Summary:
Summary Statement of Deficiencies D0000 An announced CLIA initial survey was conducted at Pinnacle Dermatology, SC on January 24, 2023 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Regulations. The specific deficiency cited is as follows: D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on a review of the laboratory's Centers for Medicare and Medicaid Services (CMS) 116 form, five (5) randomly selected patient reports, and an interview, the laboratory failed to ensure dermatopathology reports include the correct performing laboratory name and address during the timeframe of October 7, 2023 until the date of the inspection on January 24, 2023. Findings include: 1. Review of the laboratory's CMS 116 form revealed a laboratory name and physical facility location as follows: Pinnacle Dermatology, SC 6122 Franklin Park Rd. McLean, VA 22101 2. Review of 5 randomly selected patient dermatopathology reports (Specimen ID PD22-72291 report date 10/07/2022; PD22-79927 report date 11/02/2022; PD22-92709 and PD93418 report date 12/16/2022) revealed the address for Pinnacle Dermatology, SC as 820 Springer Drive, Lombard IL 60148. The surveyor inquired where the interpretation of dermatopathology slides were performed. The Laboratory Director 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 -- stated the interpretation of slides were performed at the Pinnacle Dermatology, SC, McLean, VA address not the Pinnacle Dermatology, SC, Lombard, IL address. 3. In an exit interview with the Laboratory Director on January 24, 2023, at approximately 11:00 AM, the above findings were confirmed. -- 2 of 2 --