be considered to be a condition set forth in the Table. Jerking movements or staring episodes alone are not necessarily an indication of seizure activity.

(5) Sequela. The term "sequela” means a condition or event which was actually caused by a condition listed in the Vaccine Injury Table.

(6) Chronic Arthritis. (1) For purposes of paragraph (a) of this section, chronic arthritis may be found in a person with no history in the 3 years prior to vaccination of arthropathy (joint disease) on the basis of:

(A) Medical documentation, recorded within 30 days after the onset, of objective signs of acute arthritis (joint swelling) that occurred between 7 and 42 days after a rubella vaccination;

(B) Medical documentation (recorded within 3 years after the onset of acute arthritis) of the persistence of objective signs of intermittent or continuous arthritis for more than 6 months following vaccination; and

(C) Medical documentation of an antibody response to the rubella virus.

(ii) For purposes of paragraph (a) of this section, the following shall not be considered as chronic arthritis: Musculoskeletal disorders such as diffuse connective tissue diseases (including but not limited to rheumatoid arthritis, juvenile rheumatoid arthritis, systemic lupus erythematosus, systemic sclerosis, mixed connective tissue disease, polymyositis/determatomyositis, fibromyalgia, necrotizing vascultitis and vasculopathies and Sjogren's Syndrome), degenerative joint disease, infectious agents other than rubella (whether by direct invasion or as an immune reaction) metabolic and endocrine diseases, trauma, neoplasms, neuropathic disorders, bone and cartilage disorders and arthritis associated with ankylosing spondylitis, psoriasis, inflammatory bowel disease, Reiter's syndrome, or blood disorders.

(iii) Arthralgia (joint pain) or stiffness without joint swelling shall not be viewed as chronic arthritis for purposes of paragraph (a) of this section.

(7) Brachial neuritis. (1) This term is defined as dysfunction limited to the upper extremity nerve plexus (i.e., its trunks, divisions, or cords) without involvement of other peripheral (e.g.,

nerve roots or a single peripheral nerve) or central (e.g., spinal cord) nervous system structures. A deep, steady, often severe aching pain in the shoulder and upper arm usually heralds onset of the condition. The pain is followed in days or weeks by weakness and atrophy in upper extremity muscle groups. Sensory loss may accompany the motor deficits, but is generally a less notable clinical feature. The neuritis, or plexopathy, may be present on the same side as or the opposite side of the injection; it is sometimes bilateral, affecting both upper extremities.

(ii) Weakness is required before the diagnosis can be made. Motor, sensory, and reflex findings on physical examination and the results of nerve conduction and electromyographic studies must be consistent in confirming that dysfunction is attributable to the brachial plexus. The condition should thereby be distinguishable from conditions that may give rise to dysfunction of nerve roots (i.e., radiculopathies) and peripheral nerves (i.e., including multiple monoeuropathies), as well as other peripheral and central nervous system structures (e.g., cranial neuropathies and myelopathies).

(8) Thrombocytopenic purpura. This term is defined by a serum platelet count less than 50,000/mm3. Thrombocytopenic purpura does not include cases of thrombocytopenia associated with other causes such as hypersplenism, autoimmune disorders (including alloantibodies from previous transfusions) myelodysplasias, lymphoproliferative disorders, congenital thrombocytopenia or hemolytic uremic syndrome. This does not include cases of immune (formerly called idiopathic) thrombocytopenic purpura (ITP) that are mediated, for example, by viral or fungal infections, toxins or drugs. Thrombocytopenic purpura does not include cases of thrombocytopenia associated with disseminated intravascular coagulation, as observed with bacterial and viral infections. Viral infections include, for example, those infections secondary to Epstein Barr virus, cytomegalovirus, hepatitis A and B, rhinovirus, human immunodeficiency virus (HIV), adenovirus, and

dengue virus. An antecedent viral infection may be demonstrated by clinical signs and symptoms and need not be confirmed by culture or serologic testing. Bone marrow examination, if performed, must reveal a normal or an increased number of megakaryocytes in an otherwise normal marrow.

(9) Vaccine-strain measles viral infection. This term is defined as a disease caused by the vaccine-strain that should be determined by vaccine-specific monoclonal antibody or polymerase chain reaction tests.

(10) Vaccine-strain polio viral infection. This term is defined as a disease caused by poliovirus that is isolated from the affected tissue and should be determined to be the vaccine-strain by oligonucleotide or polymerase chain reaction. Isolation of poliovirus from the stool is not sufficient to establish a tissue specific infection or disease caused by vaccine-strain poliovirus.

