Part 1.
DEPARTMENT OF STATE HEALTH SERVICES
Chapter 133.
HOSPITAL LICENSING
Subchapter C. OPERATIONAL REQUIREMENTS
25 TAC §133.41
The Executive Commissioner of the Health and Human
Services Commission (commission), on behalf of the Department of State
Health Services (department), adopts an amendment to §133.41,
general and special hospitals, concerning Preadmission Screening and
Resident Review (PASRR) and colored alert wrist bands to identify
patient risks in hospitals, with changes to proposed text as published
in the February 22, 2013, issue of the
Texas
Register
(38 TexReg 1081).
The amendment will require that general and special hospitals,
psychiatric hospitals, and crisis stabilization facilities undertake
screening, prior to discharge, of all patients being considered for
placement in a nursing facility to determine whether the patient may
have a mental illness, intellectual disability or developmental disability.
The amendments explicitly add to the State's regulatory scheme the
federal PASRR procedures which the Centers for Medicare and Medicaid
Services (CMS) require.
The PASRR screening requirements are being added to §133.41(r)
concerning quality assessment and performance improvement under the
operational requirements for general and special hospitals; §134.41(m)
concerning quality assurance under the operational requirements for
psychiatric hospitals; and §411.482(a) and §411.628(a) concerning
discharge planning as a standard of care and treatment at psychiatric
hospitals and crisis stabilization units, respectively.
BACKGROUND AND PURPOSE
The purpose of the PASRR program is to ensure that placement of
a patient in a nursing facility is necessary; to identify alternate
placement options when applicable; and to identify specialized services
that may benefit the person with a diagnosis of mental illness, intellectual
disability, or developmental disability. The requirements of the federal
PASRR program are set forth at 42 Code of Federal Regulations (CFR)
Part 483, Subpart C. To promote a clear, consistent implementation
of this federal regulatory scheme in Texas, the Department of Aging
and Disability Services (DADS), the agency primarily responsible for
administering the federal PASRR Program in Texas, is promulgating
new, detailed PASRR Program rules to which other state agencies, including
the department, may refer. DADS' new PASRR rules, which are published
in the same issue of the
Texas Register
as
the amendments described in this preamble, may be found at 40 TAC
Chapter 17, and the PASARR rule at 40 TAC Chapter 19 has been repealed.
Through promulgation of the four rule amendments described in this
preamble, the department is requiring General Hospitals, Special Hospitals,
Private Psychiatric Hospitals and Crisis Stabilization Units to comply
with the PASRR requirements "in accordance with" the specific, applicable
provisions of the new DADS' rules as well as the federal regulations.
The amendment to §133.41(f)(6) requires that the governing
body of each hospital put in place the Standardized Patient Risk Identification
System required under Health and Safety Code, §311.004 (unless
exempt to adopt an alternative), to alert hospital staff that the
following medical risks are present in patients wearing these specific
color-coded wristbands: (i) red wristbands for allergies; (ii) yellow
wristbands for fall risks; (iii) purple wristbands for do-not-resuscitate
status; and (iv) at the hospital's discretion, green wristbands for
latex allergies and pink wristbands for restricted extremity. This
system, which is consistent with, and based upon, the American Hospital
Association's recommendations, was recommended by the ad hoc committee
of hospital representatives which the Executive Commissioner of the
Health and Human Services Commission appointed pursuant to SB 7, Article
5.
SECTION-BY-SECTION SUMMARY
The four rule amendments to §§133.41, 134.41, 411.482
and 411.628 are nearly identical and require general, special, and
psychiatric hospitals and crisis stabilization facilities to screen
all patients who are being considered for discharge to a nursing facility,
prior to discharge, to determine whether the patient may have a mental
illness, intellectual disability or developmental disability. If the
screening indicates that the patient has a mental illness, intellectual
disability or developmental disability, the facility is required to
contact and arrange for the local mental health authority to conduct
an evaluation of the patient. These duties are to be carried out in
accordance with both the federal and DADS' PASRR rules.
The rule amendment to §133.41(f)(6) concerning the governing
body was revised by the addition of subparagraphs (D), (E) and (F).
The new language requires the governing body to ensure that specific
colored alert wrist bands are utilized in hospitals as follows: red
wrist bands for allergies; yellow wrist bands for fall risks; and
purple wrist bands for do-not-resuscitate status. New language also
allows the governing body to consider use of optional condition alert
wrist bands as follows: green wrist bands for latex allergies and
pink wrist bands for restricted extremity. In addition, new language
requires the governing body to implement and enforce a policy and
procedure regarding removal of personal wrist bands and bracelets
as well as a patient's right to refuse to wear condition alert wrist
bands. Section 133.41(f)(6)(B) and (C) were amended for punctuation
clarification.
COMMENTS
The department, on behalf of the commission, has reviewed and prepared
responses to the comments received regarding the proposed rules during
the comment period, which the commission has reviewed and accepts.
Comments were received from the Texas Hospital Association. The commenter
was not against the rules in their entirety; however, the commenter
suggested recommendations as discussed in the summary of comments.
Comment: The commenter requested a six-month delay in implementation
from the rules effective date for all of the agencies involved.
Response: The commission appreciates the comment, but DADS, the
agency primarily responsible for administering the federal PASRR Program
in Texas, has promulgated new, detailed PASRR Program rules to which
other state agencies, including the department, may refer, and any
new revisions are outside of the department's control. No change was
made as a result of this comment.
Comment: The commenter also submitted comments on the substance
of DADS' rules in 40 TAC Chapter 17 as they apply to hospitals under
that chapter and to rules in Chapters 133, 134, and 411. The comments/recommendations
specifically concerned §17.103, Fair Hearing Process; §17.104,
Exceptions to PASRR Level II Evaluations and Determinations; §17.201,
Preadmission Screening Process; §17.202, Expedited Admission
Process; §17.302, Nursing Facility Responsibilities; and §17.303,
Local Authority Responsibilities.
Response: The commission appreciates the comments, but DADS, the
agency primarily responsible for administering the federal PASRR Program
in Texas, has promulgated new, detailed PASRR Program rules to which
other state agencies, including the department, may refer, and any
new revisions are outside of the department's control. No change was
made as a result of this comment.
A minor clarification was made to §133.41(f)(6)(B) by replacing
the word "grated" with "granted."
LEGAL CERTIFICATION
The Department of State Health Services General Counsel, Lisa Hernandez,
certifies that the rule, as adopted, has been reviewed by legal counsel
and found to be a valid exercise of the agencies' legal authority.
STATUTORY AUTHORITY
The amendment is authorized by Health and Safety Code, §241.026,
concerning rules and minimum standards for the licensing and regulation
of hospitals; §311.004, which requires the development of a standardized
patient risk identification system; §577.010, concerning rules
and standards for the proper care and treatment of patients in private
psychiatric hospitals or mental health facilities; and Government
Code, §531.0055, 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.
§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 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's oxygen saturation
level.
(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 intellectual disability;
(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 medical director or clinical director who supervises
and administers the provision of comprehensive medical rehabilitation
services.
(i)
The medical director or clinical 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 medical director or clinical director shall
be qualified by training or at least two years training and experience
to serve as medical director or clinical 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 intellectual disability;
(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 who is the medical director
or clinical director.
(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, except for hospitals designated
as critical access hospitals (CAHs) by the Centers for Medicare &
Medicaid Services (CMS), 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, hospitals designated as CAHs
by the CMS, 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 shall develop, implement and enforce
policies and procedures to ensure that a sexual assault survivor who
presents to the hospital following a sexual assault receives one of
the following:
(i)
the care specified under subparagraph (B) of this
paragraph; or
(ii)
stabilization and transfer 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 providing care to a sexual assault survivor
shall provide the survivor with the following:
(i)
a forensic medical examination in accordance with
Government Code, Chapter 420, Subchapter B, when the examination has
been requested by a law enforcement agency under Code of Criminal
Procedure, Article 56.06, or is conducted under Code of Criminal Procedure,
Article 56.065. If a sexual assault survivor is age 18 or older and
has not reported the assault to a law enforcement agency, a hospital
shall provide this forensic medical examination, when the sexual assault
survivor has arrived at the facility not later than 96 hours after
the time the assault occurred and has consented to the examination;
(ii)
a private area, if available, to wait or speak
with the appropriate medical, legal, or sexual assault crisis center
staff or volunteer until a physician, nurse, or physician assistant
is able to treat the survivor;
(iii)
access to a sexual assault program advocate,
if available, as provided by Code of Criminal Procedure, Article 56.045;
(iv)
the information form required by Health and Safety
Code, §323.005;
(v)
a private treatment room, if available;
(vi)
if indicated by the history of contact, access
to appropriate prophylaxis for exposure to sexually transmitted infections;
and
(vii)
the name and telephone number of the nearest
sexual assault crisis center.
(C)
The hospital must obtain documented consent before
providing the forensic medical examination and treatment.
(D)
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)
In hospitals that provide obstetrical services,
the governing body shall ensure that the hospital collaborates with
physicians providing services at the hospital to develop quality initiatives,
through the adoption, implementation, and enforcement of appropriate
hospital policies and procedures, to reduce the number of elective
or nonmedically indicated induced deliveries or cesarean sections
performed at the hospital on a woman before the 39th week of gestation.
(D)
In hospitals that provide obstetrical services,
the governing body shall ensure that the hospital implements a newborn
audiological screening program, consistent with the requirements of
Health and Safety Code, Chapter 47 (Hearing Loss in Newborns), and
performs, either directly or through a transfer agreement, audiological
screenings for the identification of hearing loss on each newborn
or infant born at the facility before the newborn or infant is discharged.
These audiological screenings are required to be performed on all
newborns or infants before discharge from the facility unless:
(i)
a parent or legal guardian of the newborn or infant
declines the screening;
(ii)
the newborn or infant requires emergency transfer
to a tertiary care facility prior to the completion of the screening;
or
(iii)
the screening previously has been completed.
(E)
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.
(F)
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, §241.1015
(Physician Communication and Contracts).
(G)
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, Occupations Code, §160.002 and §160.003.
(H)
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;
(C)
a physician is on duty or on-call at all times;
(D)
specific colored condition alert wrist bands that
have been standardized for all hospitals licensed under Health and
Safety Code, Chapter 241, are used as follows:
(i)
red wrist bands for allergies;
(ii)
yellow wrist bands for fall risks; and
(iii)
purple wrist bands for do not resuscitate status;
(E)
the governing body shall consider the addition
of the following optional condition alert wrist bands. This consideration
must be documented in the minutes of the meeting of the governing
body in which the discussion was held:
(i)
green wrist bands for latex allergy; and
(ii)
pink wrist bands for restricted extremity; and
(F)
the governing body shall adopt, implement, and
enforce a policy and procedure regarding the removal of personal wrist
bands and bracelets as well as a patient's right to refuse to wear
condition alert wrist bands.
(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.
(8)
Nurse Staffing. The governing body shall adopt,
implement and enforce a written nurse staffing policy to ensure that
an adequate number and skill mix of nurses are available to meet the
level of patient care needed. The governing body policy shall require
that hospital administration adopt, implement and enforce a nurse
staffing plan and policies that:
(A)
require significant consideration be given to the
nurse staffing plan recommended by the hospital's nurse staffing committee
and the committee's evaluation of any existing plan;
(B)
are based on the needs of each patient care unit
and shift and on evidence relating to patient care needs;
(C)
ensure that all nursing assignments consider client
safety, and are commensurate with the nurse's educational preparation,
experience, knowledge, and physical and emotional ability;
(D)
require use of the official nurse services staffing
plan as a component in setting the nurse staffing budget;
(E)
encourage nurses to provide input to the nurse
staffing committee relating to nurse staffing concerns;
(F)
protect from retaliation nurses who provide input
to the nurse staffing committee; and
(G)
comply with subsection (o) of this section.
(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, Mail Code 2822, P.O.
Box 149347, Austin, Texas 78714-9347, in accordance with Chapter 97
of this title (relating to Communicable Diseases), and Health and
Safety Code, §§98.103, 98.104, and 98.1045 (relating to
Reportable Infections, Alternative for Reportable Surgical Site Infections,
and Reporting of Preventable Adverse Events).
(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 or contract with 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 the next time 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 provides care to the patient, assesses the patient,
or documents information in the patient's medical record.
(7)
All verbal orders must be dated, timed, and authenticated
within 48 hours 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. The medical history and physical
examination shall be placed in the patient's medical record within
24 hours after admission;
(D)
an updated medical record entry documenting an
examination for any changes in the patient's condition when the medical
history and physical examination are completed within 30 days before
admission. This updated examination shall be completed and documented
in the patient's medical record within 24 hours after admission;
(E)
admitting diagnosis;
(F)
diagnostic and therapeutic orders;
(G)
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;
(H)
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;
(I)
reports of procedures, tests, and their results,
including laboratory, pathology, and radiology reports;
(J)
results of all consultative evaluations of the
patient and appropriate findings by clinical and other staff involved
in the care of the patient;
(K)
discharge summary with outcome of hospitalization,
disposition of care, and provisions for follow-up care; and
(L)
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)
The hospital shall provide written notice to a
patient, or a patient's legally authorized representative, that the
hospital may authorize the disposal of medical records relating to
the patient on or after the periods specified in this section. The
notice shall be provided to the patient or the patient's legally authorized
representative not later than the date on which the patient who is
or will be the subject of a medical record is treated, except in an
emergency treatment situation. In an emergency treatment situation,
the notice shall be provided to the patient or the patient's legally
authorized representative as soon as is reasonably practicable following
the emergency treatment situation.
