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 the surveyor's review of the American Proficiency Institute (API) proficiency testing (PT) records and an interview with the testing personnel-1 (TP1), testing personnel-2 (TP2) and supervisor on April 8, 2026, the laboratory failed to attain at least 80 percent of the acceptable score in Endocrinology for the CA 15-3 analyte for the third event of 2025 (Q3-2025). The findings include: 1. The surveyor reviewed the API PT performance evaluation documentation and found that the laboratory obtained an unsatisfactory score of 60% for the CA 15-3 analyte in Q3- 2025 event. The report as followed: a. T3 Uptake analyte score for the Q2-2025 event: Sample Result Expected TM-11 129.0 113.0 - 130.6 TM-12 46.3 40.3 - 48.4 TM-13 19.0 16.2 - 19.9 TM-14 *105.0 88.8 - 104.7 TM-15 *78.8 65.1 - 76.4 Legend: * = unsatisfactory score 2. The TP1, TP2 and supervisor affirmed by an interview on April 8, 2026, at approximately 10:20 a.m. that the laboratory obtained the unsatisfactory PT scores for the CA 15-3 analyte during the Q3-2025 event as mentioned in statement #1. 3. According to the laboratory's testing declaration, the laboratory performed and reported approximately 572 CA 15-3 patient test samples annually including the time the laboratory received unsatisfactory proficiency testing scores. . D2127 HEMATOLOGY CFR(s): 493.851(d) (d) Failure to return proficiency testing results to the proficiency testing program Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- 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 the American Proficiency Institute (API) proficiency testing (PT) reports and an interview with the testing personnel-1 (TP1), testing personnel-2 (TP2) and supervisor on April 8, 2026; it was determined that the laboratory failed to return the proficiency testing results for Hematology for the second event of 2025 (Q2-2025) within the time frame specified resulting to an unsatisfactory performance score of zero percent (0%). The findings include: 1. The laboratory received an unsatisfactory score of 0% for the Q2-2025 event after failure to submit results within the time frame as mandated by the API PT program. 2. The TP1, TP2 and supervisor affirmed on April 8, 2026, at approximately 10:20 a.m. that the laboratory received the unsatisfactory score as mentioned in statement #1 due to failure to participate in the Q2-2025 event. 3. The laboratory analyzed and reported approximately 219,037 Hematology patient test samples annually during the time when the laboratory failed to submit the PT results within the timeframe resulting to an unsatisfactory score. 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 the review of the laboratory's policy and procedure, proficiency testing (PT) records, lack of