Requirements for Patient Identification, Specimen Labeling and Testing Requisitions

Specimens submitted for laboratory testing, including tissue and Cytology specimens, must be obtained from an unambiguously identified patient, labeled with key identification and collection information, and accompanied by a paper or electronic requisition that provides additional information necessary to properly perform and report the ordered studies. Results issued on the wrong patient or wrong test lead to diagnostic and therapeutic errors with the potential to cause patient harm.

The laboratory is required to provide instructions to individuals who submit specimens about proper collection and labeling, and to have a standard method for managing instances of noncompliance including corrective action and notification back to the submitting location.

Physician Order:

Tests and examinations must be ordered by a physician or other individual allowed by state law to independently do so.

In order to qualify as the order, the document must include the physician’s pen-to-paper signature or electronic signature (an electronic record created by the physician using an ID that is not in use by any other individual). A rubber stamp or electronically-generated cursive entry is not a substitute.

For inpatients and outpatient locations using the same EMR as for inpatients, it is assumed that the order is documented in the patient record and the lab ordinarily does not confirm the order prior to testing. For outpatients at locations that do not use the hospital EMR, the physician order is often included on the testing requisition. If the specimen is submitted without an order, the lab is required to request a written order be provided within 30 days of the test submission. (The order has to be requested but not necessarily received in order for testing to be performed.)

Patient Identification:

Specimens should be collected from patients with a known first and last name, and date of birth. Whenever possible, the information should be obtained from the patient. Confirmation with a government-issued photo identification card is desirable. In emergencies and in situations where the patient is unable to speak for himself, an alias name and date of birth may be assigned and used to identify the patient until his actual identification is determined, at which point the records can be merged and the actual identification information used going forward.

For patients being treated at the hospital (including admitted, ED, same day surgery, and in-hospital procedures), the patient must wear a barcoded wristband bearing his full name, date of birth and medical record number to allow positive identification by all caregivers.  This wristband is scanned at the patient bedside for blood draws by the phlebotomist for a further identification of the patient.  A second wristband bearing a special blood bank number is required for patients having transfusion compatibility testing performed and/or blood components issued. If the person obtaining the specimen finds that the patient is not wearing a wrist band, he/she must request that one be placed before performing the collection.

Labeling Practice:

Specimen labels should be printed at the bedside whenever possible. The label information must be verified prior to sample collection with the patient’s wristband (hospital patients), the patient himself, or the patient documents during a pre-procedure ID confirmation. Specimens should be labeled at the time of collection in the room with the patient, ordinarily by the person performing the collection.

For patients having transfusion compatibility testing performed and/or blood components issued, the primary label must also include the number from the special blood bank wrist band.

For specimens submitted in bags or with special packaging, the labels must be applied to the “primary” specimen container which is the innermost container that actually holds the specimen.

Label Content:

The label must provide the patient’s first and last name, and date of birth. Other identifying information such as social security number, age or account number should not be substituted.

The collection date and time, and the identification of the person collecting the specimen, must be indicated. For patients being treated at the hospital (e.g. inpatient, ED, ORs, procedure areas), the assigned Meditech mnemonic is used as the collector ID. For other submitting locations, initials or first initial with last name are often used. The submitting location is responsible for choosing a collector ID that will allow it to accurately trace back to the collector if specimen submission problems occur.

For specimens submitted for histologic or cytologic examination, and for all microbiologic studies, the label must also provide the specimen source (i.e anatomic site, sampled material or fluid). This information is also included on the requisition.

Requisition Content:

The sample must be accompanied by a paper or electronic requisition that indicates the tests and examinations to be performed, as well as the patient identification (last name, first name, date of birth), ordering location and name of the ordering physician. For tests ordered electronically, the requisition is generated from the order entry and linked to the specimen via the accession number.

For specimens submitted for histologic or cytologic examination, and for microbiologic studies, the requisition must also indicate the specimen source (i.e anatomic site, sampled material or fluid).

Clinical information (e.g. text or ICD codes) that supports the medical necessity of the testing and any information that is needed to properly perform or interpret the ordered tests should also be provided.

Patient demographic information should be provided with private outpatient samples to allow billing.   For outpatients, the physician order bearing his signature may be included on the testing requisition.