Texas Administrative Code
Title 25 - HEALTH SERVICES
Part 1 - DEPARTMENT OF STATE HEALTH SERVICES
Chapter 117 - END STAGE RENAL DISEASE FACILITIES
Subchapter D - MINIMUM STANDARDS FOR PATIENT CARE AND TREATMENT
Section 117.45 - Provision and Coordination of Treatment and Services
Universal Citation: 25 TX Admin Code ยง 117.45
Current through Reg. 49, No. 38; September 20, 2024
(a) Patient plan of care.
(1) A facility shall develop, implement, and
enforce policies and procedures on the patient's plan of care process which
specifies the services necessary to address the patient's comorbid conditions
and other needs based on the patient's interdisciplinary assessment. The
patient services are coordinated using an interdisciplinary team approach. The
interdisciplinary team shall consist of the patient, the patient's primary
dialysis physician, registered nurse, social worker, and dietitian.
(2) The interdisciplinary team shall engage
in an interactive conference in order to develop a written, individualized,
comprehensive patient plan of care that specifies the services necessary to
address the patient's medical, psychological, social, and functional needs, and
includes treatment goals.
(3) The
plan of care shall include measurable and expected outcomes and estimated
timetables to achieve these outcomes. The plan of care shall include, but not
be limited to, the patient's current dose of dialysis, dialysis adequacy, other
medical comorbidity issues, nutritional status, mineral metabolism, anemia,
vascular access, psychosocial status, modality, transplantation status,
rehabilitation status, patient's goals, and patient education and
training.
(4) The patient plan of
care shall include evidence of coordination with other service providers (e.g.,
hospitals, long term care facilities, home and community support services
agencies, or transportation providers) as needed to assure the provision of
continuity of safe care.
(5) The
patient plan of care shall include evidence of the patient's (or patient's
legal representative's) input and participation, unless they refuse to
participate. At a minimum, the patient plan of care shall demonstrate that the
content was discussed with the patient or the patient's legal representative by
a member of the interdisciplinary team.
(6) The patient plan of care shall be
developed and implemented within 30 calendar days or 13 outpatient dialysis
treatments from the patient's admission to the facility. The plan of care shall
be revised due to the patient's lack of progress towards the goals of the plan
of care, marked deterioration in health status, significant changes in the
patient's psychosocial needs, or changes in the patient's nutritional
condition, as needed but no less than annually after the date of the patient's
last plan of care.
(7) The facility
shall monitor the plan of care at least monthly to recognize and address any
deviations from the plan of care as follows:
(A) implement changes in interventions due to
the lack of progress toward the goals of the plan of care;
(B) document as to the reasons why the
patient was unable to achieve the goals; and
(C) implement changes to address the revised
plan of care.
(8) An
interdisciplinary team conference may be conducted via phone conferencing. A
phone plan of care conference conducted with the interdisciplinary team and the
patient (or their legal representative) shall be documented as a phone
conference.
(9) In the case of
disruptive patients or family members or patients who do not conform to the
treatment plan, the facility shall develop, implement, and enforce a process
for more intensive interdisciplinary team intervention with this patient to
include assessment of needs and planned interventions to assist the patient in
adjusting to the requirements for safe care.
(b) Emergency preparedness.
(1) In this subsection, unless the context
clearly indicates otherwise, "emergency" means an incident likely to threaten
the health, welfare, or safety of a facility's patients, facility staff, or the
public, including a fire, equipment failure, power outage, flood, interruption
in utility service, medical emergency, or natural or other disaster.
(2) In accordance with Texas Health and
Safety Code §
251.016, a
facility shall implement a written emergency preparedness and contingency
operations plan that describes staff and patient actions to manage potential
medical and nonmedical emergencies, including fire, equipment failure, power
outages, medical emergencies, and natural or other disasters which are likely
to threaten the health, welfare, or safety of facility patients, the staff, or
the public. The plan shall comply with the following requirements.
(A) The facility shall update the plan at
least annually.
(B) The facility's
leadership shall approve the plan each time the facility updates the
plan.
