Perkins County Community Hospital

Summary Statement of Deficiencies D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. This STANDARD is not met as evidenced by: Based on surveyor review of the laboratory's new instrumentation, observation of instrumentation in the laboratory, interview with the laboratory manager, and lack of documentation the laboratory failed to have a system that twice annually evaluates the relationship between test results using different instruments for sodium, potassium, chloride, glucose, blood urea nitrogen, carbon dioxide, and creatinine since the installment of the new chemistry instrument on September 2023. Findings are: 1. Review of the laboratory's new instrumentation revealed the laboratory began using a new chemistry analyzer on September 2023. 2. Observation of the laboratory's instrumentation revealed an iSTAT instrument in the laboratory. 3. Interview with the laboratory manager on 5/21/2025 at 12:20 PM, confirmed the laboratory performs chemistry testing for sodium, potassium, chloride, glucose, blood urea nitrogen, carbon dioxide, and creatinine on the iSTAT analyzer and on the new chemistry analyzer. 4. Interview with the laboratory manager on 5/21/2025 at 12:20 PM, and lack of documentation confirmed the laboratory did not evaluate the relationship between the two instruments for sodium, potassium, chloride, glucose, blood urea nitrogen, carbon dioxide, and creatinine since the new chemistry instrument was installed on September 2023. 5. Interview with the laboratory manager on 5/21/2025 at 12:20 PM confirmed thirteen patients were tested on the iSTAT analyzer since the new chemistry instrument was installed on September 2023. 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 --

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, review of 2021 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 revealed the laboratory performed moderate complexity Human Chorionic Gonadotropin (HCG), quantitative serum testing. 2. Review of the laboratory's 2020 proficiency testing and 2021 proficiency testing revealed the laboratory failed to enroll in an approved program for moderate complexity Human Chorionic Gonadotropin (HCG), quantitative serum. 3. Interview with the general supervisor on 8/31/2021 at 3:03 PM confirmed the laboratory had not enrolled in an approved program for moderate complexity Human Chorionic Gonadotropin (HCG), quantitative serum for 2020 and 2021. 4. Interview with the general supervisor on 8/31/2021 at 3:03 PM confirmed the laboratory performed sixty- seven moderate complexity Human Chorionic Gonadotropin (HCG) quantitative serum tests from January 2020 to August 2021. 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 --

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