Subject 111-8-22 END STAGE RENAL DISEASE FACILITIES
These rules and regulations establish minimum standards for the operation of end state renal disease facilities in order to ensure the health, safety, and protection of the patients served, and establish procedures and requirements for the licensing of such facilities.
Unless another meaning is specifically indicated by context, these selected terms shall have the following definitions when used in these rules and regulations:
|(a)||Applicant means a person, business entity, corporation, partnership or association applying for a license to operate an end stage renal disease facility in Georgia;|
|(b)||Department means the Department of Community Health of the state of Georgia;|
|(c)||Dialysis means a process by which dissolved substances are removed from a patient's body by diffusion, osmosis, and convection (ultrafiltration) from one fluid compartment to another across a semi-permeable membrane;|
|(d)||Dialysis technician means an individual who is not a registered nurse or physician and who provides dialysis care under the supervision of a registered nurse or physician;|
|(e)||End stage renal disease means that stage of renal impairment that appears irreversible and permanent and that requires a regular course of dialysis or kidney transplantation to maintain life;|
|(f)||End stage renal disease facility means a facility that provides dialysis treatment, home dialysis training, and support services, or any combination of such services, to individuals with end stage renal disease;|
|(g)||Equipment technician means an individual who performs the required tasks for the maintenance, monitoring, and repair of dialysis, reuse processing, and water treatment systems and equipment at the facility;|
|(h)||Facility means an end stage renal disease facility;|
|(i)||Healthcare personnel means any person providing healthcare services directly to patients at the facility, including but not limited to the provision of medical or nursing care;|
|(j)||Initial license means the first license issued by the Department for a particular end-stage renal disease facility, with subsequent licenses requiring review for renewal;|
|(k)||Nurse responsible for nursing services means the Georgia licensed registered nurse who has at least 12 months of experience in clinical nursing, and an additional 6 months of experience in nursing care of the patient with permanent kidney failure or undergoing kidney transplantation, including training in and experience with the dialysis process or has 18 months of experience in nursing care of the patient on maintenance dialysis, or the nursing care of the patient with a kidney transplant, including training in and experience with the dialysis process. Where the nurse responsible for nursing services is also in charge of self-care dialysis training, at least 3 months of the total required dialysis experience is in training patients in self-care;|
|(l)||Physician means an individual who is licensed to practice medicine in Georgia under O.C.G.A. Chapter 43-34;|
means an individual who provides direct supervision of the provision of
patient care by trainees who are in the process of completing training as
dialysis technicians, and who:
|(n)||Reuse technician means an individual who is not a registered nurse or licensed physician who performs the procedures necessary to clean and properly prepare kidney dialyzers for use for multiple treatments;|
|(o)||Special purpose facility means an end stage renal dialysis facility providing dialysis services at special locations on a short-term basis to a group of dialysis patients who would otherwise be unable to obtain treatment in that special location; and|
|(p)||Temporary provisional license means a license to provide end stage renal care for patients for a limited time period, not to exceed six months.|
|(1)||License Requirements. Unless
specifically exempted under 111-8-22-.03(2), no person, business entity,
association, partnership, or corporation shall operate an end stage renal
disease facility in Georgia without having first obtained a license from the
|(2)||Exempt Facilities. The
following facilities are not required to have a license:
|(1)||All applications for licenses shall be submitted on forms provided by the Department.|
|(2)||No application shall be considered by the Department unless it is complete, and is accompanied by all required attachments and fee payments.|
|(3)||The Department shall issue an annual license to an applicant if it is determined that the applicant and the facility meet the requirements of these rules.|
|(5)||Application for a New Annual
License Due to Change in Facility Name, Facility Location, or Facility
|(6)||Renewal of License. At least
30 days, but no more than 90 days, prior to the expiration of the license, the
facility shall submit an application for license renewal on forms provided by
the Department, with the applicable renewal fee.
|(7)||Denial of License Application or
Renewal Application. The Department may refuse to grant a license within
the parameters described in "General Licensing and Enforcement Requirements",
|(8)||Request for Approval for Addition
of Services. A facility shall obtain written approval from the
Department prior to any addition of services or increase in number of dialysis
|(9)||Notification of the Discontinuation of a Service. At least thirty (30) days prior to the discontinuation of a facility service, the facility shall notify the Department of the planned discontinuation, and shall provide a description of impact of the change on the care of patients currently served. The facility shall also notify the patients of its planned discontinuation of a facility service.|
|(10)||Temporary Inactive Status.
