL or 10% (greater) |
| PSA total | New 5-sample program pending | Target value ± 0.9 ng/mL or 30% (greater) | Target value ± 0.2 ng/mL or 20% (greater) |
| TIBC, measured | 1310-1322 | Target value ± 20% | Target value ± 20% |
| Troponin I | 1260 | Target value ± 2.75 SD | Target value ± 0.9 ng/mL or 30% (greater) |
| Troponin T | 1260 | Target value ± 2.75 SD | Target value ± 0.2 ng/mL or 30% (greater) |
| ENDOCRINOLOGY | |||
| CA 125 | New 5-sample program pending | Target value ± 2 SD | Target value ± 20% |
| CEA | New 5-sample program pending | Target value ± 1.2 ng/mL or 30% (greater) | Target value ± 1 ng/mL or 15% (greater) |
| Estradiol | New 5-sample program pending | Target value ± 30% | Target value ± 30% |
| Folate | New 5-sample program pending | Target value ± 0.9 ng/mL or 30% (greater) | Target value ± 1 ng/mL or 30% (greater) |
| FSH | New 5-sample program pending | Target value ± 2 mIU/mL or 25% (greater) | Target value ± 2 IU/L or 18% (greater) |
| LH | New 5-sample program pending | Target value ± 2.5 SD | Target value ± 20% |
| PTH | New 5-sample program pending | Target value ± 2.5 SD | Target value ± 30% |
| Progesterone | New 5-sample program pending | Target value ± 0.3 ng/mL or 30% (greater) | Target value ± 25% |
| Prolactin | New 5-sample program pending | Target value ± 3.6 ng/mL or 30% (greater) | Target value ± 20% |
| Testosterone, total | New 5-sample program pending | Target value ± 0.3 ng/dL or 30% (greater) | Target value ± 20 ng/dL or 30% (greater) |
| Vitamin B12 | New 5-sample program pending | Target value ± 60 pg/mL or 30% (greater) | Target value ± 30 pg/mL or 25% (greater) |
| TOXICOLOGY | |||
| Acetaminophen | 1310-1322 | Target value ± 25% | Target value ± 3 ug/mL or 15% (greater) |
| Salicylates | 1310-1322 | Target value ± 25% | Target value ± 2 ug/mL or 15% (greater) |
| Vancomycin | 1310-1322 | Target value ± 2 SD or 25% (greater) | Target value ± 2 ug/mL or 15% (greater) |
| HEMATOLOGY | |||
| INR | 2060, 2350, 2370 | Target value ± 2.5 SD or 20% (greater) | Target value ± 15% |
| IMMUNOLOGY | |||
| CRP, high sensitivity | 1260 | Target value ± 2.75 SD | Target value ± 1 mg/L or 30% (greater) |
| Anti-HBs (HBsAb) | 4190 | Reactive (positive) or non-reactive (negative) | Reactive (positive) or non-reactive (negative) |
| Anti-HCV | 4190 | Reactive (positive) or non-reactive (negative) | Reactive (positive) or non-reactive (negative) |
Revised Scoring Criteria for Currently Regulated Analytes
| CHEMISTRY | |||
|---|---|---|---|
| Analyte | WSLH Module | Current CMS Criteria | New CMS Criteria |
| ALT | 1310-1322 | Target value ± 20% | Target value ± 6 U/L or 15% (greater) |
| Albumin | 1310-1322 | Target value ± 10% | Target value ± 8% |
| ALP | 1310-1322 | Target value ± 30% | Target value ± 20% |
| Amylase | 1310-1322 | Target value ± 30% | Target value ± 20% |
| AST | 1310-1322 | Target value ± 20% | Target value ± 6 U/L or 15% (greater) |
| Blood gas pO2 | 1050, 1345 | Target value ± 3 SD | Target value ± 15 mmHg or 15% (greater) |
| Cholesterol, HDL | 1310-1322 | Target value ± 30% | Target value ± 6 mg/dL or 20% (greater) |
| Creatine Kinase (CK) | 1260, 1310-1322 | Target value ± 30% | Target value ± 20% |
| CK-MB | 1260 | Target value ± 3 SD | Target value ± 3 ng/mL or 25% (greater) |
| Creatinine | 1050, 1345, 1310-1322 | Target value ± 0.3 mg/dL or 15% (greater) | Target value ± 0.2 mg/dL or 10% (greater) |
| Glucose | 1050, 1345, 1310-1322 | Target value ± 6 mg/dL or 10% (greater) | Target value ± 6 mg/dL or 8% (greater) |
