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
25 TAC §§133.41 - 133.48
(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.
§133.41.Hospital Functions and Services.
§133.42.Patient Rights.
§133.43.Discrimination or Retaliation Standards.
§133.44.Hospital Patient Transfer Policy.
§133.45.Miscellaneous Policies and Protocols.
§133.46.Hospital Billing.
§133.47.Abuse and Neglect Issues.
§133.48.Patient Safety Program.
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-200606445
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 §§133.41 - 133.48
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.
§133.41.Hospital Functions and Services.
(a)
Anesthesia services. If the hospital furnishes anesthesia
services, these services shall be provided in a well-organized manner under
the direction of a qualified physician in accordance with the Medical Practice
Act and the Nursing Practice Act. The hospital is responsible for and shall
document all anesthesia services administered in the hospital.
(1)
Organization and staffing. The organization of anesthesia
services shall be appropriate to the scope of the services offered. Only qualified
personnel who have been approved by the facility to provide anesthesia services
shall administer anesthesia. All approvals or delegations of anesthesia services
as authorized by law shall be documented and include the training, experience,
and qualifications of the person who provided the service.
(2)
Delivery of services. Anesthesia services shall be consistent
with needs and resources. Policies on anesthesia procedure shall include the
delineation of pre-anesthesia and post-anesthesia responsibilities. The policies
shall ensure that the following are provided for each patient.
(A)
A pre-anesthesia evaluation by an individual qualified
to administer anesthesia under paragraph (1) of this subsection shall be performed
within 48 hours prior to surgery.
(B)
An intraoperative anesthesia record shall be provided.
The record shall include any complications or problems occurring during the
anesthesia including time, description of symptoms, review of affected systems,
and treatments rendered. The record shall correlate with the controlled substance
administration record.
(C)
A post-anesthesia follow-up report shall be written by
the person administering the anesthesia before transferring the patient from
the post-anesthesia care unit and shall include evaluation for recovery from
anesthesia, level of activity, respiration, blood pressure, level of consciousness,
and patient color.
(i)
With respect to inpatients, a post-anesthesia evaluation
for proper anesthesia recovery shall be performed after transfer from the
post-anesthesia care unit and within 48 hours after surgery by the person
administering the anesthesia, registered nurse (RN), or physician in accordance
with policies and procedures approved by the medical staff and using criteria
written in the medical staff bylaws for postoperative monitoring of anesthesia.
(ii)
With respect to outpatients, immediately prior to discharge,
a post-anesthesia evaluation for proper anesthesia recovery shall be performed
by the person administering the anesthesia, RN, or physician in accordance
with policies and procedures approved by the medical staff and using criteria
written in the medical staff bylaws for postoperative monitoring of anesthesia.
(b)
Chemical dependency services.
(1)
Chemical dependency unit. A hospital may not admit patients
to a chemical dependency services unit unless the unit is approved by the
Department of State Health Services (department) as meeting the requirements
of §133.163(q) of this title (relating to Spatial Requirements for New
Construction).
(2)
Admission criteria. A hospital providing chemical dependency
services shall have written admission criteria that are applied uniformly
to all patients who are admitted to the chemical dependency unit.
(A)
The hospital's admission criteria shall include procedures
to prevent the admission of minors for a condition which is not generally
recognized as responsive to treatment in an inpatient setting for chemical
dependency services.
(i)
The following conditions are not generally recognized as
responsive to treatment in a treatment facility for chemical dependency unless
the minor to be admitted is qualified because of other disabilities, such
as:
(I)
cognitive disabilities due to mental retardation;
(II)
learning disabilities; or
(III)
psychiatric disorders.
(ii)
A minor may be qualified for admission based on other
disabilities which would be responsive to chemical dependency services.
(iii)
A minor patient shall be separated from adult patients.
(B)
The hospital shall have a preadmission examination procedure
under which each patient's condition and medical history are reviewed by a
member of the medical staff to determine whether the patient is likely to
benefit significantly from an intensive inpatient program or assessment.
(C)
A voluntarily admitted patient shall sign an admission
consent form prior to admission to a chemical dependency unit which includes
verification that the patient has been informed of the services to be provided
and the estimated charges.
(3)
Compliance. A hospital providing chemical dependency services
in an identifiable unit within the hospital shall comply with Chapter 448,
Subchapter B of this title (relating to Standard of Care Applicable to All
Providers).
(c)
Comprehensive medical rehabilitation services.
(1)
Rehabilitation units. A hospital may not admit patients
to a comprehensive medical rehabilitation services unit unless the unit is
approved by the department as meeting the requirements of §133.163(z)
of this title.
(2)
Equipment and space. The hospital shall have the necessary
equipment and sufficient space to implement the treatment plan described in
paragraph (7)(C) of this subsection and allow for adequate care. Necessary
equipment is all equipment necessary to comply with all parts of the written
treatment plan. The equipment shall be on-site or available through an arrangement
with another provider. Sufficient space is the physical area of a hospital
which in the aggregate, constitutes the total amount of the space necessary
to comply with the written treatment plan.
(3)
Emergency requirements. Emergency personnel, equipment,
supplies and medications for hospitals providing comprehensive medical rehabilitation
services shall be as follows.
(A)
A hospital that provides comprehensive medical rehabilitation
services shall have emergency equipment, supplies, medications, and designated
personnel assigned for providing emergency care to patients and visitors.
(B)
The emergency equipment, supplies, and medications shall
be properly maintained and immediately accessible to all areas of the hospital.
The emergency equipment shall be periodically tested according to the policy
adopted, implemented and enforced by the hospital.
(C)
At a minimum, the emergency equipment and supplies shall
include those specified in subsection (e)(4) of this section.
(D)
The personnel providing emergency care in accordance with
this subsection shall be staffed for 24-hour coverage and accessible to all
patients receiving comprehensive medical rehabilitation services. At least
one person who is qualified by training to perform advanced cardiac life support
and administer emergency drugs shall be on duty each shift.
(E)
All direct patient care licensed personnel shall maintain
current certification in cardiopulmonary resuscitation (CPR).
(4)
Medications. A rehabilitation hospital's governing body
shall adopt, implement and enforce policies and procedures that require all
medications to be administered by licensed nurses, physicians, or other licensed
professionals authorized by law to administer medications.
(5)
Organization and Staffing.
(A)
A hospital providing comprehensive medical rehabilitation
services shall be organized and staffed to ensure the health and safety of
the patients.
(i)
All provided services shall be consistent with accepted
professional standards and practice.
(ii)
The organization of the services shall be appropriate
to the scope of the services offered.
(iii)
The hospital shall adopt, implement and enforce written
patient care policies that govern the services it furnishes.
(B)
The provision of comprehensive medical rehabilitation services
in a hospital shall be under the medical supervision of a physician who is
on duty and available, or who is on-call 24 hours each day.
(C)
A hospital providing comprehensive medical rehabilitation
services shall have a director who supervises and administers the provision
of comprehensive medical rehabilitation services.
(i)
The director shall be a physician who is board certified
or eligible for board certification in physical medicine and rehabilitation,
orthopedics, neurology, neurosurgery, internal medicine, or rheumatology as
appropriate for the rehabilitation program.
(ii)
The director shall be qualified by training or at least
two years training and experience to serve as medical director. A person is
qualified under this subsection if the person has training and experience
in the treatment of rehabilitation patients in a rehabilitation setting.
(6)
Admission criteria. A hospital providing comprehensive
medical rehabilitation services shall have written admission criteria that
are applied uniformly to all patients who are admitted to the comprehensive
medical rehabilitation unit.
(A)
The hospital's admission criteria shall include procedures
to prevent the admission of a minor for a condition which is not generally
recognized as responsive to treatment in an inpatient setting for comprehensive
medical rehabilitation services.
(i)
The following conditions are not generally recognized as
responsive to treatment in an inpatient setting for comprehensive medical
rehabilitation services unless the minor to be admitted is qualified because
of other disabilities, such as:
(I)
cognitive disabilities due to mental retardation;
(II)
learning disabilities; or
(III)
psychiatric disorders.
(ii)
A minor may be qualified for admission based on other
disabilities which would be responsive to comprehensive medical rehabilitation
services.
(B)
The hospital shall have a preadmission examination procedure
under which each patient's condition and medical history are reviewed by a
member of the medical staff to determine whether the patient is likely to
benefit significantly from an intensive inpatient program or assessment.
(7)
Care and services.
(A)
A hospital providing comprehensive medical rehabilitation
services shall use a coordinated interdisciplinary team which is directed
by a physician and which works in collaboration to develop and implement the
patient's treatment plan.
(i)
The interdisciplinary team for comprehensive medical rehabilitation
services shall have available to it, at the hospital at which the services
are provided or by contract, members of the following professions as necessary
to meet the treatment needs of the patient:
(I)
physical therapy;
(II)
occupational therapy;
(III)
speech-language pathology;
(IV)
therapeutic recreation;
(V)
social services and case management;
(VI)
dietetics;
(VII)
psychology;
(VIII)
respiratory therapy;
(IX)
rehabilitative nursing;
(X)
certified orthotics;
(XI)
certified prosthetics;
(XII)
pharmaceutical care; and
(XIII)
in the case of a minor patient, persons who have specialized
education and training in emotional, mental health, or chemical dependency
problems, as well as the treatment of minors.
(ii)
The coordinated interdisciplinary team approach used in
the rehabilitation of each patient shall be documented by periodic entries
made in the patient's medical record to denote:
(I)
the patient's status in relationship to goal attainment;
and
(II)
that team conferences are held at least every two weeks
to determine the appropriateness of treatment.
(B)
An initial assessment and preliminary treatment plan shall
be performed or established by the physician within 24 hours of admission.
(C)
The physician in coordination with the interdisciplinary
team shall establish a written treatment plan for the patient within seven
working days of the date of admission.
(i)
Comprehensive medical rehabilitation services shall be
provided in accordance with the written treatment plan.
(ii)
The treatment provided under the written treatment plan
shall be provided by staff who are qualified to provide services under state
law. The hospital shall establish written qualifications for services provided
by each discipline for which there is no applicable state statute for professional
licensure or certification.
(iii)
Services provided under the written treatment plan shall
be given in accordance with the orders of physicians, dentists, podiatrists
or practitioners who are authorized by the governing body, hospital administration,
and medical staff to order the services, and the orders shall be incorporated
in the patient's record.
(iv)
The written treatment plan shall delineate anticipated
goals and specify the type, amount, frequency, and anticipated duration of
service to be provided.
(v)
Within 10 working days after the date of admission, the
written treatment plan shall be provided. It shall be in the person's primary
language, if practicable. What is or would have been practicable shall be
determined by the facts and circumstances of each case. The written treatment
plan shall be provided to:
(I)
the patient;
(II)
a person designated by the patient; and
(III)
upon request, a family member, guardian, or individual
who has demonstrated on a routine basis responsibility and participation in
the patient's care or treatment, but only with the patient's consent unless
such consent is not required by law.
(vi)
The written treatment plan shall be reviewed by the interdisciplinary
team at least every two weeks.
(vii)
The written treatment plan shall be revised by the interdisciplinary
team if a comprehensive reassessment of the patient's status or the results
of a patient case review conference indicates the need for revision.
(viii)
The revision shall be incorporated into the patient's
record within seven working days after the revision.
(ix)
The revised treatment plan shall be reduced to writing
in the person's primary language, if practicable, and provided to:
(I)
the patient;
(II)
a person designated by the patient; and
(III)
upon request, a family member, guardian, or individual
who has demonstrated on a routine basis responsibility and participation in
the patient's care or treatment, but only with the patient's consent unless
such consent is not required by law.
(8)
Discharge and continuing care plan. The patient's interdisciplinary
team shall prepare a written continuing care plan that addresses the patient's
needs for care after discharge.
(A)
The continuing care plan for the patient shall include
recommendations for treatment and care and information about the availability
of resources for treatment or care.
(B)
If the patient's interdisciplinary team deems it impracticable
to provide a written continuing care plan prior to discharge, the patient's
interdisciplinary team shall provide the written continuing care plan to the
patient within two working days after the date of discharge.
(C)
Prior to discharge or within two working days after the
date of discharge, the written continuing care plan shall be provided in the
person's primary language, if practicable, to:
(i)
the patient;
(ii)
a person designated by the patient; and
(iii)
upon request, to a family member, guardian, or individual
who has demonstrated on a routine basis responsibility and participation in
the patient's care or treatment, but only with the patient's consent unless
such consent is not required by law.
(d)
Dietary services. The hospital shall have organized dietary
services that are directed and staffed by adequate qualified personnel. However,
a hospital that has a contract with an outside food management company or
an arrangement with another hospital may meet this requirement if the company
or other hospital has a dietitian who serves the hospital on a full-time,
part-time, or consultant basis, and if the company or other hospital maintains
at least the minimum requirements specified in this section, and provides
for the frequent and systematic liaison with the hospital medical staff for
recommendations of dietetic policies affecting patient treatment. The hospital
shall ensure that there are sufficient personnel to respond to the dietary
needs of the patient population being served.
(1)
Organization.
(A)
The hospital shall have a full-time employee who is qualified
by experience or training to serve as director of the food and dietetic service,
and be responsible for the daily management of the dietary services.
(B)
There shall be a qualified dietitian who works full-time,
part-time, or on a consultant basis. If by consultation, such services shall
occur at least once per month for not less than eight hours. The dietitian
shall:
(i)
be currently licensed under the laws of this state to use
the titles of licensed dietitian or provisional licensed dietitian, or be
a registered dietitian;
(ii)
maintain standards for professional practice;
(iii)
supervise the nutritional aspects of patient care;
(iv)
make an assessment of the nutritional status and adequacy
of nutritional regimen, as appropriate;
(v)
provide diet counseling and teaching, as appropriate;
(vi)
document nutritional status and pertinent information
in patient medical records, as appropriate;
(vii)
approve menus; and
(viii)
approve menu substitutions.
(C)
There shall be administrative and technical personnel competent
in their respective duties. The administrative and technical personnel shall:
(i)
participate in established departmental or hospital training
pertinent to assigned duties;
(ii)
conform to food handling techniques in accordance with
paragraph (2)(E)(viii) of this subsection;
(iii)
adhere to clearly defined work schedules and assignment
sheets; and
(iv)
comply with position descriptions which are job specific.
(2)
Director. The director shall:
(A)
comply with a position description which is job specific;
(B)
clearly delineate responsibility and authority;
(C)
participate in conferences with administration and department
heads;
(D)
establish, implement, and enforce policies and procedures
for the overall operational components of the department to include, but not
be limited to:
(i)
quality assessment and performance improvement program;
(ii)
frequency of meals served;
(iii)
nonroutine occurrences; and
(iv)
identification of patient trays; and
(E)
maintain authority and responsibility for the following,
but not be limited to:
(i)
orientation and training;
(ii)
performance evaluations;
(iii)
work assignments;
(iv)
supervision of work and food handling techniques;
(v)
procurement of food, paper, chemical, and other supplies,
to include implementation of first-in first-out rotation system for all food
items;
(vi)
ensuring there is a four-day food supply on hand at all
times;
(vii)
menu planning; and
(viii)
ensuring compliance with §§229.161 - 229.171
of this title (relating to Texas Food Establishments).
(3)
Diets. Menus shall meet the needs of the patients.
(A)
Therapeutic diets shall be prescribed by the physician(s)
responsible for the care of the patients. The dietary department of the hospital
shall:
(i)
establish procedures for the processing of therapeutic
diets to include, but not be limited to:
(I)
accurate patient identification;
(II)
transcription from nursing to dietary services;
(III)
diet planning by a dietitian;
(IV)
regular review and updating of diet when necessary; and
(V)
written and verbal instruction to patient and family. It
shall be in the patient's primary language, if practicable, prior to discharge.
What is or would have been practicable shall be determined by the facts and
circumstances of each case;
(ii)
ensure that therapeutic diets are planned in writing by
a qualified dietitian;
(iii)
ensure that menu substitutions are approved by a qualified
dietitian;
(iv)
document pertinent information about the patient's response
to a therapeutic diet in the medical record; and
(v)
evaluate therapeutic diets for nutritional adequacy.
(B)
Nutritional needs shall be met in accordance with recognized
dietary practices and in accordance with orders of the physician(s) or appropriately
credentialed practitioner(s) responsible for the care of the patients. The
following requirements shall be met.
(i)
Menus shall provide a sufficient variety of foods served
in adequate amounts at each meal according to the guidance provided in the
Recommended Dietary Allowances (RDA), as published by the Food and Nutrition
Board, Commission on Life Sciences, National Research Council, Tenth edition,
1989, which may be obtained by writing the National Academies Press, 500 Fifth
Street, NW Lockbox 285, Washington, D.C. 20055, telephone (888) 624-8373.
(ii)
A maximum of 15 hours shall not be exceeded between the
last meal of the day (i.e. supper) and the breakfast meal, unless a substantial
snack is provided. The hospital shall adopt, implement, and enforce a policy
on the definition of "substantial" to meet each patient's varied nutritional
needs.
(C)
A current therapeutic diet manual approved by the dietitian
and medical staff shall be readily available to all medical, nursing, and
food service personnel. The therapeutic manual shall:
(i)
be revised as needed, not to exceed 5 years;
(ii)
be appropriate for the diets routinely ordered in the
hospital;
(iii)
have standards in compliance with the RDA;
(iv)
contain specific diets which are not in compliance with
RDA; and
(v)
be used as a guide for ordering and serving diets.
(e)
Emergency services. All licensed hospital locations, including
multiple-location sites, shall have an emergency suite that complies with §133.161(a)(1)(A)
of this title (relating to Requirements for Buildings in Which Existing Licensed
Hospitals are Located) or §133.163(f) of this title, and the following.
(1)
Organization. The organization of the emergency services
shall be appropriate to the scope of the services offered.
(A)
The services shall be organized under the direction of
a qualified member of the medical staff.
(B)
The services shall be integrated with other departments
of the hospital.
(C)
The policies and procedures governing medical care provided
in the emergency suite shall be established by and shall be a continuing responsibility
of the medical staff.
(D)
Medical records indicating patient identification, complaint,
physician, nurse, time admitted to the emergency suite, treatment, time discharged,
and disposition shall be maintained for all emergency patients.
(2)
Personnel.
(A)
There shall be adequate medical and nursing personnel qualified
in emergency care to meet the written emergency procedures and needs anticipated
by the hospital.
(B)
Except for comprehensive medical rehabilitation hospitals
and pediatric and adolescent hospitals that generally provide care that is
not administered for or in expectation of compensation:
(i)
there shall be on duty and available at all times at least
one person qualified as determined by the medical staff to initiate immediate
appropriate lifesaving measures; and
(ii)
in general hospitals where the emergency treatment area
is not contiguous with other areas of the hospital that maintain 24 hour staffing
by qualified staff (including but not limited to separation by one or more
floors in multiple-occupancy buildings), qualified personnel must be physically
present in the emergency treatment area at all times.
(C)
Except for comprehensive medical rehabilitation hospitals
and pediatric and adolescent hospitals that generally provide care that is
not administered for or in expectation of compensation, the hospital shall
provide that one or more physicians shall be available at all times for emergencies,
as follows.
(i)
General hospitals located in counties with a population
of 100,000 or more shall have a physician qualified to provide emergency medical
care on duty in the emergency treatment area at all times.
(ii)
Special hospitals and general hospitals located in counties
with a population of less than 100,000 shall have a physician on-call and
able to respond in person, or by radio or telephone within 30 minutes.
(D)
Schedules, names, and telephone numbers of all physicians
and others on emergency call duty, including alternates, shall be maintained.
Schedules shall be retained for no less than one year.
(3)
Supplies and equipment. Adequate age appropriate supplies
and equipment shall be available and in readiness for use. Equipment and supplies
shall be available for the administration of intravenous medications as well
as facilities for the control of bleeding and emergency splinting of fractures.
Provision shall be made for the storage of blood and blood products as needed.
The emergency equipment shall be periodically tested according to the policy
adopted, implemented and enforced by the hospital.
(4)
Required emergency equipment. At a minimum, the age appropriate
emergency equipment and supplies shall include the following:
(A)
emergency call system;
(B)
oxygen;
(C)
mechanical ventilatory assistance equipment, including
airways, manual breathing bag, and mask;
(D)
cardiac defibrillator;
(E)
cardiac monitoring equipment;
(F)
laryngoscopes and endotracheal tubes;
(G)
suction equipment;
(H)
emergency drugs and supplies specified by the medical staff;
(I)
stabilization devices for cervical injuries;
(J)
blood pressure monitoring equipment; and
(K)
pulse oximeter or similar medical device to measure blood
oxygenation.
(5)
Participation in local emergency medical service (EMS)
system.
(A)
General hospitals shall participate in the local EMS system,
based on the hospital's capabilities and capacity, and the locale's existing
EMS plan and protocols.
(B)
The provisions of subparagraph (A) of this paragraph do
not apply to a comprehensive medical rehabilitation hospital or a pediatric
and adolescent hospital that generally provides care that is not administered
for or in expectation of compensation.
(6)
Emergency services for survivors of sexual assault.
(A)
The hospital must develop, implement and enforce policies
and procedures to ensure that a sexual assault survivor who presents to the
hospital following a sexual assault is:
(i)
provided the care specified under subparagraph (B) of this
paragraph; or
(ii)
stabilized and transferred to a health care facility designated
in a community-wide plan as the health care facility for treating sexual assault
survivors, where the survivor will receive the care specified under subparagraph
(B) of this paragraph.
(B)
A hospital which provides care to a sexual assault survivor
shall provide the survivor with the following:
(i)
a private area, if available, to wait and to speak with
the appropriate medical, legal and sexual assault crisis center staff or volunteers
until a physician, nurse, or other qualified medical personnel is able to
treat the survivor;
(ii)
a private treatment room, if available;
(iii)
a forensic medical examination in accordance with Government
Code, Subchapter B, Chapter 420, if the examination has been approved by a
law enforcement agency;
(iv)
access to a sexual assault program advocate, if available,
as provided by Code of Criminal Procedure, Article 56.045;
(v)
the department's standard Information Form for Sexual Assault
Survivors, which may be obtained through the department's website or by contacting
the hospital licensing program at (512) 834-6648;
(vi)
the name and telephone number of the nearest sexual assault
crisis center; and
(vii)
if indicated, access to appropriate prophylaxis for exposure
to sexually transmitted infections.
