Ridgeview Lesueur 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 a review of Center for Medicare and Medicaid Services (CMS) reports and American Proficiency Institute (API) proficiency testing reports, the laboratory failed to successfully participate in proficiency testing (PT) in 2019 and 2020 for Partial Thromboplastin Time under the specialty of Hematology. Findings include: 1. The CMS CASPER Report 0155D and API PT Performance Summary, reviewed on August 19, 2020, indicated the the laboratory failed to successfully participate in Partial Thromboplastin Time in 2019 and 2020. Unsatisfactory PT performance in Partial Thromboplastin Time was obtained in the following events. -2019 3rd event 60% -2020 1st event 40% 2. The CMS CASPER Report 0155D and API PT 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 -- Performance Summary indicated the laboratory failed to obtain a Partial Thromboplastin Time PT score of at least 80 percent in two out of three consecutive testing events in 2019 and 2020. See D2121 and D2130 D2121 HEMATOLOGY CFR(s): 493.851(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: . Based on review of proficiency testing (PT) reports from Center for Medicare and Medicaid Services (CMS) and the American Proficiency Institute (API), the laboratory failed to obtain a PT score for Partial Thromboplastin Time of at least 80 percent which resulted in unsatisfactory performance for the analyte. Findings include: 1. The CMS CASPER Report 0155D, reviewed on August 19, 2020, indicated the laboratory failed to obtain a Partial Thromboplastin Time PT successful score of at least 80 percent in one event in 2019 and one event in 2020. 2. The API Performance Summary confirmed the laboratory failed to obtain a Partial Thromboplastin Time PT score of at least 80 percent in one event in 2019 and one event in 2020. -2019 3rd event 60% -2020 1st event 40% D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: . Based on review of proficiency testing (PT) reports from the Center for Medicare and Medicaid Services (CMS) and the American Proficiency Institute (API), the laboratory failed to achieve successful PT performance for Partial Thromboplastin Time testing in two of three consecutive PT events in 2019 and 2020. Findings include: 1. The CMS CASPER Report 0153D, reviewed on August 19, 2020, indicated the laboratory failed to obtain a Partial Thromboplastin Time PT successful score of at least 80 percent in two out of three consecutive testing events in 2019 and 2020. 2. The API Performance Summary confirmed the laboratory failed to obtain a Partial Thromboplastin Time PT score of at least 80 percent in two out of three consecutive testing events in 2019 and 2020. -2019 3rd event 60% -2020 1st event 40% -- 2 of 2 --

Summary Statement of Deficiencies D5807 TEST REPORT CFR(s): 493.1291(d) Pertinent "reference intervals" or "normal" values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results. This STANDARD is not met as evidenced by: . Based on observation, document review and interview with laboratory personnel, the laboratory failed to ensure reference intervals were consistent between procedure and patient test report. Findings are as follows: 1. The laboratory performed Coagulation testing as confirmed by the General Supervisor (GS) during a tour of the laboratory on 8/15/18 at 10:05 a.m. 2. A Hemachron Signature Elite coagulation analyzer was observed as present and available for use during the tour. 3. The reference interval listed in the Citrate Prothrombin Time (PT) Hemachron Whole Blood Microcoagulation System Procedure, located in the Lab Testing Procedure, 2 of 2 Manual, was not consistent with that included on the patient test report (Female - 82 years, Date performed 5/26/18) reviewed on date of survey. Analyte Procedure Report ProTime 8.0 - 13.0 8.0 - 12.0 4. In an interview at 3:15 p.m. on 8/15/18, the GS confirmed the above findings. . 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 --