CMS SOM App. C, Tag D5305

(c) The laboratory must ensure the test requisition solicits the following

information:

(c)(1) The name and address or other suitable identifiers of the authorized person

requesting the test and, if appropriate, the individual responsible for using the test

results, or the name and address of the laboratory submitting the specimen,

including, as applicable, a contact person to enable the reporting of imminently life

threatening laboratory results or panic or alert values.

Interpretive Guidelines §493.1241(c)(1)-(c)(8)

The test requisition must provide the information necessary to identify and send test

results to the individual who ordered the test (the authorized person), or, where

applicable, to the authorized person’s representative. An authorized person may also use

the test requisition to designate additional individuals/entities that will be responsible for

using the test results to provide care to the subject individual.

The address(es) to which test results should be sent may include a postal address (street,

city or town, state and ZIP code), a fax number, and/or the information necessary for

electronic transmission. When appropriate, a telephone number or other mechanism to

contact the individual responsible for using the test results should be provided to the

laboratory on the requisition.

Verify that test requisitions solicit all information necessary for the proper interpretation

of results. This may include patient’s age, sex, date, fasting status, time of collection,

specimen type (e.g., plasma, urine, spinal fluid), diagnosis, and date of last menstrual

period (LMP) for Papanicolaou (PAP) smears. Verify that the instructions to clients are

clear and specify the items that must be completed.

Laboratories must have policies that guide staff on what to do if/when they receive a

requisition or patient medical chart or record that is missing required information.

Laboratories must either obtain the missing information, or report results and indicate on

the test report, medical record or chart any limitations of test results due to the omission

of patient information. If the missing information is essential (such as the family history

for certain genetic tests) for accurate test results, it must be obtained prior to reporting

patient test results.

(c)(2) The patient’s name or unique patient identifier.

(c)(3) The sex and age or date of birth of the patient.

(c)(4) The test(s) to be performed.

(c)(5) The source of the specimen, when appropriate.

(c)(6) The date and, if appropriate, time of specimen collection.

(c)(7) For Pap smears, the patient’s last menstrual period, and indication of whether

the patient had a previous abnormal report, treatment, or biopsy.

(c)(8) Any additional information relevant and necessary for a specific test to

ensure accurate and timely testing and reporting of results, including

interpretation, if applicable.

Interpretive Guidelines §493.1241(c)(8)

This may include such items as preventative or therapeutic medications, or family

history.

Probes §493.1241(c)(1)-(c)(8)

How does the laboratory uniquely identify patient specimens that share the same or

similar name, birth date, address or sex?

How does the requisition provide for inclusion of additional information when necessary

(e.g., specimen type or source)?