Manning Regional Healthcare Center

Summary Statement of Deficiencies 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 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 8:37 am on 4/9/2025, the laboratory failed to perform a self evaluation when the laboratory received ungraded PT scores from six out of six testing events from 01/01/2023- 12/31/2024. The findings include: 1. For 2023 event 1, the laboratory received a not graded score for alanine aminotrasferase specimen CET-1. 2. For 2023 event 2, the laboratory received not graded scores for mean platelet volume specimens AF5-6, AF5-7, AF5-8, AF5-9, and AF5-10. 3. For 2023 event 3, the laboratory received not graded scores for red cell distribution width and mean platelet volume specimens AF5-11, AF5-12, AF5-13, AF5-14, and AF5-15. 4. For 2024 event 1, the laboratory received not graded scores for urine propoxyphene specimen UD-1 and Norovirus GI/GII (Biofire) specimen EP-5. 5. For 2024 event 2, the laboratory received not graded scores for Adenovirus F40/41 (Biofire) specimen EP-7, Salmonella species (Biofire) specimen EP-9, total iron binding capacity specimen CET-8, and serum osmolality specimens CET-6, CET-7, CET-8, CET-9, and CET-10. 6. For 2024 event 3, the laboratory received not graded scores for total iron binding capacity and serum osmolality specimens CET-11, CET-12, CET-13, CET-14, and CET-15. 7. At the time of the survey, GS #1 confirmed the laboratory failed to perform a self evaluation for the above ungraded PTscores. D5221 EVALUATION OF PROFICIENCY TESTING 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 -- 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 8:37 am on 4/9/2025, the laboratory failed to take and document

Summary Statement of Deficiencies D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: Based on review of proficiency testing (PT) records and confirmed by laboratory personnel identifier #1 (refer to the Laboratory Personnel Report) at approximately 9: 30 am on 03/22/2023, the laboratory failed to retain PT records for two out of six testing events from 1/1/2021 - 12/31/2022. The findings include: 1. For 2021 event 1, the laboratory failed to retain the signed PT attestation form for the WSLH PT 2021 Coag1 testing event. 2. For 2022 event 3, the laboratory failed to retain the signed PT attestation form for the WSLH PT 2022 Cardiac3 testing event. 3. At the time of the survey, the laboratory did not have the PT attestation statements listed above. D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) 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)(11) Ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Based on review of personnel records and confirmed by laboratory personnel 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 -- identifier #1 (refer to the Laboratory Personnel Report) at approximately 8:20 am on 03/22/2023, the laboratory director failed to ensure that prior to testing patient specimens, testing personnel performing moderate complexity testing received the appropriate training for one out of five new testing personnel (personnel identifier #3) hired since the last survey on 07/15/2021. At the time of the survey, the laboratory did not have training records available for personnel identifier #3. D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on review of personnel records and confirmed by laboratory personnel identifier #1 (refer to the Laboratory Personnel Report) at approximately 8:20 am on 03/22/2023, the technical consultant failed to assess the competency of individuals performing moderate complexity testing at least semiannually during the first year the individual tests patient specimens for one out of five new testing personnel (personnel identifier #6) who began performing patient testing since the last survey on 07/15 /2021. At the time of the survey, the laboratory did not have a semiannual competency assessment for personnel identifier #6. D6128 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least annually after the first year, unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individual's performance must be reevaluated to include the use of the new test methodology or instrumentation. This STANDARD is not met as evidenced by: Based on review of personnel records and confirmed by laboratory personnel identifier #1 (refer to the Laboratory Personnel Report) at approximately 8:20 am on 03/22/2023, the technical supervisor failed to assess and document the competency of individuals performing high complexity testing at least annually for one out of one testing personnel (laboratory personnel identifier #2) in 2021. -- 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 fails to successfully participate in a proficiency testing program for the analyte, total bilirubin for two out of three consecutive proficiency testing events: 2021 event 3 and 2022 event 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 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, total bilirubin, for two out of three testing events for unsuccessful participation. The laboratory received unsatisfactory performance scores of 60% for 2021 testing event 3 and 20% for 2022 testing event 2. -- 2 of 2 --

