0720-33-.06
Basic Services
Cite as Tenn. Comp. R. & Regs. 0720-33-.06
(1)
Medical Staff Services.
(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 Tennessee.
(c)
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;
2.
Arrange for the delivery of emergency and medical care when the patient’s
treating and/or referring physician or his/her designated alternate is unavailable;
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 body;
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 outcomes;
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6.
Oversee so that no infectious health conditions exist which would adversely
affect patients;
7.
Advise and provide consultation on matters regarding medical care, standards of
care, surveillance and infection control;
8.
Develop 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
11.
Ensure development and implementation of all policies required by this chapter.
(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 Assistant).
(f)
Medical staff.
1.
Each patient shall be under the care of a physician on the medical staff.
2.
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 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 – as needed or indicated.
3.
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 staff.
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,
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medications including heparin, and specific infection control measures as
needed.
6.
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.
(g)
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 dietitian.
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
goals.
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 safe care.
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.
(2)
Home Dialysis Training and Support Services.
(a)
In addition to the other services contained in this chapter, a renal dialysis clinic may
provide the following services:
1.
Home dialysis training;
2.
Home dialysis support services for those patients receiving home dialysis.
(b)
Training Requirements.
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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:
1.
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 problems;
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 emergencies; and
8.
Infection control precautions and proper waste storage and disposal procedures.
(c)
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:
1.
Periodic 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 care;
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;
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4.
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)); and
5.
A review of self-monitoring data from the patient or patient’s caregiver at least
every two (2) months.
(d)
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 home dialysis;
2.
Observations and inquiries of the patient’s condition; and
3.
Patient or patient caregiver’s self-monitoring data.
(3)
Nursing Services.
(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.
(c)
A registered nurse shall be responsible for:
1.
Conducting admission nursing assessments;
2.
Conducting 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 patient’s progress;
4.
Recommending 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;
6.
Providing oversight and direction to dialysis technicians and licensed practical
nurses; and
7.
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 dialysis treatments.
(e)
If 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.
(f)
Sufficient direct care nursing staff shall be on-site to meet the needs of the patients.
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(g)
A facility shall provide a nursing station(s) to allow adequate visual monitoring of
patients by nursing staff during treatment.
(h)
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 request.
(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 treatments.
(j)
Each nurse shall have a current Tennessee license to practice nursing in good
standing.
(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.
(4)
Pharmaceutical Services.
(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.
(b)
All 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 drugs.
(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.
(g)
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.
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(h)
Preparation of doses for more than one scheduled administration time shall not be
permitted.
(i)
Medication shall 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 0720-33-.04(12)(1).
(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.
(6)
Environmental services.
(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.
(b)
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.
(7)
Medical Records.
(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 entries.
(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
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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
basis.
(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 retrieval.
(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.
(i)
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 condition.
(j)
Electronic and computer-generated records and signature entries are acceptable.
(8)
Nutrition services.
(a)
Nutrition services shall be provided to a patient and the patient’s caregiver(s) in order
to maximize the patient’s nutritional status.
(b)
The dietitian shall be responsible for:
1.
Conducting a nutrition assessment of a patient;
2.
Participating in a team review of a patient’s progress;
3.
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;
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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 in-home assistance;
6.
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.
(d)
A nutrition reassessment shall be conducted annually or more often if indicated.
(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 an appointment.
(9)
Social services.
(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
patient.
(b)
The social worker shall be responsible for:
1.
Conducting psychosocial evaluations;
2.
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 them; and
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,
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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 the patients.
(f)
Social services shall be available at the facility during the times of patient treatment.
Access to social services may require an appointment.