Nova Labs, Llc

Summary Statement of Deficiencies D3001 FACILITIES CFR(s): 493.1101(a)(1) The laboratory must be constructed, arranged, and maintained to ensure the space, ventilation, and utilities necessary for conducting all phases of the testing process. This STANDARD is not met as evidenced by: No deficiency details available. 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 --

Summary Statement of Deficiencies 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: Based on the number and severity of the deficiencies cited herein, the Condition: Facility Administration was not met. The findings include: 1. The laboratory failed to be arranged and maintained to ensure contamination of patient specimens, equipment, instruments, reagents, materials, and supplies is minimized See D3003. 2. The laboratory failed to have a uni-directional workflow for specimen preparation, extraction and amplification detection, and reagent preparation for the procedures not contained in a closed system. See D3005. 3. The laboratory failed to observe safety procedures to ensure protection from physical, chemical, biochemical, and biohazardous materials See D3011. 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. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 32 -- This STANDARD is not met as evidenced by: Based on review of the laboratory written procedures, and interview with the technical supervisor (TS-1 ) and laboratory assistant on June 11, 2020, the laboratory failed to establish policies and procedures to ensure that contamination of patient specimens, equipment, instruments, reagents, materials, and supplies for the laboratory's COVID- 19 Polymerase Chain Reaction (PCR) testing processes were minimized as evidenced by: Contamination Program: a. In review of the laboratory's written procedures for its COVID-19 PCR test processes, the laboratory failed to have written protocols for a detection program to ensure that patient specimens, equipment, instruments, reagents, materials, and supplies were not contaminated. b. The laboratory could not provide documentation to show it had performed any environmental testing to ensure that its COVID-19 PCR test processes were not contaminated. c. In an interview with the technical supervisor on 6-11-2020 @ 10:00 a.m., when asked if the laboratory conducted any COVID-19 PCR contamination detection protocols, the technical supervisor stated: "It has only been two weeks since we opened; we have not done swab [contamination] testing." 35533 Physical Lab Processes: d. The laboratory performs SARS CoV-2 (COVID-19) RT-PCR diagnostic testing. During a tour of the laboratory's molecular testing processes on June 10-11, 2020, three areas where potential contamination of patient specimens, equipment, instruments, and supplies were identified: (A) the biosafety level-2 laboratory (BSL-2) laboratory (RM-1), (B) the biosafety level-1 (BSL-1) laboratory's (RM-3's) reagents; and (C) the laboratory's contaminated pipette washing area located in a reagent storage room (RM-2). e. In RM-1, patient specimens are received (through the laboratory's front door where all packages are received). Just inside, to the left of the front receiving doorway, is located the BSL-2 fume hood where patient specimens are uncapped and deswabbed under the BSL-2 hood, and placed on a specimen media tube rack. The specimen media tube rack is then carried, uncovered, past the Elution (E171) and qPCR Hamilton Starlab (assay tray) automated pipette aliquot stations (E164 or D400) to the specimen sample aliquot station (E178 or E179). f. After the patient samples are pipetted into either the laboratory's laboratory development test (LDT) testing trays or the Centers for Disease Control and Prevention (CDC) Emergency Use Authorization (EUA) testing trays (E178 or E179), the sample trays are walked, uncovered, to the next automated pipette station for elution/extraction (E171). After the elution /extraction process is complete, the new sample trays are walked, uncovered, to the qPCR probes and primer loading stations (either E164 or D400) which are located across from the elution/extraction pipette station (E171) or across from the aliquot stations (E178 or E179). g. Once the qPCR process is complete, the samples are then removed from the pipette stations (D400 or E164), covered, and walked to the QuantStudio amplification and detection room (past the elution/extraction station (E171)), and the patient specimen aliquot stations (E178 or E179). h. During the onsite tour of the laboratory process on June 11, 2020 at 11:44 a.m., it was observed by demonstration and interview with the technical supervisor (TS-1) that the uncovered assay trays were moved from each of the pipette stations to the next pipette station in a multidirectional flow pattern, allowing for the possible introduction of contaminants during each phase of the testing process. i. The laboratory's coat rack for used laboratory coats and used goggles is located in RM-2 where contaminated pipettes are rinsed and placed in automated pipette washers, where the laboratory's glassware is washed, where the quality control materials (master mix) are prepared, and