(C)
Upon request, the hospital shall submit to the department
their plan for the provision of service to sexual assault survivors. The plan
must describe how the hospital will ensure that the services required under
subparagraph (B) of this paragraph will be provided.
(i)
The hospital shall submit the plan by the 60th day after
the department makes the request.
(ii)
The department will approve or reject the plan not later
than 120th day following the submission of the plan.
(iii)
If the department is not able to approve the plan, the
department will return the plan to the hospital and will identify the specific
provisions with which the hospital's plan failed to comply.
(iv)
The hospital shall correct and resubmit the plan to the
department for approval not later than the 90th day after the plan is returned
to the hospital.
(f)
Governing body.
(1)
Legal responsibility. There shall be a governing body responsible
for the organization, management, control, and operation of the hospital,
including appointment of the medical staff. For hospitals owned and operated
by an individual or by partners, the individual or partners shall be considered
the governing body.
(2)
Organization. The governing body shall be formally organized
in accordance with a written constitution and bylaws which clearly set forth
the organizational structure and responsibilities.
(3)
Meeting records. Records of governing body meetings shall
be maintained.
(4)
Responsibilities relating to the medical staff.
(A)
The governing body shall ensure that the medical staff
has current bylaws, rules, and regulations which are implemented and enforced.
(B)
The governing body shall approve medical staff bylaws and
other medical staff rules and regulations.
(C)
The governing body shall determine, in accordance with
state law and with the advice of the medical staff, which categories of practitioners
are eligible candidates for appointment to the medical staff.
(i)
In considering applications for medical staff membership
and privileges or the renewal, modification, or revocation of medical staff
membership and privileges, the governing body must ensure that each physician,
podiatrist, and dentist is afforded procedural due process.
(I)
If a hospital's credentials committee has failed to take
action on a completed application as required by subclause (VIII) of this
clause, or a physician, podiatrist, or dentist is subject to a professional
review action that may adversely affect his medical staff membership or privileges,
and the physician, podiatrist, or dentist believes that mediation of the dispute
is desirable, the physician, podiatrist, or dentist may require the hospital
to participate in mediation as provided in Civil Practice and Remedies Code
(CPRC), Chapter 154. The mediation shall be conducted by a person meeting
the qualifications required by CPRC §154.052 and within a reasonable
period of time.
(II)
Subclause (I) of this clause does not authorize a cause
of action by a physician, podiatrist, or dentist against the hospital other
than an action to require a hospital to participate in mediation.
(III)
An applicant for medical staff membership or privileges
may not be denied membership or privileges on any ground that is otherwise
prohibited by law.
(IV)
A hospital's bylaw requirements for staff privileges may
require a physician, podiatrist, or dentist to document the person's current
clinical competency and professional training and experience in the medical
procedures for which privileges are requested.
(V)
In granting or refusing medical staff membership or privileges,
a hospital may not differentiate on the basis of the academic medical degree
held by a physician.
(VI)
Graduate medical education may be used as a standard or
qualification for medical staff membership or privileges for a physician,
provided that equal recognition is given to training programs accredited by
the Accreditation Council for Graduate Medical Education and by the American
Osteopathic Association.
(VII)
Board certification may be used as a standard or qualification
for medical staff membership or privileges for a physician, provided that
equal recognition is given to certification programs approved by the American
Board of Medical Specialties and the Bureau of Osteopathic Specialists.
(VIII)
A hospital's credentials committee shall act expeditiously
and without unnecessary delay when a licensed physician, podiatrist, or dentist
submits a completed application for medical staff membership or privileges.
The hospital's credentials committee shall take action on the completed application
not later than the 90th day after the date on which the application is received.
The governing body of the hospital shall take final action on the application
for medical staff membership or privileges not later than the 60th day after
the date on which the recommendation of the credentials committee is received.
The hospital must notify the applicant in writing of the hospital's final
action, including a reason for denial or restriction of privileges, not later
than the 20th day after the date on which final action is taken.
(ii)
The governing body is authorized to adopt, implement and
enforce policies concerning the granting of clinical privileges to advanced
practice nurses and physician assistants, including policies relating to the
application process, reasonable qualifications for privileges, and the process
for renewal, modification, or revocation of privileges.
(I)
If the governing body of a hospital has adopted, implemented
and enforced a policy of granting clinical privileges to advanced practice
nurses or physician assistants, an individual advanced practice nurse or physician
assistant who qualifies for privileges under that policy shall be entitled
to certain procedural rights to provide fairness of process, as determined
by the governing body of the hospital, when an application for privileges
is submitted to the hospital. At a minimum, any policy adopted shall specify
a reasonable period for the processing and consideration of the application
and shall provide for written notification to the applicant of any final action
on the application by the hospital, including any reason for denial or restriction
of the privileges requested.
(II)
If an advanced practice nurse or physician assistant has
been granted clinical privileges by a hospital, the hospital may not modify
or revoke those privileges without providing certain procedural rights to
provide fairness of process, as determined by the governing body of the hospital,
to the advanced practice nurse or physician assistant. At a minimum, the hospital
shall provide the advanced practice nurse or physician assistant written reasons
for the modification or revocation of privileges and a mechanism for appeal
to the appropriate committee or body within the hospital, as determined by
the governing body of the hospital.
(III)
If a hospital extends clinical privileges to an advanced
practice nurse or physician assistant conditioned on the advanced practice
nurse or physician assistant having a sponsoring or collaborating relationship
with a physician and that relationship ceases to exist, the advanced practice
nurse or physician assistant and the physician shall provide written notification
to the hospital that the relationship no longer exists. Once the hospital
receives such notice from an advanced practice nurse or physician assistant
and the physician, the hospital shall be deemed to have met its obligations
under this section by notifying the advanced practice nurse or physician assistant
in writing that the advanced practice nurse's or physician assistant's clinical
privileges no longer exist at that hospital.
(IV)
Nothing in this clause shall be construed as modifying
Subtitle B, Title 3, Occupations Code, Chapter 204 or 301, or any other law
relating to the scope of practice of physicians, advanced practice nurses,
or physician assistants.
(V)
This clause does not apply to an employer-employee relationship
between an advanced practice nurse or physician assistant and a hospital.
(D)
The governing body shall ensure that the hospital complies
with the requirements concerning physician communication and contracts as
set out in Health and Safety Code (HSC), §241.1015 (Physician Communication
and Contracts); and
(E)
The governing body shall ensure the hospital complies with
the requirements for reporting to the Texas Medical Board the results and
circumstances of any professional review action in accordance with the Medical
Practice Act, Texas Occupations Code, §160.002 and §160.003.
(F)
The governing body shall be responsible for and ensure
that any policies and procedures adopted by the governing body to implement
the requirements of this chapter shall be implemented and enforced.
(5)
Hospital administration. The governing body shall appoint
a chief executive officer or administrator who is responsible for managing
the hospital.
(6)
Patient care. In accordance with hospital policy adopted,
implemented and enforced, the governing body shall ensure that:
(A)
every patient is under the care of:
(i)
a physician. This provision is not to be construed to limit
the authority of a physician to delegate tasks to other qualified health care
personnel to the extent recognized under state law or the state's regulatory
mechanism;
(ii)
a dentist who is legally authorized to practice dentistry
by the state and who is acting within the scope of his or her license; or
(iii)
a podiatrist, but only with respect to functions which
he or she is legally authorized by the state to perform.
(B)
patients are admitted to the hospital only by members of
the medical staff who have been granted admitting privileges; and
(C)
a physician is on duty or on-call at all times.
(7)
Services. The governing body shall be responsible for all
services furnished in the hospital, whether furnished directly or under contract.
The governing body shall ensure that services are provided in a safe and effective
manner that permits the hospital to comply with all applicable rules and standards.
(g)
Infection control. The hospital shall provide a sanitary
environment to avoid sources and transmission of infections and communicable
diseases. There shall be an active program for the prevention, control, and
surveillance of infections and communicable diseases.
(1)
Organization and policies. A person shall be designated
as infection control professional. The hospital shall ensure that policies
governing prevention, control and surveillance of infections and communicable
diseases are developed, implemented and enforced.
(A)
There shall be a system for identifying, reporting, investigating,
and controlling health care associated infections and communicable diseases
between patients and personnel.
(B)
The infection control professional shall maintain a log
of all reportable diseases and health care associated infections designated
as epidemiologically significant according to the hospital's infection control
policies.
(C)
A written policy shall be adopted, implemented and enforced
for reporting all reportable diseases to the local health authority and the
Infectious Disease Surveillance and Epidemiology Branch Department of State
Health Services, 1100 West 49th Street, Austin, Texas 78756-3199, in accordance
with Chapter 97 of this title (relating to Communicable Diseases).
(D)
The infection control program shall include active participation
by the pharmacist.
(2)
Responsibilities of the chief executive officer (CEO),
medical staff, and chief nursing officer (CNO). The CEO, the medical staff,
and the CNO shall be responsible for the following.
(A)
The hospital-wide quality assessment and performance improvement
program and training programs shall address problems identified by the infection
control professional.
(B)
Successful corrective action plans in affected problem
areas shall be implemented.
(3)
Universal precautions. The hospital shall adopt, implement,
and enforce a written policy to monitor compliance of the hospital and its
personnel and medical staff with universal precautions in accordance with
HSC Chapter 85, Acquired Immune Deficiency Syndrome and Human Immunodeficiency
Virus Infection.
(h)
Laboratory services. The hospital shall maintain directly,
or have available adequate laboratory services to meet the needs of its patients.
(1)
Hospital laboratory services. A hospital that provides
laboratory services shall comply with the Clinical Laboratory Improvement
Amendments of 1988 (CLIA 1988), in accordance with the requirements specified
in 42 Code of Federal Regulations (CFR), §§493.1 - 493.1780. CLIA
1988 applies to all hospitals with laboratories that examine human specimens
for the diagnosis, prevention, or treatment of any disease or impairment of,
or the assessment of the health of, human beings.
(2)
Contracted laboratory services. The hospital shall ensure
that all laboratory services provided to its patients through a contractual
agreement are performed in a facility certified in the appropriate specialties
and subspecialties of service in accordance with the requirements specified
in 42 CFR Part 493 to comply with CLIA 1988.
(3)
Adequacy of laboratory services. The hospital shall ensure
the following.
(A)
Emergency laboratory services shall be available 24 hours
a day.
(B)
A written description of services provided shall be available
to the medical staff.
(C)
The laboratory shall make provision for proper receipt
and reporting of tissue specimens.
(D)
The medical staff and a pathologist shall determine which
tissue specimens require a macroscopic (gross) examination and which require
both macroscopic and microscopic examination.
(E)
When blood and blood components are stored, there shall
be written procedures readily available containing directions on how to maintain
them within permissible temperatures and including instructions to be followed
in the event of a power failure or other disruption of refrigeration. A label
or tray with the recipient's first and last names and identification number,
donor unit number and interpretation of compatibility, if performed, shall
be attached securely to the blood container.
(F)
The hospital shall establish a mechanism for ensuring that
the patient's physician or other licensed health care professional is made
aware of critical value lab results, as established by the medical staff,
before or after the patient is discharged.
(4)
Chemical hygiene. A hospital that provides laboratory services
shall adopt, implement, and enforce written policies and procedures to manage,
minimize, or eliminate the risks to laboratory personnel of exposure to potentially
hazardous chemicals in the laboratory which may occur during the normal course
of job performance.
(i)
Linen and laundry services. The hospital shall provide
sufficient clean linen to ensure the comfort of the patient.
(1)
For purposes of this subsection, contaminated linen is
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.
(2)
The hospital, whether it operates its own laundry or uses
commercial service, shall ensure the following.
(A)
Employees of a hospital involved in transporting, processing,
or otherwise handling clean or soiled linen shall be given initial and follow-up
in-service training to ensure a safe product for patients and to safeguard
employees in their work.
(B)
Clean linen shall be handled, transported, and stored by
methods that will ensure its cleanliness.
(C)
All contaminated linen shall be placed and transported
in bags or containers labeled or color-coded.
(D)
Employees who have contact with contaminated linen shall
wear gloves and other appropriate personal protective equipment.
(E)
Contaminated linen shall be handled as little as possible
and with a minimum of agitation. Contaminated linen shall not be sorted or
rinsed in patient care areas.
(F)
All contaminated linen shall be bagged or put into carts
at the location where it was used.
(i)
Bags containing contaminated linen shall be closed prior
to transport to the laundry.
(ii)
Whenever contaminated linen is wet and presents a reasonable
likelihood of soak-through of or leakage from the bag or container, the linen
shall be deposited and transported in bags that prevent leakage of fluids
to the exterior.
(iii)
All linen placed in chutes shall be bagged.
(iv)
If chutes are not used to convey linen to a central receiving
or sorting room, then adequate space shall be allocated on the various nursing
units for holding the bagged contaminated linen.
(G)
Linen shall be processed as follows:
(i)
If hot water is used, linen shall be washed with detergent
in water with a temperature of at least 71 degrees Centigrade (160 degrees
Fahrenheit) for 25 minutes. Hot water requirements specified in Table 5 of §133.169(e)
of this title (relating to Tables) shall be met.
(ii)
If low-temperature (less than or equal to 70 degrees Centigrade)
(158 degrees Fahrenheit) laundry cycles are used, chemicals suitable for low-temperature
washing at proper use concentration shall be used.
(iii)
Commercial dry cleaning of fabrics soiled with blood
also renders these items free of the risk of pathogen transmission.
(H)
Flammable liquids shall not be used to process laundry,
but may be used for equipment maintenance.
(j)
Medical record services. The hospital shall have a medical
record service that has administrative responsibility for medical records.
A medical record shall be maintained for every individual who presents to
the hospital for evaluation or treatment.
(1)
The organization of the medical record service shall be
appropriate to the scope and complexity of the services performed. The hospital
shall employ adequate personnel to ensure prompt completion, filing, and retrieval
of records.
(2)
The hospital shall have a system of coding and indexing
medical records. The system shall allow for timely retrieval by diagnosis
and procedure, in order to support medical care evaluation studies.
(3)
The hospital shall adopt, implement, and enforce a policy
to ensure that the hospital complies with HSC, Chapter 241, Subchapter G (Disclosure
of Health Care Information).
(4)
The medical record shall contain information to justify
admission and continued hospitalization, support the diagnosis, reflect significant
changes in the patient's condition, and describe the patient's progress and
response to medications and services. Medical records shall be accurately
written, promptly completed, properly filed and retained, and accessible.
(5)
Medical record entries must be legible, complete, dated,
timed, and authenticated in written or electronic form by the person responsible
for providing or evaluating the service provided, consistent with hospital
policies and procedures.
(6)
All orders (except verbal orders) must be dated, timed,
and authenticated as soon as possible by the prescriber or another practitioner
who is responsible for the care of the patient and has been credentialed by
the medical staff and granted privileges which are consistent with the written
orders.
(7)
All verbal orders must be dated, timed, and authenticated
promptly as specified by hospital policy by the prescriber or another practitioner
who is responsible for the care of the patient and has been credentialed by
the medical staff and granted privileges which are consistent with the written
orders.
(A)
Use of signature stamps by physicians and other licensed
practitioners credentialed by the medical staff may be allowed in hospitals
when the signature stamp is authorized by the individual whose signature the
stamp represents. The administrative offices of the hospital shall have on
file a signed statement to the effect that he or she is the only one who has
the stamp and uses it. The use of a signature stamp by any other person is
prohibited.
(B)
A list of computer codes and written signatures shall be
readily available and shall be maintained under adequate safeguards.
(C)
Signatures by facsimile shall be acceptable. If received
on a thermal machine, the facsimile document shall be copied onto regular
paper.
(8)
Medical records (reports and printouts) shall be retained
by the hospital in their original or legally reproduced form for a period
of at least ten years. A legally reproduced form is a medical record retained
in hard copy, microform (microfilm or microfiche), or other electronic medium.
Films, scans, and other image records shall be retained for a period of at
least five years. For retention purposes, medical records that shall be preserved
for ten years include:
(A)
identification data;
(B)
the medical history of the patient;
(C)
evidence of a physical examination, including a health
history, performed no more than 30 days prior to admission or within 24 hours
after admission;
(D)
admitting diagnosis;
(E)
diagnostic and therapeutic orders;
(F)
properly executed informed consent forms for procedures
and treatments specified by the medical staff, or by federal or state laws
if applicable, to require written patient consent;
(G)
clinical observations, including the results of therapy
and treatment, all orders, nursing notes, medication records, vital signs,
and other information necessary to monitor the patient's condition;
(H)
reports of procedures, tests, and their results, including
laboratory, pathology, and radiology reports;
(I)
results of all consultative evaluations of the patient
and appropriate findings by clinical and other staff involved in the care
of the patient;
(J)
discharge summary with outcome of hospitalization, disposition
of care, and provisions for follow-up care; and
(K)
final diagnosis with completion of medical records within
30 calendar days following discharge.
(9)
If a patient was less than 18 years of age at the time
he was last treated, the hospital may authorize the disposal of those medical
records relating to the patient on or after the date of his 20th birthday
or on or after the 10th anniversary of the date on which he was last treated,
whichever date is later.
(10)
The hospital shall not destroy medical records that relate
to any matter that is involved in litigation if the hospital knows the litigation
has not been finally resolved.
(11)
If a licensed hospital should close, the hospital shall
notify the department at the time of closure the disposition of the medical
records, including the location of where the medical records will be stored
and the identity and telephone number of the custodian of the records.
(k)
Medical staff.
(1)
The medical staff shall be composed of physicians and may
also be composed of podiatrists, dentists and other practitioners appointed
by the governing body.
(A)
The medical staff shall periodically conduct appraisals
of its members according to medical staff bylaws.
(B)
The medical staff shall examine credentials of candidates
for medical staff membership and make recommendations to the governing body
on the appointment of the candidate.
(2)
The medical staff shall be well organized and accountable
to the governing body for the quality of the medical care provided to patients.
(A)
The medical staff shall be organized in a manner approved
by the governing body.
(B)
If the medical staff has an executive committee, a majority
of the members of the committee shall be doctors of medicine or osteopathy.
(C)
Records of medical staff meetings shall be maintained.
(D)
The responsibility for organization and conduct of the
medical staff shall be assigned only to an individual physician.
(E)
Each medical staff member shall sign a statement signifying
they will abide by medical staff and hospital policies.
(3)
The medical staff shall adopt, implement, and enforce bylaws,
rules, and regulations to carry out its responsibilities. The bylaws shall:
(A)
be approved by the governing body;
(B)
include a statement of the duties and privileges of each
category of medical staff (e.g., active, courtesy, consultant);
(C)
describe the organization of the medical staff;
(D)
describe the qualifications to be met by a candidate in
order for the medical staff to recommend that the candidate be appointed by
the governing body;
(E)
include criteria for determining the privileges to be granted
and a procedure for applying the criteria to individuals requesting privileges;
and
(F)
include a requirement that a physical examination and medical
history be done no more than 30 days before or 24 hours after an admission
for each patient by a physician or other qualified practitioner who has been
granted these privileges by the medical staff. When the medical history and
physical examination are completed within the 30 days before admission, an
updated examination for any changes in the patient's condition must be completed
and documented in the patient's medical record within 24 hours after admission.
(l)
Mental health services.
(1)
Mental health services unit. A hospital may not admit patients
to a mental health services unit unless the unit is approved by the department
as meeting the requirements of §133.163(q) of this title.
(2)
Admission criteria. A hospital providing mental health
services shall have written admission criteria that are applied uniformly
to all patients who are admitted to the service.
(A)
The hospital's admission criteria shall include procedures
to prevent the admission of minors for a condition which is not generally
recognized as responsive to treatment in an inpatient setting for mental health
services.
(i)
The following conditions are not generally recognized as
responsive to treatment in a hospital unless the minor to be admitted is qualified
because of other disabilities, such as:
(I)
cognitive disabilities due to mental retardation; or
(II)
learning disabilities.
(ii)
A minor may be qualified for admission based on other
disabilities which would be responsive to mental health services.
(B)
The medical record shall contain evidence that admission
consent was given by the patient, the patient's legal guardian, or the managing
conservator, if applicable.
(C)
The hospital shall have a preadmission examination procedure
under which each patient's condition and medical history are reviewed by a
member of the medical staff to determine whether the patient is likely to
benefit significantly from an intensive inpatient program or assessment.
(D)
A voluntarily admitted patient shall sign an admission
consent form prior to admission to a mental health unit which includes verification
that the patient has been informed of the services to be provided and the
estimated charges.
(3)
Compliance. A hospital providing mental health services
shall comply with the following rules administered by the department. The
rules are:
(A)
Chapter 411, Subchapter J of this title (relating to Standards
of Care and Treatment in Psychiatric Hospitals);
(B)
Chapter 404, Subchapter E of this title (relating to Rights
of Persons Receiving Mental Health Services);
(C)
Chapter 405, Subchapter E of this title (relating to Electroconvulsive
Therapy (ECT));
(D)
Chapter 414, Subchapter I of this title (relating to Consent
to Treatment with Psychoactive Medication--Mental Health Services); and
(E)
Chapter 415, Subchapter F of this title (relating to Interventions
in Mental Health Programs).
(m)
Mobile, transportable, and relocatable units. The hospital
shall adopt, implement and enforce procedures which address the potential
emergency needs for those inpatients who are taken to mobile units on the
hospital's premises for diagnostic procedures or treatment.
(n)
Nuclear medicine services. If the hospital provides nuclear
medicine services, these services shall meet the needs of the patients in
accordance with acceptable standards of practice and be licensed in accordance
with §289.256 of this title (relating to Medical and Veterinary Use of
Radioactive Material).
(1)
Policies and procedures. Policies and procedures shall
be adopted, implemented, and enforced which will describe the services nuclear
medicine provides in the hospital and how employee and patient safety will
be maintained.
(2)
Organization and staffing. The organization of the nuclear
medicine services shall be appropriate to the scope and complexity of the
services offered.
(A)
There shall be a director who is a physician qualified
in nuclear medicine.
(B)
The qualifications, training, functions, and responsibilities
of nuclear medicine personnel shall be specified by the services director
and approved by the medical staff.
(3)
Delivery of services. Radioactive materials shall be prepared,
labeled, used, transported, stored, and disposed of in accordance with acceptable
standards of practice and in accordance with §289.256 of this title.
(A)
In-house preparation of radiopharmaceuticals shall be by,
or under, the direct supervision of an appropriately trained licensed pharmacist
or physician.
(B)
There shall be proper storage and disposal of radioactive
materials.
(C)
If clinical laboratory tests are performed by the nuclear
medicine services staff, the nuclear medicine staff shall comply with CLIA
1988 in accordance with the requirements specified in 42 CFR Part 493.
(D)
Nuclear medicine workers shall be provided personnel monitoring
dosimeters to measure their radiation exposure. Exposure reports and documentation
shall be available for review.
(4)
Equipment and supplies. Equipment and supplies shall be
appropriate for the types of nuclear medicine services offered and shall be
maintained for safe and efficient performance. The equipment shall be inspected,
tested, and calibrated at least annually by qualified personnel.
(5)
Records. The hospital shall maintain signed and dated reports
of nuclear medicine interpretations, consultations, and procedures.
(A)
The physician approved by the medical staff to interpret
diagnostic procedures shall sign and date the interpretations of these tests.
(B)
The hospital shall maintain records of the receipt and
disposition of radiopharmaceuticals until disposal is authorized by the department's
Radiation Safety Licensing Branch.
(C)
Nuclear medicine services shall be ordered only by an individual
whose scope of state licensure and whose defined staff privileges allow such
referrals.
(o)
Nursing services. The hospital shall have an organized
nursing service that provides 24-hour nursing services as needed.
(1)
Organization. The hospital shall have an organized nursing
service that provides 24-hour nursing care. The nursing service shall be well-organized
with a plan of administrative authority and delineation of responsibilities
for patient care.
(A)
Nursing services shall be under the administrative authority
of a chief nursing officer (CNO) who shall be an RN and comply with one of
the following:
(i)
possess a master's degree in nursing;
(ii)
possess a master's degree in health care administration
or business administration;
(iii)
possess a master's degree in a health-related field obtained
through a curriculum that included courses in administration and management;
or
(iv)
be progressing under a written plan to obtain the nursing
administration qualifications associated with a master's degree in nursing.
The plan shall:
(I)
describe efforts to obtain the knowledge associated with
graduate education and to increase administrative and management skills and
experience;
(II)
include courses related to leadership, administration,
management, performance improvement and theoretical approaches to delivering
nursing care; and
(III)
provide a time-line for accomplishing skills.
(B)
The CNO in hospitals with 100 or fewer licensed beds and
located in counties with a population of less than 50,000, or in hospitals
that have been certified by the Centers for Medicare and Medicaid Services
as critical access hospitals in accordance with the Code of Federal Regulations,
Title 42, Volume 3, Part 485, Subpart F, §485.606(b), shall be exempted
from the requirements in subparagraph (A)(i) - (iv) of this paragraph.
(C)
The CNO shall be responsible for the operation of the services,
including determining the types and numbers of nursing personnel and staff
necessary to provide nursing care for all areas of the hospital.
(D)
The CNO shall report directly to the individual who has
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 board.
(E)
The CNO shall participate with leadership from the governing
body, medical staff, and clinical areas, in planning, promoting and conducting
performance improvement activities.
(2)
Staffing and delivery of care.
(A)
The nursing services shall adopt, implement and enforce
a procedure to verify that hospital nursing personnel for whom licensure is
required have valid and current licensure.
(B)
There shall be adequate numbers of RNs, licensed vocational
nurses (LVNs), and other personnel to provide nursing care to all patients
as needed.
(C)
There shall be supervisory and staff personnel for each
department or nursing unit to provide, when needed, the immediate availability
of an RN to provide care for any patient.
(D)
An RN shall be on duty in each licensed hospital location
at all times. The RN shall supervise and evaluate the nursing care for each
patient and assign the nursing care to other nursing personnel in accordance
with the patient's needs and the specialized qualifications and competence
of the nursing staff available.
(E)
The nursing staff shall develop and keep current a nursing
plan of care for each patient which addresses the patient's needs.
(F)
At a minimum, the following critical factors shall be considered
in the determination of staffing levels:
(i)
patient characteristics and number of patients for whom
care is being provided, including number of admissions, discharges and transfers
on a unit;
(ii)
intensity of patient care being provided and variability
of patient care across a nursing unit;
(iii)
scope of services provided;
(iv)
context within which care is provided, including architecture
and geography of the environment, and the availability of technology; and
(v)
nursing staff characteristics, including staff consistency
and tenure, preparation and experience, and the number and competencies of
clinical and nonclinical support staff the nurse must collaborate with or
supervise.
(G)
The hospital shall adopt, implement and enforce a written
process for setting staffing levels that takes into account the critical factors
specified in subparagraph (F) of this paragraph. The process shall include:
(i)
establishing presumptive or initial staffing levels that
are recalculated at least annually or as necessary;
(ii)
setting staffing levels on a unit by unit basis or other
bases appropriate to the hospital;
(iii)
adjusting of staffing levels from shift to shift based
on factors, such as, the intensity of patient care; and
(iv)
reporting to the advisory committee, as referenced in
subparagraph (H) of this paragraph, showing variance between desired and actual
staffing levels, and an explanation for the variance. The reports shall be
confidential and not subject to disclosure under Government Code, Chapter
552, and not subject to disclosure, discovery, subpoena or other means of
legal compulsion for their release.
(H)
The hospital shall designate an advisory committee established
in accordance with Health and Safety Code (HSC), §§161.031 - 161.033,
to be responsible for soliciting and receiving input from nurses on the development,
ongoing monitoring, and evaluation of the staffing plan. As provided by HSC, §161.032,
the hospital's records and review relating to evaluation of these outcomes
and indicators are confidential and not subject to disclosure under Government
Code, Chapter 552 and not subject to disclosure, discovery, subpoena or other
means of legal compulsion for their release. The committee shall:
(i)
have, as one-third of its members, registered nurses who
are involved in direct patient care at least 50% of their work time;
(ii)
include at least one representative from either infection
control, quality assessment and program improvement or risk management; and
(iii)
to the extent feasible, represent multiple areas of nursing
practice.
(I)
The hospital shall adopt, implement and enforce a written
staffing plan.
(i)
The staffing plan shall:
(I)
be consistent with standards established by the Texas nurse
licensing board and should be developed based upon a review of the codes of
ethics developed by the nursing profession through national nursing organizations;
(II)
utilize outcomes and nursing-sensitive indicators as an
integral role in setting and evaluating the adequacy of the staffing plan.
At least one from each of the following three types of outcomes shall be correlated
to the adequacy of staffing:
(-a-)
patient outcomes that are nursing-sensitive, such as,
patient falls, adverse drug events, injuries to patients, skin breakdown,
pneumonia, infection rates, upper gastrointestinal bleeding, shock, cardiac
arrest, length of stay, or patient readmissions;
(-b-)
operational outcomes, such as, work-related injury or
illness, vacancy and turnover rates, nursing care hours per patient day, on-call
use, or overtime rates; and
(-c-)
substantiated patient complaints related to staffing
levels;
(III)
incorporate a process that facilitates the timely and
effective identification of concerns about the adequacy of the staffing plan
by the advisory committee established pursuant to subparagraph (H) of this
paragraph. This process shall include:
(-a-)
a prohibition on retaliation for reporting concerns;
(-b-)
a requirement that nurses report concerns timely through
appropriate channels within the hospital;
(-c-)
orientation of nurses on how to report concerns and to
whom;
(-d-)
a process for providing feedback during the advisory
committee meeting on how concerns are addressed by the advisory committee
established under subparagraph (H) of this paragraph; and
(-e-)
use of the nurse safe harbor peer review process pursuant
to Occupations Code, §303.005;
(IV)
include policies and procedures that require:
(-a-)
orientation of nurses and other personnel who provide
nursing care to all units to which they are assigned on either a temporary
or permanent basis;
(-b-)
that the orientation of nurses and other personnel and
the competency to perform nursing services is documented in accordance with
hospital policy;
(-c-)
that nursing assignments be congruent with documented
competency; and
(V)
when utilized as a means for meeting staffing needs, include
policy and procedures for mandatory overtime. The policy and procedures shall
include:
(-a-)
documentation of the basis and justification for mandatory
overtime;
(-b-)
an action plan for the reduction or elimination of the
use of mandatory overtime to meet staffing needs;
(-c-)
a process for monitoring and evaluating the use of mandatory
overtime; and
(-d-)
procedures for notifying nurses and other personnel who
provide nursing care of the mandatory overtime policy. As used in this subsection,
"mandatory overtime" means being required to work, other than on-call time,
when not scheduled including beyond hours or days scheduled. Neither the length
of the shift (whether 4, 8, 12, or 16 hours) nor the number of shifts scheduled
to work (whether 4, 5, or 6 a week) is the determinative factor in defining
mandatory overtime.
(ii)
There shall be an annual evaluation of the nurse staffing
plan, including an evaluation of the outcomes and nursing-sensitive indicators
as set out in clause (i)(II) of this subparagraph. This evaluation shall be
documented in the minutes of the advisory committee established under subparagraph
(H) of this paragraph. Hospitals may determine whether this evaluation is
done on a unit or facility level basis.
(iii)
The staffing plan shall be retained for a period of two
years.
(J)
Nonemployee licensed nurses who are working in the hospital
shall adhere to the policies and procedures of the hospital. The CNO shall
provide for the adequate orientation, supervision, and evaluation of the clinical
activities of nonemployee nursing personnel which occur within the responsibility
of the nursing services.
(3)
Drugs and biologicals. Drugs and biologicals shall be prepared
and administered in accordance with federal and state laws, the orders of
the individuals granted privileges by the medical staff, and accepted standards
of practice.
(A)
All drugs and biologicals shall be administered by, or
under supervision of, nursing or other personnel in accordance with federal
and state laws and regulations, including applicable licensing rules, and
in accordance with the approved medical staff policies and procedures.
(B)
All orders for drugs and biologicals shall be in writing,
dated, timed, and signed by the individual responsible for the care of the
patient as specified under subsection (f)(6)(A) of this section. When telephone
or verbal orders must be used, they shall be:
(i)
accepted only by personnel who are authorized to do so
by the medical staff policies and procedures, consistent with federal and
state laws;
(ii)
dated, timed, and authenticated promptly as specified
by hospital policy by the prescriber or another practitioner who is responsible
for the care of the patient and has been credentialed by the medical staff
and granted privileges which are consistent with the written orders; and
(iii)
used infrequently.
(C)
There shall be a hospital procedure for immediately reporting
transfusion reactions, adverse drug reactions, and errors in administration
of drugs to the attending physician and, if appropriate, to the hospital-wide
quality assessment and performance improvement program.
(4)
Blood transfusions.
(A)
There shall be a written protocol for the administration
of blood and blood components and the use of infusion devices and ancillary
equipment.
(B)
Personnel administering blood transfusions and intravenous
medications shall have special training for this duty according to written,
adopted, implemented and enforced hospital policy.
(C)
Blood and blood components shall be transfused through
a sterile, pyrogen-free transfusion set that has a filter designed to retain
particles potentially harmful to the recipient.
(D)
Transfusions shall be prescribed and administered under
medical direction. The patient must be observed during the transfusion and
for an appropriate time thereafter for suspected adverse reactions.
(E)
Pretransfusion and posttransfusion vital signs shall be
recorded.
(F)
When warming of blood is indicated, this shall be accomplished
during its passage through the transfusion set. The warming system shall be
equipped with a visible thermometer and may have an audible warning system.
Blood shall not be warmed above 42 degrees Celsius.
(G)
Drugs or medications, including those intended for intravenous
use, shall not be added to blood or blood components. A 0.9% sodium chloride
injection, United States Pharmacopeia, may be added to blood or blood components.
Other solutions intended for intravenous use may be used in an administration
set or added to blood or blood components under either of the following conditions:
(i)
they have been approved for this use by the Federal Drug
Administration; or
(ii)
there is documentation available to show that addition
to the component involved is safe and efficacious.
(H)
There shall be a system for detection, reporting and evaluation
of suspected complications of transfusion. Any adverse event experienced by
a patient in association with a transfusion is to be regarded as a suspected
transfusion complication. In the event of a suspected transfusion complication,
the personnel attending the patient shall notify immediately a responsible
physician and the transfusion service and document the complication in the
patient's medical record. All suspected transfusion complications shall be
evaluated promptly according to an established procedure.
(I)
Following the transfusion, the blood transfusion record
or a copy shall be made a part of the patient's medical record.
(5)
Reporting and peer review of a vocational or registered
nurse. A hospital shall adopt, implement, and enforce a policy to ensure that
the hospital complies with the Occupations Code §§301.401 - 301.403,
301.405 and Chapter 303 (relating to Grounds for Reporting Nurse, Duty of
Nurse to Report, Duty of Peer Review Committee to Report, Duty of Person Employing
Nurse to Report, and Nursing Peer Review respectively), and with the rules
adopted by the Board of Nurse Examiners in 22 TAC §217.16 (relating to
Minor Incidents), §217.19 (relating to Incident-Based Nursing Peer Review),
and §217.20 (relating to Safe Harbor Peer Review for Nurses).
(6)
Policies and procedures related to workplace safety.
(A)
The hospital shall adopt, implement and enforce policies
and procedures related to the work environment for nurses which:
(i)
improve workplace safety and reduce the risk of injury,
occupational illness, and violence; and
(ii)
increase the use of ergonomic principles and ergonomically
designed devices to reduce injury and fatigue.
(B)
The policies and procedures adopted under subparagraph
(A) of this paragraph, at a minimum, must include:
(i)
evaluating new products and technology that incorporate
ergonomic principles;
(ii)
educating nurses in the application of ergonomic practices;
(iii)
conducting workplace audits to identify areas of risk
of injury, occupational illness, or violence and recommending ways to reduce
those risks;
(iv)
controlling access to those areas identified as having
a high risk of violence; and
(v)
promptly reporting crimes committed against nurses to appropriate
law enforcement agencies.
(7)
Safe patient handling and movement practices.
(A)
The hospital shall adopt, implement and enforce policies
and procedures to identify, assess, and develop strategies to control risk
of injury to patients and nurses associated with the lifting, transferring,
repositioning, or movement of a patient.
(B)
The polices and procedures shall establish a process that,
at a minimum, includes the following:
(i)
analysis of the risk of injury to both patients and nurses
posed by the patient handling needs of the patient populations served by the
hospital and the physical environment in which patient handling and movement
occurs;
(ii)
education of nurses in the identification, assessment,
and control of risks of injury to patients and nurses during patient handling;
(iii)
evaluation of alternative ways to reduce risks associated
with patient handling, including evaluation of equipment and the environment;
(iv)
restriction, to the extent feasible with existing equipment
and aids, of manual patient handling or movement of all or most of a patient's
weight to emergency, life-threatening, or otherwise exceptional circumstances;
(v)
collaboration with and annual report to the nurse staffing
committee;
(vi)
procedures for nurses to refuse to perform or be involved
in patient handling or movement that the nurse believes in good faith will
expose a patient or a nurse to an unacceptable risk of injury;
(vii)
submission of an annual report to the governing body
on activities related to the identification, assessment, and development of
strategies to control risk of injury to patients and nurses associated with
the lifting, transferring, repositioning, or movement of a patient; and
(viii)
development of architectural plans for constructing
or remodeling a hospital or a unit of a hospital in which patient handling
and movement occurs, with consideration of the feasibility of incorporating
patient handling equipment or the physical space and construction design needed
to incorporate that equipment at a later date.
(p)
Outpatient services. If the hospital provides outpatient
services, the services shall meet the needs of the patients in accordance
with acceptable standards of practice.
(1)
Organization. Outpatient services shall be appropriately
organized and integrated with inpatient services.
(2)
Personnel.
(A)
The hospital shall assign an individual to be responsible
for outpatient services.
(B)
The hospital shall have appropriate physicians on staff
and other professional and nonprofessional personnel available.
(q)
Pharmacy services. The hospital shall provide pharmaceutical
services that meet the needs of the patients.
(1)
Compliance. The hospital shall provide a pharmacy which
is licensed, as required, by the Texas State Board of Pharmacy. Pharmacy services
shall comply with all applicable statutes and rules.
(2)
Organization. The hospital shall have a pharmacy directed
by a licensed pharmacist.
(3)
Medical staff. The medical staff shall be responsible for
developing policies and procedures that minimize drug errors. This function
may be delegated to the hospital's organized pharmaceutical services.
(4)
Pharmacy management and administration. The pharmacy or
drug storage area shall be administered in accordance with accepted professional
principles.
(A)
Standards of practice as defined by state law shall be
followed regarding the provision of pharmacy services.
(B)
The pharmaceutical services shall have an adequate number
of personnel to ensure quality pharmaceutical services including emergency
services.
(i)
The staff shall be sufficient in number and training to
respond to the pharmaceutical needs of the patient population being served.
There shall be an arrangement for emergency services.
(ii)
Employees shall provide pharmaceutical services within
the scope of their license and education.
(C)
Drugs and biologicals shall be properly stored to ensure
ventilation, light, security, and temperature controls.
(D)
Records shall have sufficient detail to follow the flow
of drugs from entry through dispensation.
(E)
There shall be adequate controls over all drugs and medications
including the floor stock. Drug storage areas shall be approved by the pharmacist,
and floor stock lists shall be established.
(F)
Inspections of drug storage areas shall be conducted throughout
the hospital under pharmacist supervision.
(G)
There shall be a drug recall procedure.
(H)
A full-time, part-time, or consulting pharmacist shall
be responsible for developing, supervising, and coordinating all the activities
of the pharmacy services.
(i)
Direction of pharmaceutical services may not require on
premises supervision but may be accomplished through regularly scheduled visits
in accordance with state law.
(ii)
A job description or other written agreement shall clearly
define the responsibilities of the pharmacist.
(I)
Current and accurate records shall be kept of the receipt
and disposition of all scheduled drugs.
(i)
There shall be a record system in place that provides the
information on controlled substances in a readily retrievable manner which
is separate from the patient record.
(ii)
Records shall trace the movement of scheduled drugs throughout
the services, documenting utilization or wastage.
(iii)
The pharmacist shall be responsible for determining that
all drug records are in order and that an account of all scheduled drugs is
maintained and reconciled with written orders.
(5)
Delivery of services. In order to provide patient safety,
drugs and biologicals shall be controlled and distributed in accordance with
applicable standards of practice, consistent with federal and state laws.
(A)
All compounding, packaging, and dispensing of drugs and
biologicals shall be under the supervision of a pharmacist and performed consistent
with federal and state laws.
(B)
Drugs and biologicals shall be kept in a locked storage
area.
(i)
A policy shall be adopted, implemented, and enforced to
ensure the safeguarding, transferring, and availability of keys to the locked
storage area.
(ii)
Dangerous drugs as well as controlled substances shall
be secure from unauthorized use.
(C)
Outdated, mislabeled, or otherwise unusable drugs and biologicals
shall not be available for patient use.
(D)
When a pharmacist is not available, drugs and biologicals
shall be removed from the pharmacy or storage area only by personnel designated
in the policies of the medical staff and pharmaceutical service, in accordance
with federal and state laws.
(i)
There shall be a current list of individuals identified
by name and qualifications who are designated to remove drugs from the pharmacy.
(ii)
Only amounts sufficient for immediate therapeutic needs
shall be removed.
(E)
Drugs and biologicals not specifically prescribed as to
time or number of doses shall automatically be stopped after a reasonable
time that is predetermined by the medical staff.
(i)
Stop order policies and procedures shall be consistent
with those of the nursing staff and the medical staff rules and regulations.
(ii)
A protocol shall be established by the medical staff for
the implementation of the stop order policy, in order that drugs shall be
reviewed and renewed, or automatically stopped.
(iii)
A system shall be in place to determine compliance with
the stop order policy.
(F)
Drug administration errors, adverse drug reactions, and
incompatibilities shall be immediately reported to the attending physician
and, if appropriate, to the hospital-wide quality assessment and performance
improvement program. There shall be a mechanism in place for capturing, reviewing,
and tracking medication errors and adverse drug reactions.
(G)
Abuses and losses of controlled substances shall be reported,
in accordance with applicable federal and state laws, to the individual responsible
for the pharmaceutical services, and to the chief executive officer, as appropriate.
(H)
Information relating to drug interactions and information
on drug therapy, side effects, toxicology, dosage, indications for use, and
routes of administration shall be immediately available to the professional
staff.
(i)
A pharmacist shall be readily accessible by telephone or
other means to discuss drug therapy, interactions, side effects, dosage, assist
in drug selection, and assist in the identification of drug induced problems.
(ii)
There shall be staff development programs on drug therapy
available to facility staff to cover such topics as new drugs added to the
formulary, how to resolve drug therapy problems, and other general information
as the need arises.
(I)
A formulary system shall be established by the medical
staff to ensure quality pharmaceuticals at reasonable costs.
(r)
Quality assessment and performance improvement. The governing
body shall ensure that there is an effective, ongoing, hospital-wide, data-driven
quality assessment and performance improvement (QAPI) program to evaluate
the provision of patient care.
(1)
Program scope. The hospital-wide QAPI program shall reflect
the complexity of the hospital's organization and services and have a written
plan of implementation. The program must include an ongoing program that shows
measurable improvements in the indicators for which there is evidence that
they will improve health outcomes, and identify and reduce medical errors.
(A)
All hospital departments and services, including services
furnished under contract or arrangement, shall be evaluated.
(B)
Health care associated infections shall be evaluated.
(C)
Medication therapy shall be evaluated.
(D)
All medical and surgical services performed in the hospital
shall be evaluated as they relate to appropriateness of diagnosis and treatment.
(E)
The program must measure, analyze and track quality indicators,
including adverse patients' events, and other aspects of performance that
assess processes of care, hospital services and operations.
(F)
Data collected must be used to monitor the effectiveness
and safety of service and quality of care, and to identify opportunities for
changes that will lead to improvement.
(G)
Priorities must be established for performance improvement
activities that focus on high-risk, high-volume, or problem-prone areas, taking
into consideration the incidence, prevalence and severity of problems in those
areas, and how health outcomes and quality of care may be affected.
(H)
Performance improvement activities which affect patient
safety, including analysis of medical errors and adverse patient events, must
be established, and preventive actions implemented.
(I)
Success of actions implemented as a result of performance
improvement activities must be measured, and ongoing performance must be tracked
to ensure improvements are sustained.
(2)
Responsibility and accountability. The hospital's governing
body, medical staff and administrative staff are responsible and accountable
for ensuring that:
(A)
an ongoing program for quality improvement is defined,
implemented and maintained, and that program requirements are met;
(B)
an ongoing program for patient safety, including reduction
of medical errors, is defined, implemented and maintained;
(C)
the hospital-wide QAPI efforts address priorities for improved
quality of care and patient safety, and that all improvement actions are evaluated;
and
(D)
adequate resources are allocated for measuring, assessing,
improving and sustaining the hospital's resources, and for reducing risk to
patients.
(3)
Medically-related patient care services. The hospital shall
have an ongoing plan, consistent with available community and hospital resources,
to provide or make available social work, psychological, and educational services
to meet the medically-related needs of its patients. The hospital also shall
have an effective, ongoing discharge planning program that facilitates the
provision of follow-up care.
(A)
Discharge planning shall be completed prior to discharge.
(B)
Patients, along with necessary medical information, shall
be transferred or referred to appropriate facilities, agencies, or outpatient
services, as needed for follow-up or ancillary care.
(4)
Implementation. The hospital must take actions aimed at
performance improvement and, after implementing those actions, the hospital
must measure its success, and track performance to ensure that improvements
are sustained.
(s)
Radiology services. The hospital shall maintain, or have
available, diagnostic radiologic services according to needs of the patients.
All radiology equipment, including X-ray equipment, mammography equipment
and laser equipment, shall be licensed and registered as required under Chapter
289 of this title (relating to Radiation Control). If therapeutic services
are also provided, the services, as well as the diagnostic services, shall
meet professionally approved standards for safety and personnel qualifications
as required in §§289.227, 289.229, 289.230 and 289.231 of this title
(relating to Registration Regulations). In a special hospital, portable X-ray
equipment may be acceptable as a minimum requirement.
(1)
Policies and procedures. Policies and procedures shall
be adopted, implemented and enforced which will describe the radiology services
provided in the hospital and how employee and patient safety will be maintained.
(2)
Safety for patients and personnel. The radiology services,
particularly ionizing radiology procedures, shall minimize hazards to patients
and personnel.
(A)
Proper safety precautions shall be maintained against radiation
hazards. This includes adequate radiation shielding, safety procedures and
equipment maintenance and testing.
(B)
Inspection of equipment shall be made by or under the supervision
of a licensed medical physicist in accordance with §289.227(o) of this
title (relating to Use of Radiation Machines in the Healing Arts). Defective
equipment shall be promptly repaired or replaced.
(C)
Radiation workers shall be provided personnel monitoring
dosimeters to measure the amount of radiation exposure they receive. Exposure
reports and documentation shall be available for review.
(D)
Radiology services shall be provided only on the order
of individuals granted privileges by the medical staff.
(3)
Personnel.
(A)
A qualified full-time, part-time, or consulting radiologist
shall supervise the ionizing radiology services and shall interpret only those
radiology tests that are determined by the medical staff to require a radiologist's
specialized knowledge. For purposes of this section a radiologist is a physician
who is qualified by education and experience in radiology in accordance with
medical staff bylaws.
(B)
Only personnel designated as qualified by the medical staff
shall use the radiology equipment and administer procedures.
(4)
Records. Records of radiology services shall be maintained.
The radiologist or other individuals who have been granted privileges to perform
radiology services shall sign reports of his or her interpretations.
(t)
Renal dialysis services.
(1)
Equipment.
(A)
Maintenance and repair. All equipment used by a facility,
including backup equipment, shall be operated within manufacturer's specifications,
and maintained free of defects which could be a potential hazard to patients,
staff, or visitors. Maintenance and repair of all equipment shall be performed
by qualified staff or contract personnel.
(i)
Staff shall be able to identify malfunctioning equipment
and report such equipment to the appropriate staff for immediate repair.
(ii)
Medical equipment that malfunctions must be clearly labeled
and immediately removed from service until the malfunction is identified and
corrected.
(iii)
Written evidence of all maintenance and repairs shall
be maintained.
(iv)
After repairs or alterations are made to any equipment
or system, the equipment or system shall be thoroughly tested for proper operation
before returning to service. This testing must be documented.
(v)
A facility shall comply with the federal Food, Drug, and
Cosmetic Act, 21 United States Code (USC), §360i(b), concerning reporting
when a medical device as defined in 21 USC §321(h) has or may have caused
or contributed to the injury or death of a patient of the facility.
(B)
Preventive maintenance. A facility shall develop, implement
and enforce a written preventive maintenance program to ensure patient care
related equipment used in a facility receives electrical safety inspections,
if appropriate, and maintenance at least annually or more frequently as recommended
by the manufacturer. The preventive maintenance may be provided by facility
staff or by contract.
(C)
Backup machine. At least one complete dialysis machine
shall be available on site as backup for every ten dialysis machines in use.
At least one of these backup machines must be completely operational during
hours of treatment. Machines not in use during a patient shift may be counted
as backup except at the time of an initial or an expansion survey.
(D)
Pediatric patients. If pediatric patients are treated,
a facility shall use equipment and supplies, to include blood pressure cuffs,
dialyzers, and blood tubing, appropriate for this special population.
(E)
Emergency equipment and supplies. A facility shall have
emergency equipment and supplies immediately accessible in the treatment area.
(i)
At a minimum, the emergency equipment and supplies shall
include the following:
(I)
oxygen;
(II)
mechanical ventilatory assistance equipment, to include
airways, manual breathing bag, and mask;
(III)
suction equipment;
(IV)
supplies specified by the medical director;
(V)
electrocardiograph; and
(VI)
automated external defibrillator or defibrillator.
(ii)
If pediatric patients are treated, the facility shall
have the appropriate type and size emergency equipment and supplies listed
in clause (i) of this subparagraph for this special population.
(iii)
A facility shall establish, implement, and enforce a
policy for the periodic testing and maintenance of the emergency equipment.
Staff shall properly maintain and test the emergency equipment and supplies
and document the testing and maintenance.
(F)
Transducer protector. A transducer protector shall be replaced
when wetted during a dialysis treatment and shall be used for one treatment
only.
(2)
Water treatment and dialysate concentrates.
(A)
Compliance required. A facility shall meet the requirements
of this section. A facility may follow more stringent requirements than the
minimum standards required by this section.
(i)
The facility administrator and medical director shall each
demonstrate responsibility for the water treatment and dialysate supply systems
to protect hemodialysis patients from adverse effects arising from known chemical
and microbial contaminates that may be found in improperly prepared dialysate,
to ensure that the dialysate is correctly formulated and meets the requirements
of all applicable quality standards.
(ii)
The facility administrator and medical director must assure
that policies and procedures related to water treatment and dialysate are
understandable and accessible to the operator(s) and that the training program
includes quality testing, risks and hazards of improperly prepared concentrate
and bacterial issues.
(iii)
The facility administrator and medical director must
be informed prior to any alteration of, or any device being added to, the
water system.
(B)
Water treatment. These requirements apply to water intended
for use in the delivery of hemodialysis, including the preparation of concentrates
from powder at a dialysis facility and dialysate.
(i)
The design for the water treatment system in a facility
shall be based on considerations of the source water for the facility and
designed by a water quality professional with education, training, or experience
in dialysis system design.
(ii)
When a public water system supply is not used by a facility,
the source water shall be tested by the facility at monthly intervals in the
same manner as a public water system as described in 30 TAC §290.104
(relating to Summary of Maximum Contaminant Levels, Maximum Residual Disinfectant
Levels, Treatment Techniques, and Action Levels) and §290.109 (relating
to Microbial Contaminants) as adopted by the Texas Commission on Environmental
Quality (TCEQ).
(iii)
The physical space in which the water treatment system
is located must be adequate to allow for maintenance, testing, and repair
of equipment. If mixing of dialysate is performed in the same area, the physical
space must also be adequate to house and allow for the maintenance, testing,
and repair of the mixing equipment and for performing the mixing procedure.
(iv)
The water treatment system components shall be arranged
and maintained so that bacterial and chemical contaminant levels in the product
water do not exceed the standards for hemodialysis water quality described
in §4.2.1 (concerning Water Bacteriology) and §4.2.2 (concerning
Maximum Level of Chemical Contaminants) of the American National Standard,
Water Treatment Equipment for Hemodialysis Applications, August 2001 Edition,
published by the Association for the Advancement of Medical Instrumentation
(AAMI). All documents published by the AAMI as referenced in this section
may be obtained by writing the following address: 1110 North Glebe Road, Suite
220, Arlington, Virginia 22201.
(v)
Written policies and procedures for the operation of the
water treatment system must be developed and implemented. Parameters for the
operation of each component of the water treatment system must be developed
in writing and known to the operator. Each major water system component shall
be labeled in a manner that identifies the device; describes its function,
how performance is verified and actions to take in the event performance is
not within an acceptable range.
(vi)
The materials of any components of water treatment systems
(including piping, storage, filters and distribution systems) that contact
the purified water shall not interact chemically or physically so as to affect
the purity or quality of the product water adversely. Such components shall
be fabricated from unreactive materials (e.g. plastics) or appropriate stainless
steel. The use of materials that are known to cause toxicity in hemodialysis,
such as copper, brass, galvanized material, or aluminum, is prohibited.
(vii)
Chemicals infused into the water such as iodine, acid,
flocculants, and complexing agents shall be shown to be nondialyzable or shall
be adequately removed from product water. Monitors or specific test procedures
to verify removal of additives shall be provided and documented.
(viii)
Each water treatment system shall include reverse osmosis
membranes or deionization tanks and a minimum of two carbon tanks in series.
If the source water is from a private supply which does not use chlorine/chloramine,
the water treatment system shall include reverse osmosis membranes or deionization
tanks and a minimum of one carbon tank.
(I)
Reverse osmosis membranes. Reverse osmosis membranes, if
used, shall meet the standards in §4.3.7 (concerning Reverse Osmosis)
of the American National Standard, Water Treatment Equipment for Hemodialysis
Applications, August 2001 Edition, published by the AAMI.
(II)
Deionization systems.
(-a-)
Deionization systems, if used, shall be monitored continuously
to produce water of one megohm-centimeter (cm) or greater specific resistivity
(or conductivity of one microsiemen/cm or less) at 25 degrees Celsius. An
audible and visual alarm shall be activated when the product water resistivity
falls below this level and the product water stream shall be prevented from
reaching any point of use.
(-b-)
Patients shall not be dialyzed on deionized water with
a resistivity less than 1.0 megohm-cm measured at the output of the deionizer.
(-c-)
A minimum of two deionization (DI) tanks in series shall
be used with resistivity monitors including audible and visual alarms placed
pre and post the final DI tank in the system. The alarms must be audible in
the patient care area.
(-d-)
Feed water for deionization systems shall be pretreated
with activated carbon adsorption, or a comparable alternative, to prevent
nitrosamine formation.
(-e-)
If a deionization system is the last process in a water
treatment system, it shall be followed by an ultrafilter or other bacteria
and endotoxin reducing device.
(III)
Carbon tanks.
(-a-)
The carbon tanks must contain acid washed carbon, 30-mesh
or smaller with a minimum iodine number of 900.
(-b-)
A minimum of two carbon adsorption beds shall be installed
in a series configuration.
(-c-)
The total empty bed contact time (EBCT) shall be at least
ten minutes, with the final tank providing at least five minutes EBCT. Carbon
adsorption systems used to prepare water for portable dialysis systems are
exempt from the requirement for the second carbon and a ten minute EBCT if
removal of chloramines to below 0.1 milligram (mg)/1 is verified before each
treatment.
(-d-)
A means shall be provided to sample the product water
immediately prior to the final bed(s). Water from this port(s) must be tested
for chlorine/chloramine levels immediately prior to each patient shift.
(-e-)
All samples for chlorine/chloramine testing must be drawn
when the water treatment system has been operating for at least 15 minutes.
(-f-)
Tests for total chlorine, which include both free and
combined forms of chlorine, may be used as a single analysis with the maximum
allowable concentration of 0.1 mg/liter (L). Test results of greater than
0.5 parts per million (ppm) for chlorine or 0.1 ppm for chloramine from the
port between the initial tank(s) and final tank(s) shall require testing to
be performed at the final exit and replacement of the initial tank(s).
(-g-)
In a system without a holding tank, if test results at
the exit of the final tank(s) are greater than the parameters for chlorine
or chloramine described in this subclause, dialysis treatment shall be immediately
terminated to protect patients from exposure to chlorine/chloramine and the
medical director shall be notified. In systems with holding tanks, if the
holding tank tests <0.1 mg/L for total chlorine, the reverse osmosis (RO)
may be turned off and the product water in the holding tank may be used to
finish treatments in process. The medical director shall be notified.
(-h-)
If means other than granulated carbon are used to remove
chlorine/chloramine, the facility's governing body must approve such use in
writing after review of the safety of the intended method for use in hemodialysis
applications. If such methods include the use of additives, there must be
evidence the product water does not contain unsafe levels of these additives.
(ix)
Water softeners, if used, shall be tested at the end of
the treatment day to verify their capacity to treat a sufficient volume of
water to supply the facility for the entire treatment day and shall be fitted
with a mechanism to prevent water containing the high concentrations of sodium
chloride used during regeneration from entering the product water line during
regeneration.
(x)
If used, the face(s) of timer(s) used to control any component
of the water treatment or dialysate delivery system shall be visible to the
operator at all times. Written evidence that timers are checked for operation
and accuracy each day of operation must be maintained.
(xi)
Filter housings, if used during disinfectant procedures,
shall include a means to clear the lower portion of the housing of the disinfecting
agents. Filter housings shall be opaque.
(xii)
Ultrafilters, or other bacterial reducing filters, if
used, shall be fitted with pressure gauges on the inlet and outlet water lines
to monitor the pressure drop across the membrane. Ultrafilters shall be included
in routine disinfection procedures.
(xiii)
If used, storage tanks shall have a conical or bowl
shaped base and shall drain from the lowest point of the base. Storage tanks
shall have a tight-fitting lid and be vented through a hydrophobic 0.2 micron
air filter. Means shall be provided to effectively disinfect any storage tank
installed in a water distribution system.
(xiv)
Ultraviolet (UV) lights, if used, shall be monitored
at the frequency recommended by the manufacturer. A log sheet shall be used
to record monitoring.
(xv)
Water treatment system piping shall be labeled to indicate
the contents of the pipe and direction of flow.
(xvi)
The water treatment system must be continuously monitored
during patient treatment and be guarded by audible and visual alarms which
can be seen and heard in the dialysis treatment area should water quality
drop below specific parameters. Quality monitor sensing cells shall be located
as the last component of the water treatment system and at the beginning of
the distribution system. No water treatment components that could affect the
quality of the product water as measured by this device shall be located after
the sensing cell.
(xvii)
When deionization tanks do not follow a reverse osmosis
system, parameters for the rejection rate of the membranes must assure that
the lowest rate accepted would provide product water in compliance with §4.2.2
(concerning Maximum Level of Chemical Contaminants) of the American National
Standard, Water Treatment Equipment for Hemodialysis Applications, August
2001 Edition published by the AAMI.
(xviii)
A facility shall maintain written logs of the operation
of the water treatment system for each treatment day. The log book shall include
each component's operating parameter and the action taken when a component
is not within the facility's set parameters.
(xix)
Microbiological testing of product water shall be conducted.
(I)
Frequency. Microbiological testing shall be conducted monthly
and following any repair or change to the water treatment system. For a newly
installed water distribution system, or when a change has been made to an
existing system, weekly testing shall be conducted for one month to verify
that bacteria and endotoxin levels are consistently within the allowed limits.
(II)
Sample sites. At a minimum, sample sites chosen for the
testing shall include the beginning of the distribution piping, at any site
of dialysate mixing, and the end of the distribution piping.
(III)
Technique. Samples shall be collected immediately before
sanitization/disinfection of the water treatment system and dialysis machines.
Water testing results shall be routinely trended and reviewed by the medical
director in order to determine if results seem questionable or if there is
an opportunity for improvement. The medical director shall determine if there
is a need for retesting. Repeated results of "no growth" shall be validated
via an outside laboratory. A calibrated loop may not be used in microbiological
testing of water samples. Colonies shall be counted using a magnifying device.
(IV)
Expected results. Product water used to prepare dialysate,
concentrates from powder, or to reprocess dialyzers for multiple use, shall
contain a total viable microbial count less than 200 colony forming units
(CFU)/millimeter (ml) and an endotoxin concentration less than 2 endotoxin
units (EU)/ml. The action level for the total viable microbial count in the
product water shall be 50 CFU/ml and the action level for the endotoxin concentration
shall be 1 EU/ml.
(V)
Required action for unacceptable results. If the action
levels described at subclause (IV) of this clause are observed in the product
water, corrective measures shall be taken promptly to reduce the levels into
an acceptable range.
(VI)
Records. All bacteria and endotoxin results shall be recorded
on a log sheet in order to identify trends that may indicate the need for
corrective action.
(xx)
If ozone generators are used to disinfect any portion
of the water or dialysate delivery system, testing based on the manufacturer's
direction shall be used to measure the ozone concentration each time disinfection
is performed, to include testing for safe levels of residual ozone at the
end of the disinfection cycle. Testing for ozone in the ambient air shall
be conducted on a periodic basis as recommended by the manufacturer. Records
of all testing must be maintained in a log.
(xxi)
If used, hot water disinfection systems shall be monitored
for temperature and time of exposure to hot water as specified by the manufacturer.
Temperature of the water shall be recorded at a point furthest from the water
heater, where the lowest water temperature is likely to occur. The water temperature
shall be measured each time a disinfection cycle is performed. A record that
verifies successful completion of the heat disinfection shall be maintained.
(xxii)
After chemical disinfection, means shall be provided
to restore the equipment and the system in which it is installed to a safe
condition relative to residual disinfectant prior to the product water being
used for dialysis applications.
(xxiii)
Samples of product water must be submitted for chemical
analysis every six months and must demonstrate that the quality of the product
water used to prepare dialysate or concentrates from powder, meets §4.2.2
(concerning Maximum Level of Chemical Contaminants) of the American National
Standard, Water Treatment Equipment for Hemodialysis Applications, August
2001 Edition, published by the AAMI.
(I)
Samples for chemical analysis shall be collected at the
end of the water treatment components and at the most distal point in each
water distribution loop, if applicable. All other outlets from the distribution
loops shall be inspected to ensure that the outlets are fabricated from compatible
materials. Appropriate containers and pH adjustments shall be used to ensure
accurate determinations. New facilities or facilities that add or change the
configuration of the water distribution system must draw samples at the most
distal point for each water distribution loop, if applicable, on a one time
basis.
(II)
Additional chemical analysis shall be submitted if substantial
changes are made to the water treatment system or if the percent rejection
of a reverse osmosis system decreased 5.0% or more from the percent rejection
measured at the time the water sample for the preceding chemical analysis
was taken.
(xxiv)
Facility records must include all test results and evidence
that the medical director has reviewed the results of the water quality testing
and directed corrective action when indicated.
(xxv)
Only persons qualified by the education or experience
may operate, repair, or replace components of the water treatment system.
(C)
Dialysate.
(i)
Quality control procedures shall be established to ensure
ongoing conformance to policies and procedures regarding dialysate quality.
(ii)
Each facility shall set all hemodialysis machines to use
only one family of concentrates. When new machines are put into service, or
the concentrate family or concentrate manufacturer is changed, samples shall
be sent to a laboratory for verification.
(iii)
Prior to each patient treatment, staff shall verify the
dialysate conductivity and pH of each machine with an independent device.
(iv)
Bacteriological testing shall be conducted.
(I)
Frequency. Responsible facility staff shall develop a schedule
to ensure each hemodialysis machine is tested quarterly for bacterial growth
and the presence of endotoxins. Hemodialysis machines of home patients shall
be cultured monthly until results not exceeding 200 CFU/ml are obtained for
three consecutive months, then quarterly samples shall be cultured.
(II)
Acceptable limits. Dialysate shall contain less than 200
CFU/ml and an endotoxin concentration of less than 2 EU/ml. The action level
for total viable microbial count shall be 50 CFU/ml and the action level for
endotoxin concentration shall be 1 EU/ml.
(III)
Action to be taken. Disinfection and retesting shall
be done when bacterial or endotoxin counts exceed the action levels. Additional
samples shall be collected when there is a clinical indication of a pyrogenic
reaction and/or septicemia.
(v)
Only a licensed nurse may use an additive to increase concentrations
of specific electrolytes in the acid concentrate. Mixing procedures shall
be followed as specified by the additive manufacturer. When additives are
prescribed for a specific patient, the container holding the prescribed acid
concentrate shall be labeled with the name of the patient, the final concentration
of the added electrolyte, the date the prescribed concentrate was made, and
the name of the person who mixed the additive.
(vi)
All components used in concentrate preparation systems
(including mixing and storage tanks, pumps, valves and piping) shall be fabricated
from materials (e.g., plastics or appropriate stainless steel) that do not
interact chemically or physically with the concentrate so as to affect its
purity, or with the germicides used to disinfect the equipment. The use of
materials that are known to cause toxicity in hemodialysis such as copper,
brass, galvanized material and aluminum is prohibited.
(vii)
Facility policies shall address means to protect stored
acid concentrates from tampering or from degeneration due to exposure to extreme
heat or cold.
(viii)
Procedures to control the transfer of acid concentrates
from the delivery container to the storage tank and prevent the inadvertent
mixing of different concentrate formulations shall be developed, implemented
and enforced. The storage tanks shall be clearly labeled.
(ix)
Concentrate mixing systems shall include a purified water
source, a suitable drain, and a ground fault protected electrical outlet.
(I)
Operators of mixing systems shall use personal protective
equipment as specified by the manufacturer during all mixing processes.
(II)
The manufacturer's instructions for use of a concentrate
mixing system shall be followed, including instructions for mixing the powder
with the correct amount of water. The number of bags or weight of powder added
shall be determined and recorded.
(III)
The mixing tank shall be clearly labeled to indicate
the fill and final volumes required to correctly dilute the powder.
(IV)
Systems for preparing either bicarbonate or acid concentrate
from powder shall be monitored according to the manufacturer's instructions.
(V)
Concentrates shall not be used, or transferred to holding
tanks or distribution systems, until all tests are completed.
(VI)
If a facility designs its own system for mixing concentrates,
procedures shall be developed and validated using an independent laboratory
to ensure proper mixing.
(x)
Acid concentrate mixing tanks shall be designed to allow
the inside of the tank to be rinsed when changing concentrate formulas.
(I)
Acid mixing systems shall be designed and maintained to
prevent rust and corrosion.
(II)
Acid concentrate mixing tanks shall be emptied completely
and rinsed with product water before mixing another batch of concentrate to
prevent cross contamination between different batches.
(III)
Acid concentrate mixing equipment shall be disinfected
as specified by the equipment manufacturer or in the case where no specifications
are given, as defined by facility policy.
(IV)
Records of disinfection and rinsing of disinfectants to
safe residual levels shall be maintained.
(xi)
Bicarbonate concentrate mixing tanks shall have conical
or bowl shaped bottoms and shall drain from the lowest point of the base.
The tank design shall allow all internal surfaces to be disinfected and rinsed.
(I)
Bicarbonate concentrate mixing tanks shall not be prefilled
the night before use.
(II)
If disinfectant remains in the mixing tank overnight,
this solution must be completely drained, the tank rinsed and tested for residual
disinfectant prior to preparing the first batch of that day of bicarbonate
concentrate.
(III)
Unused portions of bicarbonate concentrate shall not
be mixed with fresh concentrate.
(IV)
At a minimum, bicarbonate distribution systems shall be
disinfected weekly. More frequent disinfection shall be done if required by
the manufacturer, or if dialysate culture results are above the action level.
(V)
If jugs are reused to deliver bicarbonate concentrate to
individual hemodialysis machines:
(-a-)
jugs shall be emptied of concentrate, rinsed and inverted
to drain at the end of each treatment day;
(-b-)
at a minimum, jugs shall be disinfected weekly, more
frequent disinfection shall be considered by the medical director if dialysate
culture results are above the action level; and
(-c-)
following disinfection, jugs shall be drained, rinsed
free of residual disinfectant, and inverted to dry. Testing for residual disinfectant
shall be done and documented.
(xii)
All mixing tanks, bulk storage tanks, dispensing tanks
and containers for single hemodialysis treatments shall be labeled as to the
contents.
(I)
Mixing tanks. Prior to batch preparation, a label shall
be affixed to the mixing tank that includes the date of preparation and the
chemical composition or formulation of the concentrate being prepared. This
labeling shall remain on the mixing tank until the tank has been emptied.
(II)
Bulk storage/dispensing tanks. These tanks shall be permanently
labeled to identify the chemical composition or formulation of their contents.
(III)
Single machine containers. At a minimum, single machine
containers shall be labeled with sufficient information to differentiate the
contents from other concentrate formulations used in the facility and permit
positive identification by users of container contents.
(xiii)
Permanent records of batches produced shall be maintained
to include the concentrate formula produced, the volume of the batch, lot
number(s) of powdered concentrate packages, the manufacturer of the powdered
concentrate, date and time of mixing, test results, person performing mixing,
and expiration date (if applicable).
(xiv)
If dialysate concentrates are prepared in the facility,
the manufacturers' recommendations shall be followed regarding any preventive
maintenance. Records shall be maintained indicating the date, time, person
performing the procedure, and the results (if applicable).
(3)
Prevention requirements concerning patients.
(A)
Hepatitis B vaccination.
(i)
With the advice and consent of a patient's attending nephrologist,
facility staff shall make the hepatitis B vaccine available to a patient who
is susceptible to hepatitis B, provided that the patient has coverage or is
willing to pay for vaccination.
(ii)
The facility shall make available to patients literature
describing the risks and benefits of the hepatitis B vaccination.
(B)
Serologic screening of patients.
(i)
A patient new to dialysis shall have been screened for
hepatitis B surface antigen (HBsAg) within one month before or at the time
of admission to the facility or have a known hepatitis B surface antibody
(anti-HBs) status of at least 10 milli-international units per milliliter
no more than 12 months prior to admission. The facility shall document how
this screening requirement is met.
(ii)
Repeated serologic screening shall be based on the antigen
or antibody status of the patient.
(I)
Monthly screening for HBsAg is required for patients whose
previous test results are negative for HBsAg.
(II)
Screening of HBsAg-positive or anti-HBs-positive patients
may be performed on a less frequent basis, provided that the facility's policy
on this subject remains congruent with Appendices i and ii of the National
Surveillance of Dialysis Associated Disease in the United States, 2000, published
by the United States Department of Health and Human Services.
(C)
Isolation procedures for the HBsAg-positive patient.
(i)
The facility shall treat patients positive for HBsAg in
a segregated treatment area which includes a hand washing sink, a work area,
patient care supplies and equipment, and sufficient space to prevent cross-contamination
to other patients.
(ii)
A patient who tests positive for HBsAg shall be dialyzed
on equipment reserved and maintained for the HBsAg-positive patient's use
only.
(iii)
When a caregiver is assigned to both HBsAg-negative and
HBsAg-positive patients, the HBsAg-negative patients assigned to this grouping
must be Hepatitis B antibody positive. Hepatitis B antibody positive patients
are to be seated at the treatment stations nearest the isolation station and
be assigned to the same staff member who is caring for the HBsAg-positive
patient.
(iv)
If an HBsAg-positive patient is discharged, the equipment
which had been reserved for that patient shall be given intermediate level
disinfection prior to use for a patient testing negative for HBsAg.
(v)
In the case of patients new to dialysis, if these patients
are admitted for treatment before results of HBsAg or anti-HBs testing are
known, these patients shall undergo treatment as if the HBsAg test results
were potentially positive, except that they shall not be treated in the HBsAg
isolation room, area, or machine.
(I)
The facility shall treat potentially HBsAg-positive patients
in a location in the treatment area which is outside of traffic patterns until
the HBsAg test results are known.
(II)
The dialysis machine used by this patient shall be given
intermediate level disinfection prior to its use by another patient.
(III)
The facility shall obtain HBsAg status results of the
patient no later than three days from admission.
(u)
Respiratory care services. The hospital shall meet the
needs of the patients in accordance with acceptable standards of practice.
(1)
Policies and procedures shall be adopted, implemented,
and enforced which describe the provision of respiratory care services in
the hospital.
(2)
The organization of the respiratory care services shall
be appropriate to the scope and complexity of the services offered.
(3)
There shall be a director of respiratory care services
who is a physician with the knowledge, experience, and capabilities to supervise
and administer the services properly. The director may serve on either a full-time
or part-time basis.
(4)
There shall be adequate numbers of respiratory therapists,
respiratory therapy technicians, and other personnel who meet the qualifications
specified by the medical staff, consistent with the state law.
(5)
Personnel qualified to perform specific procedures and
the amount of supervision required for personnel to carry out specific procedures
shall be designated in writing.
(6)
If blood gases or other clinical laboratory tests are performed
by the respiratory care services staff, the respiratory care staff shall comply
with CLIA 1988 in accordance with the requirements specified in 42 CFR, Part
493.
(7)
Services shall be provided only on, and in accordance with,
the orders of a physician.
(v)
Sterilization and sterile supplies.
(1)
Supervision. The sterilization of all supplies and equipment
shall be under the supervision of a person qualified by education, training
and experience. Staff responsible for the sterilization of supplies and equipment
shall participate in a documented continuing education program; new employees
shall receive initial orientation and on-the-job training.
(2)
Equipment and procedures.
(A)
Sterilization. Every hospital shall provide equipment adequate
for sterilization of supplies and equipment as needed. Equipment shall be
maintained and operated to perform, with accuracy, the sterilization of the
various materials required.
(B)
Written policy. Written policies and procedures for the
decontamination and sterilization activities performed shall be adopted, implemented
and enforced. Policies shall include the receiving, cleaning, decontaminating,
disinfecting, preparing and sterilization of reusable items, as well as those
for the assembly, wrapping, storage, distribution and quality control of sterile
items and equipment. These written policies shall be reviewed at least every
other year and approved by the infection control practitioner or committee.
(C)
Separation. Where cleaning, preparation, and sterilization
functions are performed in the same room or unit, the physical facilities,
equipment, and the policies and procedures for their use, shall be such as
to effectively separate soiled or contaminated supplies and equipment from
the clean or sterilized supplies and equipment. Hand washing facilities shall
be provided and a separate sink shall be provided for safe disposal of liquid
waste.
(D)
Labeling. All containers for solutions, drugs, flammable
solvents, ether, alcohol, and medicated supplies shall be clearly labeled
to indicate contents. Those which are sterilized by the hospital shall be
labeled so as to be identifiable both before and after sterilization. Sterilized
items shall have a load control identification that indicates the sterilizer
used, the cycle or load number, and the date of sterilization.
(E)
Preparation for sterilization.
(i)
All items to be sterilized shall be prepared to reduce
the bioburden. All items shall be thoroughly cleaned, decontaminated and prepared
in a clean, controlled environment.
(ii)
All articles to be sterilized shall be arranged so all
surfaces will be directly exposed to the sterilizing agent for the prescribed
time and temperature.
(F)
Packaging. All wrapped articles to be sterilized shall
be packaged in materials recommended for the specific type of sterilizer and
material to be sterilized.
(G)
External chemical indicators.
(i)
External chemical indicators, also known as sterilization
process indicators, shall be used on each package to be sterilized, including
items being flash sterilized to indicate that items have been exposed to the
sterilization process.
(ii)
The indicator results shall be interpreted according to
manufacturer's written instructions and indicator reaction specifications.
(iii)
A log shall be maintained with the load identification,
indicator results, and identification of the contents of the load.
(H)
Biological indicators. Biological indicators are 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).
(i)
The efficacy of the sterilizing process shall be monitored
with reliable biological indicators appropriate for the type of sterilizer
used.
(ii)
Biological indicators shall be included in at least one
run each week of use for steam sterilizers, at least one run each day of use
for low-temperature hydrogen peroxide gas sterilizers, and every load for
ethylene oxide (EO) sterilizers.
(iii)
Biological indicators shall be included in every load
that contains implantable objects.
(iv)
A log shall be maintained with the load identification,
biological indicator results, and identification of the contents of the load.
(v)
If a test is positive, the sterilizer shall immediately
be taken out of service.
(I)
Implantable items shall be recalled and reprocessed if
a biological indicator test (spore test) is positive.
(II)
All available items shall be recalled and reprocessed
if a sterilizer malfunction is found and a list of those items not retrieved
in the recall shall be submitted to infection control.
(III)
A malfunctioning sterilizer shall not be put back into
use until it has been serviced and successfully tested according to the manufacturer's
recommendations.
(I)
Sterilizers.
(i)
Steam sterilizers (saturated steam under pressure) shall
be utilized for sterilization of heat and moisture stable items. Steam sterilizers
shall be used according to manufacturer's written instructions.
(ii)
EO sterilizers shall be used for processing heat and moisture
sensitive items. EO sterilizers and aerators shall be used and vented according
to the manufacturer's written instructions.
(iii)
Flash sterilizers shall be used for emergency sterilization
of clean, unwrapped instruments and porous items only.
(J)
Disinfection.
(i)
Written policies, approved by the infection control committee,
shall be adopted, implemented and enforced for the use of chemical disinfectants.
(ii)
The manufacturer's written instructions for the use of
disinfectants shall be followed.
(iii)
An expiration date, determined according to manufacturer's
written recommendations, shall be marked on the container of disinfection
solution currently in use.
(iv)
Disinfectant solutions shall be kept covered and used
in well-ventilated areas.
(v)
Chemical germicides that are registered with the United
States Environmental Protection Agency as "sterilants" may be used either
for sterilization or high-level disinfection.
(vi)
All staff personnel using chemical disinfectants shall
have received training on their use.
(K)
Performance records.
(i)
Performance records for all sterilizers shall be maintained
for each cycle. These records shall be retained and available for review for
a minimum of five years.
(ii)
Each sterilizer shall be monitored continuously during
operation for pressure, temperature, and time at desired temperature and pressure.
A record shall be maintained and shall include:
(I)
the sterilizer identification;
(II)
sterilization date;
(III)
cycle number;
(IV)
contents of each load;
(V)
duration and temperature of exposure phase (if not provided
on sterilizer recording charts);
(VI)
identification of operator(s);
(VII)
results of biological tests and dates performed;
(VIII)
time-temperature recording charts from each sterilizer;
(IX)
gas concentration and relative humidity (if applicable);
and
(X)
any other test results.
(L)
Storage of sterilized items.
(i)
Sterilized items shall be transported so as to maintain
cleanliness and sterility and to prevent physical damage.
(ii)
Sterilized items shall be stored in well-ventilated, limited
access areas with controlled temperature and humidity.
(iii)
The hospital shall adopt, implement and enforce a policy
which describes the mechanism used to determine the shelf life of sterilized
packages.
(M)
Preventive maintenance. Preventive maintenance of all sterilizers
shall be performed according to individual adopted, implemented and enforced
policy on a scheduled basis by qualified personnel, using the sterilizer manufacturer's
service manual as a reference. A preventive maintenance record shall be maintained
for each sterilizer. These records shall be retained at least two years and
shall be available for review.
(w)
Surgical services. If a hospital provides surgical services,
the services shall be well-organized and provided in accordance with acceptable
standards of practice. If outpatient surgical services are offered, the services
shall be consistent in quality with inpatient care in accordance with the
complexity of services offered. A special hospital may not offer surgical
services.
(1)
Organization and staffing. The organization of the surgical
services shall be appropriate for the scope of the services offered.
(A)
The operating rooms shall be supervised by an experienced
RN or physician.
(B)
Licensed vocational nurses (LVNs) and surgical technologists
(operating room technicians) may serve as scrub nurses or technologists under
the supervision of an RN.
(C)
Circulating duties in the operating room must be performed
by qualified RNs. In accordance with approved medical staff polices and procedures,
LVNs and surgical technologists may assist in circulatory duties under the
direct supervision of a qualified RN circulator.
(D)
Surgical privileges shall be delineated for all physicians,
podiatrists, and dentists performing surgery in accordance with the competencies
of each. The surgical services shall maintain a roster specifying the surgical
privileges of each.
(2)
Delivery of service. Surgical services shall be consistent
with needs and resources. Written policies governing surgical care which are
designed to ensure the achievement and maintenance of high standards of medical
practice and patient care shall be adopted, implemented and enforced.
(A)
There shall be a complete medical history and physical
examination, as required under subsection (k)(3)(F) of this section, in the
medical record of every patient prior to surgery, except in emergencies. If
this has been dictated, but not yet recorded in the patient's medical record,
there shall be a statement to that effect and an admission note in the record
by the individual who admitted the patient.
(B)
A properly executed informed consent form for the operation
shall be in the patient's medical record before surgery, except in emergencies.
(C)
The following equipment shall be available in the operating
room suites:
(i)
communication system;
(ii)
cardiac monitor;
(iii)
resuscitator;
(iv)
defibrillator;
(v)
aspirator; and
(vi)
tracheotomy set.
(D)
There shall be adequate provisions for immediate postoperative
care.
(E)
The operating room register shall be complete and up-to-date.
The register shall contain, but not be limited to, the following:
(i)
patient's name and hospital identification number;
(ii)
date of operation;
(iii)
operation performed;
(iv)
operating surgeon and assistant(s);
(v)
type of anesthesia used and name of person administering
it;
(vi)
time operation began and ended;
(vii)
time anesthesia began and ended;
(viii)
disposition of specimens;
(ix)
names of scrub and circulating personnel;
(x)
unusual occurrences; and
(xi)
disposition of the patient.
(F)
An operative report describing techniques, findings, and
tissue removed or altered shall be written or dictated immediately following
surgery and signed by the surgeon.
(x)
Therapy services. If the hospital provides physical therapy,
occupational therapy, audiology, or speech pathology services, the services
shall be organized and staffed to ensure the health and safety of patients.
(1)
Organization and staffing. The organization of the services
shall be appropriate to the scope of the services offered.
(A)
The director of the services shall have the necessary knowledge,
experience, and capabilities to properly supervise and administer the services.
(B)
Physical therapy, occupational therapy, speech therapy,
or audiology services, if provided, shall be provided by staff who meet the
qualifications specified by the medical staff, consistent with state law.
(2)
Delivery of services. Services shall be furnished in accordance
with a written plan of treatment. Services to be provided shall be consistent
with applicable state laws and regulations, and in accordance with orders
of the physician, podiatrist, dentist or other licensed practitioner who is
authorized by the medical staff to order the services. Therapy orders shall
be incorporated in the patient's medical record.
(y)
Waste and waste disposal.
(1)
Special waste and liquid/sewage waste management.
(A)
The hospital shall comply with the requirements set forth
by the department in §§1.131 - 1.137 of this title (relating to
Definition, Treatment, and Disposition of Special Waste from Health Care-Related
Facilities) and the TCEQ requirements in 30 TAC §330.1207 (relating to
Generators of Medical Waste).
(B)
All sewage and liquid wastes shall be disposed of in a
municipal sewerage system or a septic tank system permitted by the TCEQ in
accordance with 30 TAC Chapter 285 (relating to On-Site Sewage Facilities).
(2)
Waste receptacles.
(A)
Waste receptacles shall be conveniently available in all
toilet rooms, patient areas, staff work areas, and waiting rooms. Receptacles
shall be routinely emptied of their contents at a central location(s) into
closed containers.
(B)
Waste receptacles shall be properly cleaned with soap and
hot water, followed by treatment of inside surfaces of the receptacles with
a germicidal agent.
(C)
All containers for other municipal solid waste shall be
leak-resistant, have tight-fitting covers, and be rodent-proof.
(D)
Nonreusable containers shall be of suitable strength to
minimize animal scavenging or rupture during collection operations.
§133.42.Patient Rights.
(a)
Patient rights requirements for all hospitals.
(1)
A hospital shall adopt, implement, and enforce a policy
to ensure patients' rights. The written policy shall include:
(A)
the right of the patient to the hospital's reasonable response
to his or her requests and needs for treatment or service, within the hospital's
capacity, its stated mission, and applicable law and regulation;
(B)
the right of the patient to considerate and respectful
care:
(i)
the care of the patient includes consideration of the psychosocial,
spiritual, and cultural variables that influence the perceptions of illness;
(ii)
the care of the dying patient optimizes the comfort and
dignity of the patient through:
(I)
treating primary and secondary symptoms that respond to
treatment as desired by the patient or surrogate decision maker;
(II)
effectively managing pain; and
(III)
acknowledging the psychosocial and spiritual concerns
of the patient and the family regarding dying and the expression of grief
by the patient and family;
(C)
the right of the patient, in collaboration with his or
her physician, to make decisions involving his or her health care, to include
the following:
(i)
the right of the patient to accept medical care or to refuse
treatment to the extent permitted by law and to be informed of the medical
consequences of such refusal; and
(ii)
the right of the patient to formulate advance directives
and to appoint a surrogate to make health care decisions on his or her behalf
to the extent permitted by law. Advance directives are 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 medical power of attorney for health
care), a written or verbal statement (a living will), or some other form of
instruction recognized under state law specifically addressing the provisions
of health care;
(I)
a hospital shall have in place a mechanism to ascertain
the existence of, and, as appropriate, assist in the development of advance
directives at the time of the patient's admission;
(II)
the provision of care shall not be conditioned on the
existence of an advance directive; and
(III)
an advance directive(s) shall be in the patient's medical
record and shall be reviewed periodically with the patient or surrogate decision
maker if the patient has executed an advance directive;
(D)
the right of the patient to the information necessary to
enable him or her to make treatment decisions that reflect his or her wishes;
a policy on informed decision making shall be adopted, implemented and enforced
by the medical staff and governing body and shall be consistent with any legal
requirements;
(E)
the right of the patient to receive, at the time of admission,
information about the hospital's patient rights policy(ies) and the mechanism
for the initiation, review, and when possible, resolution of patient complaints
concerning the quality of care;
(F)
the right of the patient or the patient's designated representative
to participate in the consideration of ethical issues that arise in the care
of the patient. The hospital shall have a mechanism for the consideration
of ethical issues arising in the care of patients and to provide education
to care givers and patients on ethical issues in health care;
(G)
the right of the patient to be informed of any human experimentation
or other research or educational projects affecting his or her care or treatment;
(H)
the right of the patient, within the limits of law, to
personal privacy and confidentiality of information;
(I)
the right of the patient or the patient's legally designated
representative access to the information contained in the patient's medical
record, within the limits of the law; and
(J)
the right of the patient's guardian, next of kin, or legally
authorized responsible person to exercise, to the extent permitted by law,
the rights delineated on behalf of the patient if the patient:
(i)
has been adjudicated incompetent in accordance with the
law;
(ii)
is found by his or her physician to be medically incapable
of understanding the proposed treatment or procedure;
(iii)
is unable to communicate his or her wishes regarding
treatment; or
(iv)
is a minor.
(2)
The hospital patient's bill of rights shall be prominently
and conspicuously posted for display in a public area of the facility that
is readily available to patients, residents, employees, and visitors.
(b)
Additional patient bill of rights requirements for hospitals
providing comprehensive medical rehabilitation services. A hospital that provides
comprehensive medical rehabilitation services shall comply with subsection
(a) of this section and with the following additional provisions.
(1)
The patient's bill of rights shall address the rights of
minors and provide that a minor is entitled to:
(A)
appropriate treatment in the least restrictive setting
available;
(B)
not receive unnecessary or excessive medication;
(C)
an individualized treatment plan and to participate in
the development of the plan;
(D)
a humane treatment environment that provides reasonable
protection from harm and appropriate privacy for personal needs;
(E)
separation from adult patients; and
(F)
regular communication between the minor patient and the
patient's family.
(2)
Prior to admission or acceptance for evaluation, a written
copy of the patient's bill of rights in the patient's primary language, if
possible, shall be given to each patient, and, as appropriate, to the patient's
parent, managing conservator, or guardian.
(3)
The hospital shall ensure that within 24 hours after the
patient is admitted to the hospital, the rights described in this subsection
are explained to the patient and, if appropriate, to the patient's parent,
managing conservator, or guardian in the following manner:
(A)
orally, in simple, nontechnical terms in the person's primary
language, if possible; or
(B)
other reasonable means calculated to communicate with a
person who has an impairment of vision or hearing, if applicable.
(4)
If the patient cannot comprehend the information because
of illness, age, or other factors, or an emergency exists that precludes immediate
presentation of the information, or the patient refused to sign the written
copy of the patient's bill of rights as provided for in paragraph (5) of this
subsection, the presentation of the document shall be witnessed by two members
of the hospital staff, and the unsigned patient's bill of rights shall be
placed in the clinical record along with a note signed by the witnesses indicating
the reasons for their signatures.
(5)
The hospital shall obtain a signed copy of the patient's
bill of rights from each patient, or, if appropriate, from the patient's parent,
managing conservator, or guardian. The signed copy shall include a statement
that the patient, patient's parent, managing conservator, or guardian has
read the document and understands the rights specified in the document. The
signed copy shall be made a part of the patient's medical record.
(c)
Additional patient bill of rights requirements for hospitals
providing chemical dependency services. A hospital that provides chemical
dependency services shall comply with subsection (a) of this section and with §448.701
of this title (relating to Client Bill of Rights).
(d)
Additional patient bill of rights requirements for hospitals
providing mental health services. A hospital that provides mental health services
shall comply with subsection (a) of this section and Chapter 404, Subchapter
E of this title (relating to Rights of Persons Receiving Mental Health Services).
(e)
Posting requirements for patient bill of rights for hospitals
providing comprehensive medical rehabilitation services, chemical dependency
services, or mental health services. The hospital shall prominently and conspicuously
post for display a copy of the patient's bill of rights in a public area of
the hospital that is readily visible to patients, residents, employees, and
visitors. The patient bill of rights posted for display shall be in English
and in a second language appropriate to the demographic makeup of the community
served.
§133.43.Discrimination or Retaliation Standards.
(a)
Posting requirements for reporting a violation of law.
In accordance with Health and Safety Code (HSC), §161.134(j) and §161.135(h),
each hospital shall prominently and conspicuously post for display in a public
area of the hospital that is readily visible to patients, residents, employees,
and visitors a statement that nonemployees, employees and staff are protected
from discrimination or retaliation for reporting a violation of law. The statement
shall be in English and in a second language appropriate to the demographic
makeup of the community served.
(b)
Discrimination relating to employee reporting a violation
of law. In accordance with HSC, §161.134(a), and §133.41(o)(2)(I)(i)(III)
of this title (relating to Hospital Functions and Services), a hospital may
not suspend or terminate the employment of, discipline, or otherwise discriminate
against an employee for reporting in good faith to the employee's supervisor,
an administrator of the hospital, a state or federal regulatory agency, a
national accrediting organization or a law enforcement agency a violation
of law, including a violation of the Act or this chapter. For purposes of
this subsection, a report is not made in good faith if there is not a reasonable
factual or legal basis for making the report.
(c)
Retaliation relating to nonemployee reporting a violation
of law. In accordance with HSC, §161.135(a), a hospital may not retaliate
against a person who is not an employee for reporting a violation of law,
including a violation of the Act or this chapter.
§133.44.Hospital Patient Transfer Policy.
(a)
Definitions.
(1)
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.
(2)
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.
(b)
General.
(1)
The governing body of each hospital shall adopt, implement,
and enforce a policy relating to patient transfers that is consistent with
this section and contains each of the requirements in subsection (c) of this
section. The policies shall identify hospital staff who have the authority
to represent the hospital and the physician with regard to the transfer from
or receipt of patients into the hospital.
(2)
The transfer policy shall be adopted by the governing body
of the hospital after consultation with the medical staff and shall apply
to transfers between hospitals licensed under the Health and Safety Code,
Chapters 241 and 577, as well as transfers to hospitals which are exempt from
licensing.
(3)
The policy shall govern transfers not covered by a transfer
agreement.
(4)
The movement of a stable patient from a hospital to another
hospital is not considered to be a transfer under this section if it is the
understanding and intent of both hospitals that the patient is going to the
second hospital only for tests, the patient will not remain overnight at the
second hospital, and the patient will return to the first hospital. This paragraph
applies only when a patient remains stable during transport to and from hospitals
and during testing.
(5)
The hospital's transfer policy shall include a written
operational plan to provide for patient transfer transportation services if
the hospital does not provide its own patient transfer transportation services.
(6)
If possible, each governing body, after consultation with
the medical staff, shall implement its transfer policy by adopting transfer
agreements with other hospitals in accordance with §133.61 of this title
(relating to Hospital Patient Transfer Agreements).
(7)
A public hospital or a hospital district shall accept the
transfer of its eligible residents if the public hospital or hospital district
has appropriate facilities, services, and staff available for providing care
to the patient.
(8)
The hospital's policy shall recognize and comply with the
requirements of the Indigent Health Care and Treatment Act, Health and Safety
Code (HSC), §§61.030 - 61.032 and §§61.057 - 61.059 (Mandated
Providers) since those requirements may apply to a patient.
(9)
The hospital's policy shall acknowledge contractual obligations
and comply with statutory or regulatory obligations which may exist concerning
a patient and a designated provider.
(10)
The hospital's policy shall require that all reasonable
steps are taken to secure the written informed consent of a patient, or of
a person acting on a patient's behalf, when refusing a transfer or related
examination and treatment. Reasonable steps include:
(A)
a factual explanation of the increased medical risks to
the patient reasonably expected from not being transferred, examined, or treated
at the transferring hospital;
(B)
a factual explanation of any increased risks to the patient
from not effecting the transfer; and
(C)
a factual explanation of the medical benefits reasonably
expected from the provision of appropriate treatment at another hospital.
(D)
The informed refusal of a patient, or of a person acting
on a patient's behalf, to examination, evaluation or transfer shall be documented
and signed if possible by the patient or by a person acting on the patient's
behalf, dated and witnessed by the attending physician or hospital employee,
and placed in the patient's medical record.
(11)
The hospital's policy shall recognize the right of an
individual to request a transfer into the care of a physician and a hospital
of the individual's own choosing.
(12)
Transfer of patients may occur routinely or as part of
a regionalized plan for obtaining optimal care for patients at a more appropriate
or specialized facility.
(c)
Requirements for transfer of patients between hospitals.
(1)
Discrimination. Except as is specifically provided in subsection
(b)(8) and (9) of this section, relating, respectively, to mandated providers
and designated providers, the hospital policy shall provide that the transfer
of a patient may not be predicated upon arbitrary, capricious, or unreasonable
discrimination based upon race, religion, national origin, age, sex, physical
condition, economic status, insurance status or ability to pay.
(2)
Disclosure. The hospital's policy shall recognize the right
of an individual to request transfer into the care of a physician and a hospital
of his own choosing; however, if a patient requests or consents to transfer
for economic reasons and the patient's choice is predicated upon or influenced
by representations made by the transferring physician or hospital administration
regarding the availability of medical care and hospital services at a reduced
cost or no cost to the patient, the physician or hospital administration shall
fully disclose to the patient the eligibility requirements established by
the patient's chosen physician or hospital.
(3)
Patient. A patient is an individual:
(A)
seeking medical treatment who may or may not be under the
immediate supervision of a personal attending physician, has one or more undiagnosed
or diagnosed medical conditions, and who, within reasonable medical probability,
requires immediate or continuing hospital services and medical care; or
(B)
admitted to the hospital as a patient.
(4)
Patient evaluation. The hospital's policy shall provide
that each patient who arrives at the hospital is:
(A)
evaluated by a physician who is present in the hospital
at the time the patient presents or is presented or evaluated by a physician
on-call who is:
(i)
physically able to reach the patient within 30 minutes
after being informed that a patient is present at the hospital who requires
immediate medical attention; or
(ii)
accessible by direct, telephone, or radio communication
within 30 minutes with a registered nurse, physician assistant or other qualified
medical personnel as established by the governing body at the hospital under
orders to assess and report the patient's condition to the physician; and
(B)
personally examined and evaluated by the physician before
an attempt to transfer is made; however:
(i)
after receiving a report on the patient's condition from
the hospital's registered nurse, physician assistant or other qualified medical
personnel as established by the governing body by telephone or radio, if the
physician on-call determines that an immediate transfer of the patient is
medically appropriate and that the time required to conduct a personal examination
and evaluation of a patient will unnecessarily delay the transfer to the detriment
of the patient, the physician on-call may order the transfer by telephone
or radio; and
(ii)
physician orders for the transfer of a patient which are
issued by telephone or radio shall be reduced to writing in the patient's
medical record, signed by the registered nurse, physician assistant or other
qualified medical personnel as established by the governing body receiving
the order, and countersigned by the physician authorizing the transfer as
soon as possible. The patient transfers resulting from physician orders issued
by telephone or radio shall be subject to automatic review by the medical
staff pursuant to paragraph (8) of this subsection.
(5)
Hospital personnel, written protocols, standing delegation
orders, eligibility and payment information. The policy of the transferring
and receiving hospital shall provide that licensed nurses and other qualified
personnel are available and on duty to assist with patient transfers and to
provide accurate information regarding eligibility and payment practices.
The policy shall provide that written protocols or standing delegation orders
are in place to guide hospital personnel when a patient requires transfer
to another hospital.
(6)
Special requirements related to the transfer of patients
who have emergency medical conditions.
(A)
If a patient at a hospital has an emergency medical condition
which has not been stabilized or when stabilization of the patient's vital
signs is not possible because the hospital or emergency treatment area does
not have the appropriate equipment or personnel to correct the underlying
process (e.g. children's hospitals, thoracic surgeon on staff, or cardiopulmonary
bypass capability), evaluation and treatment shall be performed and transfer
shall be carried out as quickly as possible.
(B)
The hospital's policy shall provide that the hospital may
not transfer a patient with an emergency medical condition which has not been
stabilized unless:
(i)
the individual (or a legally responsible person acting
on the individual's behalf), after being informed of the hospital's obligations
under this section and of the risk of transfer, requests the transfer, in
writing and indicates the reasons for the request, as well as that he or she
is aware of the risks and benefits of the transfer;
(ii)
a physician has signed a certification, which includes
a summary of the risks and benefits, that, based on the information available
at the time of transfer, the medical benefits reasonably expected from the
provision of appropriate medical treatment at another hospital outweigh the
increased risks to the patient and, in the case of labor, to the unborn child
from effecting the transfer; or
(iii)
if the physician who made the determination to transfer
a patient with an emergency condition is not physically present in the emergency
treatment area at the time of transfer, a qualified medical person may sign
a certification described in clause (ii) of this subparagraph after consultation
with the physician. The physician shall countersign the physician certification
within a reasonable period of time.
(C)
Except as is specifically provided in subsection (b)(8)
and (9) of this section, the hospital's policy shall provide that the transfer
of patients who have emergency medical conditions, as determined by a physician,
shall be undertaken for medical reasons only. The hospital must provide medical
treatment within its capacity that minimizes the risks to the individual's
health and, in the case of a woman in labor, the health of the unborn child.
(D)
A hospital that has specialized capabilities or facilities
(including, but not limited to such facilities as burn units, shock-trauma
units, neonatal intensive care units, or, with respect to rural areas, regional
referral centers) may not refuse to accept from a referring hospital an appropriate
transfer of an individual who requires such specialized capabilities or facilities
if the receiving hospital has the capacity to treat the individual. Except
as expressly permitted in clauses (i) and (ii) of this subparagraph, a hospital's
policy shall provide for the receipt of patients who have an emergency medical
condition from other hospitals so that upon notification from a transferring
physician or a transferring hospital prior to transfer, the receiving hospital
shall respond to the transferring hospital and transferring physician with
the status of the transfer request within 30 minutes and either accept or
refuse the transfer. The time period begins to run at the time a member of
the staff of the receiving hospital receives the call initiating the request
to transfer.
(i)
The receiving hospital's policy may permit response to
the transferring hospital and transferring physician within a period of time
in excess of 30 minutes but no longer than one hour if there are extenuating
circumstances for the delay. If the transfer is accepted, the reason for the
delay shall be documented on the memorandum of transfer.
(ii)
The response time may be extended before the expiration
of the initial 30 minutes period by agreement among the transferring hospital
and transferring physician and the receiving hospital and receiving physician.
If the transfer is accepted, the agreed extension shall be documented in the
memorandum of transfer.
(7)
Physician's duties and standard of care.
(A)
The policy shall provide that the transferring physician
shall determine and order life support measures which are medically appropriate
to stabilize the patient prior to transfer and to sustain the patient during
transfer.
(B)
The policy shall provide that the transferring physician
shall determine and order the utilization of appropriate personnel and equipment
for the transfer.
(C)
The policy shall provide that in determining the use of
medically appropriate life support measures, personnel, and equipment, the
transferring physician shall exercise that degree of care which a reasonable
and prudent physician exercising ordinary care in the same or similar locality
would use for the transfer.
(D)
The policy shall provide that except as allowed under paragraph
(4)(B) of this subsection, prior to each patient transfer, the physician who
authorizes the transfer shall personally examine and evaluate the patient
to determine the patient's medical needs and to ensure that the proper transfer
procedures are used.
(E)
The policy shall provide that prior to transfer, the transferring
physician shall ensure that a receiving hospital and physician that are appropriate
to the medical needs of the patient have accepted responsibility for the patient's
medical treatment and hospital care.
(8)
Record review for standard of care. The hospital's policy
shall provide that the hospital's medical staff review appropriate records
of patients transferred from the hospital to determine that the appropriate
standard of care has been met.
(9)
Medical record.
(A)
The hospital's policy shall provide that a copy of those
portions of the patient's medical record which are available and relevant
to the transfer and to the continuing care of the patient be forwarded to
the receiving physician and receiving hospital with the patient. If all necessary
medical records for the continued care of the patient are not available at
the time the patient is transferred, the records shall be forwarded to the
receiving physician and hospital as soon as possible.
(B)
The medical record shall contain at a minimum:
(i)
a brief description of the patient's medical history and
physical examination;
(ii)
a working diagnosis and recorded observations of physical
assessment of the patient's condition at the time of transfer;
(iii)
the reason for the transfer;
(iv)
the results of all diagnostic tests, such as laboratory
tests;
(v)
pertinent X-ray films and reports; and
(vi)
any other pertinent information.
(10)
Memorandum of transfer.
(A)
The hospital's policy shall provide that a memorandum of
transfer be completed for every patient who is transferred.
(B)
The memorandum shall contain the following information:
(i)
the patient's full name, if known;
(ii)
the patient's race, religion, national origin, age, sex,
physical handicap, if known;
(iii)
the patient's address and next of kin, address, and phone
number if known;
(iv)
the names, telephone numbers and addresses of the transferring
and receiving physicians;
(v)
the names, addresses, and telephone numbers of the transferring
and receiving hospitals;
(vi)
the time and date on which the patient first presented
or was presented to the transferring physician and transferring hospital;
(vii)
the time and date on which the transferring physician
secured a receiving physician;
(viii)
the name, date, and time hospital administration was
contacted in the receiving hospital;
(ix)
signature, time, and title of the transferring hospital
administration who contacted the receiving hospital;
(x)
the certification required by paragraph (6)(B)(ii) of this
subsection, if applicable (the certification may be part of the memorandum
of transfer form or may be on a separate form attached to the memorandum of
transfer form);
(xi)
the time and date on which the receiving physician assumed
responsibility for the patient;
(xii)
the time and date on which the patient arrived at the
receiving hospital;
(xiii)
signature and date of receiving hospital administration;
(xiv)
type of vehicle and company used;
(xv)
type of equipment and personnel needed in transfers;
(xvi)
name and city of hospital to which patient was transported;
(xvii)
diagnosis by transferring physician; and
(xviii)
attachments by transferring hospital.
(C)
The receipt of the memorandum of transfer shall be acknowledged
in writing by the receiving hospital administration and receiving physician.
(D)
A copy of the memorandum of transfer shall be retained
by the transferring and receiving hospitals. The memorandum shall be filed
separately from the patient's medical record and in a manner which will facilitate
its inspection by the department. All memorandum of transfer forms filed separately
shall be retained for five years. A copy of the memorandum of transfer may
also be filed with the patient's medical record.
(d)
Violations. A hospital violates the Act and this section
if:
(1)
the hospital fails to comply with the requirements of this
section; or
(2)
the governing body fails or refuses to:
(A)
adopt a transfer policy which is consistent with this section
and contains each of the requirements in subsection (c) of this section;
(B)
adopt a memorandum of transfer form which meets the minimum
requirements for content contained in this section; or
(C)
enforce its transfer policy and the use of the memorandum
of transfer.
§133.45.Miscellaneous Policies and Protocols.
(a)
Determination of death and autopsy reports. The hospital
shall adopt, implement, and enforce protocols to be used in determining death
and for filing autopsy reports which comply with Health and Safety Code (HSC),
Title 8, Subtitle A, Chapter 671 (Determination of Death and Autopsy Reports).
(b)
Organ and tissue donors. The hospital shall adopt, implement,
and enforce a written protocol to identify potential organ and tissue donors
which is in compliance with the Texas Anatomical Gift Act, HSC, Chapter 692.
The hospital shall make its protocol available to the public during the hospital's
normal business hours.
(1)
The hospital's protocol shall include all requirements
in HSC, Chapter 692, §692.013 (Hospital Protocol).
(2)
A hospital which performs organ transplants shall be a
member of the Organ Procurement and Transplantation Network in accordance
with 42 United States Code, §274 (Organ Procurement and Transplantation
Network).
(c)
All-hazard disaster preparedness.
(1)
Definitions.
(A)
Adult intensive care unit (ICU)--Can support critically
ill/injured patients, including ventilator support.
(B)
Burn or burn ICU--Either approved by the American Burn
Association or self-designated. (These beds should not be included in other
ICU bed counts.)
(C)
Medical/surgical--Also thought of as "ward" beds.
(D)
Negative pressure/isolation--Beds provided with negative
airflow, providing respiratory isolation. Note: This value may represent available
beds included in the counts of other types.
(E)
Operating rooms: An operating room that is equipped and
staffed and could be made available for patient care in a short period.
(F)
Pediatric ICU--The same as adult ICU, but for patients
17 years and younger.
(G)
Pediatrics--Ward medical/surgical beds for patients 17
years and younger.
(H)
Physically available beds--Beds that are licensed, physically
set up, and available for use. These are beds regularly maintained in the
hospital for the use of patients, which furnish accommodations with supporting
services (such as food, laundry, and housekeeping). These beds may or may
not be staffed but are physically available.
(I)
Psychiatric--Ward beds on a closed/locked psychiatric unit
or ward beds where a patient will be attended by a sitter.
(J)
Staffed beds--Beds that are licensed and physically available
for which staff members are available to attend to the patient who occupies
the bed. Staffed beds include those that are occupied and those that are vacant.
(K)
Vacant/available beds--Beds that are vacant and to which
patients can be transported immediately. These must include supporting space,
equipment, medical material, ancillary and support services, and staff to
operate under normal circumstances. These beds are licensed, physically available,
and have staff on hand to attend to the patient who occupies the bed.
(2)
A hospital shall adopt, implement, and enforce a written
plan for all-hazard, natural or man-made, disaster preparedness for effective
preparedness, mitigation, response, and recovery from disasters.
(3)
The plan, which may be subject to review and approval by
the department, shall be sent to the local disaster management authority.
(4)
The plan shall:
(A)
be developed through a joint effort of the hospital governing
body, administration, medical staff, hospital personnel and emergency medical
services partners;
(B)
include the applicable information contained in the National
Fire Protection Association 99, Standard for Health Care Facilities, 2002
edition, Chapter 12 (Health Care Emergency Management), published by the National
Fire Protection Association (NFPA), and the State of Texas Emergency Management
Plan. Information regarding the State of Texas Emergency Management Plan is
available from the city or county emergency management coordinator. The NFPA
document referenced in this section may be obtained by writing or calling
the NFPA at the following address and telephone number: 1 Batterymarch Park,
Post Office Box 9101, Quincy, Massachusetts 02269-9101, (800) 344-3555;
(C)
contain the names and contact numbers of city and county
emergency management officers;
(D)
be exercised at least annually and in conjunction with
state and local exercises. Hospitals participating in an exercise or responding
to a real life event shall develop an after action report (AAR) within 60
days. AARs shall be retained for at least three years and be available for
review by the local emergency management authority and the department;
(E)
include the methodology for notifying the hospital personnel
and the local disaster management authority of an event that will significantly
impact hospital operations;
(F)
include evidence that the hospital has communicated prospectively
with the local utility and phone companies regarding the need for the hospital
to be given priority for the restoration of utility and phone services and
a process for testing internal and external communications systems regularly;
(G)
include the use of a department approved process to update
bed availability, as follows:
(i)
as requested by the department during a public health emergency
or state declared disaster; and
(ii)
for the physically available beds, staffed beds and vacant/available
beds for the following bed types:
(I)
adult ICU;
(II)
burn or burn ICU;
(III)
medical/surgical;
(IV)
negative pressure/isolation;
(V)
operating rooms,
(VI)
pediatric ICU;
(VII)
pediatrics; and
(VIII)
psychiatric;
(iii)
emergency department divert status;
(iv)
for decontamination facility available; and
(v)
for ventilators available;
(H)
include at a minimum:
(i)
a component for the reception, treatment, and disposition
of casualties that can be used in the event that a disaster situation requires
the hospital to accept multiple patients. This component shall include at
a minimum:
(I)
process, developed in conjunction with appropriate agencies,
to allow essential healthcare workers and personnel to safely access their
delivery care sites;
(II)
procedures for the provision of personal protection equipment
for and appropriate immunization of staff, volunteers, and staff families;
and
(III)
plan to provide food and shelter for staff and volunteers
as needed throughout the duration of response;
(ii)
an evacuation component that can be engaged in any emergency
situation necessitating either a full or partial evacuation of the hospital.
