Guthrie County Hospital

Summary Statement of Deficiencies D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. In addition, retain the following: This STANDARD is not met as evidenced by: Based on review of the Vitros 7600 maintenance records and confirmed by interview with General Supervisor (GS) #1 at 8:24 am on 11/26/2025, the laboratory failed to retain daily, weekly, and monthly maintenance for the Vitros 7600 chemistry analyzer for 92 out of 92 days, 14 out of 14 weeks and three out of three months from 7/1/2025 - 9/30/2025. The findings include: 1. On 7/1/2025, the laboratory started using the Vitros 7600 chemistry analyzer to perform patient testing. 2. The laboratory performed and documented daily, weekly and monthly maintenance directly on the Vitros 7600 chemistry analyzer. 3. The Vitros 7600 chemistry analyzer would only retain approximately two months worth of maintenance records. 4. At the time of the survey, GS #1 confirmed the laboratory did not realize the Vitros 7600 chemistry analyzer wouldn't store all of the maintenance records. GS #1 confirmed the laboratory did not retain daily, weekly, and monthly maintenance records for the Vitros 7600 chemistry analyzer from 7/1/2025 - 9/30/2025. D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on review of proficiency testing (PT) records and confirmed by interview with General Supervisor (GS) #1 at 1:32 pm on 11/25/2025, the laboratory failed to perform a self evaluation when the laboratory received ungraded PT scores from five out of six PT events from 01/01/2024- 11/26/2025. The findings include: 1. For 2024 event 1, the laboratory received ungraded PT test scores for the following: *Respiratory panel sample RSP-01 (Influenza A) *Total bilirubin samples CH-02, CH- 03 and CH-05 2. For 2024 event 2, the laboratory received ungraded PT test scores for the following: *Respiratory Panel sample RSP-08 (Parainfluenza virus) *Iron sample CH-08 3. For 2024 event 3, the laboratory received ungraded PT test scores for the following: * Respiratory panel sample RSP-13 (Influenza A) 4. For 2025 event 2, the laboratory received ungraded PT test scores for the following: *Total bilirubin samples CH-07, CH-09, and CH-10 *Total iron binding capacity sample CH-06 *Folate samples IA-07 and IA-09 5. For 2025 event 3, the laboratory received ungraded PT test scores for the following: *Total bilirubin samples CH-12 and CH-15 *Low density lipoprotein samples CH-11 and CH-13 6. At the time of the survey, GS#1 confirmed the laboratory did not document a self evaluation for the above ungraded PT scores. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on review of proficiency testing (PT) records and confirmed by interview with General Supervisor (GS) #1 at 1:32 pm on 11/25/2025, the laboratory failed to take and document

Summary Statement of Deficiencies D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on lack of D-dimer calibration records and confirmed by laboratory personnel identifier #2 (refer to the Laboratory Personnel Report) at 10:26 am on 09/27/2023, the laboratory failed to retain the Sysmex CA-600 Innovance D-dimer calibration records for at least two years from 11/10/2021- 09/27/2023. At the time of the survey, the laboratory could not locate Sysmex CA-600 Innovance D-dimer calibration records for the time period of 11/10/2021- 09/27/2023. 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: Based on review of hematology and chemistry quality control (QC) records and confirmed by laboratory personnel identifier #2 (refer to the Laboratory Personnel Report) at 10:17 am and 12:58 pm on 09/27/2023, the laboratory failed to perform two levels of QC each day of patient testing for three out of 30 days of patient testing 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 -- reviewed from April 2023. The findings include: 1. Review of Sysmex XN-550 hematology QC records at 10:17 am revealed that the laboratory did not perform any levels of QC and reported complete blood count and automated differential patient test results on the following dates: *04/12/2023- 19 patients reported *04/20/2023- 17 patients reported 2. Review of Siemens Dimension EXL chemistry QC records at 12: 58 pm revealed that the laboratory only performed level three QC on 04/05/2023 and reported patient test results for the following analytes: *sodium- 14 patients reported *potassium- 14 patients reported *chloride- 14 patients reported *carbon dioxide- 14 patients reported *urea nitrogen- 14 patients reported *calcium- 14 patients reported *creatinine- 14 patients reported *glucose- 14 patients reported *albumin- 8 patients reported *alkaline phosphatase- 8 patients reported *total bilirubin- 8 patients reported *alanine transaminase- 9 patients reported *aspartate aminotransferase- 8 patients reported *amylase- 1 patient reported *total cholesterol- 4 patients reported *high- density lipoprotein cholesterol- 4 patients reported *triglycerides- 4 patients reported *thyroid stimulating hormone- 2 patients reported *magnesium- 1 patient reported *ethanol- 1 patient reported 3. At the time of the survey, personnel identifier #2 confirmed that the laboratory did not have additional QC records for the dates and analytes listed above. D5783

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 lack of performance specification records and confirmed by laboratory personnel identifier #1 (refer to the Laboratory Personnel Report) at approximately 2: 40 pm on 12/03/2021, the laboratory failed to verify the performance specifications of accuracy and precision for the test system, Qiagen Qia-Stat, prior to testing and reporting patient test results. The findings include: 1. The laboratory began using the Qiagen Qia-Stat test system to perform respiratory panel testing in October 2020. 2. At the time of the survey, personnel identifier #1 confirmed that the laboratory did not have performance specification records for the Qiagen Qia-Stat 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 D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of proficiency testing (PT) records and confirmed by laboratory personnel identifier #2 (refer to the Laboratory Personnel Report) at approximately 8: 30 am on 9/17/2019; the laboratory director failed to attest to the routine integration of PT samples into the patient workload for three out of five proficiency testing events (2018 events 2 and 3, and 2019 event 1) from 1/1/2018 - 9/17/2019. The findings include: 1. For 2018 testing event 2, the laboratory director failed to sign the chemistry-miscellaneous and hematology PT attestation statements. 2. For 2018 testing event 3, the laboratory director failed to sign the immunohematology PT attestation statement. 3. For 2019 testing event 1, the laboratory director failed to sign the chemistry-miscellaneous and immunohematology PT attestation statements. 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 procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on review of the Laboratory Test List & Annual Volume form, proficiency testing (PT) records, and confirmed by laboratory personnel identifier #2 (refer to the Laboratory Personnel Report) at approximately 8:30 am on 9/17/2019, the laboratory 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 -- failed to verify the accuracy of the analytes, manual white blood cell differential and qualitative serum human chorionic gonadotropin (hCG), at least twice annual for three out of three time periods from 1/1/2018 - 9/17/2019. The findings include: 1. The laboratory performed both automated white blood cell differentials and manual white blood cell differentials. 2. The laboratory enrolled in PT for their primary method, automated white blood cell differentials. 3. The laboratory performed quantitative serum hCG, qualitative urine hCG, and qualitative serum hCG testing. 4. The laboratory enrolled in PT for their primary methods quantitative serum hCG and qualitative urine hCG. 5. At the time of the survey, the laboratory did not have records verifying the accuracy twice annually for their non-primary methods, manual white blood cell differentials and qualitative serum hCG testing, from 1/1/2018 - 9/17/2019. -- 2 of 2 --

Summary Statement of Deficiencies No Tags No deficiency details available. 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 --