North Big Horn Hospital District

Summary Statement of Deficiencies D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on review of proficiency testing records and staff interview, the laboratory failed to maintain a copy of each step in the testing and reporting of the WSLH (Wisconsin State Laboratory of Hygiene) proficiency samples for 7 of 47 proficiency testing events reviewed from September 2022 through July 2024. The findings were: 1. Review of the proficiency testing records showed no evidence of the following documentation: a. 2023 WSLH Blood Gas Event #2, Blood Gas Event #3, Special Chemistry Event #2, and Semen Analysis Event #2 was missing the performance summary and comparative evaluation indicating the results had been reviewed by the technical supervisor. b. 2023 WSLH Coagulation/Hematology Event #3 was missing the performance summary and comparative evaluation indicating the results had been reviewed by the technical supervisor. In addition, the data submission form, the attestation form, and the worksheets/instrument printouts could not be located. c. 2022 WSLH Semen Analysis Event #2 failed to include the sample worksheets. d. 2022 WSLH Miscellaneous Event #2 was missing the performance summary and comparative evaluation indicating the results had been reviewed by the technical 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 -- supervisor. 2. Interview with the technical supervisor on 8/14/24 at 11:55 AM confirmed the proficiency testing documentation was incomplete. 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 records, lack of documentation, and staff interview, the laboratory failed to have a system in place for reviewing proficiency test results that received an artificial score of 100% for 3 of 47 WSLH (Wisconsin State Laboratory Hygiene) proficiency testing events reviewed from September 2022 to July 2024. The findings were: 1. Review of the WSLH 2023 Microbiology Event #1 proficiency testing evaluation showed the laboratory received an artificial score of 100% on the antibiotic susceptibility challenge. Minocycline and tetracycline were not scored due to an insufficient peer group; amoxicillin/clavulanate was not scored and the laboratory was directed to consult the event notes; and ceftriaxone was not scored due to non-consensus and a self-assessment was required. There was no documentation the results of the proficiency testing event had been evaluated for accuracy. 2. Review of the WSLH 2023 Chemistry/Endocrinology/Toxicology Event #1 proficiency testing evaluation showed the laboratory received an artificial score of 100% on the analyte of alanine aminotransferase and measured total iron binding capacity due to non-consensus and a self-assessment was required. There was no documentation the results of the proficiency testing event had been evaluated for accuracy. 3. Review of the WSLH 2022 Miscellaneous proficiency testing evaluation showed the laboratory received an artificial score of 100% on the manual identification of urine sediment. There was no documentation the results of the proficiency testing event had been evaluated for accuracy. 4. Interview with the technical supervisor on 8/14/24 at 11:55 AM confirmed no further documentation was available. D5431 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(2) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document function checks as defined by the manufacturer and with at least the frequency specified by the manufacturer. Function checks must be within the manufacturer's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on review of instrument maintenance records, lack of documentation, staff interview, and review of the Cepheid GeneXpertXpress operator's manual, the laboratory failed to follow the manufacturer's instructions to clean the cartridge bays and plunger rods on a quarterly basis for 5 of 6 quarters reviewed from January 2023 to June 2024. The findings were: 1. Review of the Cepheid GeneXpertXpress maintenance records showed no evidence the required quarterly maintenance on the -- 2 of 3 -- analyzer had been completed as required. 2. Review of the Cepheid GeneXpertXpress operator's manual showed the plunger rods and cartridge bays should be cleaned and disinfected quarterly (every 3 months). 3. Interview with technical supervisor on 8/15 /24 at 9:08 AM confirmed no further documentation was available. -- 3 of 3 --

