Summary:
Summary Statement of Deficiencies D2089 ROUTINE CHEMISTRY CFR(s): 493.841(c) 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 interview and record review, the laboratory failed to participate in one of three proficiency testing (PT) events (2nd event 2021) for total protein. Findings: 1. Review of the "CMS Cumulative Scores" document from the American Association of Bioanalysts (AAB) indicated that AAB received no submissions for total protein for the 2nd event of 2021, resulting in a "0" score. 2. On 03/02/2022 at 9:37 AM, SP4 (quality assurance supervisor) confirmed that the 2nd PT event for total protein in 2021 had a score of "0". 3. On 03/02/2022 at 10:24 AM, SP3 (quality assurance technician) confirmed that the laboratory missed the submission deadline for the 2nd PT event in 2021. At 10:29 AM, SP3 added that the results for this event were never submitted. 4. The annual testing volume for Routine Chemistry is approximately 60,934. D6019 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iv) The laboratory director is responsible for the overall operation and administration of 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 -- 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)(4)(iv) Ensure that an approved