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 observation and interview with the GS (general supervisor) 4/4/19, the laboratory failed to discard supplies that had exceeded their expiration dates. During a tour of the laboratory at approximately 3:10 p.m., the surveyor observed the following expired supplies in Refrigerator #4, available for use: 1. 1 box of Aptima Panel C Positive Trichomonas vaginalis (Lot #151670 H, Expiration Date: 2017-08-15); 2. 1 box of Aptima Combo 2 STD Panel B CT Positive (Lot #189367 H, Expiration Date: 2017-12-15); 3. 1 box of Aptima Panel B Positive Trichomonas vaginalis (Lot #181604 H, Expiration Date: 2018-09-15); 4. 1 box of Aptima Combo 2 STD Panel B CT Positive (Lot #229409 H, Expiration Date: 2018-12-15); 5. 1 box of Aptima Combo 2 STD Panel D Dual Positive (Lot #227129 H, Expiration Date: 2019-01-15); 6. 1 box of Aptima Combo 2 STD Panel C GC Positive (Lot #228622 H, Expiration Date: 2019-01-15). During interview at approximately 3:15 p.m., the GS stated he was unsure why the items had not been discarded. He stated that he felt sure they had not been used because they were on the lower shelf of the refrigerator in the back corner. 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 --