Central Family & 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's competency assessment policy, lack of competency evaluations for two of three testing personnel for 2024 and interview with the laboratory director, the laboratory failed to follow written policies for retaining competency assessment documentation. Findings: 1. The laboratory's competency assessment policy states, "File all records for a minimum of two years." 2. The laboratory did not have documentation to show the laboratory maintained personnel competency assessment records for testing personnel #1 and # 2 for 2024 3. Interview with the laboratory director on January 27, 2025 at 12:35 PM confirmed, the laboratory failed to follow the competency assessment policy. D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) (d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on review of the Abbott I-Stat Chem 8+ procedure and interview with the laboratory director (LD) the laboratory failed show the current LD approved, signed and dated the procedure. Findings: 1. The laboratory did not have documentation to show the current LD approved, signed and dated the Abbott I-Stat Chem 8+ 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 -- procedure. 2. Interview on January 27, 2025 at 12:35 PM the LD confirmed the laboratory failed to ensure the Abbott I-Stat Chem 8+ procedure was approved, signed and dated by the current LD. D5807 TEST REPORT CFR(s): 493.1291(d) (d) Pertinent "reference intervals" or "normal" values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results. This STANDARD is not met as evidenced by: Based on review of reference ranges stated in the I-Stat laboratory procedure manual, two of two selected test reports, patient testing volume and interview with the laboratory director (LD), the laboratory failed to ensure test reports included pertinent reference intervals (normal values) as determined by the laboratory. Seven of seven reference ranges listed on the laboratory test report differed from those stated in the procedure manual. Findings: 1. Review of patient test report # 21389393 and # 21559831 revealed normal values for seven analytes did not match those stated in the procedure manual. Patient test reports Procedure Manual Sodium 136-145 Sodium 138-146 Potassium 3.5-5.1 Potassium 3.5-4.9 Chloride 98-107 Chloride 98-109 Glucose 65-99 Glucose 70-105 BUN 10-20 BUN 8-26 Creatinine 0.6-1.1 Creatinine 0.6-1.3 CO2 23-31 CO2 24-29 2. The laboratory provided estimated annual patient chemistry test volume of 576 tests. 3. Interview with the LD on January 27, 2025 at 12:35 PM confirmed the laboratory failed to ensure pertinent reference ranges as determined by the laboratory, were included on patient test reports. -- 2 of 2 --

Summary Statement of Deficiencies D6030 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(12) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(12) Ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills; This STANDARD is not met as evidenced by: Based of the lack of policies and interview with the laboratory director (LD), the LD failed to ensure a policy is established for monitoring individuals who conduct pre- analytical, analytical and post-analytical phases of testing to assure they are competent and maintain their competency for moderate complexity testing. Findings: 1. The laboratory could not produce a policy for monitoring individuals for competency that are performing moderate complexity testing. 2. Interview with the laboratory director on April 25, 2023 at 2:00 PM confirmed the LD failed to ensure a policy is established for monitoring individuals who conduct pre-analytical, analytical and post- analytical phases of testing to assure they are competent and maintain their competency for moderate complexity testing. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the 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 -- performance of individuals responsible for moderate complexity testing at least annually, after the first year. This STANDARD is not met as evidenced by: Based on review of 2021/2022 performance evaluations and interview with laboratory director (LD), the technical consultant (whom is also the laboratory director) failed to evaluate and document annual performance evaluations for 2 of 3 testing personnel (TP). Findings: 1. Review of 2022 performance evaluations showed no annual performance evaluation for testing personnel #1 and #2 for 2022. 2. Interview with LD on April 25, 2023 at 2:00 PM confirmed the technical consultant failed to evaluate and document annual performance evaluation for TP in 2022. -- 2 of 2 --