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Ohio Laws and Rules
(A) All candidates for bone marrow transplantation shall be 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 shall undertake a thorough review of the case to determine that the transplant is appropriate. This review shall, at a minimum, include:
(1) Preparation of a detailed clinical summary of the patient including a brief medical history, complete laboratory data, a thorough psychological evaluation including the patient’s support system, any psychosocial issues, attitude toward and understanding of the transplant, informed consent, and a justification of the transplant despite failure to meet the selection criteria;
(2) Circulation of the clinical summary to a committee comprised of, at a minimum, five experienced transplant physicians from five different hospitals, an ethicist, and a lay representative who may be an attorney; and
(3) After sufficient review time, an affirmative vote of a majority of the members of the committee that the transplant is appropriate.
(4) Once a protocol has been reviewed and approved, pursuant to this paragraph, by a committee specified in paragraph (B)(2) of this rule, the bone marrow transplantation service may treat other patients with the same disease with that formal treatment/clinical research protocol that is reviewed and approved by the transplanting institution’s internal review board and renewed on an annual basis, provided that the bone marrow transplantation service determines that the protocol is appropriate for the patient based on the patient’s clinical summary specified in paragraph (B)(1) of this rule.
(C) Each bone marrow transplantation service should achieve the following volume goals per year to ensure efficiency and a minimum floor of competency:
(1) Except as specified in paragraph (C)(2) of this rule, services providing only autologous bone marrow transplantations should perform at least ten per year. From the date a service notifies the director of activation or reactivation of a service, the service should perform at least six transplants in the first twelve months and at least twenty transplants within the first twenty-four months;
(2) Services providing only autologous bone marrow transplantation exclusively to patients less than twenty-two years of age should perform at least ten transplants per twenty-four months. From the date this service notifies the director of activation or reactivation of a service, the service should perform at least four transplants in the first twelve months and at least ten transplants within the first twenty-four months;
(3) Except as specified in paragraph (C)(4) of this rule, services providing both autologous and allogeneic bone marrow transplantation should perform at least twelve per year with at least six being allogeneic bone marrow transplantations. From the date a service notifies the director of activation or reactivation of a combined autologous and allogeneic service, the service should perform at least eight transplants in the first twelve months and at least twenty-four transplants within the first twenty-four months, of which at least twelve should be allogeneic;
(4) Services providing both autologous and allogeneic bone marrow transplantation exclusively to patients less than twenty-two years of age should perform at least ten transplants per twenty-four months with at least five being allogeneic. From the date this service notifies the director of activation or reactivation of a service, the service should perform at least four transplants in the first twelve months with at least two being allogeneic and at least ten transplants within the first twenty-four months with at least five being allogeneic.
(D) Volume goals will be considered by the director in conjunction with other indicators of quality, not as the sole indicator of service performance.
(E) Failure to meet a volume goal for two consecutive years will trigger an extended review of the bone marrow transplantation service by the director, including possible inspections.
APPENDIX A
Patient Selection Criteria
I. Patients transplanted on protocols: Any patient that is registered on and treated on a protocol that has been reviewed and approved by the National Institute of Health is an appropriate bone marrow transplantation (BMT) candidate.
II. Criteria for eligibility for patients who do not meet the conditions of paragraph I, above:
A. General Considerations
1. Pulmonary function: forced expiratory volume in one second (FEVI) and diffusing capacity for carbon monoxide (DLCO) are greater than forty-five percent predicted. If the FEVI or DLCO is less than forty-five percent of predicted value, the patient should be evaluated by a pulmonologist.
2. Cardiology: multigated blood-pool imaging (MUGA) or echocardiogram showing the left ventricular ejection fraction of greater than or equal to fifty percent. If a left ventricular ejection fraction is less than fifty percent, the patient must be consulted to and approved by a cardiologist to proceed to transplant. For pediatric patients, if a left ventricular shortening fraction by echocardiogram is less than twenty-nine percent, the patient must have an evaluation and clearance by a pediatric cardiologist prior to transplant.
3. Renal: the patient must have a serum creatinine of less than two milligrams/milliliter or a glomerular filtration rate (GFR) of greater than or equal to sixty milliliters/minute/one point seven three meters squared. If the patient does not meet this criteria, a nephrology consult and clearance must be obtained prior to transplant, unless multiple myeloma is the known cause of the renal dysfunction.
4. Hepatic: patients with abnormal hepatic enzymes (bilirubin, aspartate aminotransferase (AST) or alanine aminotransferase (ALT) greater than two times normal) need to be calculated and cleared by a gastroenterologist in order to proceed with transplant.
