Antelope Memorial Hospital

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), qualitative serum. Findings are: 1. Review of the laboratory's list of tests performed revealed the laboratory performed eleven moderate complexity Human Chorionic Gonadotropin (HCG), qualitative 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), qualitative serum. 3. Interview with technical consultant on 4/21/2021 at 10: 24 AM confirmed the laboratory had not enrolled in an approved program for moderate complexity Human Chorionic Gonadotropin (HCG), qualitative serum for 2020. 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 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 desk review of proficiency testing for 2019, the laboratory had unsatisfactory performance for the pH blood gas, partial oxygen (pO2) blood gas, and partial carbon dioxide (pCO2) blood gas. See D2088. D2088 ROUTINE CHEMISTRY CFR(s): 493.841(b) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. 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 -- This STANDARD is not met as evidenced by: Based on desk review of proficiency testing for 2019 the laboratory had unsuccessful performance for the analytes pH blood gas, partial oxygen (pO2) blood gas, and partial carbon dioxide (pCO2) blood gas. Findings are: 1. 2019 second event, analyte - pH blood gas, score 0% 2. 2019 second event, analyte - pO2 blood gas, score 0% 3. 2019 second event, analyte - pCO2 blood gas, score 0% 4. 2019 third event, analyte - pH blood gas, score 0% 5. 2019 third event, analyte - pO2 blood gas, score 0% 6. 2019 third event, analyte - pCO2 blood gas, score 0% -- 2 of 2 --

Summary Statement of Deficiencies D5801 TEST REPORT CFR(s): 493.1291(a) The laboratory must have an adequate manual or electronic system(s) in place to ensure test results and other patient-specific data are accurately and reliably sent from the point of data entry (whether interfaced or entered manually) to final report destination, in a timely manner. This includes the following: (a)(1) Results reported from calculated data. (a)(2) Results and patient-specific data electronically reported to network or interfaced systems. (a)(3) Manually transcribed or electronically transmitted results and patient-specific information reported directly or upon receipt from outside referral laboratories, satellite or point-of-care testing locations. This STANDARD is not met as evidenced by: Based on lack of documentation and an interview with the general supervisor on 1-8- 19 at 3:00pm the laboratory failed to document validation and monitor the transmission of data from the laboratory information system to the clinic. Findings include: 1. No documentation could be presented on time of survey indicating verification of trasmitted data to the clinic. 2. Interview with general supervisor confirmed that routine checks of transmitted data had not been performed. The general supervisor stated the interface system was put in place in October 2018. The supervisor stated the interface was validated when put in use but the validation was not documented. 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 --