N.Y. Comp. Codes R. & Regs. Tit. 10 §§ 58-4.2

Current through Register Vol. 46, No. 45, November 2, 2024

Section 58-4.2 - Registration of source plasma donation centers

(a) Each source plasma donation center must apply for registration on forms provided by the Department, which shall include: the necessary demographic information of the source plasma donation center; current license and registration of the responsible physician overseeing collection activities; name, address and credentials of the laboratory director; name and address of the owner of the donation center; and other such information as the department may require.

(b) A source plasma donation center registration shall not be issued unless the responsible physician meets all criteria in section 58-4.1(c) of this Subpart, the laboratory director meets the requirements in section 58-4.1(e) of this Subpart, the registration fees have been paid and the registration application is complete.

(c) The source plasma donation center registration shall be valid for a period of two years from the date of issuance and may be renewed for successive two-year periods thereafter. The original application and each renewal application shall be accompanied by a registration fee of six hundred dollars. A renewal application must be received at least sixty (60) days prior to registration expiration.

(d) Source plasma donation centers shall only perform hematocrit and total protein donor eligibility tests. Any other clinical laboratory testing shall require a clinical laboratory permit pursuant to Section 574 of the Public Health Law.

(e) The responsible physician and laboratory director shall be jointly responsible for ensuring compliance with this Subpart. The responsible physician shall be responsible for ensuring compliance with the Code of Federal Regulations, Title 21, Parts 630 and 640. The laboratory director will be responsible for ensuring compliance with the Code of Federal Regulations, Title 42, Part 493.

(f) Source plasma donation centers shall notify the Department no later than sixty (60) calendar days after any change in the responsible physician, laboratory director, owner, or location. Failure to provide proper notice pursuant to this subdivision may result in the revocation of the source plasma donation center's registration.

N.Y. Comp. Codes R. & Regs. Tit. 10 §§ 58-4.2

Adopted New York State Register February 15, 2023/Volume XLIV, Issue 07, eff. 2/15/2023