(12)
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. The medical history and physical examination shall be placed
in the patient's medical record within 24 hours after admission. 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 intellectual disability;
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 medical director or clinical 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 medical director
or clinical 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 in accordance
with §289.256 of this title.
(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 a well-organized
service 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 building of a licensed
hospital that contains at least one nursing unit where patients are
present. 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)
The hospital shall establish a nurse staffing committee
as a standing committee of the hospital. The committee shall be 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. As used in this
subsection, "committee" or "staffing committee" means a nurse staffing
committee established under this subparagraph.
(i)
The committee shall be composed of:
(I)
at least 60% registered nurses who are involved
in direct patient care at least 50% of their work time and selected
by their peers who provide direct care during at least 50% of their
work time;
(II)
at least one representative from either infection
control, quality assessment and performance improvement or risk management;
(III)
members who are representative of the types of
nursing services provided at the hospital; and
(IV)
the chief nursing officer of the hospital who
is a voting member.
(ii)
Participation on the committee by a hospital employee
as a committee member shall be part of the employee's work time and
the hospital shall compensate that member for that time accordingly.
The hospital shall relieve the committee member of other work duties
during committee meetings.
(iii)
The committee shall meet at least quarterly.
(iv)
The responsibilities of the committee shall be
to:
(I)
develop and recommend to the hospital's governing
body a nurse staffing plan that meets the requirements of subparagraph
(G) of this paragraph;
(II)
review, assess and respond to staffing concerns
expressed to the committee;
(III)
identify the nurse-sensitive outcome measures
the committee will use to evaluate the effectiveness of the official
nurse services staffing plan;
(IV)
evaluate, at least semiannually, the effectiveness
of the official nurse services staffing plan and variations between
the plan and the actual staffing; and
(V)
submit to the hospital's governing body, at least
semiannually, a report on nurse staffing and patient care outcomes,
including the committee's evaluation of the effectiveness of the official
nurse services staffing plan and aggregate variations between the
staffing plan and actual staffing.
(G)
The hospital shall adopt, implement and enforce
a written official nurse services staffing plan. As used in this subsection,
"patient care unit" means a unit or area of a hospital in which registered
nurses provide patient care.
(i)
The official nurse services staffing plan and policies
shall:
(I)
require significant consideration to be given to
the nurse staffing plan recommended by the hospital's nurse staffing
committee and the committee's evaluation of any existing plan;
(II)
be based on the needs of each patient care unit
and shift and on evidence relating to patient care needs;
(III)
require use of the official nurse services staffing
plan as a component in setting the nurse staffing budget;
(IV)
encourage nurses to provide input to the nurse
staffing committee relating to nurse staffing concerns;
(V)
protect from retaliation nurses who provide input
to the nurse staffing committee; and
(VI)
comply with subsection (o) of this section.
(ii)
The plan shall:
(I)
set minimum staffing levels for patient care units
that are:
(-a-)
based on multiple nurse and patient considerations
including:
(-1-)
patient characteristics and number of patients
for whom care is being provided, including number of admissions, discharges
and transfers on a unit;
(-2-)
intensity of patient care being provided and
variability of patient care across a nursing unit;
(-3-)
scope of services provided;
(-4-)
context within which care is provided, including
architecture and geography of the environment, and the availability
of technology; and
(-5-)
nursing staff characteristics, including staff
consistency and tenure, preparation and experience, and the number
and competencies of clinical and non-clinical support staff the nurse
must collaborate with or supervise.
(-b-)
determined by the nursing assessment and in accordance
with evidence-based safe nursing standards; and
(-c-)
recalculated at least annually, or as necessary;
(II)
include a method for adjusting the staffing plan
shift to shift for each patient care unit based on factors, such as,
the intensity of patient care to provide staffing flexibility to meet
patient needs;
(III)
include a contingency plan when patient care
needs unexpectedly exceed direct patient care staff resources;
(IV)
include how on-call time will be used;
(V)
reflect current standards established by private
accreditation organizations, governmental entities, national nursing
professional associations, and other health professional organizations
and should be developed based upon a review of the codes of ethics
developed by the nursing profession through national nursing organizations;
(VI)
include a mechanism for evaluating the effectiveness
of the official nurse services staffing plan based on patient needs,
nursing sensitive quality indicators, nurse satisfaction measures
collected by the hospital and evidence based nurse staffing standards.
At least one from each of the following three types of outcomes shall
be correlated to the adequacy of staffing:
(-a-)
nurse-sensitive patient outcomes selected by
the nurse staffing committee, 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;
(VII)
incorporate a process that facilitates the timely
and effective identification of concerns about the adequacy of the
staffing plan by the nurse staffing committee established pursuant
to subparagraph (F) 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-)
encouraging nurses to provide input to the committee
relating to nurse staffing concerns;
(-e-)
review, assessment, and response by the committee
to staffing concerns expressed to the committee;
(-f-)
a process for providing feedback during the committee
meeting on how concerns are addressed by the committee established
under subparagraph (F) of this paragraph; and
(-g-)
use of the nurse safe harbor peer review process
pursuant to Occupations Code, §303.005;
(VIII)
include policies and procedures that require:
(-a-)
orientation of nurses and other personnel who
provide nursing care to all patient care 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
(IX)
be used by the hospital as a component in setting
the nurse staffing budget and guiding the hospital in assigning nurses
hospital wide.
(iii)
The hospital shall make readily available to
nurses on each patient care unit at the beginning of each shift the
official nurse services staffing plan levels and current staffing
levels for that unit and that shift.
(iv)
There shall be a semiannual evaluation by the
staffing committee of the effectiveness of the official nurse services
staffing plan and variations between the staffing plan and actual
staffing. The evaluation shall consider the outcomes and nursing-sensitive
indicators as set out in clause (ii)(VI) of this subparagraph, patient
needs, nurse satisfaction measures collected by the hospital, and
evidence based nurse staffing standards. This evaluation shall be
documented in the minutes of the committee established under subparagraph
(F) of this paragraph and presented to the hospital's governing body.
Hospitals may determine whether this evaluation is done on a unit
or facility level basis. To assist the committee with the semiannual
evaluation, the hospital shall report to the committee the variations
between the staffing plan and actual staffing. This report of variations
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.