If the facility is closing temporarily, and plans to reopen under the
same ownership and name, the facility may request to have the license placed on
temporary inactive status.
|(1)||The facility shall be available during all hours of operation for observation and examination of the facility and the entirety of its administrative and service operations, by representatives of the Department. If dialyzers are reused for dialysis at the facility, the reprocessing of the dialyzers shall be subject to inspection.|
|(3)||Periodic Inspections. Prior
to renewal of the license, and periodically as deemed necessary by the
Department, the facility shall be subject to periodic inspections to determine
that there is continued compliance with these rules.
|(4)||Plans of Correction. If as a result of an inspection violations of these licensing rules are identified, the facility will be given a written report of the inspection which identifies the rules violated. The facility shall submit to the Department a written plan of correction in response to the report of inspection, which states what the facility will do, and when, to correct each of the violations identified. The plan of correction shall be submitted within ten calendar days of the facility's receipt of the written report of inspection.|
|(1)||Governing Body. The facility
shall function under the control of an identifiable governing body, which has
full legal authority for the governance and operation of the facility.
|(1)|| The facility shall develop, adopt,
implement, and enforce policies and procedures to ensure that each patient is:
|(2)||The facility shall inform each patient upon admission of their responsibilities in the treatment process, and of the facility's rules regarding patient conduct.|
|(3)|| The facility shall report to the
Department whenever any of the following incidents involving patients receiving
dialysis services through the facility occurs:
|(4)|| The facility shall make an initial report
of the incident within twenty-four (24) hours or by the next business day from
when the incident occurred, or from when the facility has reasonable cause to
suspect a reportable incident. The initial report shall be received by the
Department in confidence, and shall include at least:
|(5)|| The facility is required to
conduct an investigation of any of the incidents listed above and to complete
and retain on site a written report of the results of the investigation within
forty-five (45) days of the discovery of the incident. The complete report of
the investigation shall be available to the Department for inspection at the
facility, and shall contain at least the following:
|(1)||Through the facility administration, the medical director, and the medical and nursing staff, the facility shall develop and implement a facility-wide continuous quality improvement program, specific to the facility and designed to perform a systematic, ongoing, concurrent, and comprehensive review of the patient care provided, both in-facility and through the home dialysis program, if provided.|
|(2)||All facility staff shall be involved in the continuous quality improvement program.|
|(3)||Policies and procedures for the continuous quality improvement program shall include the use of a defined methodology for implementation. The methodology selected must include components for measuring the facility's performance, identifying opportunities for improvement through the use of such quality improvement tools as root cause analyses, setting priorities, and identifying expected outcomes. Reporting mechanisms shall be established, including at least a quarterly review of the continuous quality improvement activities.|
|(4)|| The continuous quality improvement
program shall continuously monitor at a minimum:
|(5)||The results of continuous quality improvement activities and monitoring shall be disseminated to the governing body, the medical director, the medical staff, and any service staff impacted by the results.|
|(6)||The facility shall take and document remedial action to address service deficiencies identified through the continuous quality improvement program.|
|(1)|| Medical Director. Any medical director
beginning such a function for the first time in Georgia at any facility on or
after July 1, 2002 shall be a licensed physician who is board-certified in
nephrology. However, a physician who has completed a fellowship in nephrology
after July 1, 2002 may direct a dialysis facility in a medically- underserved
area for a maximum of two years provided that the physician obtains board
certification as a nephrologist by the end of the two-year period. Any
physician functioning as a facility medical director at the implementation date
of these rules shall be board-eligible or board-certified in nephrology,
internal medicine, or pediatrics, and shall have at least one year experience
in the care of patients at an end stage renal disease facility.
|(2)|| Medical Services. The medical
director shall ensure that each patient at the facility receives medical care
and supervision appropriate to the patient's dialysis needs.
|(5)||Water Treatment System Technician.
