(B) Each provider of a bone marrow transplantation service shall be a registered 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 shall 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, including patient selection criteria, plans for long-term management, protocols to address the prevention of opportunistic infections among bone marrow transplant recipients, and appropriate liaison with the patient's family and primary care physician. The patient management plans and protocols shall be consistent with nationally accepted standards;
(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 all other 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 provider of the bone marrow transplantation service shall specify to the director:
(1) The type of patient population to be served:
(a) Pediatric patients less than seventeen years of age;
(b) Patients greater than or equal to seventeen years of age and less than twenty-two years of age; or
(c) Adult patients twenty-two years of age or older.
A bone marrow transplantation service may serve patients greater than or equal to seventeen years of age and less than twenty-two 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:
(b) Allogeneic; or
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