Part 1.
TEXAS DEPARTMENT OF HEALTH
Chapter 133.
HOSPITAL LICENSING
(Editor's Note: The Texas Department of Health adopted amendments
to 25 TAC Chapter 133 in the March 26, 2004, issue of the Texas Register (29
TexReg 3195 - 3205). In the print version of the Texas Register, pages 3196
and 3202 were inadvertently replaced with pages 3296 and 3302 and omitted
from the issue. We are republishing the rule adoption notice for 25 TAC Chapter
133 in its entirety.)
The Texas Department of Health (department) adopts amendments
to §§133.2, 133.22, 133.23, 133.26, 133.45, 133.101, 133.121, 133.141
- 133.143 and 133.161 - 133.167, and new §133.48, concerning the regulation
of hospitals. Sections 133.2, 133.22, 133.23, 133.48 and 133.101 are adopted
with changes to the proposed text as published in the November 21, 2003, issue
of the
Texas Register
(28 TexReg 10381). Sections
133.26, 133.45, 133.121, 133.141 - 133.143 and 133.161 - 133.167 are adopted
without changes and, therefore, the sections will not be republished.
The amendments and new section in Subchapters A - C, F, and G are required
as a result of revisions and additions to sections of the Health and Safety
Code. House Bill (HB) 2292, 78th legislature, 2003, revised Health and Safety
Code, §§12.0111 and 12.0112, and requires two-year licenses effective
January 1, 2005; HB 341, 78th legislature, 2003, added Health and Safety Code, §§161.451
and 161.452, and requires parenting and postpartum counseling information
to be provided to patients; and Senate Bill 162, 78th legislature, 2003, which
amended Health and Safety Code, §241.053, and added probation to the
list of enforcement actions that can be taken against a facility; HB 15, 78th
legislature, 2003, added Health and Safety Code, Chapter 171, and requires
information and consent forms to be provided to abortion patients; HB 1614,
78th legislature, 2003, amended Health and Safety Code, Chapter 241, by adding
Subchapter H, which establishes a patient safety program. The amendments to
Subchapters H and I are necessary to make the rules compatible with the requirements
of the federal Medicare Conditions of Participation, and will eliminate burdensome
requirements concerning operable windows.
Specifically, the amendment to §133.2 includes additional definitions
for action plan, adverse event, medical error, reportable event, and root
cause analysis. Amendments to §§133.22 and 133.23 implement the
process for converting to two-year licensing cycles beginning January 1, 2005.
The amendment to §133.26 changes the description of fee assessment to
accommodate the change to the two-year license cycle. The amendment to §133.45
requires a hospital which provides obstetrical services on a routine or emergency
basis to adopt a policy concerning postpartum counseling and parental assistance,
and requires a hospital that performs abortions to adopt a policy concerning
informed consent for abortion. New §133.48 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 §133.101
clarifies limitations on the department's access related to a root analysis
and action plan. The amendment to §133.121 reflects the addition of probation
to the list of enforcement actions that can be taken against a facility. Amendments
to §§133.141 - 133.143 and 133.161 - 133.167 change all references
to compliance with National Fire Protection Association, Code for Safety to
Life from Fire in Buildings and Structures, (NFPA 101), from the 1997 edition
to the 2000 edition; update the editions of other codes referenced in NFPA
101 to those required by the 2000 edition; change chapter and section numbers
referenced in the 1997 edition to the new chapter and section numbers in the
2000 edition; and eliminate the requirement for operable windows in patient
sleeping rooms, a burdensome requirement which has resulted in numerous requests
to the department for waiver of the requirement. Operable windows are not
required in the 2000 edition of NFPA 101.
The following comments were received concerning the proposed sections.
Following each comment is the department's response and any resulting change(s).
Comment: Concerning the rules in general, one commenter requested that
the department add a definition for "legal custody", and recommended content
for that definition. The commenter stated that questions had arisen regarding
who has "legal custody" of a newborn, and whether proof of legal custody would
be required through a court document before the newborn could be released.
The commenter believed this would create an unworkable standard for the parent
or legal guardian, and felt that including a definition in the rules would
clarify what was required.
