Unitypoint Health-Grinnell Regional Medical Center

Summary Statement of Deficiencies D5473 CONTROL PROCEDURES CFR(s): 493.1256(e)(2)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (2) Each day of use (unless otherwise specified in this subpart), test staining materials for intended reactivity to ensure predictable staining characteristics. Control materials for both positive and negative reactivity must be included, as appropriate. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on lack of quality control records, review of patient test reports, and confirmed by laboratory personnel identifier #2 (refer to the Laboratory Personnel Report) at approximately 1:00 pm on 08/31/2021, the laboratory failed to document the Hematoxylin and Eosin stain quality each day of patient testing for one patient (patient identifier A) having fine needle aspirate (FNA) adequacy testing performed on 03/09/2021. The findings include: 1. Patient identifier A had an FNA performed on 03/09/2021. 2. At the time of the survey, the laboratory did not have Hematoxylin and Eosin stain quality records for the FNA testing performed on 03/09/2021. THIS IS A REPEAT DEFICIENCY CITE ON 05/24/2017. 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 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 -- 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 #2 (refer to the Laboratory Personnel Report) at approximately 1:00 pm on 08/31/2021, the laboratory failed to indicate the name and address of the laboratory performing fine needle aspirate (FNA) adequacy testing for one out of one patient (patient identifier A) tested in March 2021. The findings include: 1. The CLIA Application for Certification, Form-116 identified the name and address of the testing facility as: UnityPoint Health- Grinnell Regional Medical Center 210 4th Avenue Grinnell, Iowa 50112 2. Patient identifier A had a FNA performed at this location on 03/09/2021. 3. At the time of the survey, personnel identifier #2 confirmed that the test report for patient identifier A did not include the name and address of the laboratory that performed the FNA testing. -- 2 of 2 --

Summary Statement of Deficiencies D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(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-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: A. Based on review of Avoximeter 4000 procedure, quality control (QC) records, and confirmed by laboratory personnel identifier #2 (refer to the Laboratory Personnel Report) at approximately 2:15 pm on 6/26/2019, the laboratory failed to perform the optical QC filters for the Avoximeter 4000 as established by the laboratory for one out of four weeks and one out of one day of patient testing in November 2018. The findings include: 1. On 11/12/2018, Patient identifier A had a carboxyhemoglobin performed using the Avoximeter 4000 analyzer. 2. The procedure for the Avoximeter 4000 analyzer states, "The optical QC filters (yellow and orange) will be analyzed each day of testing and weekly." 3. QC records indicated the laboratory performed the yellow optical QC filter on: 11/9/18, 11/23/18, and 11/30/18, and the orange optical filter on: 11/9/18, 11/16/18, 11/23/18, and 11/30/18. 4. The laboratory did not have documentation of the weekly yellow optical QC filter being performed from 11/9/18 - 11/23/18. 5. The laboratory did not have documentation of the yellow and orange optical QC filter being performed on 11/12/18 (the day of patient testing). 6. At the time of the survey, the laboratory did not have additional optical QC filter records from November 2018. 37401 B. Based on lack of Individualized Quality Control Plan (IQCP) records, review of quality control (QC) records and confirmed by 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 3 -- personnel identifier #2 (refer to the Laboratory Personnel Report) at approximately 11: 30 am on 06/26/2019, the laboratory failed to perform a positive and negative control each day of patient testing for the Alere Determine Human Immunodeficiency Virus (HIV) 1/2 test system. The findings include: 1. The laboratory performed QC with each new lot and shipment of test cartridges. 2. Laboratory personnel identifier #2 indicated that the laboratory intended to follow manufacturer's instructions for performing QC. 3. At the time of the survey, the laboratory did not have an IQCP for the Alere Determine HIV 1/2 test system. 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 identifier #2 (refer to the Laboratory Personnel Report) at approximately 10:00 am on 06/26/2019, the laboratory director failed to ensure that prior to testing patients' specimens, all personnel performing arterial blood gas (ABG) testing received the appropriate training for three out of nine new testing personnel (identifiers #12, #13, and #17) hired since the last survey on 05/24/2017. At the time of the survey, the laboratory did not have training records available for laboratory personnel identifiers #12, #13, or #17. D6063 LABORATORY TESTING PERSONNEL CFR(s): 493.1421 The laboratory must have a sufficient number of individuals who meet the qualification requirements of 493.1423, to perform the functions specified in 493. 1425 for the volume and complexity of tests performed. This CONDITION is not met as evidenced by: Based on review of laboratory personnel records and confirmed by laboratory personnel identifier #2 (refer to the Laboratory Personnel Report) at approximately 10: 00 am on 06/26/2019, the laboratory failed to meet the testing personnel requirements by providing documentation to qualify the testing personnel who perform moderate complexity testing as specified in standard D6065. D6065 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(1)(2)(3)(4)(i) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located or have earned a doctoral, master's, or bachelor's degree in a -- 2 of 3 -- chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; or (b)(2) Have earned an associate degree in a chemical, physical or biological science or medical laboratory technology from an accredited institution; or (b)(3) Be a high school graduate or equivalent and have successfully completed an official military medical laboratory procedures course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); or (b)(4)(i) Have earned a high school diploma or equivalent; and This STANDARD is not met as evidenced by: Based on review of laboratory personnel records and confirmed by laboratory personnel identifier #2 (refer to the Laboratory Personnel Report) at approximately 10: 00 am on 06/26/2019, the laboratory failed to have documentation to qualify three out of 17 testing personnel (identifiers #12- #14) who perform moderate complexity testing. -- 3 of 3 --