Summary:
Summary Statement of Deficiencies D0000 Based on an on-site recertification survey conducted on May 12, 2026, deficiencies were cited for Biocomp Laboratories, Inc, in Colorado Springs, Colorado. 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 the surveyor's observation of the laboratory and an interview with the laboratory director during the survey, the laboratory failed to label reagents to indicate strength or concentration, storage requirements, preparation date and expiration date. Findings include: 1. The surveyor's observation of the laboratory during the laboratory tour on 05/12/2026 at 10:30 AM revealed that the laboratory prepares reagents in glass containers, and the containers label lacked strength, concentration, storage requirements, preparation date and expiration date. 2. An interview with the laboratory director on 05/12/2026 at 11:00 AM confirmed that the containers label lacked strength, concentration, storage requirements, preparation date and expiration date. 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 --