Community Health Center Of Central Wyoming

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on review of the Centers for Medicare and Medicaid Services Casper Report 155, review of the American Association of Bioanalysts-Medical Laboratory Evaluation reports, and staff interview, the laboratory failed to successfully participate in two consecutive testing events for the blood cell identification challenge and leukocyte count (2023 event #3, 2024 event #1). Refer to D2121. D2121 HEMATOLOGY CFR(s): 493.851(a) 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 -- Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on review of the Centers for Medicare and Medicaid Services (CMS) Casper 155 report, review of the AAB-MLE (American Association of Bioanalysts-Medical Laboratory Evaluation) reports, and staff interview, the laboratory failed to successfully participate in two consecutive testing events for the blood cell identification challenge and leukocyte count (2023 event #3, 2024 event #1). The findings were: 1. Review of the CMS Casper 155 report showed the laboratory failed to successfully obtain a passing score for the blood cell identification challenge and leukocyte count for the following proficiency testing events: a. The 2023 AAB-MLE event #3 showed the laboratory scored a 0%. b. The 2024 AAB-MLE event #1 showed the laboratory scored a 60%. 2. Interview on 4/29/24 at 1:21 PM with the technical supervisor confirmed the laboratory scored a 0% on the 2023 event #3 due to failing to submit the results prior to the deadline. The failure of the 2024 event #1 blood identification challenge required testing personnel education and the failure of the leukocyte count had not been determined. -- 2 of 2 --

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 personnel files, review of the CMS 209 Laboratory Personnel Report, lack of documentation, and staff interview, the laboratory failed to ensure an annual competency assessment had been completed for 3 of 4 mid-level testing personnel (PA-C #1, PA-C #2, DNP #1); failed to ensure a 6-month competency assessment had been completed for 1 of 1 new mid-level testing personnel (FNP #1); and failed to ensure a competency assessment for the responsibilities of the general supervisor (GS) and technical supervisor (TS) were completed for 2 of 2 years (2021, 2022) 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 TS and the GS. The following concerns were identified: a. Review of the TS /GS's personnel record showed no evidence a competency assessment had been completed in 2021 or 2022. 2. Review of the personnel records for PA-C #1, PA-C #2, and DNP #1 showed no evidence an annual competency assessment had been completed in 2022. 3. Review of the personnel record for FNP #1 showed an initial competency assessment had been completed on 5/5/22; however, there was no evidence the 6-month competency assessment had been completed. 4. Interview with the TS on 3/22/23 at 3:56 PM confirmed the competency assessments had not been completed as required. 5. Review of the "Competency Assessment" policy and procedure showed "...New employees are evaluated at 6-month review...Providers who perform wet preps outside of normal laboratory hours are required to be trained and evaluated annually..." 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 -- D6086 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(3)(ii) The laboratory director must ensure that verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method. This STANDARD is not met as evidenced by: Based on review of instrumentation method verification records and staff interview, the laboratory director failed to evaluate and approve the results of the verification study for 1 of 2 new analyzers (Horiba ABX Pentra C400 clinical chemistry analyzer). The findings were: 1. Review of the new instrumentation verification records for the Horiba ABX Pentra C400 analyzer showed no evidence the laboratory director had evaluated and signed the report as approved prior to patient testing. 2. Interview with the technical supervisor on 3/22/23 at 4:24 PM confirmed the laboratory director had not signed the new instrumentation verification study. -- 2 of 2 --

