Pathogen Dx, Inc

Summary Statement of Deficiencies 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 interview with the laboratory general supervisor (GS-TP1) on August 08, 2022, the laboratory failed for its molecular amplification procedures, (that is not contained in a closed system), to have a uni-directional workflow for specimen preparation, reagent preparation, and extraction procedures. Findings include: 1.The laboratory performs SARS CoV-2 (COVID-19) testing from specimens submitted from multiple collection sites, and performed using a laboratory developed test (LDT) which recieved FDA emergency use authorization (EUA) approval for their SARS CoV2 Rv RT-PCR assay. The laboratory initiated patient testing in November of 2020 for SARS CoV2 molecular testing. 2. The laboratory performs SARS CoV-2 RT-PCR specimen reception, preparation, extraction within the same room as the research and development portion of the facility also performs additional PCR testing. 3. The LDT for SARS CoV2 patient testing was rearranged from the original uni-directional flow to a restricted section of the research and development testing room, in an approximate eight (8) foot by ten (10) foot square, where patient sample accessioning, preparation, and extraction are performed. 4. The laboratory GS- TP1 confirmed by interview on August 08, 2022 at 09:00 am, the lack of uni- directional flow for the LDT SARS CoV2 testing performed. 5. The laboratory reports performing 2353 SARS CoV-2 patient samples from November - December, 2020 and 995 SARS CoV-2 patient samples from January 2022 through July 2022. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 9 -- Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on lack of documentation and interview with the laboratory general supervisor (GS-TP1) on August 08, 2022, the laboratory failed to provide patient testing requisitions, test reports, and patient testing records (temperature logs, training and competency records) for initial testing performed in November and December of 2020. Findings include: 1. Request for initial testing records and patient reports performed in 2020, revealed that the laboratory had a complete staffing turnover the end of December 2020. Upon reinitiating patient testing in January 2022, the GS-TP1 stated that they could not locate initial patient requisitions, staff training and competency records, temperature logs and maintenance logs. 2. Request for thermal cycler printouts and PCR assay results revealed that the initial documents could not be located prior to exit of the survey on 08/09/2022 during interview with the GS-TP1 and the TS-TP2. 3. The laboratory GS-TP1 confirmed by interview on August 08, 2022 at 09;00 am, the lack of documentation of initial patient records, analyzer printouts, temperature and maintenance records. 4. The laboratory recorded performing 2353 PathogenDX Rv RT-PCR patient test in November and December of 2022. 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 emergency use authorization (EUA) information for use (IFU) for their SARS CoV2 Rv RT-PCR testing, specimen requisition records and interview with the laboratory's general supervisor (GS-TP1) on August 08, 2022, the laboratory failed to follow written policies and procedures to ensure optimum integrity of a patient's specimen from the time of collection to the receipt of the specimen. Findings include: 1. The laboratory performs SARS CoV-2 (COVID-19) testing from specimens submitted from multiple collection sites, and performed using an FDA Emergency Use Authorized (EUA) molecular reverse transcriptase polymerase Chain Reaction (Rv RT-PCR) assay for the detection of SARS CoV-2 (COVID-19) virus on thier laboratory developed testing (LDT) platform. 2. The laboratory's PathogenDx Rv RT-PCR IFU specifies that the specimens must be maintained at 2-8 degree Celsius and tested within 72 hours, or frozen at -70 degrees Celsius. 3. The laboratory failed to record and document patient specimens temperatures upon receipt, to ensure acceptability of specimen integrity prior to testing. 4. The laboratory's GS-TP1 confirmed by interview on August 08, 2022 at 12: 44 p.m., the laboratory did not follow policies or procedures for identification and documenting the integrity of patient's specimens from the time of collection through -- 2 of 9 -- the receipt of the samples. 5. The laboratory reports performing 2353 SARS CoV-2 patient samples in November - December, 2020 and 995 SARS CoV-2 patient samples from January 2022 through July 2022. 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 CMS-209 personnel form, the laboratory's lack of delegation of responsibility Policy or procedure and interview with the laboratory general supervisor listed on the CMS-209 (GS-TP1) on August 08, 2022, the laboratory failed to establish written policies and procedures to assess employee and supervisor competency. Findings include: 1. The laboratory's CMS-209 personnel form lists two (2) testing personnel (TP). The general supervisor (GS-TP1) and the technical supervisor (TS-TP2). 2. The laboratory lacked documentation of training or competency assessments for the two (2) testing personnel listed on the CMS-209 form. 3. The laboratory lacked a policy or procedure for documenting training and competency assessments for persons performing preanalytical, analytic and post- analytic patient testing. 4. The laboratory lacked a policy or procedure for evaluation and documentation of the general supervisor and technical superviosor competency. 5. The laboratory GS-TP1 confirmed by interview on August 08, 2022 at 11:00 am, the lack of policy or procedures for performing and documenting training and competency for testing personnel, and supervisor competency. 6. The laboratory reports performing 2353 SARS CoV-2 patient samples from November - December, 2020 and 995 SARS CoV-2 patient samples from January 2022 through July 2022. 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 review of the laboratory records and lack of documentation for verification of accuracy, and interview with the laboratory General Supervisor (GS-TP1) on August 08, 2022, the laboratory failed to perform the verification of accuracy for SARS CoV-2 testing. Findings include: 1. The laboratory performs SARS CoV-2 Reverse Transcriptase Real time-PCR (Rv RT-PCR) testing with their Laboratory developed test (LDT) which recieved the Food and Drug Administration (FDA) approval under an Emergency Use Authorization (EUA). 2. The laboratory failed to perform and document twice annual verification of accuracy for the SARS CoV 2 Rv RT-PCR testing in 2021 or 2022. 3. The laboratory failed to establish a policy or procedure for performing twice annual verification of accuracy for SARS CoV 2 testing. 4. The laboratory GS-TP1 confirmed by interview on August 08, 2022 at 10: 35 am, the lack of performing twice annual verification of accuracy. 5. The laboratory -- 3 of 9 -- reported performing 2353 SARS CoV-2 Rv RT-PCR patient tests during November- December 2020, and 995 SARS CoV-2 Rv RT-PCR patient tests from January 2022- July 2022. 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 record review and the lack of a general laboratory's Policies and Procedures (P&P) and interview with the general supervisor (GS-TP1) on August 08, 2022, 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. Findings include: 1. The laboratory lacked a general P&P which included an ongoing mechanism to perform and document quality issues regarding specimen acceptability, tracking or correction of problems regarding patient specimens submitted for testing. See D5203 2. During review of patient testing records, it was revealed that two (2) of six (6) patient specimens reviewed in 2022 were not tested at the laboratory due to being an unacceptable specimen. 2a. The laboratory lacked documentation of specimen rejection and