Cody Regional Health Dba/West Park Co Hospital

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 process for 2 of 29 (2022 Immunology/Immunohematology event #2, Immunology/Immunohematology event #3) American Proficiency Institute (API) proficiency testing events reviewed from September 2022 through August 2024. The findings were: 1. Review of the laboratory's proficiency testing records showed no evidence of the performance summary, the comparative evaluations, or the signed performance reviews which indicated the results had been reviewed by the laboratory director for the 2022 Immunology/Immunohematology event #2 and event #3. 2. Interview with the laboratory manager on 8/28/24 at 11:22 AM confirmed no further documentation was available. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 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 -- 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 5 of 5 laboratory personnel (LP #1, LP #2, LP #3, LP #4, LP #5) technical supervisor and/or general supervisor's competency assessments were completed for 2 of 2 years (2022, 2023) reviewed. The findings were: 1. Review of the CMS 209 Laboratory Personnel Report showed the laboratory employed 4 technical supervisors and 4 general supervisors. The following concerns were identified: a. LP #1 performed the duties of the technical and general supervisor for Diagnostic Immunology and Hematology. Review of the personnel files for LP #1 showed no evidence a competency assessment had been completed in 2022 or 2023. b. LP #2 performed the duties of the technical supervisor for Chemistry. Review of the personnel files for LP #2 showed no evidence a competency assessment had been completed in 2022 or 2023. c. LP #3 performed the duties of the general supervisor in Chemistry. Review of the personnel files for LP #3 showed no evidence a competency assessment had been completed in 2022 or 2023. d. LP #4 performed the duties of the technical supervisor for Microbiology (bacteriology, mycology, parasitology, virology) and the general supervisor duties for Immunohematology. Review of the personnel files for LP #4 showed no evidence a competency assessment had been completed in 2022 or 2023. e. LP #5 performed the duties of the technical consultant and general supervisor for Chemistry. Review of the personnel files for LP #5 showed no evidence a competency assessment had been completed in 2022 or 2023. 2. Review of the policy titled "Laboratory Orientation and Competency", last revised and approved by the laboratory director on 1/31/20, failed to include a procedure for ensuring the competency of the technical and general supervisors. 3. Interview with the laboratory manager on 8/27/24 at 3 PM confirmed the competency assessments had not been completed for the technical and general supervisors and the policy and procedure was incomplete. D6107 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(15) The laboratory director must specify, in writing, the responsibilities and duties of each consultant and each supervisor, as well as each person engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or result reporting and whether supervisory or director review is required prior to reporting patient test results. This STANDARD is not met as evidenced by: Based on policy and procedure review and staff interview, the laboratory director failed to specify, in writing, the responsibilities and duties of the general and technical supervisors. The findings were: 1. Review of the "Lab Personnel Duties" policy, last revised and signed by the laboratory director on 1/31/20, showed the duties and responsibilities of the "Section Heads" were outlined; however, there was no delineation between the duties of the technical supervisor and the general supervisor. -- 2 of 3 -- 2. Interview with the laboratory manager on 8/27/24 at 3 PM confirmed the policy did not define the specific duties of the general supervisor and technical supervisor. -- 3 of 3 --

