2005 California Health and Safety Code Sections 1794.01-1794.29 CHAPTER 11. HOME DIALYSIS AGENCIES

1794.01.  (a) The purposes of this chapter are to provide for the
licensure of home dialysis agencies by the state department in order
to ensure the health and safety of patients who receive hemodialysis
in their homes and to permit qualified persons, political
subdivisions of the state, and governmental agencies to comply with
requirements of federal law regarding the provision of home dialysis
services.
   (b) In enacting this chapter, it is the intent of the Legislature
to allow all qualified persons, political subdivisions of the state,
and governmental agencies to provide home dialysis services to the
people of California.  It is also the intent of the Legislature to
distinguish between the functions of a home dialysis agency and a
home health agency licensed under Chapter 8 (commencing with Section
1725) and not to require a home dialysis agency to obtain licensure
as, and perform the functions of, a home health agency.  It is
further the intent of the Legislature to require the State Department
of Health Services to establish standards of quality patient care
for home dialysis agencies.
1794.02.  As used in this chapter, the following definitions shall
apply:
   (a) "Chief administrative office" means a place located in this
state where more than 50 percent of an agency's administrative tasks
are performed.
   (b) "Dialysis treatment record" means a dated, written notation by
the person providing dialysis treatment which contains a description
of all of the following:
   (1) The signs and symptoms of the patient's health status.
   (2) The machine parameters and pressure settings used during the
treatment.
   (3) The medications administered as part of the treatment.
   (4) The patient's response to treatment.
   (c) "Dietician" means a person who satisfies both of the
following:
   (1) Eligibility for registration with the American Dietetic
Association.
   (2) Satisfaction of the criteria specified in either paragraph (1)
or (2) of subdivision (a) of Section 2585.
   (d) "End stage renal disease" or "ESRD" means the stage of renal
impairment that appears irreversible and permanent and requires
regular dialysis treatment or kidney transplantation to maintain
life.
   (e) "Home" means a house, apartment, skilled nursing facility,
intermediate care facility, congregate living facility, or other
setting determined appropriate by the patient's physician and surgeon
in consultation with the home dialysis agency and the patient.  Only
a location where dialysis is provided by at least one staff person
per patient is included in this definition.
   (f) "Home dialysis agency" or "agency" means a person, political
subdivision of the state, or governmental agency which is engaged in
providing dialysis treatments and other therapeutic services to
patients in their homes.
   (g) "Home dialysis services" means the treatment and care given to
patients of a home dialysis agency which are administered by a
physician and surgeon, a qualified registered nurse, a qualified
licensed nurse, or a qualified hemodialysis technician pursuant to a
patient care plan.
   (h) "Interdisciplinary treatment team" means the patient's
physician and surgeon, who shall be board certified or board eligible
in nephrology, and a qualified registered nurse, a dietician, and a
qualified social worker employed by the home dialysis agency and
responsible for planning the care delivered to the patient.
   (i) "Long-term program" means the written documentation of the
selection of the home dialysis treatment suitable for the patient and
the home setting which has been selected by the patient's physician
and surgeon in consultation with the home dialysis agency and the
patient.
   (j) "Medical social service" means the initial and followup
psychosocial evaluation of the patient, and the provision of
assistance to the patient with identifying and obtaining access to
community resources that may be of assistance to the patient.
   (k) "Nursing director" means a registered nurse who is licensed
under Chapter 6 (commencing with Section 2700) of Division 2 of the
Business and Professions Code and has at least 18 months of
experience or training in the care of patients with ESRD, including
patients at an ESRD facility, which has occurred during the six-year
period prior to the date the application for licensure under this
chapter was filed.
   (l) "Nursing service" means the provision of direct and indirect
care which is associated with the treatment of existing or potential
health problems and are provided to dialysis patients with end stage
renal disease, including all of the following:
   (1) The establishment of objectives for individualized patient
care through an assessment of the patient and the patient's nursing
history.
   (2) The supervision and coordination of care for dialysis patients
with end stage renal disease by a qualified registered nurse
pursuant to a patient's physician and surgeon's orders.
   (3) Teaching the patient about renal diseases, medications, and
the scope of nursing services offered to the patients by the home
dialysis agency.