The evacuation component shall address at a minimum:
(I)
activation, including who makes the decision to activate
and how it is activated;
(II)
when within control of the hospital, patient evacuation
destination, including protocol to ensure that the patient destination is
compatible to patient acuity and health care needs, plan for the order of
removal of patients and planned route of movement, train and drill staff on
the traffic flow and the movement of patients to a staging area, and room
evacuation protocol;
(III)
family/responsible party notification, including the
procedure to notify patient emergency contacts of an evacuation and the patient's
destination; and
(IV)
transport of records and supplies, including the protocol
for the transfer of patient specific medications and records to the receiving
facility. These records shall include at a minimum: the patient's most recent
physician's assessment, order sheet, medication administration record (MAR),
and patient history with physical documentation. A weather-proof patient identification
wrist band (or equivalent identification) must be intact on all patients.
(d)
Voluntary paternity establishment services. A hospital
that handles the birth of newborns must provide voluntary paternity establishment
services in accordance with:
(1)
the HSC, §192.012, Record of Acknowledgment of Paternity;
and
(2)
the rules of the Office of the Attorney General found at
1 TAC Chapter 55, Subchapter J (relating to Voluntary Paternity Acknowledgment
Process).
(e)
Harassment and abuse. A hospital shall adopt, implement
and enforce a written policy for identifying and addressing instances of alleged
verbal or physical abuse or harassment of hospital employees or contracted
personnel by other hospital employees or contracted personnel or by a health
care provider who has clinical privileges at the hospital.
(f)
Information for parents of newborn children. A hospital
that provides prenatal care to a pregnant woman during gestation or at delivery
of an infant, shall adopt, implement and enforce written policies to ensure
compliance with HSC, Chapter 161, Subchapter T, §161.501 (relating to
Parenting and Postpartum Counseling Information).
(1)
The policy shall require that the woman and the father
of the infant, if possible, or another adult caregiver for the infant, be
provided with a resource pamphlet which includes:
(A)
information on professional organizations providing counseling
and assistance relating to postpartum depression and other emotional trauma
associated with pregnancy and parenting;
(B)
information regarding the prevention of shaken baby syndrome,
as specified under HSC, §167.501(a)(1)(B)(i) - (iv);
(C)
a list of diseases for which a child is required by state
law to be immunized and the appropriate schedule for the administration of
those immunizations; and
(D)
the appropriate schedule for follow-up procedure for newborn
screening.
(2)
The policy shall include a requirement that it be documented
in the woman's record that the information was provided and that the documentation
be maintained for at least five years.
(g)
Abortion. A hospital that performs abortions shall adopt,
implement and enforce policies to:
(1)
ensure compliance with HSC, Chapter 171, Subchapters A
and B (relating to Abortion and Informed Consent);
(2)
ensure compliance with Occupations Code, §164.052(a)(19)
(relating to Parental Consent for Abortion).
(h)
Influenza and pneumococcal vaccine for elderly persons.
The hospital shall adopt, implement and enforce a policy for providing influenza
and pneumococcal vaccines for elderly persons. The policy shall:
(1)
establish that an elderly person, defined as 65 years of
age older, who is admitted to the hospital for a period of 24 hours or more,
is informed of the availability of the influenza and pneumococcal vaccines,
and, if they request the vaccine, is assessed to determine if receipt of the
vaccine is in their best interest. If determined appropriate by the physician
or other qualified medical personnel, the elderly person shall receive the
vaccines prior to discharge from the hospital;
(2)
include provisions that the influenza vaccine shall be
made available in October and November, and if available, December, and pneumococcal
vaccine shall be made available throughout the year;
(3)
require that the person administering the vaccine ask the
elderly patient if they are currently vaccinated against influenza or pneumococcal
disease, assess potential contraindications, and then, if appropriate, administer
the vaccine under approved hospital protocols; and
(4)
address required documentation of the vaccination in the
patient medical record.
(5)
The department may waive requirements related to the administration
of the vaccines based on established shortages of the vaccines.
§133.46.Hospital Billing.
(a)
Itemized statements. A hospital shall adopt, implement,
and enforce a policy to ensure that the hospital complies with the Health
and Safety Code (HSC), §311.002 (Itemized Statement of Billed Services).
(b)
Audits of billing. A hospital shall adopt, implement, and
enforce a policy to ensure that the hospital complies with HSC, §311.0025(a)
(relating to Audits of Billing).
(c)
Complaint investigation procedures.
(1)
A complaint submitted to the Department of State Health
Services (department) relating to billing must specify the patient for whom
the bill was submitted.
(2)
Upon receiving a complaint warranting an investigation,
the department shall send the complaint to the hospital requesting the hospital
to conduct an internal investigation. Within 30 days of the hospital's receipt
of the complaint, the hospital shall submit to the department:
(A)
a report outlining the hospital's investigative process;
(B)
the resolution or conclusions reached by the hospital with
the patient, third party payor or complainant; and
(C)
corrections, if any, in the hospital's policies or protocols
which were made as a result of its investigative findings.
(3)
In addition to the hospital's internal investigation, the
department may also conduct an investigation to audit any billing and patient
records of the hospital.
(4)
The department shall inform in writing a complainant who
identifies himself by name and address:
(A)
of the receipt of the complaint;
(B)
if the complainant's allegations are potential violations
of the Act or this chapter warranting an investigation;
(C)
whether the complaint will be investigated by the department;
(D)
if the complaint was referred to the hospital for internal
investigation;
(E)
whether and to whom the complaint will be referred;
(F)
of the results of the hospital's investigation and the
hospital's resolution with the complainant; and
(G)
of the department's findings if an on-site audit investigation
was conducted.
(5)
The department shall refer investigative reports of billing
by health care professionals who have provided improper, unreasonable, or
medically or clinically unnecessary treatments or billed for treatments which
were not provided to the appropriate licensing agency.
§133.47.Abuse and Neglect Issues.
(a)
Reporting. Incidents of abuse, neglect, exploitation, or
illegal, unethical or unprofessional conduct as those terms are defined in
subsections (b) and (c) of this section shall be reported to the department.
(b)
Abuse or neglect of a child, and abuse, neglect or exploitation
of an elderly or disabled person. The following definitions apply only to
this subsection:
(1)
abuse or neglect of a child, as defined in §1.204(a)
and (b) of this title (relating to Investigations of Abuse, Neglect, or Exploitation
of Children or Elderly or Disabled Persons); and
(2)
abuse, neglect or exploitation of an elderly or disabled
person, as defined in §1.204(a) and (b) of this title.
(c)
Abuse and neglect of individuals with mental illness, and
illegal, unethical, and unprofessional conduct. The requirements of this subsection
are in addition to the requirements of subsection (b) of this section.
(1)
Definitions. The following definitions are in accordance
with Health and Safety Code (HSC), §161.131 and apply only to this subsection:
(A)
Abuse--
(i)
Abuse (as the term is defined in 42 United States Code
(USC), §10801 et seq.) is any act or failure to act by an employee of
a facility rendering care or treatment which was performed, or which was failed
to be performed, knowingly, recklessly, or intentionally, and which caused,
or may have caused, injury or death to a individual with mental illness, and
includes acts such as:
(I)
the rape or sexual assault of a individual with mental
illness;
(II)
the striking of a individual with mental illness;
(III)
the use of excessive force when placing a individual
with mental illness in bodily restraints; and/or
(IV)
the use of bodily or chemical restraints on a individual
with mental illness which is not in compliance with federal and state laws
and regulations.
(ii)
In accordance with HSC, §161.132(j), abuse also includes
coercive or restrictive actions that are illegal or not justified by the patient's
condition and that are in response to the patient's request for discharge
or refusal of medication, therapy or treatment.
(B)
Illegal conduct--Illegal conduct (as the term is defined
in HSC, §161.131(4)) is conduct prohibited by law.
(C)
Neglect--Neglect (as the term is defined in 42 USC, §10801
et seq.) is a negligent act or omission by any individual responsible for
providing services in a facility rendering care or treatment which caused
or may have caused injury or death to a individual with mental illness or
which placed a individual with mental illness at risk of injury or death,
and includes an act or omission such as the failure to establish or carry
out an appropriate individual program plan or treatment plan for a individual
with mental illness, the failure to provide adequate nutrition, clothing,
or health care to a individual with mental illness, or the failure to provide
a safe environment for a individual with mental illness, including the failure
to maintain adequate numbers of appropriately trained staff.
(D)
Unethical conduct--Unethical conduct (as the term is defined
in HSC, §161.131(11)) is 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.
(E)
Unprofessional conduct--Unprofessional conduct (as the
term is defined in HSC, §161.131(12)) is conduct prohibited under rules
adopted by the state licensing agency for the respective profession.
(2)
Posting requirements. A facility shall prominently and
conspicuously post for display in a public area that is readily visible to
patients, residents, volunteers, employees, and visitors a statement of the
duty to report abuse and neglect, or illegal, unethical or unprofessional
conduct in accordance with HSC, §161.132(e). The statement shall be in
English and in a second language appropriate to the demographic makeup of
the community served and contain the number of the department's patient information
and complaint line at (888) 973-0022.
(3)
Reporting responsibility.
(A)
Reporting abuse and neglect. A person, including an employee,
volunteer, or other person associated with the facility who reasonably believes
or who knows of information that would reasonably cause a person to believe
that the physical or mental health or welfare of a patient of the facility
who is receiving mental health or chemical dependency services has been, is,
or will be adversely affected by abuse or neglect (as those terms are defined
in this subsection) by any person shall as soon as possible report the information
supporting the belief to the department or to the appropriate state health
care regulatory agency in accordance with HSC, §161.132(a).
(B)
Reporting illegal, unprofessional, or unethical conduct.
An employee of or other person associated with a facility including a health
care professional, who reasonably believes or who knows of information that
would reasonably cause a person to believe that the facility or an employee
or health care professional associated with the facility, has, is, or will
be engaged in conduct that is or might be illegal, unprofessional, or unethical
and that relates to the operation of the facility or mental health or chemical
dependency services provided in the facility shall as soon as possible report
the information supporting the belief to the department or to the appropriate
state health care regulatory agency in accordance with HSC, §161.132(b).
(4)
Training requirements. A hospital that provides comprehensive
medical rehabilitation, mental health or substance abuse services shall annually
provide as a condition of continued licensure a minimum of eight hours of
in-service training designed to assist employees and health care professionals
associated with the facility in identifying patient abuse or neglect and illegal,
unprofessional, or unethical conduct by or in the facility and establish a
means for monitoring compliance with the requirement.
(d)
Investigations. A complaint under this subsection will
be investigated or referred by the department as follows:
(1)
Allegations under subsection (b) of this section will be
investigated in accordance with §1.205 of this title (relating to Reports
and Investigations) and §1.206 of this title (relating to Completion
of Investigation);
(2)
Allegations under subsection (c) of this section will be
investigated in accordance with §133.101 of this title (relating to Inspection
and Investigation Procedures). Allegations concerning a health care professional's
failure to report abuse and neglect or illegal, unprofessional, or unethical
conduct will not be investigated by the department but will be referred to
the individual's licensing board for appropriate disciplinary action.
(3)
Allegations under both subsections (b) and (c) will be
investigated in accordance with §1.205 and §1.206 of this title
except as noted in paragraph (2) of this subsection concerning a health care
professional's failure to report.
(e)
Submission of complaints. A complaint made under this section
may be submitted in writing or verbally to the Patient Quality Care Unit,
Department of State Health Services, 1100 West 49th Street, Austin, Texas
78756-3199, telephone, (888) 973-0022.
(f)
Notification.
(1)
For complaints under subsection (b) of this section, the
department shall provide notification according to the following.
(A)
The department shall notify the reporter, if known, in
writing of the outcome of the complete investigation.
(B)
The department shall notify the alleged victim, and his
or her parent or guardian if a minor, in writing of the outcome of the completed
investigation.
(2)
For complaints under subsection (c) of this section, the
department shall inform, in writing, the complainant who identifies themselves
by name and address of the following:
(A)
the receipt of the complaint;
(B)
if the complainant's allegations are potential violations
of this chapter warranting an investigation;
(C)
whether the complaint will be investigated by the department;
(D)
whether and to whom the complaint will be referred; and
(E)
the findings of the complaint investigation.
(g)
Department reporting and referral.
(1)
Reporting health care professional to licensing board.
(A)
In cases of abuse, neglect, or exploitation, as those terms
are defined in subsection (b) of this section, by a licensed, certified, or
registered health care professional, the department may forward a copy of
the completed investigative report to the state agency which licenses, certifies
or registers the health care professional. Any information which might reveal
the identity of the reporter or any other patients or clients of the facility
must be blacked out or deidentified.
(B)
A health care professional who fails to report abuse and
neglect or illegal, unprofessional, or unethical conduct as required by subsection
(c)(3) of this section may be referred by the department to the individual's
licensing board for appropriate disciplinary action.
(2)
Sexual exploitation reporting requirements. In addition
to the reporting requirements described in subsection (c)(3) of this section,
a mental health services provider must report suspected sexual exploitation
in accordance with Texas Civil Practice and Remedies Code, §81.006.
(3)
Referral follow-up. The department shall request a report
from each referral agency of the action taken by the agency six months after
the referral.
(4)
Referral of complaints. A complaint containing allegations
which are not a violation of HSC, Chapter 241, or this chapter will not be
investigated by the department but shall be referred to law enforcement agencies
or other agencies, as appropriate.
§133.48.Patient Safety Program.
(a)
General.
(1)
Definitions.
(A)
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.
(B)
Reportable event--A medical error or adverse event or occurrence
which the hospital is required to report to the department, as set out in
this section.
(C)
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.
(2)
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.
(3)
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 (2)(B) of this subsection.
(4)
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.
(5)
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.
(6)
The hospital shall submit the following to the department
on the anniversary date of the license expiration:
(A)
an annual events report in accordance with subsection (b)(1)
of this section; and
(B)
a best practices report in accordance with subsection (b)(2)
of this section.
(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 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-200606446
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 §133.61, §133.62
(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.
§133.61.Hospital Patient Transfer Agreements.
§133.62.Cooperative Agreements.
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-200606447
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 §133.61, §133.62
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), 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.
§133.61.Hospital Patient Transfer Agreements.
(a)
General provisions.
(1)
Transfer agreements between hospitals are voluntary.
(2)
Transfer agreements must comply with the transfer policies
required under §133.44 of this title (relating to Hospital Patient Transfer
Policy).
(3)
The transfer agreement shall be submitted to the Department
of State Health Services (department) for review to determine if the agreement
meets the requirements of subsection (b) of this section.
(4)
Multiple transfer agreements may be entered into by a hospital
based upon the type or level of medical services available at other hospitals.
(b)
Minimum requirements for hospital patient transfer agreements.
Patient transfer agreements must include specific language consistent with
the following requirements:
(1)
§133.44(c)(1) of this title (relating to prohibiting
discrimination);
(2)
§133.44(c)(6)(A) - (B) of this title (relating to
the transfer of patients with emergency medical conditions);
(3)
§133.44(b)(8) of this title (relating to compliance
with the Indigent Health Care and Treatment Act);
(4)
§133.44(b)(11) of this title (relating to the patient's
right to request transfer);
(5)
§133.44(c)(7) of this title (relating to the physician's
duties and standard of care); and
(6)
§133.44(c)(9) and (10) of this title (relating to
medical record and memorandum of transfer).
(c)
Review of transfer agreements.
(1)
In order that the department may review the transfer agreements
for compliance with the minimum requirements, each party to the transfer agreement
shall jointly submit the following documents to the department:
(A)
a copy of the current or proposed agreement signed by each
hospital's representative;
(B)
the date of the adoption of the agreement; and
(C)
the effective date of the agreement.
(2)
The department may waive the submittal of the documents
required under paragraph (1) of this subsection to avoid the repetitious submission
of required documentation and approved agreements.
(3)
If a governing body or a governing body's designee executes
a transfer agreement and the entire text of that agreement consists of the
entire text of an agreement that has been previously approved by the department,
the governing body or the governing body's designee is not required to submit
the later agreement for review. On the date the later agreement is fully executed
and before the later agreement is implemented, the governing body or the governing
body's designee must give adequate notice to the department that the later
agreement has been executed.
(4)
The department shall review the agreement within 30 calendar
days after the department's receipt of the agreement to determine if the agreement
is consistent with the requirements of this section.
(5)
After the department's review of the agreement, if the
department determines that the agreement is consistent with the requirements
contained in this section, the department shall notify the hospital administration
that the agreement has been approved.
(6)
If the department determines that the agreement is not
consistent with the requirements contained in this section, the department
shall give notice to the hospital administration that the agreement is deficient
and provide recommendations for correction.
(7)
A transfer agreement will be considered in compliance if
it is consistent with the rules that were in effect at the time the transfer
agreement was executed and approved by the department.
(d)
Appeals.
(1)
If the department rejects a patient transfer agreement,
the hospitals that are parties to the agreement may jointly request reconsideration
of the department's decision.
(2)
A hospital that is party to a rejected agreement shall
appeal the rejection jointly with an appeal by other appealing parties or
waive that hospital's opportunity to appeal.
(3)
To initiate the appeal process, the party hospitals shall
notify the department, in writing, that each party hospital requests formal
reconsideration of the department's decision.
(4)
The request must be received by the department within 20
calendar days from the receipt of the department's rejection notice by the
hospital that submitted the proposed agreement for review and approval.
(5)
Failure of the party hospitals to provide a written request
for appeal shall be deemed a waiver of the opportunity for an internal reconsideration
by the department, and the rejection shall become final.
(6)
An internal review of a rejection shall consist of a review
of the actions taken to-date concerning the rejection of the agreement.
(7)
The review shall be conducted by a three member panel.
The members shall be appointed by the commissioner of state health services.
The panel members shall not have participated in the department's decision.
(A)
The panel shall meet as necessary.
(B)
The panel shall review all agreement submissions for which
an appeal has been requested.
(C)
The review shall be based primarily on the documentation
provided with the request for an appeal, but the party requesting the appeal
may appear before the panel, if they desire.
(D)
The panel's decision is binding on the department and the
hospital(s).
(e)
Amendments to an agreement.
(1)
The governing body of a hospital or governing body's designee
may adopt proposed amendments to a transfer agreement which has been approved
by the department. However, before the amendments are implemented, the governing
body or the governing body's designee shall submit the proposed amendments
to the department for review in the same manner as the agreement to be amended
was submitted.
(2)
The department shall review the amendments and shall approve
or reject them in the same manner as provided for the review of the agreement
to be amended.
(f)
Complaints. Complaints alleging a violation of a transfer
agreement shall be treated in the same manner as complaints alleging violations
of the Act or this chapter.
§133.62.Cooperative Agreements.
(a)
A cooperative agreement is an agreement among two or more
hospitals for the allocation or sharing of health care equipment, facilities,
personnel, or services, and may be established in accordance with Health and
Safety Code (HSC), Chapter 314.
(b)
For purposes of this section only, the term hospital is
limited to a general or special hospital licensed under HSC, Chapter 241,
or a private mental hospital licensed under HSC, Chapter 577.
(c)
A hospital may negotiate and enter into cooperative agreements
with other hospitals in the state if the likely benefits resulting from the
agreement outweigh any disadvantages attributable to a reduction in competition
that may result from the agreements. Acting through their boards of directors,
a group of hospitals may conduct discussions or negotiations concerning cooperative
agreements, provided that the discussions or negotiations do not involve price
fixing or predatory pricing.
(d)
Parties to a cooperative agreement may apply to the department
for a certification of public advantage governing the cooperative agreement.
The application must include the application fee in accordance with §133.26(e)
of this title (relating to Fees), and a written copy of the cooperative agreement
that describes the nature and scope of the cooperation in the agreement and
any consideration passing to any party under the agreement. A copy of the
application and copies of all additional related materials must be submitted
to the attorney general and to the department at the same time.
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-200606448
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 §133.81
(Editor's note: The text of the following section proposed for
repeal will not be published. The section 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 repeal is 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 repeal affects 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.
§133.81.Waiver Provisions.
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-200606449
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 §133.81
STATUTORY AUTHORITY
The proposed new section is 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 section affects 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.
§133.81.Waiver Provisions.
(a)
Request for a waiver. A hospital may submit a written request
to the director for a waiver or modification of a particular provision of
the Texas Hospital Licensing Act (Act) or a minimum standard in this chapter,
except fire safety requirements. The written request shall specify the section(s)
of the Act or this chapter for which a waiver is requested.
(b)
Waiver request requirements. In requesting the waiver,
the hospital must address each of the following points and provide documentation
as necessary to support their position. The hospital must:
(1)
provide evidence to support why the requested waiver will
not adversely affect the health and safety of the hospital patients, employees,
or the general public;
(2)
indicate how it was determined that granting the waiver
would not adversely impact the hospital's participation in the federal Medicare
program or accreditation by a Centers for Medicare and Medicaid Services-approved
organization;
(3)
describe how not granting the waiver would impose an unreasonable
hardship on the hospital in providing adequate care for patients;
(4)
describe how the waiver would facilitate the creation or
operation of the hospital; and
(5)
explain why the waiver would be appropriate when balanced
against the best interests of the individuals served or to be served by the
hospital.
(c)
Supporting documentation. The hospital should submit supporting
documentation with the waiver request. The department may request additional
written documentation from the hospital to support the waiver or modification.
(d)
Written recommendation. The director shall submit a written
recommendation for granting or denying the waiver to the commissioner of state
health services (commissioner).
(e)
Granting order. If the director recommends that the waiver
or modification be granted, the commissioner may issue a written order granting
the waiver or modification.
(f)
Denial of order. If the director recommends that the waiver
or modification be denied, the commissioner may issue a written order denying
the waiver or modification.
(g)
File documentation. The licensing file for the hospital
maintained by the Department of State Health Services shall contain a copy
of the request, any supporting documents which were provided, the written
recommendation of the director, and the order. The hospital is to maintain
the original order in their permanent records.
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-200606450
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 §133.101, §133.102
(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.
