Genesis Diagnostics

Summary Statement of Deficiencies D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on observation, record review, and interview, the laboratory failed to ensure that changes in procedure were approved, signed, and date by the laboratory director prior to use. Findings: 1. During a tour of the laboratory, around 9:30 AM the surveyor asked for the current standard operating procedure. TS#1 provided copy of: "Rapid Real-time PCR-based Screening for SARS-COV-2 (COVID-19) on Bio-Rad CFX384 and said it was the current copy in use. 2. The document has no signature under "Annual Review by Medical Director." The document states it was revised 07 /23/2021. 3. During an interview with the laboratory director on 7/27/2021 around 4 PM, when asked how often he is on site, the laboratory director said: "I come in once a week"..."I'm only getting paid for one day a week." D5425 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(3) The laboratory must determine the test system's calibration procedures and control procedures based upon the performance specifications verified or established under paragraph (b)(1) or (b)(2) of this section. This STANDARD is not met as evidenced by: Based on record review, interview, and lack of documentation, the laboratory failed to determine the test system's control procedures based upon established performance specifications. Findings: 1. The laboratory's previous SOP "Rapid Real-time PCR- 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 -- based Screening for SARS-CoV-2 (COVID-19) in Bio-Rad CFX384" in use 4/15 /2021 contained a chart titled : "Plate Acceptability of Controls" and for Sample NEC1 the acceptable CQ value was less than 34.51. For Sample NEC2 the acceptable CQ value was less than 34.51. For For Sample NTC the acceptable CQ value was 38- N/A. The laboratory's current SOP in use 7/27/2021 has a chart titled: "Plate Acceptability of Controls" and for Sample NEC1 the acceptable CQ value was less than 40. For Sample NEC2 the acceptable CQ value was less than 40. For Sample NTC the acceptable CQ value was 1-3, and 38-N/A. 2. On 7/27/2021 around 3 PM, in an interview with the Quality Assurance manager, when asked about studies documenting that the changes in the control procedures did not affect the accuracy of the testing, she said she would have to ask the Laboratory Director and that she did not have documentation available. 3. On 7/27/2021 around 3:20 PM in an interview with the Laboratory Director, when asked about changes in control procedures he said: "They look at the graphs, results with 1-3 were little blips and the SOP changed because I didn't want people to waste time, they're getting these results intermittently but they are not positive because they stay low on the graph" and when asked if the laboratory had documentation he said: "I wish I held onto the records." D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on interview, the laboratory director has failed to provide management and direction to the laboratory. Findings: 1. During an interview with the laboratory director on 7/27/2021 around 3:30 PM, when asked how often he reviews QC, he said that was the supervisor's responsibility. He then said he leaves it up to the supervisor and if she has a problem she [TS#1] brings it to him. The laboratory director failed to review the out of range QC referenced in D5481. 2. During an interview with the laboratory director on 7/27/2021 around 3:45 PM, when asked how specimen identity and integrity is ensured in preanalytics he said: "I believe a certain number of reqs [requisitions] a day to be checked. [IT manager] would know about that and [Preanalytics lead]. It's not something in the lab, its in accessioning." When asked do you have any oversight, he said: "[IT manager] is responsible for that." 3. During an interview with the laboratory director on 7/27/2021 around 3:45 PM, when asked about temperature monitoring in the laboratory and how it has been monitored he said: "I personally no, but the supervisors should look at the charts daily. That was the disconnect before, I now have supervisors, they are responsible, I'm not responsible. Nonworking fridge or freezing, nobody has told me about that." 4. During an interview with the laboratory director on 7/27/2021 around 4:00 PM, when asked how he monitors expired reagents in the