Bone Marrow/Leukemic Blood Requisition. Hematology/Oncology Cytogenetics Requisition. Blood Bank Requisition - Outpatient. Additional information is available on the Certificate of Qualification Application(s) website.Test Requisition & Consent. Read More New Test Announcement: CD33, a biomarker that determines response to Mylotarg therapy is now availablePrior to applying for a permit, the laboratory director and any assistant directors must hold a Certificate of Qualification for all categories for which the laboratory offers testing to residents from New York State. Our News New HematoLogics Publication outlining the instrumental use of FACS FISH for the detection of BCR/ABL-1 positive T-cell lymphoblastic leukemia arising in early lymphoid progenitor cells and possible treatment implications.
Disclosure of Ownership, Controlling Interest, and Corporate Membership Statement A check in the amount of $1,100 payable to the New York State Department of Health for application and Inspection and Reference fees. Our offerings include expert bone marrow and surgical pathology consults cytogenetics with industry-leading turnaround times. Quest PathologyApplicants begin by submitting the following:Visit our Test Menu. AmeriPath Cincinnati, Inc. Toxicology/Routine Precision Genetics Genetics Progenity Genetics Quest Diagnostics.
Categories of testing can be found in the Permit Category Descriptions document. A Test Menu is required for all categories for which your laboratory performs testing on specimens from NYS. Laboratories located outside the United States must contact CLEP at to determine an acceptable alternate payment method.Test Menu: A Test Menu will be sent electronically once your application is reviewed. Checks drawn on banks located outside the United States are not accepted. Credit card payments are not accepted. This is payable by check made out to the New York State Department of Health.
Certificate of Qualification Application(s) for director and assistant directors (if individuals do not already hold Certificate)Please be advised that New York State Public Health Law stipulates that a laboratory permit is automatically void upon a change of director, owner or location. The laboratory director or an assistant director must be assigned responsibility for each category indicated on pages 6 & 7 of your Clinical Laboratory Permit Application.Optional documents, as applicable to the laboratory: Test menus should be submitted to and must include the Permanent Facility Identifier (PFI) number that will be assigned to your laboratory.
If you are a non-NYS laboratory that has applied directly to the CLIA program but have not yet received your CLIA Number, check "Pending.” If your laboratory is currently operating as a physician office laboratory (POL), provide your current CLIA registration number.Certification: It is the responsibility of both the director and the owner to ensure that the laboratory meets all legal requirements for operation on the Laws and Regulations section of our website.Notification of Laboratory Changes: Notification of changes in the laboratory name, owner, director, or location, and requests for new categories or analytes must be submitted, prior to the effective date of the change, via eCLEP. If your laboratory is located in New York State and does not yet have a CLIA registration number, check the box marked “Requested” and a CLIA number will be issued for your facility. CLIA numbers will appear on your State laboratory permit and laboratories in New York State are not required to hold a separate CLIA certificate.
The appropriate forms are available on our website at Management Contracts: Any laboratory that is operated and/or managed by an individual or entity on behalf of the owner must provide a copy of the written agreement (management contract) setting up the business relationship.Proficiency Testing: The laboratory must indicate the CMS-approved provider and survey module that has been determined to fulfill CMS proficiency testing requirements for tests/analytes included under CLIA Subpart I (CFR 493.909-493-959). Information regarding this requirement and the process for submitting proof of enrollment can be found in the New York State Workers’ Compensation Board Employers’ Handbook – A Guide to the Workers’ Compensation System for the New York State Business Owner, available at Patient Service Centers and Health Fairs: If your laboratory plans to operate PATIENT SERVICE CENTERS (collection stations), or HEALTH FAIRS (temporary off-site testing events), the laboratory must apply via eCLEP after the clinical laboratory permit has been issued.Limited Service Laboratories: If your laboratory plans to operate a LIMITED SERVICE LABORATORY (usually extension clinics offering waived or provider-performed microscopy procedures), you must complete and return an “Application for Limited Service Laboratory” (form DOH-4081) for each site. The eMedNY Call Center number is 1-80.Workers Compensation: Under the New York State Workers’ Compensation Law, businesses applying for permits or licenses issued by the State must hold workers’ compensation and disability benefits coverage or document their qualifying for an exemption. Refer to the Department of State website at Questions regarding this requirement can be directed to the Division at (518) 473-2492.Medicaid Enrollment: Refer to the webpage eMedNY for instructions on Medicaid enrollment for New York State. Applications for a Certificate of Authority to do business in New York State may be obtained from the Department of State, Division of Corporations, State Records and Uniform Commercial Code, 99 Washington Avenue, 6th floor, Albany, NY 12231. Please call CLEP at (518) 485-5378 if changes must be made before the laboratory director has been granted access to HCS.Out of State Laboratories: Non-New York State corporations may not do business in New York State until they have been authorized to do so by the New York State Secretary of State.
An acceptable module must be chosen for each analyte on the Test Menu form where proficiency testing is required.
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