Summary:
Summary Statement of Deficiencies D0000 A recertification survey was conducted on May 18, 2022. Pediatric Associates - Hollywood clinical laboratory was not in compliance with 42 CFR 493, requirements for clinical laboratories. D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to have all testing personnel rotate through performance of proficiency testing (PT) samples for four (2020 2nd, 3rd, 2021 1st, 3rd) of six events (2020 2nd, 3rd, 2021 1st, 2nd, 3rd, 2022 1st) for the specialty of hematology. The laboratory failed to have all testing personnel rotate through performance of proficiency testing (PT) samples for four (2021 1st, 2nd, 3rd, 2022 1st) of six events (2020 2nd, 3rd, 2021 1st, 2nd, 3rd, 2022 1st) for the specialty of bacteriology. Findings: Review of the American Proficiency Institute (API) PT attestations for hematology showed Testing Personnel A performed the PT for the 2020 2nd and 3rd events, 2021 1st and 3rd events, and 2022 1st event. Review of the API PT records for hematology testing listed the following submission deadlines: 2020 2nd event 07/24/2020 2020 3rd event 11/24/2020 2021 1st event 03 /31/2021 2021 2nd event 08/04/2021 2021 3rd event 11/23/2021 2022 1st event 03/30 /2022 Review of the American Proficiency Institute (API) PT attestations for bacteriology showed Testing Personnel A performed the PT for the 2021 1st, 2nd and 3rd events, and 2022 1st event. Review of the API PT records for bacteriology testing listed the following submission deadlines: 2020 2nd event 07/06/2020 2020 3rd event 10/09/2020 2021 1st event 03/03/2021 2021 2nd event 07/07/2021 2021 3rd event 10 /13/2021 2022 1st event 03/02/2022 Review of the Laboratory Personnel Report, 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 -- signed and dated by the Laboratory Director on 05/18/2022, listed two Testing Personnel (A, B). Testing Personnel A had competency evaluations performed on 03 /05/2020, 01/15/2021, and 01/15/2022. Testing Personnel B had competency evaluations performed on 12/07/2020, 06/29/2021, and 01/04/2022. Testing Personnel C, who was no longer working in the laboratory, had competency evaluations performed on 03/05/2020, and 01/15/2021. Testing Personnel A was available to perform PT from the 2020 2nd event through the 2022 1st event for hematology and bacteriology. Testing Personnel B was available to perform PT from the 2021 1st event through the 2020 3rd event for hematology and from the 2021 1st event through the 2022 1st event for bacteriology. Testing Personnel C was available to perform PT from the 2020 2nd event through the 2020 3rd event for hematology and bacteriology. On 05/18/2022 at 2:20 PM, the Laboratory Lead acknowledged the laboratory failed to rotate testing personnel. On 05/18/2022 at 2:22 PM, Laboratory Lead stated Testing Personnel B was on leave from 03/04/2022 to 05/03/2022 and Testing Personnel C's last day was 02/08/2021. -- 2 of 2 --