laboratory he said somehow when the (former supervisor) person left on the molecular side there seemed to be missing records, [TS#1] is now the person in charge, she has the book and she checks the lot number before use. 5. In an interview with the laboratory director on 7/27/2021 around 4:10 PM, when asked if he had investigated other patients that were released as negative instead on inconclusive, he said: "I admit, I looked those up." When asked: "Have you investigated any other patients?" He said: "I'm limited to the amount of time, its not my job, its actually my tech's job." 6. In an interview with the laboratory director on 7 /27/2021 around 4 PM when asked how often he is on site he said: "I come in once a -- 2 of 3 -- week, this is only recently when I got the staff, I'm only getting paid for one, I'm back to where I belong." 7. During an interview on 7/27/2021 around 4:00 PM when asked how he ensures that the techs are releasing results correctly the laboratory director said: "Again I go back to my supervisors." 7. Refer to D3000, D5200, D5300, D5400, D5800, D6079, D6108, D6168. -- 3 of 3 --

Summary Statement of Deficiencies D3009 FACILITIES CFR(s): 493.1101(c) The laboratory must be in compliance with applicable Federal, State, and local laboratory requirements. This STANDARD is not met as evidenced by: Based on interview and record review the laboratory failed to ensure that the State of Pennsylvania regulations were met regarding having a supervisor on site during all normal scheduled working hours in which tests are being performed. Findings: 1. The laboratory's CMS 209 lists two general supervisors. One general supervisor has been delegated for all areas of testing. The other general supervisor has been delegated for Chem, Immuno, Endo, Allergy and Tox. 2. During an interview on 4/15/2021 at around 3:20 pm when asked how are supervisors available to staff when not on site the laboratory director said: "The supervisors are not at the site but they are available. Technical employees can call me anytime." When asked how the laboratory ensures that a supervisor is available to laboratory personnel when the director is unavailable, he answered: "There are other people there." The surveyor asked, "have those people been delegated?" The laboratory director said: "No. Only the 2 supervisors and the QA manager (have been delegated)." D5423 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(2) Each laboratory that modifies an FDA-cleared or approved test system, or introduces a test system not subject to FDA clearance or approval (including methods developed in-house and standardized methods such as text book procedures), or uses a test system in which performance specifications are not provided by the manufacturer must, before reporting patient test results, establish for each test system the performance specifications for the following performance characteristics, as Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- applicable: (2)(i) Accuracy. (2)(ii) Precision. (2)(iii) Analytical sensitivity. (2)(iv) Analytical specificity to include interfering substances. (2)(v) Reportable range of test results for the test system. (2)(vi) Reference intervals (normal values). (2)(vii) Any other performance characteristic required for test performance. This STANDARD is not met as evidenced by: Based on record review and interview with laboratory director, the laboratory failed to establish performance specifications before reporting patient test results for 19 thermocyclers for COVID-19 testing. Findings: 1. The laboratory has 19 thermocyclers for COVID-19 testing with the following serial numbers in use during the survey on 4/14/2021: a. 786BR06155 b. 786BR04978 c. 786BR05033 d. 786BR05026 e. 786BR05032 f. 786BR05288 g. 786BR05736 h. 786BR05730 i. 786BR05788 j. 786BR05781 k. 786BR06142 l. 786BR02042 m. 786BR02037 n. 786BR02040 o. 786BR06547 p. 786BR06392 q. 786BR06393 r. 786BR02063 s. 786BR02043 2. The laboratory provided a document titled "Validation of Rt-PCR for SARS-CoV-2 method using CDC Method Kit - Validation Method Plan." The document was signed by the laboratory director on 10/14/2020. The document stated instructions for the following studies: a. Limit of detection b. Precision/Accuracy c. Specificity d. Specimen stability e. Carryover f. Patient Comparison by COVID Method 3. The laboratory provided a document titled "Performance Characteristics." The document stated contained paragraphs titled: Limit of Detection (LoD), Precision /Accuracy, Specificity/Exclusivity Testing, Specimen Stability, Carryover (signed by laboratory director 7/8/2020), Method Comparison (signed by laboratory director 10 /14/2020), Comparison of Master Mix brands (signed by laboratory director 12/1 /2020). The document states: Original validation missing. Reconstructed from available date. It provides data from a thermocyclers with a serial number 786BR04953. 