Blood Gas Lab Of Evans Memorial Hospital, Inc

Summary Statement of Deficiencies D0000 A recertification survey was performed on .April 23, 2025. The facility was found to be NOT in compliance with all applicable CLIA requirements for specialties /subspecialties for 42 CFR. 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: Review of the Laboratory Standard Operations Policies (SOP), and staff interview, the Laboratory failed to provde a policy for assessing testing personnel (TP). Findings: 1. Review of the Standard Operations Policy and Procedures revealed that there was not a written procedure for performing competency assessment of Laboratory Testing Personnel (TP). 2. Document review of the competency assessment for the 11 TP listed on the CMS 209 form, revealed there were 5 TP hired on or after 5/8/2024, 4 out of 5 did not have documentation of a six month competency assessment. TP-1 Was hired 7/1/2024 Initial 8/2024 no six month assessment TP-6 Was hired 5/8/2024 Initial 8/2024 no six month assessment TP-7 Was hired 1/15/2025 Initial 3/2025 Not due until 9/25 TP-8 Was hired 7/24/2025 Initial 8/2024 no six month assessment TP- 11 Was hired 6/18/2024 Initial 8/2024 no six month assessment 3. Interview with the General Supervisor on 4/23/2025 at approximately 2 pm in the dining room, confirmed the aforementioned statement. D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) (e)(11) Ensure that prior to testing patients specimens, all personnel have 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 2 -- appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results; This STANDARD is not met as evidenced by: Review of the Laboratory Standard Operations Policies (SOP), and staff interview, the Laboratory Director failed to provide a policy for assessing testing personnel (TP). Findings: 1. Review of the Standard Operations Policy and Procedures revealed that there was not a written Procedure for performing competency assessment of Laboratory Testing Personnel (TP). Following the required training and competency assessment of Initial training, bi-annual training every 6 months from hire date for the first full year of employment, and yearly there after. 2. Document review of the competency assessment of the eleven (11)TP listed on the CMS 209 form, revealed there were five (5)TP hired on or after 5/8/2024, four (4) did not have documentation of a six month competency assessment. TP-1 Was hired 7/1/2024 Initial 8/2024 no six month assessment TP-6 Was hired 5/8/2024 Initial 8/2024 no six month assessment TP-7 Was hired 1/15/2025 Initial 3/2025 Not due until 9/25 TP-8 Was hired 7/24 /2025 Initial 8/2024 no six month assessment TP-11 Was hired 6/18/2024 Initial 8 /2024 no six month assessment 3. Interview with the General Supervisor on 4/23/2025 at approximately 2:15 pm in the dining room, confirmed the aforementioned statement. D6127 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) (b)(9) Evaluating and documenting the performance of individuals responsible for high complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on review of the competency assessment documents for the eleven (11) Testing Personnel(TP) listed on the Centers for Medicare and Medicaid Services (CMS) form (209), the Laboratory Director (LD) acting as the Technical Supervisor (TS) failed to perform semiannual competency evaluations for four (4) out of the five (5) TP hired since 5/8/2024. Findings: 1. Document review of the competency assessment of the eleven (11) TP listed on the CMS 209 form, revealed there were five (5) TP hired on or after 5/8/2024, four (4) out of five (5) did not have documentation of a six month competency assessment. TP-1 Was hired 7/1/2024 Initial 8/2024 no six month assessment TP-6 Was hired 5/8/2024 Initial 8/2024 no six month assessment TP-7 Was hired 1/15/2025 Initial 3/2025 Not due until 9/25 TP-8 Was hired 7/24/2025 Initial 8/2024 no six month assessment TP-11 Was hired 6/18/2024 Initial 8/2024 no six month assessment 2. Interview with the General Supervisor on 4/23/2025 at approximately 2 pm in the dining room, confirmed the aforementioned statement. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on May 15, 2019. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Each quantitative procedure, include two control materials of different concentrations; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of the Quality Control (QC) procedure and QC documents for the ePOC Arterial Blood Gasses (ABG's) analyzer, and staff interview, the laboratory failed to document two controls of different concentrations at least once each day, patient specimens were assayed. Findings: 1. Review of the QC procedure and QC documents for the ePOC ABG analyzer, the laboratory did not document two controls of different concentrations each day of patient testing for ABG's. 2. Interview with staff #1 (CMS 209 form) on May 15, 2019, at approximately 1:30 pm in the Hospital Administrative Conference room, confirmed that the laboratory was not performing two levels of different concentrations at least once each day, patient specimens are assayed. It was also confirmed that an Individualized Quality Control Plan (IQCP) had not been performed. D5781