   (m) "Nutritional counseling" means the assessment of the patient's
nutritional status, the instruction of the patient in proper
nutrition, and the maintenance of ongoing nutritional followup care
for patients as determined necessary by the state department.
   (n) "Patient care plan" means a written document prepared by the
interdisciplinary treatment team for a patient that satisfies the
requirements of subdivision (d) of Section 1794.11.
   (o) "Qualified hemodialysis technician" means a person certified
by the state department pursuant to Article 3.5 (commencing with
Section 1247) of Chapter 3 of Division 2 of the Business and
Professions Code and who also satifies the requirements specified in
Sections 1794.14 and 1794.15.
   (p) "Qualified licensed nurse" means a registered nurse who is
licensed under Chapter 6 (commencing with Section 2700) of Division 2
of the Business and Professions Code or a licensed vocational nurse
who is licensed under Chapter 6.5 (commencing with Section 2840) of
Division 2 of the Business and Professions Code, and who also
satisfies the requirements specified in Section 1794.15.
   (q) "Qualified registered nurse" means a registered nurse who is
licensed under Chapter 6 (commencing with Section 2700) of Division 2
of the Business and Professions Code and who has at least 12 months
of experience providing direct nursing care to patients and at least
an additional six months of experience in providing nursing care to
patients with ESRD.
   (r) "Qualified social worker" means a person who satisfies either
of the following:
   (1) A person who is licensed as a clinical social worker under
Chapter 14 (commencing with Section 4990) of Division 2 of the
Business and Professions Code.
   (2) A person who holds a master's degree in social work and who
has provided medical social services for at least one year in a
dialysis treatment unit or a kidney transplantation program.
1794.03.  (a) No person, political subdivision of the state, or
governmental agency, which is not operating a home dialysis agency as
of January 1, 1990, shall establish or operate a home dialysis
agency without first obtaining a license under this chapter.
   (b) Any person, political subdivision of the state, or
governmental agency, which was operating a home dialysis agency as of
January 1, 1990, may continue to operate the home dialysis agency
only under the following conditions:
   (1) The person, political subdivision of the state, or
governmental agency shall apply to the state department for a license
under this chapter within 60 days after forms for the application of
licensure under this chapter are available from the state
department.
   (2) The person, political subdivision of the state, or
governmental agency shall cease operating the home dialysis agency
upon a final decision of the state department upholding the state
department's denial of an application for licensure under this
chapter.
1794.04.  Except as otherwise provided in subdivision (b) of Section
1794.03, no person, political subdivision of the state, or
governmental agency shall provide home dialysis services unless a
license has been issued under this chapter.  Any person, political
subdivision of the state, or governmental agency desiring a license
for a home dialysis agency under this chapter shall file with the
department a verified application on a form prescribed and furnished
by the department that contains any information as may be required by
the department for the proper administration and enforcement of this
chapter.
1794.05.  To qualify for a license under this chapter, an applicant
shall satisfy all of the following:
   (a) Be of good moral character.  If the applicant is a franchise,
franchisee, firm, association, organization, partnership, business
trust, corporation, company, political subdivision of the state, or
governmental agency, the person in charge of the home dialysis agency
for which application for license is made shall be of good moral
character.
   (b) Demonstrate the ability of the applicant to comply with this
chapter and any rules and regulations promulgated under this chapter
by the state department.
   (c) Have a governing body selected by the applicant to govern the
services which the agency will provide and which is composed of a
group of persons licensed pursuant to Division 2 (commencing with
Section 500) of the Business and Professions Code, including at least
one physician and surgeon with at least two years of experience
treating patients with end stage renal disease and at least one
registered nurse with at least two years' experience treating
patients with end stage renal disease.  The governing body of the
agency shall appoint a nursing director after issuance of a license
under this chapter but prior to commencing operation of the agency.
The minutes of all meetings of the governing body of the agency shall
be retained by the agency, be on file at the chief administrative
office of the agency, and be available for inspection by the state
department.
   (d) File a completed application with the state department which
was prescribed and furnished pursuant to Section 1794.04.
1794.06.  (a) Each application for a license under this chapter
shall be accompanied by a fee in an amount determined by the state
department that is sufficient to cover the cost of processing the
application.
