Ohio Admin. Code 3701-84-24

Current through all regulations passed and filed through December 2, 2024
Section 3701-84-24 - Blood and bone marrow transplantation service standards
(A) The provisions of rules 3701-84-24 to 3701-84-27 of the Administrative Code are applicable to each blood and bone marrow transplant service regardless of the date service was initiated.
(B) Each blood and bone marrow transplantation service will be located in a hospital classified as a general hospital, a children's hospital or as a specialty hospital that primarily furnishes oncology services that meets all of the following criteria:
(1) Participates with other hospitals nationally in cancer treatment research, such as national cancer institute sponsored research. The hospital's research activities should include all of the following:
(a) Use of uniform patient treatment protocols;
(b) On-site audits at least every five years by a cancer research organization or another hospital involved in national cancer treatment research; and
(c) Reporting of patient eligibility and treatment data to the research organization in which the hospital participates.
(2) Meets the following administrative requirements:
(a) Appropriate patient management plans and protocols consistent with nationally accepted standards, including:
(i) Patient selection criteria;
(ii) Plans for long-term management;
(iii) Protocols to address the prevention of opportunistic infections among blood and bone marrow transplant recipients; and
(iv) Protocols for liaising with the patient's family and primary care physician.
(b) Quality assurance standards for the procurement of hematopoietic stem cells including the procurement of bone marrow via a bone marrow harvest, as well as procurement of hematopoietic progenitor cells (stem cells) by the use of leukapheresis or umbilical cord blood collection; and
(c) A procedure for conducting systematic evaluation of clinical outcomes resulting from hematopoietic stem-cell transplantation.
(3) Has a documented agreement to cooperate with other blood and bone marrow transplantation services in Ohio relative to patient selection that is non-discriminatory as to race, gender, and ability to pay.
(C) Prior to initiating transplantation services, the blood and bone marrow transplantation service will specify to the director:
(1) The type of patient population to be served:
(a) Pediatric patients aged seventeen years or younger;

(b) Adult patients aged eighteen or older.

A blood and bone marrow transplantation service may serve patients greater than or equal to eighteen years of age as a pediatric or an adult patient, whichever best serves the needs of the patient, as determined by the transplant physician and transplant service's medical director;

(2) The type of transplantation service:
(a) Autologous;
(b) Allogeneic; or
(c) Both.

Ohio Admin. Code 3701-84-24

Effective: 5/15/2023
Five Year Review (FYR) Dates: 2/27/2023 and 05/05/2028
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: 03/01/1997, 03/24/2003, 06/01/2007, 06/21/2012, 08/01/2017