(C) The plan shall include:
(i) procedures for notifying each of the
following entities, as soon as practicable, regarding the closure or reduction
in hours of operation of the facility due to an emergency:
(I) the Texas Health and Human Services
Commission (HHSC);
(II) each
hospital with which the facility has a transfer agreement in accordance with
paragraph (10) of this subsection;
(III) the trauma service area regional
advisory council that serves the geographic area in which the facility is
located; and
(IV) each applicable
local emergency management agency;
(ii) a documented patient communications plan
that includes procedures for notifying a patient when that patient's scheduled
dialysis treatment is interrupted;
(iii) a continuity of care plan for the
provision of dialysis treatment to facility patients during an emergency that
meets the requirements under paragraph (4) of this subsection; and
(iv) a disaster preparedness plan for natural
and other disasters that:
(I) is specific to
the facility based on an assessment of the probability and type of disaster in
the region and the local resources available to the facility;
(II) incorporates the use of the
HHSC-approved reporting system and participation in the ESRD Network of Texas
disaster preparedness activities;
(III) includes procedures designed to
minimize harm to patients and staff along with ensuring safe facility
operations;
(IV) along with
in-service programs for patients and staff, includes provisions or procedures
for responsibility of direction and control, communications, alerting and
warning systems, evacuation, and closure;
(V) requires each staff member employed by or
under contract with the facility to be able to demonstrate their role or
responsibility to implement the facility's disaster preparedness
plan.
(VI) designates a person in
each facility to monitor and coordinate disaster preparedness
activities;
(VII) maintains in each
facility documentation of the monitoring and coordination of disaster
preparedness activities; and
(VIII)
addresses the continuity of essential building systems, including emergency
power and water, or a contract with another licensed ESRD facility to provide
emergency contingency care to patients to meet the requirements of §
117.91(h) of this
chapter (relating to Fire Prevention, Protection, and Emergency Contingency
Plan); and
(D)
except as provided by paragraph (3) of this subsection, requires a facility to
execute a contract with another ESRD facility located within a 100-mile radius
of the facility stipulating that the other ESRD facility will provide dialysis
treatment to facility patients who are unable to receive scheduled dialysis
treatment due to the facility's closure or reduction in
hours.
(3) A facility is
not required to contract with another ESRD facility under paragraph (2)(D) of
this subsection if:
(A) no other ESRD
facility is located within a 100-mile radius of the facility; and
(B) the facility obtains written approval
from HHSC exempting the facility from that requirement.
(4) A facility shall develop a continuity of
care plan for the provision of dialysis treatment to facility patients during
an emergency that:
(A) includes procedures for
distributing written materials to facility patients that specifically describe
the facility's emergency preparedness and contingency operations
plan;
(B) includes detailed
procedures on the facility's continency plans, based on the facility's patient
population, including transportation options, for patients to access dialysis
treatment at each ESRD facility with which the facility has an agreement or
made advance preparations to ensure that the facility's patients have the
option to receive dialysis treatment and procedures for notifying a patient
when that patient's scheduled dialysis treatment is interrupted;
(C) is approved by the facility's leadership;
and
(D) is provided by the facility
to each patient before providing or scheduling dialysis treatment.
(5) On request, a facility shall
provide the facility's emergency preparedness and contingency operations plan
adopted under paragraph (2) of this subsection to:
(A) HHSC;
(B) each hospital with which the facility has
a transfer agreement in accordance with paragraph (10) of this
subsection;
(C) the trauma service
area regional advisory council that serves the geographic area in which the
facility is located; and
(D) each
applicable local emergency management agency.
(6) A facility shall provide annual training
to facility staff on the facility's emergency preparedness and contingency
operations plan required by paragraph (2) of this subsection.
(7) A facility shall annually contact a local
and state disaster management representative, an emergency operations center,
and a trauma service area regional advisory council to:
(A) request comments on whether the emergency
preparedness and contingency plan adopted by the facility under paragraph (2)
of this subsection should be modified; and
(B) ensure that local agencies, regional
agencies, state agencies, and hospitals are aware of the facility, the
facility's policy on provision of life saving treatment, the facility's patient
population and potential transportation needs, and the anticipated number of
patients affected.
(8) A
facility shall have a functional plan to access the community emergency medical
services.
(9) A facility shall have
personnel qualified to operate emergency equipment and to provide emergency
care to patients on site and available during all treatment times. A charge
nurse qualified to provide basic cardiopulmonary life support (BCLS) shall be
on site and available to the treatment area whenever patients are present. All
direct care staff members shall maintain current certification and competency
in BCLS.
