Summary:
Summary Statement of Deficiencies 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's observation of the laboratory's testing area, review of records and an interview with the technical consultant, the laboratory was using testing materials beyond manufacturer's expiration date. FINDINGS: On July 5, 2018 at approximately 11:30 AM the technical consultant confirmed surveyor's findings that the laboratory used a bottle of Gill III Hematoxylin lot # 048303 expiration date February 2018 to stain Mohs slides from March through June 2018. An in-date container of Hematoxylin stain was not available for use. Approximately 20 Mohs patient biopsy specimens were processed and test results released using the expired stain. 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 --