Jennie M Melham Memorial Medical Center

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 surveyor off-site desk review of the laboratory's 2021 American Proficiency Institute (API) proficiency testing (PT) records and a telephone interview with the laboratory manager on 3/25/2022, it was determined the laboratory failed to successfully participate in proficiency testing for the analyte compatibility testing. Refer to D2181. D2181 COMPATIBILITY TESTING CFR(s): 493.863(e) 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 -- Failure to achieve an overall testing event score of satisfactory for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on surveyor off-site desk review of the laboratory's 2021 American Proficiency Institute (API) proficiency testing (PT) records and a telephone interview with the laboratory manager on 3/25/2022, it was determined the laboratory failed to achieve successful performance for the analyte, compatibility testing, in two out of three testing events. Findings: 1. Desk review of the laboratory's 2021 API PT records revealed Compatibility Testing scores of less than one hundred percent for the following Immunohematology events: 2021 first event, score 80% 2021 third event, score 80% 2. In a telephone interview with the laboratory manager on 3/25/2022, it was confirmed that the laboratory was unsuccessful in the PT events listed above. -- 2 of 2 --

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 surveyor review of new instrumentation, lack of documentation, and interview with the laboratory supervisor the laboratory failed to verify precision for a new sedimentation rate instrument. 1. Review of new instrumentation revealed the laboratory started patient testing on 4/8/2021 with a new sedimentation rate instrument. 2. Review of the validation of performance specifications for the new sedimentation rate instrument revealed no run to run precision studies had been performed. 3. Interview with the laboratory supervisor on 5/5/2021 at 2:55 PM confirmed run to run precision was not performed prior to patient testing. 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 --