Ecco Lab Group Co

Summary Statement of Deficiencies D0000 An announced CLIA complaint survey (#2021014912) was conducted at Ecco Lab Group Co. on 12/07/2021-12/16/2021. The laboratory is not in compliance with 42 CFR Part 493, Requirement for Laboratories. The following Condition was cited: D3000-Facility Administration 493.1100 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 all SARS-CoV-2 antigen and antibody test results to the Department of Health (DOH) for 3,605 Patients reported. Findings Included: Review of Patient test results from one Account revealed that there were 2,069 SARS-CoV-2 antigen tests and 16 SARS-CoV-2 antibody tests ran from 01/01/2020 to 12/09/2021. Interview on 12/08/2021 at 4:10 PM the Assistant Administrator confirmed that the 2,085 test results were not reported to the DOH. He stated that no tests from this Account were reported to the DOH. Review of Patient SARS-CoV-2 antigen test results of Phlebotomists who work for the Laboratory revealed that there were 1,520 Phlebotomists tests that were not reported to the DOH. Interview on 12/08/21 at 4:20 PM the Assistant Administrator stated that the Phlebotomists have been getting tested weekly since 06/25/2020 and Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 10 -- that there were 20 Phlebotomists. He confirmed that the results for the Phlebotomists were not reported to the DOH. 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 record review and interview the laboratory failed to document collection time on 5 out of 5 Patient reports reviewed. Findings Included: Review of 5 Patient reports revealed Patient #1 collected on 09/10/21 with no collection time, Patient #2 collected on 09/10/21 with no collection time, Patient #3 collected on 12/07/21 with no collection time, Patient #4 collected on 09/10/21 with no collection time, and Patient #5 collected on 09/10/21 with no collection time. Review of Policy and Procedure (signed and reviewed by the Laboratory Director 01/28/21) did not list no collection time as a reason to reject a specimen. In the "Pre- To- Post Quality Assurance" policy, there is not instruction to monitor collection times. Interview on 12 /08/2021 at 4:30 PM the Molecular Supervisor confirmed that collection times are not documented on SARS-CoV-2 test specimens. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, 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 analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on observation, record review and interview, the laboratory failed to perform a validation for the use of inactivation transport media (ITM) with ARIES SARS-CoV- 2 Assay. The laboratory failed to complete a validation for COVID-19 patient samples shipped and tested outside of manufacturer required 2-8 Celsius (C) using CDC 2019- Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel. (See D5423) D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on observations, record review, and interview the laboratory reported SARS- -- 2 of 10 -- CoV-2 Patient test result (Patient #3) when the collection tube was expired and reported 388 Sensitivities on the Biomerieux Vitek 2 from 11/30/2021 to 12/08/2021 using expired Sodium Chloride. Findings Included: During a tour of the laboratory on 12/07/2021 at 10:13 AM Patient #3's SARS-CoV-2 specimen was observed in a rack in accessioning. The US Diagnostic Virus Sampling Tube (Lot#20206011) expired on 06/09/2021. Review of Patient #3 final report revealed that the specimen was ran and reported on 12/07/2021 at 2:17 PM even though the tube was expired. The Quality Assurance policy (signed by the Laboratory Director on 01/28/2021) did no address expired collection tubes and an expired collection tube was not on their reason for specimen rejection. Interview on 12/08/2021 at 5:00 PM the Molecular Supervisor confirmed that the collection tube was expired and confirmed that the test should not have been run if collected in an expired collection tube. During a tour of the storage area 6 bags of expired 0.45% Sodium Chloride Diluent (Lot# Q2002774) that expired on 08/01/2021 was observed. Interview on 12/07/2021 at 10:45 AM the Molecular Supervisor confirmed that the bags were expired and that they were used on the Biomerieux Vitek 2 in Microbiology that read sensitivities. Observations of the Biomerieux Vitek 2 on 12/07/2021 at 10:55 AM revealed that the expired Sodium Chloride was on the instrument. There was no date of when it was put in use on the instrument. Interview on 12/07/2021 at 10:55 AM the Microbiology technologist stated that he put it on the machine on 11/30/2021 and confirmed that there was no documentation of when it was put on the instrument. "Reagent and Solution Labeling Policy" signed by the Laboratory Director on 06/11/2020 states to "Review the expiration dates on reagents and solutions prior to use." The policy also states that "No reagent is to be used after its listed expiration date." 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 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 observation, record review and interview, the laboratory failed to perform a validation for the use of inactivation transport media (ITM) with ARIES SARS-CoV- 2 Assay. The laboratory failed to complete a validation for COVID-19 patient samples shipped and tested outside of the manufacturer required guidelines of 2-8 Celsius (C) using CDC 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel. Findings Included: Review of ARIES SARS-CoV-2 Assay Package Insert stated "Materials Required but not Provided, Reagents for sample collection: Nasopharyngeal swab (NPS) (flocked or polyester swab) and Universal Transport Medium (UTM)." An observation of the sample collection area on 12/07/2021 at 11: 00 AM revealed only ITM tubes for COVID-19 testing. Review of Aries validation revealed no validation for ITM tubes testing on the Aries instrument. Review of CDC 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel -- 3 of 10 -- Instructions for Use stated "Specimens must be packaged, shipped, and transported according to the current edition of the International Air Transport Association (IATA) Dangerous Goods Regulation. Follow shipping regulations for UN 3373 Biological Substance, Category B when sending potential 2019-nCoV specimens. Store specimens at 2-8C and ship overnight to CDC on ice pack. If a specimen is frozen at -70C or lower, ship overnight to CDC on dry ice. Specimens can be stored at 2-8C for up to 72 hours after collection. If a delay in extraction is expected, store specimens at -70C or lower. Extracted nucleic acid should be stored at -70C or lower." Review of Stability Study for ITM COVID-19 samples revealed COVID-19 specimens were only tested for a stability study at 22 to 24 degrees C. Review of Molecular Room Temperature Logs revealed temperatures were below 22 degrees C for 227 out 280 days from January 2021 to December 2021. During an observation of the Molecular testing area on 12/07/2021 at 11:20 AM revealed COVID-19 ITM patient samples stored for 3 days on a metal storage shelf at room temperature. Review of COVID-19 Testing revealed 208,231 COVID-19 samples were tested by CDC 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel. 1,151 COVID-19 samples were tested by ARIES SARS-CoV-2 Assay Package Insert. During an interview on 12/08/2021 at 6:25 PM , the molecular supervisor confirmed that validation had not been completed for ARIES SARS-CoV-2 Assay and specimen stability for CDC 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel. D5781

Summary Statement of Deficiencies D0000 A complaint survey for complaint number 2021014912, was conducted on 12/07/2021 to 12/16/2021 at Ecco Lab Group Co. The laboratory was not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following Conditions were not met: D5400-Analytic Systems 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 all SARS-CoV-2 antigen and antibody test results to the Department of Health (DOH) for 3,605 Patients reported. Findings Included: Review of Patient test results from one Account revealed that there were 2,069 SARS-CoV-2 antigen tests and 16 SARS-CoV-2 antibody tests ran from 01/01/2020 to 12/09/2021. Interview on 12/08/2021 at 4:10 PM the Assistant Administrator confirmed that the 2,085 test results were not reported to the DOH. He stated that no tests from this Account were reported to the DOH. Review of Patient SARS-CoV-2 antigen test results of Phlebotomists who work for the Laboratory revealed that there were 1,520 Phlebotomists tests that were not reported to the DOH. Interview on 12/08/21 at 4:20 PM the Assistant Administrator stated that the Phlebotomists have been getting tested weekly since 06/25/2020 and Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 10 -- that there were 20 Phlebotomists. He confirmed that the results for the Phlebotomists were not reported to the DOH. 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 record review and interview the laboratory failed to document collection time on 5 out of 5 Patient reports reviewed. Findings Included: Review of 5 Patient reports revealed Patient #1 collected on 09/10/21 with no collection time, Patient #2 collected on 09/10/21 with no collection time, Patient #3 collected on 12/07/21 with no collection time, Patient #4 collected on 09/10/21 with no collection time, and Patient #5 collected on 09/10/21 with no collection time. Review of Policy and Procedure (signed and reviewed by the Laboratory Director 01/28/21) did not list no collection time as a reason to reject a specimen. In the "Pre- To- Post Quality Assurance" policy, there is not instruction to monitor collection times. Interview on 12 /08/2021 at 4:30 PM the Molecular Supervisor confirmed that collection times are not documented on SARS-CoV-2 test specimens. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, 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 analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on observation, record review and interview, the laboratory failed to perform a validation for the use of inactivation transport media (ITM) with ARIES SARS-CoV- 2 Assay. The laboratory failed to complete a validation for COVID-19 patient samples shipped and tested outside of manufacturer required 2-8 Celsius (C) using CDC 2019- Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel. (See D5423) D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on observations, record review, and interview the laboratory reported SARS- -- 2 of 10 -- CoV-2 Patient test result (Patient #3) when the collection tube was expired and reported 388 Sensitivities on the Biomerieux Vitek 2 from 11/30/2021 to 12/08/2021 using expired Sodium Chloride. Findings Included: During a tour of the laboratory on 12/07/2021 at 10:13 AM Patient #3's SARS-CoV-2 specimen was observed in a rack in accessioning. The US Diagnostic Virus Sampling Tube (Lot#20206011) expired on 06/09/2021. Review of Patient #3 final report revealed that the specimen was ran and reported on 12/07/2021 at 2:17 PM even though the tube was expired. The Quality Assurance policy (signed by the Laboratory Director on 01/28/2021) did no address expired collection tubes and an expired collection tube was not on their reason for specimen rejection. Interview on 12/08/2021 at 5:00 PM the Molecular Supervisor confirmed that the collection tube was expired and confirmed that the test should not have been run if collected in an expired collection tube. During a tour of the storage area 6 bags of expired 0.45% Sodium Chloride Diluent (Lot# Q2002774) that expired on 08/01/2021 was observed. Interview on 12/07/2021 at 10:45 AM the Molecular Supervisor confirmed that the bags were expired and that they were used on the Biomerieux Vitek 2 in Microbiology that read sensitivities. Observations of the Biomerieux Vitek 2 on 12/07/2021 at 10:55 AM revealed that the expired Sodium Chloride was on the instrument. There was no date of when it was put in use on the instrument. Interview on 12/07/2021 at 10:55 AM the Microbiology technologist stated that he put it on the machine on 11/30/2021 and confirmed that there was no documentation of when it was put on the instrument. "Reagent and Solution Labeling Policy" signed by the Laboratory Director on 06/11/2020 states to "Review the expiration dates on reagents and solutions prior to use." The policy also states that "No reagent is to be used after its listed expiration date." 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 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 observation, record review and interview, the laboratory failed to perform a validation for the use of inactivation transport media (ITM) with ARIES SARS-CoV- 2 Assay. The laboratory failed to complete a validation for COVID-19 patient samples shipped and tested outside of the manufacturer required guidelines of 2-8 Celsius (C) using CDC 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel. Findings Included: Review of ARIES SARS-CoV-2 Assay Package Insert stated "Materials Required but not Provided, Reagents for sample collection: Nasopharyngeal swab (NPS) (flocked or polyester swab) and Universal Transport Medium (UTM)." An observation of the sample collection area on 12/07/2021 at 11: 00 AM revealed only ITM tubes for COVID-19 testing. Review of Aries validation revealed no validation for ITM tubes testing on the Aries instrument. Review of CDC 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel -- 3 of 10 -- Instructions for Use stated "Specimens must be packaged, shipped, and transported according to the current edition of the International Air Transport Association (IATA) Dangerous Goods Regulation. Follow shipping regulations for UN 3373 Biological Substance, Category B when sending potential 2019-nCoV specimens. Store specimens at 2-8C and ship overnight to CDC on ice pack. If a specimen is frozen at -70C or lower, ship overnight to CDC on dry ice. Specimens can be stored at 2-8C for up to 72 hours after collection. If a delay in extraction is expected, store specimens at -70C or lower. Extracted nucleic acid should be stored at -70C or lower." Review of Stability Study for ITM COVID-19 samples revealed COVID-19 specimens were only tested for a stability study at 22 to 24 degrees C. Review of Molecular Room Temperature Logs revealed temperatures were below 22 degrees C for 227 out 280 days from January 2021 to December 2021. During an observation of the Molecular testing area on 12/07/2021 at 11:20 AM revealed COVID-19 ITM patient samples stored for 3 days on a metal storage shelf at room temperature. Review of COVID-19 Testing revealed 208,231 COVID-19 samples were tested by CDC 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel. 1,151 COVID-19 samples were tested by ARIES SARS-CoV-2 Assay Package Insert. During an interview on 12/08/2021 at 6:25 PM , the molecular supervisor confirmed that validation had not been completed for ARIES SARS-CoV-2 Assay and specimen stability for CDC 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel. D5781