Part 1.
DEPARTMENT OF STATE HEALTH SERVICES
Chapter 133.
HOSPITAL LICENSING
The Executive Commissioner of the Health and Human Services Commission,
on behalf of the Department of State Health Services (department), proposes
the repeal of §§133.1, 133.2, 133.21 - 133.26, 133.41 - 133.48,
133.61, 133.62, 133.81, 133.101, 133.102, 133.121, 133.122, 133.141 - 133.143,
and 133.161 - 133.169, and new §§133.1, 133.2, 133.21 - 133.26,
133.41 - 133.48, 133.61, 133.62, 133.81, 133.101, 133.102, 133.121, 133.141
- 133.143, and 133.161 - 133.169, concerning the regulation of hospitals.
BACKGROUND AND PURPOSE
The repeals and new sections are necessary to update, reorganize, and clarify
the rules and to implement legislation by the 79th Legislature, Regular Session,
2005, specifically, the amendments to Health and Safety Code (HSC), Chapter
161, Subchapter T (Senate Bill (SB) 316) relating to information provided
to parents of newborn children; Occupations Code, §164.052 (SB 419) relating
to parental consent for abortion; Occupations Code, §162.052 (SB 872)
relating to certain disclosure requirements regarding niche hospitals; HSC, §161.0052
(SB 1330) relating to the immunization of elderly persons; HSC, Chapter 256
(SB 1525) relating to safe patient handling and movement practices of nurses
in hospitals; HSC, Chapter 322 (House Bill (HB) 677) relating to emergency
services for sexual assault survivors; Occupations Code, §301.353 (HB
1718) relating to the regulation of certain nursing practices, including circulating
duties in an operating room; HSC, §241.023 (HB 2471) relating to the
issuance of a single license for multiple hospitals; and HSC, §241.022
(HB 3357) relating to information required on a hospital license application.
Government Code, §2001.039, requires that each state agency review
and consider for readoption each rule adopted by that agency pursuant to the
Government Code, Chapter 2001 (Administrative Procedure Act). Sections 133.1,
133.2, 133.21 - 133.26, 133.41 - 133.48, 133.61, 133.62, 133.81, 133.101,
133.102, 133.121, 133.122, 133.141 - 133.143, and 133.161 - 133.169 have been
reviewed and the department has determined that the reasons for adopting the
sections continue to exist because rules on this subject are needed.
SECTION-BY-SECTION SUMMARY
Proposed new §§133.1, 133.2, 133.21 - 133.26, 133.41 - 133.48,
133.61, 133.62, 133.81, 133.101, 133.102, 133.121, 133.141 - 133.143, and
133.161 - 133.169 provide clarification to the rules, update references to
statutes and rules, and change the name of the department and its programs.
The new §133.2 adds definitions and deletes definitions not used in the
rules and those that were moved to a specific section when the use was confined
to that section. The new §133.21 sets out conditions under which multiple
hospital locations may be licensed under one license number. New §133.22
and §133.23 include a proposal to collect additional ownership information
on hospital license applications. The new §133.41 requires all hospitals
to document all approvals or delegations of anesthesia services and include
the training, experience, and qualifications of the person who provided the
service; to have an emergency department with staff on duty and available
to initiate immediate appropriate lifesaving measures; to participate in the
local emergency medical service system; to develop, implement and enforce
policies relating to survivors of sexual assault, workplace safety, and safe
patient handling and movement practices by nurses in hospitals; to require
a registered nurse be on duty in each licensed hospital location at all times;
to comply with certain requirements for renal dialysis services; and to require
direct supervision by a qualified registered nurse circulator of licensed
vocational nurses and surgical technologists assisting in circulatory duties
in the operating room. The new §133.45 requires hospitals to develop,
implement and enforce policies to: (1) implement an all-hazard disaster preparedness
plan; (2) ensure that parents of newborn children receive information concerning
postpartum depression and other emotional trauma associated with pregnancy
and parenting, including the prevention of shaken baby syndrome, immunizations,
and newborn screening; (3) ensure compliance with statutory provisions relating
to abortion and informed consent and parental consent for abortion; and (4)
provide influenza and pneumococcal vaccines for elderly persons. The repeal
of §133.62 deletes procedural language for submission and approval of
cooperative agreements deemed unnecessary because it is duplicative of statutory
language. New §133.62 indicates current information regarding cooperative
agreements.
New §§133.141 - 133.143 and 133.161 - 133.165 change the requirement
for compliance with the National Fire Protection Association's (NFPA) Life
Safety Code from the 2000 edition to the 2003 edition, and provide new edition
dates and section numbers for NFPA and other standards referenced in the sections.
New §133.143 establishes conditions for the use of alcohol-based products
when used for surgical skin preparation; new §133.162 clarifies prohibitions
relating to hospital construction in designated 100-year flood plains and
requires a hospital to consider the provisions of HSC Chapter 256 relating
to safe patient handling and movement practices; new §133.163 clarifies
spatial requirements for patient multiple-bed rooms, establishes signage specifications
for the emergency entrance to a hospital, and sets out standards for a decontamination
room, intermediate care suite, and universal care suite when hospitals provide
the services; new §133.165 clarifies that all spaces in a hospital must
be contiguous when the building is shared with other hospitals or non-hospital
occupancies and clarifies the services and facilities that must be provided
directly by the hospital and those that may be shared; and new §133.166
clarifies requirements for mobile, relocatable and transportable units when
the units are permanently attached to a hospital. New §133.169 updates
existing tables and provides two new tables for clarity of requirements relating
to the nurses calling systems and multiple-bed room configurations.
