Part 1.
TEXAS DEPARTMENT OF HEALTH
Chapter 134.
PRIVATE PSYCHIATRIC HOSPITALS AND CRISIS STABILIZATION UNITS
The Texas Department of Health (department) proposes amendments to §§134.2,
134.22, 134.23, 134.26, 134.81 and 134.83, and new §134.47, concerning
private psychiatric hospitals and crisis stabilization units.
These amendments and new section are required as a result of revisions
to the Health and Safety Code, Chapter 577, pursuant to House Bill (HB) 1614,
HB 2292, and Senate Bill 162, 78th Legislature, 2003. Amendments to §134.2
include additional definitions for action plan, adverse event, medical error,
reportable event, and root cause analysis. Amendments to §§134.22
and 134.23 implement the process for converting to two-year licensing renewal
cycles beginning January 1, 2005, and adds a requirement to submit to the
department an annual events report, and a best practices report prior to the
expiration of the license. Amendments to §134.26 increase licensing fees
in order to implement the full cost recovery requirement for licensing programs.
New §134.47 includes requirements related to development and implementation
of a patient safety program, and establishes annual reporting requirements
related to specific events occurring at the facility, and submission of best
practice reports. The amendment to §134.81 clarifies limitations on the
department's access related to a root analysis and action plan. Amendments
to §134.83 reflect the addition of probation to the list of enforcement
actions that can be taken against a facility.
Lisa Subia, Associateship for Consumer Health Protection, has determined
that for each year of the first five years the sections are in effect, there
will be fiscal implications as a result of administering the sections. The
effect on state government will be related to the proposed increase in licensing
fees to provide for cost recovery of expenses and the conversion to the two-year
renewal cycle. Assuming an effective date of June 1, 2004, for the revised
fee schedule, the increase in revenue for fiscal year 2004 will be approximately
$47,550. In fiscal year 2005, there will be an increase in revenue of $190,200
related to the fee increase. Since fiscal year 2005 will be the first year
in a two-year phase-in process for the two-year renewal cycle, there will
be an additional temporary increase in revenue of approximately $95,100, bringing
the total estimated revenue to $285,300. This estimate is based on the fact
that during fiscal year 2005, one-half of the facilities will be renewing
their licenses to be effective for two years, and will pay a corresponding
fee to cover the two-year license period. The remainder of the facilities
will be renewing their licenses for a one-year period in fiscal year 2005,
which will result in the temporary additional revenue. This second group of
facilities will renew their licenses for the two-year period in fiscal year
2006, so the anticipated additional revenue in fiscal years 2006 through 2009
will be approximately $190,200 per year. There will be no effect on local
government unless the local government operates a private psychiatric hospital
or crisis stabilization unit. In that case, the local government would be
subject to the proposed new fees and other requirements.
Ms. Subia has also determined that for each year of the first five years
the sections are in effect, the public benefit will be to improve patient
safety in the regulated facilities, and to provide the public with basic information
about the occurrence of certain medical errors in these facilities. There
will be economic costs for micro-businesses, small businesses and persons
who are required to comply with the new sections. These costs are related
to the increase in licensing fees and conversion to two-year renewal cycles.
All regulated facilities will be subject to the fee increase, with the total
increase ranging from $2,000 per year for the smallest facility to $13,515
per year for the largest facility. Once conversion to the two-year renewal
cycle begins, facilities will be required to pay the fee for the two-year
period. This increase for each facility will range from $4,000 per two-year
licensing period for the smallest facility to $27,030 per two-year licensing
period for the largest facility. There will be no anticipated impact on local
employment.
Comments on the proposal may be submitted to Cindy Bednar, Director of
Hospital Programs, Health Facility Licensing and Compliance Division, Texas
Department of Health, 1100 West 49th Street, Austin, Texas, 78756-3182, (512)
834-6648. Comments will be accepted for 30 days following the publication
of this proposal in the
Texas Register
.
Subchapter A. GENERAL PROVISIONS
25 TAC §134.2
The amendment is proposed under Health and Safety Code, Chapter
577, concerning private mental hospitals and other mental health facilities;
and Health and Safety Code, §12.001, which provides the Texas Board of
Health (board) with the authority to adopt rules for the performance of every
duty imposed by law on the board, the department, and the commissioner of
health.
The amendment affects the Health and Safety Code, Chapters 577 and 12.
§134.2.Definitions.
The following words and terms, when used in this chapter, shall have
the following meanings, unless the context clearly indicates otherwise.
(1)
Action plan--A written document that includes
specific measures to correct identified problems or areas of concern; identifies
strategies for implementing system improvements; and includes outcome measures
to indicate the effectiveness of system improvements in reducing, controlling
or eliminating identified problem areas.
(2)
Adverse event--Untoward incident, therapeutic
misadventure or other adverse occurrence directly associated with care or
services provided within the hospital system, which may result from acts of
commission or omission.
(3)
[
(4)
[
(5)
[
(6)
[
(A)
the following human body fluids: semen, vaginal secretions,
cerebrospinal fluid, synovial fluid, pleural fluid, pericardial fluid, peritoneal
fluid, amniotic fluid, saliva in dental procedures, any body fluid that is
visibly contaminated with blood, and all body fluids in situations where it
is difficult or impossible to differentiate between body fluids;
(B)
any unfixed tissue or organ (other than intact skin) from
a human (living or dead); and
(C)
Human Immunodeficiency Virus (HIV)-containing cell or tissue
cultures, organ cultures, and HIV or Hepatitis B Virus (HBV) containing culture
medium or other solutions; and blood, organs, or other tissues from experimental
animals infected with HIV or HBV.
(7)
[
(8)
[
(9)
[
(10)
[
(11)
[
(12)
[
(13)
[
(A)
placing the health of the individual (or with respect to
a pregnant woman, the health of the woman or her unborn child) in serious
jeopardy;
(B)
serious impairment to bodily functions;
(C)
serious dysfunction of any bodily organ or part; or
(D)
with respect to a pregnant woman who is having contractions:
(i)
that there is inadequate time to effect a safe transfer
to another hospital before delivery; or
(ii)
that transfer may pose a threat to the health or safety
of the woman or the unborn child.
(14)
[
(15)
[
(16)
[
(17)
[
(18)
[
(19)
[
(20)
[
(21)
[
(22)
[
(23)
[
(24)
[
(25)
Medical error--An adverse event that was
preventable with the current state of medical knowledge.
(26)
[
(27)
[
(28)
[
(A)
substantially impairs a person's thought, perception of
reality, emotional process, or judgment; or
(B)
grossly impairs an individual's behavior as demonstrated
by recent disturbed behavior.
(29)
[
(30)
[
(31)
[
(32)
[
(33)
[
(34)
[
(A)
a corporation;
(B)
a governmental unit;
(C)
a limited liability company;
(D)
an individual;
(E)
a partnership if a partnership name is stated in a written
partnership agreement or an assumed name certificate;
(F)
all partners in a partnership if a partnership name is
not stated in a written partnership agreement or an assumed name certificate;
or
(G)
all co-owners under any other business arrangement.
(35)
[
(36)
[
(37)
[
(38)
[
(A)
licensed as a physician by the Texas State Board of Medical
Examiners in accordance with Chapter 155 of the Texas Occupations Code; or
(B)
authorized to perform medical acts under an institutional
permit at a Texas postgraduate training program approved by the Accreditation
Council on Graduate Medical Education, the American Osteopathic Association,
or the Texas State Board of Medical Examiners.
(39)
[
(40)
[
(41)
[
(42)
[
(A)
a single building where inpatients receive hospital services;
or
(B)
multiple buildings where inpatients receive hospital services,
provided that the following criteria are met:
(i)
all inpatient buildings and inpatient services are subject
to the control and direction of the governing body of the hospital;
(ii)
all inpatient buildings are within a 30-mile radius of
the main address of the licensee;
(iii)
there is integration of the organized medical staff of
the hospital;
(iv)
there is a single chief executive officer who reports
directly to the governing body and through whom all administrative authority
flows and who exercises control and surveillance over all administrative activities
of the hospital;
(v)
there is a single chief medical officer who reports directly
to the governing body and who is responsible for all medical staff activities
of the hospital; and
(vi)
each building that is geographically separate from other
buildings contains at least one nursing unit for inpatients, unless providing
only diagnostic or laboratory services, or a combination thereof, in the building
for hospital inpatients.
