Summary:
Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) (b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of laboratory records, American Proficiency Institute (API) proficiency testing (PT) records, lack of documentation, and interview with the laboratory representative; the laboratory failed to ensure PT attestation statements were completed for five of ten PT events in the subspecialties of routine chemistry and endocrinology from 2024 through the date of survey, 05/26/2026. Findings include: 1. Review of laboratory records revealed the laboratory was enrolled in API PT for the following three analytes: (Sub)specialty: Analytes: Chemistry - Core Prostate-Specific Antigen (PSA) Testosterone Chemistry - Misc* Sex Hormone- Binding Globulin (SHBG) *Misc = Miscellaneous 2. Review of API PT records revealed a lack of attestation statements for five of ten PT events reviewed. Year, Event: 2024 - Event 3, Chemistry - Core 2025 - Event 1, Chemistry - Misc 2025 - Event 1, Chemistry - Core 2025 - Event 2, Chemistry - Core 2025 - Event 2, Chemistry - Misc 3. Interview with the laboratory representative on 05/26/2026, at 1: 03 pm, confirmed the laboratory failed to ensure PT attestation statements were completed for five of ten PT events in the subspecialties of routine chemistry and endocrinology from 2024 through the date of survey, 05/26/2026. 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 --