Summary:
Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on November 29, 2022. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: D5523 PARASITOLOGY CFR(s): 493.1264(a)(d) The laboratory must have available a reference collection of slides or photographs and, if available, gross specimens for identification of parasites and use these references in the laboratory for appropriate comparison with diagnostic specimens. (d) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on review of quality control (QC) documents and staff interview, the laboratory failed to perform and document controls on KOH. The Findings include: 1. Review of QC documents revealed there were no QC records available on wet mounts at the time of the survey for 2021 and 2022 thus far. 2. During an interrview with staff Mohs Tech and the Technical Specialist(CMS 209 form) on November 29, 2022 at approximately 1:00 PM, in the Mohs laboratory, confirmed QC was not performed on wet mounts. D6093 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality control programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. 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 -- This STANDARD is not met as evidenced by: Based on the review of the laboratory records and staff interview, the laboratory director (LD) failed to ensure that quality control (QC) programs were established and maintained to ensure the quality of laboratory services provided and identify failures in quality as they occur. The Finding include: 1. No QC documents were available to review on KOH at the time of the survey for 2021 and thus far 2022. 2. During an interview with the Mohs Tech and the Technical Supervisor (CMS-209) on November 29, 2022 at approximately 1:00PM, confirmed that no QC documents were available to review on KOH for 2021 and thus far 2022. -- 2 of 2 --