(10) A facility shall have
a transfer agreement with one or more hospitals which provide acute dialysis
service for the provision of inpatient care and other hospital services to the
facility's patients. The facility shall have documentation from the hospital to
the effect that patients from the facility shall be accepted and treated in
emergencies. There shall be reasonable assurances that:
(A) the transfer or referral of patients will
be effected between the hospital and the facility whenever such transfer or
referral is determined as medically appropriate by the attending physician,
with timely acceptance and admission;
(B) the interchange of medical and other
information necessary or useful in the care and treatment of the patient
transferred shall occur within one working day; and
(C) security and accountability shall be
assured for the transferred patient's personal effects.
(11) A facility shall post a telephone number
listing specific to the facility equipment and locale to assist staff in
contacting mechanical and technical support in the event of an
emergency.
(12) The facility shall
maintain information on the HHSC approved reporting system to be updated online
monthly.
(c) Medication storage and administration.
(1) Pharmaceutical
and therapeutic items shall be provided in accordance with accepted
professional principles and federal and state laws and regulations.
(2) Medications shall be administered only if
such medication is ordered by the patient's physician or an attending
physician. Medication shall be administered as ordered.
(3) All verbal or telephone physician orders
shall be documented and authenticated or countersigned by the physician not
more than 15 calendar days from the date the order was given.
(4) Medications maintained in the facility
shall be properly stored and safeguarded in enclosures of sufficient size which
are not accessible to unauthorized persons. Refrigerators used for storage of
medications shall be maintained with documentation of the appropriate
temperatures for such storage.
(5)
A facility shall maintain emergency medications, as specified by the medical
director, to treat the emergency needs of patients.
(6) Medications shall not be prepared for
administration in the patient's immediate treatment area. The medication
preparation area shall be located in such a manner as to prevent contamination
of medicines being prepared for administration and shall include a work counter
and a sink.
(7) Medication vials
shall not be taken to a patient station. Intravenous medication vials labeled
for single-use shall not be punctured more than once.
(8) Medications not given immediately shall
be labeled with the patient's name, the name of the medication, the dosage
prepared, and the initials of the person preparing the medication, and shall be
protected to prevent contamination and casual access of the prepared
medications to unauthorized persons. All medications shall be administered by
the individual who prepared the medication.
(9) All medications shall be administered by
licensed nurses, physician assistants, or physicians except that intravenous
normal saline, intravenous heparin, subcutaneous lidocaine, and oxygen may be
administered as part of a routine hemodialysis treatment by dialysis
technicians qualified according to §
117.62 of this title (relating to
Training Curricula and Instructors) and §
117.63 of this title (relating to
Competency Evaluation). Such administration by dialysis technicians shall be in
compliance with Chapter
157 of the
Occupations Code concerning the delegation of medical acts by a licensed
physician in the State of Texas.
(d) Nursing services.
(1) Nursing services shall be provided to
prevent or reduce complications, to maximize the patient's functional status,
and to educate the ESRD patient, the patient's family, patient's caregiver, or
significant other.
(2) A full-time
supervising nurse shall be employed to supervise and manage the provision of
safe patient care. A contract staff person shall not be considered an employee,
and shall not be considered for the full-time supervising nurse.
(3) A registered nurse shall:
(A) be in the facility when patients are
present in the facility;
(B)
conduct admission nursing assessments;
(C) conduct assessments of a patient when
indicated by a question relating to a change in the patient's status, extended
or frequent hospitalizations, or at the patient's request;
(D) participate in the interdisciplinary team
review of a patient's progress;
(E)
recommend changes in treatment based on the patient's current needs;
(F) facilitate communication between the
patient, patient's family or significant other, and other interdisciplinary
members to ensure needed care is delivered;
(G) provide oversight and direction to
dialysis technicians and licensed vocational nurses; and
(H) participate in the facility's QAPI
activities.
(4) A
registered nurse functioning in the charge role shall be present during all
dialysis treatments.
(5) If
pediatric dialysis is provided, a registered nurse with experience or training
in pediatric dialysis shall be available to provide care for pediatric dialysis
patients smaller than 35 kilograms in weight.
(6) Sufficient direct care staff, as defined
in §
117.2(25) of this
title (relating to Definitions), shall be on site to meet the needs of the
patients, and at least one licensed nurse shall be available on site for every
twelve patients or portion thereof.
(A) During
treatment of seven or fewer patients, direct care staff shall consist of one
registered nurse and one direct care staff as demonstrated in Table 1 of §
117.106 of this title (relating to
Tables).
(B) During treatment of
eight but not more than twelve patients, the registered nurse functioning as
charge nurse shall not be assigned as direct care staff as demonstrated in
Table 1 of §
117.106 of this title.
