New York State Non-Permitted Laboratory Test Request Approval Form Page 3
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1
2
3NEW YORK STATE DEPARTMENT OF HEALTH
WADSWORTH CENTER
CLINICAL LABORATORY EVALUATION PROGRAM
EMPIRE STATE PLAZA, PO BOX 509
ALBANY, NY 12201-0509
Practitioner/Submitter Responsibility:
The physician or laboratory requesting the test must document that the patient or legal guardian was
informed that the laboratory performing the testing does not hold a New York State laboratory permit or that
the test is not approved by the Department. Department approval to refer a specimen to a non-permitted or
non-approved laboratory should not be considered as an endorsement of the laboratory’s competence or a
guarantee that the laboratory has complied with all relevant federal and/or State regulations. For genetic
tests, clinicians and laboratorians must comply with the New York Civil Rights Law Section 79-l provisions
for informed consent.
Instructions for Completing Request Form
Written requests for authorization to use a non-permitted or non-approved laboratory must include the
following information. A standardized form is available for your convenience.
1. Patient name and unique patient identifier (for example, a medical record number);
2. Symptoms, Diagnosis or Gene Name (as applicable);
3. Test requested;
4. Specimen type (e.g. blood, plasma, urine, etc);
5. Full justification for request;
6. Name, address, telephone number, contact person, fax number and PFI number or CLIA number of the
facility making request /sending specimen; and,
7. Name, address, telephone number and CLIA number of the non-permitted or non-approved laboratory
performing the test;
8. When requesting permission to refer in vitro fertilization (IVF) samples (blastomeres) for preimplantation
genetic diagnosis (PGD) to a laboratory that does not hold New York State clinical laboratory permit or
to a permitted laboratory that lacks test-specific approval for the intended PGD testing, please
provide the following additional information. This information will assist the Program in tracking the
chromosomes and diseases being studied, the reagents and methods used for PGD and in notifying
clinicians when approved laboratories become available.
•
The anticipated date of the IVF cycle when PGD will be performed.
•
For chromosome abnormalities (cytogenetic testing) by fluorescence in situ hybridization (FISH),
provide the type of chromosome abnormality being considered, e.g., numerical (aneuploidy) or
structural. For familial structural chromosome aberrations, provide the cytogenetic diagnosis of the
carrier parent and the FISH probes to be used in the PGD study.
•
For genetic conditions, provide the disease being considered, the gene/mutation to be detected, and
the testing methodology used.
How to Submit Requests
Requests for permission to use an unapproved laboratory may be submitted as indicated below by fax using
the form available here:
Genetic Tests to:
Cytogenetic Tests to:
All others to:
Genetic Testing Quality
Cytogenetics Quality
Clinical Laboratory Evaluation
Assurance Program
Assurance Program
Program
Wadsworth Center, NYSDOH
Wadsworth Center, NYSDOH
Wadsworth Center, NYSDOH
Ph: (518) 474-6271
Ph: (518) 474-6796
Ph: (518) 485-5378
Fax: (518) 486-2693
Fax: (518) 486-4921
Fax: (518) 449-6917
The program will respond, in writing, to each request to use a non-permitted laboratory. If the request is
rejected, the reason for denial will be explained in the department’s response. If you have any questions,
please contact the Clinical Laboratory Evaluation Program at (518) 485-5378.
REV 03/05/13
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