1 TAC §351.701
The Health and Human Services Commission adopts new §351.701,
relating to the establishment of an umbilical cord blood bank grant program
as required by House Bill number 3572 of the 77th legislative session. House
Bill 3572 requires the commission to establish a one-time grant program to
assist in the establishment of an umbilical cord blood bank in Texas for recipients
of blood and blood components who are unrelated to the donors of the blood.
The rule is adopted with changes to the proposed text as published in the
March 28, 2003, issue of the
Texas Register
(28
TexReg 2675).
The rule will expire on August 31, 2004.
Adopted §351.701 provides for the competitive award of a grant to
provide financial assistance for the establishment of an umbilical cord blood
bank. Both the initial grant awarded by the commission and any continuation
or enhancement of the grant beyond the 2002-2003 state fiscal biennium are
subject to the availability of appropriated funds. The grant is subject to
the requirements of the Uniform Grant and Contract Management Standards Act,
chapter 783, Government Code.
The adopted rule states that the grantee must provide services to recipients
who are unrelated, by either blood or marriage, to the donors of umbilical
cord blood and blood products derived from umbilical cord blood. The adopted
rule requires the grantee to be either licensed, certified, or accredited
by a competent regulatory authority or accrediting organization to operate
as a blood bank, blood and tissue center, laboratory, or other health care
facility authorized to collect, process, and preserve human umbilical cord
blood donations. The adopted rule identifies regulatory and professional organizations
that may provide such licensure, certification, or accreditation.
The adopted rule would require the grantee to enter into a contract with
the commission that requires the grantee to operate an umbilical cord blood
bank for at least eight years following the effective date of the grant. The
adopted rule also describes grantee eligibility criteria.
The Commission received no written comments on the proposed rules within
the 30-day comment period.
The new rule is adopted under 531.033, Government Code, which
authorizes the Commissioner of health and human services to adopt rules necessary
to carry out the duties of the Health and Human Services Commission under
Chapter 531, Government Code, and House Bill 3572, enacted by the 77th Texas
Legislature (Acts 2001, 77th Leg., R.S., ch. 1198, at 2574), which authorizes
the Health and Human Services Commission to adopt rules to implement a program
to award a grant for the establishment of an unrelated donor umbilical cord
blood bank in Texas.
§351.701.Unrelated Donor Umbilical Cord Blood Bank Grant Program.
(a)
Purpose. This section implements and is adopted in accordance
with the requirements of House Bill 3572 enacted by the 77th Texas Legislature
(Acts 2001, 77th Leg., R.S., ch. 1198, at 2574), which authorizes the Health
and Human Services Commission to implement a program to award a grant for
the establishment of an unrelated donor umbilical cord blood bank in Texas.
(b)
Grant objectives. The grant awarded pursuant to this section
is intended to improve public health in Texas through:
(1)
the establishment of an umbilical cord blood bank to serve
unrelated donors and recipients;
(2)
operation of such services for a minimum period of eight
years from the date of the grant award; and
(3)
the support and promotion of medical and scientific research
opportunities resulting from the operation of an unrelated donor umbilical
cord blood bank.
(c)
Definitions. The following words and terms, when used in
this section, have the following meanings, unless the context clearly indicates
otherwise:
(1)
Blood bank--A facility that:
(A)
obtains a human umbilical cord blood donation from an unrelated
donor; and is either
(B)
licensed, certified, or accredited as a blood bank, blood
and tissue center, laboratory, or other health care facility that is authorized
by state and/or federal law, rule or regulation to collect, process, and preserve
human umbilical cord blood donations; or
(C)
operated in compliance with professionally recognized standards
regarding the quality and safety of collection of human umbilical cord blood
donations, including, but not limited to:
(i)
the American Association of Blood Banks or the American
Association of Tissue Banks;
(ii)
the American Society of Blood and Marrow Transplanters;
(iii)
the Center for Biologics Evaluation and Research of the
United States Food and Drug Administration;
(iv)
the Foundation for Accreditation of Hematopoietic Cell
Therapy;
(v)
the International Society for Cellular Therapy;
(vi)
the Joint Commission for Accreditation of Health Organizations;
or
(vii)
the Cord Blood Transplantation Study sponsored by the
National, Heart, Blood, and Lung Institute of the National Institutes of Health.