(C) For pediatric dialysis patients, one
licensed nurse shall be provided on site for each patient weighing less than
ten kilograms and one licensed nurse provided on site for every two patients
weighing from ten to 20 kilograms.
(7) A facility shall ensure that patients are
in view of staff during hemodialysis treatments, and shall visualize the
patient, their access site, and their bloodline connections during the dialysis
treatment.
(8) A licensed nurse or
dialysis technician shall collect and document objective and subjective data
for each patient before and after treatment according to facility policy and
the staff member's level of training. There shall be written policies and
procedures specific to the facility to guide actions to be taken by the nursing
staff in the event a patient's condition deteriorates during treatment, to
identify parameters which would require a patient be referred to a nurse for
evaluation. A registered nurse shall conduct a patient assessment when
indicated by a question relating to a change in the patient's status or at the
patient's request.
(9) A registered
nurse shall conduct the initial patient assessment at the time of the patient's
initial dialysis treatment in the facility.
(e) This chapter does not preclude a licensed vocational nurse (LVN) from practicing in accordance with the rules adopted by the Texas Board of Nursing. If the LVN is acting in the capacity of a dialysis technician, the facility shall determine that the LVN has passed a training and competency evaluation curriculum which meets the requirements in § 117.62 of this title and § 117.63 of this title.
(f) A dialysis technician providing direct patient care shall demonstrate knowledge and competency for the responsibilities specified in § 117.62 of this title and § 117.63 of this title.
(g) Nutrition services.
(1) Nutrition services shall be provided to a
patient and the patient's caregiver(s) in order to maximize the patient's
nutritional status.
(2) The
dietitian shall be responsible for:
(A)
conducting a nutrition assessment of a patient;
(B) participating in an interdisciplinary
team review of a patient's progress;
(C) recommending therapeutic diets in
consideration of cultural preferences and changes in treatment based on the
patient's nutritional needs in consultation with the patient's
physician;
(D) counseling a
patient, a patient's family, and a patient's significant other on prescribed
diets and monitoring adherence and response to diet therapy. Correctional
institutions shall not be required to provide counseling to family members or
significant others;
(E) referring a
patient for assistance with nutrition resources such as financial assistance,
community resources, or in-home assistance;
(F) participating in the facility's QAPI
activities; and
(G) providing
ongoing monitoring of subjective and objective data to determine the need for
timely intervention and follow-up. Measurement criteria include but are not
limited to weight changes, blood chemistries, adequacy of dialysis, and
medication changes which affect nutrition status and potentially cause adverse
nutrient interactions.
(3) The initial contact between the dietitian
and the patient to assess nutritional status shall occur, and be documented,
within two weeks or seven treatments from admission to the facility, whichever
occurs later. A comprehensive nutrition assessment with an educational
component shall be completed within 30 days or 13 treatments from the patient's
admission to the facility, whichever occurs later.
(4) A nutrition reassessment shall be
conducted no less than annually or more often when indicated by a question
relating to a change in the patient's status, extended or frequent
hospitalizations, a change in the patient's modality, or at the patient's
request.
(5) Each facility shall
employ or contract with a dietitian(s) to provide clinical nutrition services
for each patient. One full-time equivalent of dietitian time shall be available
for up to 100 patients per facility with the maximum patient load per full-time
equivalent of dietitian time being 125 patients for all modalities.
(6) Nutrition services shall be available at
the facility during scheduled treatment times. Access to services may require
an appointment.
(7) There shall be
written physician standing orders specific to the facility authorizing
delegation of responsibilities for the facility dietitian as determined by the
Medical Director and the facility. These standing orders shall be reviewed and
approved by the medical director at least annually, and be consistent with the
statutes and rules of the Texas Medical Board, the Texas Board of Nursing, and
the Texas State Board of Examiners of Dietitians licensure.
(8) If the facility is using a medication
algorithm/protocol for managing renal bone disease the nutritional care for
each patient shall be individualized.
(h) Social services.
(1) Social services shall be provided to
patients and their families and shall be directed at supporting and maximizing
the adjustment, social functioning, and rehabilitation of the
patient.
