Summary:
Summary Statement of Deficiencies D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) (c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (c)(1) Identity and when significant, titer, strength or concentration. (c)(2) Storage requirements. (c)(3) Preparation and expiration dates. (c)(4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of the manufacturer's instructions for use, and staff interviews, the laboratory failed to ensure that reconstituted quality control aliquots included identity, preparation, or expiration dates for the Horiba Pentra 400 chemistry instrument used for patient testing. The findings include: 1. Observation of the laboratory on 02/11/2026 at 10:00 a.m. revealed the following used for patient chemistry testing: Horiba Pentra 400 (Serial # 312-C4-1667) chemistry instrument. A MedLab Performance refrigerator used to store reagents, quality controls, and calibrators for the Horiba Pentra 400 instrument. The refrigerator contents included a "Cuvette Segments" box that contained 3 cuvettes with aliquoted material labeled "P" and "N". During the observation, the technical consultant stated that the aliquoted material was the reconstituted Multicontrol P and N quality control used for the Horiba Pentra 400 instrument. 2. A review of the Horiba ABX Pentra MultiControl instructions for use revealed "Stability after reconstitution 5 days at 2 - 8 C". 3. An interview on 02/11/2026 at 1:30 p.m. with the laboratory director and technical consultant confirmed the survey findings. Word Key - degrees C- Celsius D6011 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(2) (e)(2) provide a safe environment in which employees are protected from physical, 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 -- chemical, and biological hazards; This STANDARD is not met as evidenced by: Based on observation of the laboratory and staff interviews, the laboratory director failed to ensure that the laboratory included an eyewash station to protect personnel from chemical and biological hazards in 2025 and 2026. The findings include 1. Observation of the laboratory on 02/11/2026 at 10:00 a.m. revealed that no eyewash station was present. 2. An interview with the laboratory director and technical consultant on 02/11/2026 at 1:30 p.m. confirmed the survey findings. -- 2 of 2 --