N.Y. Comp. Codes R. & Regs. Tit. 10 § 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.
Notes
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