Response: The department disagrees. The legislature used the term "legal
custody" in the legislation, and chose not to include any clarifying definition
of that term. The term is legally defined as "lawfully in possession; guardianship
by authority of a legal process." The department is not requiring that the
parent or legal guardian obtain official court documentation in every instance
before a newborn could be released to someone other than the parent or guardian.
The language in the statute and the rule clearly states that the hospital
is expected to exercise ordinary care in releasing a newborn to anyone other
than the parent or legal guardian. The hospital must determine what documentation
they will require and under what circumstances a newborn would be released
to anyone other than the parent or legal guardian. No change was made as a
result of this comment.
Comment: Concerning §133.2(4), one commenter was opposed to scope
of the definition of "adverse event" in the proposed rule, and recommended
that the department adopt the Institute of Medicine's definition of that term.
Response: The department agrees. Since the Institute of Medicine is a nationally
recognized authority on health care quality and patient safety, it is appropriate
to use their definition of the term "adverse event". The rule has been changed
to include the definition found in the Institute of Medicine's 2004 publication
entitled Patient Safety: Achieving a New Standard of Care.
Comment: Concerning §133.2(36), one commenter requested that the department
consider changing the definition of "medical error" to be consistent with
the definition used by the Institute of Medicine.
Response: The department agrees. Since the Institute of Medicine is a nationally
recognized authority on health care quality and patient safety, it is appropriate
to use their definition of the term "medical error". The rule has been changed
to include the definition found in the Institute of Medicine's 2004 publication
entitled Patient Safety: Achieving a New Standard of Care.
Comment: Concerning §133.48(a)(1)(B)(ii)-(iv), one commenter asked
that the department clarify that these reporting requirements applied only
to the hospitals internal reporting systems, and not to any external reporting
requirements.
Response: Although §133.48(a)(1)(B)(ii)-(iv) as proposed did not place
any external reporting requirements on the hospital, the department agreed
to include the revised language in §133.48(a)(1)(B)(ii)-(iv) to provide
the additional clarification requested by the commenter.
Comment: Concerning §133.48(a)(1)(B)(vi), one commenter stated that
the requirement that hospitals have in place a support system for staff members
who were involved in medical errors would be unduly burdensome for small and
rural facilities.
Response: The rationale for including this requirement in the proposed
rule was based on the recommendations of nationally recognized patient safety
organizations who emphasize that a patient safety program can only be successful
if it is presented in a non-punitive manner and with an organizational commitment
to providing support to those who voluntary report medical errors. However,
the department agrees that making this support system mandatory could be burdensome
on some facilities, therefore, the requirement has been deleted in §133.48(a)(1)(B)(vi)
and the subsequent clauses renumbered. Hospitals are encouraged to voluntarily
provide a support system for staff who are involved in a medical error.
Comment: Concerning §133.48(a)(1)(B)(xi), two commenters requested
that the proposed rule requiring that hospitals include a process for educating
patients regarding their shared responsibility for patient safety be deleted,
as the language was vague and it would be unduly burdensome to educate patients.
Response: The rationale for including this requirement in the proposed
rule was based on the Institute of Medicine's recommendation that health care
organizations implement polices designed to assist patients and their families
in understanding their roles in assuring the safety of patients while they
are in the hospital. However, the department understands that some hospitals
may find compliance with this requirement excessively burdensome, therefore
the requirement has been deleted from the final rule. Hospitals are strongly
encouraged to voluntarily include patient safety issues in their patient education
activities. Clause (xi) was deleted from subsection §133.48(a)(1)(B).
Comment: Concerning §133.48(a)(2), one commenter stated that, although
training of certain personnel could be inferred to be a reasonable component
of a hospital's patient safety program, the requirement to provide patient
safety education and training to all clinical and administrative staff was
excessive. The commenter believed it was not necessary to extend this requirement
to administrative staff, and recommended that rule be revised to reflect that
the training was required only for those staff directly involved with the
patient safety program.
Response: The department agrees, and has revised §133.48(a)(2) to
reflect this change.
Comment: Concerning §133.48(a)(3), one commenter stated that the proposed
rule requiring that the hospital designate an individual to serve as the Patient
Safety Program Coordinator could create an unworkable standard in many institutions.