FISCAL NOTE
Kathy Perkins, Manager, Health Care Quality Section, has determined that,
for each year of the first five-year period that the sections will be in effect,
there will be no fiscal implications to state or local governments as a result
of enforcing and administering the sections as proposed.
SMALL AND MICRO-BUSINESS IMPACT ANALYSIS
Ms. Perkins has also determined that there will be no effect on small businesses
or micro-businesses required to comply with the sections as proposed. This
was determined by interpretation of the rules that small businesses and micro-businesses
will not be required to alter their business practices in order to comply
with the sections. There are no anticipated economic costs to persons who
are required to comply with the sections as proposed. There is no anticipated
negative impact on local employment.
PUBLIC BENEFIT
In addition, Ms. Perkins has also determined that, for each year of the
first five years the sections are in effect, the public will benefit from
adoption of the sections. The public benefit anticipated as a result of enforcing
or administering the sections is to ensure patient health and safety when
hospital care is necessary.
REGULATORY ANALYSIS
The department has determined that this proposal is not a "major environmental
rule" as defined by Government Code, §2001.0225. "Major environmental
rule" is defined to mean a rule the specific intent of which is to protect
the environment or reduce risk to human health from environmental exposure
and that may adversely affect, in a material way, the economy, a sector of
the economy, productivity, competition, jobs, the environment, or the public
health and safety of a state or a sector of the state. This proposal is not
specifically intended to protect the environment or reduce risks to human
health from environmental exposure.
TAKINGS IMPACT ASSESSMENT
The department has determined that the proposed rules do not restrict or
limit an owner's right to his or her property that would otherwise exist in
the absence of government action and, therefore, do not constitute a taking
under Government Code, §2007.043.
PUBLIC COMMENT
Comments on the proposal may be submitted to Nance Stearman, Health Care
Quality Section, Division for Regulatory Services, Department of State Health
Services, 1100 West 49th Street, Mail Code CEN, Austin, Texas 78756, (512)
834-6752 or by email to nance.stearman@dshs.state.tx.us. Comments will be
accepted for 60 days following publication of the proposal in the
Texas Register
.
PUBLIC HEARING
A public hearing will be scheduled and held at the Department of State
Health Services, Room K-100, 1100 West 49th Street, Austin, Texas 78756. Further
information may be obtained from Nance Stearman, Health Care Quality Section,
Division for Regulatory Services, Department of State Health Services, 1100
West 49th Street, Austin, Texas 78756, (512) 834-6752.
LEGAL CERTIFICATION
The Department of State Health Services General Counsel, Cathy Campbell,
certifies that the proposed rules have been reviewed by legal counsel and
found to be within the state agencies' authority to adopt.
Subchapter A. GENERAL PROVISIONS
25 TAC §133.1, §133.2
(Editor's note: The text of the following sections proposed for
repeal will not be published. The sections may be examined in the offices
of the Department of State Health Services or in the Texas Register office,
Room 245, James Earl Rudder Building, 1019 Brazos Street, Austin.)
STATUTORY AUTHORITY
The proposed repeals are authorized by Health and Safety Code, §241.026,
which requires the department to develop, establish, and enforce standards
for the construction, maintenance, and operation of hospitals; Government
Code, §531.0055(e); and Health and Safety Code, §1001.075, which
authorize the Executive Commissioner of the Health and Human Services Commission
to adopt rules and policies necessary for the operation and provision of health
and human services by the department and for the administration of Health
and Safety Code, Chapter 1001.
The proposed repeals affect the Health and Safety Code, Chapters 161, 241,
256, 322 and 1001; Government Code, Chapter 2001; and Occupations Code, Chapters
162, 164 and 301. Review of the sections implements Government Code, §2001.039.
§133.1.Purpose.
§133.2.Definitions.
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 December 1, 2006.
TRD-200606441
Cathy Campbell
General Counsel
Department of State Health Services
Proposed date of adoption: February 13, 2007
For further information, please call: (512) 458-7111 x6972
25 TAC §133.1, §133.2
STATUTORY AUTHORITY
The proposed new sections are authorized by Health and Safety Code, §241.026,
which requires the department to develop, establish, and enforce standards
for the construction, maintenance, and operation of hospitals; Government
Code, §531.0055(e), and Health and Safety Code, §1001.075, which
authorize the Executive Commissioner of the Health and Human Services Commission
to adopt rules and policies necessary for the operation and provision of health
and human services by the department and for the administration of Health
and Safety Code, Chapter 1001.
The proposed new sections affect the Health and Safety Code, Chapters 161,
241, 256, 322, and 1001; Government Code, Chapter 2001; and Occupations Code,
Chapters 162, 164, and 301. Review of the sections implements Government Code, §2001.039.
§133.1.Purpose.
(a)
The purpose of this chapter is to implement the Health
and Safety Code, Chapter 241, which requires general and special hospitals
to be licensed by the Department of State Health Services.
(b)
This chapter provides procedures for obtaining a hospital
license; minimum standards for hospital functions and services; patient rights
standards; discrimination or retaliation standards; patient transfer and other
policy and protocol requirements; reporting, posting and training requirements
relating to abuse and neglect; standards for voluntary agreements; waiver
provisions; inspection and investigation procedures; enforcement standards;
fire prevention and protection requirements; general safety standards; physical
plant and construction requirements for existing and new hospitals, and mobile
transportable and relocatable units; and standards for the preparation, submittal,
review, and approval of construction documents.
