Summary:
Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on November 30, 2022. 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: D2057 VIROLOGY CFR(s): 493.831(b) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3) The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on laboratory document review and staff interview, the laboratory failed to participate in Proficiency Testing with the College of American Pathologists for Covid PCR testing. The Findings include: 1. College of American Pathologist(CAP) Proficiency Testing document review revealed that the laboratory failed to participate in Proficiency Testing (PT) for Covid PCR testing Events A and B in 2021. 2. During an interview with the Technical Supervisor, and an interview over the phone with the Laboratory Director(CMS 209), on November 30, 2022, at 11:50 AM, in the breakroom, confirmed that the Proficiency Testing was not performed for Covid PCR testing Events A and B in 2021. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- 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 laboratory competency policy review and staff interview, the Laboratory Director (LD) failed to perform competency on Testing Personnel. The Findings include: 1. Competency document review revealed the Laboratory Director failed to perform competency on all Testing Personnel (TP) for 2021 as required by policy. 2. During an interview on November 30, 2022 with the Technical Supervisor (CMS- 209), at 1:25 PM, in the breakroom, confirmed that the Laboratory Director failed to perform competency in 2021 for all Testing Personnel. D5293 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(b)(c) (b) The general laboratory systems quality assessment must include a review of the effectiveness of