(v)
The staffing plan shall be retained for a period
of two years.
(H)
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.
(I)
The hospital shall annually report to the department
on:
(i)
whether the hospital's governing body has adopted
a nurse staffing policy;
(ii)
whether the hospital has established a nurse staffing
committee that meets the membership requirements of subparagraph (F)
of this paragraph;
(iii)
whether the nurse staffing committee has evaluated
the hospital's official nurse services staffing plan and has reported
the results of the evaluation to the hospital's governing body; and
(iv)
the nurse-sensitive outcome measures the committee
adopted for use in evaluating the hospital's official nurse services
staffing plan.
(3)
Mandatory overtime. The hospital shall adopt, implement
and enforce policies on use of mandatory overtime.
(A)
As used in this subsection:
(i)
"on-call time" means time spent by a nurse who
is not working but who is compensated for availability; and
(ii)
"mandatory overtime" means a requirement that
a nurse work hours or days that are in addition to the hours or days
scheduled, regardless of the length of a scheduled shift or the number
of scheduled shifts each week. Mandatory overtime does not include
prescheduled on-call time or time immediately before or after a scheduled
shift necessary to document or communicate patient status to ensure
patient safety.
(B)
A hospital may not require a nurse to work mandatory
overtime, and a nurse may refuse to work mandatory overtime.
(C)
This section does not prohibit a nurse from volunteering
to work overtime.
(D)
A hospital may not use on-call time as a substitute
for mandatory overtime.
(E)
The prohibitions on mandatory overtime do not apply
if:
(i)
a health care disaster, such as a natural or other
type of disaster that increases the need for health care personnel,
unexpectedly affects the county in which the nurse is employed or
affects a contiguous county;
(ii)
a federal, state, or county declaration of emergency
is in effect in the county in which the nurse is employed or is in
effect in a contiguous county;
(iii)
there is an emergency or unforeseen event of
a kind that:
(I)
does not regularly occur;
(II)
increases the need for health care personnel at
the hospital to provide safe patient care; and
(III)
could not prudently be anticipated by the hospital;
or
(iv)
the nurse is actively engaged in an ongoing medical
or surgical procedure and the continued presence of the nurse through
the completion of the procedure is necessary to ensure the health
and safety of the patient. The nurse staffing committee shall ensure
that scheduling a nurse for a procedure that could be anticipated
to require the nurse to stay beyond the end of his or her scheduled
shift does not constitute mandatory overtime.
(F)
If a hospital determines that an exception exists
under subparagraph (E) of this paragraph, the hospital shall, to the
extent possible, make and document a good faith effort to meet the
staffing need through voluntary overtime, including calling per diems
and agency nurses, assigning floats, or requesting an additional day
of work from off-duty employees.
(G)
A hospital may not suspend, terminate, or otherwise
discipline or discriminate against a nurse who refuses to work mandatory
overtime.
(4)
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 within 48 hours
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.
(5)
Blood transfusions.
(A)
Transfusions shall be prescribed in accordance
with hospital policy and administered in accordance with 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)
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.
(6)
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 Whistleblower
Protections), and §217.20 (relating to Safe Harbor Peer Review
for Nurses and Whistleblower Protections).
(7)
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.
(8)
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 policies 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)
All drugs and biologicals shall be kept in a secure
area, and locked when appropriate.
(i)
A policy shall be adopted, implemented, and enforced
to ensure the safeguarding, transferring, and availability of keys
to the locked storage area.
(ii)
Drugs listed in Schedules II, III, IV, and V of
the Comprehensive Drug Abuse Prevention and Control Act of 1970 shall
be kept locked within a secure area.
(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.
(C)
Screening and evaluation before patient discharge
from hospital. In accordance with 42 Code of Federal Regulations (CFR),
Part 483, Subpart C (relating to Requirements for Long Term Care Facilities)
and the rules of the Department of Aging and Disability Services (DADS)
set forth in 40 TAC Chapter 17 (relating to Preadmission Screening
and Resident Review (PASRR)), all patients who are being considered
for discharge from the hospital to a nursing facility shall be screened,
and if appropriate, evaluated, prior to discharge by the hospital
and admission to the nursing facility to determine whether the patient
may have a mental illness, intellectual disability or developmental
disability. If the screening indicates that the patient has a mental
illness, intellectual disability or developmental disability, the
hospital shall contact and arrange for the local mental health authority
designated pursuant to Health and Safety Code, §533.035, to conduct
prior to hospital discharge an evaluation of the patient in accordance
with the applicable provisions of the PASRR rules. The purpose of
PASRR is:
(i)
to ensure that placement of the patient in a nursing
facility is necessary;
(ii)
to identify alternate placement options when applicable;
and
(iii)
to identify specialized services that may benefit
the person with a diagnosis of mental illness, intellectual disability,
or developmental disability.
(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)
Hospitals may provide inpatient dialysis services
without an additional license under HSC Chapter 251. Hospitals providing
outpatient dialysis services shall be licensed under HSC Chapter 251.
(2)
Hospitals may provide outpatient dialysis services
when the governor or the president of the United States declares a
disaster in this state or another state. The hospital may provide
outpatient dialysis only during the term of the disaster declaration.
(3)
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.
(4)
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 <1mg/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).
(5)
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 medical director or clinical director
of respiratory care services who is a physician with the knowledge,
experience, and capabilities to supervise and administer the services
properly. The medical director or clinical 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.
(E)
If the facility employs surgical technologists,
the facility shall adopt, implement, and enforce policies and procedures
to comply with Health and Safety Code, Chapter 259 (relating to Surgical
Technologists at Health Care Facilities).
(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.
This agency hereby certifies that the adoption
has been reviewed by legal counsel and found to be a valid exercise
of the agency's legal authority.
Filed with the Office
of the Secretary of State on May 3, 2013.
TRD-201301758
Lisa Hernandez
General Counsel
Department of State Health Services
Effective date: May 24, 2013
Proposal publication date: February 22, 2013
For further information, please call: (512) 776-6972
Subchapter C. OPERATIONAL REQUIREMENTS
25 TAC §134.41
The Executive Commissioner of the Health and Human
Services Commission (commission), on behalf of the Department of State
Health Services (department), adopts an amendment to §134.41,
psychiatric hospitals, concerning Preadmission Screening and Resident
Review (PASRR), without changes to proposed text as published in the
February 22, 2013, issue of the
Texas Register
(38
TexReg 1083) and, therefore, the section will not be republished.
The amendment will require that general and special hospitals,
psychiatric hospitals, and crisis stabilization facilities undertake
screening, prior to discharge, of all patients being considered for
placement in a nursing facility to determine whether the patient may
have a mental illness, intellectual disability or developmental disability.
