Men's Wellness Centers, Llc

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Men's Wellness Centers - Newport News that concluded on March 6, 2025 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Regulations. Specific deficiencies cited are as follows. 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 policies and procedures, proficiency testing (PT) records, and interviews, the laboratory failed to follow their established policy to test PT testosterone specimens in the same manner as patients for one (1) of five (5) Chemistry PT events reviewed. Findings include: 1. Review of lab's PT policy revealed the statements: "Test PT samples in the same manner as you would patient samples." "Do not repeat PT sample testing unless you would repeat a patient test in the same situation." 2. Review of the laboratory's American Proficiency Institute (API) Chemistry proficiency testing records (account # 68580) for 2023 Events 2 and 3, and 2024 Events 1 - 3 (5 events in total) revealed both testosterone proficiency samples (IA-01 and IA-02) in 2024 Event 1 were tested twice on 1/22/24. Both PT sample results were within normal range and instrument printouts contained no flags or alerts. 3. In an interview on 1/13/25 at approximately 4:30 PM when asked when 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 -- patient tests are repeated, the primary testing personnel (TP) stated that patient test reports are given to the doctor and the doctor decides if patient test needs repeating. 4. On 3/6/25 at approximately 10:10 AM, the primary testing personnel confirmed that the samples were ran twice, once on each Qualigen Fast Pack Instrument. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) (d) 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. (d)(3) At least once each day patient specimens are assayed or examined perform the following for: This STANDARD is not met as evidenced by: Based on a review of the laboratory's Individualized Quality Control Plan (IQCP), quality control (QC) records, patient test logs, and interview, the laboratory failed to follow their established schedule of performing two levels of external Testosterone and Prostate-specific Antigen (PSA) QC every 7 days during two (2) weeks out of the 17 months reviewed with sixty (60) patients resulted. Review timeframe: July 2023 through December 2024. Findings include: 1. The laboratory utilizes the Qualigen Fast Pack System to test patient Testosterone and PSA. Review of the laboratory's Individualized Quality Control Plan (IQCP) revealed that Qualigan QC is to be performed weekly (each Tuesday) prior to the 1st patient. 2. Review of the Qualigen QC records revealed Testosterone QC performed on Qualigen instrument #1 (Serial Number (SN) 0784), and PSA QC performed on Qualigen instrument #2 (SN 0373) on the 16th, 21st, and 28th of November 2023. No Testosterone and PSA QC was documented during the timeframe of November 1, 2023 to November 15, 2023. 3. Review of the November 2023 patient test logs revealed thirty three (33) patients tested for Testosterone and twenty seven (27) patients tested for PSA between November 1st and November 15th. (A total of 60 patients tested.) 4. In an exit interview on 3/6/25 at approximately 10:10 AM, the primary testing personnel confirmed there was no QC documented in the timeframe listed above. D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(g) (d)(10) Establish or verify the criteria for acceptability of all control materials. (d)(10) (i) When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (d)(10)(ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (d)(10)(iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on a review of policies and procedures, quality control (QC) records, and interview, the laboratory failed to follow their established policy to review Endocrinology quality control statistics monthly during the seventeen (17) months reviewed. Review timeframe: July 2023 through December 2024. Findings include: 1. Review of the laboratory's policy for QC review revealed that the lab director (LD) is to review and sign QC Levy Jennings (LJ) plots monthly. 2. Review of the Endocrinology QC records revealed the following dates and LD signature of review for Testosterone and Prostate-Specific Antigen (PSA) QC LJ charts: July 2023 - December 2023 review dated 6/27/24, January 2024 - June 2024 review dated 6/27 /24, and July 2024 - December 2024 review dated 12/18/24. 3. In an interview on 1/13 /25 at approximately 4:30 PM, the primary testing personnel (TP) stated that the LD reviews QC when on-site and initials/signs twice a year. 4. During an exit interview on 3/6/25 at approximately 10:10 am with the primary TP, it was confirmed that the LD documented LJ review twice a year. -- 3 of 3 --

