Broward Plastic Surgery Pa

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at BROWARD PLASTIC SURGERY PA from February 4, 2026 to February 9, 2026. The laboratory was surveyed under 42 CFR Part 493 CLIA requirements. Standard deficiencies cited are as follows: D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to verify the accuracy of Histopathology testing at least twice annually for 1 (2024) out of 2 years (2024-2025) reviewed. Findings included: 1. Personnel records reviewed revealed that in the Histopathology section there was one testing personnel TP1 (Laboratory Director, LD) as per CMS 209 Form signed by the LD on January 22, 2026. 2. Review of Subpart I, 42 CFR Part 493.901 through 493.959 revealed that there were no approved proficiency testing programs for the interpretation of stained tissues. 3. Review of the laboratory procedure stated in QA/ Proficiency Testing (PT) revealed that it did not state a twice annually minimum frequency. 4. Review of the Quality Assurance (QA) peer review found that peer review for Histopathology was done 12 /13/2023, 09/20/2024, and 4/30/2025 and 10/31/2025. 5. During an interview on 02/04 /2026 at 12:20 PM, the LD admitted to not having the twice annually QA peer review for 2024 and that the procedure was not updated. 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 conducted on 05/14/2024 found the BROWARD PLASTIC SURGERY clinical laboratory not in compliance with 42 CFR Part 493, Requirements for Laboratories. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

Summary Statement of Deficiencies D0000 A recertification survey conducted on 6-17-2020, found that Broward Plastic Surgery PA clinical laboratory was not in compliance with 42 CFR Part 493, Requirements for Laboratories. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to create job responsibility policies for technical supervisor (TS), Clinical Consultant (CC), and Laboratory director (LD) in the procedure manual. Findings Included: A review of the procedure manual revealed no job responsibility policies for TS, CC and LD. During an interview on 6/17/2020 at 12:11pm, Laboratory director confirmed the procedure manual had no job responsibility policies for LD, CC and TS D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(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: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. 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 observation, record review and interview, the laboratory failed to monitor room temperature, humidity and internal temperature from November 2018 to May 2020 for Lecia 1800 Cryocut. Findings Include: An observation of the Histopathology Room revealed no thermometer is available that records humidity and room temperature. A review of the 1800 Cryocut instrument manual showed for optimal operating conditions, it is best to position in an area that will be free from air current draughts from open windows and air conditioning. Room temperature must not exceed 35C and humidity must not exceed 60%. A review of the Cryostat Temperature Log displayed that internal temperature Cryocut was not recorded for November 2018 through December 2019. There was no documentation for Humidity and room temperature. During an interview on 6/17/2020 at 12:11pm, Laboratory director confirmed no documentation for room temperature, humidity and internal temperature from November 2018 to May 2020 for Cryocut. -- 2 of 2 --