(2) The social worker
shall be responsible for:
(A) conducting
psychosocial evaluations, which include health-related quality of life
surveys;
(B) participating in the
interdisciplinary team review of a patient's progress;
(C) providing an ongoing assessment and
recommend changes in treatment based on the patient's current psychosocial
needs;
(D) providing social work
interventions including counseling, case work and group work services to
patients and their families in dealing with the special problems associated
with end stage renal disease;
(E)
except in the case of social workers providing service in correctional
institutions, identifying community social agencies and other resources, and
assisting patients and families to utilize them;
(F) participating in the facility's QAPI
activities; and
(G) assisting
patients to achieve optimum levels of productive activity and making
rehabilitation referrals as appropriate.
(3) Initial contact between the social worker
and the patient shall occur, and be documented, within two weeks or seven
treatments from the patient's admission, whichever occurs later. A
comprehensive psychosocial assessment shall be completed within 30 days or 13
treatments from the patient's admission, whichever occurs later.
(4) A psychosocial reassessment shall be
conducted no less than annually or more often when indicated by a significant
change in the patient's psychosocial needs, extended or frequent
hospitalizations, any event that would interfere with the patient's ability to
follow aspects of the plan of care, a change in the patient's modality, or at
the patient's request.
(5) Each
facility shall employ or contract with a social worker(s) to meet the
psychosocial needs of the patients. Personnel shall be assigned to assist a
social worker(s) with ancillary tasks (e.g., assistance with financial
services, transportation, administrative, clerical, etc.), when the patient
load per facility, including all modalities, exceeds 100 patients. The maximum
patient load, including all modalities, per full-time equivalent qualified
social worker, with assigned personnel assistance, is 125 patients.
(6) Social services shall be available at the
facility during the times of patient treatment. Access to social services may
require an appointment.
(i) Medical services.
(1) The medical director is responsible for:
(A) developing facility treatment goals which
are based on review of aggregate data assessed through QAPI
activities;
(B) assuring adequate
training of licensed nurses and dialysis technicians;
(C) adequate monitoring of patients and the
dialysis process; and
(D)
developing, implementing, and enforcing all policies required by this
chapter.
(2) Medical
staff.
(A) Each patient shall be under the
care of a nephrologist on the medical staff.
(B) The care of a pediatric dialysis patient
shall be in accordance with this subparagraph. If a pediatric nephrologist is
not available as the primary physician, an adult nephrologist may serve as the
primary physician with direct patient evaluation by a pediatric nephrologist
according to the following schedule:
(i) for
patients two years of age or younger--monthly (two of three evaluations may be
by phone);
(ii) for patients three
to 12 years of age--quarterly; and
(iii) for patients 13 to 18 years of
age--semiannually.
(C) At
a minimum, each patient receiving dialysis in the facility shall be seen by a
physician on the medical staff once every two weeks during the patient's
treatment time. Home dialysis patients shall be seen by a physician, advanced
practice registered nurse, or physician's assistant no less than one time a
month. If home dialysis patients are seen by an advanced practice registered
nurse or a physician's assistant, the physician shall see the patient at least
one time every three months. This visit may be conducted in the dialysis
facility, at the physician's office, or in the patient's home. The record of
these contacts shall include evidence of assessment for new and recurrent
problems and review of dialysis adequacy each month.
(D) A physician on the medical staff shall be
on call and available 24 hours a day (in person or by telecommunication) to
patients and staff.
(E) Orders for
treatment shall be in writing and signed by the physician. Routine orders for
treatment shall be updated at least annually. Any changes in patient treatment
shall be per physician's order.
(i) Orders for
hemodialysis treatment shall include length of treatment, dialyzer, blood flow
rate, dialysate composition, target weight, medications including heparin, and,
as needed, specific infection control measures.
(ii) Orders for peritoneal dialysis treatment
shall include fill volume(s), number of exchanges, dialysate concentrations,
catheter care, medications, and, as needed, specific infection control
measures.
(3)
Physician Extenders. If advanced practice registered nurses or physician
assistants are utilized:
(A) there shall be
evidence of communication with the treating physician whenever the advanced
practice registered nurse or physician assistant changes treatment
orders;
(B) the advanced practice
registered nurse or physician assistant may not replace the physician in
participating in patient care planning or in QAPI activities;
(C) the advanced practice registered nurse or
physician assistant may not replace the physician for the every two week
evaluation of the in-center dialysis patient;
(D) the advanced practice registered nurse or
physician assistant shall notify the treating physician of patient medical
emergencies;
(E) if an advanced
practice registered nurse or physician assistant is utilized, such individuals
shall meet the requirements established by the Texas Board of Nursing (for an
advanced practice registered nurse) or the Texas Medical Board (for a physician
assistant); and
(F) if an advanced
practice registered nurse or a physician assistant is utilized such individuals
shall utilize mechanisms which provide authority for that care. These
mechanisms shall include, but are not limited to protocols or other written
authorization. The protocols or other written authorization shall be jointly
developed by the practitioner and the appropriate physician(s), be signed by
both the practitioner and the physician(s), be reviewed and re-signed at least
annually, be maintained in the practice setting of the practitioner, and be
made available as necessary to the department to verify authority to provide
medical aspects of care.