Summary Statement of Deficiencies D0000 An announced CLIA initial survey was conducted at Men's Wellness Centers, LLC (Newport News) on June 6, 2023 by the Virginia Department of Health's Office of Licensure and Certification. The inspection also included follow up interviews with the laboratory director and technical consultant on 6/8/23. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. Specific deficiencies cited are 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 the Centers for Medicare and Medicaid Services Laboratory Personnel Report form (CMS 209), chemistry proficiency testing (PT) records, and an interview, the laboratory failed to document rotation of PT among all personnel performing patient Prostate Specific Antigen (PSA) and Testosterone testing in calendar years 2021, 2022, and up to the day of the inspection on June 6, 2023. Findings include: 1. Review of the CMS 209 laboratory personnel form revealed that the lab director identified five (5) laboratory testing performing (TP) responsible for patient PSA and Testosterone testing. 2. Review of the American Proficiency Institute (API) PT Core Chemistry modules in calendar year 2021 through 6/8/23 revealed that TP A signed attestations for performance of: API Core Chemistry 2021 (Events 1-3); API Core Chemistry 2022 (Events 1-3); API Core Chemistry 2023 Event 1; TP A performed/signed attestations for 7 of 7 events reviewed and outlined above. (See attached Testing Personnel Code Sheet) 3. An interview with the technical consultant on 6/6/23 at approximately 2:30 PM 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 3 -- D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on a review of the laboratory's 2020 proficiency testing (PT) records, lack of documentation, online PT vendor score reports, and interviews, the laboratory failed to retain documentation of a review/evaluation for three (3) of 3 core chemistry immunoassay PT modules for Prostate Specific Antigen (PSA) and Testosterone in calendar year 2020 while reporting one thousand six hundred (1,600) patient test results. Findings include: 1. Review of the laboratory's 2020 American Proficiency Institute (API) chemistry PT records (Events 1-3) revealed no retained scored results or documentation of a review/evaluation for: 2020 Endocrinology/Immunoassay Event 1: PSA challenge samples IA 01-02, Testosterone challenge samples IA 01-02 2020 Endocrinology/Immunoassay Event 2: PSA challenge samples IA 06-07, Testosterone challenge samples IA 06-07 2020 Endocrinology/Immunoassay Event 3: PSA challenge samples IA 11-12, Testosterone challenge samples IA 11-12 2. The inspector requested to review the API results and evaluation documentation for the 3 chemistry module events outlined above. No documentation of an evaluation was available for review. 3. A follow up review of PT results from the API vendor on 6/7 /23 revealed the following scores were reported: Chemistry Endocrinology Immunoassay: 2020 1st - PSA 100%, Testosterone 100% 2020 2nd - PSA 100%, Testosterone 50 % - API noted unsatisfactory performance for Testosterone 2020 3rd - PSA 100%, Testosterone 100% 4. Review of Qualigen Fast Pack moderate complexity patient test logs for calendar year 2020 revealed that the laboratory analyzed and reported one thousand (1,000) Testosterone and six hundred (600) PSA, a total of 1,600 results. 5. A follow up interview with the technical consultant and lab director on 6/8/23 at approximately 5:35 PM confirmed the above findings. 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 a tour, review of manufacturer's user guide, procedures, equipment maintenance records, lack of documentation, and interviews, the laboratory failed to follow their annual calibration maintenance protocols for two (2) of 2 positive displacement sample pipettes utilized for Prostate Specific Antigen (PSA) and Testosterone patient testing during the review timeframe of August 2019 to the date of the inspection on June 6, 2023. Findings include: 1. During a laboratory tour on 6/6 /23 at approximately 11:00 AM, the inspector noted one Gilson Guest 100 microliter (ul) pipette, serial number (SN) JC05684, in use for Qualigen FastPack analyzer -- 2 of 3 -- patient sample preparation for PSA and Testosterone testing. The inspector noted a Pipette.com calibration sticker dated 11/30/2022 with note: due for calibration on 11 /30/2023. The lead testing personnel stated at approximately 11:10 AM, "we also have a second pipette as our back up". The inspector noted that the second pipette, SN JD05679, had a Pipette.com calibration sticker dated 05/03/2023 with note: due for calibration on 05/03/2024. 2. Review of the Qualigen manufacturer's user guide revealed a policy, "Annual Recalibration of the Positive Displacement Sample Pipette" which outlined instructions for pipette calibrations. The policy stated "Proper performance of pipette is critical to obtain accurate results. The pipette included with the FastPack System is a costly piece of equipment that requires periodic recalibration which must be done by a factory certified dealer". 