Summary:
Summary Statement of Deficiencies D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on observation of the laboratory and interview with the technical consultant, the laboratory failed to label saline that was being used for wet preps with lot number, open date, expiration date and storage requirements on the date of the survey (02/13 /23). The findings include: 1. Observation of the laboratory on 02/13/23 at 1:30 pm revealed a brown bottle labeled as "0.9 % Sodium Chloride" (saline) used for preparing swabs for microscopic analysis for wet prep. The label on the bottle did not include an open date, expiration date or storage requirements. 2. Interview with the technical consultant on 02/13/23 at 1:30 pm confirmed the bottle of saline being used for performing wet prep analysis was not labeled with open date, expiration date or storage requirements on the date of the survey (02/13/23). 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 --