3701-84-16. Solid organ transplant service standards

(A) The provisions of rules 3701-84-16 to 3701-84-21 of the Administrative Code are applicable to each provider of solid organ transplant services regardless of the date the service was initiated.

(B) Each provider of a solid organ transplant service shall be a registered hospital classified as a general hospital or a children's hospital that meets the following administrative requirements:

(1) Demonstrated institutional commitment to graduate medical education and research programs;

(2) Executed letters of agreement or contracts with an independent organ procurement organization which can provide sufficient numbers of organs to support the applicable volume level specified by rule 3701-84-21 of the Administrative Code;

(3) All kidney transplant services shall be a member of the appropriate end-stage renal disease coordinating council designated for the medicare program under 42 C.F.R. 405.2110 (August 26, 1986);

(4) Cooperates with all extra-renal solid organ transplant services in Ohio relative to the following:

(a) Coordination of solid organ procurement, to be achieved to the extent practicable in cooperation with all established organ procurement organizations in Ohio;

(b) Participation in an effective method for assuring access to solid organ transplantation for the uninsured or financially indigent patient;

(c) Participation in a statewide registry to follow all transplant service patients from the time they receive approval by an inter-institutional patient selection committee until death; and

(d) Participation in a statewide service review process for solid organ transplant services.

(5) Membership in good standing in a statewide consortium of solid organ transplant services which provides the functions listed in paragraph (B)(4) of this rule shall be sufficient to meet the requirements of that rule;

(6) The hospital shall have written patient management policies and protocols for organ transplantation, including:

(a) Detailed plans for the acute and long-term management of each transplant patient by a multidisciplinary care team, including the waiting period, in-hospital phase, and immediate post-discharge period ;

(b) Transplant experienced social services available to the patient and the patient's family at all times;

(c) Appropriate and thorough education of the patient;

(d) Liaison with the patient's primary care physician to provide timely notification of changes in the patient's condition; and

(e) If the solid organ transplant service performs living donor transplants, detailed plans for the donor, that include the evaluation, donation, and discharge phases of living organ donation.

Effective: 8/1/2017
Five Year Review (FYR) Dates: 02/27/2017 and 03/01/2022
Promulgated Under: 119.03
Statutory Authority: 3702.11, 3702.13
Rule Amplifies: 3702.11, 3702.12, 3702.13 , 3702.14, 3702.141, 3702.15, 3702.16, 3702.18, 3702.19, 3702.20
Prior Effective Dates: 3/1/1997, 3/24/03, 6/1/07, 6/21/12