5. Performance status: the patient must have an ECOG performance status of zero, one, or two or a Lasky performance of seventy percent or greater.
B. Criteria for Exclusion
1. The presence of an uncontrolled infection
2. A female patient who is pregnant or lactating
3. A patient with known human immunodeficiency virus (HIV) disease unless receiving HAART therapy and having a stable or negative viral load and a CD 4 count > 100
4. Patients with known metastatic intra-cranial disease (with the exception of metastatic germ cell tumors with treated intra-cranial disease or patients with neuroblastoma or active leptomeningeal disease)
C. Disease Indications for Allogeneic Bone Marrow Transplantation
1. Background
a. Ablative bone marrow transplantation
b. Non-myeloablative BMT: defined as infusion of hematopoietic cells after a nonmyeloablative preparative regimen for the purpose of attempting to treat a patients underlying disease with donor marrow and possibly the immunologic by-product of donor marrow
c. Source of stem cells
i. Five out of six phenotypic antigen related or matched unrelated donor
ii. For cord blood, a three-antigen mismatch or less by high resolution typing
2. Indications
a. Acute myelogenous leukemia
b. Acute lymphocytic leukemia
c. Chronic myelogenous leukemia
d. Chronic lymphocytic leukemia
e. Myelodysplastic syndrome
f. Severe combined immune deficiency (SCID)
g. Wiscott-Aldrich syndrome
h. Paroxysmal nocturnal hemoglobinuria
i. Adrenoleukodystrophy, Hurlers syndrome, and other storage diseases
j. Hodgkin’s disease, excluding first complete remission
k. Non-Hodgkin’s lymphoma, excluding first complete remission
l. Multiple myeloma
m. Hemoglobinopathy
n. Myeloproliferative disorder
o. Juvenile myelomonocytic leukemia (JMML)
Hemophagocytic lymphohistiocytosis (HLH)
q. Bone marrow failure syndromes
r. Osteopetrosis
s. Aplastic anemia
t. Neuroblastoma
u. Renal cell carcinoma
v. Sickle Cell Disease from matched related donor (donor without sickle disease)
3. Indications for Repeat Blood or Marrow Infusion
a. Graft rejection
b. Disease relapse
c. Engraftment failure
D. Indications for Donor Leukocyte Infusions for Relapsed or Persistent Hematologic Malignancy after Allogeneic BMT from Original Donor
1. General Considerations
a. Expected survival of greater than or equal to four weeks
b. Absence of active acute or chronic graft versus host disease (GVHD)
2. Indications: any patient treated with an allogeneic BMT suffering from disease relapse
E. Disease Indications for Autologous Hematopoietic Cell Transplantation
1. Indications
a. Hodgkin’s disease, excluding first complete remission
b. Non-Hodgkin’s lymphoma
c. Acute myelogenous leukemia
d. Acute lymphoblastic leukemia
e. Chronic myelogenous leukemia
f. Neuroblastoma
g. Breast cancer
i. Stage II to III with greater than or equal to ten positive nodes, done within six months of diagnosis
ii. Stage IV or recurrent disease
iii. Four to nine positive nodes transplanted within six months of diagnosis
iv. Inflammatory breast cancer
h. Germ cell tumors
i. Multiple myeloma
j. Ovarian cancer
k. Pediatric tumors (up to age twenty-one)
i. Brain tumors
ii. Wilms tumor
iii. Soft tissue sarcomas
iv. Ewing’s family of tumors
v. Desmoplastic small round cell tumors
vi. Neuroblastoma
2. Repeat transplants
a. Second transplants are acceptable if they are part of the “initial therapy.” Thus, a protocol that demands multiple sequential myeloablative therapies as a planned treatment course is appropriate if the patient is treated on such a protocol.
b. Treatment of relapse: if a patient achieved a complete remission after the last autologous transplant and that complete remission lasted a minimum of one year, then a second transplant is potentially reasonable. A second transplant at less than one year requires a case review as established under paragraph (B) of rule 3701-84-27 of the Administrative Code.
F. Indications for Hematopoietic Stem Cell Harvesting Without a Planned Transplant
1. Acute myelogenous leukemia: patients in complete remission
2. Acute lymphoblastic leukemia: patients in complete remission
3. Matched unrelated donor: patients undergoing a matched, unrelated donor allogeneic transplant with marrow used as “back up”
4. Pediatric tumors: (Wilms’ tumor, soft tissue sarcoma, neuroblastoma, brain tumors, Ewing’s family of tumors) and lymphomas in complete remission to receive future pelvic radiation therapy.
Effective: 09/03/2009
R.C. 119.032 review dates: 06/10/2009 and 05/28/2014
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, 7/9/07, 8/22/08