Section 3701-84-27 - Patient selection/utilization - blood and bone marrow transplantation service(A) All candidates for blood and bone marrow transplantation are subject to prospective patient selection criteria as specified in appendix A to this rule.(B) If a transplantation service desires to perform a transplant on a patient who does not meet the selection protocols set forth in appendix A to this rule, the service is obligated to undertake a thorough review of the case, conducted by a blood and bone marrow transplant team comprised of members of the service's ethics, legal, and medical staff, to determine that the transplant is appropriate and include:(1) Preparation of a detailed clinical summary of the patient that includes:(a) A brief medical history;(b) Complete laboratory data related to the diagnosis;(c) A thorough psychosocial evaluation that includes: (i) The identification of the patient's support system, including potential caregivers;(ii) Identification of psychosocial barriers;(iii) Identification of potential barriers and challenges of the transplant; and(iv) The patient's attitude toward the transplant, the patient's understanding of the transplant, and the patient's understanding of the treatment, including whether the intention is to be palliative or curative.(d) A justification of the transplant despite failure to meet the selection criteria; and(2) After sufficient review time, an affirmative vote of a majority of the members of the team that the transplant is appropriate.(C) Each blood and bone marrow transplantation service should achieve the following volume goals per year to ensure efficiency and a minimum floor of competency: (1) Adult blood and bone marrow transplantation service performing transplants at a single clinical site:(a) Autologous only transplantation services should perform an average of at least five autologous transplants per year; or(b) Combined autologous and allogeneic services should perform an average of at least ten allogeneic transplants per year.(2) Adult blood and bone marrow transplantation service performing transplants at multiple clinical sites:(a) Autologous only transplantation services should perform an average of at least five autologous transplants per year at each site; or(b) Combined autologous and allogeneic transplantation services should perform an average of at least five autologous and five allogeneic transplants per year at each site.(3) Pediatric blood and bone marrow transplantation service performing transplants at a single clinical site: or (a) Autologous only transplantation services should perform an average of at least five autologous transplants per year; or(b) Combined autologous and allogeneic services should perform an average of at least five allogeneic and five autologous transplants per year.(4) Pediatric blood and bone marrow transplantation service performing transplants at multiple clinical sites: (a) Autologous only transplantation services should perform an average of at least five autologous transplants per year at each site; or(b) Combined autologous and allogeneic transplantation services should perform an average of at least five autologous transplants per year at each site.(5) Combined adult and pediatric blood and bone marrow transplantation services performing transplants at a single clinical site: (a) Autologous only transplantation services should perform an average of at least five pediatric autologous transplants and five adult autologous transplants per year; or(b) Combined autologous and allogeneic services should perform an average of at least five pediatric allogeneic transplants and five adult allogeneic transplants per year.(6) Combined adult and pediatric blood and bone marrow transplantation services performing transplants at multiple clinical sites: (a) Autologous only transplantation services should perform an average of at least five autologous transplants per year at each site; or(b) Combined autologous and allogeneic transplantation services should perform an average of at least five pediatric and five adult autologous transplants per year and and at least five pediatric allogeneic and five adult allogeneic transplants per year at each site.(D) Volume goals may be considered by the director in conjunction with other indicators of quality, not as the sole indicator of service performance. Replaces: 3701-84-27
Click to view Appendix
Ohio Admin. Code 3701-84-27
Effective: 5/15/2023
Five Year Review (FYR) Dates: 05/05/2028
Promulgated Under: 119.03
Statutory Authority: 3702.11, 3702.13
Rule Amplifies: 3702.11, 3702.12, 3702.13, 3702.14, 3702.14, 3702.141, 3702.15, 3702.16, 3702.18, 3702.19, 3702.20
Prior Effective Dates: 03/01/1997, 03/24/2003, 07/09/2007, 08/22/2008, 09/03/2009, 06/21/2012, 11/20/2014, 08/01/2017, 01/20/2020