Iowa Specialty Hospital - Clarion

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 laboratory test menu, lack of blood gas calibration records and confirmed by interview with general supervisor identifier #1 (GS #1) at 12:44 pm on 3 /25/2025, the laboratory failed to retain blood gas calibration records for two out of two years from 3/25/2023 - 3/25/2025. The findings include: 1. The laboratory test list indicated the laboratory performed pH, partial pressure oxygen (pO2), partial pressure carbon dioxide (pCO2), oxyhemoglobin, carboxyhemoglobin, and methemoglobin using the RAPIDPoint 500e blood gas analyzer. 2. GS #1 confirmed that the RAPIDPoint 500e blood gas analyzer automatically performed calibrations daily. 3. GS #1 also confirmed the blood gas analyzer would internally store the calibration data. The laboratory intended to periodically download the calibration data as a way to retain the data. 4. Lack of pH, pO2, pCO2, oxyhemoglobin, carboxyhemoglobin, and methemoglobin revealed that the laboratory did not retain blood gas calibration records from 3/25/2023 - 3/25/2025. 5. GS #1 confirmed the lack of calibration records. The GS #1 did not realize the laboratory failed to download the calibration data from the blood gas analyzer. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be 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 2 -- This STANDARD is not met as evidenced by: Based on review of proficiency test (PT) records and confirmed by the general supervisor identifier #1 (GS #1) at 11:18 am on 3/25/2025, the laboratory failed to take and document correct action when the laboratory received unaccepable PT results for four out of six testing events from 1/1/2023 - 12/31/2024. The findings include: 1. For 2023 event 1, the laboratory received an unacceptable score of 80% for the analyte, hematocrit (specimen XE-3). 2. For 2023 event 2, the laboratory received an unacceptable score of 80% for the analyte, partial oxygen pressure (pO2) (specimen BG-10). 3. For 2024 event 1, the laboratory received an unacceptable score of 80% for the analyte, parathyroid hormone (specimen IAS-02). 4. For 2024 event 2, the laboratory received an unacceptable score of 80% for the analyte, Enterococcus faecium (Biofire, specimen BCP-07). 5. GS #1 confirmed the laboratory did not take and document

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 review of proficiency records and reports, the laboratory fails to successfully participate in a proficiency testing program for the analyte, thyroid- stimulating hormone (TSH), for two consecutive proficiency testing events: 2017 event 3 and 2018 event 1 (refer to D2107). D2107 ENDOCRINOLOGY CFR(s): 493.843(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 review of proficiency testing reports and records, the laboratory fails to achieve satisfactory performance for the analyte, thyroid-stimulating hormone (TSH), in two consecutive testing events for unsuccessful participation. The laboratory received unsatisfactory performance scores of 40% for 2017 testing event 3 and zero for 2018 testing event 1. -- 2 of 2 --