Island Coast Pediatrics Pa

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Island Coast Pediatrics PA from 01/07/2025 to 01/14/2025. The laboratory is not in compliance with 42 CFR Part 493, Requirement for Laboratories. The following Conditions were cited: D5400- Analytic Systems-493.1250 D6000-Moderate Complexity Laboratory Director- 493.1403 D6033-Technical Consultant-Moderate Complexity-493.1409 D2128 HEMATOLOGY CFR(s): 493.851(e) (e)(1) For any unsatisfactory analyte or test performance or testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on review of College of American Pathologist (CAP) evaluation reports, review of Quality Assurance policies, and interview, the laboratory failed to take and document remedial action for unacceptable analyte scores for hematology testing for three of three events (1st event of 2023, 2nd event of 2024, and 3rd event of 2024). Findings include: 1. Review of College of American Pathologist (CAP) evaluation reports for 1st event of 2023 documented an unacceptable score (80%) for Mean Corpuscular Hemoglobin Concentrate (MCHC) for sample FH1-05 and Neutrophil /Granulocyte Absolute for sample FH1-05, 2nd event of 2024 documented an unacceptable score (80%) for Hematocrit (HCT) for sample FH1-10, and 3rd event of 2024 for Lymph for sample FH1-12 (80%). The CAP records did not include any documentation of remedial actions taken for the listed unacceptable scores. 2. The Quality Assurance Program policy approved by the Lab Director on 4/22/2022 and 4 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 15 -- /24/2024 showed Proficiency Testing failures were to be investigated, remedial actions were to be taken, and any

Summary Statement of Deficiencies D0000 An announced recertification survey was conducted on 11/28/22 at Island Coast Pediatrics PA, a clinical laboratory in Fort Myers, Florida. This survey was conducted in conjunction with a special focused COVID-19 reporting survey. Island Coast Pediatrics PA is not in compliance with Code of Federal Regulations (CFR) 42, Part 493, Laboratory Requirements due to the survey completed in conjunction. 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 observation, and interview, the laboratory failed to report SARS - COV - 2 antigen test results as required by the Florida Department of Health (FDOH) from 6/25 /22 to 11/28/22. The laboratory SARS - COV - 2 antigen test volume from 6/25/22 to 11/28/22 was 1224. The findings included: A tour of the laboratory on 11/28/22 at 10: 30 a.m., revealed the laboratory was performing SARS - COV - 2 antigens tests with the Quidel Quickvue (Lot#708180 - expiration date 11/12/23). In an email on 12/01 /22 at 4:04 p.m., the Clinical Manager stated "We stopped reporting in June as we were told to. I am unsure of who the exact person was. My COVID nurse was unable to recall whoever had advised that she was instructed it was no longer needed." 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 D2122 HEMATOLOGY CFR(s): 493.851(b) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on record review and interview with laboratory personnel, the laboratory received an unsatisfactory score in hematology for the second proficiency testing event of 2018. Findings include: Review of proficiency testing records for 2017 and 2018 on 08/30/18 revealed that the laboratory received scores of 0% for platelets, white blood cell count (WBC), and erythrocyte count (RBC) resulting in an overall score of 46%. During an interview with the office supervisor at 10:15 a.m. on 08/30 /18, she confirmed that they had an unsatisfactory score on that proficiency test. D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. 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 -- This STANDARD is not met as evidenced by: Based on record review and interview with laboratory personnel, the hematology analyzer was not calibrated every six months. Findings include: Review of the cell counter calibration records for the past two years on 08/30/18 revealed that the instrument was calibrated on 02/11/17 and not again until 12/06/17. The laboratory policy was to calibrate the cell counter at least every six months. During an interview with the office supervisor at 10:45 a.m. on 08/30/18, she confirmed that there was a lapse in calibrations in 2017. D6019 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iv) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(iv) Ensure that an approved