| Iron | 1310-1322 | Target value ± 20% | Target value ± 15% |
| LDH | 1310-1322 | Target value ± 20% | Target value ± 15% |
| Magnesium | 1310-1322 | Target value ± 25% | Target value ± 15% |
| Potassium | 1050, 1345, 1310-1322 | Target value ± 0.5 mmol/L | Target value ± 0.3 mmol/L |
| Total Protein | 1310-1322 | Target value ± 10% | Target value ± 8% |
| Triglycerides | 1310-1322 | Target value ± 25% | Target value ± 15% |
| Uric Acid | 1310-1322 | Target value ± 17% | Target value ± 10% |
| ENDOCRINOLOGY | |||
| Analyte | WSLH Module | Current CMS Criteria | New CMS Criteria |
| Cortisol | 1310-1322 | Target value ± 25% | Target value ± 20% |
| FT4 | 1310-1322 | Target value ± 3 SD | Target value ± 0.3 ng/dL or 15% (greater) |
| hCG serum | 1310-1322 | Target value ± 3 SD | Target value ± 3 mIU/mL or 18% (greater) |
| T-Uptake | 1310-1322 | Target value ± 3 SD | Target value ± 18% |
| T3, total | 1310-1322 | Target value ± 3 SD | Target value ± 30% |
| TSH | 1310-1322 | Target value ± 3 SD | Target value ± 0.2 mIU/L or 20% (greater) |
| TOXICOLOGY | |||
| Analyte | WSLH Module | Current CMS Criteria | New CMS Criteria |
| Alcohol | 1000 | Target value ± 25% | Target value ± 20% |
| Blood Lead | 1080 | Target value ± 4 ug/dL or 10% (greater) | Target value ± 2 ug/dL or 10% (greater) |
| Carbamazepine | 1310-1322 | Target value ± 25% | Target value ± 1 ug/mL or 20% (greater) |
| Digoxin | 1310-1322 | Target value ± 0.2 ng/mL or 20% (greater) | Target value ± 0.2 ng/mL or 15% (greater) |
| Lithium | 1310-1322 | Target value ± 0.3 mmol/L or 20% (greater) | Target value ± 0.3 mmol/L or 15% (greater) |
| Phenobarbital | 1310-1322 | Target value ± 20% | Target value ± 2 ug/mL or 15% (greater) |
| Phenytoin | 1310-1322 | Target value ± 25% | Target value ± 2 ug/mL or 15% (greater) |
| Theophylline | 1310-1322 | Target value ± 25% | Target value ± 20% |
| Tobramcyin | 1310-1322 | Target value ± 25% | Target value ± 20% |
| Valproic Acid | 1310-1322 | Target value ± 25% | Target value ± 20% |
| HEMATOLOGY | |||
| Analyte | WSLH Module | Current CMS Criteria | New CMS Criteria |
| Erythrocyte Cell Count | multiple, see catalog | Target value + 6% | Target value ± 4% |
| Hematocrit | multiple, see catalog | Target value + 6% | Target value ± 4% |
| Hemoglobin | multiple, see catalog | Target value + 7% | Target value ± 4% |
| Leukocyte Count | multiple, see catalog | Target value + 15% | Target value ± 10% |
| Participants will be required to enroll in proficiency testing for both manual and automated blood cell differentials. Scores will be submitted to CMS. |
|||
| IMMUNOLOGY | |||
| Analyte | WSLH Module | Current CMS Criteria | New CMS Criteria |
| Alpha-1-Antitrypsin | 4290 | Target value ± 3 SD | Target value ± 20% |
| Complement C3 | 4290 | Target value ± 3 SD | Target value ± 15% |
| Complement C4 | 4290 | Target value ± 3 SD | Target value ± 5 mg/dL or 20% (greater) |
| IgA | 4290 | Target value ± 3 SD | Target value ± 20% |
| IgE | 4290 | Target value ± 3 SD | Target value ± 20% |
| IgG | 4290 | Target value ± 25% | Target value ± 20% |
| IgM | 4290 | Target value ± 3 SD | Target value ± 20% |
PDF Document Downloads:
Microbiology Changes for 2025
CLIA mandates laboratories performing regulated microbiology tests to conduct five regulated challenges per test event in each sub-specialty. Effective January 1, 2025, the following additions to each sub-specialty apply:
Additional Information
- For the link to CMS final rule, please refer to the Federal Register.