Summary:
Summary Statement of Deficiencies D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) (a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (a)(1) Patient preparation. (a)(2) Specimen collection. (a)(3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (a)(4) Specimen storage and preservation. (a)(5) Conditions for specimen transportation. (a)(6) Specimen processing. (a)(7) Specimen acceptability and rejection. (a)(8) Specimen referral. This STANDARD is not met as evidenced by: Based on direct observation, review of the Standard Operating Procedures (SOPs), as well as interview with Technical Consultant (TC), the laboratory failed to comply with established procedures for labeling patient specimens. FINDINGS: 1. The surveyor's observations in the laboratory confirmed on June 18, 2025, at approximately 12:00 P.M. one 4.0 mL green-top lithium heparin collection tube containing patient blood specimen was not labeled with patient unique identifiers as required by the current, approved patient specimen collection SOPs. 2. TC confirmed the findings on June 18, 2025, at approximately 12:00 P.M. 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 --