   (b) In addition to the fee specified in subdivision (a), the state
department shall establish and adjust annually a biennial license
fee for home dialysis agencies that is sufficient to cover the costs
of administering this chapter.
1794.07.  (a) Upon filing an application for licensure under this
chapter and compliance with this chapter and the rules and
regulations adopted by the state  department under this chapter, the
state department shall issue to the applicant a license to operate a
home dialysis agency.  Any fees required pursuant to Section 1794.06
shall be paid before a license is issued. Licensure also may be
denied by the state department as specified in Section 1794.25.
   (b) Each license issued under this chapter shall expire 24 months
from the date of its issuance.
   (c) A biennial application for the renewal of a license,
accompanied by any fee required pursuant to subdivision (c) of
Section 1794.06 shall be filed with the state department no less than
30 days prior to the expiration date of the license.  The failure to
file an application for renewal within the time required by this
subdivision shall result in the expiration of the license.
1794.08.  (a) A home dialysis agency for which a license has been
issued may, at the state department's option, be periodically
inspected by a duly authorized representative of the state
department.  Reports of each inspection shall be prepared by the
representative conducting it upon forms prepared and furnished by the
state department and filed with the state department.  The
inspection shall  be for the purpose of ensuring that this chapter
and the rules and regulations  of the state department adopted under
this chapter are being followed.
   (b) Any officer, employee, or agent of the state department may
enter and inspect any building or premises where dialysis is being
performed, record, or file of a licensee at any reasonable time to
assure compliance with, or to prevent violation of, any provision of
this chapter.
1794.09.  Each home dialysis agency shall do all of the following:
   (a) Have policies established by the governing body to govern the
services which the agency provides.  The policies shall be written
and include, but not be limited to, policies related to patient care,
personnel, personnel training and orientation, personnel
supervision, and evaluation of services provided by the agency.
   (b) Maintain the following clinical records on each patient:
   (1) A medical history and physical provided by the patient's
physician and surgeon.  The physical shall be updated annually, and
the annual update shall be maintained in the patient's medical files.
   (2) Clinical progress notes written by the patient's physician and
surgeon, a  qualified registered nurse, a qualified social worker,
and a dietician.  In addition, if any home dialysis services are
provided by a qualified licensed nurse or a qualified hemodialysis
technician, clinical progress notes shall be maintained that were
written by the qualified hemodialysis technician, the qualified
licensed nurse, or both the qualified hemodialysis technician and
qualified licensed nurse.
   (3) Dialysis treatment records.
   (4) Laboratory reports.
   (5) Patient care plan.
   (6) Patient's long-term program.
   (7) Documentation of any supervisory visit made by a qualified
registered nurse or other person.
   (8) A record of treatments prescribed by the patient's physician
and surgeon.
   (c) Have an effective procedure for each patient, agreed upon with
the patient's physician and surgeon, for the immediate transfer of
the patient to a general acute care hospital if emergency medical
care is needed.  The agency shall provide for the exchange of medical
and other information necessary or useful in the care and treatment
of patients who have been transferred to a general acute care
hospital, including the patient care plan and long-term program.
   (d) Ensure that the names of patients awaiting cadaveric donor
kidney transplantation are entered in a participating recipient
registry program.
   (e) An interdisciplinary care team or a combination of more than
one interdisciplinary care teams shall develop written criteria to
guide the agency in the selection of patients suitable for home
dialysis services and in specifying changes in a patient's condition
which would require termination of home dialysis services.
1794.10.  (a) The nursing director of the home dialysis agency shall
be responsible for the following:
   (1) Assuring adequate training of qualified registered nurses,
qualified licensed nurses, and qualified hemodialysis technicians in
dialysis techniques.
   (2) Assuring adequate monitoring of patients and dialysis
treatments.
   (3)   Determining whether treatment shall be given by a qualified
registered nurse, a qualified licensed nurse, or a qualified
hemodialysis technician, and assigning these personnel, as
appropriate, to provide care.
   (4) Assuring the development of a patient care policies and
procedures manual, the availability of the manual to the employees of
the agency, and the implementation of the policies and procedures
contained in the manual.
