Camc Respiratory W&C

Summary Statement of Deficiencies D0000 An announced, on site, routine recertification survey was conducted at CAMC Respiratory W&C on April 25, 2023, by the West Virginia Office of Laboratory Services. The laboratory was assessed for compliance with the Federal Clinical Laboratory Improvement Amendment (CLIA) regulations under 42 CFR 493. Specific deficiencies cited are explained below. D6064 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(a) Each individual performing moderte complexity testing must possess a current license issued by the State in which the laboratory is located, if such licensing is required. This STANDARD is not met as evidenced by: Based on record review and interview, 11 of 11 laboratory testing personal (TP) did not possess a current WV Clinical Laboratory Practitioner License and performed moderate complex patient testing in January , February, and March 2023. Findings: 1. WV State rule Clinical Laboratory Practitioner Licensure and Certification 64 CSR 57 states that a current license is required for any individual performing moderately complex testing. 2. Review of laboratory records identified 11 of 11 TP had no current WV license in January, February, and March 2023 and performed moderate complex testing. 3. An interview with the technical consultant and laboratory manager, 4/25/23 at approximately 9:00 AM, confirmed the 11 TP WV licenses were not obtained before April 1, 2023. 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 --

Summary Statement of Deficiencies D0000 An announced, on site, recertification survey was conducted at CAMC Respiratory on March 24, 2021, by the West Virginia Office of Laboratory Services. The laboratory was surveyed to assess compliance with the Federal Clinical Laboratory Improvement Amendment (CLIA) regulations under 42 CFR 493. Specific deficiencies are explained below. D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess and, when indicated, correct problems identified in the postanalytic systems specified in 493.1291. This STANDARD is not met as evidenced by: Based on review of the laboratory policies and procedures (P&P), quality assessment (QA) documents, and an interview with the technical consultant (TC), the laboratory failed to perform and document the evaluation of the established procedure for reporting critical (alert) values from the ABL90 analyzers. Findings: 1. Review of P&P identified a "CAMC Respiratory Performance Improvement Plan" that stated alert values were monitored as part of the post-analytical QA. 2. No documentation of the alert value assessment could be located. 3. During an interview with the TC, on 3 /24/21 at approximately 10:45 AM, the TC confirmed the lack of documentation for the monitoring of the alert values process and procedure. 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 --

Summary Statement of Deficiencies D6013 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(ii) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(3) Ensure that-- (e)(3)(ii) 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 the laboratory's records and interview with the lab supervisor and quality management coordinator, the laboratory director failed to sign off on the verification data for accuracy and precision for the new instruments in July of 2017. Findings: 1. Review of the document provided with precision and accuracy data for ABL90 #1 and ABL90 #2, dated July 2017, determined there was no signature of acceptance by the laboratory director. 2. On 2/4/2019 at approximately 12:00 PM, the supervisor was unable to find the original, signed copy of the performance characteristics of accuracy and precision for the new instruments, ABL90 #1 and ABL90 #2, performed in July of 2017. 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 --