By Ellis S.B. No. 1149
74R1518 DLF-D
A BILL TO BE ENTITLED
1-1 AN ACT
1-2 relating to regulation of end stage renal disease facilities;
1-3 providing criminal penalties.
1-4 BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
1-5 SECTION 1. Subtitle B, Title 4, Health and Safety Code, is
1-6 amended by adding Chapter 251 to read as follows:
1-7 CHAPTER 251. END STAGE RENAL DISEASE FACILITIES
1-8 SUBCHAPTER A. GENERAL PROVISIONS
1-9 Sec. 251.001. DEFINITIONS. In this chapter:
1-10 (1) "Board" means the Texas Board of Health.
1-11 (2) "Commissioner" means the commissioner of public
1-12 health.
1-13 (3) "Department" means the Texas Department of Health.
1-14 (4) "Dialysis" means a process by which dissolved
1-15 substances are removed from a patient's body by diffusion from one
1-16 fluid compartment to another across a semipermeable membrane.
1-17 (5) "Dialysis technician" means an individual who does
1-18 not hold a professional license and who provides dialysis care
1-19 under the supervision of a registered nurse or physician.
1-20 (6) "End stage renal disease" means that stage of
1-21 renal impairment that appears irreversible and permanent and that
1-22 requires a regular course of dialysis or kidney transplantation to
1-23 maintain life.
1-24 (7) "End stage renal disease facility" means a
2-1 facility that provides treatment, including renal dialysis
2-2 treatment and kidney transplantation, to individuals with end stage
2-3 renal disease.
2-4 (8) "Physician" means an individual who is licensed to
2-5 practice medicine under the Medical Practice Act (Article 4495b,
2-6 Vernon's Texas Civil Statutes).
2-7 Sec. 251.002. FEES. The board shall set fees imposed by
2-8 this chapter in amounts reasonable and necessary to defray the cost
2-9 of administering this chapter.
2-10 Sec. 251.003. ADOPTION OF RULES. The board shall adopt
2-11 rules to implement this chapter, including requirements for the
2-12 issuance, renewal, denial, suspension, and revocation of a license
2-13 to operate an end stage renal disease facility.
2-14 (Sections 251.004-251.010 reserved for expansion
2-15 SUBCHAPTER B. LICENSING OF END STAGE RENAL DISEASE FACILITIES
2-16 Sec. 251.011. LICENSE REQUIRED. Except as provided by
2-17 Section 251.012, a person may not operate an end stage renal
2-18 disease facility without a license issued under this chapter.
2-19 Sec. 251.012. EXEMPTIONS FROM LICENSING REQUIREMENT. The
2-20 following facilities are not required to be licensed under this
2-21 chapter:
2-22 (1) a home and community support services agency
2-23 licensed under Chapter 142 with a home dialysis designation;
2-24 (2) a hospital licensed under Chapter 241 that
2-25 provides dialysis only to individuals receiving inpatient services
2-26 from the hospital;
2-27 (3) an ambulatory surgical center licensed under
3-1 Chapter 243;
3-2 (4) the office of a physician unless the office is
3-3 used primarily as an end stage renal disease facility; or
3-4 (5) a facility owned or operated by a state agency.
3-5 Sec. 251.013. ISSUANCE AND RENEWAL OF LICENSE. (a) An
3-6 applicant for a license under this chapter must submit an
3-7 application to the department on a form prescribed by the board.
3-8 (b) Each application must be accompanied by a nonrefundable
3-9 license fee.
3-10 (c) Each application must contain evidence that there is at
3-11 least one qualified physician on the staff of the facility and
3-12 that each dialysis technician on staff has completed the training
3-13 program required by this chapter.
3-14 (d) The department may grant a temporary initial license to
3-15 an applicant. The temporary initial license expires on the earlier
3-16 of:
3-17 (1) the date that the department issues or denies the
3-18 license; or
3-19 (2) the date six months after the date the temporary
3-20 initial license was issued.
3-21 (e) The department shall issue a license if, after
3-22 inspection and investigation, it finds the applicant meets the
3-23 requirements of this chapter and the standards adopted under this
3-24 chapter.
