Davis County Hospital

Summary Statement of Deficiencies D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on review of calibration records, lack of calibration verification records, and confirmed by laboratory personnel identifier #2 (refer to the Laboratory Personnel Report) at approximately 2:30 pm on 01/26/2023, the laboratory failed to perform and document calibration verification every 6 months for D-dimer testing for one out of two time periods from 03/21/2022- 01/26/2023. The findings include: 1. The laboratory calibrated and began using a new lot number of Innovance D-dimer reagent 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 -- (lot 568816, expiration 06/20/2023) for patient testing on 03/21/2022. 2. At the time of the survey, the laboratory did not have additional calibration or calibration verification records for D-dimer reagent lot number 568816, expiration 06/20/2023. D5507 BACTERIOLOGY CFR(s): 493.1261(b)(c) (b) For antimicrobial susceptibility tests, the laboratory must check each batch of media and each lot number and shipment of antimicrobial agent(s) before, or concurrent with, initial use, using approved control organisms. (b)(1) Each day tests are performed, the laboratory must use the appropriate control organism(s) to check the procedure. (b)(2) The laboratory's zone sizes or minimum inhibitory concentration for control organisms must be within established limits before reporting patient results. (c) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on review of antimicrobial susceptibility testing (AST) quality control (QC) records, the laboratory's AST Individualized Quality Control Plan (IQCP), and confirmed by laboratory personnel identifier #2 (refer to the Laboratory Personnel Report) at approximately 12:15 pm on 01/26/2023, the laboratory failed to perform one out of five QC organisms for gram positive AST QC for one out of four weeks in July 2022. The findings include: 1. The laboratory's written IQCP stated that the following QC organisms would be performed weekly for gram positive panels: Staphylococcus aureus 29213, Enterococcus faecalis 29212, Escherichia coli 35218, Staphylococcus aureus BAA-977, and Staphylococcus aureus 43300. 2. The laboratory performed gram positive AST QC testing on 07/03/2022, 07/12/2022, 07/17 /2022, and 07/24/2022. 3. On 07/12/2022, the laboratory had gram positive AST QC records for the organisms, Staphylococcus aureus 29213, Enterococcus faecalis 29212, Staphylococcus aureus BAA-977, and Staphylococcus aureus 43300. 4. At the time of the survey, personnel identifier #2 confirmed that the laboratory did not have AST QC records for the organism, Escherichia coli 35218, from 07/12/2022. D5783

