New York State Non-Permitted Laboratory Test Request Approval Form Page 2
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3NEW YORK STATE DEPARTMENT OF HEALTH
WADSWORTH CENTER
CLINICAL LABORATORY EVALUATION PROGRAM
EMPIRE STATE PLAZA, PO BOX 509
ALBANY, NY 12201-0509
NEW YORK STATE NON-PERMITTED LABORATORY TEST REQUEST FORM INSTRUCTIONS
Background:
New York State Public Health Law (Article 5, Title V, Section 574) and regulations (Part 58-1.10 (g) of
10NYCRR) require that all specimens obtained within New York State be tested by a laboratory that holds a
New York State clinical laboratory permit, including test-specific approval when required. Test-specific
approval is not required for tests designated as FDA-cleared, approved or exempt. Notification to add such
tests to the laboratory’s test menu is still required.
Due to the rarity of many diseases, testing for all potential conditions may not be available from permit-
holding laboratories or there may be adequate justification for use of a specific laboratory that does not hold
a permit. In these cases, the department’s approval must be received prior to submitting a specimen
collected in New York State for testing by a non-permitted laboratory or a permitted laboratory that does not
hold approval for that particular test. All laboratories performing testing, however, must hold a valid CLIA
number.
Administration:
The Clinical Laboratory Evaluation Program (CLEP) administers this process and monitors the volume and
frequency of requests. Approval (a Restricted Laboratory Permit) is issued to the requesting physician or
laboratory and to the laboratory requested to perform the test. Restricted Laboratory Permits are one-
time approvals to perform the test is issued to the testing laboratory. With each issuance of a Restricted
Laboratory Permit, laboratories are reminded of the permit and test-specific approval requirements.
Approval Rationale:
Approval to submit specimens to laboratories that do not hold New York State permits or test-specific
Department approval will be granted if the requests to conduct the test are limited in number and if a New
York State approved laboratory does not provide the requested test. Approval to use a non-approved
laboratory, when there exists an approved laboratory, may be granted in the following circumstances:
•
Continuity of care: If the patient (or in the case of a genetic mutation, a member of the patient’s
family) was previously tested at a non-approved laboratory and subsequent testing must be
performed at the same laboratory and on the same instrumentation to allow relevant comparisons of
test results over time. The necessity for continuity must be well-established and justified for the test
requested.
•
Specimen integrity: If referring a specimen to an approved laboratory would compromise specimen
integrity as in the following situations:
o the sample would have to be split to allow testing at another facility that is approved to
perform the test and such splitting would put the specimen at risk of compromise.
o the sample must be tested within a defined timeframe to provide accurate results and
shipping of the specimen to another facility approved to perform the test would delay the
receipt of the sample beyond this timeframe. Laboratories should be cognizant of the
specimen integrity requirements prior to sending the specimen to a laboratory that does not
hold approval to perform the test. Please note: Reference laboratories must have
mechanisms in place to avoid unnecessary delays that would affect specimen
integrity when seeking approval for a restricted permit.
Each test request justification is evaluated specifically in light of current patient circumstances and status of
approved laboratories. Requests will not be approved based on cost, reimbursement, or customer service
considerations. Denials for request to send specimens to a non-permitted laboratory are issued when there
exist New York State permitted/approved laboratory(ies) or when there is a documented lack of analytical
and/or clinical validity for the test requested.
REV 03/05/13
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