Summary:
Summary Statement of Deficiencies D2006 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b) (b)The laboratory must examine or test, as applicable, the proficiency testing samples it receives from the proficiency testing program in the same manner as it tests patient specimens. This testing must be conducted in conformance with paragraph (b)(4) of this section. If the laboratory's patient specimen testing procedures would normally require reflex, distributive, or confirmatory testing at another laboratory, the laboratory should test the proficiency testing sample as it would a patient specimen up until the point it would refer a patient specimen to a second laboratory for any form of further testing. This STANDARD is not met as evidenced by: . Based on record review and interview with the technical consultant (TC), the laboratory failed to examine and report proficiency testing sample results as it would for a patient for 1 (Hematology Event 3 2025) of 7 events reviewed. Findings include: 1. Review of the laboratory's proficiency testing (PT) report from the American Association of Bioanalysts Medical Laboratory Evaluation (AAB-MLE) program and instrument values obtained from the testing events revealed the following discrepancy: a. Hematology Event 3 2025 i. Sample vial 13 had a result of 2.0 for Leukocytes reported to the PT provider. ii. Sample vial 13 had a result of 8.1 for Leukocytes on the laboratory's instrument printout. 2. An interview on 10/15/2025 at 1:15 pm with the TC confirmed results listed above were inaccurately entered and submitted to the proficiency testing provider. D5805 TEST REPORT CFR(s): 493.1291(c) (c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient 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 -- identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: . Based on record review and interview with Testing Personnel #1 (TP1), the laboratory failed to include the name, address and CLIA number of the referral laboratory performing complete blood count testing for 2 (P1, P6) of 9 patient test reports reviewed. Findings include: 1. A review of patient test reports revealed the name, address and CLIA number of the referral laboratory performing complete blood count testing was not included on the following patient test reports: a. Patient 1 (P1) had a complete blood count ordered and specimen collected on 10/16/2025. P1's result was reported on 10/17/2025. b. Patient 6 (P6) had a complete blood count ordered and specimen collected on 03/08/2025. P6's result was reported on 03/09/2025. 2. On 10 /15/2025 at 12:45 pm, an interview with TP1 confirmed that the patient test reports did not include the referral laboratory information. -- 2 of 2 --