4. The laboratory provided a document titled "Comparison Verification of Performance All Bio-Rad CFX384 used for detection of SARS-CoV-2" which was signed by the laboratory director on 3/8/2021. The document did not follow the laboratory's document "Validation of Rt-PCR for SARS-CoV-2 method using CDC Method Kit - Validation Method Plan." 5. In an interview with the laboratory director on 4/15/2021 around 4 PM when asked if the laboratory had documentation of the establishment of performance specifications for all 19 thermocyclers the laboratory director said, "it's not a method, it's a machine" and also said that the laboratory did a comparison of all thermocyclers every 6 months. 6. Another document provided by the laboratory that was signed by the laboratory director on 12/1/2020 stated: "Comparison Study of Master Mix Brands: Supplies of the Master Mix are sometimes delayed in shipping or are in short supply. This can affect the testing process by stopping the ability to test or stop the testing process at a stage require deep freezing of the plate until the Master Mix is delivered. It was necessary to find alternate vendors of Master Mix that can be used interchangeably and have the same response to the Master mix currently in use. This study will be performed on several available Master Mix brands that could be used whenever there is a delay or a short supply of a brand we are currently using." 7. The Emergency Use Authorization titled "CDC 2019- nCoV Real-Time RT-PCR Diagnostic Panel - Instructions for Use" listed the following options for rRT-PCR Enzyme Mastermix Options: a. Quantabio qScript XLT One-Step RT-qPCR ToughMix (catalog numbers: 95132-100, 95132-02K, 95132-500) b. Quantabio UltraPlex 1-Step ToughMix (4X) (catalog numbers: 95166- 100, 95166-500, 95166-01K) c. Promega GoTaq Probe 1- Step RT-qPCR System (catalog numbers: A6120, A6121) d. Thermofisher TaqPath (Trademark) 1-Step RT- qPCR Master Mix, CG (catalog numbers: A15299, A15300) 8. The laboratory's SOP "Rapid Real-time PCR based Screening for SARS-CoV-2 (COVID-19) on Bio-Rad -- 2 of 6 -- CFX384" listed the following options for Master Mix: a. Quantabio: Cat# 95112 b. Takara: Cat# RR60HW c. Promega Cat# M7133 d. LGC: Cat# ERT12925K + Cat# 30050-1 9. The laboratory provided a document titled "COVID-19 Detection in Nasopharyngeal Swabs" signed by the laboratory director on 4/17/2020. The document states: "Conclusions: Naso and oropharyngeal sample collections sites and medium of collection (PBS and VTM) do not influence the overall amplifications and COVID-19 result interpretations per se. Terminal amplifications can influence the false positives and false negatives rates. Hence, a visual inspection with RFU is taken as a base to interpret and distinguish from [sic] positive cases from false positives." 10. The laboratory's SOP "Rapid Real-time PCR based Screening for SARS-CoV-2 (COVID-19) on Bio-Rad CFX384" does not define a process for a visual inspection with RFU to distinguish positive cases from false positives. 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 lack of documentation, interview, and record review, the laboratory failed to ensure that the results of control materials met the laboratory's criteria for acceptability before reporting patient test results for 76 of 189 quality control records reviewed. Findings: 1. In a sampling of a review of quality control records, 76 of 189 contained control results out of range of the laboratory's control limits and no