(c)
Compliance with this chapter does not constitute release
from the requirements of other applicable federal, state, or local laws, codes,
rules, regulations, and ordinances. This chapter must be followed where it
exceeds other codes and ordinances.
§133.2.Definitions.
The following words and terms, when used in this chapter, shall have
the following meanings, unless the context clearly indicates otherwise.
(1)
Act--The Texas Hospital Licensing Law, Health and Safety
Code, Chapter 241.
(2)
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.
(3)
Advanced practice nurse (APN)--A registered nurse, currently
licensed in the State of Texas, who has been approved by the Board of Nurse
Examiners for the State of Texas to practice as an advanced practice nurse
based on completing an advanced educational program of study acceptable to
the board. The term includes a nurse practitioner, nurse-midwife, nurse anesthetist,
and a clinical nurse specialist.
(4)
Adverse event--An event that results in unintended harm
to the patient by an act of commission or omission rather than by the underlying
disease or condition of the patient.
(5)
Applicant--The person legally responsible for the operation
of the hospital, whether by lease or ownership, who seeks a hospital license
from the department.
(6)
Available--When referring to on-site personnel, on the
premises and able to rapidly perform hands-on care in an emergency situation.
(7)
Chemical dependency services--A planned, structured, and
organized program designed to initiate and promote a person's chemical-free
status or to maintain the person free of illegal drugs. It includes, but is
not limited to, the application of planned procedures to identify and change
patterns of behavior related to or resulting from chemical dependency that
are maladaptive, destructive, or injurious to health, or to restore appropriate
levels of physical, psychological, or social functioning lost due to chemical
dependency.
(8)
Comprehensive medical rehabilitation--The provision of
rehabilitation services that are designed to improve or minimize a person's
physical or cognitive disabilities, maximize a person's functional ability,
or restore a person's lost functional capacity through close coordination
of services, communication, interaction, and integration among several professions
that share responsibility to achieve team treatment goals for the person.
(9)
Comprehensive medical rehabilitation hospital--A general
hospital that specializes in providing comprehensive medical rehabilitation
services, including surgery and related ancillary services.
(10)
Comprehensive medical rehabilitation unit--An identifiable
part of a hospital which provides comprehensive medical rehabilitation services
to patients admitted to the unit.
(11)
Cooperative agreement--An agreement among two or more
hospitals for the allocation or sharing of health care equipment, facilities,
personnel, or services.
(12)
Dentist--A person licensed to practice dentistry by the
Texas State Board of Dental Examiners. This includes a doctor of dental surgery
or a doctor of dental medicine.
(13)
Department--The Department of State Health Services, 1100
West 49th Street, Austin, Texas 78756-3199.
(14)
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.
(15)
Director--The hospital licensing director, Department
of State Health Services.
(16)
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:
(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.
(17)
General hospital--An establishment that:
(A)
offers services, facilities, and beds for use for more
than 24 hours for two or more unrelated individuals requiring diagnosis, treatment,
or care for illness, injury, deformity, abnormality, or pregnancy; and
(B)
regularly maintains, at a minimum, clinical laboratory
services, diagnostic X-ray services, treatment facilities including surgery
or obstetrical care or both, and other definitive medical or surgical treatment
of similar extent.
(18)
Governing body--The governing authority of a hospital
which is responsible for a hospital's organization, management, control, and
operation, including appointment of the medical staff; includes the owner
or partners for hospitals owned or operated by an individual or partners.
(19)
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.
(20)
Hospital--A general hospital or a special hospital.
(21)
Hospital administration--Administrative body of a hospital
headed by an individual who has the authority to represent the hospital and
who is responsible for the operation of the hospital according to the policies
and procedures of the hospital's governing body.
(22)
Inpatient--An individual admitted for an intended length
of stay of 24 hours or greater.
(23)
Inpatient services--Services provided to an individual
admitted to a hospital for an intended length of stay of 24 hours or greater.
(24)
Licensed vocational nurse (LVN)--A person who is currently
licensed under the Nursing Practice Act by the Board of Nurse Examiners for
the State of Texas as a licensed vocational nurse or who holds a valid vocational
nursing license with multi-state licensure privilege from another compact
state.
(25)
Licensee--The person or governmental unit named in the
application for issuance of a hospital license.
(26)
Medical staff--A physician or group of physicians and
a podiatrist or group of podiatrists who by action of the governing body of
a hospital are privileged to work in and use the facilities of a hospital
for or in connection with the observation, care, diagnosis, or treatment of
an individual who is, or may be, suffering from a mental or physical disease
or disorder or a physical deformity or injury.
(27)
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 disorder or disability, including persons whose mental disorders
or disabilities result from alcoholism or drug addiction.
(28)
Mental retardation--Significantly subaverage general intellectual
functioning that is concurrent with deficits in adaptive behavior and originates
during the developmental period.
(29)
Niche hospital--A hospital that:
(A)
classifies at least two-thirds of the hospital's Medicare
patients or, if data is available, all patients:
(i)
in not more than two major diagnosis-related groups; or
(ii)
in surgical diagnosis-related groups;
(B)
specializes in one or more of the following areas:
(i)
cardiac;
(ii)
orthopedics;
(iii)
surgery; or
(iv)
women's health; and
(C)
is not:
(i)
a public hospital;
(ii)
a hospital for which the majority of inpatient claims
are for major diagnosis-related groups relating to rehabilitation, psychiatry,
alcohol and drug treatment, or children or newborns; or
(iii)
a hospital with fewer than 10 claims per bed per year.
