Empire City Laboratories, Inc

Summary Statement of Deficiencies D0000 An onsite complaint visit, #2021017256, conducted on 02/01/2022 to 02/11/2022 at Empire City Laboratories. The laboratory was not in compliance with 42 CFR 493, Requirements for Clinical Laboratories. The following Condition was cited: -D3000 - Facility Administration. 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 lack of Covid 19 reporting records, laboratory testing records review and interview with Laboratory Director (LD), the laboratory failed to report 90,508 tests results to Florida Department of Health (FDOH) from 09/21/2021 to 02/02/2022. The laboratory failed to report 90,547 out of 90,547 tests to detect SARS CoV-2 virus using Polymerase chain reaction (PCR) test performed from 09/20/2021 to 02/02/2022 and 61 out of 61 test SARS-COV-2 nucleic acid test results to Florida Department of Health (FDOH) 09/20/2021 to 02/02/2021. Findings include: -Review of laboratory testing records from 09/20/2022 to Present, revealed that the laboratory performed the following tests: a) 90256 Roche cobas SARS- CoV PCR tests b) 291 Cepheid Xpert Xpress CoV-2/Flu/RSV plus PCR tests. c) 61 Mesa Biotech Inc Accula SARS-CoV-2 Nucleic Acid detection tests - The laboratory had no records of reporting the SARS Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- CoV 2 tests results to the Florida Department of Health (FDOH) from 09/20/2021 to 02/02/2022. During an interview on 02/02/2022 at 6:30 PM, the LD confirmed the laboratory was not reporting results to FDOH for SARS CoV-2 test results from 09/20 /2021 to 02/02/2022 and the testing volume for this period was as listed above. D3027 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(1) Test requisitions and authorizations. Retain records of test requisitions and test authorizations, including the patient's chart or medical record if used as the test requisition or authorization, for at least 2 years. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to keep COVID-19 test requisitions for 7 out of 7 patients from 9/20/2021 -1/19/2022 for 2 years. Finding Include: Review of COVID-19 patient results from 9/20/2021 -1/19/2022 revealed the following: 1. Patient 1 was missing a requisition tested for COVID-19 test performed 9 /20/2021. 2. Patient 2 was missing a requisition tested for COVID-19 test performed 9 /21/2021. 3. Patient 3 was missing a requisition tested for COVID-19 test performed 9 /20/2021. 4. Patient 4 was missing a requisition tested for COVID-19 test performed 12/15/2021. 5. Patient 5 was missing a requisition tested for COVID-19 test performed 1/04/2022. 6. Patient 6 was missing a requisition tested for COVID-19 test performed 1/04/2022. 7. Patient 7 was missing a requisition tested for COVID-19 test performed 1/19/2022. During an interview on 2/01/2022 at 12pm, the Laboratory Director confirmed COVID-19 test requisitions were missing for 7 out of 7 patients from 9/20/2021 -1/19/2022. D5300 PREANALYTIC SYSTEMS CFR(s): 493.1240 Each laboratory that performs nonwaived testing must meet the applicable preanalytic system(s) requirements in 493.1241 and 493.1242, 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 preanalytic systems and correct identified problems as specified in 493. 1249 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 validate their laboratory information management system (LIMS) before use to ensure the specimen collection times and dates were transcribed on to final reports from the requisition since 9/20/2021. (see 5309) D5309 TEST REQUEST CFR(s): 493.1241(e) If the laboratory transcribes or enters test requisition or authorization information into a record system or a laboratory information system, the laboratory must ensure the information is transcribed or entered accurately. -- 2 of 7 -- This STANDARD is not met as evidenced by: Based on observation, record reviewed, and interview, the laboratory failed to validate their laboratory information management system (LIMS) before use to ensure the specimen collection times and dates were transcribed on to final reports from the requisition since 9/20/2021. Finding Include: Review of LIMS records revealed CrelioHealth software was used as LIMS in the laboratory. There was a certificate of validation for the CrelioHealth without documentation the system was working for transcribing specimen collection date and times for requisitions. During an observation on 2/03/2022 at 5:03 PM of Digital COVID-19 requisitions on CrelioHealth software revealed that requisitions printed from the system would display a specimen collection date and time for the current date and time. Review of COVID-19 patient records revealed the following: 1. Patient 2293 was tested for COVID-19 on 12/16/2021. Patient 2293 COVID-19 requisition specimen collection time was 02/03/2022 at 4:52 PM. Patient 2293 final COVID-19 report revealed a received date and time for 12/16/2021 at 1:44 PM and specimen collection time and date for 12/16/2021 at 1:44 PM. 2. Patient 6279 was tested for COVID-19 on 12/16 /2021. Patient 6279 COVID-19 requisition specimen collection time was 02/03/2022 at 4:52 PM. Patient 6279 final COVID-19 report revealed a received date and time for 12/16/2021 at 12:13 AM and specimen collection time and date for 12/16/2021 at 12: 13 AM. 3. Patient 8127 was tested for COVID-19 on 12/16/2021. Patient 8127 COVID-19 requisition specimen collection time was 02/03/2022 at 5:01 PM. Patient 8127 final COVID-19 report revealed a received date and time for 12/16/2021 at 8:02 PM and specimen collection time and date for 12/16/2021 at 8:02 PM. During an interview on 2/4/2022 at 5:00 PM with the laboratory director, he revealed that 90,256 patients were tested for COVID-19 from 9/20/201 to present and confirmed the CrelioHealth software was not transcribing specimen collection times and dates. 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 D0000 An onsite complaint visit, #2021017256, conducted on 02/01/2022 to 02/11/2022 at Empire City Laboratories. The laboratory was not in compliance with 42 CFR 493, Requirements for Clinical Laboratories. The following Condition was cited: -D3000 - Facility Administration. 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 lack of Covid 19 reporting records, laboratory testing records review and interview with Laboratory Director (LD), the laboratory failed to report 90,508 tests results to Florida Department of Health (FDOH) from 09/21/2021 to 02/02/2022. The laboratory failed to report 90,547 out of 90,547 tests to detect SARS CoV-2 virus using Polymerase chain reaction (PCR) test performed from 09/20/2021 to 02/02/2022 and 61 out of 61 test SARS-COV-2 nucleic acid test results to Florida Department of Health (FDOH) 09/20/2021 to 02/02/2021. Findings include: -Review of laboratory testing records from 09/20/2022 to Present, revealed that the laboratory performed the following tests: a) 90256 Roche cobas SARS- CoV PCR tests b) 291 Cepheid Xpert Xpress CoV-2/Flu/RSV plus PCR tests. c) 61 Mesa Biotech Inc Accula SARS-CoV-2 Nucleic Acid detection tests - The laboratory had no records of reporting the SARS Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- CoV 2 tests results to the Florida Department of Health (FDOH) from 09/20/2021 to 02/02/2022. During an interview on 02/02/2022 at 6:30 PM, the LD confirmed the laboratory was not reporting results to FDOH for SARS CoV-2 test results from 09/20 /2021 to 02/02/2022 and the testing volume for this period was as listed above. D3027 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(1) Test requisitions and authorizations. Retain records of test requisitions and test authorizations, including the patient's chart or medical record if used as the test requisition or authorization, for at least 2 years. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to keep COVID-19 test requisitions for 7 out of 7 patients from 9/20/2021 -1/19/2022 for 2 years. Finding Include: Review of COVID-19 patient results from 9/20/2021 -1/19/2022 revealed the following: 1. Patient 1 was missing a requisition tested for COVID-19 test performed 9 /20/2021. 2. Patient 2 was missing a requisition tested for COVID-19 test performed 9 /21/2021. 3. Patient 3 was missing a requisition tested for COVID-19 test performed 9 /20/2021. 4. Patient 4 was missing a requisition tested for COVID-19 test performed 12/15/2021. 5. Patient 5 was missing a requisition tested for COVID-19 test performed 1/04/2022. 6. Patient 6 was missing a requisition tested for COVID-19 test performed 1/04/2022. 7. Patient 7 was missing a requisition tested for COVID-19 test performed 1/19/2022. During an interview on 2/01/2022 at 12pm, the Laboratory Director confirmed COVID-19 test requisitions were missing for 7 out of 7 patients from 9/20/2021 -1/19/2022. D5300 PREANALYTIC SYSTEMS CFR(s): 493.1240 Each laboratory that performs nonwaived testing must meet the applicable preanalytic system(s) requirements in 493.1241 and 493.1242, 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 preanalytic systems and correct identified problems as specified in 493. 1249 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 validate their laboratory information management system (LIMS) before use to ensure the specimen collection times and dates were transcribed on to final reports from the requisition since 9/20/2021. (see 5309) D5309 TEST REQUEST CFR(s): 493.1241(e) If the laboratory transcribes or enters test requisition or authorization information into a record system or a laboratory information system, the laboratory must ensure the information is transcribed or entered accurately. -- 2 of 7 -- This STANDARD is not met as evidenced by: Based on observation, record reviewed, and interview, the laboratory failed to validate their laboratory information management system (LIMS) before use to ensure the specimen collection times and dates were transcribed on to final reports from the requisition since 9/20/2021. Finding Include: Review of LIMS records revealed CrelioHealth software was used as LIMS in the laboratory. There was a certificate of validation for the CrelioHealth without documentation the system was working for transcribing specimen collection date and times for requisitions. During an observation on 2/03/2022 at 5:03 PM of Digital COVID-19 requisitions on CrelioHealth software revealed that requisitions printed from the system would display a specimen collection date and time for the current date and time. Review of COVID-19 patient records revealed the following: 1. Patient 2293 was tested for COVID-19 on 12/16/2021. Patient 2293 COVID-19 requisition specimen collection time was 02/03/2022 at 4:52 PM. Patient 2293 final COVID-19 report revealed a received date and time for 12/16/2021 at 1:44 PM and specimen collection time and date for 12/16/2021 at 1:44 PM. 2. Patient 6279 was tested for COVID-19 on 12/16 /2021. Patient 6279 COVID-19 requisition specimen collection time was 02/03/2022 at 4:52 PM. Patient 6279 final COVID-19 report revealed a received date and time for 12/16/2021 at 12:13 AM and specimen collection time and date for 12/16/2021 at 12: 13 AM. 3. Patient 8127 was tested for COVID-19 on 12/16/2021. Patient 8127 COVID-19 requisition specimen collection time was 02/03/2022 at 5:01 PM. Patient 8127 final COVID-19 report revealed a received date and time for 12/16/2021 at 8:02 PM and specimen collection time and date for 12/16/2021 at 8:02 PM. During an interview on 2/4/2022 at 5:00 PM with the laboratory director, he revealed that 90,256 patients were tested for COVID-19 from 9/20/201 to present and confirmed the CrelioHealth software was not transcribing specimen collection times and dates. 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)