Bay Dermatology & Cosmetic Surgery Pa

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Bay Dermatology and Cosmetic Surgery PA on 8/11/22 to 8/17/22. The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level deficiencies: D5293 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(b)(c) (b) The general laboratory systems quality assessment must include a review of the effectiveness of

Summary Statement of Deficiencies D6102 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(12) The laboratory director must ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Based on record review and interview with the Assistant Office Manager, the laboratory director did not ensure that there was documentation to indicate that the two out of four testing personnel (#C and #D) had laboratory training to perform the mycology, parasitology, and histology testing. Findings included: Review of testing personnel records for Testing Personnel #C and #D revealed that the laboratory did not have training records for #C and #D for mycology, parasitology, and histology testing. Interview at 2:30 PM on November 27, 2018 with the Assistant Office Manager confirmed there were no training records for #C and #D for mycology, parasitology, and histology. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --