Current through Reg. 49, No. 38; September 20, 2024
(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 Chapter 228
of this title (relating to Retail Food).
(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.
(E) Each
freestanding emergency medical care facility shall advertise as an emergency
room. The facility shall display notice that it functions as an emergency room.
(i) The notice shall explain that patients
who receive medical services will be billed according to comparable rates for
hospital emergency room services in the same region.
(ii) The notice shall be prominently and
conspicuously posted for display in a public area of the facility that is
readily available to each patient, managing conservator, or guardian. The
postings shall be easily readable and consumer-friendly. The notice shall be in
English and in a second language appropriate to the demographic makeup of the
community served.
(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 sexual assault survivors. This section does not affect
the duty of a health care facility to comply with the requirements of the
federal Emergency Medical Treatment and Active Labor Act of 1986 (
42
U.S.C. §
1395dd) that are applicable to
the facility. The hospital shall develop, implement, and enforce policies and
procedures to ensure that after a sexual assault survivor presents to the
hospital following a sexual assault, the hospital shall provide the care
specified under the Health and Safety Code, Chapter 323.
(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 referral to another program,
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;
(iii) the screening
previously has been completed; or
(iv) the newborn was discharged from the
facility not more than 10 hours after birth and a referral for the newborn was
made to another program.
(E) In hospitals that provide obstetrical
services, the governing body shall adopt, implement, and enforce policies and
procedures related to the testing of any newborn for critical congenital heart
disease (CCHD) that may present themselves at birth. The facility shall
implement testing programs for all infants born at the facility for CCHD. In
the event that a newborn is presented at the emergency room following delivery
at a birthing center or a home birth that may or may not have been assisted by
a midwife, the facility shall ascertain if any testing for CCHD had occurred
and, if not, shall provide the testing necessary to make such determination.
The rules concerning the CCHD procedures and requirements are described in
Chapter 37, Maternal and Infant Health Services, Subchapter E, Newborn
Screening for Critical Congenital Heart Disease, §§
37.75-
37.79 of
this title.
(F) 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 registered nurses (APRNs)
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
APRNs or physician assistants, an individual APRN 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 APRN 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 APRN or physician
assistant. At a minimum, the hospital shall provide the APRN 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 APRN or physician assistant conditioned on the APRN or
physician assistant having a sponsoring or collaborating relationship with a
physician and that relationship ceases to exist, the APRN 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 APRN or physician assistant and the physician, the hospital shall be
deemed to have met its obligations under this section by notifying the APRN or
physician assistant in writing that the APRN'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, APRNs,
or physician assistants.
(V) This
clause does not apply to an employer-employee relationship between an APRN or
physician assistant and a hospital.
(G) 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).
(H) 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.
(I) 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; and
(G) the governing body shall adopt,
implement, and enforce policies and procedures regarding DNR orders issued in
the hospital by the attending physician that comply with Health and Safety
Code, Chapter 166, Subchapter E (relating to Health Care Facility
Do-Not-Resuscitate Orders), including policies and procedures regarding the
rights of a patient and person authorized to make treatment decisions regarding
the patient's DNR status; notice and medical record requirements for DNR orders
and revocations; and actions the attending physician and hospital must take
pursuant to Health and Safety Code §
166.206 when
the attending physician or hospital and the patient or person authorized to
make treatment decisions regarding the patient's DNR status are in disagreement
about the execution of, or compliance with, a DNR order. The policies and
procedures shall include that:
(i) Except in
circumstances described by Health and Safety Code §
166.203(a)(2),
a DNR order issued for a patient is valid only if the patient's attending
physician issues the order, the order is dated, and the order is issued in
compliance with:
(I) the written and dated
directions of a patient who was competent at the time the patient wrote the
directions;
(II) the oral
directions of a competent patient delivered to or observed by two competent
adult witnesses, at least one of whom must be a person not listed under Health
and Safety Code §
166.003(2)(E) or
(F);
(III) the directions in an advance directive
enforceable under Health and Safety Code §
166.005 or
executed in accordance with Health and Safety Code §§
166.032,
166.034, or
166.035;
(IV) the directions of a patient's legal
guardian or agent under a medical power of attorney acting in accordance with
Health and Safety Code, Chapter 166, Subchapter D (relating to Medical Power of
Attorney); or
(V) a treatment
decision made in accordance with Health Safety Code
§166.039.