The commenter recommended that the rule be revised to allow more than one
individual, or an interdisciplinary group, to be designated as responsible
for the management of patient safety program.
Response: The department agrees, and has revised §133.48(a)(3) to
reflect this change as well as grammatical changes to the subparagraphs of
the paragraph.
Comment: Concerning §133.48(b), a commenter stated that the proposed
rule which would require a hospital to report a best practice and safety measure
for each type of reported event was not required by the legislation. It was
the commenter's opinion that the legislation only required that hospitals
submit one best practices report for a reported event, even if multiple types
of reportable events were identified in the reporting year.
Response: Although the department believes that the legislation, as written,
can be interpreted to mean that a best practice report should be submitted
for each type of reported occurrence, the author of the legislation has clarified
that the intent was only to require submission of one best practice report
for each facility, not for each type of reported occurrence. The department
believes this interpretation can also be considered consistent with the legislation,
therefore the rule has been revised to reflect this change to paragraphs (1)(A)
and (2)(A) of the subsection.
Comment: Concerning §133.48(b)(2)(A), a commenter requested that the
rule be clarified to indicate the if a facility had no adverse events or occurrences
to report, then no best practice reports would be required.
Response: The department disagrees. The rule clearly states that the required
submission of a best practice and safety measure report is related to a reported
occurrence. No change was made to the rule as a result of this comment.
The department is making the following minor changes due to staff comments
to clarify the intent and improve the accuracy of the sections.
Change: Concerning §133.2(19), the definition of director was changed
to reflect the correct title of the division, Health Facility Licensing and
Compliance Division.
Change: Concerning §133.2(21), the definition of division was changed
to reflect the correct name of the division, Health Facility Licensing and
Compliance Division.
Change: Concerning §133.22(e)(2)(B), a comma was added after the date
to be consistent with the punctuation following dates throughout the chapter.
Change: Concerning §133.23(b)(1)(E), the change from "and;" to ";
and" in the subparagraph corrects the formatting in proposed.
Change: Concerning §133.48(a)(1)(B)(ix), the word "causeanalysis"
was corrected to "cause analysis."
Change: Concerning §133.101(d)(1), the word "section" was deleted
before "§133.48" to be consistent.
The commenters were the Texas Hospital Association and the Texas Scottish
Rite Hospital for Children. The commenters were neither for nor against the
rules in their entirety; however, they expressed concerns and made recommendations
for change as discussed in the summary of comments.
Subchapter A. GENERAL PROVISIONS
25 TAC §133.2
The amendment is adopted under Health and Safety Code, §241.026,
concerning rules and minimum standards to protect and promote the public health
and welfare by providing for the development, establishment, and enforcement
of standards in the construction, maintenance, and operation of hospitals
in Texas; 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 commissioner
of health.
§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)
Advance directive--Written instructions recognized under
state law relating to the provision of health care when individuals are unable
to communicate their wishes regarding medical treatment. The advance directive
may be a written document authorizing an agent or surrogate to make decisions
on an individual's behalf (a durable power of attorney for health care), a
written or oral statement (a living will), or some other form of instruction
recognized under state law specifically addressing the provisions of health
care.
(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)
Attorney general--The attorney general of Texas or any
assistant attorney general acting under the direction of the attorney general
of Texas.
(7)
Biological indicator--Commercially-available microorganisms
(e.g., United States Food and Drug Administration (FDA) approved strips or
vials of Bacillus species endospores) which can be used to verify the performance
of waste treatment equipment and processes (or sterilization equipment and
processes).
(8)
Board--The Texas Board of Health.
(9)
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.
(10)
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.
(11)
Comprehensive medical rehabilitation hospital--A general
hospital that specializes in providing comprehensive medical rehabilitation
services, including surgery and related ancillary services.
(12)
Comprehensive medical rehabilitation unit--An identifiable
part of a hospital which provides comprehensive medical rehabilitation services
to patients admitted to the unit.
(13)
Contaminated linen--Linen which has been soiled with blood
or other potentially infectious materials or may contain sharps. Other potentially
infectious materials means:
(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.
(14)
Cooperative agreement--An agreement among two or more
hospitals for the allocation or sharing of health care equipment, facilities,
personnel, or services.
(15)
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.
