Thomas H Boyd Memorial Hospital

Summary Statement of Deficiencies D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on review of laboratory policies and procedures, review of laboratory records, lack of documentation, direct observation, and interviews with the general supervisor and testing personnel; the laboratory failed to outline all components of test procedures in the specialty of microbiology (see D5403); the laboratory failed to perform calibration verifications every six months as required for two of two applicable analytes in the specialty of chemistry (see D5439); the laboratory failed to ensure negative and positive control materials were tested each day of patient testing in the specialty of microbiology (see D5449); the laboratory failed to ensure media checks were performed on blood culture medium in the specialty of microbiology (see D5477); and the laboratory failed to have a system in place that twice a year evaluates and defines the comparison of test results between separate analyzers performing the same analyte (see D5775). 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 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 -- 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 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 CASPER Report 0155D and interview with a American Proficiency Institute (API) representative the laboratory failed to successfully participate in proficiency testing (PT) for the routine chemistry analyte partial pressure of carbon dioxide (PCO2) blood gas during events one and two of 2022. See D2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) 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 achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of CASPER Report 0155D and interview with a American Proficiency Institute (API) representative; the laboratory failed to successfully participate in proficiency testing (PT) for the routine chemistry analyte partial pressure of carbon dioxide (PCO2) blood gas during events one and two of 2022. Findings include: 1. Review of the CASPER Report 0155D ran on 8-1-2022 identified the initial unsuccessful PT performance for the specialty of chemistry for PCO2 Blood Gas. ROUTINE CHEMISTRY PCO2 Blood Gas - EVENT-1, 2022 = 60% - Unsatisfactory PCO2 Blood Gas - EVENT-2, 2022 = 40% - Unsatisfactory 2. A phone interview with the API PT representative on 08/01/2022, at 9:55 AM, confirmed the unsuccessful PT performance for PCO2 blood gas during events one and two of 2022. -- 2 of 2 --

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 CASPER Report 0155D and interview with an American Proficiency Institute (API) representative the laboratory failed to successfully participate in proficiency testing (PT) for the immunohematology analyte compatibility testing during events 1 and 2 of 2021. See D2181. D2181 COMPATIBILITY TESTING CFR(s): 493.863(e) Failure to achieve an overall testing event score of satisfactory for two consecutive 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 -- testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of CASPER Report 0155D and interview with an American Proficiency Institute (API) representative the laboratory failed to successfully participate in proficiency testing (PT) for compatibility testing in events 1 and 2 of 2021, under the specialty of immunohematology. Findings include: 1. Review of the CASPER Report 0155D revealed that the initial unsuccessful PT performance occurred during API PT events 1 and 2 of 2021, as listed below. IMMUNOHEMATOLOGY EVENT -1, 2021 Compatibility Testing, 80% Unsatisfactory EVENT -2, 2021 Compatibility Testing, 80% Unsatisfactory 2. Interview with the API PT representative on 10-04-2021, at 9:32 AM confirmed the unsuccessful PT performance for compatibility testing in events 1 and 2 of 2021. -- 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 record review, the Laboratory Personnel Report (CMS 209), and interview with the general supervisor (GS); the laboratory failed to follow written procedures to assess employees performing moderately and highly complex testing for 10 out of 10 testing personnel (TP). Findings: 1. The CMS 209, personnel records for the years of 2019, 2020, and 2021, and laboratory manuals were reviewed. 2. The personnel records revealed competency procedures used to assess TP were changed for the following specialties: *Immunohematology *Blood Chemistry *Hematology 3. Further review showed the laboratory began to use the changed competency procedure in January of 2019. 4. The manual showed the changed competency procedure was not included in the "Personnel training policies and procedures" section and had not been approved and signed by the laboratory director (LD). 5. The laboratory failed to follow written competency procedures to assess and evaluate TPs (TP1, TP2, TP3, ... thru TP10) who were performing moderately and highly complex testing since January of 2019. 6. On a Recertification survey conducted on 05/13/2021 at 2:45 PM, the GS confirmed the above findings. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --