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 Surveyor review of laboratory's proficiency testing (PT) records, and interview with the laboratory director on April 27, 2022, at 12:10 pm, the laboratory failed to participate in the 1st PT event of 2022 for the analytes creatinine (Cr) and blood urea nitrogen (BUN). The findings include: 1. The laboratory used Abbott i-Stat instrument to test BUN and Cr. It enrolled and participated in College of American Pathologists (CAP) PT program for the year 2022 and received samples for the 1st event (AQI-A). However, the laboratory did not test the PT sample due to the lack of test cartridge. On the other hand, the laboratory had been testing patient samples for Cr and BUN. Therefore, the accuracy of the reported result cannot be assured and might had affected patient care adversely. 2. The laboratory director on April 27, 2022, at 12:10 pm, affirmed that the testing person was unable to analyze the PT sample due to the lack of test cartridge. 3. The laboratory's testing declaration form, signed by the laboratory director on 4/26/2022, stated that the laboratory performed 3,000 routine chemistry tests, annually. D6016 LABORATORY DIRECTOR RESPONSIBILITIES 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 -- CFR(s): 493.1407(e)(4)(i) 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)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on Surveyor review of laboratory's proficiency testing (PT) records, and interview with the laboratory director on April 27, 2022, at 12:10 pm, the laboratory director failed to ensure that the PT samples were tested as required by the regulation, 493.841. The findings include: See D2089. -- 2 of 2 --