(30)
Outpatient--An individual who presents for diagnostic
or treatment services for an intended length of stay of less than 24 hours;
provided, however, that an individual who requires continued observation may
be considered as an outpatient for a period of time not to exceed a total
of 48 hours.
(31)
Outpatient services--Services provided to patients whose
medical needs can be met in less than 24 hours and are provided within the
hospital; provided, however, that services that require continued observation
may be considered as outpatient services for a period of time not to exceed
a total of 48 hours.
(32)
Owner--One of the following persons or governmental unit
which will hold or does hold a license issued under the statute in the person's
name or the person's assumed name:
(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.
(33)
Patient--An individual who presents for diagnosis or treatment.
(34)
Pediatric and adolescent hospital--A general hospital
that specializes in providing services to children and adolescents, including
surgery and related ancillary services.
(35)
Person--An individual, firm, partnership, corporation,
association, or joint stock company, and includes a receiver, trustee, assignee,
or other similar representative of those entities.
(36)
Physician--A physician licensed by the Texas Medical Board.
(37)
Physician assistant--A person licensed as a physician
assistant by the Texas State Board of Physician Assistant Examiners.
(38)
Podiatrist--A podiatrist licensed by the Texas State Board
of Podiatric Medical Examiners.
(39)
Practitioner--A health care professional licensed in the
State of Texas, other than a physician, podiatrist, or dentist. A practitioner
shall practice in a manner consistent with their underlying practice act.
(40)
Premises--A premises may be any of the following:
(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 buildings in which inpatients receive hospital services
are subject to the control and direction of the same governing body;
(ii)
all buildings in which inpatients receive hospital services
are within a 30-mile radius of the primary hospital location;
(iii)
there is integration of the organized medical staff of
each of the hospital locations to be included under the single license;
(iv)
there is a single chief executive officer for all of the
hospital locations included under the license 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 for all of the
hospital locations under the license who reports directly to the governing
body and who is responsible for all medical staff activities of the hospital;
(vi)
each hospital location to be included under the license
that is geographically separate from the other hospital locations contains
at least one nursing unit for inpatients which is staffed and maintains an
active inpatient census, unless providing only diagnostic or laboratory services,
or a combination of diagnostic or laboratory services, in the building for
hospital inpatients; and
(vii)
each hospital that is to be included in the license complies
with the emergency services standards:
(I)
for a general hospital, if the hospital provides surgery
or obstetrical care or both; or
(II)
for a special hospital, if the hospital does not provide
surgery or obstetrical care.
(41)
Presurvey conference--A conference held with department
staff and the applicant or the applicant's representative to review licensure
rules and survey documents and provide consultation prior to the on-site licensure
inspection.
(42)
Psychiatric disorder--A clinically significant behavioral
or psychological syndrome or pattern that occurs in an individual and that
is typically associated with either a painful syndrome (distress) or impairment
in one or more important areas of behavioral, psychological, or biological
function and is more than a disturbance in the relationship between the individual
and society.
(43)
Quality improvement--A method of evaluating and improving
processes of patient care which emphasizes a multidisciplinary approach to
problem solving, and focuses not on individuals, but systems of patient care
which might be the cause of variations.
(44)
Registered nurse (RN)--A person who is currently licensed
by the Board of Nurse Examiners for the State of Texas as a registered nurse
or who holds a valid registered nursing license with multi-state licensure
privilege from another compact state.
(45)
Special hospital--An establishment that:
(A)
offers services, facilities, and beds for use for more
than 24 hours for two or more unrelated individuals who are regularly admitted,
treated, and discharged and who require services more intensive than room,
board, personal services, and general nursing care;
(B)
has clinical laboratory facilities, diagnostic X-ray facilities,
treatment facilities, or other definitive medical treatment;
(C)
has a medical staff in regular attendance; and
(D)
maintains records of the clinical work performed for each
patient.
(46)
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.
(47)
Transfer--The movement (including the discharge) of an
individual outside a hospital's facilities at the direction of any person
employed by (or affiliated or associated, directly or indirectly, with) the
hospital, 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.
(48)
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 and Prevention (CDC) of the Department
of Health and Human Services. 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 hospitals.
(49)
Violation--Failure to comply with the licensing statute,
a rule or standard, special license provision, or an order issued by the commissioner
of state health services (commissioner) 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.
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 December 1, 2006.
TRD-200606442
Cathy Campbell
General Counsel
Department of State Health Services
Proposed date of adoption: February 13, 2007
For further information, please call: (512) 458-7111 x6972
25 TAC §§133.21 - 133.26
(Editor's note: The text of the following sections proposed for
repeal will not be published. The sections may be examined in the offices
of the Department of State Health Services or in the Texas Register office,
Room 245, James Earl Rudder Building, 1019 Brazos Street, Austin.)
STATUTORY AUTHORITY
The proposed repeals are authorized by Health and Safety Code, §241.026,
which requires the department to develop, establish, and enforce standards
for the construction, maintenance, and operation of hospitals; and Government
Code, §531.0055(e), and Health and Safety Code, §1001.075, which
authorize the Executive Commissioner of the Health and Human Services Commission
to adopt rules and policies necessary for the operation and provision of health
and human services by the department and for the administration of Health
and Safety Code, Chapter 1001.
The proposed repeals affect the Health and Safety Code, Chapters 161, 241,
256, 322 and 1001; Government Code, Chapter 2001; and Occupations Code, Chapters
162, 164 and 301. Review of the sections implements Government Code, §2001.039.
