Summary:
Summary Statement of Deficiencies D3009 FACILITIES CFR(s): 493.1101(c) The laboratory must be in compliance with applicable Federal, State, and local laboratory requirements. This STANDARD is not met as evidenced by: Based on surveyor record review (Application for Exception to Section 5.22(f)) and interview with testing personnel #1 (TP) and TP #2, the laboratory failed to ensure that the State of Pennsylvania (PA) regulations were met regarding having a supervisor on site during all normal scheduled working hours in which tests are being performed. Findings Include: 1. The PA regulations (5.23 (b)(1)) states: "A general supervisor who meets all the requirements of subsection (a)(1), (2) or (3) and is on the laboratory premises during all normal scheduled working hours in which tests are being performed." 2 . Review of the application for Exception to Section 5.22 (f) form signed by the laboratory director (LD) on 04/26/2021 states: " the laboratory director will appoint a qualified general supervisor for each laboratory who will be on-site to oversee laboratory operations during all hours in which testing is being performed and who will review quality control records on a weekly basis". 3. On the day of the survey, 06/28/2023 at 12:30 pm, during an interview, TP #1 and TP #2 stated that the laboratory did not have a qualified supervisor onsite for every hour of patient testing as required by the State of PA. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- This STANDARD is not met as evidenced by: Based on lack of documentation and interview with Testing Personnel #1 (TP) and TP #2, the laboratory failed to ensure that the verifications of accuracy for urine creatinine, pH, and specific gravity examinations were performed at least twice annually, as required for tests not included in subpart I from 04/06/2021 to the date of the survey. Findings include: 1. On the day of the survey, 06/28/2023 at 11:32 am, the laboratory could not provide documentation that the verification of accuracy for urine creatinine, pH, and specific gravity examinations were performed on Thermo Fisher Indiko Plus analyzer at least twice annually from 04/06/2021 to the date of the survey. 2. TP #1 and TP #2 confirmed the findings above on 06/28/2023 around 12:30 pm. D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) 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)(iii) Ensure that all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require