(ii) A DNR
order that is not issued in accordance with Health and Safety Code §
166.203(a)(1)
is valid only if the patient's attending physician issues the order, the order
is dated, and:
(I) the order is not contrary
to the directions of a patient who was competent at the time the patient
conveyed the directions;
(II) in
the reasonable medical judgment of the patient's attending physician, the
patient's death is imminent, regardless of the provision of cardiopulmonary
resuscitation; and
(III) in the
reasonable medical judgment of the patient's attending physician, the DNR order
is medically appropriate.
(iii) A DNR order takes effect at the time
the order is issued, as provided by Health and Safety Code §
166.203(b).
(iv) Before placing in a patient's medical
record a DNR order described by Health and Safety Code §
166.203(a)(2),
the physician, physician assistant, nurse, or other person acting on behalf of
the hospital shall:
(I) notify the patient of
the order's issuance; or
(II) if
the patient is incompetent, make a reasonably diligent effort to contact or
cause to be contacted and notify of the order's issuance the patient's known
agent under a medical power of attorney or legal guardian or, for a patient who
does not have a known agent under a medical power of attorney or legal
guardian, a person described by Health and Safety Code §
166.039(b)(1),
(2), or (3).
(v) A physician providing direct care to a
patient for whom a DNR order is issued shall revoke the patient's DNR order if
the patient, or the patient's agent under a medical power of attorney or the
patient's legal guardian if the patient is incompetent:
(I) effectively revokes an advance directive,
in accordance with Health and Safety Code §
166.042, for
which a DNR order is issued under Health and Safety Code §
166.203(a);
or
(II) expresses to any person
providing direct care to the patient a revocation of consent to or intent to
revoke a DNR order issued under Health and Safety Code §
166.203(a).
(vi) A person providing direct care to a
patient under the supervision of a physician shall notify the physician of a
request to revoke a DNR order under Health and Safety Code §
166.205(a).
(vii) A patient's attending physician may at
any time revoke a DNR order executed under Health and Safety Code §
166.203(a)(2).
(viii) On admission to the hospital, the
hospital shall provide to the patient or person authorized to make treatment
decisions regarding the patient's DNR status notice of the policies and
procedures adopted under this subparagraph.
(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 applicable rules and standards. At hospitals that have a mental health
service unit, the governing body shall adopt, implement, and enforce procedures
for the completion of criminal background checks on all prospective employees
that would be considered for assignment to that unit, except for persons
currently licensed by this state as health professionals.
(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.
(9)
Photo identification badge. The governing body shall adopt a policy requiring
employees, physicians, contracted employees, and individuals in training who
provide direct patient care at the hospital to wear a photo identification
badge during all patient encounters, unless precluded by adopted isolation or
sterilization protocols. The badge must be of sufficient size and worn in a
manner to be visible and must clearly state:
(A) at minimum the individual's first or last
name;
(B) the department of the
hospital with which the individual is associated;
(C) the type of license held by the
individual, if applicable under Title 3, Occupations Code; and
(D) the provider's status as a student,
intern, trainee, or resident, if applicable.
(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) and Subchapter E, §241.103 (Preservation of Records) and
§241.1031 (relating to Preservation of Record from Forensic Medical
Examination).
(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) If an attending physician issues a DNR
order for a patient under Health and Safety Code, Chapter 166, Subchapter E
(relating to Health Care Facility Do-Not-Resuscitate Orders), that order shall
be entered into the patient medical record as soon as practicable. In the event
a physician revokes a DNR order under Health and Safety Code, Chapter 166,
Subchapter E, that revocation shall be entered into the patient medical record
as soon as practicable. To the extent this paragraph conflicts with
requirements elsewhere in this subsection, this paragraph prevails.
(6) 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.
(7) 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.
(8) All verbal orders must be dated, timed,
and authenticated within 96 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.
(9) 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.
(10) A
hospital may not destroy a medical record from the forensic medical examination
of a sexual assault victim until the 20th anniversary of the date the record
was created, in accordance with HSC, Chapter 241, Subchapter E,
§241.1031.
(11) 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.
(12) 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.
(13) 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.