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of proficiency testing records, lack of documentation, and staff interview, the individual testing the proficiency testing samples and the laboratory director failed to attest to the routine integration of the American Proficiency Institute (API) proficiency tests into the patient workload for 1 of 26 proficiency testing events reviewed from September 2020 through August 2022. The findings were: 1. Review of the 2022 API Immunology/Immunohematology Event #1 showed the attestation statement was not signed by the laboratory director. In addition the testing personnel performing the Immunohematology testing failed to sign the attestation statement. 2. Interview with the laboratory manager on 8/30/22 at 12:07 PM confirmed the attestation statements had not been signed. 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 personnel files, review of the CMS (Centers for Medicare and Medicaid Services) 209 Laboratory Personnel Report, lack of documentation, and Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- staff interview, the laboratory failed to retain documentation of competency assessments for 3 of 20 testing personnel reviewed (TP #1, TP #2, TP #3). The findings were: 1. Review of the personnel file or TP #1 showed he was hired on 11/30 /20 in the cardiopulmonary department and had an annual competency assessment in 2022; however there was no evidence the initial and 6 month competency assessment had been retained. 2. Review of the personnel file for TP #2 showed she was hired on 11/16/20 in the cardiopulmonary department and had an annual competency assessment in 2021 and 2022; however there was no evidence the initial and 6 month competency assessment had been retained. 3. Review of the personnel file for TP #3 showed she worked in the cardiopulmonary department and had a competency assessment in 2020 and 2022; however there was no evidence the 2021 competency assessment had been retained. 4. Interview with the cardiopulmonary department manager and lead respiratory therapist on 8/30/22 at 2:10 PM confirmed the documentation could not be located. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. 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 review and evaluate proficiency testing results for 5 of 26 proficiency testing events reviewed from September 2020 to August 2022. The findings were: 1. Review of the American Proficiency Institute (API) proficiency testing (PT) report failed to include documentation the laboratory had evaluated test scores of less than 100%. The following concerns were identified: a. Review of the 2021 API Chemistry Core Event #3 results showed the laboratory scored an 80% on carbon dioxide and an 80% on neonatal bilirubin. There was no documentation the laboratory had evaluated the test results. b. Review of the 2021 API Microbiology Event #2 results showed the laboratory scored an 80% on norovirus detection. There was no documentation the laboratory had evaluated the test results. c. Review of the 2021 API Microbiology Event #3 showed the laboratory scored an 80% on adenovirus and rhinovirus/enterovirus detection. There was no documentation the laboratory had evaluated the test results. d. Review of the 2022 API Chemistry Core Event #1 showed the laboratory scored an 80% on sodium, phosphorus, and troponin. There was no documentation the laboratory had evaluated the test results. e. Review of the 2022 API Microbiology Event #1 showed the laboratory scored an 80% on gram stain morphology. There was no documentation the laboratory had evaluated the test results. 2. Interview with the laboratory manager on 8/30/22 at 12:07 PM confirmed the PT scores of less than 100% had not been investigated. 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. -- 2 of 5 -- This STANDARD is not met as evidenced by: Based on review of the CMS (Centers for Medicare and Medicaid Services) 116 form, lack of documentation, and staff interview, the laboratory failed to have a written procedure for reporting SARS-CoV-2 test results to the appropriate agencies. The findings were: 1. Review of the CMS-116 form showed the laboratory performed SARS-CoV-2 testing using the Abbott ID NOW and BD Max test systems. 2. Review of the laboratory's procedure manuals showed no evidence the laboratory had developed a policy and procedure for reporting SARS-CoV-2 test results to the appropriate agencies. 2. Interview with the laboratory manager on 8/31/22 at 11 AM confirmed the laboratory did not have a written procedure for reporting SARS-CoV-2 patient test results. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

Summary Statement of Deficiencies D5313 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(b) The laboratory must document the date and time it receives a specimen. This STANDARD is not met as evidenced by: Based on patient test reports review and interview with staff, the laboratory failed to document the date and time it received specimens collected at satellite locations. The number of tests collected at satellite locations and sent to the laboratory was not determined. Findings include: 1. Patient test reports reviewed included documentation for the date and time specimens were collected and received. Patient specimens from approximately 6 satellite laboratory locations included the same time for specimens collected as the time received at the laboratory where testing was performed. 2. In an interview with the laboratory supervisor on 05/02/2018 at approximately 2:00 P.M., the supervisor confirmed the satellite locations entered the time they collected specimens and entered the time the satellite locations accessioned the specimens as the time the laboratory where testing was performed received the specimens. The laboratory supervisor also confirmed satellite facilities operate under separate CLIA numbers and are not located at the same address as the laboratory that performed and reported tests. 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, Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- the director failed to sign and date procedural changes prior to use for 6 of approximately 49 test changes reviewed. Findings include: 1. Procedure manual review failed to include the director's approval with signature and date prior to implementation of changes for: A. New instrumentation and testing location changes for transition from the Rapid Point Instrument to the iSTAT instrument and testing being performed by respiratory therapy staff for arterial blood gas testing. The director failed to approve the changes for quality control, daily start up, instrument calibration, and specimen collection. B. Procedural documentation modification for Microbiology testing to document each Gram negative organism presented for identification have the Oxidase test result recorded prior to placing the test into the instrument for identification and susceptibility testing. C. New procedures for Vitamin D and Parathyroid Hormone testing. 2. In an interview with staff on 05/03/2018 at approximately 6:30 P.M., staff confirmed approvals for the changes to the procedures had not been approved by the director prior to being used to test and report patient samples. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on iSTAT cartridge storage temperature records review, lack of documentation, manufacturer's cartridge storage requirements, and interview with staff, the laboratory failed to ensure cartridge storage temperatures were monitored and documented and