3-25 (f) The license is renewable annually after submission of:
3-26 (1) the renewal application and fee; and
3-27 (2) an annual report on a form prescribed by the
4-1 board.
4-2 Sec. 251.014. MINIMUM STANDARDS. The rules adopted under
4-3 Section 251.003 must contain minimum standards to protect the
4-4 health and safety of a patient of an end stage renal disease
4-5 facility, including standards for:
4-6 (1) the qualifications and supervision of the
4-7 professional staff, including physicians, and other personnel;
4-8 (2) the equipment used by the facility that is
4-9 essential to the health and safety of the patients;
4-10 (3) the sanitary and hygienic conditions in the
4-11 facility;
4-12 (4) quality assurance for patient care;
4-13 (5) the provision and coordination of treatment and
4-14 services by the facility;
4-15 (6) clinical and business records maintained by the
4-16 facility;
4-17 (7) design and space requirements for the facility for
4-18 safe access by patients and personnel and for ensuring patient
4-19 privacy;
4-20 (8) the management, ownership, and organizational
4-21 structure of the facility, including lines of authority and
4-22 delegation of responsibility;
4-23 (9) water treatment and reuse by the facility; and
4-24 (10) any other aspect of end stage renal disease
4-25 services necessary to protect the public.
4-26 (Sections 251.015-251.030 reserved for expansion
4-27 SUBCHAPTER C. DIALYSIS TECHNICIANS
5-1 Sec. 251.031. TRAINING REQUIRED. An individual may not act
5-2 as a dialysis technician employed by or working in an end stage
5-3 renal disease facility unless that individual is trained and
5-4 competent under this subchapter.
5-5 Sec. 251.032. EXEMPTIONS FROM TRAINING REQUIREMENT. The
5-6 following individuals are not required to meet the requirements of
5-7 this subchapter:
5-8 (1) a physician;
5-9 (2) an individual registered by the Board of Nurse
5-10 Examiners as a registered nurse;
5-11 (3) an individual licensed by the Board of Vocational
5-12 Nurse Examiners as a licensed vocational nurse;
5-13 (4) any other individual who may perform the functions
5-14 of a dialysis technician under a license or certification issued in
5-15 this state under other law; or
5-16 (5) an individual acting under the direct supervision
5-17 and in the physical presence of a physician.
5-18 Sec. 251.033. MINIMUM REQUIREMENTS; TRAINING. The rules
5-19 adopted by the board under Section 251.003 shall establish:
5-20 (1) minimum standards for the curricula and
5-21 instructors used to train individuals to act as dialysis
5-22 technicians;
5-23 (2) minimum standards for the determination of the
5-24 competency of individuals who have been trained as dialysis
5-25 technicians;
5-26 (3) minimum requirements for documentation that an
5-27 individual has been trained and determined to be competent as a
6-1 dialysis technician and the acceptance of that documentation by an
6-2 end stage renal disease facility, other than a facility that
6-3 provided the training, for a period of time determined by the
6-4 board; and
6-5 (4) the acts and practices that are allowed or
6-6 prohibited for dialysis technicians.
6-7 (Sections 251.034-251.050 reserved for expansion
6-8 SUBCHAPTER D. INSPECTIONS
6-9 Sec. 251.051. INSPECTIONS. (a) During each two-year
6-10 period, the department shall conduct at least one unannounced
6-11 inspection of each end stage renal disease facility.
6-12 (b) The department may conduct additional inspections.
6-13 Sec. 251.052. DISCLOSURE OF UNANNOUNCED INSPECTION; CRIMINAL
6-14 PENALTY. (a) A person commits an offense if the person
6-15 intentionally, knowingly, or recklessly discloses to an
6-16 unauthorized person the date, time, or any other fact about an
6-17 unannounced inspection of an end stage renal disease facility
6-18 before the inspection occurs.
6-19 (b) In this section, "unauthorized person" does not include:
6-20 (1) the department;
6-21 (2) the office of the attorney general; or
6-22 (3) any other person authorized by law to make an
6-23 inspection or to accompany an inspector.
6-24 (c) An offense under this section is a Class B misdemeanor.
6-25 (d) A person convicted under this section is not eligible
6-26 for state employment.
6-27 (Sections 251.053-251.060 reserved for expansion
7-1 SUBCHAPTER E. ENFORCEMENT
7-2 Sec. 251.061. DENIAL, SUSPENSION, OR REVOCATION OF LICENSE.
7-3 (a) The department may deny, suspend, or revoke a license issued
7-4 under this chapter for a violation of this chapter or a rule
7-5 adopted under this chapter.
7-6 (b) The denial, suspension, or revocation of a license by
7-7 the department and the appeal from that action are governed by the
7-8 procedures for a contested case hearing under Chapter 2001,
7-9 Government Code.
7-10 Sec. 251.062. INJUNCTION. (a) The department may petition
7-11 a district court for a temporary restraining order to restrain a
7-12 continuing violation of this chapter or a rule or standard adopted
7-13 under this chapter if the department finds that the violation
7-14 creates an immediate threat to the health and safety of patients of
7-15 an end stage renal disease facility.
7-16 (b) A district court, on petition of the department and on a
7-17 finding that a person is violating this chapter or a rule or
7-18 standard adopted under this chapter, may by injunction:
7-19 (1) prohibit a person from continuing the violation;
7-20 (2) restrain or prevent the operation of an end stage
7-21 renal disease facility without a license issued under this chapter;
7-22 or
7-23 (3) grant other injunctive relief warranted by the
7-24 facts.
7-25 (c) The attorney general may institute and conduct a suit
7-26 authorized by this section at the request of the department.
7-27 (d) Venue for a suit brought under this section is in the
8-1 county in which the end stage renal disease facility is located or
8-2 in Travis County.
8-3 Sec. 251.063. CRIMINAL PENALTY. (a) A person commits an
8-4 offense if the person violates Section 251.011 or 251.031.
8-5 (b) An offense under this section is a Class C misdemeanor.
8-6 (c) Each day of a continuing violation constitutes a
8-7 separate offense.
8-8 Sec. 251.064. CIVIL PENALTY. (a) A person who knowingly
8-9 violates this chapter or who knowingly fails to comply with a rule
8-10 adopted under this chapter is liable for a civil penalty of not
8-11 more than $1,000 for each violation if the department finds that
8-12 the violation threatens the health and safety of a patient of an
8-13 end stage renal disease facility.
8-14 (b) Each day of a continuing violation constitutes a
8-15 separate ground for recovery.
8-16 Sec. 251.065. ADMINISTRATIVE PENALTY. (a) The department
8-17 may assess an administrative penalty against a person who violates
8-18 this chapter or a rule adopted under this chapter for each
8-19 violation.
8-20 (b) The penalty may not exceed $1,000 for each violation.
8-21 Each day of a continuing violation constitutes a separate
8-22 violation.
8-23 (c) In determining the amount of an administrative penalty
8-24 assessed under this section, the board shall consider:
8-25 (1) the seriousness of the violation;
8-26 (2) the history of previous violations;
8-27 (3) the amount necessary to deter future violations;
9-1 (4) efforts made to correct the violation; and
9-2 (5) any other matters that justice may require.
9-3 (d) All proceedings for the assessment of an administrative
9-4 penalty under this chapter are subject to Chapter 2001, Government
9-5 Code.
9-6 Sec. 251.066. REPORT RECOMMENDING ADMINISTRATIVE PENALTY.
9-7 If, after investigation of a possible violation and the facts
9-8 surrounding that possible violation, the department determines that
9-9 a violation has occurred, the department shall issue a preliminary
9-10 report stating the facts on which the conclusion that a violation
9-11 occurred is based, recommending that an administrative penalty
9-12 under Section 251.065 be imposed on the person charged, and
9-13 recommending the amount of that proposed penalty. The department
9-14 shall base the recommended amount of the proposed penalty on the
9-15 factors set forth in Section 251.065(c).