(14) 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;
(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; and
(G) include
procedures regarding DNR orders issued in the hospital by an attending
physician that comply with Health and Safety Code, Chapter 166, Subchapter E
(relating to Health Care Facility Do-Not-Resuscitate Orders), including
policies and procedures regarding the rights of a patient and person authorized
to make treatment decisions regarding the patient's DNR status; notice and
medical record requirements for DNR orders and revocations; and actions the
attending physician and hospital must take pursuant to Health and Safety Code
§
166.206 when
the attending physician or hospital and the patient or person authorized to
make treatment decisions regarding the patient's DNR status are in disagreement
about the execution of, or compliance with, a DNR order. The procedures shall
include that:
(i) Except in circumstances
described by Health and Safety Code §
166.203(a)(2),
a DNR order issued for a patient is valid only if the patient's attending
physician issues the order, the order is dated, and the order is issued in
compliance with:
(I) the written and dated
directions of a patient who was competent at the time the patient wrote the
directions;
(II) the oral
directions of a competent patient delivered to or observed by two competent
adult witnesses, at least one of whom must be a person not listed under Health
and Safety Code §
166.003(2)(E) or
(F);
(III) the directions in an advance directive
enforceable under Health and Safety Code §
166.005 or
executed in accordance with Health and Safety Code §§
166.032,
166.034, or
166.035;
(IV) the directions of a patient's legal
guardian or agent under a medical power of attorney acting in accordance with
Health and Safety Code, Chapter 166, Subchapter D (relating to Medical Power of
Attorney); or
(V) a treatment
decision made in accordance with Health Safety Code
§166.039.
(ii) A DNR
order that is not issued in accordance with Health and Safety Code §
166.203(a)(1)
is valid only if the patient's attending physician issues the order, the order
is dated, and:
(I) the order is not contrary
to the directions of a patient who was competent at the time the patient
conveyed the directions;
(II) in
the reasonable medical judgment of the patient's attending physician, the
patient's death is imminent, regardless of the provision of cardiopulmonary
resuscitation; and
(III) in the
reasonable medical judgment of the patient's attending physician, the DNR order
is medically appropriate.
(iii) A DNR order takes effect at the time
the order is issued, as provided by Health and Safety Code §
166.203(b).
(iv) Before placing in a patient's medical
record a DNR order described by Health and Safety Code §
166.203(a)(2),
the physician, physician assistant, nurse, or other person acting on behalf of
the hospital shall:
(I) notify the patient of
the order's issuance; or
(II) if
the patient is incompetent, make a reasonably diligent effort to contact or
cause to be contacted and inform of the order's issuance the patient's known
agent under a medical power of attorney or legal guardian or, for a patient who
does not have a known agent under a medical power of attorney or legal
guardian, a person described by Health and Safety Code §
166.039(b)(1),
(2), or (3).
(v) A physician providing direct care to a
patient for whom a DNR order is issued shall revoke the patient's DNR order if
the patient or the patient's agent under a medical power of attorney or the
patient's legal guardian if the patient is incompetent:
(I) effectively revokes an advance directive,
in accordance with Health and Safety Code §
166.042, for
which a DNR order is issued under Health and Safety Code §
166.203(a);
or
(II) expresses to any person
providing direct care to the patient a revocation of consent to or intent to
revoke a DNR order issued under Health and Safety Code §
166.203(a).
(vi) A person providing direct care to a
patient under the supervision of a physician shall notify the physician of the
request to revoke a DNR order under Health and Safety Code §
166.205(a).
(vii) A patient's attending physician may at
any time revoke a DNR order executed under Health and Safety Code §
166.203(a)(2).
(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.
(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 <1 mg/L for total chlorine, the
reverse osmosis (RO) may be turned off and the product water in the holding
tank may be used to finish treatments in process. The medical director shall be
notified.
(-h-) If means other than
granulated carbon are used to remove chlorine/chloramine, the facility's
governing body must approve such use in writing after review of the safety of
the intended method for use in hemodialysis applications. If such methods
include the use of additives, there must be evidence the product water does not
contain unsafe levels of these additives.
(ix) Water softeners, if used, shall be
tested at the end of the treatment day to verify their capacity to treat a
sufficient volume of water to supply the facility for the entire treatment day
and shall be fitted with a mechanism to prevent water containing the high
concentrations of sodium chloride used during regeneration from entering the
product water line during regeneration.
