N.J. Admin. Code § 10:61-1.6 - Orders for laboratory tests; recordkeeping

(a) All orders for clinical laboratory services shall be in the form of an explicit order personally signed by the physician or other licensed practitioner requesting the services, or be in an alternative form of order specifically authorized in (b)1 through 3 below. The written order shall contain the specific clinical laboratory test(s) requested, shall be on file with the billing laboratory and shall be available for review by Medicaid/NJ FamilyCare representatives upon request.

(b) If a signed order is not utilized, then clinical laboratory services shall be ordered in one of the following ways:

1. In the absence of a written order, the patient's chart or medical record may be used as the test requisition or authorization, but must be physically present at the laboratory at the time of testing and available to Federal or State representatives upon request;

2. A test request also may be submitted to the laboratory electronically, if the system used to generate and transmit the electronic order has adequate security and system safeguards to prevent and detect fraud and abuse and to protect patient confidentiality. The system shall be designed to prevent and detect unauthorized access and modification or manipulation of records, and shall include, at a minimum, electronic encryption; or

3. Telephoned or other oral laboratory orders are also permissible, but shall be followed up with a written or electronic request within 30 days of the telephone or other oral request, which shall be maintained on file with the clinical laboratory. If the laboratory is unable to obtain the written or electronic request, it must maintain documentation of its efforts to obtain them.

(c) Standing orders shall be:

1. Patient specific, and not blanket requests from the physician or licensed practitioner;

2. Medically necessary and related to the diagnosis of the recipient; and

3. Effective for no longer than a 12-month period from the date of the physician's/practitioner's order.

(d) The laboratory must ensure that all orders described in (a) through (c) above contain the following information:

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;

2. The patient's name or unique patient identifier;

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

4. The test(s) to be performed;

5. The source of the specimen, when appropriate;

6. The date and, if appropriate, time of specimen collection;

7. For Pap smears, the patient's last menstrual period, and indication of whether the patient had a previous abnormal report, treatment or biopsy; and

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.

(e) The results of the tests billed shall be on file with the billing laboratory performing tests. The results shall be available for review by Medicaid/NJ FamilyCare representatives.

(f) The Medicaid/NJ FamilyCare program shall have the right to inspect all records, files and documents of in-State and out-of-State service and reference clinical laboratories which provide laboratory tests and services for Medicaid/NJ FamilyCare beneficiaries.

(g) All laboratory test orders shall be supported by documentation in the referring physician's/practitioner's medical records.

(h) If the laboratory transcribes or enters test requisition or authorization information into a record system or a laboratory information system, the laboratory must ensure that the information is transcribed or entered accurately.

Notes

N.J. Admin. Code § 10:61-1.6

Amended by R.2006 d.37, effective 1/17/2006.
See: 37 N.J.R. 3182(a), 38 N.J.R. 807(a).
In (a), (e) and (f), added "NJ FamilyCare" following "Medicaid/" throughout; in (f), deleted "New Jersey" preceding "Medicaid" throughout, substituted "Program" for "program" and "beneficiaries" for "recipients".
Amended by R.2011 d.069, effective 2/22/2011.
See: 42 N.J.R. 1670(a), 43 N.J.R. 423(a).
Section was "Recordkeeping". Rewrote (a), (b) and (d); in (c)3, substituted "12-month" for "12 month" and "order" for "signature"; and added (g) and (h).