(j) Home dialysis service.
(1) A dialysis facility that provides home
dialysis training and support shall be approved to provide home dialysis
services, and ensure through its interdisciplinary team that home dialysis
services are at least equivalent to those provided to in-facility patients and
meet all applicable licensure rules.
(2) A facility shall provide a separate room
for home dialysis services.
(A) The room shall
include a hand washing sink with hands-free operable controls, warm water, and
soap to facilitate hand washing. Provisions for hand drying shall be included
at each hand washing sink.
(B)
Clean areas shall be clearly designated for the preparation, handling, and
storage of medications and unused supplies and equipment. Medications or clean
supplies shall not be handled and stored in the same or an immediately adjacent
area to that where used supplies, equipment, or blood samples are
handled.
(C) There shall be a
designated area in the facility with a separate sink for the disposal of blood
or body fluids. Contaminated areas where used supplies, equipment, or blood
samples are handled shall be clearly designated.
(3) On completion of training, each
individual home dialysis patient, regardless of modality, shall be assigned one
machine for the patient's exclusive use in the home.
(4) The staffing level for home dialysis
patients, including all modalities, shall be one full-time equivalent
registered nurse per 20 patients, or portion thereof.
(5) The training curriculum for the facility
that provides home dialysis training and support shall be developed and
approved by the medical director of the facility and include, but not be
limited to, the following:
(A) be conducted by
a registered nurse with at least 12 months clinical experience and six months
experience in the specific modality with the responsibility for training the
patient, and the patient's caregiver;
(B) be conducted for each home dialysis
patient and address the specific needs of the patient, in the nature and
management of end stage renal disease;
(C) include the full range of techniques
associated with the treatment modality selected, including effective use of
dialysis supplies and equipment in achieving and delivering the physician's
prescription;
(D) training of the
patient, and/or caregiver regarding the effective, and safe administration of
erythropoiesis-stimulating agent(s) (if prescribed) to achieve and maintain a
target level hemoglobin, hematocrit, and blood pressure levels, or hematocrit
as written in the patient's plan of care;
(E) training of the patient, and/or caregiver
how to detect, report, and manage potential dialysis complications, including
water treatment problems;
(F)
training of the patient, and/or caregiver regarding the availability of support
resources and how to access and use resources;
(G) training of the patient, and/or caregiver
how to self-monitor health status and record and report health status
information;
(H) training of the
patient, and/or caregiver how to handle medical and nonmedical
emergencies;
(I) training of the
patient, and/or caregiver regarding infection control precautions;
(J) training of the patient, and/or caregiver
regarding proper waste storage and disposal procedures;
(K) training of the patient, and/or caregiver
how to order supplies on an ongoing basis;
(L) training of the patient, and/or caregiver
that non-medical electrical equipment shall not be used within 6 feet of the
home hemodialysis machine; and
(M)
maintain the documentation in the clinical record that the patient, the
caregiver, or both received and demonstrated adequate comprehension of the
training.
(6) The
interdisciplinary team shall oversee training of the home dialysis patient and
the designated caregiver before the initiation of home dialysis, and when the
home dialysis caregiver or home dialysis modality changes.
(7) The dialysis facility shall retrieve and
review complete self-monitoring data and other information from the home
dialysis self-patient or their designated caregiver(s) at least every two
months, and maintain this information in the patient's clinical record in the
facility.
(8) A home dialysis
facility shall furnish home dialysis support services, regardless of whether
dialysis supplies may be provided by the dialysis facility or a durable medical
equipment company.
(9) Services
include, but are not limited to, the following:
(A) initial monitoring visit of the patient's
home adaptation, including visits to the patient's home by facility personnel
(including, but not limited to, the registered nurse responsible for training
the patient in the chosen modality and technical staff as appropriate) in
accordance with the patient's plan of care, and no less than annually
thereafter. The initial home visit shall be completed prior to the patient
beginning training for the selected home modality.
