BILL ANALYSIS
C.S.H.B. 1023
By: Coleman (Ellis)
Health and Human Services
5-24-95
Senate Committee Report (Substituted)
BACKGROUND
In May 1994, an outbreak of Hepatitis B infected nine patients at
an end stage renal disease facility in Houston. The outbreak was
due to poor patient screening procedures and a lack of quality
inspection mechanisms. Currently, end stage renal disease
facilities are overseen by the federal Health Care Financing
Administration. Monitoring of compliance with regulations has been
minimal.
PURPOSE
As proposed, C.S.H.B. 1023 requires the Texas Department of Health
to license and regulate end stage renal disease facilities, and
provides criminal penalties.
RULEMAKING AUTHORITY
It is the committee's opinion that rulemaking authority is granted
to the Texas Board of Health under SECTION 1 (Sections 251.003,
251.014, and 251.033, Health and Safety Code) of this bill.
SECTION BY SECTION ANALYSIS
SECTION 1. Amends Title 4B, Health and Safety Code, by adding
Chapter 251, as follows:
CHAPTER 251. END STAGE RENAL DISEASE FACILITIES
SUBCHAPTER A. GENERAL PROVISIONS
Sec. 251.001. DEFINITIONS. Defines "board," "commissioner,"
"department," "dialysis," "dialysis technician," "end stage
renal disease," "end stage renal disease facility," "medical
review board," and "physician."
Sec. 251.002. FEES. (a) Requires the Texas Board of Health
(board) to set fees necessary to defray the cost of
administering this chapter.
(b) Requires the board, in setting fees under this section,
to consider setting a range of license and renewal fees
based on the number of dialysis stations at each end stage
renal disease facility (facility) and the patient census.
(c) Provides that a facility owned or operated by a state
agency is not required to pay fees imposed under this
chapter.
Sec. 251.003. ADOPTION OF RULES. Requires the board to adopt
rules to implement this chapter.
SUBCHAPTER B. LICENSING OF END STAGE RENAL DISEASE FACILITIES
Sec. 251.011. LICENSE REQUIRED. Prohibits a person from
operating an end stage renal disease facility (facility)
without a license issued under this chapter.
Sec. 251.012. EXEMPTIONS FROM LICENSING REQUIREMENT. Exempts
certain facilities from the license requirement under this
chapter.
Sec. 251.013. ISSUANCE AND RENEWAL OF LICENSE. (a) Requires
an applicant for a license under this chapter to submit an
application, on a form prescribed by the board, to the Texas
Department of Health (department).
(b) Requires each application to be accompanied by a
nonrefundable license fee.
(c) Requires each application to contain evidence that there
is at least one qualified physician on the staff of the
facility and that each dialysis technician on staff has
completed the training program required by this chapter.
(d) Authorizes the department to grant a temporary initial
license to an applicant, to expire on a specific date.
(e) Requires the department to issue a license if it finds
that the applicant meets the requirements and standards
under this chapter.
(f) Makes the license renewable annually after the
submission of the renewal application and fee, and an annual
report.
(g) Requires the annual report to include information
related to the quality of care at the facility, and to be in
the form and documented by evidence as required by board
rule.
Sec. 251.014. MINIMUM STANDARDS. (a) Requires the rules
adopted under Section 251.003 to contain certain minimum
standards to protect the health and safety of a facility
patient.
(b) Requires the standards described in Subsection (a)(7) of
this section to apply only to certain facilities.
Sec. 251.015. MEDICAL REVIEW BOARD. (a) Requires a medical
review board to advise the board on minimum standards and
rules to be adopted under this chapter.
(b) Requires the medical review board to review the
information on quality of care provided in the annual report
under Section 251.013(f) and other appropriate information
provided to or compiled by the department with respect to a
facility. Authorizes the medical review board to advise the
department about the quality of care provided by a facility,
and to recommend an appropriate corrective action plan under
Section 251.061 or other enforcement proceedings against the
facility.
(c) Provides that information concerning quality of care
provided to or compiled by the department or medical review
board and a recommendation of the medical review board are
confidential. Provides that the information or
recommendation may not be made available for public
inspection, and is not subject to disclosure, discovery,
subpoena, or other compulsory legal process.
(d) Authorizes the department to release to a facility
information relating to that facility that is made
confidential under Subsection (c). Provides that release of
information to a facility under this section does not waive
the confidentiality of that information or the privilege
from compulsory legal process.
SUBCHAPTER C. DIALYSIS TECHNICIANS
Sec. 251.031. TRAINING REQUIRED. Prohibits an individual
from acting as a dialysis technician employed by or working in
a facility unless that individual is trained and competent
under this subchapter.
Sec. 251.032. MINIMUM REQUIREMENTS; TRAINING. Requires the
rules adopted under Section 251.003 to establish minimum
standards for the curricula and instructors for dialysis
technician training and for determining the competency of
individuals trained as dialysis technicians, minimum
requirements for documentation of training and competency, and
the acts and practices allowed or prohibited for dialysis
technicians.
SUBCHAPTER D. INSPECTIONS
Sec. 251.051. INSPECTIONS. (a) Authorizes the department to
inspect a facility to verify compliance with this chapter,
rules adopted under this chapter, or a corrective action plan
under Section 251.061.
(b) Authorizes an inspection under this section to be
unannounced.
Sec. 251.052. DISCLOSURE OF UNANNOUNCED INSPECTION; CRIMINAL
PENALTY. (a) Provides that a person commits an offense if the
person intentionally, knowingly, or recklessly discloses to an
unauthorized person the date, time, or any other facts about
an unannounced inspection of a facility before the inspection
occurs.
(b) Exempts certain entities from the definition of
"unauthorized person."
SUBCHAPTER E. ENFORCEMENT
Sec. 251.061. CORRECTIVE ACTION PLAN. (a) Authorizes the
department to use a corrective action plan (action plan) as an
alternative to enforcement action.
(b) Requires the department, before taking enforcement
action, to consider whether the use of an action plan is
appropriate.
(c) Authorizes the department to use a level one, level two,
or level three action plan after inspection of the facility.
(d) Describes a level one action plan and the
appropriateness of its use.
(e) Describes a level two action plan and the
appropriateness of its use.
(f) Describes a level three action plan and the
appropriateness of its use.
(g) Provides that an action plan is not confidential, and
that information in the plan may be excepted from required
disclosure.
(h) Requires the department to select the monitor for an
action plan in order to observe, supervise, consult, and
educate the facility and employees of that facility under an
action plan. Sets forth qualifications for a monitor.
Requires the facility to pay the cost of the monitor.
Sec. 251.062. DENIAL, SUSPENSION, OR REVOCATION OF LICENSE.
(a) Authorizes the department to deny, suspend, or revoke a
license under this chapter for a violation of or rules adopted
under this chapter.
(b) Provides that an action under Subsection (a) and the
appeal from that action are governed by the procedures for
a contested case hearing under Chapter 2001, Government
Code.
Sec. 251.063. INJUNCTION. (a) Authorizes the department to
petition a district court for a temporary restraining order to
restrain a continuing violation of this chapter, if the
department finds that the violation creates an immediate
threat to the health and safety of facility patients.
(b) Authorizes a district court, by injunction, to prohibit
a person from continuing the violation, restrain or prevent
the operation of a facility without a license under this
chapter, or grant other injunctive relief warranted by the
facts.
(c) Authorizes the attorney general to institute and conduct
a suit authorized by this section at the request of the
department.
(d) Provides that venue for a suit brought under this
section is in the county where the facility is located or in
Travis County.
Sec. 251.064. CRIMINAL PENALTY. Provides that a person
commits an offense, classified as a Class C misdemeanor, if
the person violates Section 251.011 or 251.031, and that each
day of a continuing violation constitutes a separate offense.
Sec. 251.065. CIVIL PENALTY. Provides that a person who
knowingly violates this chapter or fails to comply with a rule
under this chapter is liable for a civil penalty of not more
than $1,000 for each violation, if the department finds that
the violation threatens the health and safety of a facility
patient; and that each day of continuing violation constitutes
a separate ground for recovery.
Sec. 251.066. ADMINISTRATIVE PENALTY. (a) Authorizes the
department to assess an administrative penalty against a
person in violation of this chapter.
(b) Prohibits the penalty from exceeding $1,000 for each
violation, and provides that each day of a continuing
violation constitutes a separate violation.
(c) Requires the board to consider certain factors in
determining the amount of an administrative penalty.
(d) Subjects all proceedings for the assessment of an
administrative penalty under this chapter to Chapter 2001,
Government Code.
Sec. 251.067. REPORT RECOMMENDING ADMINISTRATIVE PENALTY.
Requires the department, if it determines that a violation has
occurred, to give written notice of the violation, including
certain information, to the person alleged to have committed
the violation.
(b) Authorizes the person notified, not later than the 20th
day after the date the notice is received, to accept the
determination or make a written request for a hearing on the
determination.
(c) Requires the commissioner of public health
(commissioner) or designee, if the person notified accepts
the determination, to issue an order approving the
determination and ordering the person to pay the recommended
penalty.
Sec. 251.068. HEARING; ORDER. (a) Requires the commissioner
or designee, if the person notified fails to respond in a
timely manner or requests a hearing, to set a hearing, give
written notice of the hearing to the person, and designate a
hearings examiner to conduct the hearing.
(b) Requires the hearings examiner to make findings of fact
and conclusions of law and to promptly issue to the
commissioner a proposal for decision concerning the
violation and a recommendation for the amount of the
proposed penalty.
