N.Y. Comp. Codes R. & Regs. Tit. 10 §§ 52-3.8

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

Section 52-3.8 - Special circumstances

(a) The department may exempt a tissue bank from a specific standard contained in this Part, provided:

(1) the tissue bank has applied to the department for an exemption for limited circumstances prior to the noncompliance with the standard; and

(2) the tissue bank has demonstrated to the department that application of the standard to the bank under the limited circumstances for which an 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 an exemption is sought, and the department determines that the requirement imposed by the Federal or other state's governmental unit's requirement 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 provision of services necessitated by a medical emergency or special medical conditions. Persons seeking an exemption pursuant to this subparagraph shall describe the nature of the emergency or special medical conditions 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 Part shall be approved by the director of the tissue transplantation service.

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

N.Y. Comp. Codes R. & Regs. Tit. 10 §§ 52-3.8