where room temperature reagents are stored. There is an open doorway between the specimen processing room (RM-1) and this room (RM-2). j. The laboratory procedures, for each of the laboratory processing steps references the CDC Interim -- 2 of 32 -- Guidelines located at: https://www.cdc.gov/coronavirus/2019-ncov/lab/lab-biosafety- guidelines.html for the staff to follow for "Safe laboratory procedures". This link does not provide testing personnel and those engaged in preanalytic, and analytic processes, as to what the "safe laboratory procedures" are, (which the procedures refer to), for each of the tasks being performed. k. According to the CDC COVID-19 EUA, the personnel are to "Wear a clean lab coat and powder-free disposable gloves (not previously worn) when setting up assays". During the laboratory tour of the COVID- 19 testing process demonstration on June 11, 2020, the technical supervisor (TS-1) at 11:44 a.m. stated: "I do not get a new lab coat between the assay steps; I change my gloves, but hang up my lab coat unless it is visibly soiled or I believe I have contaminated it." l. It was observed during the three days of onsite survey (June 10 - 12, 2020), each person (conducting specimen preparation and testing for COVID-19), reused their same laboratory coat or no laboratory coat when performing tasks in the BSL-2 laboratory (RM-1). m. The TS-1 confirmed by interview on June 11, 2020 at approximately 11:44 a.m. the reuse of laboratory coats for herself and other laboratory personnel used during COVID-19 preanalytic and analytic assay procedures. n. The laboratory's written procedure "Labware Cleaning (SOP #C5 - C7)" established the laboratory's glassware and used pipette cleaning procedures. SOP #C7 states: "Deep well plates and buffer plates can be cleaned in the lab sink." o. The laboratory's sink is located in RM-2 where room temperature reagents are stored, used pipettes are rinsed and placed in the automatic pipette washers, used deep well and buffer plates are cleaned and stored, and where the coat rack for reused laboratory coats and used googles, is located. p. TS-1 confirmed on June 11, 2020 at approximately 11:44 a.m. that the room temperature reagents storage area and cleaning procedures are performed in the same room (RM-2) where the used laboratory coats are stored. q. The laboratory's BSL-1 laboratory (RM-3) contained the refrigerated reagents for the laboratory's COVID-19 RT-PCR testing, as well as a sink used for the laboratory's histopathology testing. r. During a tour of RM-3 on June 11, 2020 at 09:30 a.m., the federal surveyor directly observed one of the laboratory's staff drinking one of two beverages located on a preparation table while using a laptop . s. The laboratory policies and procedures all state: "Do not eat, drink, smoke, apply cosmetics or handle contact lenses in areas where reagents and human specimens are handled." t. The RM- 3 also contained a three- gallon water dispenser. When interviewed on June 11, 2020 at 09:30 am, a laboratory assistant stated: ". . . that's for the histopathology department; it's not for drinking." The water dispenser was not labeled as to the use for the water. u. The laboratory does not have a procedure/policy for labeling of reagents. v. According to laboratory records, the laboratory reports performing approximately 15,893 patient COVID-19 assays from May 22, 2020 to June 12, 2020. 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 direct observation of the laboratory's COVID-19 Polymerase Chain Reaction (PCR) testing, and interviews with the technical supervisor (TS-1) and laboratory staff on June 10, 2020, for its molecular amplification procedure, which is not contained in a closed system, the laboratory failed to have a uni-directional workflow for specimen preparation, extraction and amplification detection, and -- 3 of 32 -- reagent preparation. The findings include: a. During an onsite tour of the laboratory processes, it was noted that, (for the laboratory's COVID-19 PCR testing), patient samples trays were moved, uncovered, from various locations within the laboratory, in a multidirectional workflow pattern, allowing for the possible introduction of contaminants during each phase of the testing process. See D3003. b. The laboratory's molecular COVID-19 PCR testing is set up in one room with two adjoining rooms. Patient specimen receipt and deswabbing of patient specimens are performed under a hood in the back of the main laboratory (RM-1). The patient specimens are then placed in a sample rack and moved to the next station , across the laboratory (approximately five (5) feet), past the elution station and the two PCR stations to the patient specimen pipette station. See D3003. c. The laboratory's molecular COVID-19 PCR testing is not set up in a unidirectional workflow, but crisscrosses between various locations within the laboratory. See D3003. d. TS-1 confirmed by interview on June 11, 2020 at approximately 11:44 a.m. that the laboratory's molecular COVID- 19 PCR testing was not set up in a unidirectional flow. e. Based on laboratory records, the laboratory performed and reported approximately 15,893 COVID-19 patient tests from