(x) If used, the face(s) of timer(s) used to
control any component of the water treatment or dialysate delivery system shall
be visible to the operator at all times. Written evidence that timers are
checked for operation and accuracy each day of operation must be
maintained.
(xi) Filter housings,
if used during disinfectant procedures, shall include a means to clear the
lower portion of the housing of the disinfecting agents. Filter housings shall
be opaque.
(xii) Ultrafilters, or
other bacterial reducing filters, if used, shall be fitted with pressure gauges
on the inlet and outlet water lines to monitor the pressure drop across the
membrane. Ultrafilters shall be included in routine disinfection
procedures.
(xiii) If used, storage
tanks shall have a conical or bowl shaped base and shall drain from the lowest
point of the base. Storage tanks shall have a tight-fitting lid and be vented
through a hydrophobic 0.2 micron air filter. Means shall be provided to
effectively disinfect any storage tank installed in a water distribution
system.
(xiv) Ultraviolet (UV)
lights, if used, shall be monitored at the frequency recommended by the
manufacturer. A log sheet shall be used to record monitoring.
(xv) Water treatment system piping shall be
labeled to indicate the contents of the pipe and direction of flow.
(xvi) The water treatment system must be
continuously monitored during patient treatment and be guarded by audible and
visual alarms which can be seen and heard in the dialysis treatment area should
water quality drop below specific parameters. Quality monitor sensing cells
shall be located as the last component of the water treatment system and at the
beginning of the distribution system. No water treatment components that could
affect the quality of the product water as measured by this device shall be
located after the sensing cell.
(xvii) When deionization tanks do not follow
a reverse osmosis system, parameters for the rejection rate of the membranes
must assure that the lowest rate accepted would provide product water in
compliance with §4.2.2 (concerning Maximum Level of Chemical Contaminants)
of the American National Standard, Water Treatment Equipment for Hemodialysis
Applications, August 2001 Edition published by the AAMI.
(xviii) A facility shall maintain written
logs of the operation of the water treatment system for each treatment day. The
log book shall include each component's operating parameter and the action
taken when a component is not within the facility's set parameters.
(xix) Microbiological testing of product
water shall be conducted.
(I) Frequency.
Microbiological testing shall be conducted monthly and following any repair or
change to the water treatment system. For a newly installed water distribution
system, or when a change has been made to an existing system, weekly testing
shall be conducted for one month to verify that bacteria and endotoxin levels
are consistently within the allowed limits.
(II) Sample sites. At a minimum, sample sites
chosen for the testing shall include the beginning of the distribution piping,
at any site of dialysate mixing, and the end of the distribution
piping.
(III) Technique. Samples
shall be collected immediately before sanitization/disinfection of the water
treatment system and dialysis machines. Water testing results shall be
routinely trended and reviewed by the medical director in order to determine if
results seem questionable or if there is an opportunity for improvement. The
medical director shall determine if there is a need for retesting. Repeated
results of "no growth" shall be validated via an outside laboratory. A
calibrated loop may not be used in microbiological testing of water samples.
Colonies shall be counted using a magnifying device.
(IV) Expected results. Product water used to
prepare dialysate, concentrates from powder, or to reprocess dialyzers for
multiple use, shall contain a total viable microbial count less than 200 colony
forming units (CFU)/millimeter (ml) and an endotoxin concentration less than 2
endotoxin units (EU)/ml. The action level for the total viable microbial count
in the product water shall be 50 CFU/ml and the action level for the endotoxin
concentration shall be 1 EU/ml.
(V)
Required action for unacceptable results. If the action levels described at
subclause (IV) of this clause are observed in the product water, corrective
measures shall be taken promptly to reduce the levels into an acceptable
range.
(VI) Records. All bacteria
and endotoxin results shall be recorded on a log sheet in order to identify
trends that may indicate the need for corrective action.
(xx) If ozone generators are used to
disinfect any portion of the water or dialysate delivery system, testing based
on the manufacturer's direction shall be used to measure the ozone
concentration each time disinfection is performed, to include testing for safe
levels of residual ozone at the end of the disinfection cycle. Testing for
ozone in the ambient air shall be conducted on a periodic basis as recommended
by the manufacturer. Records of all testing must be maintained in a
log.
