White River Health Family Care

Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: . Through a review of the laboratory policy and procedures, temperature logs for 2020, lack of documentation and interviews with staff, it was determined the laboratory failed to monitor and document room temperatures, refrigerator temperatures and humidity conditions that are essential for the proper storage of reagents and supplies. Survey findings follow: A. A review of the laboratory policy and procedure revealed: "The temperature and humidity of the laboratory must be monitored and kept between the posted acceptable ranges to ensure the proper storage and/or testing environment for all reagents and patient specimens used. Testing personnel will check daily and recorded on the temperature logs. Refrigerator range 2- 8 degrees Celsius: Room Temperature Range 18-25 degrees Celsius and humidity 20- 80%." B. A review of the refrigerator temperatures for January- December 2020 (twelve of twelve months) revealed the laboratory failed to monitor and document refrigerator and humidity temperatures on one of thirty-one days in March; four of thirty days in April; one of thirty-one days in October and two of thirty-one days in December. C. In an interview on 9/2/2021 at 10:30, the technical consultant confirmed the laboratory failed to monitor or document room temperature and humidity on the days mentioned. 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 -- D5785

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 2019 and 2020 CMS Casper Reports 155D, 153D and the American Proficiency Institute (API) proficiency testing results, it was determined the laboratory failed to participate in the second Hematology proficiency testing event of 2019 and the first Hematology proficiency testing event of 2020 for the Specialty of Hematology and each Hematology test as evidenced by: Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event as cited at D 2123. D2123 HEMATOLOGY 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 -- CFR(s): 493.851(c) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3) The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: . Based on review of the 2019 and 2020 CMS Casper Reports 155D and 153D and API proficiency testing results, it was determined the laboratory failed to participate in the second proficiency testing event of 2019 and the first proficiency testing events of 2020, resulting in a score of 0% for the Specialty of Hematology and the test of White Blood Cell Differential (WBC DIFF), Red Blood Cell Count (RBC), Hemoglobin ( HGB), Hematocrit (HCT), White Blood Cell Count (WBC), and Platelets (PLTS) as evidenced by: A. The laboratory received a score of 0% for the Specialty of Hematology in the second proficiency testing event of 2019 and the first proficiency testing event of 2020. B. The laboratory received a score of 0% for the test of WBC DIFF, RBC, HGB, HCT, WBC and PLTS in the second proficiency testing event of 2019 and the first proficiency testing event of 2020. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: . Based on a review of the 2019 and 2020 proficiency testing results, it was determined the Laboratory Director failed to ensure that