Nova Diagnostics Labs

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 record review and interview, the laboratory failed to report the Nucleic Acid Amplification Test (NAAT) SARS-CoV-2 test results as required for three out of five days reviewed affecting for 1563 patients. Findings include: 1. The Nova Diagnostic Laboratory's State reporting lists for 07/13/2022, 05/25/2022, 02/04/2022, 12/21/2021, and 10/12/2021 and the laboratory's procedures manual were reviewed. 2. The Nova's State reporting lists revealed that SARS-CoV-2 test results were not reported as required for 3 selected dates: 10/12/2021, 12/21/2021, and 02/02/2022. 3. 1563 test results were not reported as required during the period reviewed. 4. Staff #1 confirmed the above findings on July 13, 2022 at 11:25 AM. 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. 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 -- This STANDARD is not met as evidenced by: Based on direct observation, record review, lack of documentation, and interview, the laboratory failed to ensure for five of five days the uni-directional workflow established by the laboratory minimized contamination affecting 1653 patients' tests. Findings Include: 1. On July 12, 2022 at 2:10 PM during a tour of the laboratory, the surveyor observed the following workflow of the laboratory: Receiving area (office lobby) - Accessioning (down the hall, the Room behind the receiving area) - Clean /Extraction Room (back down the hall, second room to the left from the office lobby) - Amplification Room (located at the end of the hall, past the Clean/Extraction room). 2. The Nova Diagnostic Laboratory's State reporting lists for 07/13/2022, 05/25/2022, 02/04/2022, 12/21/2021, and 10/12/2021, the laboratory's procedures manual, and decontamination logs were reviewed. 3. Interview with Staff #1 on July 12, 2022 at 3: 33 PM, the surveyor ask if the laboratory had a "Wipe Test" procedure to detect amplification contamination. Staff #1 state that they have Ultraviolet lights in the hoods and decontamination procedures for surfaces, but do not check for possible amplification contamination on equipment, doors, etc. 4. The contamination procedures provided showed the laboratory failed to include a procedure to check for amplification contamination. 5. The decontamination logs for five of five dates reviewed failed to include a test for amplification contamination. 6. 1653 patients' test were performed during the time period reviewed. 7. The laboratory director and staff on July 13, 2022 at 11:25 AM, confirmed the above findings. 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 direct observation, record review, lack of documentation, and interview, the laboratory failed to follow established written procedures to assess four of four employees performing three of three different Reverse Transcriptase (RT) Polymerase Chain Reaction (PCR) Assays on three of three different PCR analyzers, affecting 83,702 patients' tests. Findings include: 1. On July 12, 2022 at 2:10 PM during a tour of the laboratory, the surveyor observed the following instruments: *One CWBIO machine (for the CWE3200 Automated Nucleic Acid Extraction System) *One BioRad CFX384-C1000 Touch (S/N-CT060113) RT-PCR analyzer *Five MIC qPCR analyzers and *One Applied Biosystems - ABI-7500 Fast Real-Time (S/N- 275010635) RT-PCR analyzer. 2. The laboratory's procedures manual, competency policy and procedures, the Laboratory Personnel Report (CMS-209), test records, the test volume worksheet, and employee files were reviewed. 3. The laboratory used the extractor and PCR analyzers listed in findings #1 to perform RT-PCR assays to detect and identify SARS-CoV-2 virus. 4. The CMS 209 listed four testing personnel (TP1, TP2, TP3 and TP4) performing the SARS-Cov-2 RT-PCR assays. 5. The test records and procedures manual revealed the following: *The laboratory used the BIOGX (with extraction), the BioGX Xfree COVID-19 Direct RT-PCR and the Bio-Speedy Direct RT-qPCR SARS-CoV-2 assays for RT-PCR testing. *Four of four TP used these assays to test patients. 6. The laboratory competency policy included a step-by- step procedure to assess the competency of its TP and stated training and assessment -- 2 of 6 -- are to be completed prior to testing patients. 7. The employee files did not include any documentation of training or competency for the four TP that used the three different assays performed by the laboratory. 8. 83,702 patients were tested during July 2021 to July 2022 by the four TP. 9. The laboratory director and staff on July 13, 2022 at 11: 25 AM, confirmed the above findings. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