   (b) The agency shall maintain on file the following information
regarding the nursing director:
   (1) A curriculum vitae of the nursing director which documents
undergraduate and all relevant postgraduate training.
   (2) Evidence of current licensure of the nursing director under
Chapter 6 (commencing with Section 2700) of Division 2 of the
Business and Professions Code.
   (3) Evidence of the nursing director's minimum of 18 months of
experience or training in the care of patients with ESRD, including
patients at an ESRD facility, which has occurred during the six-year
period prior to the date the application for licensure under this
chapter was filed.
1794.11.  (a) Prior to the performance of the first home dialysis
service for a patient, a qualified registered nurse shall perform an
assessment of the patient's home to ensure a safe physicial
environment for the performance of dialysis.  In addition, if there
is a change in the dialysis setting, such as a change in the patient'
s home, prior to the performance of the first dialysis service in the
new setting, a qualified registered nurse shall perform an
assessment of the patient's home to ensure a safe physical
environment for the performance of dialysis.
   (b) Prior to the performance of any dialysis treatment, the home
dialysis agency shall obtain orders from a patient's physician and
surgeon which outline the specifics of prescribed treatment.  If
these orders are received verbally, they shall be confirmed by the
agency to the patient's physician and surgeon within 14 days of the
physician and surgeon's verbal order.  Orders by a patient's
physician and surgeon shall be reviewed and updated at least every
six months and also shall be revised as necessary.
   (c) The initial orders from the patient's physician and surgeon
for home dialysis services shall be received prior to the first
treatment and shall include the patient's diagnosis, including, but
not limited to, the patient's mental status, the prognosis of the
patient, and functional limitations of the patient.  The initial
orders also shall include activities permitted by the patient,
nutritional requirements of the patient, medications and treatments
to be given to the patient, and any safety measures to be taken to
protect the patient against injury.  Orders from a patient's
physician and surgeon for home dialysis services shall include the
frequency and length of treatment, weight to be maintained by the
patient, the type of dialyzer, the dialysate heparin dosage, and the
blood flow rate.  The physician may consult with the nursing director
to determine whether the treatment may be given by a qualified
registered nurse, a qualified licensed nurse, or a qualified
hemodialysis technician.
   (d) Each patient of a home dialysis agency shall have a patient
care plan to personalize the care to be given to the patient, to
reflect ongoing psychological, social, and functional needs of the
patient, and to enable short- and long-term goals to be met.  The
patient care plan shall be developed after consultation with the
patient, the patient's family, or both the patient and the patient's
family by the interdisciplinary treatment team.  The plan shall
implement the orders of the patient's physician and surgeon and shall
include an identification of the patient's problems, methods of
intervention in treating the problems, potential services to be given
to the patient, and the assignment of agency personnel to care for
the patient.  The initial patient care plan shall be completed by the
interdisciplinary treatment team within 10 days after the first home
dialysis treatment.  The patient care plan for nonstabilized
patients, including, but not limited to, patients with changes in
treatments, changes in laboratory values, weight gains, and
infections, shall be reviewed at least monthly by the
interdisciplinary treatment team.  For a stable patient, the patient
care plan shall be reviewed at least every six months by the
interdisciplinary treatment team.
   (e) Each patient of a home dialysis agency shall have a long-term
program.  The long-term program shall be revised as needed and
reviewed by the interdisciplinary treatment team at least annually.
   (f) Medication shall be administered by a qualified registered
nurse, qualified licensed nurse, or a qualified hemodialysis
technician only if that medication has been ordered by the patient's
physician and surgeon.  A record of the administration of medication
shall be entered in the dialysis treatment record by the person
administering the medication.
1794.12.  (a) A home dialysis agency shall, at a minimum, provide
nursing services, nutritional counseling, and medical social
services.  Nursing services and nutritional counseling shall be
provided either at the patient's home or, if there is no health risk
to the patient, as determined by a qualified registered nurse, by
telephone.  Medical social services shall be provided at the patient'
s home or, if there is no risk to the patient, as determined by a
qualified social worker in consultation with a qualified registered
nurse, by telephone.
