Florida Healthcare Associates Pl

Summary Statement of Deficiencies D0000 A recertification survey was conducted on March 13 - 18 , 2024. Florida Healthcare Associates PL clinical laboratory was not in compliance with 42 CFR 493, requirements for clinical laboratories. D6063 LABORATORY TESTING PERSONNEL CFR(s): 493.1421 The laboratory must have a sufficient number of individuals who meet the qualification requirements of 493.1423, to perform the functions specified in 493. 1425 for the volume and complexity of tests performed. This CONDITION is not met as evidenced by: Based on review of the Laboratory Personnel Report, personnel records, and interview, the laboratory failed to verify educational qualifications (degrees) for 1 Testing Personnel (B) out of 2 Testing Personnel (A, B). (See 6065) D6065 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(1)(2)(3)(4)(i) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located or have earned a doctoral, master's, or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; or (b)(2) Have earned an associate degree in a chemical, physical or biological science or medical laboratory technology from an accredited institution; or (b)(3) Be a high school graduate or equivalent and have successfully completed an official military medical laboratory procedures course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); or (b)(4)(i) Have earned a high school diploma or equivalent; and 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 review of the Laboratory Personnel Report, personnel records, and interview, the laboratory failed to verify educational qualifications (degrees) for 1 Testing Personnel (B) out of 2 Testing Personnel (A, B). Findings: Review of the Laboratory's Personnel Report, signed by the Laboratory Director on 03/13/2024, showed there were two employees listed as moderate complexity testing personnel. Review of the laboratory personnel records showed there was no documentation of the educational degree for Testing Personnel B available for review. On 03/13/2024 at 5: 00 PM, the Laboratory Consultant stated they were unable to locate Testing Personnel B's degree. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An onsite special focused COVID-19 reporting survey was conducted on November 18, 2021 to November 22, 2021 at Florida Healthcare Associates PL, a clinical laboratory in Boynton Beach, Florida. Florida Healthcare Associates PL was not in compliance with Code of Federal Regulations (CFR), Part 493, requirements of clinical laboratories. The following Condition was cited: D3000 - 42 C.F.R. 493.1101: Facility Administration 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 with the Office Manager, the laboratory failed to report SARS-CoV-2 antibody results to the Department of Health (DOH) from January 26, 2021 through November 22, 2021 for a total of 10,146 Patient results. The findings included: Review of the Clinical Laboratory Improvement Amendments (CLIA) Application for Certification (Form CMS-116) signed by the Laboratory Director on November 17, 2021 revealed that the laboratory performed Anti-SARS- CoV-25 (COVID vaccine spike protein testing) on their Roche Cobas 501 Chemistry analyzer. On 11/22/2021 at 12:56 p.m., per electronic mail (email), Office Manager stated with our results export project manager from Labdaq on Friday as well as to Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- DOH regarding our interface. In our communication, we discovered a problem with the results export interface where it is not transmitting to the DOH as it should. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on record review and interview with the technical supervisor, the laboratory failed to ensure

Summary Statement of Deficiencies D0000 An onsite special focused COVID-19 reporting survey was conducted on November 18, 2021 to November 22, 2021 at Florida Healthcare Associates PL, a clinical laboratory in Boynton Beach, Florida. Florida Healthcare Associates PL was not in compliance with Code of Federal Regulations (CFR), Part 493, requirements of clinical laboratories. The following Condition was cited: D3000 - 42 C.F.R. 493.1101: Facility Administration 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 with the Office Manager, the laboratory failed to report SARS-CoV-2 antibody results to the Department of Health (DOH) from January 26, 2021 through November 22, 2021 for a total of 10,146 Patient results. The findings included: Review of the Clinical Laboratory Improvement Amendments (CLIA) Application for Certification (Form CMS-116) signed by the Laboratory Director on November 17, 2021 revealed that the laboratory performed Anti-SARS- CoV-25 (COVID vaccine spike protein testing) on their Roche Cobas 501 Chemistry analyzer. On 11/22/2021 at 12:56 p.m., per electronic mail (email), Office Manager stated with our results export project manager from Labdaq on Friday as well as to Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- DOH regarding our interface. In our communication, we discovered a problem with the results export interface where it is not transmitting to the DOH as it should. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on record review and interview with the technical supervisor, the laboratory failed to ensure

Summary Statement of Deficiencies No Tags No deficiency details available. 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 --