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: Through observations made during a tour of the laboratory and interviews with laboratory staff it was determined that the laboratory had supplies that had exceeded their expiration date available for use. Findings follow: A) During a tour of the laboratory on 2/5/21 at approximately 02:00 PM, seven of seven containers of marking dye lot # 073430 with an expiration date of 12/01/20 and 2 of 2 bottle of Richard Allen Neg-50 Orange stain lot number 361135 with an expiration date of 12 /19 and lot number 463852 with an expiration date of 12/20 were observed in the laboratory area. B) In an interview on 2/5/21 at approximately 02:30 PM the laboratory staff members, identified as numbers one and two on the CMS 209 form, confirmed that the supplies identified above had exceeded their expiration date and were available for use. 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 --