   (b) The nursing director shall designate a qualified registered
nurse to be available by telephone whenever dialysis treatments are
in progress in a patient's home.  The nursing director also shall
designate an alternate qualified registered nurse who also shall be
available by telephone in the event that the first qualified
registered nurse is not available.
   (c) A qualified social worker shall be employed by, or under
contract with, the agency to provide medical social services to
patients.
   (d) A dietician shall be employed by, or under contract with, the
agency to provide nutritional counseling services to patients.
   (e)  Training of personnel to recognize and respond to emergency
conditions shall be provided by the agency to persons providing home
dialysis treatments.
1794.13.  (a) A qualified hemodialysis technician, a qualified
licensed nurse, or a qualified registered nurse may be employed or
under contract with the home dialysis agency  except that no such
individual may work under contract with an agency for more than 20
hours per week for more than six months unless at least one of the
following requirements is met:
   (1) The individual has continuously been, and remains, an employee
of another entity, such as a nurses' registry or other employment
agency, and receives the rights and protections of an employee.
   (2) The individual, who is not an employee, receives all the
rights, benefits, and protections accorded to other full-time,
permanent employees in a similar classification.  For purposes of
this chapter, all requirements applicable to employees of an agency
shall apply to a qualified hemodialysis technician, a qualified
licensed nurse, a qualified registered nurse, a qualified social
worker, or dietician under contract with the agency.
   (b) A qualified hemodialysis technician, a qualified licensed
nurse, or a qualified registered nurse may administer home dialysis
treatments to a patient only if the requirements of this chapter are
satisfied.
   (c) Every employee of a home dialysis agency shall be tested for
hepatitis prior to employment.  In addition, every employee providing
patient care shall have a physical at least annually.
   (d) All qualified hemodialysis technicians, qualified licensed
nurses, and qualified registered nurses employed by an agency shall
have current CPR certification.
   (e) A home dialysis agency shall do performance evaluations of the
nursing director and each qualified registered nurse, qualified
licensed nurse, qualified hemodialysis technician, qualified social
worker, and dietician employed by the agency at least annually.
1794.14.  (a) A qualified hemodialysis technician shall be certified
by the state department pursuant to Article 3.5 (commencing with
Section 1247) of Chapter 3 of Division 2 of the Business and
Professions Code and also shall satisfy either of the following
requirements:
   (1) A minimum of a high school education or passage of a general
educational development (GED) test, and one year of full-time
experience performing dialysis.
   (2) Eighteen months of full-time experience performing dialysis.
   (b) If the qualified hemodialysis technician is going to perform
peritoneal dialysis, including, but not limited to, intermittent
peritoneal dialysis, continuous ambulatory peritoneal dialysis, or
continuous cycles peritoneal dialysis, then he or she, in addition to
the requirements of subdivision (a), shall have at least six months
of full-time experience performing peritoneal dialysis.
   (c) A qualified hemodialysis technician shall not do any of the
following:
   (1) Administer blood, blood products, antibiotics, albumin, or
insulin.
   (2) Draw arterial blood gases.
   (3) Administer mesylate.
   (4) Initiate patient home education on dialysis procedures,
diagnosis, safety, or medications.  The initial home education of a
patient shall be provided by a qualified registered nurse.  However,
after the initial home education is provided by a licensed nurse or a
registered nurse, the qualified dialysis technician may provide
education on dialysis procedures and safety.
   (d) A qualified hemodialysis technician shall only administer the
following medications:
   (1) Lidocaine which shall only be administered subcutaneously.
   (2) Heparin which shall only be administered intravenously.
   (3) Saline solution which shall only be administered
intravenously.
   (4) Upon request for assistance with medications by a patient, a
patient's family, or both the patient and the patient's family, a
qualified registered nurse  employed by the agency may assign a
qualified hemodialysis technician to assist with the administration
of oral medications necessary for the performance of dialysis which
normally would be self-administered by a patient.  The request shall
be documented in the patient's treatment record by the qualified
registered nurse assigning the task.
   (5) Any other medication that the state department finds is
routinely necessary for the performance of dialysis and which may be
safely administered by a qualified hemodialysis technician.
1794.15.  (a) Qualified hemodialysis technicians and qualified
licensed nurses shall receive orientation and training and shall
demonstrate knowledge of the following:
   (1) Anatomy and physiology of the normal kidney.
