N.Y. Public Health Law 575 – Issuance of permits
§ 575. Issuance of permits. 1. Application for a permit shall be made by the owner and the director of the clinical laboratory or blood bank in a manner and format prescribed by the department. The application shall contain the name of the owner, the name of the director, the procedures or categories of procedures or services for which the permit is sought, the location or locations and physical description of the facility or location or locations at which tests are to be performed or at which a blood bank is to be operated, and such other information as the department may require.
Terms Used In N.Y. Public Health Law 575
- Blood bank: means a facility for the collection, processing, storage and/or distribution of human blood, blood components or blood derivatives, but shall not mean a source plasma donation center. See N.Y. Public Health Law 571
- Clinical laboratory: means a facility for the microbiological, immunological, chemical, hematological, biophysical, cytological, pathological, genetic, or other examination of materials derived from the human body, for the purpose of obtaining information for the diagnosis, prevention, or treatment of disease or the assessment of a health condition or for identification purposes. See N.Y. Public Health Law 571
- Director: means the person who is responsible for administration of the technical and scientific operation of a clinical laboratory or blood bank, including supervision of procedures and reporting of findings of tests. See N.Y. Public Health Law 571
2. A permit or permit category shall not be issued unless a valid certificate of qualification in the category of procedures for which the permit is sought has been issued to the director pursuant to the provisions of section five hundred seventy-three of this title, unless all fees and outstanding penalties, if any, have been paid, and the department finds that the clinical laboratory or blood bank is competently staffed and properly equipped, and will be operated in the manner required by this title.
3. The permit shall be issued jointly to the owner and the director and they jointly and severally shall be responsible to the department for the maintenance and operation of the clinical laboratory or blood bank and for any violations of this title and the rules and regulations promulgated thereunder.
4. A permit shall be valid for the year for which it is issued. The initial application for a permit shall be accompanied by a registration fee of one hundred dollars.
5. The permit shall specify the names of the owners and the director, the procedures or categories of procedures or services authorized, and the locations at which such procedures or services may be performed. The permit and the certificate of qualification shall be displayed at all times in a prominent place in the laboratory.
6. A permit shall become void by a change in the director, owner, or location. A category on a permit shall become void by a change in the director for that category. The department may, pursuant to regulations adopted under this title, extend the date on which a permit or category on a permit shall become void for a period not to exceed sixty days from the date of a change of the director, owner or location. An application for a new permit must be made in the manner provided by this section.