§133.21.General.
§133.22.Application and Issuance of Initial License.
§133.23.Application and Issuance of Renewal License.
§133.24.Change of Ownership.
§133.25.Time Periods for Processing and Issuing Hospital Licenses.
§133.26.Fees.
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 December 1, 2006.
TRD-200606443
Cathy Campbell
General Counsel
Department of State Health Services
Proposed date of adoption: February 13, 2007
For further information, please call: (512) 458-7111 x6972
25 TAC §§133.21 - 133.26
STATUTORY AUTHORITY
The proposed new sections are authorized by Health and Safety Code, §241.026,
which requires the department to develop, establish, and enforce standards
for the construction, maintenance, and operation of hospitals; and Government
Code, §531.0055(e), and Health and Safety Code, §1001.075, which
authorize the Executive Commissioner of the Health and Human Services Commission
to adopt rules and policies necessary for the operation and provision of health
and human services by the department and for the administration of Health
and Safety Code, Chapter 1001.
The proposed new sections affect the Health and Safety Code, Chapters 161,
241, 256, 322 and 1001; Government Code, Chapter 2001; and Occupations Code,
Chapters 162, 164 and 301. Review of the sections implements Government Code, §2001.039.
§133.21.General.
(a)
License required.
(1)
A hospital shall obtain a license prior to admitting patients.
(2)
Upon written request, the Department of State Health Services
(department) shall furnish a person with an application for a hospital license.
(3)
The license application shall be submitted in accordance
with §133.22 of this title (relating to Application and Issuance of Initial
License). The applicant shall retain copies of all application documents submitted
to the department.
(b)
Compliance. A hospital shall comply with the provisions
of the Act and this chapter during the licensing period.
(c)
Scope of hospital license.
(1)
A hospital license is issued for the premises and person
or governmental unit named in the application.
(2)
A hospital license shall not include off-site outpatient
facilities.
(3)
Multiple hospitals may share one building.
(A)
Each hospital shall be licensed separately.
(B)
No part of the building may be dually licensed by more
than one hospital; and
(C)
Each hospital in the building shall comply with the requirements
of §133.165 of this title (relating to Building with Multiple Occupancies).
(4)
Multiple hospitals may be licensed under one license provided
the following conditions are met.
(A)
The hospitals must comply with the requirements for multiple
hospitals under a single license as specified under §133.2(40) of this
title (relating to Definitions).
(B)
Each hospital location under the hospital license must:
(i)
provide emergency services in compliance with §133.41(e)
of this title (relating to Hospital Functions and Services); and
(ii)
meet the requirements as an existing hospital in accordance
with §133.161 of this title (relating to Requirements for Buildings in
Which Existing Licensed Hospitals are Located) as determined by the department;
or
(iii)
meet the requirements of a new hospital in accordance
with §133.162 of this title (relating to New Construction Requirements)
as determined by the department.
(C)
The administration of the primary hospital location must
submit to the department the following:
(i)
a complete and accurate multiple-location application;
(ii)
a licensing fee for the number of design beds at the multiple-location
hospital in accordance with §133.26(b) of this title (relating to Fees);
(iii)
a copy of a hospital fire safety survey of the multiple-location
hospital indicating approval by the local fire authority in whose jurisdiction
the hospital is based that is dated no earlier than one year prior to the
multiple-location application; and
(iv)
if the main hospital is accredited by a Centers for Medicare
and Medicaid Services-approved organization, a letter extending the accreditation
of the main hospital to the multiple location.
(D)
If a change of ownership is concurrent with the request
for a hospital to become a multiple location of another, the department will
require the new owners to submit the documents in subparagraph (C) of this
paragraph and a signed copy of the bill of sale or lease agreement that reflects
the effective date of the sale or lease. No change of ownership application
will be required.
(5)
A hospital license and an ambulatory surgical center license
shall not be issued for the same premises.
(d)
Display. A hospital shall prominently and conspicuously
display the hospital license in a public area of the licensed premises that
is readily visible to patients, employees, and visitors.
(e)
Alteration. A hospital license shall not be altered.
(f)
Transfer or assignment prohibited. A hospital license shall
not be transferred or assigned. The hospital shall comply with the provisions
of §133.24 of this title (relating to Change of Ownership) in the event
of a change in the ownership of a hospital.
(g)
Changes which affect the license.
(1)
A hospital shall notify the department in writing prior
to the occurrence of any of the following:
(A)
addition or deletion of those services indicated on the
license application;
(B)
changes in design bed capacity as the phrase is used in §133.26(b)(1)(A)
- (C) of this title;
(C)
request to change license classification; and
(D)
any construction, renovation, or modification of the hospital
buildings.
(2)
A hospital shall notify the department in writing at the
time of the occurrence of any of the following:
(A)
cessation of operation of the hospital. The hospital shall
include in the written notice the location where the medical records will
be stored and the identity and telephone number of the custodian of the medical
records;
(B)
change in certification or accreditation status;
(C)
change in hospital name, telephone number or administrator;
and
(D)
change in the emergency contact name and phone number.
§133.22.Application and Issuance of Initial License.
