Iowa Specialty Hospital Belmond

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, blood gas quality control (QC) and calibration records and confirmed by interview with general supervisor identifier #1 (GS #1) at 9:37 am on 3/26/2025, the laboratory failed to retain blood gas QC records for 51 out of 177 days and calibration records for 149 out of 177 days from 10/1/2024 - 3/26/2025. 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 QC and calibrations daily. 3. GS #1 also confirmed the blood gas analyzer would internally store the QC and calibration data and the laboratory would periodically download the information as a way to retain the data. The laboratory learned the day of the survey, the blood gas analyzer would only store a set number of data points for QC and calibration. 4. Review of pH, pO2, pCO2, oxyhemoglobin, carboxyhemoglobin, and methemoglobin QC records revealed that the laboratory did not retain the QC records on 11/4/2024 - 12/4/2024 and 1/16/2025 - 2/6/2025. 5. Review of pH, pO2, pCO2, oxyhemoglobin, carboxyhemoglobin, and methemoglobin calibration records revealed that the laboratory did not retain the calibration records on 10/1/2024 - 10/29/2024, 11/5/2024 - 1/8/2025 and 1/16/2025 - 3 /11/2025. 6. GS #1 confirmed the lack of QC and calibration records. D5775 COMPARISON OF TEST RESULTS 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 -- 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 review of the laboratory test list and confirmed by interview with general supervisor identifier (GS #1) at 11:05 am on 03/26/2025, the laboratory failed to perform comparison testing twice annually for four out of four time periods from 3/26 /2023 - 3/26/2025 for Clostridium difficile testing. The findings include: 1. The laboratory test list indicated the laboratory performed Clostridium difficile testing using the Alere C. Diff Quik Check, Cepheid GeneXpert, and BioFire Torch test systems. 2. At the time of the survey, GS #1 confirmed the laboratory did not perform comparison testing for Clostridium difficile testing between the three different test system from 3/26/2023 - 3/26/2025. -- 2 of 2 --

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 the Certification and Survey Provider Enhanced Reporting (CASPER) 155 report and graded results from the American Proficiency Institute (API), the laboratory failed to successfully participate in two consecutive testing events for the analytes, PH and partial pressure of carbon dioxide (PCO2). The laboratory had unsatisfactory scores for 2024 events1 and 2. Refer to D2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) 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 -- Failure to achieve satisfactory performance for the same analyte or test in two 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 the Certification and Survey Provider Enhanced Reporting (CASPER) 155 report and graded results from the American Proficiency Institute (API), the laboratory failed to achieve satisfactory performance (100% or greater) for two consecutive testing events for the analytes, PH and partial pressure of carbon dioxide (PCO2). The findings include: 1. For the analyte, PH, the laboratory received unsatisfactory performance scores of 20% for 2024 testing event 1 and 60% for 2024 testing event 2. 2. For the analyte, PCO2, the laboratory received unsatisfactory performance scores of 40% for 2024 testing event 1 and 60% for 2024 testing event 2. 3. The CASPER 155 report and graded results from API confirm the findings listed above. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on review of the Certification and Survey Provider Enhanced Reporting (CASPER) 155 report and graded results from API (2024 events 1 and 2), the laboratory director failed to provide overall management and direction of the laboratory services. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on review of the Certification and Survey Provider Enhanced Reporting (CASPER) 155 report and graded results from the American Proficiency Institute (API), the laboratory director failed to ensure successful participation in an HHS approved proficiency testing program. Refer to D2096. -- 2 of 2 --

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 failed to successfully participate in a proficiency testing program for the analyte, partial pressure of oxygen (P02) for two out of three consecutive proficiency testing events: 2023 event 2 and 2024 event 1 (refer to 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 review of proficiency testing reports and records, the laboratory failed to achieve satisfactory performance for the analyte, partial pressure of oxygen (PO2) for two out of three testing events for unsuccessful participation. The laboratory received unsatisfactory performance scores of 60% for 2023 testing event 2 and 20% for 2024 testing event 1. -- 2 of 2 --

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 failed to successfully participate in a proficiency testing program for the analyte, arterial blood gas pCO2, for two out of three consecutive proficiency testing events: 2021 event 2 and 2022 event 1 (refer to 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 review of proficiency testing reports and records, the laboratory failed to achieve satisfactory performance for the analyte, arterial blood gas pCO2, for two out of three testing events for unsuccessful participation. The laboratory received unsatisfactory performance scores of 60% for 2021 testing event 2 and 20% for 2022 testing event 1. -- 2 of 2 --

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 failed to successfully participate in a proficiency testing program for the analyte, digoxin, for two consecutive proficiency testing events: 2020 events 1 and 2 (refer to D2096). D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is 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 -- unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of proficiency testing reports and records, the laboratory failed to achieve satisfactory performance for the analyte, digoxin, for two consecutive testing events for unsuccessful participation. The laboratory received unsatisfactory performance scores of 60% for 2020 testing event 1 and 20% for 2020 testing event 2. -- 2 of 2 --

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 review of Abbott Architect c4000 and Abbott Architect i1000SR performance specification records and confirmed by laboratory personnel identifier #2 (refer to the Laboratory Personnel Report) at approximately 1:30 pm on 02/27/2019, the laboratory failed to perform the performance specification of reportable range for three out of three new analytes (lactic acid, procalcitonin, and total testosterone) added from 2017-2018. The findings include: 1. The laboratory began performing patient testing on the Abbott Architect c4000 test system for the analyte, lactic acid, in November 2017. 2. The laboratory began performing patient testing on the Abbott Architect i1000sr test system for the analyte, procalcitonin, in November 2017. 3. The laboratory began performing patient testing on the Abbott Architect i1000sr test system for the analyte, total testosterone, in May 2018. 4. For the analytes, lactic acid, procalcitonin and total testosterone, the laboratory performed and documented the performance specifications of accuracy, precision and verification of the reference intervals. 5. At the time of the survey, personnel identifier #2 confirmed that the laboratory did not perform and document the performance specification of reportable range for the analytes, lactic acid, procalcitonin and total testosterone. 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 --