David B Hevert Md Pa

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at David B Hevert MD PA on January 6, 2026. The laboratory was surveyed under 42 CFR Part 493 CLIA requirements. Standard deficiencies cited are as follows: D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to document refrigerator 1, refrigerator 2 , Biorad freezer, Freezer ,room temperature, and humidity for October 2024 and 27 out of 30 days in April 2025. Findings included: 1. Review of Temperature and Humidity logs revealed the following: A. October 2024 had no documentation of temperatures for refrigerator 1, refrigerator 2, Biorad freezer, Freezer, room temperature, and humidity. B. April 2025 had 27 out of 30 days had no documentation for refrigerator 1, refrigerator 2, Biorad freezer, Freezer, room temperature, and humidity. 2. On 01/06/2026 at 5:11 PM, Testing Personnel A and the Office Manager confirmed there was no documentation of refrigerator 1, refrigerator 2, Biorad freezer, Freezer, room temperature and humidity for October 2024 and 27 out of 30 days in April 2025. D5447 CONTROL PROCEDURES 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 -- CFR(s): 493.1256(d)(3)(i)(g) (d)(3)(i) Each quantitative procedure, include two control materials of different concentrations; This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to run two levels of controls for Free T4 (Thyroxine) on 1/8/2024 for 24 out of 24 patients reviewed. Findings included: 1. Review of Free T4 controls revealed the following: A. Biorad immunoassay control level 2 Lot: 40432 was run on 01/08/2024 for Free T4 B. No Biorad immunoassay control level 1 was ran on 01/08/2024. 2. Review of Free T4 Patient reports revealed the following: A. 24 patients were tested on 01/08/2024 for Free T4. 3. Review of Daily Controls policy read, "Daily controls of a known concentrations are processed each day of instrument use .If these fail to reproduce within the manufacturers acceptable limits remedial action must be followed and documented according to the instrument manufacturer." 4. On 01/06/2026 at 5:11 PM, Testing Personnel A and the Office Manager confirmed two levels of controls were not ran for Free T4 (Thyroxine) on 01/08/2024 prior to Patient testing. D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. The procedures for evaluation of the competency of the staff must include, but are not limited to-- This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to ensure that competency evaluations were performed by a qualified Technical Consultant for two (A and C) of three (A - C) Testing Personnel's competencies for 2024 and one (A) of three (A - C) Testing Personnel's competency for 2025; and the laboratory failed to have a policy for competency assessments. Findings Included: 1. Review of the Laboratory Personnel Report, signed and dated on 01/05/2026 by the Laboratory Director, listed the Laboratory Director was also the Clinical Consultant and the Technical Consultant; and there were three Testing Personnel. 2. Review of the personnel file for Testing Person A revealed, the Lab Personnel Evaluation Checklist on 11/24/2024 and 11/17/2025 were completed and signed by the Office Manager. 3. Review of the personnel file for Testing Person C revealed, the Lab Personnel Evaluation Checklist on 11/24/2024 was completed and signed by the Office Manager. 4. Review of the procedure manual showed there was no procedure on competency evaluations. 5. During an interview on 01/06/2026 at 11:30 AM, the Testing Person A confirmed the competency evaluations were performed by the Office Manager. 6. During an interview on 01/06/2026 at 5:30 PM, the Testing Person A acknowledged she did not find procedure on competency evaluations. -- 2 of 2 --

