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 one of one specimen collection containers with patient name or unique patient identifier. Findings follow: A) During a tour of the laboratory on 1/29/21 at approximately 11:45 AM one urine specimen was observed in a sink in the testing area labeled with the patient's first and last name only. B) Review of the laboratory policy and procedure revealed that specimen containers are to be labeled with the patient's first and last names and a unique patient identifier, patient number or patient's date of birth. C) In an interview on 1/29/21 at approximately 12:00 , the laboratory staff member, identified as number two on the CMS 209 form, confirmed that the specimen identified above lacked proper patient identification on the container 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 --