(B) The patient shall be seen by the
prescribing physician, advanced practice registered nurse, or physician's
assistant no less than one time a month. The prescribing physician shall see
the patient at least one time every three months, if an advanced practice
registered nurse, or physician's assistant sees the patient on a monthly basis.
This visit may be conducted in the dialysis facility, at the physician's
office, or in the patient's home.
(C) The development and periodic review of
the patient's individualized comprehensive plan of care that specifies the
services necessary to address the patient's needs and meets the measurable and
expected outcomes, which meet a hemodialysis Kt/V of at least 1.2 (3 times a
week), or standard Kt/V of 2.0 (4-6 times a week), or a peritoneal dialysis
weekly Kt/V of at least 1.7, or meet an alternative equivalent
professionally-accepted clinical practice standard for adequacy of
dialysis.
(D) The facility shall
provide patient consultation with members of the interdisciplinary team, as
needed.
(10) A home
dialysis facility shall monitor the quality of water and dialysate used by a
home hemodialysis patient including an on-site evaluation and testing of the
water and dialysate system initially, and any time repairs or exchanges of the
water treatment equipment are made.
(A) An
AAMI analysis of the product water used for dialysate preparation shall be
performed annually.
(B) The water
and dialysate system shall be tested in accordance with the manufacturer's
direction for use.
(C) The water
and dialysate system shall be tested in accordance with the system's Food and
Drug Administration (FDA) approved labeling, for integrated dialysis system
designed, tested, and validated to meet AAMI quality (which includes standards
for chemical and chlorine/chloramines testing) water and dialysate. The
facility shall meet testing and other requirements of AAMI RD 52:2004, when
using an integrated water and dialysate system, which is designed and validated
to meet AAMI quality.
(D) The
bacteriological and endotoxin testing of water used for dialysate preparation
and dialysate shall be performed monthly until results do not exceed 200 CFU/ml
and an endotoxin concentration less than 2 EU/ml are obtained for three
consecutive months and quarterly thereafter, on a more frequent basis as
needed, to ensure that the water and dialysate are within the AAMI
limits.
(11) The dialysis
facility shall correct any water and dialysate quality problem for the home
hemodialysis patient, and if necessary, arrange for backup dialysis until the
problem is corrected if:
(A) an analysis of
the water and dialysate quality indicates contamination; or
(B) if the home hemodialysis patient
demonstrates clinical symptoms associated with water and dialysate
contamination.
(12) The
dialysis facility shall be responsible for the purchase, lease, or rent, and
delivery, installation, repair, and shall maintain medically necessary home
dialysis supplies and equipment (including supportive equipment) as prescribed
by the attending physician. (If the patient purchases, leases or rents dialysis
equipment, the facility shall ensure that the equipment is installed, repaired
and maintained in accordance with the manufacturer's directions for
use.)
(13) The dialysis facility
shall identify a plan and arrange for emergency backup dialysis services when
needed.
(14) The dialysis facility
shall maintain a record keeping system that ensures continuity of care and
patient privacy.
(15) Hemodialysis
machines of home patients shall be cultured and measured for colony forming
units and endotoxins prior to disinfection, if the machine is to be
disinfected.
(16) All dialysis
machines and dialysis equipment shall have maintenance logs maintained at the
dialysis facility.
(17) The
electrical connection for the home hemodialysis machines shall be connected to
a GFCI receptacle in accordance with §
117.102(i)(8)(F)
of this title (relating to Construction Requirements for a New End Stage Renal
Disease Facility).
(18) Equipment
for home hemodialysis includes the conventional (single pass) dialysis machine,
the integrated dialysis system, the dialysis system which uses manufactured
bagged dialysate, the peritoneal dialysis system which uses manufactured bagged
dialysis solution, and the sorbent regeneration system.
(A) The conventional (single pass) dialysis
machine shall comply with the requirements at §
117.31 of this title (relating to
Equipment), and §
117.32 of this title (relating to
Water Treatment, Dialysate Concentrates, and Reuse). The facility shall ensure
that the water pressure in the patient's home meets the minimum requirement
specified by the manufacturer of the water treatment system.
(B) Integrated dialysis system.
(i) The facility shall perform an analysis of
the source water used for dialysate to ensure the water quality meets the
manufacturer's guidelines for source water purity annually or if there is a
change in the source water.
