Summary:
Summary Statement of Deficiencies D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on record review, the College of American Pathologists (CAP) proficiency testing (PT) records, and an interview with the technical consultant (TC1); the laboratory failed to evaluate the Rubella results obtained on proficiency testing performed during the year of 2020 when testing was not scored by the PT program. Findings: 1. The CAP-PT Immunology results for 2019 through 2021 and the laboratory's PT policy and procedures were reviewed. 2. The CAP-PT records showed the Rubella PT results were not scored and reported to the Centers of Medicare and Medicaid services (CMS) for the year of 2020 3. Further review of these documents revealed the following notification from the CAP-PT program: *"Only qualitative ...... Rubella PT scores will be reported to CMS, as stated in the Federal Register, Vol. 57, No. 40 , Section 493.927. Quantitative results are graded but will not be reported to CMS."* 4. The laboratory failed to follow it's PT policy and procedure to evaluate unscored PT results. 5. The laboratory failed to make the necessary Rubella PT sample reporting adjustments needed to meet the PT program's reporting requirements for CMS during the year of 2020. 6. On a recertification survey conducted 04/13/2021 at 1:45 PM, the TC1 confirmed the above findings. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --