Gamma Healthcare - St Louis

Summary Statement of Deficiencies 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 the performance verification procedures for the DXI 600 immunoassay testing and interview with the laboratory director, the laboratory failed to verify reference intervals(normal values). Findings: 1. Review of the verification procedures for the DXI 600 chemistry analyzer for Ferritin, Folate, Free T4, PSA, PTH, T uptake, T4, TSH, Vitamin B12, Vitamin D showed no verification of normal values. 2. Interview with the laboratory director on November 8, 2018 at 11:30 confirmed the laboratory failed to ensure the verification procedures for normal values for the DXI 600 analyzer were appropriate for the laboratory's patient population. D5801 TEST REPORT CFR(s): 493.1291(a) The laboratory must have an adequate manual or electronic system(s) in place to ensure test results and other patient-specific data are accurately and reliably sent from the point of data entry (whether interfaced or entered manually) to final report destination, in a timely manner. This includes the following: (a)(1) Results reported from calculated data. (a)(2) Results and patient-specific data electronically reported to network or interfaced systems. (a)(3) Manually transcribed or electronically 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 -- transmitted results and patient-specific information reported directly or upon receipt from outside referral laboratories, satellite or point-of-care testing locations. This STANDARD is not met as evidenced by: Based on lack of documentation and interview with the laboratory director, the laboratory failed to ensure test results and patient specific data were reliably sent from the Beckman Coulter DXH 800 hematology analyzer and the DXI 600 chemistry analyzer to the laboratory information system(LIS). Findings: 1. Review of documentation revealed the laboratory failed to check patient data and test results sent from the new hematology analyzer, DXH 800 and the new chemistry analyzer, DXI 600, to the LIS. The new instruments were put into use on March 1 and April 1, 2018. 2. Interview with the laboratory director on November 8, 2018 at 11:30 AM confirmed the laboratory failed to check patient test results and patient specific data electronically transmitted from the DXH 800 and DXI 600 analyzers to the LIS for accuracy. -- 2 of 2 --

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on review of 2018 proficiency testing (PT) results reported to the CLIA database by the PT provider and phone interview with the general supervisor, the laboratory failed to successfully participate in PT. See D-tag 2064, unsatisfactory performance in two consecutive Influenza PT challenges. D2064 VIROLOGY CFR(s): 493.831(e) Failure to achieve an overall testing event score of satisfactory performance for two 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 -- consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of virology proficiency testing (PT) results for 2018 and phone interview with the general supervisor, the laboratory failed to achieve satisfactory performance for Influenza A and B testing in two consecutive PT events. Findings: 1. Review of the virology PT results for the first event of 2018 revealed the laboratory obtained an unsatisfactory score of 60 percent for Influenza A and B. 2. Review of the virology PT results for the second event of 2018 revealed the laboratory obtained an unsatisfactory score of 40 percent for Influenza A and B. 3. Phone interview with the general supervisor on September 13, 2018 at 9:30 AM confirmed the laboratory failed to achieve satisfactory performance for Influenza A and B testing in two consecutive events for 2018. -- 2 of 2 --