9-16 Sec. 251.067. NOTICE; REQUEST FOR HEARING; ORDER. (a) Not
9-17 later than the 14th day after the date on which the preliminary
9-18 report under Section 251.066 is issued, the department shall give
9-19 written notice of the violation to the person charged. The notice
9-20 shall include:
9-21 (1) a brief summary of the charges;
9-22 (2) a statement of the amount of the penalty
9-23 recommended; and
9-24 (3) a statement of the right of the person charged to
9-25 a hearing on the occurrence of the violation, the amount of the
9-26 penalty, or both the occurrence of the violation and the amount of
9-27 the penalty.
10-1 (b) Not later than the 20th day after the date on which the
10-2 notice is received, the person charged may accept the determination
10-3 of the department made under Section 251.066, including the
10-4 recommended penalty, or make a written request for a hearing on
10-5 that determination.
10-6 (c) If the person charged with the violation accepts the
10-7 determination of the department, the commissioner or the
10-8 commissioner's designee shall issue an order approving the
10-9 determination and ordering that the person pay the recommended
10-10 penalty.
10-11 Sec. 251.068. HEARING; ORDER. (a) If the person charged
10-12 fails to respond in a timely manner to the notice under Section
10-13 251.067(b) or if the person requests a hearing, the commissioner or
10-14 the commissioner's designee shall:
10-15 (1) set a hearing;
10-16 (2) give written notice of the hearing to the person;
10-17 and
10-18 (3) designate a hearings examiner to conduct the
10-19 hearing.
10-20 (b) The hearings examiner shall make findings of fact and
10-21 conclusions of law and shall promptly issue to the commissioner a
10-22 proposal for decision as to the occurrence of the violation and a
10-23 recommendation as to the amount of the proposed penalty if a
10-24 penalty is determined to be warranted.
10-25 (c) Based on the findings of fact and conclusions of law and
10-26 the recommendations of the hearings examiner, the commissioner by
10-27 order may find that a violation has occurred and may assess a
11-1 penalty, or may find that no violation has occurred.
11-2 Sec. 251.069. NOTICE AND PAYMENT OF ADMINISTRATIVE PENALTY;
11-3 JUDICIAL REVIEW; REFUND. (a) The commissioner or the
11-4 commissioner's designee shall give notice of the commissioner's
11-5 order under Section 251.068(c) to the person charged. The notice
11-6 must include:
11-7 (1) separate statements of the findings of fact and
11-8 conclusions of law;
11-9 (2) the amount of any penalty assessed; and
11-10 (3) a statement of the right of the person charged to
11-11 judicial review of the commissioner's order.
11-12 (b) Not later than the 30th day after the date on which the
11-13 decision is final as provided by Chapter 2001, Government Code, the
11-14 person charged shall:
11-15 (1) pay the penalty in full;
11-16 (2) pay the amount of the penalty and file a petition
11-17 for judicial review contesting the occurrence of the violation, the
11-18 amount of the penalty, or both the occurrence of the violation and
11-19 the amount of the penalty; or
11-20 (3) without paying the amount of the penalty, file a
11-21 petition for judicial review contesting the occurrence of the
11-22 violation, the amount of the penalty, or both the occurrence of the
11-23 violation and the amount of the penalty.
11-24 (c) Within the 30-day period, a person who acts under
11-25 Subsection (b)(3) may:
11-26 (1) stay enforcement of the penalty by:
11-27 (A) paying the amount of the penalty to the
12-1 court for placement in an escrow account; or
12-2 (B) giving to the court a supersedeas bond that
12-3 is approved by the court for the amount of the penalty and that is
12-4 effective until all judicial review of the board's order is final;
12-5 or
12-6 (2) request the court to stay enforcement of the
12-7 penalty by:
12-8 (A) filing with the court a sworn affidavit of
12-9 the person stating that the person is financially unable to pay the
12-10 amount of the penalty and is financially unable to give the
12-11 supersedeas bond; and
12-12 (B) giving a copy of the affidavit to the
12-13 executive director by certified mail.
12-14 (d) An executive director who receives a copy of an
12-15 affidavit under Subsection (c)(2) may file with the court, within
12-16 five days after the date the copy is received, a contest to the
12-17 affidavit. The court shall hold a hearing on the facts alleged in
12-18 the affidavit as soon as practicable and shall stay the enforcement
12-19 of the penalty on finding that the alleged facts are true. The
12-20 person who files an affidavit has the burden of proving that the
12-21 person is financially unable to pay the amount of the penalty and
12-22 to give a supersedeas bond.