Summary Statement of Deficiencies D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 Each laboratory that performs nonwaived testing must meet the applicable requirements under 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State Operations Manual (CMS Pub. 7). (a) Reporting of SARS-CoV-2 test results During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: Based on review of the Laboratory Test List & Annual Volume form, the BioFire Film Array Torch - Procedure, and confirmed by laboratory personnel identifier #1 (refer to the Laboratory Personnel Report) at approximately 12:30 pm on 7/15/2021, the laboratory failed to report negative SARS-CoV-2 test results to the Iowa Department of Public Health (IDPH) for 13 out of 14 days of patient testing from 3/1 /2021 - 3/31/2021. The findings include: 1. The Laboratory Test List & Annual Volume form stated the laboratory performed SARS-CoV-2 testing using the BioFire Film Array Torch and the Abbott ID Now test systems. 2. The BioFire Film Array Torch - Procedure stated, "If a sample is positive for severe acute respiratory syndrome coronavirus (SARS-CoV-2) it needs to be emailed to IDPH as soon as possible." 3. The laboratory received negative SAR-CoV-2 results using the BioFire Film Array Torch on the following dates: *3/1/21 - 1 patient *3/4/21 - 2 patients *3/11 /21 - 1 patient *3/13/21 - 1 patient *3/15/21 - 1 patient *3/17/21 - 2 patients *3/19/21 - 1 patient *3/23/21 - 3 patients *3/24/21 - 1 patient *3/25/21 - 4 patients *3/27/21 - 1 patient *3/29/21 - 4 patients *3/30/21 - 4 patients 4. At the time of the survey, the laboratory did not have documentation of sending the negative SARS-CoV-2 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 -- using the BioFire Film Array Torch test system to IDPH. 5. At the time of the survey, the laboratory provided documentation of sending positive SARS-CoV-2 results using Biofire Film Array Torch and positive and negative SARS-CoV-2 results using the Abbott ID Now test systems to IDPH. D5775 COMPARISON OF TEST RESULTS 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. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: Based on review of proficiency testing (PT) records, the Laboratory Test List and Annual Volume report, and confirmed by laboratory personnel identifier #1 (refer to Laboratory Personnel Report) at approximately 10:45 am on 07/15/2021, the laboratory failed to evaluate the accuracy for manual white blood differential testing twice annually for three out of three semiannual time periods (1/1/2020 - 7/15/2021). The findings include: 1. The Laboratory Test List and Annual Volume report stated the laboratory performed both manual and automated white blood cell differentials. 2. Review of PT records indicated the laboratory performed PT testing for automated white blood cell differentials, but not manual white blood cell differentials. 3. At the time of the survey, the laboratory did not verify the accuracy of manual white blood cell differentials twice annually. -- 2 of 2 --

Summary Statement of Deficiencies D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 Each laboratory that performs nonwaived testing must meet the applicable requirements under 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State Operations Manual (CMS Pub. 7). (a) Reporting of SARS-CoV-2 test results During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: Based on review of the Laboratory Test List & Annual Volume form, the BioFire Film Array Torch - Procedure, and confirmed by laboratory personnel identifier #1 (refer to the Laboratory Personnel Report) at approximately 12:30 pm on 7/15/2021, the laboratory failed to report negative SARS-CoV-2 test results to the Iowa Department of Public Health (IDPH) for 13 out of 14 days of patient testing from 3/1 /2021 - 3/31/2021. The findings include: 1. The Laboratory Test List & Annual Volume form stated the laboratory performed SARS-CoV-2 testing using the BioFire Film Array Torch and the Abbott ID Now test systems. 2. The BioFire Film Array Torch - Procedure stated, "If a sample is positive for severe acute respiratory syndrome coronavirus (SARS-CoV-2) it needs to be emailed to IDPH as soon as possible." 3. The laboratory received negative SAR-CoV-2 results using the BioFire Film Array Torch on the following dates: *3/1/21 - 1 patient *3/4/21 - 2 patients *3/11 /21 - 1 patient *3/13/21 - 1 patient *3/15/21 - 1 patient *3/17/21 - 2 patients *3/19/21 - 1 patient *3/23/21 - 3 patients *3/24/21 - 1 patient *3/25/21 - 4 patients *3/27/21 - 1 patient *3/29/21 - 4 patients *3/30/21 - 4 patients 4. At the time of the survey, the laboratory did not have documentation of sending the negative SARS-CoV-2 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 -- using the BioFire Film Array Torch test system to IDPH. 5. At the time of the survey, the laboratory provided documentation of sending positive SARS-CoV-2 results using Biofire Film Array Torch and positive and negative SARS-CoV-2 results using the Abbott ID Now test systems to IDPH. D5775 COMPARISON OF TEST RESULTS 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. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: Based on review of proficiency testing (PT) records, the Laboratory Test List and Annual Volume report, and confirmed by laboratory personnel identifier #1 (refer to Laboratory Personnel Report) at approximately 10:45 am on 07/15/2021, the laboratory failed to evaluate the accuracy for manual white blood differential testing twice annually for three out of three semiannual time periods (1/1/2020 - 7/15/2021). The findings include: 1. The Laboratory Test List and Annual Volume report stated the laboratory performed both manual and automated white blood cell differentials. 2. Review of PT records indicated the laboratory performed PT testing for automated white blood cell differentials, but not manual white blood cell differentials. 3. At the time of the survey, the laboratory did not verify the accuracy of manual white blood cell differentials twice annually. -- 2 of 2 --