|(6)||Equipment Technicians. An
individual first hired after the effective date of these rules who functions as
an equipment technician shall have at least the following minimum
|(7)||Dietitian. Any dietitian employed by the facility shall hold a current license in the state of Georgia to practice as a dietitian.|
|(8)||Social Worker. The social worker employed by the facility shall hold a current license in the state of Georgia as either a Master's Social Worker or a Licensed Clinical Social Worker.|
|(9)||Continuing Education. Facility staff providing patient care shall attend a minimum of twelve clock hours of continuing education activities related to end stage renal disease and treatment within twelve months of the effective date of these rules and annually thereafter. Continuing education activities may consist of, but are not limited to, seminars, lectures, and educational workshops or one-on-one training. Continuing education provided at the facility, including technician training programs, shall be accepted toward satisfaction of this requirement. The facility orientation program shall not be accepted for satisfaction of this requirement. Documentation of attendance at continuing education activities shall be kept in the personnel file for each staff member.|
|(1)|| Nursing Services.
|(2)|| Nutrition Services.
The facility shall provide nutrition services to the patients and the patients'
families and caregivers, which are designed to maximize the patient's
nutritional status. Services shall be provided by a qualified dietitian, as
defined by these rules, and shall include at a minimum:
|(3)|| Social Work Services. The
facility shall provide social services which are directed toward supporting and
maximizing the patient's social functioning and adjustment to management of end
stage renal disease. Services shall be provided by a qualified social worker,
as defined by these rules, and shall include at a minimum:
|(4)|| Laboratory Services. The
facility shall provide or arrange for the laboratory services needed for safe
and effective patient treatment.
|(5)|| Administration and Storage of
Controlled Substances and Dangerous Drugs.
|(6)|| Home Training Services for Hemodialysis
or Peritoneal Dialysis.
|(1)|| The facility shall coordinate services
for each patient through an interdisciplinary treatment team approach. An
interdisciplinary treatment team shall be identified at the time of admission
for each patient and shall consist of at least:
|(2)||There shall be documentation of the participation of the patient (or their representative) in the development and review of the patient's plan of care, with consideration given to the patient's preferences. If participation is declined, the declination shall be documented, and there shall be evidence that the content of the plan(s) or decisions were reviewed with the patient or their representative.|
|(3)|| The treatment
team shall develop a written, individualized plan of care for each patient,
designating a selected treatment modality and a selected setting for treatment.
|(a)|| Facilities processing dialyzers for reuse
shall adhere to the current American National Standard, Reuse of Hemodialyzers,
published by the Association for the Advancement of Medical Instrumentation
(AAMI), which are incorporated herein by reference.
|(1)||A current and complete medical record shall be maintained for each patient.|
|(2)||The facility shall designate a supervisor for the medical records who shall be responsible for the organization, proper documentation, completion and preservation of the facility's medical records.|
|(3)||The medical records shall be organized in a manner to facilitate the completion and retrieval of information.|
|(4)||Patients' medical records for the most recent two years shall be kept on site. The remainder of the patient's medical record may be stored off-site if the record is readily available. Medical records shall be retained for at least five years following the date of death or discharge. For pediatric patients, the records shall be retained for three years after the patient reaches the age of majority, or at least five years, whichever is longer.|
|(5)|| Medical records shall be available for
inspection only to members of the professional staff, the patient,
representatives of the Department acting in an official capacity, or persons
authorized in writing by the patient to have access to the medical record.
|(1)||Safety. The facility shall
have sufficient staff, systems and equipment in place to provide a safe
environment for patients, staff, and visitors, to include at least:
|(2)||Cleanliness and Sanitation.
The facility premises and equipment shall be maintained in a clean and
orderly condition. There must be evidence that the facility has systems that
satisfactorily address at least the following:
|(3)||Space and Equipment. The facility shall provide adequate space and
equipment to provide the scope of services offered, while ensuring the health
and safety of patients and staff.
|(4)||Water Treatment System.
