Summary:
Summary Statement of Deficiencies D0000 This Form CMS-2567 has been amended on 6/5/2018 at D2010 and D6018. D2010 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(2) The laboratory must test samples the same number of times that it routinely tests patient samples. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to test bacteriology proficiency testing (PT) samples in 2017 and 2018 the same number of times that it routinely tests patient samples. Findings include: 1) Review on 5/17/18 of urine colony count PT records for 2017 and 2018 revealed two of two PT samples were read by three testing personnel in College of American Pathologists (CAP) events MC3-A 2017, MC3-B 2017, MC3-C 2017, and MC3-A 2018. Review of throat culture PT records for 2017 revealed five PT samples were read by two testing personnel in CAP event D1-A 2017. 2) Review on 5/17/18 of two final reports for urine colony counts and one final report for presumptive beta hemolytic group A Streptococcus throat cultures from 2018 revealed one testing personnel performed testing for each patient urine colony counts and throat culture. 3) Interview on 5/17/18 at 11:45 a.m. with the laboratory's CLIA compliance officer revealed all patient urine colony counts and throat cultures are read by one testing personnel and confirmed the PT samples were not tested in the same manner as routine patient samples. 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