Kiowa County Memorial Hospital

Summary Statement of Deficiencies D0000 Kiowa County Memorial Hospital laboratory was found to be in substantial compliance with 42 CFR Part 493, Requirements for Laboratories as a result of an onsite survey on February 29, 2024. 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 the review of proficiency testing (PT) records, the laboratory failed to successfully participate in PT from American Proficiency Institute (API) under the specialties: 1. Routine Chemistry for the regulated analytes: Bilirubin, Total. See 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 a desk review of PT scores from the provider API under Routine Chemistry and phone interview, the laboratory failed to achieve an acceptable score of 80% or higher for two of three consecutive testing events on the regulated analyte bilirubin, total. Findings: 1 .Third Event Chemistry 2021 revealed a score of 40% for bilirubin, total. 2. Second Event Chemistry 2022 revealed a score of 40% for bilirubin, total. 3. Phone interview with the lab manager on 8/1/22 at 11 a.m. confirmed, the laboratory failed to achieve an acceptable score of 80% or higher for two of three consecutive testing events on the regulated analyte bilirubin, total. -- 2 of 2 --

Summary Statement of Deficiencies D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Each qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on the review of the procedure manual, FDA test classification, quality control (QC) records, patient test reports and interview, the laboratory failed to perform a positive and negative control material each day of patient testing on the MedTox Drug of Abuse test system. Findings: 1. Review of the procedure "MEDTOXSCAN DRUGS OF ABUSE" approved for use by the laboratory director on 1/9/18, page 4, second paragraph states "External controls are urine-based materials that contain the drugs to be tested at concentrations above the cutoff (positive control) or contain no drug (negative control) .... You should run external controls routinely ..." No stated interval of QC testing was found in this procedure. 2. This 13 analyte panel is FDA approved and classified as moderate complexity. 3. Surveyor asked how often external QC was performed. Testing personnel (TP) #1 stated the Positive and Negative QC Test Devices (electronic QC) was performed each day of patient testing. No external QC material was used. 4. Review of patient test reports revealed 89 patient results were reported from 12/20/21 to 6/30/22 without external QC testing. 6. Interview with the TP#1 on 6/30/22 at 310:15a.m. confirmed, the laboratory failed to perform a positive and negative control material each day of patient testing on the MedTox Drug of Abuse test system. 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 D5393 PREANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1249(b)(c) The preanalytic systems assessment must include a review of the effectiveness of

Summary Statement of Deficiencies D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Each quantitative procedure, include two control materials of different concentrations; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Review of Accu-Sed Plus control package inserts, Excyte Mini sedimentation rate (ESR) test records and interview with staff reveals that the laboratory failed to perform two levels of acceptable quality control (QC) material each day of patient testing for the Excyte Mini sedimentation rate (ESR) analyzer. Findings were: 1. Review of the Accu-Sed Plus Abnormal ESR control kit, lot. 177110, expiration date 2-28-2019 had an acceptable range of 45 to 81 mm/hr for the Excyte Mini ESR analyzer. 2. Review of the Accu-Sed Plus Normal ESR control kit, lot. 177010, expiration date 2-28-2019 had an acceptable range of 3 to 11 mm/hr for the Excyte Mini ESR analyzer. 3. Review of ESR test records, at the time of the survey, had normal quality control ranges of 4 - 12 and abnormal quality control ranges of 40 - 76 for May 2018 to September 2018. Some pages of the ESR test records had control ranges but didn't contain control lot numbers or expiration dates. 4. Controls out-of- range on the ESR test records, at the time of the survey, had no