(16)
Department--The Texas Department of Health, 1100 West
49th Street, Austin, Texas 78756-3199.
(17)
Designated provider--A provider of health care services,
selected by a health maintenance organization, a self-insured business corporation,
a beneficial society, the Veterans Administration, CHAMPUS, a business corporation,
an employee organization, a county, a public hospital, a hospital district,
or any other entity to provide health care services to a patient with whom
the entity has a contractual, statutory, or regulatory relationship that creates
an obligation for the entity to provide the services to the patient.
(18)
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.
(19)
Director--The hospital licensing director, Health Facility
Licensing and Compliance Division, Texas Department of Health.
(20)
Disciplinary action--Denial, suspension, or revocation
of a license, issuance of an emergency order or imposition of an administrative
penalty.
(21)
Division--The Health Facility Licensing and Compliance
Division, Texas Department of Health.
(22)
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.
(23)
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.
(24)
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.
(25)
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.
(26)
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.
(27)
Hospital--A general hospital or a special hospital.
(28)
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.
(29)
Illegal conduct--A conduct prohibited by federal or state
law.
(30)
Inpatient--An individual admitted for an intended length
of stay of 24 hours or greater.
(31)
Inpatient services--Services provided to an individual
admitted to a hospital for an intended length of stay of 24 hours or greater.
(32)
Legally reproduced form--A medical record retained in
hard copy, microform (microfilm or microfiche), or other electronic medium.
(33)
Licensed vocational nurse--A person who is currently licensed
under the Vocational Nurse Act by the Board of Vocational Nurse Examiners
for the State of Texas as a licensed vocational nurse (LVN).
(34)
Licensee--The person or governmental unit named in the
application for issuance of a hospital license.
(35)
Mandated provider--A person who provides health care services,
is selected by a county, public hospital, or hospital district, and agrees
to provide health care services to eligible residents.
(36)
Medical error--The failure of a planned action to be completed
as intended, the use of a wrong plan to achieve an aim, or the failure of
an unplanned action that should have been completed, that results in an adverse
event.
(37)
Medical staff--A physician or group of physicians or 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 mental or physical disease
or disorder, or a physical deformity or injury.
(38)
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.
(39)
Mental retardation--Significantly subaverage general intellectual
functioning that is concurrent with deficits in adaptive behavior and originates
during the developmental period.
(40)
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.
(41)
Outpatient--An individual who presents for diagnostic
or treatment services for an intended length of stay of less than 24 hours.
(42)
Outpatient services--Services provided to patients whose
medical needs can be met in less than 24 hours and are provided within the
hospital.
(43)
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.
(44)
Patient--An individual who presents for diagnosis or treatment.
(45)
Pediatric and adolescent hospital--A general hospital
that specializes in providing services to children and adolescents, including
surgery and related ancillary services.
(46)
Person--An individual, firm, partnership, corporation,
association, or joint stock company, and includes a receiver, trustee, assignee,
or other similar representative of those entities.
(47)
Physician--A physician licensed by the Texas State Board
of Medical Examiners.
(48)
Podiatrist--A podiatrist licensed by the Texas State Board
of Podiatry Examiners.
(49)
Practitioner--A health care professional licensed in the
State of Texas, other than a physician, podiatrist, or dentist.
(50)
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 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.
(51)
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.
(52)
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.
(53)
Registered nurse--A person who is currently licensed by
the Board of Nurse Examiners for the State of Texas as a registered nurse
(RN).
(54)
Relocatable unit--Any structure, not on wheels, built
to be relocated at any time and provide medical services. These structures
vary in size.
(55)
Reportable event--A medical error or adverse event or
occurrence which the hospital is required to report to the department, as
set out in §133.48 of this title (relating to Patient Safety Program).
(56)
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.
(57)
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.
(58)
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.
(59)
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.
(60)
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.
(61)
Unethical conduct--Conduct prohibited by the ethical standards
adopted by state or national professional organizations for their respective
professions or by rules established by the state licensing agency for the
respective profession.
(62)
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 hospitals.
(63)
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.
This agency hereby certifies that the adoption has been
reviewed by legal counsel and found to be a valid exercise of the agency's
legal authority.
Filed with the Office of
the Secretary of State on March 15, 2004.
TRD-200401890
Susan K. Steeg
General Counsel
Texas Department of Health
Effective date: April 4, 2004
Proposal publication date: November 21, 2003
For further information, please call: (512) 458-7236
25 TAC §§133.22, 133.23, 133.26
The amendments are adopted under Health and Safety Code, §241.026,
concerning rules and minimum standards to protect and promote the public health
and welfare by providing for the development, establishment, and enforcement
of standards in the construction, maintenance, and operation of hospitals
in Texas; 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 commissioner
of health.
§133.22.Application and Issuance of Initial License.
(a)
Application submittal. The applicant shall submit the following
documents to the Texas Department of Health (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(b)(11)(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)
if the applicant is a sole proprietor, partnership with
individuals as a partner, or a corporation in which an individual has an ownership
interest of at least 25% of the business entity, the names and social security
numbers of the individuals.
(b)
Verification of franchise tax status. Upon receipt of the
application documents, the department shall verify the franchise tax status
of an applicant who is a corporation prior to the issuance of a license. In
accordance with Article 2.45, Part Two, Texas Business Corporation Act, the
department will not issue a hospital license to an applicant who is a corporation
if the corporation is delinquent in franchise tax owed to the state under
the Tax Code, Texas Codes Annotated, Chapter 171.
(c)
Additional documentation for new hospitals or conversions
from nonhospital buildings. In addition to the document submittal requirements
in subsection (a) of this section, and verification of the franchise tax information
in subsection (b) 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 nonhospital buildings.
(1)
Preliminary and final architectural plans and specifications
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).
(2)
For new construction, necessary preliminary inspections
and final construction inspections shall be conducted by the department in
accordance with §133.167(e)(4) of this title 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 §133.167(e)(4) 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, accurate, and notarized Affidavit for Final
Construction Approval form shall be submitted to the department.
(7)
The project architect shall submit a statement to the department
that the hospital's project plans and specifications have been submitted to
the Texas Department of Licensing and Regulation.
(d)
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.
(e)
Issuance of license. When it is determined that the hospital
has complied with subsections (a)-(d) 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)-(d) 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)
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.
(f)
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.
(g)
Denial of a license. Denial of a license shall be governed
by §133.121 of this title (relating to Enforcement Action).
(h)
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 Medicare 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 Texas Department of Health (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 the Joint Commission
on Accreditation of Healthcare Organizations or the American Osteopathic Association,
a copy of documentation from the accrediting body showing the current accreditation
status of the hospital;
(E)
an annual events report in accordance with §133.48(b)(1)
of this title (relating to Patient Safety Program); and
(F)
a best practices report in accordance with §133.48(b)(2)
of this title.
(2)
Upon receipt of the renewal documents, the department shall
verify the franchise tax status of an applicant who is a corporation prior
to the issuance of a license. In accordance with Article 2.45, Part Two, Texas
Business Corporation Act, the department will not issue a hospital license
to an applicant who is a corporation if the corporation is delinquent in franchise
tax owed to the State under the Tax Code, Texas Codes Annotated, Chapter 171.
(3)
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).
(4)
Renewal licenses issued prior to January 1, 2005, will
be valid for 12 months.
(5)
Renewal licenses issued January 1, 2005, through December
31, 2005, will be valid for either 12 months or 24 months, to be determined
by the department prior to the time of license renewal.
(6)
Renewal licenses issued January 1, 2006, or after 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).
This agency hereby certifies that the adoption has been reviewed
by legal counsel and found to be a valid exercise of the agency's legal authority.
Filed
with the Office of the Secretary of State on March 15, 2004.
TRD-200401891
Susan K. Steeg
General Counsel
Texas Department of Health
Effective date: April 4, 2004
Proposal publication date: November 21, 2003
For further information, please call: (512) 458-7236
25 TAC §133.45, §133.48
The amendment and new section are adopted under Health and
Safety Code, §241.026, concerning rules and minimum standards to protect
and promote the public health and welfare by providing for the development,
establishment, and enforcement of standards in the construction, maintenance,
and operation of hospitals in Texas; 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 commissioner of health.
§133.48.Patient Safety Program.
(a)
General.
