Skin Specialists Of The Capital Region Pllc

Summary Statement of Deficiencies D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) (c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (c)(1) Identity and when significant, titer, strength or concentration. (c)(2) Storage requirements. (c)(3) Preparation and expiration dates. (c)(4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on direct observations, review of the laboratory's Standard Operating Procedures (SOPs) manual, as well as interview with the Histotechnician (HT), the laboratory failed to properly label reagents with identity, storage requirements, preparation, and expiration dates. FINDINGS: 1. The surveyor's observations in the Mohs processing laboratory on February 5, 2026, at approximately 10:30 A.M., confirmed the following reagents utilized by the Thermo Scientific Shandon Linistain Linistat Linear Stainers, SN: LS1541A1205 and SN: B100305466, in the Mohs laboratory, were not labeled with identification, concentration, lot number, expiration date, and storage requirements: a. 100% Alcohol. b. Water. c. Hematoxylin. d. Bluing reagent. e. Clarifier (acid alcohol). f. Eosin Y alcoholic. g. Xylene substitute. 2. The current, approved SOP, "B3.2 Specimen Workflow- Routine Hematoxylin and Eosin Staining", did not include instructions for performing such activities. 3. The HT confirmed the findings on February 5, 2026, at approximately 11:00 A.M. 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 D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on the lack of 2-year verification records for the calendar year 2022 and an interview with the clinical manager, the laboratory failed to perform 2-year verification for KOH slides in the calendar year 2022 for the three providers who perform PPMP testing. FINDINGS: 1. The clinical manager confirmed on March 27, 2023, at approximately 2:00 P.M. that the laboratory failed to verify and document the accuracy of interpretation of KOH slides at least twice per year in calendar year 2022. a. Approximately ten patient samples were tested for KOH for the calendar year 2022. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)