Mens Wellness Centers

Summary Statement of Deficiencies D0000 An announced CLIA Recertification survey was conducted at the Men's Wellness Centers on 04/04/22 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: D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on the review of proficiency testing (PT) records, lack of documentation, and an interview, the testing personnel (TP) failed to sign three of three attestation statements reviewed for the year 2020. Findings include: 1. Review of the American Proficiency Institute (API) chemistry PT records for all three (3) events in 2020 revealed lack of TP signature(s) of the attestation statements for the following: 2020 Event 1, 2020 Event 2 and 2020 Event 3. 2. An exit interview with the testing personnel and patient coordinator on 04/04/22 at 1600 confirmed the findings. 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 the review of proficiency testing (PT) records, lack of documentation and 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 primary testing personnel, the lab failed to verify the accuracy of the prostate specific antigen (PSA) and testosterone (TESTS) analytes twice a year in 2021. Findings include: 1. The laboratory utilizes American Proficiency Institute (API) PT for verification of accuracy of the PSA and TESTS analytes, categorized as non-regulated analytes. 2. Review of the API PT records revealed the lab participated in a Self-Evaluation on 10/29/21. The inspector requested to review additional accuracy verification documents for the calendar year 2021. The documents were not available for review. 3. An exit interview with the testing personnel and patient coordinator on 04/04/22 at 1600 confirmed the 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: Based on the review of policy and procedures (P&P), proficiency testing (PT) records, testing personnel (TP) records, quality assurance (QA) check lists, lack of documentation, and an interview, the current QA procedure failed to identify and address analytic issues in the subspecialty of chemistry from 01/01/20 and up to 12/31 /21, twenty-four months. Findings include: 1. Review of P&P, proficiency testing (PT) records, and testing personnel records revealed the following analytic issues in the subspecialty of chemistry: - Lack of documentation by TP for all three attestatments in 2020 (Refer to D2009), - Lack of documentation of verification of accuracy twice annually in 2021 (Refer to D5217) and, - Lack of documentation of TP annual competency assessments in 2020 (Refer to D6064). 2. Review of the current P&P and quality assessment policy (signed by the LD on 02/01/2016) revealed the following statement: "The laboratory director oversees the implementation of this QA Assessment Plan and helps identify and correct problems as they occur. When problems are identified, adjustments to the QA plan are made and implemented. Our laboratory assesses the QA plan monthly, using the QA Assessment, which (1) evaluates and monitors the overall quality of our testing; (2) helps evaluate how well our policies and procedures are working; and (3) minimizes the possibility of recurrent problems." 3. The QA review revealed that the laboratory utilizes a quality assurance checklist that included the following statements: Write "Y" for Yes, "N" No or "NA" for not applicable to indicate the outcome of the assessed item. Items of assessment include but not limited: Notification of any situation that could affect the FastPack IP test performance; personnel competency assessment review; proficiency testing; required controls, calibration and maintenance performed; and QA monitoring reviewed." 4. Review of the QA checklists revealed TP and the lab director signed all 12 QA checklists in 2020. All 12 checklists for 2021 lacked documentation of review and signature by the lab director. There was no documentation of issues or problems identified on all 24 QA checklists. 5. An exit interview with the testing personnel and patient coordinator on 04/04/22 at 1600 confirmed the findings. D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of -- 2 of 3 -- 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 the review of Laboratory Personnel Report Form (CLIA) (CMS-209 Form), testing personnel (TP) records, lack of documentation, Policy and Procedures (P&P), and an interview, the technical conusltant (TC) failed to perform and document the annual competency assessments for three of six TP in 2020. Findings include: 1. Review of the CMS-209 form revealed the lab director performs the duties of TC and there were a total of six TP performing patient testing 2020. 2. Review of the TP records revealed lack of documentation by the TC of an annual competency assessments for the following in 2020: TP A, TP B, and TP C. See attached TP code sheet. The inspector requested to review the annual competency assessments. No records were avaiable for review. 3. Review of the P&P revealed a Personal Evaluations Checklist that stated, "Evaluate those individuals that operate the FastPack IP System after first 6 months of testing, then yearly thereafter." 4. An exit interview with the testing personnel and patient coordinator on 04/04/22 at 1600 confirmed the findings. -- 3 of 3 --

Summary Statement of Deficiencies D0000 An announced CLIA Recertification survey was conducted at the Men's Wellness Centers on January 13, 2020 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: D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) 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 of the laboratory, review of the policy and procedures (P&P), 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 -- calibration verification documentation, and an interview with the clinical operations manager, the laboratory failed to follow the manufacturer's six (6) month calibration verification instructions for Testosterone and Prostate Specific Antigen (PSA) analytes in calendar year 2018 and up to the date of the inspection on January 13, 2020. Findings include: 1. During a tour of the laboratory at approximately 1:10 PM, the inspector noted two (2) Qualigen FastPack analyzers in use for patient immunoassay PSA and Testosterone testing: Machine 1 (SN 0902), Machine 2 (SN 0802). 2. Review of P&P revealed the following statement by manufacturer: "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." The laboratory director signed review and approval of the manufacturer operation guide on March 1, 2016. 3. Review of the Testosterone and PSA calibration verification records from June 1, 2018 up to the date of the inspection, revealed: Machine 1 (SN 0902) - PSA calibration verification performed 3/1/18 and 3/16/19; Machine 2 (SN 0802) - Testosterone calibration verification performed 3/1/18 and 3/16/19. The inspector requested to review additional calibration verification documentation as described by manufacturer instructions. The documentation was not available for review. 4. An exit interview with the clinical operations manager at approximately 4:00 PM confirmed the findings. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Men's Wellness Centers- Glen Allen on March 7, 2018 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: 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 failed to maintain documentation of personnel education qualification for six (6) of thirteen (13) testing personnel. 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 least 50 weeks duration and have held the military enlisted occupational specialty of 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 -- 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), available personnel records, and an interview, the laboratory director failed to maintain documentation of personnel qualifications for six (6) of thirteen (13) testing personnel from February 2016 up to the date of the survey on 3/7/18. Findings include: 1. Review of the CMS 209 Laboratory Personnel Report revealed thirteen (13) testing personnel. 2. Review of the laboratory's personnel records revealed no documentation of education for: Testing Personnel A Testing Personnel B Testing Personnel C Testing Personnel D Testing Personnel E Testing Personnel F (See Personnel Code Sheet) The inspector requested to review the documentation. No records were available for review on the day of the survey. 3. In an interview with the laboratory director and general supervisor at approximately 2:00 PM on 3/7/18, it was confirmed that the laboratory failed to maintain documentation of the personnel education qualifications for the six (6) of thirteen (13) testing personnel listed above. -- 2 of 2 --