The amendment explicitly adds to the State's regulatory scheme the
federal PASRR procedures which the Centers for Medicare and Medicaid
Services (CMS) require.
The PASRR screening requirements are being added to §133.41(r)
concerning quality assessment and performance improvement under the
operational requirements for general and special hospitals; §134.41(m)
concerning quality assurance under the operational requirements for
psychiatric hospitals; and §411.482(a) and §411.628(a) concerning
discharge planning as a standard of care and treatment at psychiatric
hospitals and crisis stabilization units, respectively.
BACKGROUND AND PURPOSE
The purpose of the PASRR program is to ensure that placement of
a patient in a nursing facility is necessary; to identify alternate
placement options when applicable; and to identify specialized services
that may benefit the person with a diagnosis of mental illness, intellectual
disability, or developmental disability. The requirements of the federal
PASRR program are set forth at 42 Code of Federal Regulations (CFR)
Part 483, Subpart C. To promote a clear, consistent implementation
of this federal regulatory scheme in Texas, the Department of Aging
and Disability Services (DADS), the agency primarily responsible for
administering the federal PASRR Program in Texas, is promulgating
new, detailed PASRR Program rules to which other state agencies, including
the department, may refer. DADS' new PASRR rules, which are published
in the same issue of the
Texas Register
as
the amendments described in this preamble, may be found at 40 TAC
Chapter 17, and the PASARR rule at 40 TAC Chapter 19 has been repealed.
Through promulgation of the four rule amendments described in this
preamble, the department is requiring General Hospitals, Special Hospitals,
Private Psychiatric Hospitals and Crisis Stabilization Units to comply
with the PASRR requirements "in accordance with" the specific, applicable
provisions of the new DADS' rules as well as the federal regulations.
SECTION-BY-SECTION SUMMARY
The four rule amendments to §§133.41, 134.41, 411.482
and 411.628 are nearly identical, and require general, special, and
psychiatric hospitals and crisis stabilization facilities to screen
all patients who are being considered for discharge to a nursing facility,
prior to discharge, to determine whether the patient may have a mental
illness, intellectual disability or developmental disability. If the
screening indicates that the patient has a mental illness, intellectual
disability or developmental disability, the facility is required to
contact and arrange for the local mental health authority to conduct
an evaluation of the patient. These duties are to be carried out in
accordance with both the federal and DADS' PASRR rules.
COMMENTS
The department, on behalf of the commission, has reviewed and prepared
responses to the comments received regarding the proposed rules during
the comment period, which the commission has reviewed and accepts.
Comments were received from the Texas Hospital Association. The commenter
was not against the rules in their entirety; however, the commenter
suggested recommendations as discussed in the summary of comments.
Comment: The commenter requested a six-month delay in implementation
from the rules effective date for all of the agencies involved.
Response: The commission appreciates the comment, but DADS, the
agency primarily responsible for administering the federal PASRR Program
in Texas, has promulgated new, detailed PASRR Program rules to which
other state agencies, including the department, may refer, and any
new revisions are outside of the department's control. No change was
made as a result of this comment.
Comment: The commenter also submitted comments on the substance
of DADS' rules in 40 TAC Chapter 17 as they apply to hospitals under
that chapter and to rules in Chapters 133, 134, and 411. The comments/recommendations
specifically concerned §17.103, Fair Hearing Process; §17.104,
Exceptions to PASRR Level II Evaluations and Determinations; §17.201,
Preadmission Screening Process; §17.202, Expedited Admission
Process; §17.302, Nursing Facility Responsibilities; and §17.303,
Local Authority Responsibilities.
Response: The commission appreciates the comments, but DADS, the
agency primarily responsible for administering the federal PASRR Program
in Texas, has promulgated new, detailed PASRR Program rules to which
other state agencies, including the department, may refer, and any
new revisions are outside of the department's control. No change was
made as a result of this comment.
LEGAL CERTIFICATION
The Department of State Health Services General Counsel, Lisa Hernandez,
certifies that the rule, as adopted, has been reviewed by legal counsel
and found to be a valid exercise of the agencies' legal authority.
STATUTORY AUTHORITY
The amendment is authorized by Health and Safety Code, §241.026,
concerning rules and minimum standards for the licensing and regulation
of hospitals; §311.004, which requires the development of a standardized
patient risk identification system; §577.010, concerning rules
and standards for the proper care and treatment of patients in private
psychiatric hospitals or mental health facilities; and Government
Code, §531.0055, 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.
This agency hereby certifies that the adoption has been
reviewed by legal counsel and found to be a valid exercise of the
agency's legal authority.
Filed with the Office
of the Secretary of State on May 3, 2013.
TRD-201301759
Lisa Hernandez
General Counsel
Department of State Health Services
Effective date: May 24, 2013
Proposal publication date: February 22, 2013
For further information, please call: (512) 776-6972
The Executive Commissioner of the Health and Human Services
Commission (commission), on behalf of the Department of State Health
Services (department), adopts amendments to §411.482 and §411.628,
psychiatric hospitals and crisis stabilization units, concerning Preadmission
Screening and Resident Review (PASRR), without changes to the proposed
text as published in the February 22, 2013, issue of the
Texas Register
(38 TexReg 1085) and, therefore,
the sections will not be republished.
The amendments will require that general and special hospitals,
psychiatric hospitals, and crisis stabilization facilities undertake
screening, prior to discharge, of all patients being considered for
placement in a nursing facility to determine whether the patient may
have a mental illness, intellectual disability or developmental disability.
The amendments explicitly add to the State's regulatory scheme the
federal PASRR procedures which the Centers for Medicare and Medicaid
Services (CMS) require.
The PASRR screening requirements are being added to §133.41(r)
concerning quality assessment and performance improvement under the
operational requirements for general and special hospitals; §134.41(m)
concerning quality assurance under the operational requirements for
psychiatric hospitals; and §411.482(a) and §411.628(a) concerning
discharge planning as a standard of care and treatment at psychiatric
hospitals and crisis stabilization units, respectively.
BACKGROUND AND PURPOSE
The purpose of the PASRR program is to ensure that placement of
a patient in a nursing facility is necessary; to identify alternate
placement options when applicable; and to identify specialized services
that may benefit the person with a diagnosis of mental illness, intellectual
disability, or developmental disability. The requirements of the federal
PASRR program are set forth at 42 Code of Federal Regulations (CFR)
Part 483, Subpart C. To promote a clear, consistent implementation
of this federal regulatory scheme in Texas, the Department of Aging
and Disability Services (DADS), the agency primarily responsible for
administering the federal PASRR Program in Texas, is promulgating
new, detailed PASRR Program rules to which other state agencies, including
the department, may refer. DADS' new PASRR rules, which are published
in the same issue of the
Texas Register
as
the amendments described in this preamble, may be found at 40 TAC
Chapter 17, and the PASARR rule at 40 TAC Chapter 19 has been repealed.
