Avera Merrill Pioneer

Summary Statement of Deficiencies D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on review of proficiency testing records and confirmed by laboratory personnel identifiers #3 and #5 (refer to Laboratory Personnel Report) at approximately 9:00 am on 05/19/2021, the laboratory failed to enroll in an approved proficiency testing (PT) program for the analyte, blood alcohol, for three out of three years. At the time of the survey, personnel identifiers #3 and #5 confirmed that the laboratory did not enroll in PT for the analyte, blood alcohol, in 2019, 2020, or 2021. 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 patient test reports, instrument printouts and confirmed by laboratory personnel identifiers #3 and #5 (refer to the Laboratory Personnel Report) at approximately 11:40 am on 05/19/2021, the laboratory failed to include all units of measure for two out of 13 patient test reports (patient identifiers A and B). The findings include: 1. Patient A had complete blood count (CBC) testing performed on 11/02/2020. 2. The electronic health record (EHR) test report for patient A did not include units of measure for the following CBC parameters: mean corpuscular volume (MCV) and mean corpuscular hemoglobin concentration (MCHC). 3. Patient B had erythrocyte sedimentation rate (ESR) testing performed on 11/06/2020. 4. The EHR test report for patient B did not include the unit of measure for the ESR. 5. At the time of the survey, personnel identifiers #3 and #5 confirmed that the EHR test reports for patients A and B did not include the units of measure listed above. -- 2 of 2 --

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. This STANDARD is not met as evidenced by: Based on review of calibration records and confirmed by laboratory personnel #2 (refer to the Laboratory Personnel Report) at approximately 3:30 pm on 10/23/2019, the laboratory failed to retain daily calibration records for the analytes: sodium, potassium, and chloride for 146 out of 146 days (5/1/2019 - 9/23/2019). The findings include: 1. On 5/1/2019, the laboratory began performing patient testing for the analytes: sodium, potassium and chloride. 2. The chemistry analyzer required the laboratory calibrate the analytes: sodium, potassium and chloride each day of patient testing. 3. The laboratory retained the calibrations electronically on the chemistry analyzer. 4. At the time of the survey, the laboratory discovered the chemistry analyzer only retained the calibrations for the analytes: sodium, potassium, and chloride for 30 days. 5. The laboratory did not have calibration records for the analytes: sodium, potassium and chloride from 5/1/2019 - 9/23/2019. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. 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 immunohematology policies and procedures and confirmed by laboratory personnel identifier #2 (refer to the Laboratory Personnel Report) at approximately 9:15 am on 10/24/2019, the laboratory failed to have a procedure for performing transfusion reaction investigation(s) and a procedure for the screening and dosing for Rh immune globulin (Rhogam). D6094 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures and confirmed by laboratory personnel identifier #2 (refer to the Laboratory Personnel Report) on 10/24/2019 at approximately 11:00 am, the laboratory director failed to ensure that the laboratory established a written quality assessment procedure that included the four quality systems: general laboratory, pre analytical, analytical, and post analytical. -- 2 of 2 --