Adult & Pediatric Dermatology, Pc

Summary Statement of Deficiencies D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on review of the laboratory's testing personnel (TP) competency and Proficiency Testing (PT) records and interview with the Regional Operations Director (ROD), the Technical Consultant (TC) failed to ensure TP had yearly competency assessment using all required elements to ensure their ability to perform test procedures accurately in the specialty of Microbiology. Findings include: 1. Record review on 2/27/2024 of the laboratory's 2022 and 2023 KOH Prep TP competency and PT records revealed: a. 2 of 4 KOH Prep TP did not have documented competency assessment in 2022. b. 2 of 4 KOH Prep TP were evaluated using only 1 of the 6 required elements by performing only PT in 2022. c. 4 of 6 KOH Prep TP did not have documented competency assessment in 2023. d. 2 of 6 KOH Prep TP were evaluated using only 1 of the 6 required elements by performing only PT in 2023. 2. Record review on 2/27/2024 of the electronic patient medical record for patient #1 compared to the KOH Prep test intermediate test results worksheet log revealed: a. The intermediate test results worksheet listed the KOH Prep test as negative. b. The patient chart indicated the patient was treated for Tinea Pedis and Onchyomycosis at this visit, but did not list the KOH Prep test as ordered or resulted. 3. Staff interview with the ROD on 2/27/2024 at 11:00 AM confirmed competency assessment was not documented for all TP in 2022 and 2023. The ROD stated, "The laboratory doesn't do many KOH prep tests in general and did not perform any KOH Prep testing in 2023." The ROD also stated, "The laboratory does not do any kind assessment to check intermediate test results written on the worksheet log." 4. The laboratory performs 20 KOH Prep tests annually in the specialty of Microbiology. 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 D0000 A CLIA recertification survey was conducted for the Adult & Pediatric Dermatology, PC laboratory pursuant to the Clinical Laboratory Improvement Amendments (CLIA) of 1988 and CLIA regulations at 42 CFR 493. . 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 observation and record review, the laboratory failed to ensure laboratory reagents were not used when they had exceeded their expiration date as evidenced by the following: a) During a tour of the laboratory on 11/22/19 at 10:20 AM, the surveyor observed the following expired item in the laboratory area where Physician Performed Microscopy Procedures (PPMP) are performed: * One (1) bottle of Potassium Hydroxide (KOH), lot number 1828308, expiration date 10/10/19. b) There were no other in-date reagents available in the laboratory. Based on this evidence the accuracy and reliability of microscopic examinations, utilizing this reagent, could not be assured. One patient sample for KOH was tested on 10/22/19. c) The laboratory performs approximately 50 KOH preparations annually. 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 --