Through promulgation of the four rule amendments described in this
preamble, the department is requiring General Hospitals, Special Hospitals,
Private Psychiatric Hospitals and Crisis Stabilization Units to comply
with the PASRR requirements "in accordance with" the specific, applicable
provisions of the new DADS' rules as well as the federal regulations.
SECTION-BY-SECTION SUMMARY
The four rule amendments to §§133.41, 134.41, 411.482
and 411.628 are nearly identical and require general, special, and
psychiatric hospitals and crisis stabilization facilities to screen
all patients who are being considered for discharge to a nursing facility,
prior to discharge, to determine whether the patient may have a mental
illness, intellectual disability or developmental disability. If the
screening indicates that the patient has a mental illness, intellectual
disability or developmental disability, the facility is required to
contact and arrange for the local mental health authority to conduct
an evaluation of the patient. These duties are to be carried out in
accordance with both the federal and DADS' PASRR rules.
COMMENTS
The department, on behalf of the commission, has reviewed and prepared
responses to the comments received regarding the proposed rules during
the comment period, which the commission has reviewed and accepts.
Comments were received from the Texas Hospital Association. The commenter
was not against the rules in their entirety; however, the commenter
suggested recommendations as discussed in the summary of comments.
Comment: The commenter requested a six-month delay in implementation
from the rules effective date for all of the agencies involved.
Response: The commission appreciates the comment, but DADS, the
agency primarily responsible for administering the federal PASRR Program
in Texas, has promulgated new, detailed PASRR Program rules to which
other state agencies, including the department, may refer, and any
new revisions are outside of the department's control. No change was
made as a result of this comment.
Comment: The commenter also submitted comments on the substance
of DADS' rules in 40 TAC Chapter 17 as they apply to hospitals under
that chapter and to rules in Chapters 133, 134, and 411. The comments/recommendations
specifically concerned §17.103, Fair Hearing Process; §17.104,
Exceptions to PASRR Level II Evaluations and Determinations; §17.201,
Preadmission Screening Process; §17.202, Expedited Admission
Process; §17.302, Nursing Facility Responsibilities; and §17.303,
Local Authority Responsibilities.
Response: The commission appreciates the comments, but DADS, the
agency primarily responsible for administering the federal PASRR Program
in Texas, has promulgated new, detailed PASRR Program rules to which
other state agencies, including the department, may refer, and any
new revisions are outside of the department's control. No change was
made as a result of this comment.
LEGAL CERTIFICATION
The Department of State Health Services General Counsel, Lisa Hernandez,
certifies that the rules, as adopted, have been reviewed by legal
counsel and found to be a valid exercise of the agencies' legal authority.
Subchapter J. STANDARDS OF CARE AND TREATMENT IN PSYCHIATRIC HOSPITALS
5.
DISCHARGE
25 TAC §411.482
STATUTORY AUTHORITY
The amendment is authorized by Health and Safety Code, §241.026,
concerning rules and minimum standards for the licensing and regulation
of hospitals; §311.004, which requires the development of a standardized
patient risk identification system; §577.010, concerning rules
and standards for the proper care and treatment of patients in private
psychiatric hospitals or mental health facilities; and Government
Code, §531.0055, 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.
This agency hereby certifies that the adoption has been
reviewed by legal counsel and found to be a valid exercise of the
agency's legal authority.
Filed with the Office
of the Secretary of State on May 3, 2013.
TRD-201301760
Lisa Hernandez
General Counsel
Department of State Health Services
Effective date: May 24, 2013
Proposal publication date: February 22, 2013
For further information, please call: (512) 776-6972
5.
DISCHARGE
25 TAC §411.628
STATUTORY AUTHORITY
The amendment is authorized by Health and Safety Code, §241.026,
concerning rules and minimum standards for the licensing and regulation
of hospitals; §311.004, which requires the development of a standardized
patient risk identification system; §577.010, concerning rules
and standards for the proper care and treatment of patients in private
psychiatric hospitals or mental health facilities; and Government
Code, §531.0055, 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.
This agency hereby certifies that the adoption has been
reviewed by legal counsel and found to be a valid exercise of the
agency's legal authority.
Filed
with the Office of the Secretary of State on May 3, 2013.
TRD-201301761
Lisa Hernandez
General Counsel
Department of State Health Services
Effective date: May 24, 2013
Proposal publication date: February 22, 2013
For further information, please call: (512) 776-6972
Subchapter D. MENTAL HEALTH SERVICES--ADMISSION, CONTINUITY, AND DISCHARGE
5.
DISCHARGE AND ATP FROM SMHF
25 TAC §412.202
The Executive Commissioner of the Health and Human
Services Commission (commission), on behalf of the Department of State
Health Services (department), adopts an amendment to §412.202,
concerning the Mental Health Services--Admission, Continuity, and
Discharge, with changes to the text as proposed in the February 22,
2013, issue of the
Texas Register
(38
TexReg 1087).
BACKGROUND AND PURPOSE
In accordance with 42 Code of Federal Regulations Part 483, Subpart
C, concerning Preadmission Screening and Resident Review (PASRR),
the amended section sets forth the requirements for state mental health
facilities (SMHFs) and local mental health authorities (LMHAs) to
perform PASRR screenings and evaluations of patients who are being
considered for nursing home placement upon discharge.
The purpose of PASRR is to ensure that placing the patient in a
nursing facility is necessary, to identify alternate placement options
when applicable, and to identify specialized services that may benefit
the person with a diagnosis of mental illness, intellectual disability,
or developmental disability. To promote a clear, consistent implementation
of the PASRR Program, the Department of Aging and Disability Services
(DADS), who is designated with the responsibility for administering
the PASRR Program in Texas, is promulgating PASRR Program rules with
which LMHAs and SMHFs must comply. The department is amending an applicable
rule in Chapter 412, Subchapter D, §412.202, concerning admission,
continuity, and discharge to require that LMHAs and SMHFs comply with
federal regulations and the rules in 40 TAC Chapter 17, concerning
substantially the same matter. DADS' new PASRR rules, which are published
in the same issue of the
Texas Register
as
the amendment in this preamble and repeal of the department's rules
in Chapter 415, Subchapter J, may be found at 40 TAC Chapter 17. The
DADS' PASARR rule at 40 TAC Chapter 19, Subchapter Z, has been repealed.
The department rules in Chapter 415, Subchapter J, concerning PASARR
are repealed because they are no longer necessary.