   (2) Fluid, electrolyte, and acid-base balance.
   (3) Pathophysiology of renal disease.
   (4) Acceptable laboratory values for the patient with renal
disease.
   (5) Theoretical aspects of dialysis.
   (6) Vascular access and maintenance of blood flow.
   (7) Technical aspects of dialysis.
   (8) If the person is going to be performing peritoneal dialysis,
the peritoneal dialysis catheter and peritoneal dialysis clearance.
   (9) The monitoring of clients during the initiation of treatment,
the treatment itself, and the termination of treatment.
   (10) The recognition of dialysis complications, emergency
conditions, and the institution of the appropriate corrective action,
including the use of emergency equipment for emergency conditions.
   (11) Psychological, social, financial, and other aspects related
to long-term dialysis.
   (12) Care of the client with chronic renal failure.
   (13) Dietary modifications and medications for the uremic patient.
   (14) Alternative forms of treatment for ESRD.
   (15) The role of renal health team members including, the
physician and surgeon, qualified licensed nurse, qualified
hemodialysis technician, qualified social worker, and dietitian.
   (16) Performance of the following laboratory tests:
   (A) Hematocrit.
   (B) Clotting time.
   (C) Blood glucose.
   (17) The theory of blood products and blood administration.
   (18) Standards regarding infection control developed by the
California Occupational Safety and Health Administration.
   (b) A home dialysis agency shall develop an 80-hour orientation
and training program, which includes a classroom component that
covers theory, written assignments, and direct observations of a
qualified registered nurse, qualified licensed nurse, or qualified
hemodialysis technician performing hemodialysis treatments on a
patient in his or her home.  The orientation and training shall be
provided by a qualified registered nurse.
   (c) If a qualified hemodialysis technician or qualified licensed
nurse is able to demonstrate knowledge of the theory of those
subjects specified in subdivision (a) by written examination, then
the classroom component of the training program required by
subdivision (a) may be waived by the home dialysis agency.
   (d) A qualified registered nurse shall directly supervise a
qualified hemodialysis technician or qualified licensed nurse for a
minimum of three dialysis treatments prior to the qualified
hemodialysis technician or qualified licensed nurse independently
performing dialysis treatments.  The qualified registered nurse  who
provided the direct supervision shall complete an orientation skills
checklist relating to the qualified hemodialysis technician or
qualified licensed nurse to assure that the level of his or her
performance of dialysis treatments is of the quality to enable him or
her to perform dialysis treatments independently.  Depending upon
the qualified dialysis technician's or qualified registered nurse's
level of performance reflected on the skills checklist, additional
supervised dialysis treatments may be required.
   (e) A qualified registered nurse shall directly supervise at a
patient's home each qualified hemodialysis technician and qualified
licensed nurse employed by the agency at least monthy and more often
if determined necessary by a qualified registered nurse.
   (f) A home dialysis agency shall provide continuing education for
qualified hemodialysis technicians and qualified licensed nurses
employed by the agency at least semiannually.
1794.16.  (a) Hematocrits, clotting times, and blood glucose tests
may be performed at the patient's home by a qualified hemodialysis
technician, qualified licensed nurse, or qualified registered nurse.
   (b) Maintenance, calibration, and quality control studies of all
laboratory equipment utilized to perform the laboratory tests
specified in subdivision (a) shall be performed according to the
equipment manufacturer's suggestions, and the records and any results
of the maintenance, calibration, and quality control studies shall
be maintained in the records of the agency at its chief
administrative office.
   (c) Except as provided in subdivision (a), all laboratory services
ordered for the patient by the patient's physician and surgeon shall
be performed by a  clinical laboratory licensed pursuant to Chapter
3 (commencing with Section 1200) of Division 2 of the Business and
Professions Code, or a facility located outside of the State of
California that is licensed to engage in interstate commerce in
accordance with subdivision (a) of Section 262 of Title 42 of the
United States Code.  The services provided by the clinical laboratory
shall be performed in accordance with a written agreement or
arrangement that the clinical laboratory has with the home dialysis
agency.
   (d) Copies of all laboratory reports shall be maintained in the
patient's clinical record.