Summary Statement of Deficiencies D0000 An unannounced complaint investigation was conducted on site with 42 CFR regulations through February 11-12. The complaint was substantiated in regards to COVID-19 testing. The laboratory was surveyed and failed to meet the following condition of the CLIA regulations found at CFR 42 493.1 through 493.1780 resulting in the following IMMEDIATELY JEOPARDY finding: D5200 - 493.1230 - General laboratory systems D5300 - 493.1240 - Preanalytic systems D5400- 493.1250 Condition: Analytic systems D6168 - 493.1487 - Laboratories performing high complexity testing; testing personnel In addition, the laboratory also had the following CONDITION LEVEL finding: D3000 - 42 C.F.R. 493.1100 Condition: Facility Administration D5010 - 42 C.F.R. 493.1205 Condition: Virology; D5800 - 42 C.F.R. 493.1290 Condition: Postanalytic systems; D6033 - 42 C.F.R. 493.1409 Condition: Laboratories performing moderate complexity testing; technical consultant; D6108 - 42 C.F.R. 493.1447 Condition: Laboratories performing high complexity testing; technical supervisor; D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 Each laboratory that performs nonwaived testing must meet the applicable requirements under 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State Operations Manual (CMS Pub. 7). (a) Reporting of SARS-CoV-2 test results During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: 1. The laboratory failed to maintain an environment where contamination was Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 24 -- minimized (Refer to D3003). 2. The laboratory failed to maintain a unidirectional workflow for molecular testing (Refer to D3005). D3003 FACILITIES CFR(s): 493.1101(a)(2) The laboratory must be constructed, arranged, and maintained to ensure contamination of patient specimens, equipment, instruments, reagents, materials, and supplies is minimized. This STANDARD is not met as evidenced by: Based on observations, interviews, and review of procedures the laboratory failed to maintain an environment where contamination of patient specimens, equipment, instruments, reagents, materials, and supplies is minimized. 1. A tour of the accessioning area took place on 2/11/2021 at 9:45 am where several accessioning staff were not wearing gloves or laboratory coats. No hand sanitizer or sink was available for hand washing upon entry or exit of the accessioning room. Food and drink were on counters in the accessioning area, including but not limited to: a paper coffee cup, bottles of water, a container of food with silverware, and honey packets kept in storage containers next to laboratory supplies. 2. A tour of the extraction room on 2/11 /2021 at 10:15 am showed no staff wearing laboratory coats. Only one box of gloves in one size was immediately available. No hand sanitizer or sink was available for hand washing upon entry or exit of the extraction room. 3. The laboratory's VP of R&D stated that laboratory personnel did not need to wear laboratory coats if they were wearing scrubs. 4. Testing personnel (TP) #5 was chewing gum while manually extracting specimens during observation of COVID standard operating procedure on 2 /11/2021 around 10:30 am. 5. TP#1 stated during an interview on 2/11/2021 at 12:30 pm that lab coats were "normally worn but I don't know where they are right now." 6. The laboratory's standard operating procedure (SOP) "Rapid Real-time PCR-based Screening for SARS-COV-2 (COVID-19) on Bio-Rad CFX384" states "Do not eat, smoke, apply cosmetics, or handle contact lenses in areas where reagents and human specimens are handled" and "Use personal protective equipment such as (but not limited to) gloves, eye protection, masks, and lab coats when handling kit reagents while performing this assay and handling materials including samples, reagents, pipettes, and other equipment and reagents." D3005 FACILITIES CFR(s): 493.1101(a)(3) Molecular amplification procedures that are not contained in closed systems have a uni-directional workflow. This must include separate areas for specimen preparation, amplification and product detection, and, as applicable, reagent preparation. This STANDARD is not met as evidenced by: Based on observation and record review the laboratory failed to have a uni-directional workflow for molecular amplification systems. 1. The laboratory's standard operating procedure (SOP) "Rapid Real-time PCR-based Screening for SARS-COV-2 (COVID- 19) on Bio-Rad CFX384" states "workflow in the laboratory should proceed in a unidirectional manner" and "wear a clean lab coat and powder free disposable gloves (not previously worn) when setting up assay." The laboratory's SOP states "Between extractions and/or handling DNA/RNA, use 70% ethanol to clean gloves and wait for -- 2 of 24 -- it to evaporate before proceeding with work." 2. Testing personnel moved freely from extraction room to amplification room and back with no decontamination process in between rooms during observation of COVID standard operating procedure on 2/11 /2021 around 10:30 am and around 12:30pm. 3. The laboratories 2020 internal audit observed "overcrowding conditions in the molecular preparatory room providing opportunities for method and run contamination." There was no

Summary Statement of Deficiencies D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on the general laboratory policy/procedure manual review and interview with the Laboratory Manager (LM) the Laboratory Director (LD) listed on the CLIA certificate failed to approve, sign and date 5 of 5 laboratory procedure manuals reviewed at the time of complaint investigation (4/12/19). Findings include: 1. The LD name listed on the CLIA certificate is Dr. Deborah Carroll. 2. Three of five were procedure manuals were signed by Dr. Thomas Domenico on 06/20/18. a. Reporting of Results, Ref #9013, Revised 12/17/15 b. Specimen Requisition & Receipt of Specimens, Ref #9012, Revised 06/26/17 c. Error Reporting and Investigation, Ref #9007, Revised 12/17/15 3. Two of five were not signed by the current LD. 4. At 09: 14 am on 04/15/19, LM confirmed over the phone the person listed on the CLIA certificate is the LD. D5815 TEST REPORT CFR(s): 493.1291(h) When the laboratory cannot report patient test results within its established time frames, the laboratory must determine, based on the urgency of the patient test(s) requested, the need to notify the appropriate individual(s) of the delayed testing. This STANDARD is not met as evidenced by: Based on review of patient reports from Genesis Diagnostics and Quest Diagnostics and interview with the Laboratory Manager (LM) the Laboratory failed to report 6 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 3 -- 7 patient results in a timely and reliable manner and failed to notify the ordering physician of delayed reporting from 02/11/19 to 03/19/19. Findings include: 1. The Quality Management Program policy, Ref # 9003, Effective 04/01/11, section 9. Information Management, states, e) Reporting Systems: Each laboratory system is adequate to report results in a timely, accurate and reliable manner. 2. The turnaround time (TAT) policy Ref # JCL - 10019, Revised 02/01/16, section Procedure #4 states, If there is to be a specific delay in TAT for any testing (due to instrument malfunction, etc) preventing the reporting of STAT results within 4 hours and/or routine tests within 6 - 8 hours the client/physician are to be notified. 3. LM interviewed at around 10:20 am on 04/12/2019 stated, there was a delay in reporting patients because some specimens were sent to Quest Diagnostics but records reviewed indicated that Quest Diagnostics reported results 5 to 6 before Genesis Diagnostics issued the final report. a. Patient A: Lab Accession Number: 190227438 Specimen Collected: 02/26/2019 Specimen Received: 02/27/2019 Quest Reported: 03/03/2019 Genesis Reported: 03/12/19 b. Patient B: Lab Accession Number: 190227412 Specimen Collected: 02/26/2019 Specimen Received: 02/27/2019 Quest Reported: 03 /01/2019 Genesis Reported: 03/07/2019 c. Patient C: Lab Accession Number: 190307454 Specimen Collected: 03/06/2019 Specimen Received: 03/07/2019 Quest Reported: 03/14/2019 Genesis Reported: 03/19/2019 4. Reports of patient specimens that were not sent to Quest Diagnostics also showed a delay in reporting. The following specimens were tested at Genesis Diagnostics: a. Patient D: Lab Accession Number: 1902200225 Specimen Collected: 02/19/2019 Specimen Received: 02/20 /2019 Specimen Reported: 03/05/2019 b. Patient E: Lab Accession Number: 1902200226 Specimen Collected: 02/19/2019 Specimen Received: 02/20/2019 Specimen Reported: 02/28/2019 c. Patient F: Lab Accession Number: 1902200223 Specimen Collected: 02/19/2019 Specimen Received: 02/20/2019 Specimen Reported: 02/28/2019 5. Laboratory could not provide documentation that the physicians or patients were notified of delayed reporting. D5893 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(b)(c) (b) The postanalytic systems quality assessment must include a review of the effectiveness of