Men's Wellness Centers Llc

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Men's Wellness Centers, LLC (Virginia Beach) on September 20, 2023 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. Specific deficiency cited is as follows: 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 proficiency testing (PT) records, the Centers for Medicare and Medicaid Services Laboratory Personnel Report form (CMS 209), personnel files, and an interview, the laboratory failed to rotate two (2) of three (3) PT chemistry event challenges among testing personnel (TP) responsible for Prostate Specific Antigen (PSA) and Testosterone patient testing in calendar year 2022. Findings include: 1. Review of the 2022 American Proficiency Institute (API) Core Chemistry PT records (2022 Events 1-3) revealed that TP A signed the PT attestation as performing 2022 Event 2 and 3. TP A performed two (2) of three (3) events in calendar year 2022. **See Testing Personnel Code Sheet. 2. Review of the CMS 209 laboratory personnel form and personnel files revealed that the lab director identified five qualified TP who performed routine non-waived patient PSA and Testosterone testing during the timeframe of the events reviewed and outlined above. 3. An exit interview with the laboratory technical consultant on 9/20/23 at 3:30 PM on confirmed the above findings. 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 An announced CLIA recertification survey was conducted at Men's Wellness Centers, LLC (Virginia Beach) on November 9, 2021 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. Specific deficiencies cited are as follows and include the Condition under 42 CFR part 493 CLIA Regulation: D6033 -42 CFR. 493.1409 Technical Consultant-Moderate Complexity. D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) 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. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on a review of proficiency testing (PT) documentation, and an interview, the laboratory failed to retain attestation statements signed by the laboratory director and testing personnel for three (3) of five (5) events reviewed. Findings include: 1. Review of the laboratory's American Proficiency Institute (API) chemistry PT documentation (2019 Event 3, 2020 Events 1-3, 2021 Special Self Evaluation 1) revealed no signed attestation statements for: 2020 Event 1, 2020 Event 2, 2021 Self Evaluation 1. The inspector requested to review the attestation documentation for the chemistry events listed above. No documentation was available for review. 2. An exit 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 -- interview with the testing personnel and patient coordinator on 11/9/21 at approximately 12:30 PM confirmed the above findings. D6033 TECHNICAL CONSULTANT-MODERATE COMPEXITY CFR(s): 493.1409 The laboratory must have a technical consultant who meets the qualification requirements of 493.1411 of this subpart and provides technical oversight in accordance with 493.1413 of this subpart. This CONDITION is not met as evidenced by: Based on a review of Centers for Medicare and Medicaid Services Laboratory Personnel Report form (CMS 209), laboratory personnel files, procedures, and an interview, the technical consultant failed to provide laboratory oversight as the laboratory failed to follow the approved Qualigen FastPack policy for personnel semi- annual and annual chemistry competency assessments during the twenty-seven months reviewed (August 2019 to the date of the survey on 11/9/21). Cross Reference: D6046 and D6053 (REPEAT DEFICIENCIES). 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 a review of the Centers for Medicare and Medicaid Services Laboratory Personnel Report form (CMS 209), testing personnel (TP) records, procedures, and an interview, the technical consultant (TC) failed to perform annual competency evaluations for TP A in calendar years 2019 and 2020. (See Personnel Code Sheet.) *REPEAT DEFICIENCY Findings include: 1. Review of the CMS 209 form revealed that the laboratory director also performs the duties of TC and 6 personnel were identified as responsible for performing patient Prostate Specific Antigen (PSA) and Testosterone chemistry testing during the review timeframe of August 2019 to 11/9 /21. 2. Review of the laboratory personnel files revealed TP A lacked documentation of an annual chemistry competency evaluation in calendar years 2019, 2020, and year to date 2021. The inspector requested to review the annual competency assessments. No records were available for review. 3. Review of the laboratory's Qualigen FastPack procedures revealed a Personnel Evaluations Checklist that stated: "Evaluate those individuals that operate the FastPack IP System after the first 6 months of testing, then yearly thereafter." 4. An exit interview with the testing personnel and patient coordinator on 11/9/21 at approximately 12:30 PM confirmed the above findings D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on a review of the Centers for Medicare and Medicaid Services Laboratory Personnel Report form (CMS 209), testing personnel (TP) records, procedures, and an interview, the technical consultant (TC) failed to document performance of the semi- annual competency assessment for one (1) new laboratory staff member (TP B) in calendar year 2020. (See Personnel Code Sheet.) *REPEAT DEFICIENCY Findings include: 1. Review of the CMS 209 form revealed that the laboratory director also performs the duties of TC and 6 personnel were identified as responsible for performing patient Prostate Specific Antigen (PSA) and Testosterone testing. 2. Review of personnel records revealed that TP B was initially trained and started performing PSA/Testosterone chemistry testing in November 2019. The record review revealed no semi-annual competency assessment for TP B. The inspector requested to view the semi-annual competency assessment. No record was available. 3. Review of the laboratory's Qualigen FastPack procedures revealed a Personnel Evaluations Checklist that stated: "Evaluate those individuals that operate the FastPack IP System after the first 6 months of testing, then yearly thereafter." 4. An exit interview with the testing personnel and patient coordinator on 11/9/21 at approximately 12:30 PM confirmed the above findings. -- 3 of 3 --

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Men's Wellness Centers, LLC (Virginia Beach) on July 25, 2019 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. Specific deficiencies cited are as follows: D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on a tour, review of procedures, calibration verification documentation, quality control (QC) records, manufacturer's user guide, Individualized Quality Control Plan (IQCP), patient test logs, and an interview, the laboratory failed to: 1. follow the manufacturer's six month calibration verification instructions for Testosterone and Prostate Specific Antigen (PSA) in calendar year 2018 and up to the date of the inspection on 7/25/19. Cross Reference D5439; **REPEAT DEFICIENCY. 2. provide documentation of a lab director approved IQCP (for discontinuance of daily QC/ implementing once weekly QC) with Risk Assessment for PSA and Testosterone testing from 7/5/18 to the date of the inspection while reporting five thousand one hundred fifteen patient results. Cross Reference D5445. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(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 5 -- Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on a tour, review of the laboratory's procedure manual, calibration verification documentation, and an interview, the laboratory failed to follow the manufacturer's six (6) month calibration verification instructions for Testosterone and Prostate Specific Antigen (PSA) in calendar year 2018 and up to the date of the inspection on 7/25/19. **REPEAT DEFICIENCY Findings include: 1. During a tour of the laboratory at approximately 10 AM, the inspector noted two (2) Qualigen FastPack analyzers in use for patient immunoassay PSA and Testosterone testing: Machine 1 (SN 0939) Machine 2 (SN 0530) 2. Review of the procedure manual revealed manufacturer's policy instructions to perform Qualigen FastPack chemistry analyzer calibration verification twice annually. The policy stated "At least once every six months, verify calibration of the FastPack System using FastPack Method Verification Kits to verify that the instrument is accurate to the limits of the reportable range specified by Qualigen." 3. Review of the laboratory's Qualigen analyzer's Testosterone and PSA calibration verification records from August 2017 up to the date of the inspection, revealed: Machine 1 (SN 0939) - No PSA calibration verification records from January 2018 up to 7/25/19; Machine 2 (SN 0530) - No Testosterone calibration verification recorded in calendar year 2018. The inspector requested to review documentation of the calibration verification procedures outlined above. The documentation was not available for review. 4. In an exit interview with the clinical operations manager at approximately 1:30 PM, the above findings were confirmed. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(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-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The -- 2 of 5 -- laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of quality control (QC) records, manufacturer's user guide, the laboratory's Individualized Quality Control Plan (IQCP), patient test logs, and an interview, the laboratory failed to provide documentation of a lab director (LD) approved IQCP with Risk Assessment (RA) for Prostate Specific Antigen (PSA) and Testosterone testing from 7/5/18 to the date of the survey on 7/25/19 while reporting five thousand one hundred fifteen (5,115) patient results. Findings include: 1. Review of the laboratory's Qualigen FastPack PSA and Testosterone QC records from August 2017 to the date of the survey revealed a change in QC documentation from two (2) levels of QC per day of testing to 2 levels of QC once per week starting on 7/5/18 and up to 7/25/19. 