BILL ANALYSIS
Public Health Committee
H.B. 1023
By: Coleman
04-19-95
Committee Report (Substituted)
BACKGROUND
In May 1994, an outbreak of Hepatitis B infected nine patients at
an End Stage Renal Disease (ESRD) facility in Houston. The outbreak
was due to poor patient screening procedures and a lack of quality
inspection mechanisms. Currently ESRD facilities are overseen by
the federal Health Care Financing Administration. Monitoring of
compliance with regulations has been minimal.
PURPOSE
This legislation would authorize the Texas Department of Health
(TDH) to license and routinely inspect ESRD facilities, create
civil and administrative penalties for patient health and safety
violations and establish minimum education qualifications for ESRD
employees. It would also standardize the certification process and
establish a training program for dialysis technicians.
RULEMAKING AUTHORITY
It is the committee's opinion that SECTION 1 of the bill grants
additional rulemaking authority to the Texas Board of Health in the
following sections of Chapter 251, the Health and Safety Code: Sec.
251.003, Sec. 251.013(g), Sec. 251.014, and Sec. 251.032. In
addition, the bill establishes a medical review board, which is
required in Sec. 251.015 to advise the Texas Board of Health on
rules to be adopted under this chapter, among other matters.
SECTION BY SECTION ANALYSIS
SECTION 1. Adds Chapter 251 to Subtitle B, Title 4, Health and
Safety Code, "END STAGE RENAL DISEASE FACILITIES," as follows:
SUBCHAPTER A: GENERAL PROVISIONS.
Sec. 251.001. Defines terms used in this Chapter.
Sec. 251.002. Requires the Texas Board of Health to set fees
imposed by this Chapter, stipulates factors the Board must consider
in setting the fees, and exempts a facility owned or operated by a
state agency from paying the fees.
Sec. 251.003. Requires the board to adopt rules to implement the
Chapter and outlines matters which the rules must address.
Sec. 251.004-251.010 are reserved for expansion.
SUBCHAPTER B. LICENSING OF END STAGE RENAL DISEASE FACILITIES.
Sec. 251.011. Prohibits a person from operating an end stage renal
disease facilities without a license, except as provided in Sec.
251.012 of this subchapter.
Sec. 251.012. Exempts the following entities from licensing
requirements:
(1) a specified home community support services agency.
(2) a hospital that provides dialysis on inpatient basis only.
(3) a physician whose office is not primarily used as an end
stage renal disease facility.
Sec. 251.013. (a) States that an applicant for licensure must
submit an application to the TDH on a form prescribed by the
TBH.
(b) Requires a nonrefundable license fee to be submitted.
(c) States that each applying facility must have at least one
qualified physician on staff and each technician must have
completed the training program required by this chapter.
(d) Allows the TDH to grant temporary initial licenses, which
expire no later than six months after issuance.
(e) Requires the TDH to issue a license if the applicant meets
requirements and standards of this chapter.
(f) States that the license is renewable annually after a
renewal application, fee, and an report are submitted to TDH.
(g) The annual report required under Subsection (f) must
include information regarding the quality of care at the ESRD
facility, and must be in the form and documented by evidence
as required by board rule.
Sec. 251.014. Requires the rules adopted under Section 251.003 to
contain minimum standards, and specifies that the standards must
address the following factors:
(1) professional staff qualifications and supervision;
(2) equipment;
(3) sanitary and hygienic conditions;
(4) quality;
(5) treatment coordination;
(6) clinical and business records;
(7) facility design and space requirements to ensure safety
and privacy of patients;
(8) management structure;
(9) indicators of the quality of care;
(10) water treatment and reuse;
(11) any other aspect of service necessary to protect public
health.
Section 251.015 (a) Requires a medical review board to advise the
TBH on minimum standards and rules to be adopted under this
Chapter. Subsection (b) requires the medical review board to review
information on the quality of care in the annual report as required
by Section 251.013(f), and gives the review board the authority to
advise the department about the quality of care and recommend an
appropriate corrective action plan under Section 251.061 or other
remedy provided by the Chapter. Subsection (c) states that
information gathered by the TDH or review board concerning quality
of care and the review board's recommendation are confidential and
are not subject to disclosure. Subsection (d) allows TDH to release
the confidential information gathered to that facility only. States
that release of this information to a facility does not waive the
confidentiality of the information or the privilege from compulsory
legal process.