3. Review of the laboratory's procedure manual revealed a quality assurance "Quick Reference Task Log" that outlined Pipette Recalibration to be completed annually (QA Manual Tab 18-5). 4. Review of the laboratory's equipment maintenance records from August 2019 to the date of the survey on 6/6/23 revealed no additional pipette calibration documentation other than the Pipette.com stickers observed on the pipettes as outlined above. The inspector requested to review additional annual calibration records. The requested documentation was not available for review. 5. A follow up interview with the technical consultant and lab director on 6/8/23 at approximately 5:35 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 (Newport News) on July 23, 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: 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 testing personnel for three (3) of five (5) immunoassay PT events in the review timeframe of June 2017 to July 2019. Findings include: 1. Review of the laboratory's American Proficiency Institute (API) Prostate Specific Antigen (PSA) and Testosterone immunoassay PT documentation (2017 Event 1 and 2, 2018 Event 1 and 2, 2019 Event 1), a total of 5 events, revealed no testing personnel signed attestation statements for: 2017 Event 2 2018 Event 1 2018 Event 2 The inspector requested to review the attestation Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- documentation for the 3 PSA and Testosterone PT events outlined above. No documentation was available for review. 2. In an exit interview with the clinical operations manager at approximately 1:30 PM, the above findings were confirmed. 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 performance verification records for the Qualigen FastPack IP System 2 analyzers, patient test logs, quality control records, manufacturer's user guide, the laboratory's Individualized Quality Control Plan (IQCP), immunoassay analyzer validation study, and an interview, the laboratory failed to: 1. document review or evaluation, by the laboratory director, of the accuracy, precision, and reportable range for Prostate Specific Antigen (PSA) testing prior to reporting three hundred thirty-eight patient results on a newly installed Qualigen instrument from March 20, 2019 to the date of the survey on July 23, 2019; Cross Reference D5421. 2. provide documentation of a lab director approved IQCP with Risk Assessment for PSA and Testosterone testing from 7/5/18 to the date of the survey on 7/23/19 prior to reporting two thousand two hundred seventy-one patient test results; Cross Reference D5445. 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 a tour, review of performance verification records for the Qualigen FastPack IP System 2 analyzers, patient test logs, and an interview, the laboratory director (LD) failed to document review/evaluate the accuracy, precision, and reportable range for Prostate Specific Antigen (PSA) testing prior to reporting three hundred thirty-eight (338) patient results on the newly installed instrument from March 20, 2019 to the date of the survey on July 23, 2019. 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 0784; for Testosterone) Machine 2 (SN 0321; for PSA) 2. Review of all analyzer performance verification documentation records revealed that the laboratory installed a new FastPack instrument (SN 0321) on 03/20/19. The validation documentation for -- 2 of 7 -- SN 0321 revealed no LD evaluation or verification of PSA accuracy, precision, or reportable range. The inspector requested to review documentation that the LD verified the Qualigen FastPack validation studies prior to patient testing for the newly installed analzyer. No documentation was available. 3. Review of patient test logs revealed that the laboratory reported 338 patient PSA results from analyzer (SN 0321) from March 2019 to the date of the survey on 7/23/19. 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 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), immunoassay analyzer validation study, 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 7/23/19 prior to reporting two thousand two hundred seventy-one (2,271) patient test 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 daily QC (two levels per day of patient testing) was discontinued in July 2018. The inspector noted 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 /23/19. 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 at this office. I may have one completed for one of our other locations but that would have been completed in 2019." 4. Review of all analyzer performance verification documentation records revealed that the laboratory installed a new FastPack instrument (SN 0321) on 03/20/19. The validation documentation for SN 0321 revealed no LD evaluation or verification of PSA and Testosterone accuracy, precision, or reportable range, or RA for an IQCP for once per week QC. The inspector requested to review documentation that the LD verified the -- 3 of 7 -- Qualigen FastPack validation studies and reviewed an IQCP RA prior to patient testing on the newly installed analyzer. No documentation was available. 