(c) Authorizes the commissioner to find that a violation has
occurred and to assess a penalty, or to find that no
violation has occurred.
Sec. 251.069. NOTICE AND PAYMENT OF ADMINISTRATIVE PENALTY;
JUDICIAL REVIEW; REFUND. (a) Requires the commissioner or
designee to give notice of the order under Section 251.068(c),
including specific information, to the person notified.
(b) Requires the person, within a certain 30-day period, to
pay the penalty, or, with or without paying the penalty in
full, to file a petition for judicial review contesting the
occurrence of the violation, the amount of the penalty, or
both.
(c) Authorizes the person, within the 30-day period, to stay
enforcement of the penalty or request the court to stay
enforcement of the penalty.
(d) Authorizes the department, if it receives a copy of an
affidavit under Subsection (c)(2) to file with the court a
contest to the affidavit. Requires the court to hold a
hearing on the facts alleged in the affidavit, and to stay
enforcement of the penalty if it finds the alleged facts to
be true. Places the burden of proving financial inability
to pay the penalty and to give a supersedeas bond on the
person filing the affidavit.
(e) Authorizes the executive director, if the person does
not pay the penalty and the enforcement of the penalty is
not stayed, to refer the matter to the attorney general for
collection of the amount of the penalty.
(f) Provides that judicial review of the board's order is
instituted by filing a petition under Chapter 2001G,
Government Code, and is under the substantial evidence rule.
(g) Authorizes the court, if it sustains the occurrence of
the violation, to uphold or reduce the amount of the penalty
and to order the person to pay the full or reduced amount of
the penalty. Requires the court, if it does not sustain the
occurrence of the violation, to order that no penalty is
owed.
(h) Requires the court to proceed under this subsection when
the court's judgment becomes final. Sets forth requirements
when a person pays the amount of the penalty or gave a
supersedeas bond and the amount of the penalty or bond is
reduced or not upheld by the court.
Sec. 251.070. PENALTY DEPOSITED TO STATE TREASURY. Requires
a civil or administrative penalty collected under this chapter
to be deposited in the state treasury to the credit of the
general revenue fund.
Sec. 251.071. RECOVERY OF COSTS. (a) Authorizes the
department to assess reasonable expenses and costs against a
person in an administrative hearing if, as a result of the
hearing, the person's license is denied, suspended, or
revoked, or if administrative penalties are assessed against
the person. Sets forth requirements for payment.
(b) Authorizes the attorney general, when an injunction is
granted to a person or the person is found liable of a civil
or administrative penalty under certain conditions, to
recover reasonable expenses and costs.
(c) Defines "reasonable expenses and costs."
SUBCHAPTER F. TEMPORARY MANAGER
Sec. 251.091. APPOINTMENT BY AGREEMENT. (a) Authorizes a
person holding a controlling interest in a facility to request
the department to assume the management of the facility
through the appointment of a temporary manager.
(b) Authorizes the department to enter into an agreement
providing for the appointment of a temporary manager to
manage the facility under conditions considered appropriate
by both parties if the department considers the appointment
desirable.
(c) Sets forth requirements for an agreement under this
section.
(d) Declares that the primary duty of the temporary manager
is to ensure that adequate and safe services are provided to
patients until temporary management ceases.
(e) Declares that the appointment terminates at the time
specified by the agreement.
Sec. 251.092. INVOLUNTARY APPOINTMENT. (a) Authorizes the
department to request the attorney general to bring an action
in the name and on behalf of the state for the appointment of
a temporary manager under certain circumstances.
(b) Requires the court, after a hearing, to appoint a
temporary manager if the court finds that the appointment is
necessary.
(c) Requires the court order to address the duties and
authority of the temporary manager.
(d) Requires the court to appoint as temporary manager an
individual whose background includes administration of end
stage renal disease facilities or similar facilities.
(e) Declares that venue for an action under this section is
in Travis County.
Sec. 251.093. FEE; RELEASE OF FUNDS. (a) Entitles a
temporary manager to a reasonable fee, to be paid by the
facility, as determined by the court.
(b) Authorizes the temporary manager to petition the court
to order the release to the manager of any payment owed the
manager for care and services provided to patients of the
facility if the payment has been withheld.
(c) Authorizes withheld payments that may be released under
Subsection (b) to include payments withheld by a
governmental agency or other entity before or during the
appointment of the temporary manager.
SECTION 2. (a) Effective date: September 1, 1995, except as
provided by Subsection (b), except as provided by Subsection (b)
and SECTION 3.
(b) Effective date of Sections 251.011 and 251.031 and
Subchapter E, Health and Safety Code: September 1, 1996.
SECTION 3. Provides that a person is not required to obtain a
license under Chapter 251B, Health and Safety Code, and an
individual is not required to be trained and competent under
Chapter 251C, Health and Safety code, until September 1, 1996.
SECTION 4. Emergency clause.