Summary:
Summary Statement of Deficiencies D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (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 analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: ___________________________________ Based on review of the Taxo Disc quality control sheets for 2016 and 2017, which lacked lot numbers and expiration dates with no quality assessment review to show problem identified and corrected and an interview with the Laboratory Manager, determined the laboratory failed to establish and follow a procedure for acknowledging and correcting problems associated with not documenting lot numbers and expiration dates for Taxo Discs used. The findings include: 1. Review of the Taxo Disc quality control sheets with designation for lot numbers and expiration dates which failed to be documented for the 2 year period and no quality assessment review to show problem identified and corrected. 2. Interview at approximately 2:00 p.m. January 25, 2018, with the Laboratory Manager, confirmed the laboratory failed to establish and follow a procedure for acknowledging and correcting problems associated with not documenting lot numbers and expiration dates for taxo discs for the two year period. ____________________________________ 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 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 -- 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