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's reagent materials used for decontamination of surface areas and other reagents used in the laboratory and interview with the laboratory director (LD) and technical supervisor (TS); it was determined that the laboratory failed to label various reagents to indicate preparation and expiration dates when such reagents are used in the laboratory. The findings included: 1. Based on the surveyor's observation during the laboratory tour on September 7, 2022, at approximately 12:30 pm.; no opening, preparation, or expiration date labels were used or documented for various reagents used throughout the laboratory (1:10 Sodium hypochlorite and sterile water). 2. The laboratory's LD and TS affirmed in an interview conducted 9/7/ 2022, at approximately 1:15 p.m. that the reagents mentioned in statement 1 were not labeled with the opening, preparation, and expiration dates or documented. 3. Based on the laboratory's annual testing declaration submitted at the time of the survey, the laboratory analyzed approximately 39,308 test samples. 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 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on the surveyors' observation, examination of laboratory reagents, and interview with the laboratory director (LD) and technical supervisor (TS); it was determined that the laboratory failed to not use reagents when they have exceeded their expiration date. The findings included: 1. On the day of inspection, September 7, 2022, at approximately 12:30 p.m. the surveyor found while touring the Microbiology laboratory the following reagent used beyond its expiration date: 50% Ethanol. Expired 7/2022 1% Sulfuric acid. Expired 7/12/2022 2. The LD and TS affirmed on 9 /7/2022 at approximately 11:45 a.m. using the reagents listed on 1 beyond its expiration date. 3. Based on the laboratory's submitted testing declaration volume, the laboratory tests and reports approximately 27,508 Microbiology tests samples. D6144 GENERAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1463 The general supervisor is responsible for day-to-day supervision or oversight of the laboratory operation and personnel performing testing and reporting test results. This STANDARD is not met as evidenced by: Based on survey findings and deficiencies cited D5415 and D5417; the General Supervisor (Testing Person/ Technical Supervisor/ Laboratory Director) is herein cited for deficient practice in providing general oversight of the laboratory and personnel. Findings included: 1. The General Supervisor (Testing Person/ Technical Supervisor/ Laboratory Director) failed to have a mechanism or practice in place to proper label reagents and not use reagents beyond their expiration date. -- 2 of 2 --