Cherry County Hospital

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 off-site desk review of the laboratory's 2022 and 2023 American Proficiency Institute proficiency testing (PT) records and a phone interview with the technical consultant on March 29, 2023, it was determined the laboratory failed to successfully participate in proficiency testing for the analyte Bilirubin, Total. Refer to D2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in 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 off-site desk review of the laboratory's 2022 and 2023 American Proficiency Institute (API) proficiency testing (PT) records and a phone interview with the technical consultant on March 29, 2023, it was determined the laboratory failed to achieve satisfactory performance for the analyte, Bilirubin, Total, in two out of three consecutive testing events. Findings are: 1. Desk review of the laboratory's 2022 and 2023 API PT records revealed Bilirubin, Total scores of less than eighty percent for the following events: 2022 Event 2 - Score 40% 2023 Event 1 - Score 60% 2. In a phone interview with the technical consultant on March 29, 2023 at 12:10 PM confirmed 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 technical consultant the laboratory failed to verify precision on the laboratory's handheld blood analyzer. 1. Review of new instrumentation revealed the laboratory started patient testing on 8/19/2021 with the new handheld blood analyzer. 2. Review of the validation of performance specifications for the new handheld blood analyzer revealed no run to run precision studies had been performed. 3. Interview with the technical consultant on 9/13/2021 at 9:00 AM confirmed run to run precision was not performed prior to patient testing. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the 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 -- condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on surveyor review of test reports and interview with the technical consultant, the test report dates changed when test report copies were generated at a later time. 1. Review of three chemistry test reports, one blood bank test report, and one hematology test report revealed the report dates changed with subsequent printing of test reports. 2. Interview with the technical consultant on 9/13/2022 confirmed the report dates changed with subsequent printing of test reports. -- 2 of 2 --

Summary Statement of Deficiencies D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on review of the laboratory's list of tests performed, review of 2020 proficiency testing, and interview with general supervisor the laboratory failed to enroll in an approved proficiency testing program for moderate complexity Human Chorionic Gonadotropin (HCG), quantitative serum. Findings are: 1. Review of the laboratory's list of tests performed revealed the laboratory had a yearly volume of sixty-five moderate complexity Human Chorionic Gonadotropin (HCG), quantitative serum tests for 2020. 2. Review of the laboratory's 2020 proficiency testing revealed the laboratory failed to enroll in an approved program for moderate complexity Human Chorionic Gonadotropin (HCG), quantitative serum. 3. Interview with general supervisor on 6/15/2021 at 1:40 PM confirmed the laboratory had not enrolled in an approved program for moderate complexity Human Chorionic Gonadotropin (HCG), quantitative serum for 2020. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or 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 -- procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on surveyor review of list of tests performed, surveyor review of proficiency testing (PT) records, a lack of verification records, an interview with the general supervisor, the laboratory failed to have a system for verifying the accuracy of the testing for urine protein, urine chloride, urine sodium, and urine potassium. Findings are: 1. Review of the laboratory's list of tests performed revealed the laboratory had performed testing for urine protein, urine chloride, urine sodium, and urine potassium in 2019 and 2020. 2. The laboratory's proficiency test results for 2019 and 2020 did not include testing for urine protein, urine chloride, urine sodium, and urine potassium. 3. Interview with the general supervisor on 6/15/2021 at 1:44 PM confirmed the laboratory had not enrolled in PT for urine protein, urine chloride, urine sodium, and urine potassium, nor had the laboratory performed accuracy verification for these analytes. -- 2 of 2 --

Summary Statement of Deficiencies D5293 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(b)(c) (b) The general laboratory systems quality assessment must include a review of the effectiveness of