(xxi) If used, hot water
disinfection systems shall be monitored for temperature and time of exposure to
hot water as specified by the manufacturer. Temperature of the water shall be
recorded at a point furthest from the water heater, where the lowest water
temperature is likely to occur. The water temperature shall be measured each
time a disinfection cycle is performed. A record that verifies successful
completion of the heat disinfection shall be maintained.
(xxii) After chemical disinfection, means
shall be provided to restore the equipment and the system in which it is
installed to a safe condition relative to residual disinfectant prior to the
product water being used for dialysis applications.
(xxiii) Samples of product water must be
submitted for chemical analysis every six months and must demonstrate that the
quality of the product water used to prepare dialysate or concentrates from
powder, meets §4.2.2 (concerning Maximum Level of Chemical Contaminants)
of the American National Standard, Water Treatment Equipment for Hemodialysis
Applications, August 2001 Edition, published by the AAMI.
(I) Samples for chemical analysis shall be
collected at the end of the water treatment components and at the most distal
point in each water distribution loop, if applicable. All other outlets from
the distribution loops shall be inspected to ensure that the outlets are
fabricated from compatible materials. Appropriate containers and pH adjustments
shall be used to ensure accurate determinations. New facilities or facilities
that add or change the configuration of the water distribution system must draw
samples at the most distal point for each water distribution loop, if
applicable, on a one time basis.
(II) Additional chemical analysis shall be
submitted if substantial changes are made to the water treatment system or if
the percent rejection of a reverse osmosis system decreased 5.0% or more from
the percent rejection measured at the time the water sample for the preceding
chemical analysis was taken.
(xxiv) Facility records must include all test
results and evidence that the medical director has reviewed the results of the
water quality testing and directed corrective action when indicated.
(xxv) Only persons qualified by the education
or experience may operate, repair, or replace components of the water treatment
system.
(C) Dialysate.
(i) Quality control procedures shall be
established to ensure ongoing conformance to policies and procedures regarding
dialysate quality.
(ii) Each
facility shall set all hemodialysis machines to use only one family of
concentrates. When new machines are put into service or the concentrate family
or concentrate manufacturer is changed, samples shall be sent to a laboratory
for verification.
(iii) Prior to
each patient treatment, staff shall verify the dialysate conductivity and pH of
each machine with an independent device.
(iv) Bacteriological testing shall be
conducted.
(I) Frequency. Responsible facility
staff shall develop a schedule to ensure each hemodialysis machine is tested
quarterly for bacterial growth and the presence of endotoxins. Hemodialysis
machines of home patients shall be cultured monthly until results not exceeding
200 CFU/ml are obtained for three consecutive months, then quarterly samples
shall be cultured.
(II) Acceptable
limits. Dialysate shall contain less than 200 CFU/ml and an endotoxin
concentration of less than 2 EU/ml. The action level for total viable microbial
count shall be 50 CFU/ml and the action level for endotoxin concentration shall
be 1 EU/ml.
(III) Action to be
taken. Disinfection and retesting shall be done when bacterial or endotoxin
counts exceed the action levels. Additional samples shall be collected when
there is a clinical indication of a pyrogenic reaction and/or
septicemia.
(v) Only a
licensed nurse may use an additive to increase concentrations of specific
electrolytes in the acid concentrate. Mixing procedures shall be followed as
specified by the additive manufacturer. When additives are prescribed for a
specific patient, the container holding the prescribed acid concentrate shall
be labeled with the name of the patient, the final concentration of the added
electrolyte, the date the prescribed concentrate was made, and the name of the
person who mixed the additive.
(vi)
All components used in concentrate preparation systems (including mixing and
storage tanks, pumps, valves and piping) shall be fabricated from materials
(e.g., plastics or appropriate stainless steel) that do not interact chemically
or physically with the concentrate so as to affect its purity, or with the
germicides used to disinfect the equipment. The use of materials that are known
to cause toxicity in hemodialysis such as copper, brass, galvanized material
and aluminum is prohibited.
(vii)
Facility policies shall address means to protect stored acid concentrates from
tampering or from degeneration due to exposure to extreme heat or
cold.
(viii) Procedures to control
the transfer of acid concentrates from the delivery container to the storage
tank and prevent the inadvertent mixing of different concentrate formulations
shall be developed, implemented and enforced. The storage tanks shall be
clearly labeled.
