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 upon review of the laboratory policy and procedure, observation, and interview, the laboratory failed to label two of three urine specimens with the patient name and unique patient identifier. Findings follow: A) Review of the laboratory's "General Polcy and Procedure" paragraph 6.2 "Patient Identification and Labeling" revealed "labels must be legible and include at minimum the patient name, identification number, and date". B) During a tour of the laboratory on 6/17/26 at 11:34 a.m., two of three specimen cups were observed in the laboratory testing area with handwritten labels consisting of the patient's first and last names only. C) In an interview on 6/17 /26 at 11:45 a.m., the laboratory staff member (# 1 on the form CMS 209) confirmed that the specimens identified above were labeled with patient name only, had been tested and reported, and should have also been labeled with a second unique patient identifier . 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 --