N.Y. Comp. Codes R. & Regs. Tit. 10 §§ 58-5.12

Current through Register Vol. 46, No. 50, December 11, 2024

Section 58-5.12 - Special circumstances

(a) The department may exempt a hematopoietic progenitor cell bank from a specific standard contained in this Subpart, provided:

(1) the hematopoietic progenitor cell bank has requested an exemption under limited circumstances prior to the noncompliance with the standard; and

(2) the hematopoietic progenitor cell bank has demonstrated to the department that application of the standard to such bank under the limited circumstances for which the exemption is sought:

(i) is inconsistent with the provision of the particular service, as documented in properly conducted current medical or scientific research, or current scientific literature;

(ii) is incompatible with a requirement imposed by a Federal or other state's government unit which is similar to the standard for which the exemption is sought, and the department determines that the requirement imposed by the Federal or other state' s governmental unit adequately protects the public health, safety and welfare, based upon commonly accepted medical standards, properly conducted medical or scientific research, or current scientific literature; or

(iii) would prevent or impair the provision of services necessitated by a medical emergency or special medical condition. Hematopoietic progenitor cell banks seeking an exemption pursuant to this subparagraph shall describe the nature of the emergency or special medical condition and the exemption requested, for review on a case-by-case basis by the department. All such emergencies or special medical conditions shall be documented in the medical record, and any action taken in response which is contrary to the requirements of this Subpart shall be approved by the director of the hematopoietic progenitor cell transplantation service.

(b) A copy of the department's approval for an exemption shall be maintained by the hematopoietic progenitor cell transplantation facility and the hematopoietic progenitor cell bank releasing the cells.

N.Y. Comp. Codes R. & Regs. Tit. 10 §§ 58-5.12