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on review of the CMS (Centers for Medicare and Medicaid Services) 209 Laboratory Personnel Report, review of personnel records, policy and procedure review, and staff interview, the laboratory failed to ensure the technical supervisor and general supervisor's competency assessmenst were completed for 1 of 2 years (2021) reviewed. The findings were: 1. Review of the CMS 209 Laboratory Personnel Report showed the laboratory employed one staff member which performed the duties of the technical supervisor (TS) and the general supervisor. The following concerns were identified: a. Review of the technical supervisor/general supervisor's personnel record showed no evidence a competency assessment had been completed in 2021. b. Interview with the TS on 8/9/22 at 10:10 AM confirmed a competency assessment had not been completed in 2021. c. Review of the policy and procedure titled "Laboratory Testing Staff Competency", last reviewed 6/2/22, failed to include a procedure for assessing the competency of the technical supervisor and the general supervisor. d. Review of the policy and procedure titled "Delegation of Duties", issued on 5/2/22, showed the laboratory director was responsible for the assessment of technical supervisor/consultant responsibilities and competency and the "Technical Supervisor/consultant" was responsible for the assessment of the general supervisory tasks. D5431 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(2) 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 -- For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document function checks as defined by the manufacturer and with at least the frequency specified by the manufacturer. Function checks must be within the manufacturer's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on observation, review of the immunohematology records, lack of documentation, review of the Thermo Fisher Centra W cell washer/centrifuge operator's manual, and staff interview, the laboratory failed to follow the manufacturer's instructions to perform centrifuge and cell washer revolutions per minute (RPM) and timer checks every three months for 2 of 2 years (2021, 2022) reviewed. The laboratory performed approximately 111 immunohematology patient tests per year. The findings were: 1. Observation of the Centra W cell washer /centrifuge showed a maintenance sticker which showed the RPM and timer was checked 4/2022 and noted the next maintenance was due 4/2023. The previous years maintenance stickers were not visible. 2. Review of the immunohematology records showed no evidence the Centra W cell washer/centrifuge RPM and timer had been checked every 3 months as required. 3. Review of the Thermo Fisher Centra W cell washer/centrifuge operator's manual retrieved at https://assets.thermofisher.com/TFS- Assets/LED/manuals/D21694~.pdf on 8/13/22 specified RPM and speed function be checked once every 3 months. 4. Interview with the technical supervisor on 8/9/22 at 3:59 PM confirmed the

Summary Statement of Deficiencies D5407 PROCEDURE MANUAL CFR(s): 493.1251(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 procedure manual review, lack of documentation, and interview with staff, the director failed to sign and date as approved a procedure for least incompatible blood compatibility testing prior to use since 09/01/2018. Findings include: 1. Procedure manual review included emailed instructions for testing personnel to follow for crossmatching a patient with multiple antibodies. The procedure was used following the reference laboratory identification of multiple Red Blood Cell antibodies. 2. The special procedure for least incompatible crossmatch failed to include the director's signature and date of approval. 3. In an interview conducted on 09/01/2020 at approximately 5:00 P.M., and via email on 09/03/2020, the laboratory manager confirmed the director had not approved the procedure for least incompatible blood transfusions. Staff stated the same patient returned on a regular basis for transfusion and the laboratory used the least incompatible procedure for compatibility testing. D5431 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(2) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document function checks as defined by the manufacturer and with at least the frequency specified by the manufacturer. Function checks must be within the manufacturer's established limits before patient testing is conducted. 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 immunohematology records review, direct observation, Thermo Fisher Centra W cell washer/centrifuge operators manual review, lack of documentation, and interview with staff, the laboratory failed to document immunohematology centrifuge and cell washer revolutions per minute (RPM) and timer checks every three months for 2 of 2 years reviewed (September 2018 to the sticker dates of 2019 and 2020). The laboratory performed approximately 550 compatibility tests per year. Findings include: 1. Thermo Fisher operator's manual on page 4.2 specified RPM and speed functions be checked once every 3 months for the Centra W cell washer/centrifuge. 2. Immunohematology cell washer/centrifuge function check records review failed to include documentation of the 4th quarter 2018, 3 of 4 quarters of 2019 and 2 of 3 quarters of 2020 of RPM and timer checks for the Thermo Fisher Centra W cell washer/centrifuge used for A, B, O Group, Rh Typing, Antibody Screens, and Compatibility testing. Stickers were observed on 09/01/2020 at approximately 2:30 P. M. for one RPM and timer check in 2019 and one for 2020 and none in 2018. The dates the checks were performed were not noted by the surveyor. 