May 22, 2020 through June 12, 2020. D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: Based on direct observation, interview with the TS-1 and review of the CDC EUA protocol on June 11, 2020, the laboratory failed to observe safety procedures to ensure protection from physical, chemical, biochemical, and biohazardous materials. The findings include: a. The laboratory performs molecular testing for SARS CoV-2. In the biosafety laboratory one (BSL-1) room of the laboratory, the refrigerated reagents for SARS CoV-2 testing and histopathology reagents are stored. b. During a tour of the BSL-1 (room RM-3 of the laboratory) June 11, 2020 at 09:20 a.m., with a laboratory assistant, the surveyor directly observed another laboratory staff with two beverages at the preparation table where the other staff was working on a laptop. c. The laboratory's policies and procedures all state: "Do not eat, drink, smoke, apply cosmetics or handle contact lenses in areas where reagents and human specimens are handled." d. The BSL-1 (RM-3) also contained a three gallon water dispenser located inside the room. When interviewed, the laboratory assistant stated on June 11, 2020 at approximately 09:20 a.m.:". . .that's for the histopathology department, it's not for drinking." The water dispenser was not labeled regarding how the water was to be used. e. The laboratory does not have a policy or procedure regarding labeling of reagents. See D5407. f. The laboratory's technical supervisor (TS-1) and laboratory assistant confirmed by interview on June 11, 2020 at approximately 09:20 a.m. that laboratory staff were not following the laboratory's policy regarding eating and drinking in the laboratory, and she confirmed the laboratory did not maintain a policy for labeling of reagents in the BSL-1 laboratory. g. The laboratory coat rack for used laboratory coats and goggles is located in room RM-2 of the laboratory. In this same room, used, contaminated pipettes are rinsed and placed in automated pipette washers, and the laboratory's glassware and quality control materials (mastermix) is prepared. There is also an open doorway between the specimen processing room (RM-1) and this room (RM-2). h. According to the Centers for Disease Control and Prevention -- 4 of 32 -- (CDC) Emergency Use Authorization (EUA) laboratory personnel are to "wear a clean lab coat and powder-free disposable gloves (not previously worn) when setting up assays." During a tour of the laboratory, the laboratory technical supervisor (TS-1) stated on June 11, 2020 at 11:00 a.m.: "I do not get a new lab coat between the assay steps; I change my gloves but hang up my lab coat unless it is visibly soiled or I believe I have contaminated it." i. It was observed during the three days of onsite survey, that each person conducting various phases of COVID-19 patient specimen processing and assay preparation wore the same laboratory coat or no laboratory coat. j. The laboratory staff did not follow their policy's and procedures as listed in the CDC-EUA protocols that the laboratory had implemented. See D3003 k. TS-1 confirmed by interview on June 11, 2020 at approximately 11:45 a.m. the reuse of laboratory coats by testing personnel and other laboratory personnel while conducting COVID-19 preanalytic and analytic assay procedures. l. According to laboratory records, the laboratory performed and reported 15,893 patient COVID-19 assays from May 22, 2020 to June 12, 2020. D5200 GENERAL LABORATORY SYSTEMS CFR(s): 493.1230 Each laboratory that performs nonwaived testing must meet the applicable general laboratory systems requirements in 493.1231 through 493.1236, 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 general laboratory systems and correct identified problems specified in 493.1239 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on records review and interview with the laboratory technical supervisor (TS-1) on June 11, 2020, the laboratory failed to monitor and evaluate the overall quality of the general laboratory systems and correct identified problems specified in 42 C.F.R. 493.1239 for the high complexity molecular testing performed. The findings include: 1. The laboratory failed to establish and follow written policies and procedures that ensure optimum integrity of patient specimens from the time of collection to the receipt of the specimen through completion of testing and reporting of results. (See D5203) 2. The laboratory failed to establish written policies and procedures to assess employee and consultant competency. (See D5209) 3. The laboratory failed to establish written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the general laboratory systems requirements specified at 42 C.F.R.493.1231 through 493.1236. (See D5291) D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. This STANDARD is not met as evidenced by: Based on review of the laboratory's nine (9) signed policies and procedures for SARS nCOV-2 molecular testing and interview with the laboratory's technical supervisor -- 5 of 32 -- (TS-1) on June 10, 2020, the laboratory failed to establish and follow written policies and procedures to ensure optimum integrity of a patient's specimen from the