(ii)
The chemical quality of the product water shall be obtained every six months
prior to a replacement of the water purification disposable component, or when
any modifications are made to the integrated dialysis system to ensure that the
product water meets the primary standards of AAMI RD 52:2004.
(iii) A means shall be provided to sample the
product water to test for chlorine/chloramines levels immediately prior to
using the dialysate. Chlorine/chloramines level shall be less that 0.1 mg/L,
and the results shall be documented.
(iv) The microbiological quality of the
dialysate shall be obtained at the end of a prepared dialysate bag, with the
requirements at §
117.32 of this title.
(C) The dialysis system, which
uses sterile manufactured bagged dialysate, in its existing form, shall be used
according to manufacturer's directions for use.
(D) The peritoneal dialysis system, which
uses manufactured bagged dialysis solution, shall be used according to
manufacturer's directions for use.
(E) When sorbent technology is used, the
quantity of water used shall not exceed six liters per treatment; and testing
for chlorine/chloramines is not required. Prior to each treatment the sorbent
regeneration dialysis system (machine) shall be tested through the
manufacturer's self-test method, and the evidence of the self-test shall be
documented. The facility shall perform an analysis of the source water used for
dialysate to ensure the water quality meets the manufacturer's guidelines for
source water purity annually or if there is a change in the source
water.
(19) A facility
which was licensed prior to the effective date of these rules shall comply with
§
117.101 of this title (relating to
Construction Requirements for an Existing End Stage Renal Disease Facility). A
facility which is licensed after the effective date of these rules shall
provide a separate training room for home dialysis patients in compliance with
§
117.102(d)(5) of
this title.
(k) If a facility dialyzes a patient who is normally dialyzed in a distant facility, the facility shall meet the requirements in this subsection.
(1) The facility shall continuously evaluate
staffing levels and utilize this information in determining whether to accept a
transient patient for treatment.
(2) The facility shall obtain the information
described in §
117.47(e) of this
title (relating to Clinical Records) prior to providing dialysis. However, if
the transient patient arrives unannounced, the facility may provide dialysis
with, at a minimum, the following information:
(A) evidence of evaluation of the patient by
a physician on the staff of the facility;
(B) orders for treatment;
(C) hepatitis B status; and
(D) medical justification by the physician
ordering treatment that the patient's need for dialysis outweighs the need for
the additional clinical information set out in §
117.47(e) of this
title.
(3) In the event a
transient patient's hepatitis status is unknown, the patient may undergo
treatment as if the HBsAg test results were potentially positive, except that
such a patient shall not be treated in the HBsAg isolation room, area, or
machine.
(l) A facility that provides laboratory services shall comply with the requirements of Federal Public Law 100- 578, Clinical Laboratory Improvement Amendments of 1988 (CLIA 1988). CLIA 1988 applies to all facilities 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.
(m) A facility shall not violate Occupations Code, Chapter 102, concerning the prohibition on soliciting patients or patronage.
(n) The facility shall comply with the Health and Safety Code, Chapter 166, concerning out-of-hospital do-not-resuscitate orders.
(o) A facility or its corporate ownership, shall develop, implement, and enforce a compliance policy for monitoring its receipt and expenditure of state or federal funds.
(p) If the facility has a contract or agreement with an accredited school of health care to use their facility for a portion of the students' clinical experience, those students may provide care under the following conditions.
(1) Students
may be used in facilities, provided the instructor gives class supervision and
assumes responsibility for all student activities occurring within the
facility. If the student is licensed (e.g., a licensed vocational nurse
attending a registered nurse program for licensure as a registered nurse) the
facility shall ensure that the administration of any medication(s) is within
the student's licensed scope of practice.
(2) A student may administer medications only
if:
(A) on assignment as a student of his or
her school of health care; and
(B)
the instructor is on the premises and immediately supervises the administration
of medication by an unlicensed student and the administration of such
medication is within the instructor's licensed scope of practice.
(3) Students shall not be used to
fulfill the requirement for administration of medications by licensed
personnel.
(4) Students shall not
be considered when determining staffing levels required by the
facility.
(q) A facility shall adopt, implement, and enforce procedures for the resolution of complaints relevant to quality of care or services rendered by licensed health care professionals and other members of the facility staff, including contract services or staff. The facility shall document the receipt and the disposition of the complaint. The investigation and documentation shall be completed within 30 calendar days after the facility receives the complaint, unless the facility has and documents reasonable cause for a delay.
Disclaimer: These regulations may not be the most recent version. Texas may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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