(ix) Concentrate
mixing systems shall include a purified water source, a suitable drain, and a
ground fault protected electrical outlet.
(I)
Operators of mixing systems shall use personal protective equipment as
specified by the manufacturer during all mixing processes.
(II) The manufacturer's instructions for use
of a concentrate mixing system shall be followed, including instructions for
mixing the powder with the correct amount of water. The number of bags or
weight of powder added shall be determined and recorded.
(III) The mixing tank shall be clearly
labeled to indicate the fill and final volumes required to correctly dilute the
powder.
(IV) Systems for preparing
either bicarbonate or acid concentrate from powder shall be monitored according
to the manufacturer's instructions.
(V) Concentrates shall not be used, or
transferred to holding tanks or distribution systems, until all tests are
completed.
(VI) If a facility
designs its own system for mixing concentrates, procedures shall be developed
and validated using an independent laboratory to ensure proper
mixing.
(x) Acid
concentrate mixing tanks shall be designed to allow the inside of the tank to
be rinsed when changing concentrate formulas.
(I) Acid mixing systems shall be designed and
maintained to prevent rust and corrosion.
(II) Acid concentrate mixing tanks shall be
emptied completely and rinsed with product water before mixing another batch of
concentrate to prevent cross contamination between different batches.
(III) Acid concentrate mixing equipment shall
be disinfected as specified by the equipment manufacturer or in the case where
no specifications are given, as defined by facility policy.
(IV) Records of disinfection and rinsing of
disinfectants to safe residual levels shall be maintained.
(xi) Bicarbonate concentrate mixing tanks
shall have conical or bowl shaped bottoms and shall drain from the lowest point
of the base. The tank design shall allow all internal surfaces to be
disinfected and rinsed.
(I) Bicarbonate
concentrate mixing tanks shall not be prefilled the night before use.
(II) If disinfectant remains in the mixing
tank overnight, this solution must be completely drained, the tank rinsed and
tested for residual disinfectant prior to preparing the first batch of that day
of bicarbonate concentrate.
(III)
Unused portions of bicarbonate concentrate shall not be mixed with fresh
concentrate.
(IV) At a minimum,
bicarbonate distribution systems shall be disinfected weekly. More frequent
disinfection shall be done if required by the manufacturer, or if dialysate
culture results are above the action level.
(V) If jugs are reused to deliver bicarbonate
concentrate to individual hemodialysis machines:
(-a-) jugs shall be emptied of concentrate,
rinsed and inverted to drain at the end of each treatment day;
(-b-) at a minimum, jugs shall be disinfected
weekly, more frequent disinfection shall be considered by the medical director
if dialysate culture results are above the action level; and
(-c-) following disinfection, jugs shall be
drained, rinsed free of residual disinfectant, and inverted to dry. Testing for
residual disinfectant shall be done and documented.
(xii) All mixing tanks, bulk
storage tanks, dispensing tanks and containers for single hemodialysis
treatments shall be labeled as to the contents.
(I) Mixing tanks. Prior to batch preparation,
a label shall be affixed to the mixing tank that includes the date of
preparation and the chemical composition or formulation of the concentrate
being prepared. This labeling shall remain on the mixing tank until the tank
has been emptied.
(II) Bulk
storage/dispensing tanks. These tanks shall be permanently labeled to identify
the chemical composition or formulation of their contents.
(III) Single machine containers. At a
minimum, single machine containers shall be labeled with sufficient information
to differentiate the contents from other concentrate formulations used in the
facility and permit positive identification by users of container
contents.
(xiii)
Permanent records of batches produced shall be maintained to include the
concentrate formula produced, the volume of the batch, lot number(s) of
powdered concentrate packages, the manufacturer of the powdered concentrate,
date and time of mixing, test results, person performing mixing, and expiration
date (if applicable).
(xiv) If
dialysate concentrates are prepared in the facility, the manufacturers'
recommendations shall be followed regarding any preventive maintenance. Records
shall be maintained indicating the date, time, person performing the procedure,
and the results (if applicable).
(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
Chapter 326, Medical Waste Management, §326.17, §326.19,
§326.21, and §326.23 (relating to Packaging, Labeling and Shipping
Requirements) and §326.31 (relating to Exempt Medical Waste
Operations).
(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.