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Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(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 record review and staff interview with the laboratory director (LD), the LD and testing personnel (TP) failed to sign the attestation sheets for the American Proficiency Institute (API) proficiency testing (PT) samples in the specialty of Hematology. Findings include: 1. Record review on 11/19/2024 of the laboratory's PT attestation sheets for API Hematology surveys revealed the following: a. Events 2 and 3 2023, and Events 1, 2, and 3 2024; Not signed by the LD. b. Events 1 and 3 2023, and Events 1, 2, and 3 2024; Not signed by TP. 2. Staff interview on 11/19/2024 at 9: 30am with the LD confirmed the above findings. 3. The laboratory performs 500 tests annually in the specialty of Hematology. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on record review and interview with the laboratory director (LD), the laboratory failed to ensure controls were controls were within their expiration date before use in the specialty of Hematology. Findings include: 1. Record review of 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 -- laboratory 2023

Summary Statement of Deficiencies D2123 HEMATOLOGY CFR(s): 493.851(c) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3) The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on surveyor review of the CASPER Proficiency Testing (PT) data report 155, lack of PT records and documentation, and staff interviews, the laboratory failed to participate in an approved PT program for Hematology. Findings include: 1. Record review on 9/6/2022 of the CASPER 155 report revealed PT scores of 0% for Hematology (HSY-11 through HSY-15) 2021 Event 3. 2. Record review on 9/6/2022 of the laboratory's American Proficiency Institute performance summary documentation revealed a "Failure to Participate" result in Hematology for PT 2021 Event 3. 3. Staff interview with testing personnel #1 (TP1) on 9/6/2022 at 9:30 AM confirmed the laboratory failed to participate in PT for 2021 Event 3. 4. The laboratory performs approximately 2000 tests annually in the specialty of Hematology. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test 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 -- procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)