(43)
[
(44)
[
(45)
[
(46)
Reportable event--A medical error or adverse
event or occurrence which the hospital is required to report to the Department,
as set out in §134.47 of this title (relating to Patient Safety Program).
(47)
Root cause analysis--An interdisciplinary
review process for identifying the basic or contributing causal factors that
underlie a variation in performance associated with an adverse event or reportable
event. It focuses primarily on systems and processes, includes an analysis
of underlying cause and effect, progresses from special causes in clinical
processes to common causes in organizational processes, and identifies potential
improvements in processes or systems.
(48)
[
(49)
[
(50)
[
(51)
[
(52)
[
This agency hereby certifies that the proposal has been
reviewed by legal counsel and found to be within the agency's legal authority
to adopt.
Filed with the Office of
the Secretary of State on January 2, 2004.
TRD-200400003
Susan K. Steeg
General Counsel
Texas Department of Health
Earliest possible date of adoption: February 15, 2004
For further information, please call: (512) 458-7236
25 TAC §§134.22, 134.23, 134.26
The amendments are proposed under Health and Safety Code,
Chapter 577, concerning private mental hospitals and other mental health facilities;
and Health and Safety Code, §12.001, which provides the Texas Board of
Health (board) with the authority to adopt rules for the performance of every
duty imposed by law on the board, the department, and the commissioner of
health.
The amendments affect the Health and Safety Code, Chapters 577 and 12.
§134.22.Application and Issuance of Initial License.
(a) - (c)
(No change.)
(d)
Issuance of license. When it is determined that the facility
has complied with subsections (a)-(c) of this section, the department shall
issue the license to the applicant.
(1)
(No change.)
(2)
Expiration date.
(A)
For initial licenses issued prior to January 1, 2005.
[
(i)
If the effective date of the license is
the first day of a month, the license expires on the last day of the 11th
month after issuance.
(ii)
If the effective date of the license is
the second or any subsequent day of a month, the license expires on the last
day of the 12th month after issuance.
(B)
For initial licenses issued January 1, 2005 or after.
[
(i)
If the effective date of the license is
the first day of a month, the license expires on the last day of the 23rd
month after issuance.
(ii)
If the effective date of the license is
the second or any subsequent day of a month, the license expires on the last
day of the 24th month after issuance.
(e) - (g)
(No change.)
§134.23.Application and Issuance of Renewal License.
(a)
(No change.)
(b)
Renewal license. The department shall issue a renewal license
to a facility which meets the minimum requirements for a license.
(1)
The facility shall submit the following to the department
prior to the expiration date of the license:
(A) - (B)
(No change.)
(C)
the renewal license fee; [
(D)
documentation of accreditation by the Joint Commission
on Accreditation of Healthcare Organizations, if applicable
;
[
(E)
an annual events report in accordance with §134.47(b)(1)
of this title (relating to Patient Safety Program); and
(F)
a best practices report in accordance with §134.47(b)(2)
of this title.
(2)
(No change.)
(3)
Renewal licenses issued prior to January
1, 2005, will be valid for 12 months.
(4)
Renewal licenses issued January 1, 2005,
through December 31, 2005, will be valid for either 12 or 24 months, to be
determined by the department prior to the time of license renewal.
(5)
Renewal licenses issued January 1, 2006,
or after will be valid for 24 months.
(c)
(No change.)
§134.26.Fees.
(a)
(No change.)
(b)
License fees.
(1)
The fee for an initial license or a renewal license is
$100
[
(A) - (C)
(No change.)
(2) - (3)
(No change.)
(c) - (e)
(No change.)
This agency hereby certifies that the proposal has been reviewed
by legal counsel and found to be within the agency's legal authority to adopt.
Filed
with the Office of the Secretary of State on January 2, 2004.
TRD-200400004
Susan K. Steeg
General Counsel
Texas Department of Health
Earliest possible date of adoption: February 15, 2004
For further information, please call: (512) 458-7236
(1)
] Applicant--The person legally
responsible for the operation of the facility, whether by lease or ownership,
who seeks a license from the department.
(2)
] Board--The Texas Board of
Health.
(3)
] Community center--A center
established under Health and Safety Code, Chapter 534, Subchapter A.