(1)
The hospital must develop, implement and maintain an effective,
ongoing, organization-wide, data driven Patient Safety Program (PSP).
(A)
The governing body must ensure that the PSP reflects the
complexity of the hospital's organization and services, including those services
furnished under contract or arrangement, and focuses on the prevention and
reduction of medical errors and adverse events.
(B)
The PSP must be in writing, approved by the governing body
and made available for review by the department. It must include the following
components:
(i)
the definition of medical errors, adverse events and reportable
events;
(ii)
the process for internal reporting of medical errors,
adverse events and reportable events;
(iii)
a list of events and occurrences which staff are required
to report internally;
(iv)
time frames for internal reporting of medical errors,
adverse events and reportable events;
(v)
consequences for failing to report events in accordance
with hospital policy;
(vi)
mechanisms for preservation and collection of event data;
(vii)
the process for conducting root cause analysis;
(viii)
the process for communicating action plans; and
(ix)
the process for feedback to staff regarding the root cause
analysis and action plan.
(2)
The hospital must provide patient safety education and
training to staff who have responsibilities related to the implementation,
development, supervision or evaluation of the PSP. Training must include all
PSP components as set out in paragraph (1)(B) of this subsection.
(3)
The hospital must designate one or more individuals, or
an interdisciplinary group, qualified by training or experience to be responsible
for the management of the patient safety program. These responsibilities shall
include:
(A)
coordinating all patient safety activities;
(B)
facilitating assessment and appropriate response to reported
events;
(C)
monitoring root cause analysis and resulting action plans;
and
(D)
serving as liaison among hospital departments and committees
to ensure hospital-wide integration of the PSP.
(4)
Within 45 days of becoming aware of a reportable event
specified under subsection (b)(1)(A) of this section, the hospital must:
(A)
complete a root cause analysis to examine the cause and
effect of the event through an impartial process; and
(B)
develop an action plan identifying the strategies that
the hospital intends to employ to reduce the risk of similar events occurring
in the future. The action plan must:
(i)
designate responsibility for implementation and oversight;
(ii)
specify time frames for implementation; and
(iii)
include a strategy for measuring the effectiveness of
the actions taken.
(C)
The hospital must make the root cause analysis and action
plan available for on-site review by department representatives.
(b)
Reporting requirements.
(1)
Annual events report.
(A)
On the renewal of the hospital's license, or annually based
on the hospital's original licensing date, the hospital shall submit to the
department a report that lists the number of occurrences at the hospital,
including any outpatient facility owned or operated by the hospital, of each
of the following events occurring during the preceding year:
(i)
a medication error resulting in a patient's unanticipated
death or major permanent loss of bodily function in circumstances unrelated
to the natural course of the illness or underlying condition of the patient;
(ii)
a perinatal death unrelated to a congenital condition
in an infant with a birth weight greater that 2,500 grams;
(iii)
the suicide of a patient in a setting in which the patient
received care 24 hours a day;
(iv)
the abduction of a newborn infant patient from the hospital
or the discharge of a newborn infant patient from the hospital into the custody
of an individual in circumstances in which the hospital knew, or in the exercise
of ordinary care should have known, that the individual did not have legal
custody of the infant;
(v)
the sexual assault of a patient during treatment or while
the patient was on the premises of the hospital or facility;
(vi)
a hemolytic transfusion reaction in a patient resulting
from the administration of blood or blood products with major blood group
incompatibilities;
(vii)
a surgical procedure on the wrong patient or on the wrong
body part of a patient;
(viii)
a foreign object accidentally left in a patient during
a procedure; and
(ix)
a patient death or serious disability associated with
the use or function of a device designed for patient care that is used or
functions other than as intended.
(B)
The hospital is not required to include any information
other than the total number of occurrences of each of the events listed under
subparagraph (A) of this paragraph.
(2)
Best practices report.
(A)
On the renewal of the hospital's license, or annually based
on the hospital's original licensing date, the hospital shall submit to the
department at least one report of the best practices and safety measures related
to a reported event.
(B)
The best practice report may be submitted on a form to
be prescribed by the department, or the hospital may submit a copy of a report
submitted to a patient safety organization.
