Summary:
Summary Statement of Deficiencies D2010 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(2) (b)(2) The laboratory must test samples the same number of times that it routinely tests patient samples. This STANDARD is not met as evidenced by: Based on record review, staff interview, and policy review, the laboratory failed to test proficiency samples the same as patient samples for 2 of 3 hematology /coagulation events (3rd Event 2025 and 1st Event 2026). The laboratory performed 30 manual differentials, 477 Prothrombin Time/International Normalized Ratio (PT /INR), and 208 Partial Thromboplastin Time (PTT) tests in the past year. Findings include: 1. Review of the 1st Event 2026 Hematology/Coagulation proficiency records, at approximately 2:25 p.m. on 06/15/26, indicated the laboratory tested PT /INR and PTT proficiency testing samples COA-01, COA-02, COA-03, COA-04, and COA-05 between 11:04 a.m. and 11:16 a.m. on 03/17/26 and again between 11:41 a. m. and 12:04 p.m. on 03/17/26 before submitting the results to the proficiency testing company. The testing personnel (#1) and lab director had signed the attestation statement documenting staff treated the proficiency testing samples the same as patients. 2. During an interview at 2:53 p.m. on 06/15/26, testing personnel (#2) confirmed staff repeated the samples, but did not know why staff would have repeated on the same day. Testing personnel (#2) confirmed that the laboratory would not routinely repeat all patient coagulation samples on the same day. 3. Review of the 3rd Event 2025 Hematology/Coagulation proficiency records, at approximately 4:30 p.m. on 06/15/26, indicated five testing personnel (#1, #2, #3, #4, and #5) documented blood cell identifications for BCI-11, BCI-12, BCI-13, BCI-14, and BCI-15. The testing personnel (#1, #2, #3, and #4) and lab director had signed the attestation statement documenting staff treated the samples the same as patients. 4. During an interview at 4:39 p.m. on 06/15/26, testing personnel (#2) confirmed that five testing personnel (#1, #2, #3, #4, and #5) all documented the blood cell identifications. 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 -- Testing personnel (#2) confirmed that all testing personnel would not routinely review the same patient manual differentials. 5. Reviewed the afternoon of 06/15/26, the policy "Proficiency Test Policy", dated May 2024, stated, ". . . Proficiency Testing (PT) . . . specimens, images, and results shall not be referred to, tested by, or discussed with any external laboratory or individual. Internal review, quality assurance activities, and educational peer review shall be made and limited to authorized laboratory personnel only. Proficiency testing is tested in the same manner as patient samples. . . ." -- 2 of 2 --