(4)
] Contaminated linen--Linen
which has been soiled with blood or other potentially infectious materials
or may contain sharps. Other potentially infectious materials means:
(5)
] Crisis stabilization unit
(CSU)--A mental health facility operated by a community center or other entity
designated by the Texas Department of Mental Health and Mental Retardation
in accordance with Texas Health and Safety Code, §534.054, that provides
treatment to individuals who are the subject of a protective custody order
issued in accordance with Texas Health and Safety Code, §574.022.
(6)
] Dentist--A person licensed
to practice dentistry by the State Board of Dental Examiners. This includes
a doctor of dental surgery or a doctor of dental medicine.
(7)
] Department--The Texas Department
of Health, 1100 West 49th Street, Austin, Texas 78756-3199.
(8)
] Dietitian--A person who is
currently licensed by the Texas State Board of Examiners of Dietitians as
a licensed dietitian or provisional licensed dietitian, or who is a registered
dietitian with the American Dietetic Association.
(9)
] Director--The director of
the Health Facility Licensing and Compliance Division, Texas Department of
Health.
(10)
] Division--The Health Facility
Licensing and Compliance Division, Texas Department of Health.
(11)
] Emergency medical condition--A
medical condition manifesting itself by acute symptoms of sufficient severity
(including severe pain, psychiatric disturbances or symptoms of substance
abuse) such that the absence of immediate medical attention could reasonably
be expected to result in one or all of the following:
(12)
] Facility--A private psychiatric
hospital or a crisis stabilization unit.
(13)
] Facility administration--Administrative
body of a facility headed by an individual who has the authority to represent
the facility and who is responsible for the operation of the facility according
to the policies and procedures of the facility governing body.
(14)
] Fast-track projects--A construction
project in which it is necessary to begin initial phases of construction before
later phases of the construction documents are fully completed in order to
establish other design conditions or because of time constraints such as mandated
deadlines.
(15)
] Governing body--The governing
authority of a facility which is responsible for the facility's organization,
management, control, and operation, including appointment of the medical staff;
includes the owner or partners for facilities owned or operated by an individual
or partners.
(16)
] Governmental unit--A political
subdivision of the state, including a hospital district, county, or municipality,
and any department, division, board, or other agency of a political subdivision.
(17)
] Hospital--A private psychiatric
hospital.
(18)
] Inpatient services--Services
provided to a patient admitted to a hospital for an intended length of stay
of 24 hours or greater.
(19)
] Learning disability--When
a severe discrepancy exists when the individual's assessed intellectual ability
is above the mentally retarded range, but where the individual's assessed
educational achievement in areas specified is more than one standard deviation
below the individual's intellectual ability.
(20)
] Legally reproduced form--A
medical record retained in hard copy, microform (microfilm or microfiche),
or other electronic medium.
(21)
] Licensed vocational nurse--An
individual who is currently licensed as a licensed vocational nurse (LVN)
by the Board of Vocational Nurse Examiners in accordance with Texas Occupations
Code, Chapter 302.
(22)
] Licensee--A person or governmental
unit who has been granted a private psychiatric hospital license or crisis
stabilization unit license.
(23)
] Medical staff--Licensed
physicians and other licensed practitioners permitted by law and by the facility
to provide medical care independently in the facility.
(24)
] Mental health services--All
services concerned with research, prevention, and detection of mental disorders
and disabilities and all services necessary to treat, care for, supervise,
and rehabilitate persons who have a mental illness.
(25)
] Mental illness--An illness,
disease, or condition (other than a sole diagnosis of epilepsy, senility,
substance use disorder, mental retardation, autism, or pervasive developmental
disorder) that:
(26)
] Mental retardation--Significantly
subaverage general intellectual functioning that is concurrent with deficits
in adaptive behavior and originates during the developmental period.
(27)
] Minor--A person under 18
years of age who is not and has not been married or who has not had the disabilities
of minority removed for general purposes.
(28)
] Mobile unit--Any pre-manufactured
structure, trailer, or self-propelled unit equipped with a chassis on wheels
and intended to provide shared medical services to the community on a temporary
basis. Some of these units are equipped with expanding walls, and designed
to be moved on a daily basis.
