(a) Policies and procedures
concerning services provided by the renal dialysis clinic shall be available
for the treating and/or referring physicians.
(b) Each physician on the medical staff shall
have a current license to practice medicine in the State of
The governing body
of a facility shall designate a medical director. The Medical Director shall:
1. Delineate the responsibilities of and
communicate with treating and /or referring physicians to ensure that each
patient receives medical care;
Arrange for the delivery of emergency and medical care when the patient's
treating and/or referring physician or his/her designated alternate is
3. Review reports of
all accidents or unusual events occurring on the premises, identifying hazards
to health and safety and recommending corrective action to the governing
4. Make periodic visits not
less than quarterly, to the renal dialysis clinic to evaluate the
existing conditions and make recommendations for improvements;
5. Review and take appropriate action on
reports regarding significant clinical practices, guidelines and
6. Oversee so that no
infectious health conditions exist which would adversely affect
7. Advise and provide
consultation on matters regarding medical care, standards of care, surveillance
and infection control;
facility treatment goals which are based on review of aggregate data assessed
through quality management activities;
9. Assure adequate training of licensed
nurses and dialysis technicians;
10. Assure adequate monitoring of patients
and the dialysis process; and
Ensure development and implementation of all policies required by this
(d) The members
of the medical staff shall include nephrologists and other physicians with
training or demonstrated experience in the care of end stage renal disease
patients that consists, at a minimum, of having worked within the field of
kidney dialysis for at least 12 months in the past five (5) years.
(e) If a Nurse Practitioner or Physician
Assistant is utilized, such individuals shall meet the requirements established
by the Board of Nursing (for a Nurse Practitioner) or the Board of Medical
Examiners and its Committee on Physician Assistants (for a Physician
1. Each patient shall be under the care of a
physician on the medical staff.
The care of a pediatric dialysis patient shall be in accordance with this
subparagraph. If a pediatric nephrologist is not available as the primary
nephrologist, an adult nephrologist may serve as the primary nephrologist with
direct patient evaluation by a pediatric nephrologist according to the
(i) for patients two years
of age or younger - monthly (two of three evaluations may be by
(ii) for patients three to
12 years of age - quarterly; and
(iii) for patients 13 to 18 years of age - as
needed or indicated.
At a minimum, each patient receiving dialysis in the facility shall be seen by
a member of the medical staff monthly. Following the initial visit, at the
option of the physician, a Nurse Practitioner or Physician Assistant may be
utilized on an alternating basis every other month. Home patients shall be seen
at least every three months. There shall be evidence of monthly assessment for
new and recurrent problems and review of dialysis adequacy.
4. A physician on the medical staff or
his/her designee shall be on call and available 24 hours a day to patients and
5. Orders for treatment
shall be in writing and signed by the prescribing physician. Routine orders for
treatment shall be updated at least annually. Orders for treatment shall
include treatment time, dialyzer, blood flow rate, target weight , medications
including heparin, and specific infection control measures as needed.
If Nurse Practitioners or Physician
Assistants are utilized:
(i) there shall be
evidence of communication with the treating physician whenever the Nurse
Practitioner or Physician Assistant changes treatment orders;
(ii) the Nurse Practitioner or Physician
Assistant may not replace the physician in participating in patient care
planning or in quality management activities; and
(iii) the treating physician shall be
notified and direct the care of patient medical emergencies.
Patient care plan.
1. A facility shall establish, implement, and
enforce a policy whereby patient services are coordinated using an
interdisciplinary team approach. The interdisciplinary team shall consist of
the patient's primary dialysis physician, registered nurse, social worker, and
2. The interdisciplinary
team shall develop a written, individualized, comprehensive patient care plan
that specifies the services necessary to address the patient's medical,
psychological, social, and functional needs, and includes treatment
3. The patient care plan
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
4. The patient care plan
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 care plan shall demonstrate that the content was shared with the
patient or the patient's legal representative.
