Warthan Dermatology Nacogdoches Pllc

Summary Statement of Deficiencies D0000 An onsite survey conducted 10/24/2022 found the laboratory in compliance with 42 CFR Part 493, Requirements for Laboratories. D6151 GENERAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1463(b)(3)(4) (3) The director or technical supervisor may delegate to the general supervisor the responsiblity for providing orientation to all testing personnel; and (4) Annually evaluating and documenting the performance of all testing personnel. This STANDARD is not met as evidenced by: Based on a review of the Centers for Medicare and Medicaid (CMS) form 209, laboratory documents, and confirmed in an interview, the general supervisor failed to perform competency assessments for one of two testing persons performing high complexity testing, grossing, in 2021. The findings include: 1. Review of the CMS personnel form 209 had the following testing person (TP) qualified to perform the high complexity testing, grossing: TP2 2. Review of the laboratory job responsibilities and delegations of duty for the general supervisor had the following delegation: "Ensuring annual personnel performance evaluation and documentation of testing personnel performance competency are complete." Surveyor queried the office manager for the competency evaluations for TP2 and none was provided. 3. In an interview on 10/24/2022 at 14:20, in the laboratory, the office manager confirmed that competency assessment documentation was missing for TP2 for 2021. 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 --

Summary Statement of Deficiencies D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on surveyor observations, review of manufacturer's expiration dates, and confirmed in interview of laboratory personnel, the laboratory failed to ensure expired items were not available for use in patient testing. The findings included: 1. Surveyor observation made on January 24, 2022 at 14:45 hours in the laboratory found the following expired items: a. Black Tissue Marking Dye Lot Number: 050953 Manufacturer Expiration Date: 12-2018 b. Green Tissue Marking Dye Lot Number: 050817 Manufacturer Expiration Date: 12-2018 c. Red Tissue Marking Dye Lot Number: 064699 Manufacturer Expiration Date: 03-2020 2. The findings were confirmed in interview with the office manager on January 24, 2022 at 14:50 hours in the laboratory upon her review of the expired items. 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 --