time of collection, to the receipt by the laboratory of the specimen, to the completion of testing and reporting of patient results. The findings include: a. The laboratory's FDA CDC EUA approved COVID-19 methodology, and it's non-FDA approved LDT protocols specify that patient specimens must be maintained at 2 - 8 degree C, and tested within 72 hours of collection, or frozen at -70 degree C. b. The laboratory records indicate that the laboratory received and tested 188 patient COVID-19 specimens on May 29, 2020 which had been collected on May 25, 2020. The laboratory did not have documentation as to time and temperatures for the patient samples received, (if the specimens were frozen at -70 C). c. The laboratory's established policies and procedures did not include a patient specimen assessment criteria component for documentation for acceptability in regards to time and temperature of patient specimens upon receipt, in accordance with the CDC protocols or the LDT protocols used in the laboratory for optimum integrity. d. The laboratory did not have a client services testing procedure manual, describing specimen collection specifications, specimen transportation (including packaging, time and temperature requirements) for acceptable specimen submission. See D-5317. e. The laboratory's policies and procedures did not include processes for identification of acceptable or unacceptable specimens or a process for documenting rejection processes. See D-5403 f. The laboratory TS-1 confirmed by interview on June 11, 2020 at approximately 12:44 p.m. that the laboratory had not established written policies or procedures for identification and documenting the integrity of patient's specimens from the time of collection through the receipt of the samples, or identification criteria for rejection of patient specimens. See D-5391 and D-5491. g. According to laboratory records, the laboratory performed and reported approximately 15,893 SARS CoV-2 patient samples from May 22, 2020 through June 12, 2020. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on review of the laboratory's most recently completed Form CMS-209, Laboratory Personnel Report (CLIA) and the laboratory's written delegation of responsibility policy, and interview with the laboratory technical supervisor (TS-1), who was listed on the most recently completed Form CMS-209, on June 10, 2020, the laboratory failed to establish and follow written policies and procedures to assess employee and consultant competency. The findings include: a. The laboratory performs molecular Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) testing for the detection of SARS nCoV-2 (COVID-19) virus in patient specimens. b. The laboratory's most recently completed Form CMS-209 lists five (5) testing personnel and six (6) laboratory personnel who are engaged in preanalytic testing processes. c. The laboratory did not have documentation of competency assessment for the (5) testing personnel listed on the most recently completed Form CMS-209 or for the (6) laboratory personnel who are engaged in preanalytic testing processes. d. During the onsite survey, a technical supervisor referred to as a "Scientific Consultant", not listed on the most recently completed Form CMS-209, but provided technical information on the COVID-19 testing the laboratory performed related the -- 6 of 32 -- laboratory's selection and establishment and verification of test performance specifications, validations and verifications studies for the laboratory's LDT and CDC EUA platforms. e. The technical supervisor (TS-2) stated on June 10, 2020 that he had selected the testing methods implemented for the laboratory's COVID-19 testing and had established the verification of test methodology correlation studies for the two COVID-19 testing platform selected. f. The laboratory maintained no documentation that TS-2 had a competency evaluation for the testing performed. g. TS-1 confirmed by interview on June 10, 2020 at approximately 12:44 p.m. that the laboratory had not established written competency policies or procedures to assess employee or consultant competency. h. According to laboratory records, the laboratory performed and reported approximately 15,893 COVID-19 patient specimens from May 22, 2020 to June 12, 2020. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(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 general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on interview with the TS-1 and review of the laboratory's (9) written policies and procedures (P&P) for COVID-19 patient testing on June 11, 2020, the laboratory failed to establish written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. The findings include: a. The laboratory's P&P did not include an ongoing mechanism to perform or document quality issues regarding specimen acceptability, and tracking or correction of problems regarding patient specimens submitted for testing. b. The laboratory's technical supervisor (TS-1) stated that there were two (2) instances regarding acceptable patient specimen submissions potentially affecting patient testing results. The laboratory had documented one of these instances on the laboratory's