Bill not drafted by TLC or Senate E&E.
Line and page numbers may not match official copy.
By: Carona S.B. No. 1160
A BILL TO BE ENTITLED
AN ACT
1-1 relating to the licensing of eye banks and the use of donations of
1-2 gifts of bodies or parts; providing criminal and civil penalties.
1-3 BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
1-4 SECTION 1. Section 692.005. PERSONS WHO MAY BECOME DONEES.
1-5 The following persons may become donees of gifts of bodies or
1-6 parts:
1-7 (1) a hospital or physician, to be used only for
1-8 medical or dental education, research, therapy, [transplantation,]
1-9 or the advancement of medical or dental science;
1-10 (2) an accredited medical, chiropractic, or dental
1-11 school, college, or university, to be used only for education,
1-12 research, therapy, or the advancement of medical or dental science;
1-13 (3) a bank or storage facility for human organs or
1-14 tissues other than eyes or corneas to be used only for medical or
1-15 dental education, research, therapy, transplantation, or the
1-16 advancement of medical or dental science;
1-17 (4) a person specified by a physician, to be used only
1-18 for therapy or transplantation needed by the person;
1-19 (5) a licensed [an] eye bank the medical activities of
1-20 which are directed by a physician; or
1-21 (9) the Anatomical Board of the State of Texas.
1-22 SECTION 2. Chapter 693, Health and Safety Code, is amended
1-23 by adding Subchapter D to read as follows:
2-1 SUBCHAPTER D. LICENSING OF EYE BANKS
2-2 Sec. 693.051. DEFINITIONS. In this subchapter:
2-3 (1) "Board" means the Texas Board of Health.
2-4 (2) "Department" means the Texas Department of Health.
2-5 (3) "Eye bank" means a nonprofit corporation chartered
2-6 under the laws of this state to obtain, store, and distribute donor
2-7 eyes or donated organic material from eyes to be used for corneal
2-8 transplants, research, or other medical purposes.
2-9 (4) "Certified eye bank" means an eye bank that has
2-10 been inspected by the Eye Bank Association of America, the
2-11 nationally recognized accrediting association, and certified as
2-12 meeting the accepted medical standards of that association or,
2-13 should such certification be unavailable, inspected by the
2-14 department and certified as meeting the departments minimum
2-15 standards.
2-16 (5) "Certified technician" means an eye bank
2-17 technician that has been tested by the Eye Bank Association of
2-18 America, the nationally recognized accrediting association, and
2-19 certified as meeting the accepted standards for eye bank
2-20 technicians or, should such certification be unavailable, tested by
2-21 the department and certified as meeting requirements set forth by
2-22 the department.
2-23 Sec. 693.052. LICENSE REQUIRED. (a) A person may not
2-24 establish or operate an eye bank in this state without an
2-25 appropriate license issued under this subchapter.
3-1 (b) Each eye bank must have a separate license.
3-2 (c) A license is not transferable or assignable.
3-3 Sec. 693.053. LICENSE APPLICATION AND ISSUANCE. (a) An
3-4 applicant for an eye bank license must submit an application to the
3-5 department on a form prescribed by the department.
3-6 (b) Each application must be accompanied by a nonrefundable
3-7 license fee in an amount set by the board.
3-8 (c) The department shall issue a license if it finds that
3-9 the applicant and the eye bank meet the requirements of this
3-10 subchapter and the standards adopted under this subchapter.
3-11 (d) A license expires and may be renewed at the times
3-12 provided by and in accordance with the rules of the board. As a
3-13 condition for renewal of a license, the licensee must submit to the
3-14 department the applicable license renewal fee.
3-15 (e) Information regarding the licensing status of an eye
3-16 bank is an open record for the purposes of Chapter 552, Government
3-17 Code.
3-18 (f) Eye banks in operation as of the date this legislation
3-19 becomes effective that meet the requirements for licensing will be
3-20 licensed. In the event an eye bank not in operation as of the date
3-21 this legislation becomes effective applies for a license, the
3-22 department shall determine whether there is a need for an eye bank
3-23 in the area to be served and may deny a license should no need be
3-24 found.
3-25 Sec. 693.054. INSPECTIONS. The department may inspect an
4-1 eye bank at reasonable times if necessary to assure compliance with
4-2 this subchapter.
4-3 Sec. 693.055. FEES. The board shall set fees imposed by
4-4 this subchapter in amounts reasonable and necessary to defray the
4-5 cost of administering this subchapter.
4-6 Sec. 693.056. DISPOSITION OF FEES. All fees collected under
4-7 this subchapter shall be deposited to the credit of the general
4-8 revenue fund and may be appropriated only to the department to
4-9 administer and enforce this subchapter.
4-10 Sec. 693.057. ADOPTION OF RULES. The board shall adopt
4-11 rules necessary to implement this subchapter, including
4-12 requirements for the issuance, renewal, denial, suspension, and
4-13 revocation of a license to operate an eye bank.
4-14 Sec. 693.058. MINIMUM STANDARDS. (a) The department by
4-15 rule shall prescribe as minimum standards the Medical Standards for
4-16 eye banks of the Eye Bank Association of America or of another
4-17 nationally recognized accrediting association. In the event that
4-18 such standards should no longer be nationally recognized, the
4-19 department shall develop appropriate minimum standards.
4-20 (b) An applicant for an eye bank license if not already a
4-21 certified eye bank must be certified by its medical director, as
4-22 defined in (f) below, as meeting the minimum standards of the
4-23 department and must be a certified eye bank within eighteen months
4-24 of the date on which the eye bank began operation.
4-25 (c) An eye bank must be a certified eye bank in the time
5-1 provided by Subsection (b) and must be recertified at least every
5-2 three years.
5-3 (d) An eye bank that applies for and fails to receive
5-4 recertification must apply for and receive and receive
5-5 recertification not later than fifteen months after the date the
5-6 eye bank initially failed to receive recertification. The
5-7 department may revoke a license of an eye bank if the eye bank
5-8 fails to receive recertification during this period.
5-9 (e) An eye bank must have on staff at least one certified
5-10 eye bank technician.
5-11 (f) An eye bank must have a medical director to direct the
5-12 medical activities of the eye bank. The medical director must be:
5-13 (1) licensed by and practicing in the state as an
5-14 ophthalmologist; and
5-15 (2) board certified as an ophthalmic surgeon.
5-16 (g) An eye bank licensed by the State of Texas is expected
5-17 to give priority to the needs of patients in the State of Texas.
5-18 Hospitals and other agents or agencies handling donor referrals are
5-19 required to have an agreement with and make timely referrals of all
5-20 potential eye/cornea donors to an eye bank licensed in accordance
5-21 with this subchapter.
5-22 Sec. 693.059. REPORTING REQUIREMENTS. (a) Each eye bank
5-23 must submit an annual report to the department. The report must be
5-24 submitted in the form prescribed by the department.
5-25 (b) The report must include:
6-1 (1) the certification status of the eye bank;
6-2 (2) the certification status of the certified
6-3 technician empooed by the eye bank;
6-4 (3) the number of whole eyes received by the eye bank
6-5 during the period covered by the report.
6-6 (4) the number of corneas only received by the eye
6-7 bank during the period covered by the report.
6-8 (5) the number of corneas provided for transplant for
6-9 patients in Texas
6-10 (6) the number of corneas provided for transplant for
6-11 out of state patients.
6-12 (7) the total number of corneas, eyes and other eye
6-13 parts provided for research.
6-14 (8) the number scleras provided for surgical purposes.
6-15 Sec. 693.060. DENIAL, SUSPENSION, OR REVOCATION OF LICENSE.
6-16 (a) The department may deny, suspend, or revoke a license for a
6-17 violation of this subchapter or a rule adopted under this
6-18 subchapter.
6-19 (b) The denial, suspension, or revocation of a license by
6-20 the department and the appeal from that action are governed by the
6-21 procedures for a contested case hearing under Chapter 2001,
6-22 Government Code.
6-23 Sec. 693.061. INJUNCTION. (a) The department may petition
6-24 a district court for a temporary restraining order to restrain a
6-25 continuing violation of the standards or licensing requirements
7-1 provided under this subchapter if the department finds that the
7-2 violation creates an immediate threat to the health and safety of
7-3 the recipients of organic material from an eye bank.
7-4 (b) A district court, on petition of the department and on
7-5 finding by the court that a person is violating the standards or
7-6 licensing requirements provided under this subchapter, may by
7-7 injunction:
7-8 (1) prohibit a person from continuing a violation of
7-9 the standards or licensing requirements provided under this
7-10 subchapter;
7-11 (2) restrain or prevent the establishment or operation
7-12 of an eye bank without a license issued under this subchapter; and
7-13 (3) grant any other injunctive relief warranted by the
7-14 facts.
7-15 (c) The attorney general may institute and conduct a suit
7-16 authorized by this section at the request of the department.
7-17 (d) Venue for a suit brought under this section is in the
7-18 county in which the eye bank is located or in Travis County.
7-19 Sec. 693.062. CRIMINAL PENALTY. (a) A person who knowingly
7-20 violates this subchapter or who knowingly fails to comply with a
7-21 rule adopted under this subchapter is liable for a civil penalty of
7-22 not less than $100 or more than $500 for each violation if the
7-23 department determines that the violation threatens the health and
7-24 safety of a recipient of organic material from an eye bank.
7-25 (b) Each day of a continuing violation constitutes a
8-1 separate ground for recovery.
8-2 SECTION 3. (a) This Act takes effect September 1, 1997.
8-3 The Texas Department of Health shall prescribe minimum safety
8-4 standards for eye banks in accordance with this subchapter not
8-5 later than December 1, 1997.
8-6 (b) An eye bank in operation before January 1, 1998, is
8-7 governed by the law as it existed immediately before September 1,
8-8 1997, and that law is continued in effect for that purpose until
8-9 January 1, 1998. An eye bank in operation on or after January 1,
8-10 1998, must have an eye bank license.
8-11 SECTION 4. The importance of this legislation and the
8-12 crowded condition of the calendars in both houses create an
8-13 emergency and an imperative public necessity that the
8-14 constitutional rule requiring bills to be read on three several
8-15 days in each house be suspended, and this rule is hereby suspended.