5. The patient care plan shall be developed
within 30 days from the patient's admission to the facility and updated as
indicated by any change in the patient's medical, nutritional, or psychosocial
condition, or at least every six months. Evidence of the review of the patient
care plan with the patient and the interdisciplinary team to evaluate the
patient's progress or lack of progress toward the goals of the care plan, and
interventions taken when the goals are not achieved, shall be documented and
included in the patient's clinical record.
Home Dialysis Training and Support
In addition to the other
services contained in this chapter, a renal dialysis clinic may provide the
1. Home dialysis
2. Home dialysis support
services for those patients receiving home dialysis.
Unless otherwise provided by this rule, a renal dialysis
clinic providing home dialysis training shall ensure that the training will be
conducted by a registered nurse having at least twelve (12) months of
experience in providing nursing care and at least three (3) months of
experience working in hemodialysis or peritoneal dialysis and that the
registered nurse shall teach the following:
Full range of techniques associated with
treatment modality selected, including but not limited to:
(i) specific instructions on the use of the
dialysis equipment to be used at home;
(ii) procedures the patient is expected to
use in order to perform the home dialysis;
(iii) instructions on the use of supplies and
equipment to achieve the physician's prescription; and
(iv) anemia management.
2. Implementation of a nutritional care plan,
provided however, a dietitian or nutritionist holding a valid license in this
state may provide such training in lieu of a registered nurse;
3. Methods used to achieve and maintain
emotional and social well-being, provided however, a licensed master's social
worker, licensed advanced practice social worker, or licensed clinical social
worker holding a valid certificate of registration or license in this state may
provide such training in lieu of a registered nurse;
4. The detection, reporting, and management
of potential dialysis complications, including water treatment
5. The availability of
support resources and how to access and use resources;
6. Self-monitoring health status, including
recording and reporting health status information;
7. Handling medical and non-medical
control precautions and proper waste storage and disposal procedures.
Support Services. A renal
dialysis clinic providing home dialysis training shall provide a patient with
the following support services for the length of time that the patient is
receiving home dialysis:
monitoring of the patient's home adaptation, including visits to the patient's
home by facility personnel in accordance with the patient's plan of
2. Development and periodic
review of the patient's individualized comprehensive care plan;
3. Patient consultation with members of the
clinic's interdisciplinary team as needed;
Periodic monitoring of the quality of
waters and dialysate used by home dialysis patients. The renal dialysis clinic
shall correct the water quality if needed and arrange for backup dialysis until
the water quality is corrected. All periodic monitoring of water quality and
dialysate shall be performed in accordance with federal laws and rules ( 42
C.F.R. § 494.100(c)(v)
5. A review of self-monitoring data from the
patient or patient's caregiver at least every two (2) months.
Recordkeeping. As a part of
the support services provided by the renal dialysis clinic, the clinic shall
ensure that the individuals providing support services shall maintain records
of the following:
1. Documentation that the
patient or patient caregiver received home dialysis training before performing
2. Observations and
inquiries of the patient's condition; and
3. Patient or patient caregiver's
(a) Nursing services to prevent or reduce
complications and to maximize the patient's functional status shall be provided
to a patient and the patient's family or significant other.
(b) A full-time Nursing Manager shall be
employed to manage the provision of patient care.
A registered nurse shall be responsible
1. conducting admission nursing
assessments of a patient when indicated by a question relating to a change in
the patient's status or at the patient's request;
3. participating in team review of a
changes in treatment based on the patient's current needs;
5. facilitating communication between the
patient, patient's family or significant other, and other team members to
ensure needed care is delivered;
providing oversight and direction to dialysis technicians and licensed
practical nurses; and
participating in continuous quality improvement activities.
(d) A charge nurse shall be on
site and available to the treatment area to provide patient care during all
pediatric dialysis is provided, a registered nurse shall coordinate with a
pediatric dialysis center that has a pediatric nephrologist on staff to provide
care of pediatric dialysis patients younger than 14 years of age or smaller
than 35 kilograms in weight.