1794.17.  (a) All drugs, biologics, and medical devices furnished by
the home  dialysis agency shall be obtained for each patient
pursuant to the orders of a licensed physician and surgeon and in
accordance with law.
   (b) It shall be the agency's responsibility, in conjunction with
the patient's physician and surgeon, to ensure that there are
sufficient supplies maintained in each patient's home to perform the
scheduled home dialysis services.  In addition, backup supplies shall
be maintained in each patient's home for replacements, if needed,
for any purpose, including, but not limited to, breakage,
contamination, or a defective product.
   (c) All dialysis supplies, including drugs and biologics, shall be
delivered directly to the patient's home by a vendor of the
supplies.  However, personnel of the agency may transport dialysis
supplies, including drugs and biologics, from a vendor's place of
business to the patient's home for the patient's convenience if the
item is properly labeled with the patient's name and direction for
use.
   (d) There shall be no reuse or reprocessing of disposable medical
devices, including, but not limited to, dialyzers, end caps, and
blood lines.
1794.18.  (a) A planned program for preventative maintenance of home
dialysis  equipment shall be established by a home dialysis agency
to ensure the delivery of quality patient care.  The program shall be
in accordance with the equipment manufacturer's suggestions and as
often as necessary.  In the absence of specific manufacturer's
suggestions, preventative maintenance shall be in accordance with the
guidelines published by the Emergency Care Research Institute on
Health Devices, July 1978, Volume 7, Number 9, and as subsequently
revised.  Copies of these guidelines shall be filed in the chief
administrative office of an agency and shall be made available for
public inspection during the agency's regular working hours.
   (b) In the event that the water used for dialysis purposes or home
dialysis equipment is found not to meet safe operating parameters
and corrections cannot be done promptly to ensure safe patient care,
the patient shall be transferred to a facility that can perform the
dialysis treatments until the time when the water or equipment is
found to be operating within safe parameters.
   (c) Records of equipment maintenance required pursuant to this
section shall be maintained at the chief administrative office of the
agency.
1794.19.  (a) Except as provided in subdivision (b), a home dialysis
agency shall have water used for home dialysis treatments analyzed
at least annually and treated as necessary to maintain a continuous
water supply that is biologically and chemically compatible with
acceptable dialysis techniques as determined by the state department.
   (b) Water used to prepare dialysate shall meet the requirements
set forth in Sections 3.2 and 4.2 of the American National Standards
for Hemodialysis Systems, as revised, published by the Association
for the Advancement of Medical Instrumentation and as approved by the
American National Standards Institute, Inc., and as subsequently
revised.  The frequency of monitoring water purity for water used to
prepare dialysate shall be in accordance with the suggestions in
Section B5 of Appendix B of these standards.  Copies of Sections 3.2
and 4.2 and Section B5 of Appendix B of the standards shall be filed
in the chief administrative office of an agency and shall be
available for public inspection during the agency's regular working
hours.
   (c) Records of test results performed pursuant to subdivisions (a)
and (b) shall be maintained at the chief administrative office of
the agency.
1794.20.  A home dialysis agency shall ensure that infectious waste,
as defined in Section 25117.5, including, but not limited to,
needles, syringes, artificial kidneys, arterial and venous lines, and
any other blood contaminated material, is removed from the patient's
home and disposed of in a lawful manner.
1794.21.  (a) A home dialysis agency shall have written policies and
procedures for emergencies which address fire, natural disaster, and
medical emergencies.
   (b) An agency shall familiarize the employees of the agency and
each patient of the agency with the policies and procedures specified
in subdivision (a).  Emergency procedures shall be individualized
for each patient to include an appropriate evacuation from the
patient's home and the emergency telephone numbers needed for each
patient.
   (c) An agency shall make each patient familiar with the procedure
for disconnecting the patient's dialysis equipment in the event of an
emergency.
   (d) In the event of a medical emergency, an agency shall telephone
the patient's physician and surgeon and follow his or her
instructions.  If the patient's physician and surgeon is not
available and no other physician and surgeon is available who has
been designated by the patient's physician and surgeon, then the
agency shall telephone the nearest hospital emergency room and seek
instruction from the emergency room.