Summary Statement of Deficiencies D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 Each laboratory that performs nonwaived testing must meet the applicable requirements under 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State Operations Manual (CMS Pub. 7). (a) Reporting of SARS-CoV-2 test results During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: Based on review of the laboratory's Billing Summary Report, review of reporting documentation, and staff interview, the laboratory failed to report 487 SARS-CoV-2 negative test results from 9/28/20 through 7/7/21. The findings were: 1. Review of the "Billing Summary Report" from 9/28/20 through 7/7/21 showed the laboratory had performed 579 SARS-CoV-2 tests. 2. Review of the laboratory's reporting documentation from 9/28/20 through 7/7/21 showed the laboratory had reported 92 positive SARS-CoV-2, as required, to the State Public Health Laboratory, however the laboratory had not reported the 487 negative test results. 3. Documentation revealed that SARS-CoV-2 negative test reports were not reported, as required, for 3 days in September 2020; 18 days in October 2020; 21 days in November 2020; 17 days in December 2020; 21 days in January 2021; 19 days in February 2021; 17 days in March 2021; 18 days in April 2021; 20 days in May 2021; 17 days in June 2021; and 4 days from 7/1/21 through 7/7/21. 4. Interview with the laboratory manager on 7 /7/21 at 11:45 AM revealed she was unaware of the regulation which required 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 6 -- reporting of both positive and negative test results. In addition, the laboratory manager confirmed the negative test results had not been reported to the State Public Health Laboratory. D5010 VIROLOGY CFR(s): 493.1205 If the laboratory provides services in the subspecialty of Virology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1265, and 493. 1281 through 493.1299. This CONDITION is not met as evidenced by: Based on new test method verification study review, lack of documentation, quality control record review, review of the patient testing log, and staff interview, the laboratory failed to ensure the Cepheid respiratory virus panel was verified for precision (D5421) prior to testing patient samples and failed to ensure two levels of quality control were performed each day of testing (D5447). 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. This STANDARD is not met as evidenced by: Based on lack of documentation and staff interview, the laboratory failed to have a written procedure for reporting SARS-CoV-2 positive and negative test results. The findings were: Review of the laboratory's procedure manuals showed no evidence a policy and procedure had been developed in regard to reporting SARS-CoV-2 positive and negative test results to the appropriate agencies. Interview with the laboratory manager on 7/7/21 at 11:45 AM confirmed the laboratory did not have a written procedure for reporting SARS-CoV-2 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 D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 Each laboratory that performs nonwaived testing must meet the applicable requirements under 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State Operations Manual (CMS Pub. 7). (a) Reporting of SARS-CoV-2 test results During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: Based on review of the laboratory's Billing Summary Report, review of reporting documentation, and staff interview, the laboratory failed to report 487 SARS-CoV-2 negative test results from 9/28/20 through 7/7/21. The findings were: 1. Review of the "Billing Summary Report" from 9/28/20 through 7/7/21 showed the laboratory had performed 579 SARS-CoV-2 tests. 2. Review of the laboratory's reporting documentation from 9/28/20 through 7/7/21 showed the laboratory had reported 92 positive SARS-CoV-2, as required, to the State Public Health Laboratory, however the laboratory had not reported the 487 negative test results. 3. Documentation revealed that SARS-CoV-2 negative test reports were not reported, as required, for 3 days in September 2020; 18 days in October 2020; 21 days in November 2020; 17 days in December 2020; 21 days in January 2021; 19 days in February 2021; 17 days in March 2021; 18 days in April 2021; 20 days in May 2021; 17 days in June 2021; and 4 days from 7/1/21 through 7/7/21. 4. Interview with the laboratory manager on 7 /7/21 at 11:45 AM revealed she was unaware of the regulation which required 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 6 -- reporting of both positive and negative test results. In addition, the laboratory manager confirmed the negative test results had not been reported to the State Public Health Laboratory. D5010 VIROLOGY CFR(s): 493.1205 If the laboratory provides services in the subspecialty of Virology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1265, and 493. 1281 through 493.1299. This CONDITION is not met as evidenced by: Based on new test method verification study review, lack of documentation, quality control record review, review of the patient testing log, and staff interview, the laboratory failed to ensure the Cepheid respiratory virus panel was verified for precision (D5421) prior to testing patient samples and failed to ensure two levels of quality control were performed each day of testing (D5447). 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. This STANDARD is not met as evidenced by: Based on lack of documentation and staff interview, the laboratory failed to have a written procedure for reporting SARS-CoV-2 positive and negative test results. The findings were: Review of the laboratory's procedure manuals showed no evidence a policy and procedure had been developed in regard to reporting SARS-CoV-2 positive and negative test results to the appropriate agencies. Interview with the laboratory manager on 7/7/21 at 11:45 AM confirmed the laboratory did not have a written procedure for reporting SARS-CoV-2 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)