Atlantic Men's Clinic Boca Raton, Llc

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Atlantic Men's Clinic Boca Raton LLC on July 16, 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 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 record review and interview, the laboratory failed to have 2 of 5 Testing Personnel (B and F) qualified for Testosterone and Prostate-Specific Antigen (PSA) testing on the Fast Pack System (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 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 -- 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 This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to have 2 of 5 Testing Personnel (B and F) qualified for Testosterone and Prostate-Specific Antigen (PSA) testing on the Fast Pack System. Findings Included: 1. Review of Personnel Records revealed Testing Personnel B and Testing Personnel F had translated foreign high school diplomas. Both translated high school diplomas did not state the diplomas met United States (US) high school standards. 2. Review of Testing personnel B's Personnel Evaluation Checklist revealed Testing Personnel B had performed Fast Pack testing from 3/31/2025 to 2/01/2026 with the Laboratory Director's signature. 3. Review of Testing Personnel F's Personnel Evaluation Checklist revealed Testing Personnel F had performed Fast Pack testing from 8/01/2023 -2/01/2025 with the Laboratory Director's signature. 4. On 7/16/2026 at 12:00 PM, Operations Manager A and Operations Manager B confirmed Testing Personnel B and Testing Personnel F had no foreign equivalences for US standards. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A recertification survey was conducted on June 17, 2024. Atlantic Men's Clinic Boca Raton LLC clinical laboratory was not in compliance with 42 CFR 493, requirements for clinical laboratories. D5781

Summary Statement of Deficiencies D0000 A recertification survey conducted on 6-18-2020, found that Atlantic Men's Clinic clinical laboratory is 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 consulant (TC) and Clinical Consultant (CC) in the procedure manual. Findings Included: A review of the procedure manual revealed no job responsibility policies for TC and CC . During an interview on 6/18/2020 at 1: 52 pm, testing person A confirmed the procedure manual had no job responsibility policies for CC and TC. D6013 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(ii) 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)(3) Ensure that-- (e)(3)(ii) Verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method; 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, the laboratory director (LD) failed to approve and sign testosterone (TSA) and prostate-specific antigen (PSA) instrumentation validations for 0373 and 0389 Qualigen Fast Pack IP System Instruments in 2019. Findings Include: A review of 0373 Qualigen Fast Pack IP System manual revealed that TSA and PSA validation for Fast Pack IP system instrument was not signed by LD in April and September 2019, as required. During an interview on 6-18-2020 at 1: 52pm, testing person A and laboratory director confirmed that 0373 and 0389 Qualigen Fast Pack IP system Instrument validations were not approved and signed by the LD. -- 2 of 2 --