§133.101.Inspection and Investigation Procedures.
§133.102.Complaint Against a Texas Department of Health Surveyor.
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-200606451
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 §133.101, §133.102
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.
§133.101.Inspection and Investigation Procedures.
(a)
Routine inspections. The Department of State Health Services
(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 a Centers for Medicare and Medicaid Services-approved
organization.
(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 90 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 state health services (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(d) of this title (relating to Abuse and Neglect
Issues).
(3)
Complaint investigations may be coordinated with the federal
Centers for Medicare and Medicaid Services 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 unannounced.
(5)
Following the investigation of a complaint, the department
shall notify the complainant if the complaint was substantiated and if regulatory
violations were identified.
(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).
(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.
§133.102.Complaint Against a Department of State Health Services Surveyor.
(a)
A hospital may register a complaint against a Department
of State Health Services surveyor who conducts an inspection or investigation
in accordance with §133.101 of this title (relating to Inspection and
Investigation Procedures).
(b)
A complaint against a surveyor shall be registered with
the Patient Quality Care Unit, Department of State Health Services, 1100 West
49th Street, Austin, Texas 78756-3199, telephone (512) 834-6650 or (888) 973-0022.
(1)
A complaint against a surveyor which is received by telephone
will be referred within two working days to the appropriate supervisor. The
caller will be requested to submit the complaint in writing.
(2)
When a complaint is received in writing, it will be forwarded
to the appropriate supervisor within two working days. Within 10 calendar
days of receipt of the complaint, the department will inform the complainant
in writing that the complaint has been forwarded to the appropriate supervisor.
(3)
Within 10 calendar days of the supervisor's receipt of
the complaint, the supervisor will notify the complainant in writing that
an investigation will be done.
(4)
The supervisor will review the documentation in the survey
packet and interview the surveyor identified in the complaint to obtain facts
and assess the objectivity of the surveyor in the surveyor's application of
this chapter during the hospital's inspection or investigation.
(5)
The supervisor will review the applicable rules, personnel
policies, and review the training and qualifications of the surveyor as it
relates to the inspection or investigation.
(6)
The supervisor will document the investigation. A report
of the investigation will be placed in the hospital's file if the complaint
and investigation affected the inspection process. A counseling form will
be used and placed in the surveyor's personnel file if the complaint relates
to personnel performance.
(7)
The supervisor shall offer to meet with the complainant
to resolve the issue. The surveyor identified in the complaint will participate
in the discussion. The resolution meeting may be conducted at the division's
office or during an on-site follow-up visit to the hospital.
(8)
Changes and deletions will be made to the inspection report,
if necessary.
(9)
The supervisor will notify the complainant in writing of
the status of the investigation within 30 calendar days of the date the supervisor
received the complaint.
(10)
The supervisor will forward all final documentation to
the director of the Patient Quality Care Unit and notify the complainant of
the results.
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-200606452
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 §133.121, §133.122
(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.
§133.121.Enforcement Action.
§133.122.Administrative 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-200606453
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 §133.121
STATUTORY AUTHORITY
The proposed new section is 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 section affects 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.
§133.121.Enforcement Action.
Enforcement action may be taken for the following reasons.
(1)
Denial, suspension or revocation of a license or imposition
of an administrative penalty. The department has jurisdiction to enforce violations
of the Act or the rules adopted under this chapter. The department may deny,
suspend, or revoke a license or impose an administrative penalty if the licensee
or applicant:
(A)
fails to comply with any provision of Health and Safety
Code (HSC), Chapters 241 or 311;
(B)
fails to comply with any provision of this chapter (25
Texas Administrative Code, Chapter 133);
(C)
fails to comply with a special license condition;
(D)
fails to comply with an order of the department or another
enforcement procedure under HSC, Chapters 241 or 311;
(E)
has a history of failure to comply with the rules adopted
under this chapter relating to patient environment, health, safety, and rights;
(F)
has aided, abetted or permitted the commission of an illegal
act;
(G)
has committed fraud, misrepresentation, or concealment
of a material fact on any documents required to be submitted to the department
or required to be maintained by the facility pursuant to the provisions of
this chapter;
(H)
fails to pay administrative penalties in accordance with
HSC, Chapter 241;
(I)
fails to implement plans of corrections to deficiencies
cited by the department; or
(J)
fails to comply with applicable requirements within a designated
probation period.
(2)
Denial of a license. The department has jurisdiction to
enforce violations of the HSC, Chapters 241 and 311 and this chapter. The
department may deny a license if the applicant:
(A)
fails to provide timely and sufficient information required
by the department that is directly related to the application;
(B)
has had the following actions taken against the applicant
within the two-year period preceding the application:
(i)
decertification or cancellation of its contract under the
Medicare or Medicaid program in any state;
(ii)
federal Medicare or state Medicaid sanctions or penalties;
(iii)
unsatisfied federal or state tax liens;
(iv)
unsatisfied final judgments;
(v)
eviction involving any property or space used as a hospital
in any state;
(vi)
unresolved state Medicaid or federal Medicare audit exceptions;
(vii)
denial, suspension, or revocation of a hospital license,
a private psychiatric hospital license, or a license for any health care facility
in any state; or
(viii)
a court injunction prohibiting ownership or operation
of a facility.
(3)
Emergency suspension. Following notice and opportunity
for hearing, the commissioner of the department of state health services (commissioner)
or a person designated by the commissioner may issue an emergency order in
relation to the operation of a hospital licensed under this chapter if the
commissioner or the commissioner's designee determines that the hospital is
violating this chapter, a rule adopted pursuant to this chapter, a special
license provision, injunctive relief, an order of the commissioner or the
commissioner's designee, or another enforcement procedure permitted under
this chapter and the provision, rule, license provision, injunctive relief,
order, or enforcement procedure relates to the health or safety of the hospital's
patients.
(A)
The department shall send written notice of the hearing
and shall include within the notice the time and place of the hearing. The
hearing must be held within 10 days after the date of the hospital's receipt
of the notice.
(B)
The hearing shall be held in accordance with the department's
informal hearing rules.
(C)
The order shall be effective on delivery to the hospital
or at a later date specified in the order.
(4)
Probation. In lieu of suspending or revoking the license,
the department may schedule the facility for a probation period of not less
than 30 days if the facility is found in repeated noncompliance with these
rules or HSC, Chapter 241, and the facility's noncompliance does not endanger
the health and safety of the public.
(5)
Administrative penalty. The department has jurisdiction
to impose an administrative penalty against a facility licensed or regulated
under this chapter for violations of the HSC, Chapters 241 and 311 and this
chapter. The imposition of an administrative penalty shall be in accordance
with the provisions of the HSC, §241.059 and §241.060.
(6)
Licensure of persons or entities with criminal backgrounds.
The department may deny a person or entity a license or suspend or revoke
an existing license on the grounds that the person or entity has been convicted
of a felony or misdemeanor that directly relates to the duties and responsibilities
of the ownership or operation of a facility. The department shall apply the
requirements of the Occupations Code, Chapter 53.
(A)
The department is entitled to obtain criminal history information
maintained by the Texas Department of Public Safety (Government Code, §411.122),
the Federal Bureau of Investigation (Government Code, §411.087) or any
other law enforcement agency to investigate the eligibility of an applicant
for an initial or renewal license and to investigate the continued eligibility
of a licensee.
(B)
In determining whether a criminal conviction directly relates,
the department shall consider the provisions of Occupations Code, §53.022
and §53.023.
(C)
The following felonies and misdemeanors directly relate
because these criminal offenses indicate an inability or a tendency for the
person to be unable to own or operate a facility:
(i)
a misdemeanor violation of HSC, Chapter 241;
(ii)
a misdemeanor or felony involving moral turpitude;
(iii)
a misdemeanor or felony relating to deceptive business
practices;
(iv)
a misdemeanor or felony of practicing any health-related
profession without a required license;
(v)
a misdemeanor or felony under any federal or state law
relating to drugs, dangerous drugs, or controlled substances;
(vi)
a misdemeanor or felony under the Texas Penal Code (TPC),
Title 5, involving a patient or a client of any health care facility, a home
and community support services agency or a health care professional;
(vii)
a misdemeanor or felony under the TPC:
(I)
Title 4--offenses of attempting or conspiring to commit
any of the offenses in this clause;
(II)
Title 5--offenses against the person;
(III)
Title 7--offenses against property;
(IV)
Title 8--offenses against public administration;
(V)
Title 9--offenses against public order and decency;
(VI)
Title 10--offenses against public health, safety and morals;
or
(VII)
Title 11--offenses involving organized crime.
(viii)
Offenses listed in subparagraph (C) of this paragraph
are not exclusive in that the department may consider similar criminal convictions
from other state, federal, foreign or military jurisdictions that demonstrate
the inability of the person or entity to own or operate a facility.
(ix)
A license shall be revoked on the licensee's imprisonment
following a felony conviction, felony community supervision revocation, revocation
of parole, or revocation of mandatory supervision.
(7)
Notice. If the department proposes to deny, suspend or
revoke a license, or impose an administrative penalty, the department shall
send a notice of the proposed action by certified mail, return receipt requested,
at the address shown in the current records of the department or the department
may personally deliver the notice. The notice to deny, suspend, or revoke
a license, or impose an administrative penalty, shall state the alleged facts
or conduct to warrant the proposed action, provide an opportunity to demonstrate
or achieve compliance, and shall state that the applicant or license holder
has an opportunity for a hearing before imposition of the action.
(8)
Acceptance. Within 20 days after receipt of the notice,
the applicant or licensee may notify the department, in writing, of acceptance
of the department's determination or request a hearing.
(9)
Hearing request.
(A)
A request for a hearing by the applicant or licensee shall
be in writing and submitted to the department within 20 calendar days of receipt
of the notice. Receipt of the notice is presumed to occur on the 30th day
after the date the notice is mailed by the department to the last address
known of the applicant or licensee.
(B)
A hearing shall be conducted pursuant to the Administrative
Procedure Act, Government Code, Chapter 2001.
(10)
No response to notice. If the applicant or licensee fails
to timely respond to the notice or does not request a hearing in writing within
30 days after the date of the notice, the case shall be set for a hearing.
(11)
Notification of department's final decision. The department
shall send the licensee or applicant a copy of the department's decision for
denial, suspension or revocation of license or imposition of an administrative
penalty by registered mail, which shall include the findings of fact and conclusions
of law on which the department based its decision.
(12)
Decision to suspend or revoke. When the department's decision
to suspend or revoke a license is final, the licensee must immediately cease
operation, unless a stay of such action is issued by the district court.
(13)
Return of original license. Upon suspension, revocation
or non-renewal of the license, the original license shall be returned to the
department upon the effective date of the department's determination.
(14)
Reapplication following denial or revocation.
(A)
After the department's decision to deny or revoke, or the
voluntary surrender of a license by a facility while enforcement action is
pending, a facility may petition the department, in writing, for a license.
(B)
The department may allow a reapplication for licensure
if there is proof that the reasons for the original action no longer exist.
(C)
The department may deny reapplication for licensure if
the department determines that:
(i)
the reasons for the original action continues;
(ii)
the petitioner has failed to offer sufficient proof that
conditions have changed; or
(iii)
the petitioner has demonstrated a repeated history of
failure to provide patients a safe environment or has violated patient rights.
(D)
If the department allows a reapplication for licensure,
the petitioner shall be required to meet the requirements as described in §133.22
of this title (relating to Application and Issuance of Initial License).
(15)
Expiration of a license during suspension. A facility
whose license expires during a suspension period may not reapply for license
renewal until the end of the suspension period.
(16)
Surrender of a license. In the event that enforcement,
as defined in this subsection, is pending or reasonably imminent, the surrender
of a facility license shall not deprive the department of jurisdiction in
regard to enforcement against the facility.
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-200606454
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 §§133.141 - 133.143
(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.
§133.141.Fire Prevention and Protection.
§133.142.General Safety.
§133.143.Handling and Storage of Gases, Anesthetics, and Flammable Liquids.
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-200606455
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 §§133.141 - 133.143
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.
§133.141.Fire Prevention and Protection.
(a)
Fire inspections.
(1)
Annual inspection. Approval of the fire protection of a
hospital by the local fire department shall be a prerequisite for licensure.
(2)
Purpose of inspection. The purpose of these inspections
shall be to ascertain and to cause to be corrected any conditions liable to
cause fire or violations of any of the provisions or intent of these rules,
or of any other applicable ordinances, which affect fire safety in any way.
(3)
Hazardous or dangerous conditions or materials. Whenever
any of the officers, members, or inspectors of the fire department or bureau
of fire prevention find in any building or upon any premises dangerous or
hazardous conditions or materials, removal or remedy of dangerous conditions
or materials shall be carried out in a manner specified by the head of the
local fire department.
(4)
Access for inspection. At all reasonable hours, the chief
of the fire department, the chief of the bureau of fire prevention, or any
of the fire inspectors may enter any building or premises for the purpose
of making an inspection or investigation which may be deemed necessary under
the provisions of these rules.
(b)
Fire reporting. All occurrences of fire shall be reported
to the local fire authority and shall be reported in writing to the hospital
licensing director as soon as possible but not later than 10 calendar days
following the occurrence.
(c)
Fire protection. Fire protection shall be provided in accordance
with the requirements of National Fire Protection Association 101, Life Safety
Code, 2003 edition (NFPA 101), §18.7, and §133.161(a)(1) of this
title (relating to Requirements for Buildings in Which Existing Licensed Hospitals
are Located), and §133.162(a)(1) and (d) of this title (relating to New
Construction Requirements). When required or installed, sprinkler systems
for exterior fire exposures shall comply with National Fire Protection Association
80A, Recommended Practice for Protection of Buildings from Exterior Fire Exposures,
2001 edition. All documents published by NFPA as referenced in this section
may be obtained by writing or calling the NFPA at the following address or
telephone number: National Fire Protection Association, 1 Batterymarch Park,
Post Office Box 9101, Quincy, MA 02269-9101 or (800) 344-3555.
(d)
Smoking rules. Each hospital shall adopt, implement and
enforce a smoking policy. The policy shall include the minimal provisions
of NFPA 101, §18.7.4.
(e)
Fire extinguishing systems. Inspection, testing, and maintenance
of fire-fighting equipment shall be conducted by each hospital.
(1)
Water-based fire protection systems. All fire sprinkler
systems, fire pumps, fire standpipe and hose systems, water storage tanks,
and valves and fire department connections shall be inspected, tested and
maintained in accordance with National Fire Protection Association 25, Standard
for the Inspection, Testing and Maintenance of Water-Based Fire Protection
Systems, 2002 edition.
(2)
Range hood extinguishers. Fire extinguishing systems for
commercial cooking equipment, such as at range hoods, shall be inspected and
maintained in accordance with National Fire Protection Association 96, Standard
for Ventilation Control and Fire Protection of Cooking Operations, 2001 edition.
(3)
Portable fire extinguishers. Every portable fire extinguisher
located in a hospital or upon hospital property shall be installed, tagged,
and maintained in accordance with National Fire Protection Association 10,
Standard for Portable Fire Extinguishers, 2002 edition.
(f)
Fire protection and evacuation plan. A plan for the protection
of patients in the event of fire and their evacuation from the building when
necessary shall be formulated according to NFPA 101, §18.7. Copies of
the plan shall be available to all staff.
(1)
Posting requirements. An evacuation floor plan shall be
prominently and conspicuously posted for display throughout the hospital in
public areas that are readily visible to patients, residents, employees, and
visitors.
(2)
Annual training. Each hospital shall conduct an annual
training program for instruction of all personnel in the location and use
of fire-fighting equipment. All employees shall be instructed regarding their
duties under the fire protection and evacuation plan.
(g)
Fire drills. The hospital shall conduct at least 12 fire
drills each year, one fire drill per shift per quarter, which shall include
communication of alarms, simulation of evacuation of patients and other occupants,
and use of fire-fighting equipment.
(h)
Fire alarm system. Every hospital and building used for
patient care shall have an approved fire alarm system. Each fire alarm system
shall be installed and tested in accordance with §133.161(a)(1)(A) of
this title for existing hospitals, and §133.162(d)(5)(N) of this title
for new construction.
(i)
System for communicating an alarm of fire. A reliable communication
system shall be provided as a means of reporting a fire to the fire department.
This is in addition to the automatic alarm transmission to the fire department
required by NFPA 101, §18.3.4.3.2.
(j)
Fire department access. As an aid to fire department services,
every hospital shall provide the following.
(1)
Driveways. The hospital shall maintain driveways, free
from all obstructions, to main buildings for fire department apparatus use.
(2)
Submission of plans. Upon request, the hospital shall submit
a copy of the floor plans of the building to the local fire department officials.
(3)
Outside identification. The hospital shall place proper
identification on the outside of the main building showing the locations of
siamese connections and standpipes as required by the local fire department
services.
(k)
Fire department protection. When a hospital is located
outside of the service area or range of the public fire protection, arrangements
shall be made to have the nearest fire department respond in case of a fire.
§133.142.General Safety.
(a)
Safety committee. Each hospital shall have a multidisciplinary
safety committee. The hospital chief executive officer (CEO) shall appoint
the chairman and members of the safety committee.
(1)
Safety officer. The CEO shall appoint a safety officer
who is knowledgeable in safety practices in health care facilities. The safety
officer shall be a member of the safety committee, and shall carry out the
functions of the safety program.
(2)
Safety committee meetings. The safety committee shall meet
as required by the chairman, but not less than quarterly. Written minutes
of each meeting shall be retained for at least one year.
(3)
Safety activities.
(A)
Incident reports. The safety committee shall establish
an incident reporting system which includes a mechanism to ensure that all
incidents recorded in safety committee minutes are evaluated, and documentation
is provided to show follow-up and corrective actions.
(B)
Safety policies and procedures. Safety policies and procedures
for each department or service shall be developed, implemented and enforced.
(C)
Safety training and continuing education. Safety training
shall be established as part of new employee orientation and in the continuing
education of all employees.
(4)
Written authority. The authority of the safety committee
to take action when conditions exist that are a possible threat to life, health,
or building damage, shall be defined in writing and approved by the governing
body.
(b)
Safety manual. Each department or service shall have a
safety policy and procedure manual within their own area that becomes a part
of the overall facility safety manual.
(c)
Emergency communication system. An emergency communication
system shall be provided in each facility. The system shall be self-sufficient
and capable of operating without reliance on the building's service or emergency
power supply. Such system shall have the capability of communicating with
the available community or state emergency networks, including police and
fire departments.
§133.143.Handling and Storage of Gases, Anesthetics, and Flammable Liquids.
(a)
Flammable germicides. If flammable germicides, including
alcohol-based products, are used for preoperative surgical skin preparation,
the facility must:
(1)
use only self-contained, single-use, pre-measured applicators
to apply the surgical skin preparations;
(2)
follow all manufacturer product safety warnings and guidelines;
(3)
develop, implement and enforce written policies and procedures
outlining the safety precautions required related to the use of the products,
which, at a minimum, must include minimum drying times, prevention and management
of product pooling, parameters related to draping and the use of ignition
sources, staff responsibilities related to ensuring safe use of the product,
and documentation requirements sufficient to evaluate compliance with the
written policies and procedures;
(4)
ensure that all staff working in the surgical environment
where flammable surgical skin preparation products are in use have received
training on product safety and the facility policies and procedures related
to the use of the product;
(5)
develop, implement and enforce an interdisciplinary team
process for the investigation and analysis of all surgical suite fires and
alleged violations of the policies; and
(6)
report all occurrences of surgical suite fires to the department
in care of the Facility Licensing Group within two business days, and complete
an investigation of the occurrence and develop and implement a corrective
action plan within 30 days.
(b)
Flammable and nonflammable gases and liquids. Flammability
of liquids and gases shall be determined by National Fire Protection Association
329, Handling Releases of Flammable and Combustible Liquids and Gases, 1999
edition. All documents published by National Fire Protection Association (NFPA)
as referenced in this section may be obtained by writing or calling the NFPA
at the following address or telephone number: National Fire Protection Association,
1 Batterymarch Park, P.O. Box 9101, Quincy, MA 02269-9101 or (800) 344-3555.
(1)
Nonflammable gases (examples include, but are not limited
to, oxygen and nitrous oxide) shall be stored and distributed in accordance
with Chapter 5 of the National Fire Protection Association 99, Standard for
Health Care Facilities, 2002 edition (NFPA 99).
(A)
Medical gases and liquefied medical gases shall be handled
in accordance with the requirements of NFPA 99, Chapter 9.
(B)
Oxygen shall be administered in accordance with NFPA 99, §9.6.
(2)
Piped flammable gas systems intended for use in laboratories
and piping systems for fuel gases shall comply with requirements of NFPA 99, §11.11.
(3)
Flammable gases shall be stored in accordance with NFPA
99, §11.10.
(4)
Flammable and combustible liquids used in laboratories
shall be handled and stored in accordance with NFPA 99, §11.7, and National
Fire Protection Association 101, Life Safety Code, 2003 edition, §18.3.2.2.
(5)
Other flammable agents shall be stored in accordance with
NFPA 99, Chapter 7.
(c)
Gasoline and gasoline powered equipment. No motor vehicles
including gasoline powered standby generators or any amount of gasoline shall
be located within the hospital building. Other devices which may cause or
communicate fire, and which are not necessary for patient treatment or care,
shall not be stored within the hospital building. All such devices and materials
when necessary shall be used within the building only with precautions ensuring
a reasonable degree of safety from fire.
(d)
Gas fired appliances. The installation, use and maintenance
of gas fired appliances and gas piping installations shall comply with the
National Fire Protection Association 54, National Fuel Gas Code, 2002 edition.
The use of portable gas heaters and unvented open flame heaters is specifically
prohibited.
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-200606456
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
Subchapter D. VOLUNTARY AGREEMENTS
Subchapter E. WAIVERS
Subchapter E. WAIVER PROVISIONS
Subchapter F. INSPECTION AND INVESTIGATION PROCEDURES
Subchapter G. ENFORCEMENT
Subchapter H. FIRE PREVENTION AND SAFETY REQUIREMENTS
Subchapter I. PHYSICAL PLANT AND CONSTRUCTION REQUIREMENTS