3. In an interview with staff on 09/01/2020 at approximately 5:00 P.M., and also by email received on 09 /03/2020, the laboratory manager confirmed the laboratory lacked documentation of centrifuge speed (RPM) and timer checks to ensure optimal cell packing for immunohematology Grouping, typing, antibody screening, and compatibility interpretation. 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 bacteriology test records review, lack of documentation, and interview with staff, the laboratory failed to check antibiotic susceptibility each day of testing for 2 of 2 days of testing reviewed 11/29/2018 and 08/26/2020. The laboratory performed approximately 362 susceptibility tests per year. Findings include: 1. Bacteriology test records review failed to include susceptibility quality control performed each day of testing for urine cultures collected on 11/28/2018 for an E. coli organism that was resistant to Ampicillin and Intermediate susceptibility against Ampicillin/Sulbactam; and on 08/27/2020 for K. ascorbata. 2. In an interview with staff on 09/01/2020 at approximately 5:00 P.M., staff stated the laboratory was operating under an Individualized Quality Control Plan (IQCP) for reduced frequency of susceptibility testing but was not able to locate the approved IQCP. -- 2 of 2 --

Summary Statement of Deficiencies D5407 PROCEDURE MANUAL CFR(s): 493.1251(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 procedure manual review, lack of documentation, and interview with staff, the laboratory director failed to sign and date as approved 1 new test system procedure for the XN 550 complete blood cell counter prior to use and failed to sign and date as approved 2 of 6 test systems in use prior to the change of director (Cobas e411 and c311 chemistry analyzers). The laboratory tested approximately 1500 complete blood count specimens per year and 70,000 specimens per year for tests performed on the chemistry analyzers. Findings include: 1. The operator's manual for the XN 550 instrument failed to include the director's signature and date of approval prior to using the instrument to test and report patient specimens. 2. The operator's manual for the Cobas e411 and c311 failed to include the date of approval by the current director. 3. In an interview on 08/03/2018 at approximately 4:00 P.M., the laboratory manager stated the director signed the verification study and was not aware the operator's manual, serving as the procedure manual, also needed the director's signature and date of approval. The laboratory manager stated the operators manuals were the procedure manuals. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. 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 bacteriology organism identification reports review, lack of documentation and interview with staff, the laboratory failed to document the lot numbers and expiration dates of biochemical reagents to ensure the reagents were not used past their expiration dates for 1 of 6 biochemicals reviewed. The laboratory performed approximately 300 bacterial organism identifications annually. Findings include: 1. Microscan organism ID reports failed to include the accurate reagent lot number or expiration date. The Sulfanilic Acid culture organism test report stated the lot number was 2017/12/05. No expiration date was recorded. 2. Reagent containers lacked the manufacturer's expiration dates since the original expiration dates had been partially to completely rubbed off the label over time with use. 3. In an interview with the laboratory manager on 08/03/2018 at approximately 3:30 P.M., the laboratory manager confirmed the laboratory did not have a reliable source to determine the expiration date for the reagents used for identification of the cultured organism. D5809 TEST REPORT CFR(s): 493.1291(e) The laboratory must, upon request, make available to clients a list of test methods employed by the laboratory and, as applicable, the performance specifications established or verified as specified in 493.1253. In addition, information that may affect the interpretation of test results, for example test interferences, must be provided upon request. Pertinent updates on testing information must be provided to clients whenever changes occur that affect the test results or interpretation of test results. This STANDARD is not met as evidenced by: Based on new test verification studies review, lack of documentation and interview with staff, the laboratory failed to notify clients when the white blood cell differential test method changed the lymphocyte and monocyte white blood cell percentages. Findings include: 1. Verification studies included documentation the monocyte bias was 28.8% with an r value of 0.3497 and the lymphocyte bias was 17.4% with an r value of .896. (An R value of 1.0 is complete agreement.) 2. The laboratory failed to document clients were notified of the bias. 3. In an interview conducted on 08/03 /2018 at approximately 4:00 P.M., the laboratory manager stated staff were advised of the bias in the medical staff meeting but did not have written documentation of the notice. -- 2 of 2 --