Sufficient direct care nursing staff shall be on-site to meet the needs of the
(g) A facility shall
provide a nursing station(s) to allow adequate visual monitoring of patients by
nursing staff during treatment.
A licensed nurse or dialysis technician shall evaluate each patient before and
after treatment according to facility policy and the staff member's level of
training. 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
(i) The initial nursing
assessment shall be initiated by a registered nurse at the time of the first
treatment in the facility and completed within the first three
(j) Each nurse shall
have a current Tennessee license to practice nursing in good
(k) Each nurse assigned
charge responsibilities shall be a registered nurse and have six months
experience in hemodialysis obtained within the last 24 months. A RN who holds a
current certification from a nationally recognized board in nephrology nursing
or hemodialysis may substitute the certification for the six months experience
in dialysis obtained within the last 24 months.
(a) The renal dialysis clinic shall have
pharmaceutical services that meet the needs of the patients during dialysis and
are in accordance with the Tennessee Board of Pharmacy statutes and rules. The
governing body is responsible for implementing policies and procedures that
minimize drug errors.
internal and external medications and preparations intended for human use shall
be stored separately. They shall be properly stored in medicine compartments,
including cabinets on wheels, or drug rooms. Such compartments, cabinets or
drug rooms shall be kept securely locked when not in use, and the key must be
in the possession of the supervising nurse or other authorized persons. Poisons
or external medications shall not be stored in the same compartment and shall
be labeled as such.
(c) Schedule II
drugs must be stored behind two (2) separately locked doors at all times and
accessible only to persons in charge of administering medication.
(d) Every renal dialysis clinic shall comply
with all state and federal statutes and regulations governing Schedule II
(e) A notation shall be made
in a Schedule II drug book and in the patient's nursing notes each time a
Schedule II drug is given. The notation shall include the name of the patient
receiving the drug, name of the drug, the dosage given, the method of
administration, the date and time given and the name of the practitioner
prescribing the drug, and shall be signed or initialed by the prescribing
practitioner according to renal dialysis clinic policy.
(f) Medications not specifically limited as
to time or number of doses when ordered shall be controlled by automatic stop
orders or other methods in accordance with written policies. No Schedule II
drug shall be given or continued beyond seventy-two (72) hours without a
written order by the physician.
Medication administration records (MAR) shall be checked against the
physician's orders. Each dose shall be properly recorded in the clinical record
after it has been administered.
Preparation of doses for more than one scheduled administration time shall not
be administered only by licensed medical or licensed nursing personnel or other
licensed health professionals acting within the scope of their licenses,
excluding medications as described in
(j) Unless the unit dose package system is
used, individual prescriptions of drugs shall be kept in the original container
with the original label intact showing the name of the patient, the drug, the
physician, the prescription number and the date dispensed.
(k) Any unused portions of prescriptions
shall be turned over to the patient only on a written order by the physician. A
notation of drugs released to the patient shall be entered into the medical
record. All unused prescriptions left in a renal dialysis clinic must be
destroyed on the premises and recorded by a registered nurse. Such record shall
be kept in the renal dialysis clinic.
(5) Laboratory Services. The renal dialysis
clinic must maintain or have available, either directly or through a
contractual agreement, adequate laboratory services to meet the needs of the
patients. The renal dialysis clinic must ensure that all laboratory services
provided to its patients are performed in a facility licensed in accordance
with the Tennessee Medical Laboratory Act (TMLA), if located in Tennessee. All
technical laboratory staff shall be licensed in accordance with the TMLA
facility and shall be qualified by education, training and experience for the
type of services rendered.
(a) Space and
facilities for housekeeping equipment and supply storage shall be provided in
each service area. Storage for bulk supplies and equipment shall be located
away from patient care areas. The building shall be kept in good repair, clean,
sanitary and safe at all times.
The physical environment of the clinic shall be maintained in a safe, clean and
sanitary manner. Any condition of the clinic site conducive to the harboring or
breeding of insects, rodents or other vermin shall be prohibited. Chemical
substances shall not be stored with or near food or medications.