(a)
Application submittal. The applicant shall submit the following
documents to the Department of State Health Services (department) no earlier
than 60 calendar days prior to the projected opening date of the hospital:
(1)
an accurate and complete application form;
(2)
a copy of the hospital's patient transfer policy which
is developed in accordance with §133.44 of this title (relating to Hospital
Patient Transfer Policy) and is signed by both the chairman and secretary
of the governing body attesting to the date the policy was adopted by the
governing body and the effective date of the policy;
(3)
a copy of the hospital's memorandum of transfer form which
contains at a minimum the information described in §133.44(c)(10)(B)
of this title;
(4)
if the application is for a special hospital license, a
copy of a written agreement the special hospital has entered into with a general
hospital which provides for the prompt transfer to and the admission by the
general hospital of any patient when special services are needed but are unavailable
at the special hospital. This agreement is required and is separate from any
voluntary patient transfer agreements the hospital may enter into in accordance
with §133.61 of this title (relating to Hospital Patient Transfer Agreements);
(5)
copies of any patient transfer agreements entered into
between the hospital and another hospital in accordance with §133.61
of this title;
(6)
for existing facilities, a copy of a hospital fire safety
survey indicating approval by the local fire authority in whose jurisdiction
the hospital is based that is dated no earlier than one year prior to the
hospital opening date. For new construction, addition, and renovation projects,
written approval by the local building department and local fire authority
shall be submitted during the final construction inspection by the department;
(7)
the appropriate license fee as required in §133.26
of this title (relating to Fees); and
(8)
the following ownership information:
(A)
the name and social security number of the sole proprietor,
if the applicant is a sole proprietor;
(B)
the name and social security number of each general partner
who is an individual, if the applicant is a partnership;
(C)
the name and social security number of any individual who
has an ownership interest of more than 25% in the corporation, if the applicant
is a corporation; and
(D)
if the applicant is a niche hospital, the names and license
numbers of any physicians licensed by the Texas Medical Board who have a financial
interest in the applicant or any entity which has an ownership interest in
the applicant.
(b)
Additional documentation for new hospitals or conversions
from non-hospital buildings. In addition to the document submittal requirements
in subsection (a) of this section, the following shall be completed prior
to the issuance of a hospital license to newly constructed hospitals or hospitals
from conversions of non-hospital buildings.
(1)
Final construction documents shall be reviewed and approved
by the department in accordance with §133.167 of this title (relating
to Preparation, Submittal, Review and Approval of Plans, and Retention of
Records).
(2)
For new construction, necessary intermediate inspections
and final construction inspections shall be conducted by the department in
accordance with §133.168(b) of this title (relating to Construction,
Inspections, and Approval of Project) to determine that the hospital was constructed
or remodeled in accordance with this chapter.
(3)
When an applicant intends to reopen and relicense a building
formerly licensed as a hospital, an on-site inspection shall be conducted
by the department in accordance with §133.168 of this title to determine
compliance with applicable construction and fire safety requirements.
(4)
All plan review and construction inspection fees shall
be paid to the department.
(5)
A certificate of occupancy approved by the local fire authority,
and issued by the city building inspector, if applicable, shall be obtained
and a copy submitted to the department.
(6)
A complete and accurate Final Construction Approval form
shall be submitted to the department.
(c)
Presurvey conference. The applicant or the applicant's
representative shall attend a presurvey conference at the office designated
by the department. The designated survey office may waive the presurvey conference
requirement.
(d)
Issuance of license. When it is determined that the hospital
has complied with subsections (a) - (c) of this section, the department shall
issue the license to the applicant.
(1)
Effective date. The license shall be effective on the date
the hospital is determined to be in compliance with subsections (a) - (c)
of this section. The effective date shall not be prior to the date of the
final construction inspection conducted by the department.
(2)
Expiration date.
(A)
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.
(B)
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)
Withdrawal of application. If an applicant decides not
to continue the application process for a license or renewal of a license,
the application may be withdrawn. If a license has been issued, the applicant
shall return the license to the department with its written request to withdraw.
The department shall acknowledge receipt of the request to withdraw.
(f)
Denial of a license. Denial of a license shall be governed
by §133.121 of this title (relating to Enforcement Action).
(g)
Inspection. During the licensing period, the department
shall conduct an inspection of the hospital to ascertain compliance with the
provisions of the Act and this chapter.
(1)
If a hospital has applied to participate in the federal
Medicare program, the inspection may be conducted in conjunction with the
inspection to determine compliance with 42 Code of Federal Regulations, Part
482 (relating to Conditions of Participation for Hospitals).
(2)
A hospital shall have admitted and be providing services
to at least one inpatient in the hospital at the time of the inspection.
§133.23.Application and Issuance of Renewal License.
(a)
Renewal notice. The Department of State Health Services
(department) shall send a renewal notice to a hospital at least 60 calendar
days before the expiration date of a license.
(1)
If the hospital has not received the renewal notice from
the department within 45 calendar days prior to the expiration date, it is
the duty of the hospital to notify the department and request a renewal application
for a license.
(2)
If the hospital fails to submit the application and fee
within 15 calendar days prior to the expiration date of the license, the department
shall send by certified mail to the hospital a letter advising that unless
the license is renewed, the hospital must cease operations upon the expiration
of the hospital's license.
(b)
Renewal license. The department shall issue a renewal license
to a hospital which meets the minimum requirements for a license.