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 record review and interview, the laboratory failed to report the Nucleic Acid Amplification Test (NAAT) SARS-CoV-2 test results as required for three out of five days reviewed affecting for 1563 patients. Findings include: 1. The Nova Diagnostic Laboratory's State reporting lists for 07/13/2022, 05/25/2022, 02/04/2022, 12/21/2021, and 10/12/2021 and the laboratory's procedures manual were reviewed. 2. The Nova's State reporting lists revealed that SARS-CoV-2 test results were not reported as required for 3 selected dates: 10/12/2021, 12/21/2021, and 02/02/2022. 3. 1563 test results were not reported as required during the period reviewed. 4. Staff #1 confirmed the above findings on July 13, 2022 at 11:25 AM. 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. 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 -- This STANDARD is not met as evidenced by: Based on direct observation, record review, lack of documentation, and interview, the laboratory failed to ensure for five of five days the uni-directional workflow established by the laboratory minimized contamination affecting 1653 patients' tests. Findings Include: 1. On July 12, 2022 at 2:10 PM during a tour of the laboratory, the surveyor observed the following workflow of the laboratory: Receiving area (office lobby) - Accessioning (down the hall, the Room behind the receiving area) - Clean /Extraction Room (back down the hall, second room to the left from the office lobby) - Amplification Room (located at the end of the hall, past the Clean/Extraction room). 2. The Nova Diagnostic Laboratory's State reporting lists for 07/13/2022, 05/25/2022, 02/04/2022, 12/21/2021, and 10/12/2021, the laboratory's procedures manual, and decontamination logs were reviewed. 3. Interview with Staff #1 on July 12, 2022 at 3: 33 PM, the surveyor ask if the laboratory had a "Wipe Test" procedure to detect amplification contamination. Staff #1 state that they have Ultraviolet lights in the hoods and decontamination procedures for surfaces, but do not check for possible amplification contamination on equipment, doors, etc. 4. The contamination procedures provided showed the laboratory failed to include a procedure to check for amplification contamination. 5. The decontamination logs for five of five dates reviewed failed to include a test for amplification contamination. 6. 1653 patients' test were performed during the time period reviewed. 7. The laboratory director and staff on July 13, 2022 at 11:25 AM, confirmed the above findings. 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 direct observation, record review, lack of documentation, and interview, the laboratory failed to follow established written procedures to assess four of four employees performing three of three different Reverse Transcriptase (RT) Polymerase Chain Reaction (PCR) Assays on three of three different PCR analyzers, affecting 83,702 patients' tests. Findings include: 1. On July 12, 2022 at 2:10 PM during a tour of the laboratory, the surveyor observed the following instruments: *One CWBIO machine (for the CWE3200 Automated Nucleic Acid Extraction System) *One BioRad CFX384-C1000 Touch (S/N-CT060113) RT-PCR analyzer *Five MIC qPCR analyzers and *One Applied Biosystems - ABI-7500 Fast Real-Time (S/N- 275010635) RT-PCR analyzer. 2. The laboratory's procedures manual, competency policy and procedures, the Laboratory Personnel Report (CMS-209), test records, the test volume worksheet, and employee files were reviewed. 3. The laboratory used the extractor and PCR analyzers listed in findings #1 to perform RT-PCR assays to detect and identify SARS-CoV-2 virus. 4. The CMS 209 listed four testing personnel (TP1, TP2, TP3 and TP4) performing the SARS-Cov-2 RT-PCR assays. 5. The test records and procedures manual revealed the following: *The laboratory used the BIOGX (with extraction), the BioGX Xfree COVID-19 Direct RT-PCR and the Bio-Speedy Direct RT-qPCR SARS-CoV-2 assays for RT-PCR testing. *Four of four TP used these assays to test patients. 6. The laboratory competency policy included a step-by- step procedure to assess the competency of its TP and stated training and assessment -- 2 of 6 -- are to be completed prior to testing patients. 7. The employee files did not include any documentation of training or competency for the four TP that used the three different assays performed by the laboratory. 8. 83,702 patients were tested during July 2021 to July 2022 by the four TP. 9. The laboratory director and staff on July 13, 2022 at 11: 25 AM, confirmed the above findings. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)