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). Section 412.202 has been reviewed and the department has determined
that the reasons for adopting the rule continue to exist.
SECTION-BY-SECTION SUMMARY
Amendments to §412.202(b) cite the federal PASRR regulations;
set forth the basic requirements for LMHAs and SMHFs in the conduct
of preadmission screenings, evaluations, and resident reviews; and
require compliance with federal regulations and DADS' rules concerning
PASRR in 40 TAC Chapter 17. Section 412.202(b)(5) has been deleted
because it conflicts with the DADS' rules.
COMMENTS
The department, on behalf of the commission, has reviewed and prepared
responses to the comments received regarding the proposed rules during
the comment period, which the commission has reviewed and accepts.
Comments were received from the MHMR Authority of Brazos Valley of
Bryan, Disability Rights Texas, Inc., of Austin, and National Association
of Social Workers - Texas Chapter of Austin. The commenters were not
against the rules in their entirety; however, the commenters suggested
recommendations for change as discussed in the summary of comments.
Comment: With regard to §412.202(b)(5), the commenter suggested
that these provisions should be the responsibility of the state facility
that made the placement, these actions should be taken at a level
higher than the LMHA, and this level of involvement could result in
conflicts between the LMHA and the local nursing facilities. Further,
the commenter offered that qualified mental health professionals (QMHPs)
would likely be evaluating appropriate care and indicated that it
is unreasonable to expect a QMHP to evaluate appropriate medical care.
The commenter expressed concern over the potential for future legal
implications resulting from the determination of "appropriate care"
and asked whether "appropriate" implied "adequate."
Response: Although the information contained in §412.202 is
not new and, therefore, adds no new requirements for LMHAs, the department
does recognize that this language has the potential to cause confusion
in light of the requirements set forth in the new DADS' PASRR rules
in 40 TAC Chapter 17 published in the same issue of the
Texas Register.
Therefore, the department
has deleted §412.202(b)(5).
Comment: Concerning the rules in general, a commenter advised that
the concerns raised during informal comments appear to have been addressed
in the proposed published version.
Response: The department appreciates the commenter's time and effort
in responding during the formal comment period.
Comment: A commenter supports the idea of proper placement of individuals
but expressed concern over the lack of resources, thereby creating
a barrier to care for individuals with mental health diagnoses and
medical problems. Further, if individuals are inappropriately placed
in nursing facilities when the individual needs mental health or developmental
disability treatment that cannot be provided by or arranged by the
nursing home, the nursing home will not be paid for the days the individual
is in the nursing facility without prior approval for admission. The
commenter indicates that the seven-day timeframe for the PASRR screening
is insufficient and would result in a revolving door for individuals
going from group home placement, where medical needs cannot always
be met appropriately, to a hospital, then to a nursing home, and back
to a group home.
Response: The amendment to §412.202 does not alter or establish
conditions for payment for nursing facility services. The department
does not have the statutory authority to regulate or to establish
conditions for payment to these entities.
The language referencing the seven-day period in §412.202(b)(5)(A)
applies only to individuals who are already placed in a nursing facility,
so there is no possibility of such a requirement having an impact
either on placement in the nursing facility nor upon hospital discharge
since it only applies after both events have occurred. Since there
are new DADS' PASRR rules that address this, the department has deleted §412.202(b)(5)
to avoid further confusion in the interpretation of this provision.
LEGAL CERTIFICATION
The Department of State Health Services General Counsel, Lisa Hernandez,
certifies that the rules, as adopted, have been reviewed by legal
counsel and found to be a valid exercise of the agencies' legal authority.
STATUTORY AUTHORITY
The amendment is authorized by Government Code, §531.0055(e),
and Health and Safety Code, Chapter 35 and §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 review of the rule implements
Government Code, §2001.039.
§412.202.Special Considerations.
(a)
Persons admitted to a SMHF three times in 180 days.
Persons who are admitted to a SMHF three times in 180 days are considered
to be at risk for future admission to inpatient services. Pursuant
to the Texas Government Code, §531.0244(b)(4), to prevent the
unnecessary placement in an institution, the SMHF and designated LMHA
shall:
(1)
during discharge planning, review the patient's
previous continuing care plans to determine the effectiveness of the
clinical and non-clinical services and supports identified, and recommend
in the patient's current continuing care plan those services and supports
that have been effective and as well as those designed to prevent
unnecessary admission to the SMHF;
(2)
determine the availability and appropriateness
of clinical and non-clinical services and supports in the intensity
needed by the patient (i.e., type, amount, scope, and duration) which
will prevent unnecessary admission to the SMHF; and
(3)
consider appropriateness of the patient's continued
stay in the SMHF.
(b)
Preadmission Screening and Evaluation (PASRR).
As described in 42 Code of Federal Regulations Part 483, Subpart C,
all patients who are being considered for nursing home placement shall
be screened prior to nursing facility admission. The purpose of the
PASRR Level I Screening and PASRR Level II Evaluation is:
(1)
to ensure that placement of the patient in a nursing
facility is necessary;
(2)
to identify alternate placement options when applicable;
and
(3)
to identify specialized services that may benefit
the person with a diagnosis of mental illness, intellectual disability,
or developmental disability.
(A)
PASRR Level I Screening. The SMHF shall complete,
and may collaborate with a nursing facility, a PASRR Level I Screening
in accordance with the rules of the Department of Aging and Disability
Services (DADS) set forth in the 40 TAC Chapter 17 (relating to Preadmission
Screening and Resident Review (PASRR)).
(B)
PASRR Level II Evaluation. If the PASRR Level I
Screening indicates that the patient might have a mental illness,
intellectual disability, or developmental disability, the SMHF shall
arrange with LMHA who shall conduct a PASRR Level II Evaluation in
accordance with 40 TAC Chapter 17.
(C)
Resident Review. The LMHA shall conduct PASRR Level
II Evaluations as part of the resident review process required by
40 TAC Chapter 17.
(4)
ATP. If a patient is admitted to a nursing facility
on ATP, then the designated LMHA shall conduct and document, including
justification for its recommendations, the activities described in
this paragraph.
(A)
The designated LMHA shall make at least one face-to-face
contact with the patient at the nursing facility. The contact shall
include:
(i)
a review of the patient's medical record at the
nursing facility; and
(ii)
discussions with the patient and LAR, if any,
the nursing facility staff, and other staff who provide care to the
patient regarding:
(I)
the needs of the patient and the care he/she is
receiving;
(II)
the ability of the nursing facility to provide
the appropriate care;
(III)
the provision of mental health services, if needed
by the patient; and
(IV)
the patient's adjustment to the nursing facility.