Sections 251.016-.030 reserved for expansion.
Subchapter C. DIALYSIS TECHNICIANS.
Sec. 251.031. Requires end stage renal disease dialysis
technicians be trained and competent.
Sec. 251.032. Outlines areas for which the board must establish
minimum standards and requirements in adopting rules under Section
251.003, as follows:
(1) Curricula and instructors used to train individuals as
dialysis technicians.
(2) Dialysis technician competency.
(3) Documentation of dialysis technician competency.
(4) Prohibited and allowable practices.
Sections 251.033-.050 are reserved for expansion.
Subchapter D. INSPECTIONS.
Sec. 251.051. Subsection (a) allows TDH to conduct an inspection
of an ESRD facility to verify compliance with this chapter.
Subsection (b) states that the inspection may be unannounced.
Sec. 251.052. Subsection (a) states that a person commits an
offense if the person discloses specified information about an
unannounced inspection to an authorized person, and Subsection (b)
clarifies the terms "unauthorized person." Subsection (c)
classifies the offense as a Class B misdemeanor, and Subsection (d)
excludes a person convicted under this section from eligibility for
state employment.
Sections 251.053-.060 are reserved for expansion.
Subchapter E. ENFORCEMENT.
Sec. 251.061. Subsection (a) allows TDH to use a corrective action
plan as an alternative to enforcement action, and (b) stipulates
that TDH must determine whether the use of a corrective action plan
is appropriate by considering specified factors related to a
facility's history and actions. Subsection (c) allows TDH to use a
level one, level two, or level three plan, and (d), (e), and (f)
describe the plans and violations for which each is appropriate.
Subsection (g) states that the corrective action plan is not
confidential but may be excepted from required disclosure as
allowed in this Chapter, and (h) stipulates that TDH shall select
the monitor for the plan and defines a monitor and the purposes of
a monitor. Requires the facility to pay for the cost of the
monitor.
Sec. 251.062. Allows TDH to (a) deny, suspend or revoke a license
for violation of Chapter 251, and (b) stipulates that such actions
by the TDH and the appeal of those actions are governed by Chapter
2001, Government Code.
Sec. 251.063. Subsection (a) allows TDH to petition for a
temporary restraining order in a district court to restrain a
continuing violator of the Chapter or rules adopted under it if it
is found that the facility creates an immediate threat to health
and safety of patients. Subsection (b) prescribes actions allowed
by injunction, (c) allows the attorney general to institute a suit
at the request of TDH, and (d) specifies the venue for such a suit.
Sec. 251.064. (a) An offense is committed if Section 251.011 or
251.031 are violated.
(b) Violation is a Class C misdemeanor.
(c) Each day of continuing violation is a separate offense.
Sec. 251.065. (a) Penalty assessed can be no more than $1,000 per
violation.
(b) Each day is a separate violation.
Sec. 251.066. (a) TDH may assess an administrative penalty against
violators.
(b) Prohibits the penalty from exceeding $1,000.
(c) In determining the amount of the penalty, the board shall
consider the following:
(1) seriousness of the violation;
(2) history of previous violations;
(3) deterrent effect of fine;
(4) efforts to rectify violation;
(5) any other matters the board deems as necessary;
Sec. 251.067. Subsection (a) requires TDH to give written notice
of the violation to the person alleged to have committed the
violation. Requires the notice to include a brief summary of the
violation, the amount of the proposed penalty, and a statement of
the person's right to hearings on the violation and the penalty
amount. Subsection (b) gives the person 20 days to respond to the
notice of the TDH's determination, and (c) states that if the
determination is accepted by the person notified, the commissioner
or the commissioner's designee shall issue an order approving the
determination and ordering the person to pay the penalty.
Sec. 251.068. Subsection (a) requires the commissioner or a
designee to set a hearing, give written notice of a hearing, and
designate an examiner if the person either fails to respond, or
requests a hearing. Subsection (b) requires the hearing examiner to
issue a proposal for decision regarding the occurrence of the
violation and recommended penalty. Subsection (c) stipulates that
upon recommendation of the hearings examiner, the commissioner may
find by order that the violation has occurred and assess a penalty,
or decide no violation has occurred.
Sec. 251.069. (a) Requires the commissioner or the designee to give
notice of the commissioner's order. It must include the following:
(1) Statements of the findings of fact.
(2) Penalty assessed.
