Optumcare New Mexico Llc Journal Center Urgent

Summary Statement of Deficiencies D0000 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 of Health and Human Services in such form and manner, and at such timing and frequency, as the Secretary may prescribe. During an initial survey completed on 03/17/2021 for 42 CFR part 493 Laboratory Requirements, the facility was found out of compliance with the following condition: 42 CFR Part 493.1100 Condition: Reporting of SARS-CoV-2 test results. D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: Based on observation, the review of laboratory procedures, manufacturer instructions, and interview with Testing Person #1, the laboratory failed to follow manufacturer's instructions for SARS-CoV-2 (COVID19) testing and provide the Patient Fact Sheets to each patient tested. The laboratory performed 196 patient tests for COVID19 January 8, 2021 through March 17, 2021. A. Review of the Becton Dickinson Veritor SARS-CoV-2 (Rapid Detection of COVID19) instructions for use (IFU) under "Conditions of Authorization for the Laboratory" indicated "Authorized laboratories* using your product must include with test result reports, all authorized Fact Sheets. B. Review of the Becton Dickinson Veritor SARS-CoV-2 (Rapid Detection of COVID19), procedure dated 11/12/2020 revealed no reference to providing the Patient Fact Sheets to each patient tested for COVID19. C. During interview on 03/17 /2021 at 03:10 pm, Testing Person #1 stated she did not hand out Patient Fact Sheets to patients. D. During observation of laboratory supplies on 03/17/2021 at 03:11 pm, Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- the Technical Consultant and the surveyor did not find any Patient Fact Sheets in the test kit/box to give to patients. 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 review of the BD Veritor Plus SARS-CoV-2 Patient Quality Control logs, the Procedure for the BD Veritor Plus system for the Detection of SARS-CoV-2 Antigens, the memo from the New Mexico Health Alert Network (HAN), and interviews with laboratory staff, the laboratory failed to provide and retain written verification that all the SARS-CoV-2 results were reported to the New Mexico Department of Health (NMDOH) from January 8, 2021 through March 17, 2021. Findings are: A. Review of the SARS-CoV-2 Patient Quality logs from January 8, 2021 through March 17, 2021 the following was revealed: 1. For the month of January a total of 72 tests were performed. a. Of the total 72 tests performed, 8 were positive, 63 were negative, and 1 was invalid. 2. For the month of February a total of 71 tests were performed. a. Of the total 71 tests performed, 3 were positive, 68 were negative. 3. From March 1, 2021 to March 17, 2021, a total of 55 tests were performed. a. Of the total 55 tests performed, 1 was positive, 53 were negative, and 1 was invalid. B. Review of the written procedure for the BD Veritor Plus system for the Detection of SARS-CoV-2 reveals that the procedure dated 11/12/2020, did not include a process for reporting and tracking the reporting of both positive and negative test results to NMDOH. 1. On page 15 of the SARS-CoV-2 procedure, Section labeled "Clinical Significance" the procedure states "Laboratories within the United States and its territories are required to report all positive results to the appropriate health authorities." The written procedure does not mention that negative results should also be reported to the appropriate health authorities. 2. The written COVID-19 procedure does not include a mechanism/process for tracking which tests have been reported and which ones have not been reported. C. Review of the Memo from the New Mexico Health Alert Network (HAN) , released December 3, 2020, and followed by the laboratory, revealed that the memo does not include guidelines regarding the verification/tracking of the transmitted patient test results. 1. The memo states that the New Mexico Department of Health created a specific fax line/number, to be used to report only the new COVID-19 positive test results daily. 2. The memo also instructs the laboratory to batch all negative COVID-19 results and send to NMDOH on a weekly basis via fax to a specific fax number. D. During interview on 03/17/2021 at 2: 45 pm, the clinic Supervisor, stated that they are not tracking/assuring that the patient test results are being transmitted accurately and reliably to the local/State NMDOH. He stated that they are faxing the positive results as soon as they are obtained but they -- 2 of 3 -- are not keeping the fax transmission sheets to prove they were faxed. He stated that they are following the instructions provided in the December 3 memo from the NM health alert network. -- 3 of 3 --

