Summary:
Summary Statement of Deficiencies D0000 An offsite revisit survey was conducted on March 21, 2019, for all previous deficiencies cited on 2/13/2019. All deficiencies have been corrected. The facility is in compliance with with all regulations surveyed. D5219 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(2) At least twice annually, the laboratory must verify the accuracy of any test or procedure listed in subpart I of this part for which compatible proficiency testing samples are not offered by a CMS-approved proficiency testing program. This STANDARD is not met as evidenced by: Based on review of proficiency test (PT) results and staff interview, the laboratory failed to twice annually verify the accuracy of any test or procedure for which compatible PT samples are not offered by a CMS-approve PT program. Findings include: 1. PT document review revealed the laboratory failed to verify twice annually in 2018 the accuracy of their clinical cytogenetics testing. 2. An interview with the General Supervisor in the front office on 2/13/2019 at approximately 2 p.m. confirmed PT was only performed once in 2018. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on laboratory maintenance document review and staff interview, the laboratory 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 -- failed to document instrument maintenance as required. Findings include: 1. Laboratory maintenance document review revealed the laboratory was unable to produce Illumina maintenance logs for 2017, 2018, and 2019 thus far. 2. An interview with the General Supervisor in the front office on 2/13/2019 at approximately 2:00 p. m. confirmed there were no Illumina maintenance logs available at the time of survey for 2017, 2018, and 2019 thus far. 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