2. Review of the Qualigen FastPack IP System 2 manufacturer's guide revealed a quality assurance protocol ("Steps to Complete for Patient Testing- How to Use the QA Log") which stated under topic "Before You Begin Testing Patients: Run QC before testing patient samples. Ensure that QC results are within the correct range before testing patient patients. Note- if your laboratory has implemented an approved IQCP option for QC and qualify to run weekly controls, run QC before testing patients once per week, on the same day." 3. The inspector requested to review the laboratory director's approved IQCP with RA documentation for the Qualigen analyzer completed prior to the implementation of the once weekly QC in July 2018. No records were available for review. The clinical operations manager stated at approximately 12:30 PM, "Our former lab director contacted the manufacturer and was informed we could go to once per week QC at all of our offices. I do not have the documentation of assessment checklists performed for the time that we switched to weekly but I have a checklist that was started in June 2019." 4. Review of the Qualigen patient test logs revealed the laboratory reported the following number of patient results from 7/5/18 to 7/25/19 without daily QC monitoring: Testosterone - two thousand eight hundred ninety-seven (2,897); PSA- two thousand two hundred eighteen (2,218); a total of 5,115 patient results. 5. In an exit interview with the clinical operations manager at approximately 1:30 PM, the above findings were confirmed. 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 a review of the Centers for Medicare and Medicaid Services Laboratory Personnel Report form (CMS 209), laboratory personnel files, and an interview, the technical consultant (TC) failed to assess annual Qualigen FastPack immunoassay competency assessments for two (2) of six (6) testing personnel in 2017 and 2018. Findings include: 1. Review of the CMS 209 form revealed that the laboratory director also performed the duties of TC and that 6 testing personnel performed patient Qualigen FastPack Prostate Specific Antigen and Testosterone testing during the twenty-four months reviewed (review timeframe June 2017 to 07/25/19). 2. Review of the laboratory personnel files revealed no annual competency assessment documentation for: Testing Personnel B (TP B) in calendar years 2017 and 2018; -- 3 of 5 -- Testing Personnel D (TP D) in 2018. (See Personnel Code Sheet.) The inspector requested to review the competency assessments outlined above for TP B and TP D. The records were not available for review. 3. In an exit interview with the clinical operations manager at approximately 1:30 PM, the above findings were confirmed. D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on a review of the Centers for Medicare and Medicaid Services Laboratory Personnel Report form (CMS 209), personnel records, and an interview, the technical consultant (TC) failed to document performance of the semi-annual competency assessment for one (1) new laboratory testing personnel (TP C) in calendar year 2018. (See Personnel Code Sheet.) Findings include: 1. Review of the CMS 209 form revealed that the laboratory director (LD) also performed the duties of TC. 2. Review of personnel records for TP C revealed documentation of initial training checklists for Qualigen FastPack immunoassay testing on 10/17/17. The inspector noted an annual competency assessment recorded in October 2018 for TP C. The inspector requested to view the semi-annual competency assessment documentation for TP C. No documentation was available for review. 3. In an exit interview with the clinical operations manager at approximately 1:30 PM, the above findings were confirmed. 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 a review of the Centers for Medicare and Medicaid Services Laboratory Personnel Report form (CMS 209), laboratory personnel files, and an interview, the laboratory director failed to retain documentation of personnel qualifications for one of six testing personnel performing Prostate Specific Antigen and Testosterone patient testing from May 2019 to the date of the inspection on July 25, 2019. 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 have earned a doctoral, master's, or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; or (b)(2) Have earned an associate degree in a chemical, physical or biological science or medical laboratory technology from an accredited institution; or (b)(3) Be a high school graduate or equivalent and have successfully completed an official military medical laboratory procedures course of at -- 4 of 5 -- least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); or (b)(4)(i) Have earned a high school diploma or equivalent; and This STANDARD is not met as evidenced by: Based on a review of the Centers for Medicare and Medicaid Services Laboratory Personnel Report form (CMS 209), personnel records, and an interview, the laboratory director (LD) failed to retain documentation of personnel qualifications for one (1) of six (6) testing personnel from May 2019 to the date of the survey on July 25, 2019. Findings include: 1. Review of the CMS 209 form revealed 6 testing personnel performed patient Prostate Specific Antigen (PSA) and Testosterone testing during the twenty-four (24) months of review. 2. Review of the laboratory's personnel records revealed no documentation of education for Testing Personnel A (TP A). TP A's initial Qualigen FastPack training and start of patient testing was documented on 05/07/19. The inspector requested to review TP A's education documentation. No records were available for review. (See Personnel Code Sheet.) 3. In an exit interview with the clinical operations manager at approximately 1:30 PM, the above findings were confirmed. -- 5 of 5 --