Summary:
Summary Statement of Deficiencies 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. This STANDARD is not met as evidenced by: Through review of the CMS 116 form sumitted by the laboratory, review of the "KOH Log", lack of documentation and interview it was determined that the laboratory failed to verify the accuracy of KOH tests at least twice annually. Findings follow: A) The CMS 116 applicaton submitted by the laboratory stated that 88 provider performed microscopy procedures, identified as KOH were performed annually. B) Review of the "KOH Log" revealed that 78 KOH tests were performed in the calendar year 2019 to the date of the survey. C) Upon request, the laboratory could not produce documentation that the accuracy of the KOH tests were verified at least twice annually. D) In an interview on 10/9/19 at approximately 11:00 AM the laboratory coordinator, identified on the "Entrance and/or Exit Conference Attendance Record, confirmed that the accuracy of KOH tests were not verified at least twice annually by proficiency test samples or other methods. D6107 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(15) The laboratory director must specify, in writing, the responsibilities and duties of each consultant and each supervisor, as well as each person engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or result reporting and whether supervisory or director review is required prior to reporting patient test 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 -- results. This STANDARD is not met as evidenced by: Through a review of personnel files for the ten testing personnel listed on the CMS- 209 form as well as interviews with staff, it was determined the laboratory director failed to specify, in writing, the procedures each testing person can perform and whether supervision is required for two of the ten testing personnel. Survey findings follow: A) In an interview at approximately 09:48 AM on 10/09/19, the laboratory coordinator stated that the two testing personnel listed on the form CMS-209 as employee #10 and #11 perform tissue gross descriptions. B) Through a review of testing personnel employment files it was revealed that testing personnel, identified as numbers 10 and 11 on the CMS 209 form, personnel files lacked documented authorizations to perform tissue gross decriptions. C) In an interview on 10/09/19 at approximately 10:00 AM the laboratory coordinator, identified on the Entrance and/or Exit Conference Attendance Record, confirmed the laboratory director failed to give written authorization for employee #10 and #11 perform tissue gross descriptions. -- 2 of 2 --