(3) The person's right to judicial review of order.
(b) No more than 30 days after final decision, the person must
do one of the following: pay the penalty in full; pay and file
a petition for judicial review contesting the violation, the
amount of the penalty, or both; or file a petition for review
without paying the penalty.
(c) A person who does not pay the penalty and files for review
within 30 days may give the amount of penalty to a court to
hold in escrow, or give to the court a bond in the amount of
the penalty that is effective until all matters of judicial
review are final. The person may also request a stay of
enforcement of the penalty by filing a sworn affidavit saying
the person is unable to pay with the court, or by giving a
copy to the executive director by certified mail.
(d) If the TDH receives an affidavit, it may contest the
affidavit in court within five days of receiving the
affidavit. The court then shall hold a hearing on the facts
alleged in the affidavit. The person who files the affidavit
has the burden of proving he or she is unable to pay the fine.
(e) If the person does not pay the fine after it has not been
stayed, the TDH may refer the matter to the attorney general.
(f) Judicial review is instituted by filing a petition under
Subchapter G, Chapter 2001, Government Code, and is under the
substantial evidence rule.
(g) The court may uphold or reduce the fine and order the
person to pay the full or reduced amount. Requires the court
to order that no penalty is owed if the court does not sustain
the violation.
(h) Outlines procedures the court shall follow when the
judgment of the court becomes final, including ordering that
interest be paid by the person charged if the penalty is not
upheld or reduced. If the person paid a bond, the court shall
release the bond.
Sec. 251.070. States that an administrative or civil penalty
collected to be deposited in the state treasury.
Sec. 251.071. TDH may assess expenses to recover costs. This
payment shall be paid within 30 days of the board's order to
reimburse. The attorney general may also recover expenses if an
action is brought against the person. Defines reasonable expenses
and costs.
Sec. 251.072 through Sec. 251.090 reserved for expansion.
SUBCHAPTER F. TEMPORARY MANAGER.
Sec. 251.091. Subsection (a) states that a person holding a
controlling interest in an ESRD facility may, at any time, request
TDH to assume the management of the facility by appointing a
temporary manager in accordance with this subchapter. Subsection
(b) stipulates that upon receiving such a request, TDH may enter
into an agreement for a temporary manager. Subsection (c) states
that an agreement for a temporary manager must specify the terms of
the appointment, and preserve individual rights of the facility
under law, and (d) states that the primary duty of a temporary
manager is to ensure that service to the patients is safe and
adequate. Subsection (e) stipulates that the appointment ends at
a time specified by the agreement.
Sec. 251.092. Subsection (a) states that TDH may request the
attorney general to bring action on behalf of the state to appoint
a temporary manager if one of six specified circumstances exists.
Subsection (b) states that a court shall appoint a temporary
manager if, after a hearing, it deems one necessary, and (c) states
that the order must outline the manager's duties and authority.
Subsection (d) states that the court shall appoint someone with a
background in ESRD if possible, and (e) stipulates the venue for a
proceeding.
Sec. 251.093. Subsection (a) stipulates that the temporary manager
is entitled to a reasonable fee as determined by the court and
required to be paid by the facility. Subsection (b) states that the
temporary manager may petition the court to order payment if it has
been previously withheld. Subsection (c) states that withheld
payments that may be released under (b) may include payments from
governmental agencies or another third party.
SECTION 2. The Act takes effect September 1, 1995, with
exceptions.
SECTION 3. Exceptions under Subchapter B in which facilities are
not required to obtain license or training until September 1, 1996.
SECTION 4. Emergency clause.
COMPARISON OF ORIGINAL TO SUBSTITUTE
The substitute version of the bill adds provisions for the
establishment and operation of a medical review board, appointment
of a temporary manager as requested by the affected facility, a
court-appointed temporary manager requested by the TDH, and defines
corrective action plans, which are given as an alternative to other
enforcement measures outlined in both versions of the bill.
SUMMARY OF COMMITTEE ACTION
H.B. 1023 was considered by the Public Health Committee in a public
hearing on April 4, 1995.
The bill was left pending.
The committee considered the bill in a public hearing on April 19,
1995, as pending business. The committee considered a complete
substitute for the bill. The substitute was adopted without
objection.
The bill was reported favorably as substituted, with the
recommendation that it do pass and be printed, by a record vote of
7 AYES, 0 NAYS, 0 PNV, and 2 ABSENT.