(1)
The hospital shall submit the following to the department
prior to the expiration date of the license:
(A)
a complete and accurate application form;
(B)
a copy of a hospital fire safety survey indicating approval
by the local fire authority in whose jurisdiction the hospital is based that
is dated no earlier than one year prior to the application date;
(C)
the renewal license fee;
(D)
if the applicant is accredited by a Centers for Medicare
and Medicaid Services-approved organization, a copy of documentation from
the accrediting body showing the current accreditation status of the hospital;
and
(E)
the following ownership information:
(i)
the name and social security number of the sole proprietor,
if the applicant is a sole proprietor;
(ii)
the name and social security number of each partner who
is an individual, if the applicant is a partnership;
(iii)
the name and social security number of any individual
who has an ownership interest of more than 25% in the corporation, if the
applicant is a corporation; and
(iv)
if the applicant is a niche hospital, the names and license
numbers of any physicians licensed by the Texas Medical Board who have a financial
interest in the applicant or any entity which has an ownership interest in
the applicant.
(2)
The department may conduct an inspection prior to issuing
a renewal license in accordance with §133.101 of this title (relating
to Inspection and Investigation Procedures).
(3)
Renewal licenses will be valid for 24 months.
(c)
Notice to cease operation and return license. If a hospital
fails to submit the application, documents, and fee by the expiration date
of the hospital's license, the department shall notify the hospital by certified
mail that it must cease operation and immediately return the license by certified
mail to the department. If the hospital wishes to provide services after the
expiration date of the license, it shall apply for a license under §133.22
of this title (relating to Application and Issuance of Initial License).
§133.24.Change of Ownership.
(a)
Change of ownership defined. A change of ownership of a
hospital occurs when there is a change in the person legally responsible for
the operation of the hospital, whether by lease or by ownership.
(1)
If a corporate licensee amends its articles of incorporation
to revise its name and the tax identification number does not change, this
subsection does not apply, except that the corporation must notify the department
within 10 calendar days after the effective date of the name change.
(2)
The sale of stock of a corporate licensee does not cause
this subsection to apply.
(b)
License application required. The new owner shall submit
an application for an initial license to the Department of State Health Services
(department) prior to the date of the change of ownership or not later than
10 calendar days following the date of a change of ownership. The application
shall be in accordance with §133.22 of this title (relating to the Application
and Issuance of Initial License) except that the applicant need not submit
any transfer agreements previously approved by the department and the current
applicant has affirmatively indicated it has adopted the transfer agreement.
In addition to the documents required in §133.22 of this title, the applicant
shall include a copy of the signed bill of sale or lease agreement that reflects
the effective date of the sale or lease.
(c)
Inspections. The on-site construction and health inspections
required by §133.22 of this title may be waived by the department.
(d)
Issuance of license. When the new owner has complied with
the provisions of §133.22 of this title, the department shall issue a
license which shall be effective the date of the change of ownership.
(e)
Expiration of license. The expiration date of the license
shall be in accordance with §133.22(d)(2) of this title.
(f)
License void. The previous owner's license shall be void
on the effective date of the new owner's license.
§133.25.Time Periods for Processing and Issuing Hospital Licenses.
(a)
General.
(1)
The receipt date for an application for an initial license
or a renewal license is the date the application is received by the Facility
Licensing Group, Department of State Health Services (department).
(2)
An application for an initial license is complete when
the department has received, reviewed, and found acceptable the information
described in §133.22(a) - (b) of this title (relating to Application
and Issuance of Initial License).
(3)
An application for a renewal license is complete when the
department has received, reviewed, and found acceptable the information described
in §133.23(b) of this title (relating to Application and Issuance of
Renewal License).
(b)
Time periods. An application for a hospital initial license
or renewal license shall be processed in accordance with the following time
periods.
(1)
The first time period begins on the date the department
receives the application and ends on the date the hospital license is issued,
or, if the application is received incomplete, the period ends on the date
the hospital is issued a written notice that the application is incomplete.
The written notice shall describe the specific information that is required
before the application is considered complete. The first time period is 20
working days.
(2)
The second time period begins on the date the department
receives the last item necessary to complete the application and ends on the
date the hospital license is issued. The second time period is 20 working
days.
(c)
Reimbursement of fees.
(1)
In the event the application is not processed in the time
periods as stated in subsection (b) of this section, the applicant has the
right to request the department to reimburse in full the fee paid in that
particular application process. If the department does not agree that the
established periods have been violated or finds that good cause existed for
exceeding the established periods, the request shall be denied.
(2)
Good cause for exceeding the period established is considered
to exist if:
(A)
the number of applications for licenses to be processed
exceeds by 15% or more the number processed in the same calendar quarter the
preceding year;
(B)
another public or private entity utilized in the application
process caused the delay; or
(C)
other conditions existed which gave good cause for exceeding
the established periods.
(d)
Appeal. If the request for full reimbursement authorized
by subsection (c) of this section is denied, the applicant may then appeal
to the commissioner of state health services (commissioner) for a resolution
of the dispute. The applicant shall give written notice to the commissioner
requesting full reimbursement of all filing fees paid because the application
was not processed within the adopted time period. The department shall submit
a written report of the facts related to the processing of the application
and good cause for exceeding the established time periods. The commissioner
shall make the final decision and provide written notification of the decision
to the applicant and the department.
§133.26.Fees.
(a)
General.
(1)
All fees paid to the Department of State Health Services
(department) are nonrefundable with the exception of inspection fees for inspections
that were not conducted.
(2)
All fees shall be paid by check or money order made payable
to the Department of State Health Services.
(b)
License fees.
(1)
The fee for an initial license or a renewal license is
$39 per bed based upon the design bed capacity of the hospital. The design
bed capacity of a hospital is determined as follows.