(11) Early-onset Hib disease. This term is defined as invasive bacterial illness associated with the presence of Hib organism on culture of normally sterile body fluids or tissue, or clinical findings consistent with the diagnosis of epiglottitis. Hib pneumonia qualifies as invasive Hib disease when radiographic findings consistent with the diagnosis of pneumonitis are accompanied by a blood culture positive for the Hib organism. Otitis media, in the absence of the above findings, does not qualify as invasive bacterial disease. A child is

considered to have suffered this injury only if the vaccine was the first Hib immunization received by the child.

(c) Coverage provisions. (1) Except as provided in paragraph (c) (2) or (3) of this section, the revised Table of Injuries set forth in paragraph (a) of this section and the Qualifications and Aids to Interpretation set forth in paragraph (b) of this section apply to petitions for compensation under the Program filed with the United States Court of Federal Claims on or after March 24, 1997. Petitions for compensation filed before such date shall be governed by section 2114(a) and (b) of the Public Health Service Act as in effect on January 1, 1995, or by § 100.3 as in effect on March 10, 1995 (see 60 FR 7678, et seq., February 8, 1995), as applicable.

(c)(2) Hepatitis B, Hib, and varicella vaccines (Items VIII, IX, X, and XI of the Table) are included in the Table as of August 6, 1997.

(c)(3) Other new vaccines (Item XII of the Table) will be included in the Table as of the effective date of a tax enacted to provide funds for compensation paid with respect to such vaccines. An amendment to this section will be published in the FEDERAL REGISTER to announce the effective date of such a tax.

[60 FR 7694, Feb. 8, 1995, as amended at 62 FR 7688, Feb. 20, 1997; 62 FR 10626, Mar. 7, 1997; 63 FR 25778, May 11, 1998]

PART 110 [RESERVED]

$121.1 Applicability.

(a) The provisions of this part apply to the operation of the Organ Procurement and Transplantation Network (OPTN) and to the Scientific Registry.

(b) In accordance with Section 1138 of the Social Security Act, hospitals in which organ transplants are performed and which participate in the programs under titles XVIII or XIX of that Act, and organ procurement organizations designated under Section 1138(b)(1)(F) of the Social Security Act, are subject to the requirements of this part.

$121.2 Definitions.

As used in this part

Act means the Public Health Service Act, as amended.

Designated transplant program means a transplant program that has been found to meet the requirements of §121.9.

Family member means a family member of a transplant candidate, transplant recipient, or organ donor.

National list means the OPTN computer-based list of transplant candidates nationwide.

OPTN computer match program means a set of computer-based instructions which compares data on a cadaveric organ donor with data on transplant candidates on the national list and ranks the candidates according to OPTN policies to determine the priority for allocating the donor organ(s).

Organ means a human kidney, liver, heart, lung, or pancreas, and for purposes of the Scientific Registry, the term also includes bone marrow.

or

Organ donor means a human being who is the source of an organ for transplantation into another human being. Organ procurement organization OPO means an entity so designated by the Secretary under Section 1138(b) of the Social Security Act.

Organ procurement and transplantation network or OPTN means the network established pursuant to Section 372 of the Act.

Potential transplant recipient or potential recipient means a transplant candidate who has been ranked by the OPTN computer match program as the person to whom an organ from a specific cadaveric organ donor is to be offered.

Scientific Registry means the registry of information on transplant recipients established pursuant to Section 373 of the Act.

Secretary means the Secretary of Health and Human Services and any official of the Department of Health and Human Services to whom the authority involved has been delegated.

Transplant candidate means an individual who has been identified as medically suited to benefit from an organ transplant and has been placed on the national list by the individual's transplant program.

Transplant hospital means a hospital in which organ transplants are performed.

Transplant physician means a physician who provides non-surgical care and treatment to transplant patients before and after transplant.

Transplant program means a component within a transplant hospital which provides transplantation of a particular type of organ.

(C) Histocompatibility experts;

(ii) Eight individuals representing transplant candidates, transplant recipients, organ donors, and family members;

(iii) Ten members from the following categories (two members each):

(A) Transplant surgeons;
(B) Transplant physicians;
(C) Transplant hospitals;

(D) Voluntary health associations; and

(E) Other experts from related fields including medical examiners, hospital administration, or donor hospital personnel in such fields as trauma, emergency medical services, critical care, neurology, or neurosurgery; and

(iv) Six members from the general public from fields such as behavioral science, computer science, economics, ethics, health care financing, law, policy analysis, sociology, statistics, or theology. These members need not have technical expertise in organ donation or allocation.

(2) None of the members who are transplant recipients, transplant candidates, organ donors, family members, or general public members under paragraph (a)(1) of this section shall be employees of, or have a similar relationship with, the categories of members listed in paragraph (a)(1)(i) or paragraph (a)(1)(iii) or the OPTN.