(C)
Hospitals may voluntarily report additional best practices
and safety measures.
This agency hereby certifies that the adoption
has been reviewed by legal counsel and found to be a valid exercise of the
agency's legal authority.
Filed
with the Office of the Secretary of State on March 15, 2004.
TRD-200401892
Susan K. Steeg
General Counsel
Texas Department of Health
Effective date: April 4, 2004
Proposal publication date: November 21, 2003
For further information, please call: (512) 458-7236
25 TAC §133.101
The amendment is adopted under Health and Safety Code, §241.026,
concerning rules and minimum standards to protect and promote the public health
and welfare by providing for the development, establishment, and enforcement
of standards in the construction, maintenance, and operation of hospitals
in Texas; 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 commissioner
of health.
§133.101.Inspection and Investigation Procedures.
(a)
Routine inspections. The Texas Department of Health (department)
may conduct an inspection of each hospital prior to the issuance or renewal
of a hospital license.
(1)
A hospital is not subject to routine inspections subsequent
to the issuance of the initial license while the hospital maintains:
(A)
certification under Title XVIII of the Social Security
Act, 42 United States Code (USC), §§1395 et seq; or
(B)
accreditation by the Joint Commission on Accreditation
of Healthcare Organizations or by the American Osteopathic Association.
(2)
The department may conduct an inspection of a hospital
exempt from an annual licensing inspection under paragraph (1) of this subsection
before issuing a renewal license to the hospital if the certification or accreditation
body has not conducted an on-site inspection of the hospital in the preceding
three years and the department determines that an inspection of the hospital
by the certification or accreditation body is not scheduled within 60 days.
(b)
Complaint investigations.
(1)
Complaint investigations are conducted if the department
finds that reasonable cause exists to believe that the hospital has violated
provisions of the Act, this chapter, special license conditions, or orders
of the commissioner of health (commissioner).
(2)
Complaints received by the department concerning abuse
and neglect, or illegal, unprofessional, or unethical conduct will be conducted
in accordance with §133.47(c) of this title (relating to Abuse and Neglect
Issues).
(3)
Complaint investigations are coordinated with the federal
Health Care Financing Administration and its agents responsible for the inspection
of hospitals to determine compliance with the conditions of participation
under Title XVIII of the Social Security Act, (42 USC, §§1395 et
seq), so as to avoid duplicate investigations.
(4)
Complaint investigations are generally unannounced.
(c)
Reinspection.
(1)
Reinspections may be conducted by the department if a hospital
applies for the reissuance of its license after the suspension or revocation
of the hospital's license, the assessment of administrative or civil penalties,
or the issuance of an injunction against the hospital for violations of the
Act, this chapter, a special license condition, or an order of the commissioner.
(2)
A reinspection may be conducted to ascertain compliance
with either health or construction requirements or both.
(d)
General.
(1)
The department may make any inspection, survey, or investigation
that it considers necessary. A representative of the department may enter
the premises of a hospital at any reasonable time to make an inspection or
an investigation to ensure compliance with or prevent a violation of the Act,
the rules adopted under the Act, an order or special order of the commissioner,
a special license provision, a court order granting injunctive relief, or
other enforcement procedures. Ensuring compliance includes permitting photocopying
of any records or other information by or on behalf of the department as necessary
to determine or verify compliance with the statute or rules adopted under
the statute, except that the department may not photocopy, reproduce, remove
or dictate from any part of the root cause analysis or action plan required
under §133.48 of this title (relating to Patient Safety Program).
(2)
The department or a representative of the department is
entitled to access to all books, records, or other documents maintained by
or on behalf of the hospital to the extent necessary to enforce the Act, this
chapter, an order or special order of the commissioner, a special license
provision, a court order granting injunctive relief, or other enforcement
procedures. The department shall maintain the confidentiality of hospital
records as applicable under federal or state law.
(3)
By applying for or holding a hospital license, the hospital
consents to entry and inspection or investigation of the hospital by the department
or a representative of the department in accordance with the Act and this
chapter.
(e)
Inspection and investigation protocol.
(1)
The department surveyor(s) shall hold a conference with
the hospital administrator or designee before beginning the on-site inspection
or investigation to explain the nature, scope, and estimated time schedule
of the inspection or investigation.
