Audubon County Memorial Hospital

Summary Statement of Deficiencies D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) (d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on review of the hematology and blood gas instrument operator's manuals and confirmed by interview with General Supervisor #1 (GS #1) at 1:00 pm on 02/27 /2025, the laboratory director failed to approve, sign, and date all laboratory policies and procedures. The findings include: 1. The laboratory used the Sysmex XN-450 test system to perform hematology testing and the Opti CCA- TS2 test system to perform blood gas testing. 2. The laboratory intended to use the electronic operator's manuals as the procedure manual for both test systems. 3. At the time of the survey, GS #1 confirmed the laboratory director did not approve, sign, or date the Sysmex XN-450 or Opti CCA-TS2 operator's manuals. D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) (b)(2)(i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (b)(2)(ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on review of the 2024 September maintenance checklist, the laboratory's blood 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 -- bank policy and procedure manual, and confirmed by interview with General Supervisor #1 (GS #1) at 12:00 pm on 02/27/2025, the laboratory failed to document monthly blood bank dispenser volume checks for one out of three months reviewed from August 2024- October 2024. The findings include: 1. The laboratory used an Ortho MTS saline dispenser to perform immunohematology testing. 2. The 2024 September maintenance checklist indicated that blood bank dispenser volume checks would be performed monthly. 3. At the time of the survey, GS #1 confirmed the laboratory did not document monthly blood bank dispenser volume checks in September 2024. In addition, GS #1 confirmed the laboratory did not have a written policy/procedure for performing blood bank dispenser volume checks. This is a repeat deficiency previously cited on 03/22/2023. D5801 TEST REPORT CFR(s): 493.1291(a) (a) The laboratory must have an adequate manual or electronic system(s) in place to ensure test results and other patient-specific data are accurately and reliably sent from the point of data entry (whether interfaced or entered manually) to final report destination, in a timely manner. This includes the following: (a)(1) Results reported from calculated data. (a)(2) Results and patient-specific data electronically reported to network or interfaced systems. (a)(3) Manually transcribed or electronically transmitted results and patient-specific information reported directly or upon receipt from outside referral laboratories, satellite or point-of-care testing locations. This STANDARD is not met as evidenced by: Based on review of patient test reports, PolyMedco Sedimat 15 instrument printouts, and confirmed by interview with general supervisor identifier #1 (GS #1) at 12:25 pm on 02/27/2025, the laboratory failed to have a system in place to ensure the accuracy and reliability of erythrocyte sedimentation rate (ESR) test results manually transcribed into the laboratory's electronic health record (EHR) for one out of one patient test report reviewed from February 2025. The findings include: 1. Patient A had ESR testing performed on 02/19/2025. 2. Patient A's EHR record recorded the test result as 8 mm/hr. 3. Review of patient A's PolyMedco Sedimat 15 instrument printout showed the result to be 5 mm/hr. 4. At the time of the survey, GS #1 confirmed patient A's EHR record did not include the correct test result. In addition, GS #1 confirmed the laboratory did not have a system in place to ensure the accurate and reliable transcription of manual test results into the EHR. -- 2 of 2 --

Summary Statement of Deficiencies D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must: (i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on lack of MTS-dispenser volume check records and confirmed by laboratory personnel identifier #1 (refer to the Laboratory Personnel Report) at approximately 11: 30 am on 3/22/2023, the laboratory failed to define the frequency for performing volume checks on the MTS-dispenser used for blood bank testing. Additionally, the laboratory failed to perform MTS-dispenser volume checks from 1/1/2021 - 3/24 /2023. D6055 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 whenever test methodology or instrumentation changes. The individual's performance must be reevaluated to include the use of the new test methodology or instrumentation prior to reporting patient 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 -- This STANDARD is not met as evidenced by: Based on review of personnel training and competency records and confirmed by laboratory personnel identifier #1 (refer to the Laboratory Personnel Report), at approximately 9:30 am on 3/22/2023, the technical consultant failed to document training for the Sysmex XN-L 450 and Qiastat test systems prior to reporting patient test results for two out of two testing personnel (identifiers #1 and #2). The findings include: 1. The laboratory began using the Sysmex XN-L 450 hematology analyzer in October of 2021. 2. The laboratory began using the Qiastat test system in March of 2021. 3. At the time of the survey, the laboratory did not have training records for testing personnel identifiers #1 and #2. -- 2 of 2 --

Summary Statement of Deficiencies D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on review of the Clinical Laboratory Improvement Amendments (CLIA) Application for Certification, Form-116, patient test reports and confirmed by laboratory personnel identifier #1 (refer to the Laboratory Personnel Report) at approximately 9:30 am on 04/15/2021, the laboratory failed to indicate the name and address of the laboratory performing frozen section testing for one out of one patient (patient identifier A) tested in November 2020. The findings include: 1. The CLIA Application for Certification, Form-116 identified the name and address of the testing facility as: Audubon County Memorial Hospital 515 Pacific Avenue Audubon, IA 50025 2. Patient identifier A had a frozen section performed at this location on 11/17 /2020. 3. At the time of the survey, personnel identifier #1 confirmed that the test report for patient identifier A did not include the name and address of the laboratory that performed the frozen section 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 1 --

Summary Statement of Deficiencies D5783