1794.22.  An agency shall provide to each patient a statement of the
patient's rights and responsibilities, which shall include the
following:
   (a) The patient's right to be informed of all rules and
regulations governing patient conduct and responsibilities, services
available in the patient's home which are provided by the agency, and
the patient's medical condition.
   (b) The patient's opportunity to participate in the planning of
his or her medical treatment.
   (c) The patient's right to the confidential treatment of his or
her clinical records and all information obtained by the agency,
including, but not limited to, personal items observed in the home.
   (d) The right to have assistance and understanding in exercising
his or her patient's rights.
   (e) There shall be a written grievance procedure under which the
patient may file a grievance concerning the agency or its personnel
and under which the patient can participate without fear of reprisal
by the agency.  Steps to resolve a grievance within the agency shall
be outlined and instructions provided to allow the patient to contact
the state department if a dispute is not resolved with the agency.
   (f) All agencies licensed pursuant to this chapter or paragraph
(2) of subdivision (b) of Section 1204 providing services to patients
with end stage renal disease shall provide every patient, during the
first treatment session, with information regarding other modalities
of care, including in-center dialysis, home dialysis, peritoneal
dialysis, and the potential for transplantation.
1794.23.  The state department shall adopt, amend, or repeal, in
accordance with Chapter 3.5 (commencing with Section 11340) of Part 1
of Division 3 of Title 2 of the Government Code, reasonable rules
and regulations as may be necessary or proper to carry out the
purposes and intent of this chapter and to enable the state
department to exercise the powers and perform the duties conferred
upon it by this chapter.
1794.24.  Any licensee may, with the approval of the state
department, surrender his or her license for suspension or
cancellation by the state department.  Any license suspended or
cancelled pursuant to this section may be reinstated by the state
department on receipt of an application showing compliance with this
chapter.
1794.25.  The state department may deny any application for, or
suspend or revoke any license issued under this chapter upon any of
the following grounds:
   (a) Violation by the applicant or licensee of any provision of
this chapter or any rules and regulations promulgated by the state
department under this chapter.
   (b) Any felony conviction of the applicant or licensee for the
violation of any law of this state.
   (c) Any conviction of the applicant or licensee for aiding,
abetting, or permitting the commission of any act that is a felony in
this state.
   (d) The applicant's or licensee's misrepresentation of a material
fact in the  application for a license under this chapter.
1794.26.  (a) Proceedings for the denial, suspension, or revocation
of licenses under this chapter shall be conducted in accordance with
Chapter 5 (commencing with Section 11500) of Part 1 of Division 3 of
Title 2 of the Government Code. In the case of a conflict between
this chapter and Chapter 5 (commencing with Section 11500) of Part 1
of Division 3 of Title 2 of the Government Code, Chapter 5
(commencing with Section 11500) shall control.
   (b) The suspension, expiration, or forfeiture by operation of law
of a license issued by the state department under this chapter, its
suspension or cancellation by order of the state department or by
order of a court of law, or its surrender without the written consent
of the state department shall not deprive the state department of
its authority to institute or continue any disciplinary proceeding
against the licensee pursuant to this chapter.
   (c) Any license revoked pursuant to this chapter may be reinstated
pursuant to the provisions of Section 11522 of the Government Code.
1794.27.  Any person who violates any provision of this chapter or
any rule or regulation promulgated under this chapter is guilty of a
misdemeanor and upon conviction thereof shall be punished by a fine
not to exceed five hundred dollars ($500), by imprisonment in the
county jail for a period not to exceed 180 days, or by both the fine
and imprisonment.
1794.28.  The state director may bring an action to enjoin the
violation or threatened violation of Section 1794.04 in the superior
court in and for the county in which the violation occurred or is
about to occur.  Any proceeding under this section shall conform to
the requirements of Chapter 3 (commencing with Section 525) of Title
7 of Part 2 of the Code of Civil Procedure, except that the state
director shall not be required to allege facts necessary to show or
tending to show the lack of an adequate remedy at law or to allege
facts necessary to show or tending to show irreparable damage or
loss.
1794.29.  The district attorney of every county shall, upon
application by the state department or its authorized representative,
institute and conduct the prosecution within his or her county of
any action for violation of this chapter.