|(1)|| The facility shall have an infection
control committee composed of at least the facility administrator, a physician,
and a registered nurse. The infection control committee shall develop and
implement policies and procedures for preventing and controlling hepatitis and
other infections at the facility, including but not limited to:
|(2)||Reports of infections such as bacterimia, septicemia, hepatitis, any wound that may allow for cross-contamination of patients and any suspected pyrogenic reactions and other communicable diseases of patients shall be made to the infection control committee through established mechanisms, and noted in patient files. Reports maintained by the infection control committee shall include documentation of efforts to determine the origin of the infection, and, where the dialysis procedure or environment was found to be related to the transmission of the infection, shall include documentation of the actions taken to prevent recurrence.|
|(3)||Facility policies and procedures shall require that all employees be tested upon employment and that attending physicians and physician extenders, be tested at the time privileges are granted for hepatitis B virus and tuberculosis infection and any other infectious diseases which the Centers for Disease Control have deemed to be endemic to the area served. The facility policy and procedures shall also require all employees, attending physicians and physician extenders to be tested for the diseases listed herein at least annually and when the health and safety of the patients require it. The facility shall have a mechanism for monitoring the health status of employees and referring for health evaluations and treatments as necessary to ensure the safety of patients.|
|(4)||Dialysis patients shall be tested initially and at least annually for the presence of Hepatitis B surface antigen, and for tuberculosis and any other infectious diseases which the Centers for Disease Control have deemed to be endemic to the area served, to determine the need for special treatment precautions and surveillance of the infection. Results of the screenings, as well as any refusals to submit to such testing signed by the patient, shall be included in the patient's medical record.|
|(1)||The facility shall establish and implement procedures that describe staff and patient actions in medical and non-medical emergencies, including at least fire, equipment failure, power outages, medical emergencies, unscheduled facility closing, and natural disasters which are likely to threaten the health and safety of patients or staff.|
|(2)||The facility shall provide training for staff and patients in where to go, what to do, and whom to contact if a medical or non-medical emergency occurs. Patient training in the handling of emergencies shall be documented in the patient's medical record and review with the patient at least annually.|
|(3)||The facility plan shall include method of access to community emergency services. Contact numbers for emergency needs, shall be conspicuously posted near a telephone readily available to the clinical treatment area.|
facility shall have and maintain appropriate equipment and supplies, in
ready-to-operate condition, for managing medical emergencies, in a location
accessible by all healthcare personnel. By October 1, 2002, all licensed
facilities shall have an automatic external defibrillator. Emergency trays or
carts shall include at least:
facility shall establish and implement a plan for management of staff and
patients in the event of a fire and provide for patient education on emergency
|(1)||A facility may request a waiver or variance of a specific rule by application on forms provided by the Department.|
|(2)|| The Department may
grant or deny the request for waiver or variance at its discretion. If the
waiver or variance is granted, the Department may establish conditions, which
must be met by the facility in order to operate under the waiver or variance.
Waivers or variances may be granted with consideration of the following:
|(3)||Experimental Waiver or Variance. The Department may grant a waiver or variance to allow experimentation and demonstration of new and innovative approaches to delivery of services, upon a showing by the applicant that the intended protections afforded by the rule or regulation in question are met and that the innovative approach has the potential to improve service delivery.|
|(4)||Waivers and variances granted by the Department shall be for a time certain, as determined by the Department.|
|(1)||An end stage renal disease facility that fails to comply with these rules and regulations shall be subject to sanctions and/or license revocation as provided by law.|
|(2)||The Department may take actions to enforce these rules and regulations as prescribed in the Rules and Regulations for General Licensing and Enforcement Requirements, Chapter 111-8-25, pursuant to O.C.G.A. § 31-2-8, and/or by appointment of a temporary manager as described in these rules.|
Appointment of a Temporary Manager. A person holding a controlling
interest in an end stage renal disease facility may, at any time, request the
Department to assume the management of the facility through the appointment of
a temporary manager.
|(4)||Involuntary Appointment of a
Temporary Manager. The Department may request that the state Attorney
General bring an action for the appointment of a temporary manager to manage
the facility, if:
|(5)||A temporary manager appointed under either voluntary or involuntary condition shall be entitled to a reasonable fee as determined by the court. The fee shall be paid by the facility.|
|(6)||A temporary manager appointed voluntarily may petition the court to order the release of any payment owed to him/her for care and services provided to patients at the facility if the payment has been withheld before or during the period of appointment, including any Medicaid, Medicare, or insurance payment, or payment from another third party.|
In the event that any rule, sentence, clause or phrase of any of these rules and regulations may be construed by any court or competent jurisdiction to be invalid, illegal, unconstitutional, or otherwise unenforceable, such determination or adjudication shall in no manner affect the remaining rules or portions thereof. The remaining rule or portions of rules shall remain in full force and effect, as if such rule or portions thereof so determined, declared, or adjudged invalid or unconstitutional were not originally a part of these rules.