Healthykids Of Gardendale

Summary Statement of Deficiencies D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on a review of the Hematology calibration and Quality Control (QC) records, and an interview with Testing Personnel #1, the laboratory used expired QC and expired calibration material on the Beckman Coulter AcT Diff Hematology analyzer. The surveyor noted the laboratory utilized an expired kit for one of three calibrations in 2022, and expired QC for one day of patient testing in January 2023. The findings include: 1. A review of the Hematology Calibration and QC records revealed the following: a) The Hematology AcT Diff analyzer was calibrated on 11/17/2022; the calibrator used expired on 11/12/2022. b) QC was performed on 1/17/2023; all three levels of QC expired on 1/16/2023. A review of the patient log revealed one patient CBC (Complete Blood Count) was performed on 1/17/2023. 2. During an interview on 2/2/2023, at 11:55 AM, Testing Personnel #1 confirmed the above findings. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the 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 a review of the personnel records and an interview with Testing Personnel 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 -- #1, the technical consultant failed to ensure all testing personnel had documentation of annual competency assessments. The surveyor noted no documentation of the 2021 annual competency assessment for one of six testing personnel listed on the CMS-209 (Laboratory Personnel Report). The findings include: 1. A review of the personnel records revealed Testing Personnel #2's annual competency evaluations were performed in September 2020 (reviewed during the previous survey) and in July 2022. There was no documentation of a 2021 annual competency assessment. 2. During an interview on February 2nd, 2023, at 11:50 AM, Testing Personnel #1 confirmed the above findings. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The surveyor determined this laboratory is in substantial compliance with the requirements of the Clinical Laboratory Improvement Amendments of 1988 (CLIA'88). D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 Each laboratory that performs nonwaived testing must meet the applicable requirements under 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State Operations Manual (CMS Pub. 7). (a) Reporting of SARS-CoV-2 test results During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: Based on record review and interview, the laboratory failed to report SARS-CoV-2 (Severe Acute Respiratory Syndrome Coronovirus 2) test results for negative Coronovirus Disease 2019 (COVID-19) performed on the Quidel Sofia SARS Antigen FIA test from January 8, 2021 [the date State Surveyors received CMS guidance for surveying on this deficiency] to April 13, 2021. The laboratory failed to report negative results for SARS-CoV-2 for the COVID-19 antigen test results to the Alabama Department of Public Health and positive results were reported to the Report Card for Alabama Department of Public Health (which is not the mechanism to use to report a patient that has a reportable disease). Findings include: 1. A review of SARS- CoV-2 test results revealed patients were tested for SARS-CoV-2 using the Quidel Sofia SARS Antigen FIA test, starting November 29, 2020 through April 13, 2021. A total of 98 test were performed (12 Positives and 86 Negatives) during this time 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 -- period. 2. During an interview on April 13, 2021 at 09:00 AM, Testing Personnel #1 stated positive results were reported to the Novel Coronavirus (COVID-19) Report Card to the Alabama Department of Public Health. The Report Card has the following statement "If you are a Laboratorian, reporting on behalf of a laboratory, blood bank, or plasma center, the REPORT Card is not the mechanism you should use to report a patient that has a reportable disease or health condition." Testing Personnel #1 confirmed the laboratory had reported only positives (to the Report Card) but none of the negative SARS-CoV-2 patient test results to the Alabama Department of Public Health. -- 2 of 2 --