Summary:
Summary Statement of Deficiencies D2093 ROUTINE CHEMISTRY CFR(s): 493.841(d) (d) Failure to return proficiency testing results to the proficiency testing program within the time frame specified by the program is unsatisfactory performance and results in a score of 0 for the testing event. This STANDARD is not met as evidenced by: Based on the surveyor's review of American Proficiency Institute (API)proficiency testing (PT) documentation, randomly selected patient test records and interviews with the technical consultant (TC) and laboratory assistants (LAs), the laboratory failed to report results for the proficiency testing samples within the time frame specified by API, resulting in scores of 0%, constituting unsatisfactory performances. The findings include: 1. The laboratory was enrolled in the API PT program for the Troponin I analyte. However, during the first event of 2023 (Q1-2023), the laboratory failed to submit the PT samples within the timeframe specified by the program resulting in an unsatisfactory score of 0%. 2. The TC and LAs affirmed by interviews on January 16, 2026, at approximately 11:15 a.m. that laboratory obtained an unsatisfactory score of 0% for the Troponin I analyte for the Q1-2023 event due to failure in submitting within the timeframe specified by the program. 3. According to the testing declaration form (Lab-144) submitted at the time of survey, the laboratory performed and reported 120 Troponin I tests samples including the period when unsatisfactory scores were obtained. . D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) (e)(4)(i) The proficiency testing samples are tested as required under Subpart H of this part; 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 -- This STANDARD is not met as evidenced by: Based on the surveyor's review of the laboratory's proficiency testing documentation, patient test records, and interviews with the technical consultant and laboratory assistant on January 16, 2026, this deficiency is herein cited for the laboratory director due to failure to ensure that proficiency testing samples were tested as required under Subpart H of this part. See D2093. -- 2 of 2 --