Summary:
Summary Statement of Deficiencies D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on review of the temperature log sheet and interview with the laboratory director, the laboratory failed to follow posted range for room temperature for seven of nine days in 2024. Findings: 1. Review of temperature log states room temperature range is "68-76 F." 2. Review of temperature log sheet for January 1, 2024 to date March 13, 2024, showed the temperature failed to meet stated parameters on log sheet for the following days. January 2, 9, 15, 23, and 30 February 13 and 20 3. Interview with the laboratory director on March 13, 2024 at 9:30 AM confirmed the laboratory failed to follow posted range for room temperature for seven out of nine days in 2024. 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 of tissue marking and margin dyes and interview with the laboratory director (LD), the laboratory failed to discard expired tissue marking dyes. Findings: 1. Observation of tissue marking and margin dyes showed: Yellow tissue 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 -- marking dye lot #143908, expiration date February 29, 2024 still in use. Blue tissue marking dye lot #140452, expiration date February 29, 2024 still in use. 2. Interview with LD on March 13, 2024 at 9:30 AM confirmed the laboratory failed to discard expired tissue marking dyes. -- 2 of 2 --