Covington Pediatrics, Llc

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on May 15, 2025. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: D3003 FACILITIES CFR(s): 493.1101(a)(2) (a)(2) Contamination of patient specimens, equipment, instruments, reagents, materials, and supplies is minimized. This STANDARD is not met as evidenced by: A tour of the laboratory with Testing Personnel #1 (TP1), as dentified on the CMS Form 209-Laboratory Personnel Report, confirmed that the facility failed to provide adequate facilities to minimize potential contamination. THE FINDINGS INCLUDE: 1.A tour of the clinical laboratory confirmed that one sink was serving as the clean (non-contaminated) sink and the dirty (contamiinated) sink for disposal of completed testing specimens. 2. Interview with TP1 during the tour confirmed that the singular sink was in use for the disposal of test specimens as well as used for handwashing and the eyewash station. 3. An exit interview conducted with TP1 on May 15, 2025 at 11: 30am in the conference room confirmed that the facility failed to provide adequate facilities to minimize potential contamination. 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. 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 -- This STANDARD is not met as evidenced by: A review of the 2025 Personnel Competency Records confirmed that the laboratory failed to perform personnel competencies as required. THE FINDINGS INCLUDE: 1. A review of the 2025 Personnel Competency Records confirmed that testing personnel (TP) performed competencies on each other. 2. A review of the Testing Personnel Qualifications revealed that the Testing Personnel did not meet the qualifications required to perform competencies. 3. A review of the Procedure Manual confirmed that no written delegation for the perfomance of competencies was available during the time of inspection. 4. An exit interview, conducted with TP1, on May 15, 2025, at 11:30am, in the conference room confirmed the findings above. 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 established or verified in 493.1253. (b)(7) Control procedures. (b)(8)

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on April 25, 2023. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: Based on review of the laboratory policy and procedure manual (SOP) and staff interview, the laboratory failed to ensure a policy for the eyewash station. Findings include: 1. SOP review revealed the laboratory failed to establish an eyewash procedure for safety of testing personnel. 2. During an interview with Testing Personnel #1(CMS-209) on April 25, 2023 in the breakroom, confirmed that there was not an eyewash procedure present, during the survey. D5205 COMPLAINT INVESTIGATIONS CFR(s): 493.1233 The laboratory must have a system in place to ensure that it documents all complaints and problems reported to the laboratory. The laboratory must conduct investigations of complaints, when appropriate. This STANDARD is not met as evidenced by: Based on review of the laboratory policy and procedure manual and interview with 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 -- Testing Personnel, the laboratory failed to have a policy and procedure in place for complaint investigations. The Finding include: 1. SOP document review revealed that the laboratory did not have a policy and procedure for complaint investigations, during the time of the survey. 2. During an interview with Testing Personnel#1(CMS- 209) on April 25, 2023 at approximately 11:20 AM, in the breakroom, confirmed that the laboratory did not have a SOP in place for complaint investigations. 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 personnel records and interview with Testing Personnel (TP) revealed that the laboratory failed to establish a written policy to assess the six required criteria for employee competency for hematology and microbiology testing. The findings include: 1. The laboratory failed to have a written policy and procedure for competency that included the six criteria for testing personnel for 2021, 2022, and thus far 2022 (January-April). 2. During an interview with Testing Personnel #1(CMS-209) on April 25, 2023, at approximately 11:15 AM in the breakroom, confirmed the laboratory did not have a policy to assess the required six competency criteria for testing personnel in the laboratory. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on review of the American Academy of Family Physicians (AAFP) Proficiency Testing (PT) documents for 2021 for Hematology, and staff interview, the laboratory failed to provide evaluation documentation. The Findings include: 1. A review of the AAFP-PT hematology overall score (90%) for the specific analyte red blood cell (80%), hemoglobin (80%), and hematocrit (80%) evaluation report for event C, the laboratory failed to provide

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on April 20, 2021. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test 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)