5. Review of the Qualigen FastPack patient test logs revealed the laboratory reported the following patient results from 7/5/18 and up to 7/23/19: Testosterone: one thousand one hundred fifty-seven (1,157); PSA- one thousand one hundred fourteen (1,114); a total of 2,271 patient results. 6. In an exit interview with the clinical operations manager at approximately 1:30 PM, the above findings were confirmed. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on a tour, review of instrument validation documents, patient test logs, the Centers for Medicare and Medicaid Services Laboratory Personnel Report form, procedures, laboratory personnel files, proficiency testing (PT) records, and an interview, the laboratory director failed to: 1. document review and evaluation of the accuracy, precision, and reportable range for Prostate Specific Antigen (PSA) testing prior to reporting three hundred thirty-eight patient results on a newly installed immunoassay instrument from March 20, 2019 to the date of the survey on July 23, 2019. Cross Reference D6013. 2. to ensure the quality assurance (QA) policy for personnel competency assessments was followed for two of five personnel in calendar years 2017 and 2018. Cross Reference D6014. 3. document review of the laboratory's performance of immunoassay PT challenges on four out of five events reviewed (review timeframe: June 2017 to July 2019). Cross Reference D6018. 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; This STANDARD is not met as evidenced by: Based on a tour, review of performance verification records for the Qualigen FastPack IP System 2 analyzers, patient test logs, and an interview, the laboratory director (LD) failed to document review/evaluate the accuracy, precision, and reportable range for Prostate Specific Antigen (PSA) testing prior to reporting three hundred thirty-eight (338) patient results on a newly installed instrument from March 20, 2019 to the date of the survey on July 23, 2019. 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 0784; for Testosterone) Machine 2 (SN 0321; for PSA) 2. Review of all analyzer performance verification documentation records revealed that the laboratory installed a new -- 4 of 7 -- FastPack instrument (SN 0321) on 03/20/19. The validation documentation for SN 0321 revealed no LD evaluation or verification of PSA accuracy, precision, or reportable range. The inspector requested to review documentation that the LD verified the Qualigen FastPack validation studies prior to patient testing for the newly installed analyzer. No documentation was available. 3. Review of patient test logs revealed that the laboratory reported 338 patient PSA results from analyzer (SN 0321) from March 2019 to the date of the survey on 7/23/19. 4. In an exit interview with the clinical operations manager at approximately 1:30 PM, the above findings were confirmed. D6014 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(iii) 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)(iii) Laboratory personnel are performing the test methods as required for accurate and reliable results. 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), procedure manual, personnel documentation, and an interview, the laboratory director failed to ensure the quality assurance (QA) policy for personnel competency assessments was followed for two (2) of five (5) personnel in calendar years 2017 and 2018. Findings include: 1. Review of the CMS 209 form revealed 5 testing personnel performed patient Qualigen FastPack Prostate Specific Antigen (PSA) and Testosterone testing during the twenty-four (24) months reviewed (review timeframe June 2017 to 07/23/19). 2. Review of the laboratory's procedure manual revealed a Qualigen FastPack QA policy (titled "Steps to Complete for Patient Testing- How to Use this Quality Assurance Log"). The policy stated "annually, the lab director will evaluate the personnel who perform the testing using the Personnel Evaluation Checklist". The inspector noted that the procedure manual competency checklist outlined three (3) forms: an initial evaluation, semi-annual, and annual. 3. Review of the laboratory personnel files revealed: Testing Personnel B: No annual competency assessment documentation in calendar years 2017 and 2018. Testing Personnel C: Documentation of an initial training checklist for Qualigen FastPack immunoassay testing on 10/17/17. The inspector noted no semi-annual review was included in the file. The inspector requested to review the competency assessments outlined above for Testing Personnel B and C. 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. D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) 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)(iii) Ensure that all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to -- 5 of 7 -- identify any problems that require