Summary:
Summary Statement of Deficiencies D0000 A Recertification survey was conducted on April 4, 2024. Dermatology and Cutaneous Surgery Institute PA clinical laboratory was not in compliance with 42 CFR 493, requirements for clinical laboratories. 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 observation, review of the procedure manual and reagent log, and interview, the laboratory used expired Scotts Tap Water in their Hematoxylin and Eosin Stain from 07/02/2023 to 04/04/2024. Findings: During a tour of the laboratory on 04/04 /2024 at 9:15 AM, the Scotts Tap Water Substitute lot # 2217514 with expiration date of 07/01/2023 was observed in the flammable cabinet. No other Scotts Tap Water was seen in the laboratory. Review of the procedure titled Histopathology-Mohs Surgery in the section Reagent Storage, Use and Handling noted "Do not use reagents after expiration date." Review of the Reagent Receipt Log showed the Scotts Tap Water was received on 04/07/2023 and no other Scotts Tap Water had been received after 04 /07/2023. According to the Clinical Laboratory Improvement Amendments (CLIA) Application for Certificate signed and dated by the Laboratory Director on 04/03 /2024, the laboratory's total estimated annual test volume was 140 tests. On 04/04 /2024 at 11:42 AM, the Office Manager acknowledged the Scotts Tap Water was expired. 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 --