Laboratory Exemption Application Form. This is a Nevada form and can be use in Health Division Statewide.
Tags: Laboratory Exemption Application, Nevada Statewide, Health Division
LABORATORY EXEMPTION APPLICATION Page 1 of 2 NEVADA STATE HEALTH DIVISION Bureau of Health Care Quality and Compliance 727 Fairview Drive, Suite E Carson City, Nevada 89701 Phone: (775) 684-1030 Fax: (775) 684-1075 http://www.health.nv.gov/HCQC_Medical.htm This application must be accompanied by a check for the appropriate amount made payable to the Nevada State Health Division. Under Nevada Administrative Code (NAC) 652.488 the fee is non-refundable. Insufficient funds charge: $25.00 per NAC 353C.400. The fee for registration is $500.00 and is valid for two years. Regulations may be viewed at http://leg.state.nv.us. Current State Exemption Number: This application is for: New Lab Reactivation Changes to an Existing Exempt Lab Certificate Outpatient Center of a Lab Licensed Lab Number: Changes to an existing lab (check all that apply): Existing Test Addition Director Location Ownership Name New The fee for making any changes to the director, location, name or test addition of the lab is $300.00. Laboratory/Business Name Doing Business As (DBA) Phone Number (starting with the area code) Fax Number (starting with the area code) Street Address Mailing Address (if different from street address) City City County County State State Zip Code Zip Code Director Contact Person and Phone Number Hours of Operation CLIA Number Criteria to qualify for exemption defined in NAC 652.155 are as follows: 1. (a) Physicians Performing Testing: The operating physician performs the tests on his own patients and makes his own readings of the tests. Please list all tests performed solely by the physician: (b) (c) Advanced Practitioner of Nursing (APN): Name of APN Physicians Assistant (PA): Name of PA Tests performed by APN Test performed by PA 11/30/2010 American LegalNet, Inc. www.FormsWorkFlow.com LABORATORY EXEMPTION APPLICATION Page 2 of 2 2. All Assistants Performing Waived Tests and/or Collecting Specimens: A person who is employed by a laboratory that is licensed by or registered with the health division pursuant to NRS 652 may perform a test without complying with the provisions of NAC 652 if: (a) the test has been classified as a waived test pursuant to 42 C.F.R. Part 493, Subpart A; and (b) the director or designee of the director at the laboratory at which the test is performed: (a) verifies that the person is competent to perform the tests; (b) ensures that the test is performed in accordance with instructions of the manufacturer of the test; (c) validates and verifies the manner in which the test is performed by using controls which insure that the results of the test will be accurate and reliable. List Laboratory Personnel 3. List Tests Laboratory Personnel Perform Section 2 does not relieve a person who performs a test of the requirement to: (a) Comply with the policies and procedures that the director of the laboratory at which the test is performed has established pursuant to NAC 652.280; and (b) Obtain certification pursuant to NAC 652.470. Ownership Information: List names and addresses of all individuals or organizations having direct or indirect ownership or control of 10% or more in the lab NRS 652.090. Please attach a complete listing if additional space is needed. Name Address COPY OF PHYSICIAN’S CURRENT LICENSE (WALLET SIZE IS ACCEPTABLE) MUST BE INCLUDED. MUST BE NOTARIZED BELOW I have read, understood and agree to comply with the rules and regulations pertaining to the specific type of laboratory for which licensure applications are herein made. Lab Physician/Director’s Signature Please PRINT and SIGN Name Must be an ORIGINAL: photocopies or signature stamps are not acceptable. Name and Signature of Notary: Date: State of: County of: Subscribed and sworn before me this: Day of: 11/30/2010 American LegalNet, Inc. www.FormsWorkFlow.com