Trugenomix Endeavor Lab

Summary Statement of Deficiencies D0000 An off-site CLIA proficiency testing desk review of Trugenomix Endeavor Lab was completed on August 14, 2024 by a Medical Facilities Inspector of the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Regulations. The laboratory was found not in compliance with the following Conditions under 42 CFR part 493 CLIA Regulations: D2016 - 42 C.F.R. 493.803 (a)(b)(c) Condition- Successful Participation. D2004 ENROLLMENT CFR(s): 493.801(a)(3) For each specialty, subspecialty and analyte or test, participate in one approved proficiency testing program or programs, for one year before designating a different program and must notify CMS before any change in designation; This STANDARD is not met as evidenced by: Based on review of the laboratory's proficiency testing (PT) records, Certification and Survey Provider Enhanced Reporting (CASPER)-0155 report and an email, the laboratory failed to remain enrolled with their designated 2024 PT program for the subspecialty of Virology for the calendar year of 2024 before designating a change in PT program.. Record review was from January 2024 until August 2024. The findings include: 1. Review of the laboratory's PT records and CASPER-0155 report revealed the laboratory participated in the following events and PT programs: American Proficiency Institute-Virology 2024 Events 1 and 2; College of American Pathologists (CAP)-Virology 2024 Event 2. 2. In an email from the technical supervisor (TS) on August 13, 2024 at 7:42 PM, the TS stated, "We received the PT samples from CAP as part of our annual contract before deciding to close the laboratory services and decided to run just as practice but not as proof of proficiency for the COVID-19 qPCR test. We have not run any patient samples since March 2023." D2016 SUCCESSFUL PARTICIPATION 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 -- CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on a proficiency testing (PT) desk review of the laboratory's Certification and Survey Provider Enhanced Reporting (CASPER)-0155 report and American Proficiency Institute (API) for 2024 (Events one, and two), the laboratory failed to successfully participate in a proficiency testing program approved by Health and Human Services (HHS) for the subspecialty of Virology. Refer to D2064. D2064 VIROLOGY CFR(s): 493.831(e) Failure to achieve an overall testing event score of satisfactory performance for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a proficiency testing (PT) desk review of the laboratory's Certification and Survey Provider Enhanced Reporting (CASPER)-0155 report, American Proficiency (API) evaluation reports for 2024 (Events one, and two), and an email, the laboratory failed to achieve satisfactory performance (80%) for the subspecialty Virology for two consecutive proficiency testing (PT) events reviewed. The laboratory had unsatisfactory scores for Virology for API 2024 Event one (1) and Event two (2) resulting in an initial unsuccessful participation. The findings include: 1. Review of the CASPER-0155 report revealed the following unsatisfactory scores: 2024 Event 1: Virology = 0%, 2024 Event 2: Virology = 0%, Failure to participate. 2. A review of the laboratory's 2024 API PT scores for the subspecialty virology confirmed the above findings resulting in an initial unsuccessful participation for the subspecialty of Virology. 3. In an email from the laboratory director (LD) on August 12, 2024 at 11: 14 PM, the LD confirmed the unsuccessful participation. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Trugenomix Endeavor Lab on May 24, 2023 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Regulations. The specific deficiencies cited are as follows: 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 a review of the laboratory's policies and procedures, accuracy verification records, lack of documentation, and interviews, the laboratory failed to perform method accuracy verification twice annually for the the Yale Saliva Direct SARS CoV-2 (COVID-19) method in calendar year 2022 (dates of review 2021 until May 24, 2023). The findings include: 1. During an entrance interview with the laboratory director (LD) and technical supervisor (TS) on May 24, 2023 at approximately 9:00 AM, the LD and TS stated the laboratory performs COVID-19 testing utilizing the Yale Saliva Direct Method. 2. Review of the laboratory's policies and procedures revealed a policy, "Saliva Direct Split Sample Testing", with the following statements, "Spilt sample testing is used to compare lab methodology and testing result accuracy between clinical labs." 3. Review of the laboratory's "split sample" or twice annual accuracy verification records for the Yale Saliva Direct SARS CoV-2 (COVID-19) method from 2021 until May 24, 2023 revealed split sample testing performed with an outside laboratory in 5/2021, 12/2021 and 9/2022. The surveyor requested to review documentation of the laboratory's second accuracy verification for 2022. The laboratory provided no further documentation of the 2022 accuracy verification. The 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 -- TS stated "We sent out a split-sample analysis with another laboratory on 5/18/2023." 