Summary Statement of Deficiencies D0000 Recertification survey was conducted on November 15, 2023. David B Hevert MD PA clinical laboratory was not in compliance with 42 CFR 493, requirements for clinical laboratories. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on review of Quality Control (QC) documentation and interview, the laboratory failed to maintain documentation of the background counts performed on the Horiba ABX Micros 60 Hematology Analyzer from 11/15/2021 to 11/15/2023. Findings: Review of the QC documents for hematology revealed there was not any documentation of the daily background check available for review. On 11/15/2023 at 3:28 PM, Testing Personnel A and B confirmed they did not retain a copy of the background counts. 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 D0000 An announced CLIA recertification survey was conducted at David B. Hevert MD on 10/20/2021. The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level deficiencies: 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 antibody results to the Department of Health since August 31, 2021 for a total of 282 Patient results. Findings Included: Review of the CMS 116 revealed that the laboratory performed Anti-SARS-CoV-2 and SARS-CoV-2-Spike-AB antibody testing on their Roche Cobas E411 Chemistry analyzer. Review of policy and procedures (signed by the Laboratory Director on 04/19/2021) revealed a print off from the Department of Health stating that "COVID-19 antibody test results are no longer required to be reported to the Florida Department of Health (Department)." Interview on 10/20/2021 at 4:00 PM Testing Person #A and #B confirmed that they stopped reporting their SARS-CoV-2 antibody results to the Department of Health since August 31, 2021 and that they have tested 282 Patient samples since they stopped reporting. 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 -- D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on record review and interview the laboratory failed to evaluate American Proficiency Institute (API) proficiency results that received a score of "Not Graded" for 3 (1st and 2nd event in 2020 and 2nd event in 2021) out of 6 (1st, 2nd, and 3rd events in 2020 and 2021) Testing Events (TE) in Chemistry and 1 (3rd event in 2020) out of 6 (1st, 2nd, and 3rd events in 2020 and 2021) TE in Hematology. Findings Included: Review of API proficiency testing results for Chemistry revealed a score of "Not Graded" for Folate specimen IA-01 in the 1st TE of 2020, IA-07 in the 2nd TE of 2020, and IA-07 in the 2nd TE of 2021. Review of API proficiency testing results for Hematology revealed a score of "Not Graded" for Urine Sediment specimen US- 06 in the 3rd TE of 2020. There was no evaluation or

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at David B Hevert MD on 10/20/2021. The laboratory is not in compliance with 42 CFR Part 493, Requirement for Laboratories. The following Conditions were cited: D3000 Facility Administration- 493.1100 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 antibody results to the Department of Health since August 31, 2021 for a total of 282 Patient results. Findings Included: Review of the CMS 116 revealed that the laboratory performed Anti-SARS-CoV-2 and SARS-CoV-2-Spike-AB antibody testing on their Roche Cobas E411 Chemistry analyzer. Review of policy and procedures (signed by the Laboratory Director on 04/19/2021) revealed a print off from the Department of Health stating that "COVID-19 antibody test results are no longer required to be reported to the Florida Department of Health (Department)." Interview on 10/20/2021 at 4:00 PM Testing Person #A and #B confirmed that they 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 -- stopped reporting their SARS-CoV-2 antibody results to the Department of Health since August 31, 2021 and that they have tested 282 Patient samples since they stopped reporting. D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on record review and interview the laboratory failed to evaluate American Proficiency Institute (API) proficiency results that received a score of "Not Graded" for 3 (1st and 2nd event in 2020 and 2nd event in 2021) out of 6 (1st, 2nd, and 3rd events in 2020 and 2021) Testing Events (TE) in Chemistry and 1 (3rd event in 2020) out of 6 (1st, 2nd, and 3rd events in 2020 and 2021) TE in Hematology. Findings Included: Review of API proficiency testing results for Chemistry revealed a score of "Not Graded" for Folate specimen IA-01 in the 1st TE of 2020, IA-07 in the 2nd TE of 2020, and IA-07 in the 2nd TE of 2021. Review of API proficiency testing results for Hematology revealed a score of "Not Graded" for Urine Sediment specimen US- 06 in the 3rd TE of 2020. There was no evaluation or

Summary Statement of Deficiencies D0000 A recertification survey conducted on 11/19/2019 found that David B Hevert MD PA clinical laboratory was not in compliance with 42 CFR Part 493, Requirements for 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 review of CMS 209 Laboratory Personnel form, personnel files review, a review of American Proficiency Institute (API) proficiency testing (PT) records and staff interviews, the laboratory failed to have all testing personnel (TP) rotate through the testing of PT for Chemistry and Hematology specialties for 2019. Findings include: 1-Review of CMS 209 form signed and dated by the Laboratory Director (LD) on 10/22/2019 had 2 testing personnel listed (TPA, TP B). 2-Personnel files review revealed that TP B started on April 2018. 3- Review of API PT records for 2018 and 2019, revealed that, there was no documentation of PT testing in 2019 for the specialties of Chemistry and Hematology specialties for TP B. During an interview on 11/19/2019 at 112:00 AM, Testing personnel A confirmed that TP B failed to participate in PT during 2019. 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 --