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 observation, record review, and interview, the laboratory failed to establish and follow a policy to ensure specimen labeling for one of one patient's (PT#1) urine specimen collected. Findings include: 1) During a tour of the patient restroom on 9/22 /25 at 11:40 am, a small plastic (light blue) container was observed, unattended sitting on a small shelf. The container was half-full and contained a light-yellow liquid that appeared to be urine. 2) In an interview on 9/22/25 at 11:42 am, SP-5 acknowledged the blue cup containing urine from patient (PT#1) was left in the patient restroom, not contained/sealed and without a patient label. SP-5 stated the urine sample was going to be sent to reference laboratory (laboratory B) for further testing. 3) Review of policy titled, "Protocols, Guidelines Standing Orders," signed by SP-4 (laboratory director) on 3/26/25 was reviewed for urinalysis processing protocol. There was no written protocol on how a urine sample should be labeled. 4) Annual Urine testing volume is approximately=250. 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 --