4. In an exit interview with the LD and TS on May 24, 2023, at approximately 12:30 PM, the findings were confirmed. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on a review of the laboratory's policies and procedures, equipment calibration records, interviews, and lack of documentation, the laboratory failed to follow manufacturer's instructions and perform pipette calibration every six (6) months for three (3) of 3 multi-channel pipettes and fourteen (14) of 14 fixed volume single channel pipettes utilized for SARS CoV-2 (COVID-19) testing in calendar year 2022 until the date of the survey on May 24, 2023. The findings include: 1. Review of the laboratory's policies and procedures revealed a "QA Review Plan" with the following statements: "In order to ensure that our lab is adhering to all protocols for best performance practices, the following quality parameters will be reviewed...."May- Calibrations/Equipment, thermometer, pipettor (manual, electronic)." The surveyor requested to review a laboratory policy for pipette calibrations. The laboratory provided no policy for review. 2. In an interview with the technical supervisor (TS) on May 24, 2023 at approximately 10:30 AM, the surveyor inquired how pipette calibrations were performed. The TS stated, "The pipettes are sent to an outside vendor every 6 months for calibration". 3. Review of the laboratory's pipette calibration records from October 2021 until the dare of the survey on May 24, 2023 revealed the following pipettes were calibrated on 11/10/2021 with expiration date of 5 /10/2022, and 6/16/2022 with expiration date of 12/31/2022: Eppendorf multichannel pipettes-Serial Number (SN) O51546G and SN P59581G; Eppendorf single volume pipettes-SN J21211H and G32228H; Rainin Pipet-Lite multichannel pipette-SN B1208405T; Rainin Pipet-Lite single volume pipettes-SN B540516933, SN E0300306A, SN I0661464A; IVYX Scientific single volume pipettes-SN YE189AL0089337, SN YE188AL0081113, SN YE188AL0081118, SN YE189AL0117857, SN YE189AL0117874, SN YE193AM0059055; Genemate single volume pipettes-SN 641130139 and SN 841150010; Huawei single volume pipette- SN 17020708. The surveyor requested to review the pipette calibration records for May 2022, November 2022 and May 2023. The laboratory provided no documentation to review. The TS stated, "I sent the pipettes out for calibration on May 21, 2023." 4. Review of the Eppendorf, Rainin, IVYX Scientific, Genemate and Huawei pipette manufacturer's instructions for calibration/maintenance stated pipette calibrations should be performed at six month intervals. 5. In an exit interview with the Lab Director and TS on May 24, 2023, at approximately 12:30 PM, the findings were confirmed. D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) 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: (i) Define a -- 2 of 4 -- function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on a tour, review of the laboratory's policies and procedures, maintenance documents, lack of documentation, and an interview, the laboratory failed to follow their established policy and document function checks for the Scientific Industries Microplate Genie, and Benchmark Scientific Platefuge Microcentrifuge monthly for five (5) of twenty (20) months from October 2021 until the date of the survey on May 24, 2023. The findings include: 1. During a tour of the laboratory on May 24, 2023 at approximately 9:00 AM, the surveyor noted the laboratory utilizes the Scientific Industries Microplate Genie, and Benchmark Scientific Platefuge Microcentrifuge with the Yale Saliva Direct method. 2. Review of the laboratory's maintenance records revealed a Scientific Industries Microplate Genie Validation Log (S/N: M4A- 1463), and a Benchmark Scientific Platefuge Microcentrifuge Validation Log (S/N: A101804414). The logs stated "Validate at least once a month by a technician using a tachometer (Westward, MN:5URH0A)." Each log was completed with dates of validation from October 2021 until December 2022. The surveyor requested to review documentation of validations for the Microplate Genie and Platefuge Microcentrifuge from January 2023 until the date of the survey on May 24, 2023. The laboratory provided no documentation to review. 3. In an exit interview with the Lab Director and Technical Supervisor on May 24, 2023, at approximately 12:30 PM, the findings were confirmed. D5793 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(b)(c) (b) The analytic systems quality assessment must include a review of the effectiveness of