12-23 (e) If the person does not pay the amount of the penalty and
12-24 the enforcement of the penalty is not stayed, the executive
12-25 director may refer the matter to the attorney general for
12-26 collection of the amount of the penalty.
12-27 (f) Judicial review of the order of the board:
13-1 (1) is instituted by filing a petition as provided by
13-2 Subchapter G, Chapter 2001, Government Code; and
13-3 (2) is under the substantial evidence rule.
13-4 (g) If the court sustains the occurrence of the violation,
13-5 the court may uphold or reduce the amount of the penalty and order
13-6 the person to pay the full or reduced amount of the penalty. If
13-7 the court does not sustain the occurrence of the violation, the
13-8 court shall order that no penalty is owed.
13-9 (h) When the judgment of the court becomes final, the court
13-10 shall proceed under this subsection. If the person paid the amount
13-11 of the penalty and if that amount is reduced or is not upheld by
13-12 the court, the court shall order that the appropriate amount plus
13-13 accrued interest be remitted to the person. The rate of the
13-14 interest is the rate charged on loans to depository institutions by
13-15 the New York Federal Reserve Bank, and the interest shall be paid
13-16 for the period beginning on the date the penalty was paid and
13-17 ending on the date the penalty is remitted. If the person gave a
13-18 supersedeas bond and if the amount of the penalty is not upheld by
13-19 the court, the court shall order the release of the bond. If the
13-20 person gave a supersedeas bond and if the amount of the penalty is
13-21 reduced, the court shall order the release of the bond after the
13-22 person pays the amount.
13-23 Sec. 251.070. PENALTY DEPOSITED TO STATE TREASURY. A civil
13-24 or administrative penalty collected under this chapter shall be
13-25 deposited in the state treasury to the credit of the general
13-26 revenue fund.
13-27 Sec. 251.071. RECOVERY OF COSTS. (a) The department may
14-1 assess reasonable expenses and costs against a person in an
14-2 administrative hearing if, as a result of the hearing, the person's
14-3 license is denied, suspended, or revoked or if administrative
14-4 penalties are assessed against the person. The person shall pay
14-5 expenses and costs assessed under this subsection not later than
14-6 the 30th day after the date of a board order requiring the payment
14-7 of expenses and costs is final. The department may refer the
14-8 matter to the attorney general for collection of the expenses and
14-9 costs.
14-10 (b) If the attorney general brings an action against a
14-11 person under Section 251.062 or 251.064 or to enforce an
14-12 administrative penalty assessed under Section 251.068, and an
14-13 injunction is granted against the person or the person is found
14-14 liable for a civil or administrative penalty, the attorney general
14-15 may recover, on behalf of the attorney general and the department,
14-16 reasonable expenses and costs.
14-17 (c) For purposes of this section, "reasonable expenses and
14-18 costs" include expenses incurred by the department and the attorney
14-19 general in the investigation, initiation, or prosecution of an
14-20 action, including reasonable investigative costs, court costs,
14-21 attorney's fees, witness fees, and deposition expenses.
14-22 SECTION 2. (a) Except as provided by Subsection (b) of this
14-23 section and Section 3, this Act takes effect September 1, 1995.
14-24 (b) Sections 251.011 and 251.031 and Subchapter E, Chapter
14-25 251, Health and Safety Code, as added by this Act, take effect
14-26 September 1, 1996.
14-27 SECTION 3. A person is not required to obtain a license
15-1 under Subchapter B, Chapter 251, Health and Safety Code, as added
15-2 by this Act, and an individual is not required to be trained and
15-3 competent under Subchapter C, Chapter 251, Health and Safety Code,
15-4 as added by this Act, until September 1, 1996.
15-5 SECTION 4. The importance of this legislation and the
15-6 crowded condition of the calendars in both houses create an
15-7 emergency and an imperative public necessity that the
15-8 constitutional rule requiring bills to be read on three several
15-9 days in each house be suspended, and this rule is hereby suspended.