Florida Pediatric Group Pa

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Florida Pediatric Group PA on March 31, 2026. The laboratory is not in compliance with 42 CFR Part 493, Requirement for Laboratories. The following Condition was cited: D6063 493.1421 - Condition: Laboratory Testing Personnel D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) (b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of the American Proficiency Institute (API), Proficiency Testing (PT) records and interview, the Laboratory Director failed to sign the attestation for two (2025 2nd , 3rd) of six (2024 1st, 2nd, 3rd and 2025 1st, 2nd, 3rd) events and the Testing Personnel failed to sign the attestation for one (2025 3rd ) of six (2024 1st, 2nd, 3rd and 2025 1st, 2nd, 3rd) events in the specialty of hematology. Findings: 1. Review of the API Attestation Statement noted, "Signatures Required - For all PT results, an attestation statement must be signed by Testing Personnel and Laboratory Director and retained for a minimum of 2 years." 2. Review of the API PT records revealed, the attestations for 2025 2nd event and 2025 3rd event were not signed by the Laboratory Director. 3. Review of the API PT records revealed, the attestations for 2025 3rd event was not signed by the Testing Personnel. 4. During an interview on 03 /31/2026 at 3:06 AM, Testing Personnel A acknowledged the attestations were not signed by the Laboratory Director and Testing Personnel. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) 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 -- (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 observation, review of the instrument manual, and interview, the laboratory failed to monitor and document temperatures and humidity of the laboratory from 12 /13/2023 to 03/31/2026. Findings: 1. During a tour of the laboratory on 03/31/2026 at 1:30 PM, the Cell-Dyn Emerald hematology analyzer was seen in the laboratory. 2. Review of the Cell-Dyn Emerald Operations Manual noted the environmental requirements as "Temperature Range: 64 degrees - 90 degrees Fahrenheit (F) (18 degrees - 32 degrees Celsius (C)" and "Maximum relative humidity 80% for temperatures up to 90 degrees F (32 degrees C)." 3. During an interview on 03/31 /2026 at 3:05 PM, Testing Personnel A stated they were not taking the temperatures or humidity of the laboratory where the hematology analyzer was located. 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 (degree) for one (B) out of four Testing Personnel (A - D). (See D6065) 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 (b)(2) Have earned a doctoral, master's, or bachelor's degree in a chemical, biological, clinical or medical laboratory science, or medical technology, or nursing from an accredited institution; or (b)(3) Meet the requirements in 493.1405(b)(3)(i)(B), (b)(4)(i)(B), (b)(4)(i)(C) or (b)(5)(i)(B); or (b)(4) Have earned an associate degree in a chemical, biological, clinical or medical laboratory science, or medical laboratory technology or nursing from an accredited institution; or (b)(5) Be a high school graduate or equivalent and have successfully completed an official military medical laboratory procedures course of at least a duration of 50 weeks and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); or (b)(6)(i) Have earned a high school diploma or equivalent; and -- 2 of 3 -- 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 (degree) for one (B) out of four Testing Personnel (A - D). Findings: 1. Review of the Laboratory's Personnel Report, signed by the Laboratory Director on 03/30/2024, showed there were four Testing Personnel employees listed as moderate complexity Testing Personnel. 2. Review of the laboratory's personnel records revealed there was no documentation of the educational degree (high school) for Testing Personnel B available for review. 3. During an interview on 03/31/2026 at 3:06 PM, Testing Personnel A revealed they did not have a copy of Testing Personnel B's high school diploma. -- 3 of 3 --

Summary Statement of Deficiencies D0000 A recertification survey was conducted from December 8, 2023 to December 12, 2023. Florida Pediatric Group PA clinical laboratory was not in compliance with 42 CFR 493, requirements for clinical laboratories. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on review of the maintenance logs, and interview, the laboratory failed to document the semi annual maintenance on the Cell-DYN Emerald hematology analyzer from 09/01/2023 to 12/08/2023. Findings: Review of the Cell-DYN Emerald maintenance logs noted to lubricate the pistons semi-annually. Review of the Cell- DYN Emerald maintenance logs showed the lubrication of the pistons was not documented. On 12/08/2023 at 12:47 PM, Testing Personnel A stated she did lubricate the pistons, but failed to document it on the maintenance logs. D6045 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(7) (b) The technical consultant is responsible for-- (b)(7) Identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed; This STANDARD is not met as evidenced by: 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 -- Based on review of personnel records, and interview, the laboratory failed to document the initial training of four (D, E, F, G) of seven testing personnel (A to G) hired in 2023. Findings: Review of personnel documents showed there were no records of the training for Testing Personnel D, E, F, or G. On 12/08/2023 at 1:35 PM, Testing Personnel A stated she did not think the Laboratory Director had any documentation of training for the employees hired in 2023. On 12/12/23 in an email correspondence, Testing Personnel A reported Testing Personnel D was hired on 03/31 /2023, Testing Personnel E was hired on 10/16/2023, Testing Personnel F was hired on 04/25/2023, and Testing Personnel G was hired on 10/02/2023 D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (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. This STANDARD is not met as evidenced by: Based on review of competency evaluations, and interview, the Technical Consultant (Laboratory Director) failed to evaluate competency of testing personnel listed on the Laboratory's Personnel Report for seven of seven testing personnel (A, B, C, D, E, F, G) for 2022 and 2023. Findings: Review of the Laboratory Personnel Report signed by the Laboratory Director on 12/06/2023 showed there were eight employees listed on the form, that included the Laboratory Director and seven Testing Personnel. The Laboratory Director was also listed as the Clinical Consultant and Technical Consultant. Review of the Annual Evaluation of Testing Personnel Competency for Testing Personnel A to G, dated 11/09/2023 showed they were signed by Testing Personnel A. Review of the Annual Evaluation of Testing Personnel Competency for Testing Personnel A, B, and C, dated 04/11/2022 showed they were signed by Testing Personnel A. On 12/08/2022 at 12:53 PM, Testing Personnel A stated it was her signature on the competency evaluations for 2022 and 2023. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A recertification survey was conducted September 9, 2021. Florida Pediatric Group PA 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 interview, the laboratory failed to have all testing personnel rotate through performance of proficiency testing (PT) samples for 6 of 6 events (2019 3rd, 2020 1st, 2nd 3rd, 2021 1st, 2nd) for the specialty of hematology. Findings: Review of the American Proficiency Institute PT showed Testing Personnel A was the only staff that had signed the attestation forms as the person performing PT. Review of the Laboratory Personnel Report signed and dated by the Laboratory Director on 09/07/2021 showed there were 4 testing personnel. Review of the 2019 Laboratory Personnel Report signed and dated by the Laboratory Director on 08/06 /2019 showed all four of the current testing personnel were also listed as testing personnel in 2019. On 09/09/2021 at 12:10 PM, Testing Personnel A stated she was the only person who performed the PT. 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 A Recertification survey was conducted on August 10, 2019. Florida Pediatric Group PA was not in compliance with 42 CFR 493, requirements for clinical laboratories. 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, the laboratory failed to receive a passing proficiency test (PT) score for the second testing event of 2018 for the specialty of Hematology. Findings: Review of the PT Performance Summary from American Proficiency Institute (API) for the second event of 2018 showed unsatisfactory scores for the CMS (Center for Medicare & Medicaid Services) reportable analytes of Erythrocyte Count (20%), Hematocrit (60%), and Hemoglobin (80%). The overall score for the specialty of hematology was 76% (Erythrocyte count 20% + Hematocrit 60% + Hemoglobin 80% + Leukocyte Count 100% + Platelet Count 100% + White Blood Cell Differential 100% = 460% divided by 6 analytes = 77%). During an interview on 8/06/19 at 1:30 PM, Testing Personnel A confirmed the laboratory had failed proficiency testing. D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- Establish or verify the criteria for acceptability of all control materials. (i) When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control 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 -- materials must be defined and available. (ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to perform quality control lot to lot comparisons from 8/06/17 to 8/06/19 for hematology. Findings: Review of the quality control logs showed that there were no lot to lot comparisons of the hematology controls from 8/06/17 to 8/06/19 for the Horiba ABX Micros 60 and the Cell Dyn Emerald hematology analyzers. During an interview on 8/06/19 at 2:32 PM, Testing Personnel A acknowledged that the laboratory did not perform quality control lot to lot comparisons. -- 2 of 2 --