(B)
Before the end of the initial ATP period as described
in §412.206(b)(2) of this title (relating to Absence for Trial
Placement (ATP)), the designated LMHA shall recommend to the SMHF
one of the following:
(i)
discharging the patient if the LMHA determines
that:
(I)
the nursing facility is capable of providing, and
willing to provide, appropriate care to the patient after discharge;
(II)
any mental health services needed by the patient
are being provided to the patient while he/she is residing in the
nursing facility; and
(III)
the patient and LAR, if any, agrees to the nursing
facility placement;
(ii)
extending the patient's ATP period in accordance
with §412.206(b)(3) of this title;
(iii)
returning the patient to the SMHF in accordance
with §412.205(b)(2) of this title (relating to Absences From
a SMHF); or
(iv)
initiating involuntary admission to the SMHF in
accordance with §412.205(a)(2) of this title.
(c)
Assisted living.
(1)
A SMHF or LMHA may not refer a person to an assisted
living facility that is not licensed under the Texas Health and Safety
Code, Chapter 247.
(2)
As required by the Texas Health and Safety Code, §247.063(b),
if a SMHF or LMHA gains knowledge of an assisted living facility that
is not operated or licensed by TDHS, an LMHA, or TDMHMR, and that
has four or more residents who are unrelated to the proprietor of
the facility, then the SMHF or LMHA shall report the name, address,
and telephone number of the facility to TDHS.
(d)
Minors.
(1)
To the extent permitted by medical privacy laws,
the SMHF and designated LMHA shall make a reasonable effort to involve
a minor's LAR or the LAR's designee.
(2)
A minor committed to or placed in a SMHF under
the Texas Family Code, Chapter 55, Subchapter C or D, shall be discharged
in accordance with the Texas Family Code, Chapter 55, Subchapter C
or D, as appropriate.
(e)
Patients suspected of having mental retardation.
If the SMHF suspects a patient has mental retardation, then the SMHF
shall notify the designated LMHA liaison staff and the designated
MRA. The designated MRA shall assign an MRA liaison staff to the patient
to ensure compliance with Chapter 415, Subchapter D of this title
(concerning Diagnostic Eligibility for Services and Supports--Mental
Retardation Priority Population and Related Conditions).
(f)
Criminal Code.
(1)
Texas Code of Criminal Procedure (TCCP), Article
46.02 or Chapter 46B: Incompetency to stand trial.
(A)
Discharge of a patient committed under TCCP, Article
46.02, §6 (Civil commitment--charges pending) or Article 46B.102
(Commitment Hearing: Mental Illness), shall be in accordance with
the TCCP, Article 46.02, §8 (General) or Article 46B.107 (Release
of Defendant After Commitment).
(B)
Discharge of a patient committed under TCCP, Article
46.02, §5 (Criminal commitment) or Article 46B.073 (Commitment
For Restoration to Competency), shall be in accordance with TCCP,
Article 46.02, §5 (Criminal commitment) or Article 46B.083 (Report
By Facility Head).
(C)
For a patient committed under TCCP, Article 46.02
or Chapter 46B, who is discharged and returned to the committing court,
the SMHF shall, within 24 hours after discharge, notify the following
of the discharge:
(i)
the patient's designated LMHA; and
(ii)
the Texas Correctional Office on Offenders with
Medical or Mental Impairments.
(2)
TCCP, Article 46.03: Insanity defense. A person
acquitted by reason of insanity and committed to a SMHF under TCCP,
Article 46.03, may be discharged only upon order of the committing
court in accordance with TCCP, Article 46.03, §4(d)(5) (Disposition
following acquittal by reason of insanity) (Judicial release).
(g)
Special needs offenders.
(1)
Pre-admission assessment after release from county
or city jail. If a county or city jail refers a special needs offender
(SNO) in the priority population to an LMHA and notifies the LMHA
of the referral at least 24 hours prior to the SNO's release from
a county or city jail, then the LMHA shall arrange for a face-to-face
contact between the SNO and a QMHP-CS to occur within seven days after
the SNO's release.
(A)
If the SNO is currently receiving LMHA services
from the LMHA that is notified of the referral, then at the face-to-face
contact the QMHP-CS shall re-assess the SNO and arrange for appropriate
services.
(B)
If the SNO is not currently receiving LMHA services
from the LMHA that is notified of the referral, then at the face-to-face
contact the QMHP-CS shall conduct a pre-admission assessment in accordance
with §412.315(a) of this title (relating to Assessment and Treatment
Planning) and comply with §412.161(b)(2)(A) or (B) of this title
(relating to Screening and Assessment), as appropriate).
(C)
If the LMHA does not have a face-to-face contact
with a SNO, then the LMHA shall document the reasons for not doing
so.
(2)
Pre-admission assessment after release from state
prison or state jail. If an LMHA is notified of the anticipated release
from prison or a state jail of a SNO in the priority population who
is currently taking psychoactive medication(s) for a mental illness
and who will be released with a 10-day supply of the psychoactive
medication(s), then the LMHA shall arrange for a face-to-face contact
between the SNO and QMHP-CS to occur within seven days after the SNO's
release.
(A)
At the face-to-face contact, the QMHP-CS shall
conduct a pre-admission assessment in accordance with §412.315(a)
of this title and comply with §412.161(b)(2)(A) or (B) of this
title (as appropriate). If the LMHA determines that the SNO should
receive services immediately, then the LMHA must arrange for the SNO
to meet with a prescriber of medication before the SNO's entire supply
of psychoactive medication has been administered.
(B)
If the LMHA does not have a face-to-face contact
with the SNO, then the LMHA shall document the reasons for not doing
so.
This agency hereby certifies that the adoption
has been reviewed by legal counsel and found to be a valid exercise
of the agency's legal authority.
Filed with the Office
of the Secretary of State on May 3, 2013.
TRD-201301756
Lisa Hernandez
General Counsel
Department of State Health Services
Effective date: May 24, 2013
Proposal publication date: February 22, 2013
For further information, please call: (512) 776-6972
Subchapter J. PREADMISSION SCREENING AND RESIDENT REVIEW (PASARR)--MENTAL HEALTH SERVICES
Chapter 134.
PRIVATE PSYCHIATRIC HOSPITALS AND CRISIS STABILIZATION UNITS
Chapter 411.
STATE MENTAL HEALTH AUTHORITY RESPONSIBILITIES
Subchapter M. STANDARDS OF CARE AND TREATMENT IN CRISIS STABILIZATION UNITS
Chapter 412.
LOCAL MENTAL HEALTH AUTHORITY RESPONSIBILITIES
Chapter 415.
PROVIDER CLINICAL RESPONSIBILITIES--MENTAL HEALTH SERVICES