Summary Statement of Deficiencies D0000 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 of Health and Human Services in such form and manner, and at such timing and frequency, as the Secretary may prescribe. During an initial survey completed on 03/17/2021 for 42 CFR part 493 Laboratory Requirements, the facility was found out of compliance with the following condition: 42 CFR Part 493.1100 Condition: Reporting of SARS-CoV-2 test results. D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: Based on observation, the review of laboratory procedures, manufacturer instructions, and interview with Testing Person #1, the laboratory failed to follow manufacturer's instructions for SARS-CoV-2 (COVID19) testing and provide the Patient Fact Sheets to each patient tested. The laboratory performed 196 patient tests for COVID19 January 8, 2021 through March 17, 2021. A. Review of the Becton Dickinson Veritor SARS-CoV-2 (Rapid Detection of COVID19) instructions for use (IFU) under "Conditions of Authorization for the Laboratory" indicated "Authorized laboratories* using your product must include with test result reports, all authorized Fact Sheets. B. Review of the Becton Dickinson Veritor SARS-CoV-2 (Rapid Detection of COVID19), procedure dated 11/12/2020 revealed no reference to providing the Patient Fact Sheets to each patient tested for COVID19. C. During interview on 03/17 /2021 at 03:10 pm, Testing Person #1 stated she did not hand out Patient Fact Sheets to patients. D. During observation of laboratory supplies on 03/17/2021 at 03:11 pm, Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- the Technical Consultant and the surveyor did not find any Patient Fact Sheets in the test kit/box to give to patients. 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 review of the BD Veritor Plus SARS-CoV-2 Patient Quality Control logs, the Procedure for the BD Veritor Plus system for the Detection of SARS-CoV-2 Antigens, the memo from the New Mexico Health Alert Network (HAN), and interviews with laboratory staff, the laboratory failed to provide and retain written verification that all the SARS-CoV-2 results were reported to the New Mexico Department of Health (NMDOH) from January 8, 2021 through March 17, 2021. Findings are: A. Review of the SARS-CoV-2 Patient Quality logs from January 8, 2021 through March 17, 2021 the following was revealed: 1. For the month of January a total of 72 tests were performed. a. Of the total 72 tests performed, 8 were positive, 63 were negative, and 1 was invalid. 2. For the month of February a total of 71 tests were performed. a. Of the total 71 tests performed, 3 were positive, 68 were negative. 3. From March 1, 2021 to March 17, 2021, a total of 55 tests were performed. a. Of the total 55 tests performed, 1 was positive, 53 were negative, and 1 was invalid. B. Review of the written procedure for the BD Veritor Plus system for the Detection of SARS-CoV-2 reveals that the procedure dated 11/12/2020, did not include a process for reporting and tracking the reporting of both positive and negative test results to NMDOH. 1. On page 15 of the SARS-CoV-2 procedure, Section labeled "Clinical Significance" the procedure states "Laboratories within the United States and its territories are required to report all positive results to the appropriate health authorities." The written procedure does not mention that negative results should also be reported to the appropriate health authorities. 2. The written COVID-19 procedure does not include a mechanism/process for tracking which tests have been reported and which ones have not been reported. C. Review of the Memo from the New Mexico Health Alert Network (HAN) , released December 3, 2020, and followed by the laboratory, revealed that the memo does not include guidelines regarding the verification/tracking of the transmitted patient test results. 1. The memo states that the New Mexico Department of Health created a specific fax line/number, to be used to report only the new COVID-19 positive test results daily. 2. The memo also instructs the laboratory to batch all negative COVID-19 results and send to NMDOH on a weekly basis via fax to a specific fax number. D. During interview on 03/17/2021 at 2: 45 pm, the clinic Supervisor, stated that they are not tracking/assuring that the patient test results are being transmitted accurately and reliably to the local/State NMDOH. He stated that they are faxing the positive results as soon as they are obtained but they -- 2 of 3 -- are not keeping the fax transmission sheets to prove they were faxed. He stated that they are following the instructions provided in the December 3 memo from the NM health alert network. -- 3 of 3 --

Summary Statement of Deficiencies D0000 During a recertification survey completed on 10/14/2020 for 42 CFR part 493 Laboratory Requirements, the facility was found out of compliance with the following conditions: 493.1403 Laboratory Director, Moderate Complexity 493.1409 Technical Consultant, Moderate Complexity 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 the review of the Point-of-Care Testing General Policy and interview with the Technical Consultant, the laboratory failed to have a written policy for assessing the competency of the Technical Consultant. Findings are: A. Review of the Point-of- Care Testing General Policy including competency dated 01/2016 indicated no policy or process for evaluating the competency of the Technical Consultant: B. During the exit conference on 10/14/2020 at 01:00 pm, the Technical Consultant stated Technical Consultant competency wasn't required and not performed. 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. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 8 -- (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 The following deficiency was cited as the result of a recertification survey on July 25, 2018 for 42 CFR part 493 Laboratory Requirements. D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on the review of proficiency test records, CMS Laboratory Personnel Report Form 209, personnel records and interview with the technical consultant, the laboratory failed to rotate the proficiency testing samples among all testing personnel. Findings are: A. Review of the CMS Laboratory Personnel Report Form 209 indicated 8 current testing personnel (TP #1-7 and #9) in the laboratory. B. Review of personnel records indicated 7 (TP #1- TP #7) of the current employees worked in the laboratory in 2017 and 4 (TP #2, TP #4 - TP #7) in 2016. C. Review of the 2016-2018 Troponin proficiency testing records revealed the following: 1. The samples for 2 of 3 test events (1 & 2) 2016 were tested by TP #7. 2. The samples for 2 of 3 test events (1 & 2) 2017 were tested by TP #7. 3. The samples for 2 of 2 test events in 2018 were tested by TP #7. 4. There were no records indicating participation in troponin proficiency testing for TP #1, TP #2, TP #4, TP #5, or TP #6. D. The technical consultant confirmed during the exit conference on 07/25/2018 at 12:15 pm that she was aware of this deficient practice. 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 --