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 identifier #1 (refer to Laboratory Personnel Report) at approximately 11:00 am on 05 /05/2021, the laboratory failed to enroll in an approved proficiency testing program for the analyte, rheumatoid factor for two out of two years. The laboratory did not enroll in an approved proficiency testing program in 2020 or 2021 for the analyte rheumatoid factor. D5024 HEMATOLOGY CFR(s): 493.1215 If the laboratory provides services in the specialty of Hematology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1269, and 493. 1281 through 493.1299. This CONDITION is not met as evidenced by: Based on review of coagulation reagent verification records, observations of the 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 -- coagulation analyzer and confirmed by laboratory personnel identifier #2 (refer to the Laboratory Personnel Report) at approximately 1:30 pm on 5/5/2021, the laboratory fails to meet the hematology (coagulation) requirements for test system/equipment /reagent verification as specified in the standard D5411. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on review of the Laboratory Test List & Annual Volume report, proficiency testing records and confirmed by laboratory personnel identifier #1 (refer to Laboratory Personnel Report) at approximately 1:00 pm on 5/5/2021, the laboratory failed to verify the accuracy twice annually for the analyte, lactoferrin for 3 out of 3 time periods from 1/1/2020 - 5/5/2021. The findings include: 1. The Laboratory Test List & Annual Volume report indicated the laboratory performed lactoferrin testing. 2. At the time of the survey, the laboratory did not enroll in proficiency testing for the analyte lactoferrin. The laboratory did not have any additional records indicating the laboratory verified the accuracy twice annually for lactoferrin testing. D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on review of coagulation reagent verification records, observations of the coagulation analyzer and confirmed by laboratory personnel identifier #2 (refer to the Laboratory Personnel Report) at approximately 1:30 pm on 5/5/2021, the laboratory failed to have the correct normal patient mean programmed into the ACL Elite coagulation analyzer for lot number N0998826, expiration date 09/2021 of prothrombin time reagent. The findings include: 1. The coagulations reagent verification records indicate the normal patient mean of 11.63 for lot number N0998826, expiration date 09/2021 of prothrombin time reagent. 2. At the time of the survey, the laboratory had the normal patient mean of 11.4 programmed into the ACL Elite coagulation analyzer. 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 -- 2 of 3 -- 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 Clinical Laboratory Improvement Amendment (CLIA) application (Form CMS-116), patient test reports and confirmed by laboratory personnel identifier #1 (refer to Laboratory Personnel Report) at approximately 12:30 pm on 05/05/2021, the laboratory failed to indicate the name and address of the testing facility for four out of 12 patient test reports from December 2020. The findings include: 1. Patient identifier A had mycoplasma testing performed on 12/15/20. 2. Patient identifier B had an erthrocyte sedimentation rate performed on 12/17/20. 3. Patient identifier C had a comprehensive chemistry panel performed on 12/17/20. 4. Patient identifier D had microalbumin testing performed on 12/18/20. 5. The CLIA application indicated the name and address of the facility as Davis County Hospital, 509 N Madison St, Bloomfield, IA, 52537. 6. The test report for the above four patients indicated the name and address of the testing facility as Davis County Medical Associates, 509 N Madison St, Suite 100, Bloomfield, IA, 52537. -- 3 of 3 --

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 (PT) records, the Laboratory Test List & Volume form, and confirmed by laboratory personnel identifier #3 (refer to the Laboratory Personnel Report) at approximately 12:30 pm on 01/16/2019, the laboratory failed to enroll in an approved proficiency testing program for one out of one year (2018) for the analytes: immunoglobulin A (IgA), immunoglobulin G (IgG), immunoglobulin M (IgM), rheumatoid factor (RF), complement C3, and complement C4. The findings include: 1. The Laboratory Test List & Annual Volume form included the analytes, IgA, IgG, IgM, RF, complement C3, and complement C4. 2. The laboratory installed and began using a new chemistry analyzer (Beckman Coulter AU480) in December 2017. 3. Personnel identifier #3 stated that the laboratory forgot to enroll in PT after the new install and did not perform PT for the analytes, IgA, IgG, IgM, RF, complement C3, and complement C4. 4. At the time of the survey, personnel identifier #3 confirmed that the laboratory did not enroll in PT testing in 2018 for the following analytes: IgA, IgG, IgM, RF, complement C3, and complement C4. D5215 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 3 -- 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 laboratory personnel identifier #3 (refer to the Laboratory Personnel Report) at approximately 11: 00 am on 01/16/2019, the laboratory failed to perform a self evaluation of ungraded PT scores for four out of six PT testing events in 2017 and 2018 (2017 events 1 and 2 and 2018 events 2 and 3). The findings include: 1. For 2017 testing event 1, the laboratory received ungraded PT test scores for the following: *2017 Chemistry Core 1st event- triglycerides (specimen CH-01) and free thyroxine (specimen CH-01) 2. For 2017 testing event 2, the laboratory received ungraded PT test scores for the following: *2017 Microbiology 2nd event- campylobacter (specimen CPL-03) 3. For 2018 testing event 2, the laboratory received ungraded PT test scores for the following: *2018 Hematology and Coagulation 2nd event- blood cell identification (specimen BCL-10) and partial thromboplastin time (specimen COA-07) *2018 Microbiology 2nd event- blood culture (specimen BL-01) and minimum inhibitory concentration testing/piperacillin/tazobactam (specimen UR-06) 4. For 2018 testing event 3, the laboratory received ungraded PT test scores for the following: *2018 Hematology and Coagulation 3rd event- partial thromboplastin time (specimen COA- 12) 5. At the time of the survey, the laboratory did not have additional documentation or