(2)
Department surveyor(s) may conduct interviews with any
person with knowledge of the facts.
(3)
The department surveyor(s) shall inform the hospital administrator
or designee of the preliminary findings of the inspection or investigation
and shall give the person a reasonable opportunity to submit additional facts
or other information to the department's authorized representative in response
to those findings.
(4)
Following an inspection or investigation of a hospital
by the department, the department surveyor(s) shall hold an exit conference
with the hospital administrator or designee and other invited staff and provide
the following to the hospital administrator or designee:
(A)
the specific nature of the inspection or investigation;
(B)
any alleged violations of a specific statute or rule;
(C)
identity of any records that were duplicated;
(D)
the specific nature of any finding regarding an alleged
violation or deficiency;
(E)
if the deficiency is alleged, the severity of the deficiency;
and
(F)
if there are no deficiencies found, a statement indicating
this fact.
(5)
If deficiencies are cited, the department surveyor(s) shall
obtain either at the time of the exit conference or within 10 days of the
hospital's receipt of the statement of deficiencies a plan of correction which
is provided by the hospital and indicates the date(s) by which correction(s)
will be made and any other written comments, if any, by the hospital administrator
or designee concerning the inspection or investigation. Additional facts,
written comments, or other information provided by the hospital in response
to the findings shall be made a part of the record of the inspection or investigation
for all purposes.
(6)
The department surveyor(s) shall obtain the signature of
the hospital administrator or designee acknowledging the receipt of the statement
of deficiencies and plan of correction form.
(7)
The department surveyor(s) shall inform the administrator
or designee of the hospital's right to an informal administrative review when
there is disagreement with the surveyor's findings and recommendations or
when additional information bearing on the findings is available.
(8)
If deficiencies are cited and the plan of correction is
not acceptable, the department shall notify the hospital in writing and request
that the plan of correction be resubmitted within 10 calendar days of the
hospital's receipt of the department's written notice. Upon resubmission of
an acceptable plan of correction, written notice shall be sent by the department
to the hospital acknowledging same.
(9)
Responses to the department may be submitted by facsimile.
(10)
The hospital shall come into compliance by the completion
date provided on the statement of deficiencies and plan of correction form.
(11)
The department shall verify the correction of deficiencies
either by mail or by an on-site inspection or investigation.
(12)
Acceptance of a plan of correction does not preclude the
department from taking enforcement action under §133.121 of this title
(relating to Enforcement Action) or under §133.122 of this title (relating
to Administrative Penalty).
(f)
Release of information by the department.
(1)
Upon written request, the department shall provide information
on the identity, including the signature, of each department representative
conducting, reviewing, or approving the results of the inspection or investigation,
and the date on which the department representative acted on the matter.
(2)
Upon written request, the department shall release inspection
documents in accordance with state and federal law.
This agency hereby certifies that the adoption has been
reviewed by legal counsel and found to be a valid exercise of the agency's
legal authority.
Filed
with the Office of the Secretary of State on March 15, 2004.
TRD-200401893
Susan K. Steeg
General Counsel
Texas Department of Health
Effective date: April 4, 2004
Proposal publication date: November 21, 2003
For further information, please call: (512) 458-7236
25 TAC §133.121
The amendment is adopted under Health and Safety Code, §241.026,
concerning rules and minimum standards to protect and promote the public health
and welfare by providing for the development, establishment, and enforcement
of standards in the construction, maintenance, and operation of hospitals
in Texas; 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 commissioner
of health.
This agency hereby certifies that the adoption has been reviewed
by legal counsel and found to be a valid exercise of the agency's legal authority.
Filed
with the Office of the Secretary of State on March 15, 2004.
TRD-200401894
Susan K. Steeg
General Counsel
Texas Department of Health
Effective date: April 4, 2004
Proposal publication date: November 21, 2003
For further information, please call: (512) 458-7236
Subchapter B. HOSPITAL LICENSE
Subchapter C. OPERATIONAL REQUIREMENTS
Subchapter F. INSPECTION AND INVESTIGATION PROCEDURES
Subchapter G. ENFORCEMENT
Subchapter H. FIRE PREVENTION AND SAFETY REQUIREMENTS