Summary:
Summary Statement of Deficiencies D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Through review of laboratory policy and procedure, observation and interview it was determined that the laboratory failed to label three of four specimen collection containers with patient name or unique patient identifier. Findings follow: A) During a tour of the laboratory on 9/27/22 at 1:52 pm four urine specimen containers were observed in the laboratory testing area; two labeled with the patient's first and last names only, one with the patient's first name only, and one labeled correctly with the patient's first and last name and the date of birth. B) Review of the laboratory policy and procedure revealed that "patient specimens must be labeled with the patient's name and chart number, in the event the chart number is not available, then the date of birth should be utilized". . C) In an interview on 9/27/22 at 3:58 pm , the laboratory staff member (#1 on the CMS 209 form) confirmed that the specimens identified above had been analyzed and three lacked proper patient identification on the containers as required by policy and procedure. 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 --