Vitality Center Of Charlotte

Summary Statement of Deficiencies 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 review of 2020, 2021, 2022 and 2023 API (American Proficiency Institute) proficiency testing records and interview with TP (Testing Personnel) #1 on 8/1/23, the laboratory failed to include all testing personnel in the performance of proficiency testing events. Finding include: Review of 2020, 2021, 2022 and 2023 API proficiency testing records revealed that TP #1 performed all 11 of 11 proficiency testing events received by the laboratory. TP #1 signed all attestation statements in the years 2020, 2021 and 2022. An interview with TP #1 at approximately 10:05 a.m. confirmed that other testing personnel did not participate in proficiency testing events. 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 review of 2020, 2021, 2022 and 2023 API proficiency testing records, review of the laboratory's policies and procedures, and interview with TP #1 on 8/1 /23, the laboratory failed to sign and maintain attestation statements for 2 of 2 proficiency testing events in 2023. Findings include: Review of 2020, 2021, 2022 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 -- 2023 API proficiency testing records revealed the absence of signed attestation statements for the First and Second Chemistry events of 2023. Review of the laboratory's "Tab 3: Proficiency Testing Policies" states "Carefully complete all PT forms...have the Lab Director sign the Attestation statement..." An interview with TP #1 at approximately 10:05 a.m. confirmed the laboratory did not sign and retain attestation statements for proficiency testing events performed in 2023. 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 review of 2020, 2021, 2022 and 2023 API proficiency testing records, review of the laboratory's policies and procedures, and interview with TP #1 on 8/1 /23, the laboratory failed to perform

Summary Statement of Deficiencies D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) (f) Results of control materials must meet the laboratory's and, as applicable, the manufacturer's test system criteria for acceptability before reporting patient test results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of 2017 and 2018 Qualigen FastPack Testosterone QC (Quality Control) records, review of the laboratory's Risk Assessment and IQCP (Individualized Quality Control Plan), and review of patient logs 9/25/19, the laboratory failed to ensure the results of QC testing were acceptable before reporting patient results. Findings: The laboratory's risk assessment and IQCP for the Qualigen FastPack Testosterone Test states on page 3 "...CONTROLS OUT of RANGE Patient testing should not be performed if external Quality Controls are out of range for that product. This error could have high impact..." Review of the FastPack Testosterone QC records revealed Control Level 1 was outside of the QC acceptable range on 12 days from 12/15/17 through 12/13/18. Daily QC was performed as part of the risk assessment until 3/16/18, when the laboratory began performing QC weekly based on the IQCP. Approximately 177 patients were tested during the time frames when Control level 1 was unacceptable. The dates, results and number of patients are as follows: Control Level 1 (C1) lot # 1704036 (acceptable range:110-310 nanogram per deciliter(ng/dL) tested on the following: 1. 12/15/17: C1 result 706 ng/dL -2 patients; 2. 1/9/18: C1 result 314 ng/dL- 4 patients; 3. 5/24/18: C1 result 364 ng/dL- 22 patients between last acceptable QC run 5/17/18 to 5/29/18; 4. 7/25/18: C1 result 315 ng/dL - 34 patients between last acceptable QC run 7/19/18 to 8/2/18; 5. 9/6/18: C1 result 333 ng/dL; 6. 9/12/18: C1 result 519 ng/dL; 7 9/20/18: C1 result 319 ng/dL - 39 patients between last acceptable QC run 8/30/18 to 9/27/18; 8. 10/25/18: C1 result 321 ng/dL -30 patients between last acceptable QC run 10/18/19 to 11/1/18; 9. 11/26/18: C1 result 479 ng/dL; 10. 11/29/18: C1 result 603 ng/dL; 11. 12/6/18: C1 result 475 ng/dL; 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 -- 12. 12/13/18: C1 result 599 ng/dL -46 patients between last acceptable QC run 11/15 /18 to 12/20/18. D5783

Summary Statement of Deficiencies D0000 Revisit survey found the deficiencies cited during the 9/14/17 on-site survey are corrected and lab is in compliance with 42 CFR Part 493 Requirements for Laboratories. 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 --