Summary:
Summary Statement of Deficiencies D0000 An announced recertification survey was conducted on 12/10/19 at Skin And Cancer Associates LLP, a clinical laboratory in Lake Worth, Florida. Skin And Cancer Associates LLP is not in compliance with Code of Federal Regulations (CFR), Part 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 and interview with laboratory personnel, the laboratory had used reagents that had exceeded their expiration date. The findings included: During a tour of the laboratory on 12/10/19 three unopened and one opened container of xylene substitute, lot # 073275 expiration date 11/01/2019, were observed in the flammable storage cabinet. There were no other containers of xylene substitute in the laboratory. Seven patients were done in November and thirteen were done in December. During an interview with the laboratory consultant at 9:55 a.m. on 12/10/19, he confirmed that the xylene substitute had 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 --