Alpha Men's Health

Summary Statement of Deficiencies D0000 An announced routine recertification survey of the laboratory was completed on 03/02 /2026. The laboratory was found in compliance with applicable CLIA regulations (42 CFR Part 493, Requirements for Laboratories) for the specialties/subspecialties for which it was surveyed. Standard level deficiencies were cited. D2014 TESTING OF PROFICIENCY TESTING SAMPLES (b)(6) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. This STANDARD is not met as evidenced by: Based on review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile, review of the American Proficiency Institute (API) Performance Summary, review of the laboratory's proficiency testing (PT) records, and confirmed in interview, the laboratory failed to retain a copy of all Endocrinology PT records for three of three events in 2025. Findings include: 1. Review of the CASPER Report 155 determined the laboratory was enrolled in PT for the specialty of Endocrinology for Testosterone in 2025. 2. A review of the laboratory's PT records in 2025 determined the laboratory failed to retain a copy of all Endocrinology PT records for Testosterone for three of three events in 2025: API original forms Test records Attestation statements 3. The clinic owner confirmed the laboratory failed to retain a copy of all PT records during an interview on 03/06/2026 at 1025 hours in the office. 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 review of the American Proficiency Institute (API) Performance Summary, review of the laboratory's proficiency testing (PT) records, and confirmed in interview, the laboratory failed to have documentation of evaluation of a zero score for nonparticipation in the speciality of Endocrinology for Testosterone for one of three PT events in 2025 (Event 2). Findings include: 1. Review of the API performance summary determined the laboratory received a zero score for nonparticipation for Testosterone for one of three events in 2025 (Event 2). 2. A review of the laboratory's PT records in 2025 determined the laboratory failed to have documentation of evaluation of a zero score for nonparticipation for Testosterone for one of three PT events in 2025 (Event 2). The surveyor requested documentation of evaluation of a zero score for nonparticipation for Testosterone for Event 2 of 2025. No documentation was provided. 3. The clinic owner confirmed the findings in an interview on 03/06/2026 at 1025 hours in the office. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The laboratory was found to be in substantial compliance with CLIA regulations 42 CFR Part 493. Standard level deficiencies were cited. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on surveyor observation, review of laboratory Qualigen Individualized Quality Control Plan (IQCP), calibration and quality control (QC) records, and confirmed in interview, the laboratory failed to follow their own policy for performing quality control following calibration for six of twelve calibrations performed in 2024. Findings Included: 1. During a tour of the laboratory on 06/18/2024 at 11:15 AM, the surveyor observed one Qualigen Immunoassay analyzer (Serial Number: 02187) currently in use for patient testosterone testing. 2. Review of laboratory's Qualigen testosterone IQCP (Approved by the Laboratory Director on 02/2024) revealed the following: "Quality Control Plan ...QC is still performed at the time of opening a new shipment of FastPacks, after calibration or maintenance, if improper storage is suspected, or a patient test result appears to be questionable." Further review of the IQCP revealed the following: "If QC results are in range, and the overall risk of the lab is manageable, QC frequency is reduced to once per week and after each calibration." 3. Review of calibration and QC records revealed the following days calibrations were performed on the Qualigen FastPack testosterone analyte, and QC was not documented following calibration in 2024: Calibration performed on: a. 02/23 /2024; No testosterone QC documented b. 03/11/2024; No testosterone QC documented c. 03/19/2024; No testosterone QC documented d. 04/03/2024; No 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 -- testosterone QC documented e. 05/24/2024; No testosterone QC documented f. 06/07 /2024; No testosterone QC documented The surveyor requested QC documentation for the above days calibrations were performed on 06/18/2024 at 11:45 AM, and none were provided. 4. In an interview on 06/18/2024 at 12:05 PM, the laboratory owner confirmed the laboratory failed to follow their own policy for performing quality control following calibration for six of twelve calibrations performed in 2024. 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 surveyor observation, review of laboratory Qualigen FastPack Testosterone verification study, and confirmed in interview, the laboratory failed to have documentation of verifying its patient population reference range for one of one analyte performed in 2024. Findings Included: 1. During a tour of the laboratory on 06 /18/2024 at 11:15 AM, the surveyor observed one Qualigen Immunoassay analyzer (Serial Number: 02187) currently in use for patient testosterone testing. 2. Review of laboratory Qualigen FastPack Testosterone verification study performed in January 2024 revealed the following: "Installation and Method Validation Method validation is performed for each test being used per system serial number and consists of the following: ...Identifying your Reference Ranges In this step you are identifying the reference range that is appropriate for your patient population." Directly under this statement was a provided table with the header, "Your Reference (Normal) Ranges". The table had no documentation for the laboratory's reference range. The surveyor requested documentation of the laboratory verifying its patient population reference range on 06/18/2024 at 11:48 AM, and none was provided. 3. In an interview on 06/18 /2024 at 12:05 PM, the laboratory owner confirmed the laboratory failed to have documentation of verifying its patient population reference range for one of one analyte performed in 2024. D5779