Delmar Pediatrics Pllc

Summary Statement of Deficiencies D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) (a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: Based on review of College of American Pathologists (CAP) Proficiency Testing (PT) records, the laboratory's Standard Operating Procedure (SOP) manual, as well as interview with the Laboratory Director (LD), the laboratory failed to retain all PT records for at least two years. FINDINGS: 1. There was no documentation of CAP PT signed attestation records for Event 2 (D1-B2024) and Event 3 (D1-C2024) for calendar year 2024. 2. This was contrary to instructions indicated in the current, approved SOP for record retention. 3. The LD confirmed the findings on February 4, 2025, at approximately 1:15 P.M. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on review of laboratory's SOP manual, PT records, as well as interview with the LD, the laboratory failed to verify the accuracy of the test or procedure twice annually including the accuracy of calculated results. FINDINGS: 1. Testing Personnel (TP) performed, documented initial urine colony counts on March 26, 2024, and August 6, 2024, however there was no documentation of second TP performance 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 -- urine colony counts to verify the accuracy of the results. 2. This was contrary to instructions included in the current, approved SOP for twice-year verification of urine culture colony counts. 3. The LD confirmed the findings on February 4, 2026, at approximately 1:00 P.M. 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 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 College of American Pathologists (CAP) Proficiency Testing (PT) summary reports and interview with the laboratory director (LD), the LD failed to document review and date of review for the CAP bacteriology PT summary reports. FINDINGS: 1. There was no documented CAP bacteriology PT summary report LD review and date of review for the third event of 2022 as well as the first and second events of 2023. 2. The LD confirmed on January 3, 2024, at approximately 11:00 A. M. the LD signature and date of signature were not included on the respective CAP bacteriology PT summary reports. 3. It was noted that the laboratory scored 100% for the third event of 2022 as well as the first and second events of 2023. 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 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 -- 493.1253. (7) Control procedures. (8)