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Health ny professionalsemsNEW YORK STATE DEPARTMENT OF HEALTH LIMITED TESTING

Health ny professionalsemsNEW YORK STATE DEPARTMENT OF HEALTH LIMITED TESTING 2025

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The document outlines the application process for not-for-profit and government Limited Service Laboratories in New York State to register additional permanent testing locations under a multi-site network. It provides detailed instructions on eligibility, required information for primary and additional testing sites, types of tests that can be performed, and certification requirements. The goal is to streamline the registration process for laboratories performing waived and provider-performed microscopy procedures under a single CLIA registration number.

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Click ‘Get Form’ to open it in the editor.
Begin with Section 1 - Primary Laboratory Information. Fill in the legal name and address of your Primary Limited Service Laboratory, along with the CLIA & PFI numbers if available.
Proceed to Section 2 - Additional Testing Site Information. Enter details for the new permanent testing location, including its name, county, address, and contact information.
In Section 3A, list all Waived test procedures you wish to perform at the new site. Provide estimated annual test volumes for each procedure.
Complete Section 3B by indicating any Provider-performed Microscopy (PPM) Procedures you plan to conduct and their estimated annual volumes.
Finally, ensure that Section 4 is signed by the Laboratory Director responsible for the testing. Remember that original signatures are required.

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Versions	Form popularity	Fillable & printable
2022	4.5 Satisfied (56 Votes)
2020	4.9 Satisfied (40 Votes)
2012	4.1 Satisfied (45 Votes)

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What NYS regulation is required for all specimens?

New York State Public Health Law (Article 5, Title V, Section 574) and regulations (Subsection 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.

What does the NYS Department of health do?

Phone. 1-800-663-6114 - Complaints/Inquiries (Monday-Friday 9:00 a.m - 5:00 p.m.)

What New York state regulation is required for all specimens?

The New York State Department of Health (State DOH) protects, improves, and promotes the health, productivity, public safety, and wellbeing of all New Yorkers.

What is needed to operate a laboratory in NYC?

General Requirements submit the application and fee for initial certification; be of good moral character; be at least 18 years of age; meet education or alternative to education requirements; and. meet examination requirements.

Who sets regulations for all performing labs in the US?

The Centers for Medicare Medicaid Services (CMS) regulates all laboratory testing (except research) performed on humans in the U.S. through the Clinical Laboratory Improvement Amendments (CLIA) program. The objective of CLIA is to ensure quality laboratory testing.