(2)
Commission--The Health and Human Services Commission.
(3)
Donation--Human umbilical cord blood obtained from an unrelated
donor and resulting from a live birth.
(4)
Grant--The funding assistance authorized by House Bill
3572 enacted by the 77th Texas Legislature (Acts 2001, 77th Leg., R.S., ch.
1198, at 2574) and awarded pursuant to this section for the sole purpose of
establishing an unrelated donor umbilical cord blood bank program in Texas.
(5)
Grantee--The recipient of the grant awarded under this
section.
(6)
Services--Umbilical cord blood collection, storage, preservation,
and/or processing services provided by a blood bank.
(7)
Unrelated donor--A person who:
(A)
is legally authorized or competent;
(B)
voluntarily provides a donation; and
(C)
is not related by affinity or consanguinity (as determined
under Chapter 573, Government Code) to the recipient of the donation.
(d)
General conditions of the grant. The grant awarded pursuant
to this section, and any extension, continuation, or addition to such grant,
are subject to:
(1)
the availability of appropriated state funds;
(2)
a competitive award process as established by the commission;
(3)
the requirements of the Uniform Grant and Contract Management
Standards Act, Chapter 783, Government Code and the rules and standards adopted
by the Office of the Governor in accordance with Chapter 783, Government Code,
and codified at Title 1, Texas Administrative Code. Sections 5.141, et seq.;
(4)
the requirements of the contract executed by the commission
with the grantee as required under subsection (f) of this section; and
(5)
audit by the commission, the State Auditor's Office, or
an entity approved by the commission of the grantee's performance of the services
or compliance with the rules and standards adopted by the Office of the Governor
in accordance with Chapter 783, Government Code, and codified at Title 1,
Texas Administrative Code. Sections 5.141, et seq.
(e)
Applicant eligibility criteria. A blood bank may apply
for the grant awarded under this section and must, at a minimum, demonstrate:
(1)
the ability to establish, operate, and maintain an unrelated
donor umbilical cord blood bank in Texas and to provide related services,
including, but not limited to:
(A)
experience operating similar facilities in this state;
(B)
affiliation or agreements with research institutions or
other similar blood banks and facilities to conduct related research or improve
the accessibility of umbilical cord blood services in Texas;
(2)
possession of an appropriate, current license, certification,
or certificate of good standing to operate as a blood bank;
(3)
a plan to continue the operation of the unrelated donor
umbilical cord blood bank beyond the term of the contract required by subsection
(f) of this section, including an appropriate financial plan;
(4)
the financial stability and resources sufficient to ensure
the achievement of the grant objectives and operation of the unrelated donor
umbilical cord blood bank;
(5)
appropriate donor and recipient management plans, protocols,
including long-term management plans where clinically appropriate;
(6)
policies relating to non-discrimination regarding the selection
and treatment of donors and recipients of donations on the basis of race,
sex, national origin, or ability to pay;
(7)
a quality improvement process or mechanism to:
(A)
identify problems relating to the delivery of the services;
(B)
measure and document improvement in the delivery of the
services, and
(C)
provide appropriate monitoring of patient outcomes, to
the degree permitted under state and federal law and the informed consent
of donors and recipients of donations.
(f)
Contract. The grantee must enter into a contract with the
commission that requires, among other things, that the grantee:
(1)
operate and maintain an unrelated donor umbilical cord
blood bank in this state in accordance with standards described in subsection
(c)(1)(C) of this section;
(2)
operate the blood bank at least until the eighth anniversary
of the effective date of the contract;
(3)
gather, collect, and preserve umbilical cord blood only
from live births;
(4)
comply with any financial or reporting requirements imposed
on the grantee specified in the contract; and
(5)
comply with all applicable federal and state laws, as amended,
and their implementing regulations.
(g)
Expiration. This section expires August 31, 2004.
This agency hereby certifies that the adoption has been reviewed
by legal counsel and found to be a valid exercise of the agency's legal authority.
Filed with the Office of
the Secretary of State on July 16, 2003.
TRD-200304329
Steve Aragón
General Counsel
Texas Health and Human Services Commission
Effective date: August 5, 2003
Proposal publication date: March 28, 2003
For further information, please call: (512) 424-6576