(a) The renal dialysis clinic shall comply
with the Tennessee Medical Records Act, T.C.A. §§
68-11-301, et seq.
(b) The renal dialysis clinic must maintain a
medical record for each patient. Medical records must be accurate, promptly
completed, properly filed and retained, and accessible. The facility must use a
system of author identification and record maintenance that ensures the
integrity of the authentication and protects the security of all record
(c) All medical records,
in either written, electronic, graphic or otherwise acceptable form, must be
retained in their original or legally reproduced form for a minimum period of
at least ten (10) years after which such records may be destroyed. However, in
cases of patients under mental disability or minority, their complete facility
records shall be retained for the period of minority or known mental
disability, plus one (1) year, or ten (10) years following the discharge of the
patient, whichever is longer. Records destruction shall be accomplished by
burning, shredding or other effective method in keeping with the confidential
nature of the contents. The destruction of records must be made in the ordinary
course of business, must be documented and in accordance with the facility's
policies and procedures, and no record may be destroyed on an individual
(d) When a renal dialysis
clinic closes with no plans of reopening, an authorized representative of the
facility shall request final storage or disposition of the facility's medical
records by the department. Upon transfer to the department, the facility
relinquishes all control over final storage of the records and the files shall
become property of the State of Tennessee.
(e) The renal dialysis clinic must have a
system of coding and indexing medical records. The system must allow for timely
(f) The renal dialysis
clinic must have a procedure for ensuring the confidentiality of patient
records. Information from or copies of records may be released only to
authorized individuals, and the facility must ensure that unauthorized
individuals cannot gain access to or alter patient records. Original medical
records must be released by the facility only in accordance with federal and
state laws, court orders or subpoenas.
(g) The medical record must contain
information to justify admission, support the diagnosis, and describe the
patient's progress and response to services.
(h) All entries must be legible, complete,
dated and authenticated according to facility policy.
All records must document the following:
1. Admitting diagnosis;
2. Documentation of complications;
3. Properly executed informed consent forms
for procedures and treatments specified by facility policy, or by federal or
state law if applicable, as requiring written patient consent;
4. All practitioners' orders, reports of
treatment, medication records, radiology and laboratory reports, and vital
signs and other information necessary to monitor the patient's
Electronic and computer-generated records and signature entries are
(a) Nutrition services
shall be provided to a patient and the patient's caregiver(s) in order to
maximize the patient's nutritional status.
The dietitian shall be responsible for:
1. conducting a nutrition assessment of a
2. participating in a team
review of a patient's progress;
recommending therapeutic diets in consideration of cultural or religious
preferences and changes in treatment based on the patient's nutritional needs
in consultation with the patient's physician;
4. 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;
5. referring a patient for assistance with
nutrition resources such as financial assistance, community resources or
participating in continuous quality improvement activities; and
7. 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.
(c) The collection of objective
and subjective data to assess nutrition status shall occur 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 admission to the facility,
whichever occurs later.
nutrition reassessment shall be conducted annually or more often if
(e) Each facility shall
employ or contract with a sufficient number of dietitian(s) to provide clinical
nutrition services for each patient.
(f) Nutrition services shall be available at
the facility during scheduled treatment times. Access to services may require
(a) 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
The social worker
shall be responsible for:
participating in team review of patient progress;
3. recommending changes in services based on
the patient's current psychosocial needs;
4. providing case work and group work
services to patients and their families in dealing with the special problems
associated with end stage renal disease;
5. except in the case of social workers
providing service in correctional institutions, identifying community social
agencies and other resources and assisting patients and families in utilizing
6. participating in
continuous quality improvement activities.
(c) 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.
(d) A psychosocial reassessment shall be
conducted annually or more often if indicated.
(e) Each facility shall employ or contract
with a sufficient number of social worker(s) to meet the psychosocial needs of
(f) Social services
shall be available at the facility during the times of patient treatment.
Access to social services may require an appointment.