(3) The Board of Directors shall include:

(i) Individuals representing the diversity of the population of transplant candidates and recipients served by the OPTN, including, to the extent prac

ticable, minority and gender representation reflecting the population of potential transplant candidates served by the OPTN;

(ii) No more than 50 percent transplant surgeons or transplant physicians; and

(iii) At least 25 percent transplant candidates, transplant recipients, organ donors and family members. (4) Individuals on the Board shall be elected for a two-year term.

(b) Duties of the OPTN Board of Directors-(1) Executive Committee. The Board of Directors shall elect an Executive Committee from the membership of the Board. The Executive Committee shall include at least one member who is a transplant candidate, transplant recipient, organ donor, or family member; one general public member, one OPO representative, and not more than 50 percent transplant surgeons and transplant physicians.

(2) Executive Director. The Board of Directors shall appoint an Executive Director of the OPTN. The Executive Director may be reappointed upon the Board's determination that the responsibilities of this position have been accomplished successfully.

(3) Committees. The Board of Directors shall establish such other committees as are necessary to perform the duties of the OPTN. Committees established by the Board of Directors shall include:

(i) Representation by transplant coordinators, organ procurement organizations, and transplant hospitals, and at least one transplant candidate, transplant recipient, organ donor or family member; and

(ii) To the extent practicable, minority and gender representation reflecting the diversity of the population of potential transplant candidates served by the OPTN.

(4) The Board of Directors shall develop and propose policies for the equitable allocation of organs, as described in § 121.8.

(c) Membership of the OPTN. (1) The OPTN shall admit and retain as members the following:

(i) All organ procurement organizations;

(ii) Transplant hospitals participating in the Medicare or Medicaid programs; and

(iii) Other organizations, institutions, and individuals that have an interest in the fields of organ donation or transplantation.

(2) To apply for membership in the OPTN:

(i) An OPO shall provide to the OPTN the name and address of the OPO, and the latest year of designation under section 1138(b) of the Social Security Act;

(ii) A transplant hospital shall provide to the OPTN the name and address of the hospital, a list of its transplant programs by type of organ; and

(iii) Any other organization, institution, or individual eligible under paragraph (c)(1)(iii) of this section shall demonstrate to the OPTN an interest in the fields of organ donation or transplantation.

(3) The OPTN shall accept or reject as members entities or individuals described in paragraph (c)(1)(iii) of this section within 90 days.

(4) Applicants rejected for membership in the OPTN may appeal to the Secretary. Appeals shall be submitted in writing within 30 days of rejection of the application. The Secretary may:

(1) Deny the appeal; or

(ii) Direct the OPTN to take action consistent with the Secretary's response to the appeal.

(d) Corporate Status of the OPTN. (1) The OPTN shall be a private, not-forprofit entity.

(2) The requirements of this section do not apply to any parent, sponsoring, or affiliated organization of the OPTN, or to any activities of the contracting organization that are not integral to the operation of the OPTN. Such an organization is free to establish its own corporate procedures.

(3) No OPTN member is required to become a member of any organization that is a parent, sponsor, contractor, or affiliated organization of the OPTN, to comply with the by-laws of any such organization, or to assume any corporate duties or obligations of any such organization.

(e) Effective date. The organization designated by the Secretary as the OPTN shall have six months from October 1, 1998, or six months from its initial designation as the OPTN, whichever is later, to meet the board com

position requirements of paragraph (a) of this section. The organization designated by the Secretary as the OPTN shall have six months from October 1, 1998, or six months from initial designation as the OPTN, whichever is later, to meet any other requirements of this section, except that the Secretary may extend such period for good

cause.

[63 FR 16332, Apr. 2, 1998, as amended at 63 FR 35847, July 1, 1998]

§ 121.4 OPTN policies: Secretarial review and appeals.

(a) The OPTN Board of Directors shall be responsible for developing, with the advice of the OPTN membership and other interested parties, policies within the mission of the OPTN as set forth in section 372 of the Act and the Secretary's contract for the operation of the OPTN, including:

(1) Policies for the equitable allocation of cadaveric organs in accordance with § 121.8;

(2) Policies, consistent with recommendations of the Centers for Disease Control and Prevention, for the testing of organ donors and follow-up of transplant recipients to prevent the spread of infectious diseases;

(3) Policies that reduce inequities resulting from socioeconomic status, including, but not limited to:

(i) Ensuring that patients in need of a transplant are listed without regard to ability to pay or source of payment;

(ii) Procedures for transplant hospitals to make reasonable efforts to make available from their own resources, or obtain from other sources, financial resources for patients unable to pay such that these patients have an opportunity to obtain a transplant and necessary follow-up care;

(iii) Recommendations to private and public payers and service providers on ways to improve coverage of organ transplantation and necessary followup care; and

(iv) Reform of allocation policies based on assessment of their cumulative effect on socioeconomic inequities;

(4) Policies regarding the training and experience of transplant surgeons