Summary:
Summary Statement of Deficiencies D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) (a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: Based on surveyor review of Proficiency Testing (PT) records and interview with the Technical Consultant (TC), the laboratory lacked copies of all PT records for testing performed with the American Proficiency Institute (API) for Hematology and Routine Chemistry for the 3rd PT event of 2025. The finding includes: 1. The laboratory lacked the work records, attestation pages and graded results for the 3rd PT event of 2025. 2. The TC confirmed on 5/6/26 at 11:30 am, all PT records were not retained. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on surveyor review of the Proficiency Testing (PT) records and interview with the Techincal Consultant (TC), the laboratory failed to review PT results obtained from the American Proficiency Institute (API) for Hematology and Routine Chemistry tests in the calendar year 2025. The findings include: 1. The there was no documented evidence that PT result were reviewed in the calendar year 2025. 2. The TC confirmed on 5/6/26 at 11:15 am, the there was no documented evidence that PT result were reviewed in the calendar year 2025. 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 --