Children's Doctor,The

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) (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 review of proficiency testing (PT) records and interview with the technical consultant (TC), the laboratory failed to ensure that the testing personnel (TP) and laboratory director (LD) attested to the routine integration of the samples into the patient workload using the laboratory's routine methods in two of six PT events reviewed. Findings: 1. Records from the third PT event in 2024 through the third PT event in 2025 were reviewed for a total of six events. 2. The laboratory recorded the PT sample results on the patient testing log which captured the initials of the TP who performed the testing for each PT sample. 3. Attestation forms from the 2024 first PT event were not signed by the LD or TP. 4. Attestation forms from the 2025 first PT event were not signed by the TP who performed testing and whose initials were documented on the patient testing log 5. During the survey on 12/03/2025 at 11:00 AM, the TC confirmed that attestations were missing signatures from the LD and/or TP in two of six PT events reviewed. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

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 review of the proficiency testing (PT) records, microbiology patient log and interview with the office manager, the laboratory failed to list the PT samples on the microbiology patient log in the same manner as the patient specimens. Findings: 1. Review of the PT records and microbiology patient logs for 2018 and 2019 showed that the laboratory did not maintain the original worksheet for recording the PT results for urine colony counts in the same manner as the patient specimens. 2. When interviewed the office manager stated that the PT results were given to her on a post-it note. Once the results were recorded on the PT worksheet the post-it note was thrown away. 3. During the survey on 09/12/19 at 11:15 AM the office manager confirmed that the PT samples were not listed on the microbiology patient log in the same manner as the patient specimens. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --