Modern Male T Clinic

Summary Statement of Deficiencies D0000 The Modern Male T Clinic laboratory was found to be in compliance with the Conditions of the CLIA regulations found at 42 CFR 493.1 through 493.1780, CLIA requirements for laboratories as a result of a recertification survey on December 2, 2025 and (re)certification is recommended. Standard level deficiencies were cited. D2006 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b) (b)The laboratory must examine or test, as applicable, the proficiency testing samples it receives from the proficiency testing program in the same manner as it tests patient specimens. This testing must be conducted in conformance with paragraph (b)(4) of this section. If the laboratory's patient specimen testing procedures would normally require reflex, distributive, or confirmatory testing at another laboratory, the laboratory should test the proficiency testing sample as it would a patient specimen up until the point it would refer a patient specimen to a second laboratory for any form of further testing. This STANDARD is not met as evidenced by: Based on a review of American Proficiency Institute (API) attestation statements, the laboratory's policies, the laboratory's API proficiency testing records, and staff interview, the laboratory failed to test proficiency samples for Testosterone in the same manner it tested patient samples for four of six Chemistry Core events in 2024 and 2025. Findings include: 1. A review of the API attestation statement, signed by the laboratory's testing personnel for each proficiency testing event, revealed the following: "The undersigned certify that, as closely as possible, these proficiency testing samples were tested in the same manner as patient specimens." 2. A review of the laboratory's policy titled 'Proficiency Testing Policies' stated the following: "Follow your normal routine: Test PT samples in the same manner as you would patient samples. In other words, test PT samples with the regular patient workload using a staff member who routinely performs FastPack IP System testing. Do not 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 -- repeat PT sample testing unless you would repeat a patient test in the same situation." 3. A review of the laboratory's API proficiency testing records for 2024 and 2025 revealed the proficiency test samples for Testosterone were tested on one FastPack IP System and then repeated (on the same day) on the other FastPack IP System for the following 4 testing events: a) 2024 Chemistry Core 1st Event - Samples IA-01 and IA- 02 were run on 3/19/24 on analyzer serial numbers: 0789 and 1225 b) 2024 Chemistry Core 2nd Event - Samples IA-06 and IA-07 were run on 5/23/24 on analyzer serial numbers: 0789 and 1225 c) 2025 Chemistry Core 1st Event - Samples IA-01, IA-02, IA-03, IA-04, IA-05 were run on 1/27/25 on analyzer serial numbers: 0789 and 1225 d) 2025 Chemistry Core 3rd Event - Samples IA-11, IA-12, IA-13, IA-14, IA-15 were run on 8/20/25 on analyzer serial numbers: 1220 and 1225 4. In an interview on 12/2 /25 at 10:45 a.m. in the break room, after review of the records, the technical consultant (as indicated on the CMS 209 form) confirmed that patient samples are only run on one FastPack IP System analyzer and not repeated on the second analyzer. 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 a review of the laboratory's policies and forms, the laboratory's American Proficiency Institute (API) proficiency testing results, the laboratory's records, and staff interview, the laboratory failed to follow its policy for performing

Summary Statement of Deficiencies D0000 Noted deficiencies and plans of correction were discussed with the laboratory representative(s) at the exit conference. The facility representative(s) were given an opportunity to provide evidence of compliance with the noted deficiencies, and no such evidence was provided prior to survey exit. The facility was found to be in compliance with applicable Conditions of Participation in the CLIA program, and recertification is recommended. Note: The CMS-2567 (Statement of Deficiencies) is an official, legal document. All information must remain unchanged except for entering the

Summary Statement of Deficiencies D0000 The laboratory was found out of compliance with the CLIA regulations. The condition not met was: 493.1421 D6063 Condition: Laboratories performing moderate complexity testing; testing personnel Noted deficiencies and plans of correction were discussed with the laboratory representative at the exit conference. The facility representatives were given an opportunity to provide evidence of compliance with noted deficiencies and no such evidence was provided prior to survey exit. Note: The CMS-2567 (Statement of Deficiencies) is an official, legal document. All information must remain unchanged except for entering the

Summary Statement of Deficiencies D0000 Noted deficiencies and plans of correction were discussed with the laboratory representative(s) at the exit conference. The facility representative(s) were given an opportunity to provide evidence of compliance with the noted deficiencies, and no such evidence was provided prior to survey exit. The facility was found to be in compliance with applicable Conditions of Participation in the CLIA program, and recertification is recommended. 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 a review of American Proficiency Institute (API) proficiency testing records from 2016 and 2017 and confirmed in interview, the laboratory failed to test all proficiency samples in the same manner as it tests patient specimens by personnel who routinely performed the testing in the laboratory. Findings were: 1. A review of 2016 and 2017 proficiency testing events revealed that for 4 of 4 events (2016 1st and 2nd event in chemistry and 2017 1st and 2nd events in Chemistry) were tested by the same testing person, testing person #1. The facility listed 3 testing persons on the CMS209 involved in testing patient specimens. 2. An interview with the testing person #1 on 02/06/18 at 0940 hours in the laboratory confirmed the above findings. key: CMS - Center for Medicare and Medicaid Services D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- current laboratory director before use. This STANDARD is not met as evidenced by: Based on review of the laboratory Individualized Quality Control Plan (IQCP) and confirmed in interview, the laboratory failed to ensure that all laboratory quality control plan was approved, signed and dated by the laboratory director before use for the Qualigen FastPack Testosterone and FastPack PSA. Findings were: 1. Review of the IQCP for the Qualigen FastPack Testosterone and FastPack PSA Risk Assessment checklist revealed no documentation of the lab director approval signature and date prior to use. 2. An interview with the testing person # 1 on 02/06/18 at 0930 hours in the laboratory confirmed the above findings. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on review of the laboratory policy and test records and confirmed in interview, the laboratory failed to perform a complete verification study for Testosterone and total PSA on the Qualigen Fastpack IP System analyzer. (normal patient study) Findings were: 1. Review of the laboratory policy Method Validation (65000160 Rev. 007, 06/15) revealed "each laboratory should determine their own reference range appropriate for their population." 2. Review of the verification study for Testosterone and total PSA performed on 11/2015 reveled no documentation of a normal patient study. 3. An interview with the testing person #1 on 02/06/18 at 0930 hours in the laboratory confirmed the above findings. He was unaware the normal range study was needed. 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 manufacturer's instructions and confirmed in interview, the laboratory failed to perform the manufacturer required maintenance for the Qualigen FastPack IP System analyzer. Findings were: 1. Review of the Qualigen FastPack IP System analyzer procedure manual (65000159 Rev.008 06/17) revealed under Cleaning the FastPack IP System "that the FastPack IP System analyzer is completely self-enclosed, and only requires periodic cleaning to remove excess sample. Use a damp cloth to wipe down the entire exterior and interior compartment of the analyzer. -- 2 of 4 -- Do not use solvents to wipe down the exterior of the analyzer." 2. Review of the Daily Environment Log from January 2016 to January 2018 revealed no documentation of the above maintenance. 3. An interview with the testing person #1 02/06/18 at 1025 hours in the laboratory confirmed the above findings. He was unaware he needed to perform maintenance. . D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. The laboratory must perform and document the maintenance activities specified in paragraph (b)(1)(i) of this section. This STANDARD is not met as evidenced by: Based on review of the manufacturer's instructions and confirmed in interview, the laboratory failed to establish the frequency of the required periodic maintenance for the Qualigen FastPack IP System analyzer. Findings were: 1. Review of the Qualigen FastPack IP System analyzer procedure manual (65000159 Rev.008 06/17) revealed under Cleaning the FastPack IP System "that the FastPack IP System analyzer is completely self-enclosed, and only requires periodic cleaning to remove excess sample. Use a damp cloth to wipe down the entire exterior and interior compartment of the analyzer. Do not use solvents to wipe down the exterior of the analyzer." 2. The laboratory was asked for documentation that stated how often periodic cleaning should be performed. No documentation was provided. 3. An interview with the testing person #1 02/06/18 at 1025 hours in the laboratory confirmed the above findings. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Review of the laboratory quality assurance policy and checklists, and confirmed in interview, the laboratory quality assurance assessment program failed to identify and correct problems in analytic systems. Findings were: 1. The laboratory failed to perform a complete a normal patient verification study for Testosterone and total PSA on the Qualigen Fastpack IP System analyzer. (refer to D5421) 2. The laboratory failed to perform the manufacturer required maintenance for the Qualigen FastPack IP System analyzer. (Refer to D5429) D6013 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(ii) -- 3 of 4 -- 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; This STANDARD is not met as evidenced by: Based on review of the laboratory policy and test records and confirmed in interview, the laboratory director failed to ensure the laboratory performed a complete verification study for Testosterone and total PSA on the Qualigen Fastpack IP System analyzer. (refer to D5421) D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) 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)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on review of the laboratory's proficiency test records and interview, the laboratory director failed to ensure proficiency samples were tested in the same manner it tested patient specimens. (Refer to D2007) -- 4 of 4 --