(A)
The design bed capacity is the maximum number of patient
beds that a hospital can accommodate in rooms that comply with the requirements
for patient room suites in §133.163 of this title (relating to Spatial
Requirements for New Construction) including beds, bassinets or cribs in critical
care units (including neonatal nurseries), continuing care nursery beds, hospital-based
skilled nursing units, medical nursing units, mental health and chemical dependency
nursing units, pediatric and adolescent nursing units, obstetrical suites
(including labor/delivery/recovery/postpartum (LDRP) beds), intermediate care
beds, universal care beds, antepartum beds and postpartum beds. The design
bed capacity does not include labor/delivery/recovery (LDR) beds, newborn
nursery bassinets, or recovery beds.
(B)
The maximum design bed capacity includes beds that comply
with the requirements in §133.163 of this title even if the beds are
unoccupied or the space is used for other purposes such as offices or storage
rooms, provided such rooms can readily be returned to patient use. All required
support and service areas must be maintained in place. For example, the removal
of a nurse station in an unused patient bedroom wing of 20 beds would effectively
eliminate those 20 beds from the design capacity. Eliminating access to the
medical gas outlets and nurse call would also remove bed(s) from the design
capacity.
(C)
The number of licensed beds in a multiple-occupancy room
shall be determined by the design even if the number of beds actually placed
in the room is less than the design capacity.
(2)
A hospital shall submit a license fee for each design bed
added as a result of adding a multiple-location hospital to its license. The
fee is $39 per bed, regardless of the number of months remaining in the license
period.
(3)
A hospital shall submit an additional license fee with
the Final Construction Approval form for each new design bed resulting from
an approved construction project. The fee is $39 per bed, regardless of the
number of months remaining in the license period. The hospital shall also
submit an additional plan review fee if the construction cost increases to
the next higher fee schedule according to subsection (c)(4) of this section.
(4)
A hospital will not receive a refund of previously submitted
fees should the hospital's design capacity decrease as a result of an approved
construction project.
(c)
Plan review fees. This subsection outlines the fees which
must accompany the application for plan review and all proposed plans and
specifications covering the construction of new buildings or alterations to
existing buildings which must be submitted for review and approval by the
department in accordance with §133.167 of this title (relating to Preparation,
Submittal, Review and Approval of Plans, and Retention of Records).
(1)
Construction plans will not be reviewed or approved until
the required fee and an application for plan review are received by the department.
(2)
Plan review fees are based upon the estimated construction
project costs which are the total expenditures required for a proposed project
from initiation to completion, including at least the following items.
(A)
Construction project costs shall include expenditures for
physical assets such as:
(i)
site acquisition;
(ii)
soil tests and site preparation;
(iii)
construction and improvements required as a result of
the project;
(iv)
building, structure, or office space acquisition;
(v)
renovation;
(vi)
fixed equipment; and
(vii)
energy provisions and alternatives.
(B)
Construction project costs shall include expenditures for
professional services including:
(i)
planning consultants;
(ii)
architectural fees;
(iii)
fees for cost estimation;
(iv)
legal fees;
(v)
management fees; and
(vi)
feasibility study.
(C)
Construction project costs shall include expenditures or
costs associated with financing, excluding long-term interest, but including:
(i)
financial advisor;
(ii)
fund-raising expenses;
(iii)
lender's or investment banker's fee; and
(iv)
interest on interim financing.
(D)
Construction project costs shall include expenditure allowances
for contingencies including:
(i)
inflation;
(ii)
inaccurate estimates;
(iii)
unforeseen fluctuations in the money market; and
(iv)
other unforeseen expenditures.
(3)
Regarding purchases, donations, gifts, transfers, and other
comparable arrangements whereby the acquisition is to be made for no consideration
or at less than the fair market value, the project cost shall be determined
by the fair market value of the item to be acquired as a result of the purchase,
donation, gift, transfer, or other comparable arrangement.
(4)
The plan review fee schedule based on cost of construction
is:
(A)
$100,000 or less--$300;
(B)
$100,001 to $600,000--$850;
(C)
$600,001 to $2,000,000--$2,000;
(D)
$2,000,001 to $5,000,000--$3,000;
(E)
$5,000,001 to $10,000,000--$4,000; and
(F)
$10,000,001 and over--$5,000.
(5)
If an estimated construction cost cannot be established,
the estimated cost shall be based on $225 per square foot. No construction
project shall be increased in size, scope, or cost unless the appropriate
fees are submitted with the proposed changes.
(d)
Construction inspection fees. A fee of $500 and an application
for construction inspection for each inspection shall be submitted to the
department at least three weeks prior to the anticipated inspection date.
Construction inspections will not be conducted until all required fees are
received by the department. If additional construction inspections of the
proposed project are requested by the hospital, the appropriate additional
fees shall be submitted prior to any inspections conducted by the staff of
the department. When follow-up construction inspections are performed to verify
plans of correction, the fee shall be submitted upon completion of the inspection.
(e)
Cooperative agreement application fee. The application
fee for a cooperative agreement is $10,000. The application fee shall be submitted
with an application for a cooperative agreement and other documents in accordance
with §133.62 of this title (relating to Cooperative Agreements).
(f)
Subscription and convenience fee. The department is authorized
to collect subscription and convenience fees, in amounts determined by the
TexasOnline Authority, to recover costs associated with application and renewal
application processing through TexasOnline, in accordance with Texas Government
Code, §2054.111.
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 December 1, 2006.
TRD-200606444
Cathy Campbell
General Counsel
Department of State Health Services
Proposed date of adoption: February 13, 2007
For further information, please call: (512) 458-7111 x6972
Subchapter B. HOSPITAL LICENSE
Subchapter C. OPERATIONAL REQUIREMENTS