(29)
] Oral surgeon--A person licensed
by the State Board of Dental Examiners in the specialty of dentistry which
includes the diagnosis, surgical and adjunctive treatment of diseases, injuries,
and defects involving both the functional and esthetic aspects of the hard
and soft tissues of the oral and maxillofacial regions.
(30)
] Outpatient services--Services
provided to patients whose medical needs can be met in less than 24 hours
and are provided within the facility.
(31)
] Owner--One of the following
persons which will hold or does hold a license issued under Health and Safety
Code, Chapter 577, in the person's name or the person's assumed name:
(32)
] Patient--An individual who
is receiving mental health services under this chapter.
(33)
] Person--An individual, firm,
partnership, corporation, association, joint stock company, joint venture,
or local authority, and includes a receiver, trustee, assignee, or other similar
representative of those entities.
(34)
] Pharmacist--A person who
is licensed to practice pharmacy by the Texas Board of Pharmacy in accordance
with Texas Occupations Code, Chapter 558.
(35)
] Physician--An individual
who is:
(36)
] Podiatrist--A podiatrist
licensed by the Texas State Board of Podiatry Examiners.
(37)
] Political subdivision--A
county, municipality, or hospital district in this state but does not include
a department, board, or agency of the state that has statewide authority and
responsibility.
(38)
] Practitioner--A health care
professional licensed in the State of Texas, other than a physician.
(39)
] Premises--A premises may
be any of the following:
(40)
] Private psychiatric hospital--A
hospital that provides inpatient mental health services to individuals with
a mental illness or with a substance use disorder except that, at all times,
a majority of the individuals admitted are individuals with a mental illness.
Such services include psychiatric assessment and diagnostic services, physician
services, professional nursing services, and monitoring for patient safety
provided in a restricted environment.
(41)
] Registered nurse--An individual
who is licensed as a registered nurse by the Board of Nurse Examiners in accordance
with Texas Occupations Code, Chapter 301.
(42)
] Relocatable unit--Any structure,
not on wheels, built to be relocated at any time and provide medical services.
These structures vary in size.
(43)
] Stabilize--With respect
to an emergency medical condition, to provide such medical treatment of the
condition necessary to assure, within reasonable medical probability, that
no material deterioration of the condition is likely to result from or occur
during the transfer of the individual from a facility, or that the woman has
delivered the child and the placenta.
(44)
] Transfer--The movement (including
the discharge) of an individual outside a facility at the direction of any
person employed by (or affiliated or associated, directly or indirectly, with)
the facility, but does not include such a movement of an individual who has
been declared dead, or leaves the facility without the permission of any such
person.
(45)
] Transportable unit--Any
pre-manufactured structure or trailer, equipped with a chassis on wheels,
intended to provide shared medical services to the community on an extended
temporary basis. These units are designed to be moved periodically, depending
on need.
(46)
] Universal precautions--Procedures
for disinfection and sterilization of reusable medical devices and the appropriate
use of infection control, including hand washing, the use of protective barriers,
and the use and disposal of needles and other sharp instruments as those procedures
are defined by the Centers for Disease Control (CDC) of the United States
Public Health Service. This term includes standard precautions as defined
by CDC which are designed to reduce the risk of transmission of blood borne
and other pathogens in facilities.
(47)
] Violation--Failure to comply
with the licensing statute, a rule or standard, special license provision,
or an order issued by the commissioner of health or the commissioner's designee,
adopted or enforced under the licensing statute. Each day a violation continues
or occurs is a separate violation for purposes of imposing a penalty.
Subchapter B. APPLICATION AND ISSUANCE OF A LICENSE
If the effective date of the license is the first day of a month,
the license expires on the last day of the month preceding the issuance month
of the next year. For example, if a license is effective September 1, the
license expires on August 31 of the next year and every year thereafter unless
a change of ownership occurs.
]
If the effective date of the license is the second or any subsequent
day of a month, the license expires on the last day of the month of the next
year. For example, if the license is effective September 2, the license expires
on September 30 of the next year and every year thereafter unless a change
of ownership occurs.
]
and
]
.
]
$15
] per bed
per 12 months
based upon the
designed bed capacity. The total fee may not be less than
$3,000 per
12 months
[
$1,000
]. The designed bed capacity is determined
as follows.
Subchapter C. OPERATIONAL REQUIREMENTS