Summary:
Summary Statement of Deficiencies D2098 ENDOCRINOLOGY CFR(s): 493.843(a) (a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on a review of the College of American Pathologists (CAP) proficiency testing (PT) records, eight (8) random patient test results, and interview with the laboratory director (LD) and testing personnel (TP) on June 9, 2026, it was determined that the laboratory failed to attain a score of at least 80 percent of acceptable responses for the specialty of endocrinology for 1 of 6 analytes in its endocrinology panel during the first event of 2025. The findings included: 1. The laboratory enrolled in the CAP proficiency testing program for endocrinology testing using Tosoh ST AIA-PACK analyzer. According to the CAP evaluation, the laboratory attained an unsatisfactory score of %40 for the analyte progesterone in the first event of 2025. 2. On June 9, 2026, at approximately 11:00 am, the TP confirmed that the laboratory received the above unsatisfactory proficiency scores. 3. The laboratory's testing declaration form, signed by the laboratory director on June 4, 2026, stated that the laboratory performed approximately 4,823 endocrinology tests including progesterone annualy. D6090 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(ii) (e)(4)(ii) The results are returned within the timeframes established by the proficiency testing program; This STANDARD is not met as evidenced by: Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- Based on a review of the College of American Pathologists (CAP) proficiency testing (PT) records, eight (8) random patient test results, and interview with the laboratory director (LD) and testing personnel (TP) on June 9, 2026, it was determined that the laboratory director failed to ensure the PT results for 6 of 6 analytes in the specialty of endocrinology returned within the timeframes established by CAP in the first event of 2023. The findings included: 1. The laboratory was enrolled in the CAP proficiency testing program for endocrinology testing using the Tosoh ST AIA-PACK analyzer. According to the CAP evaluation, the laboratory received an unsatisfactory score of 0% in the specialty of endocrinology during the first event of 2023. 2. On June 9, 2026, at approximately 11:00 a.m., the TP confirmed that the laboratory did not submit the PT sample results to CAP for the first event of 2023. 3. The laboratory's testing declaration form, signed by the laboratory director on June 4, 2026, stated that the laboratory performed approximately 4,823 endocrinology tests annually. -- 2 of 2 --