Boyette Orthpedics & Sports Medicine

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on review of laboratory records, absence of records, and interview with the technical consultant (TC) 04/30/2025, the laboratory failed to establish a policy for TC competency assessment and failed to assess competency of the TC in 2023, 2024, and 2025, a period of approximately 3 years. Findings: Review of laboratory records revealed no documentation of a policy for TC competency assessment. Review of laboratory records revealed no documentation of TC competency assessments in 2023, 2024, and 2025. During interview at approximately 10:38 a.m., TC said he wasn't aware that was a thing, and confirmed no TC competency assessments were available for 2023, 2024, and 2025. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) (b) The procedure manual must include the following when applicable to the test procedure: (b)(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. (b)(2) Microscopic examination, including the detection of inadequately prepared slides. (b)(3) Step-by- step performance of the procedure, including test calculations and interpretation of results. (b)(4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (b)(5) Calibration and calibration verification procedures. (b)(6) The reportable range for test results for the test system as Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- established or verified in 493.1253. (b)(7) Control procedures. (b)(8)

Summary Statement of Deficiencies D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on review of 2019, 2020, 2021, and 2022 hematology records and interview with TC (technical consultant) #1 on 4/28/22, the laboratory failed to retain all analytic systems records for at least two years. Review of 2019, 2020, 2021, and 2022 hematology records revealed there were no backgrounds available for the Sysmex XS 1000i hematology analyzer prior to 10/25/21. During interview at approximately 2:45 p.m., TC #1 stated that they make sure backgrounds are acceptable prior to patient testing each day, but they do not usually print them. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and procedures, review of 2020, 2021, and 2022 American Proficiency Institute (API) proficiency testing results, and technical consultant (TC) #1 interview 4/28/22, the laboratory failed to review and evaluate all results obtained on proficiency testing to ensure