Midlands Family Urgent Care

Summary Statement of Deficiencies D0000 An unannounced CLIA complaint survey was conducted at GS Labs LLC on 9/22 /2021 and 10/1/2021 by the Nebraska Department of Health and Human Services. Immediate Jeopardy was identified related to the following conditions: D3000 - Facility administration D5400 - Analytic systems D6000 - Laboratories performing moderate complexity testing; laboratory director 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: The laboratory failed to retain analytic systems records (Refer to D3031). D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) 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. 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 -- This STANDARD is not met as evidenced by: The laboratory was unable to provide records for 3/1/2021 - 5/18/2021 and 9/3/2021 - 9/6/2021 during time of survey. Findings are: 1. The laboratory was unable to provide quality control records, instrument print outs, and patient reports from 3/1/2021 - 5/18 /2021 and 9/3/2021 - 9/6/2021. 2. Confirmed via interview with the laboratory director and technical consultant on 10/1/2021 at 9:50 AM. 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 record review and interview, the laboratory failed to follow controls procedure and have a complete procedure (Refer to D5401 and D5403); failed to monitor temperatures (Refer to D5413); failed to perform the verification of performance specifications on 20 of 20 DiaSorin analyzers prior to performing patient testing (Refer to D5421); failed to document

Summary Statement of Deficiencies 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: The laboratory failed to perform the verification of performance specifications on the Beckman Coulter AU480 analyzer before patient testing. Refer to D5421. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on review of verification of performance specifications on Beckman Coulter AU480, review of Beckman Coulter AU480 instrument print outs, and review of laboratory's analytic quality check revealed the laboratory reported patient test 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 2 -- before verifying the performance specifications of the Beckman Coulter AU480. 1. Review of verification of performance specifications on Beckman Coulter revealed completion date of 11/11/2020. 2. Review of Beckman Coulter AU480 instrument print outs revealed nine patient results. Patient testing occurred on 10/5/2020, 10/6 /2020, 10/9/2020, and 10/20/2020. 3. Review of laboratory's analytic quality check revealed the laboratory director reviewed the instrument print out from patient tested on 10/5/2020. -- 2 of 2 --