Current through Register Vol. 56, No. 18, September 16, 2024
(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.
