D.C. Mun. Regs. tit. 17, r. 17-10006

Current through Register Vol. 71, No. 49, December 6, 2024

Rule 17-10006 - APPROVAL OF PROTOCOLS OUTSIDE THE STANDARD OF CARE

10006.1

If a physician and a pharmacist intend to manage or treat a condition or disease state for which there is not a protocol that is generally accepted as the clinical standard of care, the physician and pharmacist shall apply for approval. The Boards shall receive and review the proposed treatment protocol and jointly approve or disapprove.

10006.2

Any procedure outside generally accepted clinical practice shall be approved by the Boards, and any changes to a protocol for procedures outside the generally accepted clinical practice shall be approved by the Boards before they are implemented.

10006.3

Application and approval are not needed for treatment of conditions for which there is a generally accepted clinical standard of care, but for which the physician wants to increase the monitoring and oversight of the condition over what the protocol recommends.

10006.4

In order to apply for approval of a protocol outside the generally accepted clinical standard of care, the physician and the pharmacist shall jointly submit:

(a) An application on the required form and the required fee;

(b) A copy of the proposed protocol; and

(c) Supporting documentation that the protocol is safe and effective for the particular condition or disease state for which the physician and the pharmacist intend to manage or treat through a collaborative practice agreement.

10006.5

To apply for approval to make changes to an approved protocol outside of the generally accepted clinical standard of care, the physician and the pharmacist shall jointly submit:

(a) An application on the required form and the required fee;

(b) A copy of the proposed changes to the protocol; and

(c) Supporting documentation that the change(s) to the protocol is safe and effective for the particular condition or disease state for which the physician and the pharmacist intend to manage or treat through a collaborative practice agreement.

D.C. Mun. Regs. tit. 17, r. 17-10006

Final Rulemaking published at 65 DCR 8528 (8/17/2018)