Limited Testing Registration printable pdf download

NEW YORK STATE DEPARTMENT OF HEALTH

LIMITED TESTING REGISTRATION

CLINICAL LABORATORY EVALUATION PROGRAM

INSTRUCTIONS

WADSWORTH CENTER P.O. BOX 509

ALBANY, NEW YORK 12201-0509

A. BACKGROUND AND GENERAL INFORMATION

The New York State Public Health Law requires that “no person shall own or operate a clinical laboratory

located in or accepting specimens from New York State . . . unless a valid permit has been issued as provided

in section five hundred seventy-five of this title.” The only exception to the permit requirement is for clinical

laboratories operated by a licensed physician (as described in Section B).

Additionally, the federal Clinical Laboratory Improvement Amendments of 1988 (CLIA ’88), requires that all

facilities performing clinical laboratory procedures register with the federal Centers for Medicare and Medicaid

(CMS), formerly known as the Health Care Financing Administration. One of the requirements for such

registration is compliance with state law. The Department of Health Clinical Laboratory Evaluation Program

(CLEP) was granted exempt status under CLIA ‘88. All facilities required to obtain a clinical laboratory permit

must obtain their CLIA registration numbers from CLEP. CLIA registration numbers will not be issued or

reissued unless the facility has applied for a New York State clinical laboratory permit.

However, in an effort to enhance patient management, a limited testing registration process was established for

facilities that perform only Waived and/or Provider-performed Microscopy Procedures (PPMP). Waived testing

includes tests performed using a kit, device or procedure which has been designated by the Food and Drug

Administration as Waived for the purposes of the CLIA’88. Sites performing these tests shall maintain a copy

of the documentation that the tests in use have been so designated. Provider-performed Microscopy

Procedures (PPMP) includes tests personally performed as part of physical examinations by health care

providers, licensed and currently registered in New York State, including physicians, dentists, podiatrists,

physician assistants, nurse practitioners and certified midwives operating within the scope of practice for their

profession and which have been designated as PPMP by the Centers for Disease Control. Sites performing

these tests shall maintain a copy of the documentation that the tests in use have been so designated.

B. HOW TO DETERMINE IF YOUR FACILITY QUALIFIES FOR THE PHYSICIAN OFFICE EXCEPTION

The only facilities that are exempt from the laboratory permit requirements or limited testing registration are

private physician office laboratories (POLs) operated by individual practitioners or as part of a legally

constituted, independently owned and managed partnership or group practice. The tests performed must be

conducted by the providers or by their own employees, utilizing their own reagents and instrumentation, solely

as an adjunct to the practice of medicine for their patients. POLs must submit a CMS-116 to CMS in order to

receive a CLIA number. Information and applications may be obtained by calling the Physician Office

Laboratory Evaluation Program at 518-485-5352.

However, laboratories which are set up as a joint venture of several practitioners, partnerships or practices and

practices which are owned, managed and/or operated by managed care organizations, hospitals or consulting

firms are not included within the POL exemption and must obtain a permit. If you have any question about

whether a permit is required, contact the program at 518-485-5391(voice), 518-485-5414 (fax), or via e-mail at

CLEP@health.state.ny.us.

DOH-4081(i) (04/03)

Limited Testing Registration