Current through all regulations passed and filed through September 16, 2024
(A) Each dialysis
center shall:
(1) Develop and follow policies
and procedures for the provision of care consistent with national standards of
care or guidelines;
(2) Develop and
follow protocols for the prevention of disease and infection transmission
utilizing standards of care or guidelines for dialysis patients that comply
with the regulations for end stage renal disease services contained in
42 C.F.R.
494.30 (October 1, 2009);
(3) Provide services in accordance with the
clinical capabilities of the facility;
(4) Develop and follow policies and
procedures for the administration of medication;
(5) Develop and follow policies and
procedures for the provision of water and dialysate that comply with the
regulations for end stage renal disease services contained in
42 C.F.R.
494.40 (October 1, 2009) and are consistent
with the association for advancement of medical instrumentation (AAMI)
standards, including criteria for the biological and chemical composition of
the water;
(6) Develop and follow
policies and procedures for the re-use of hemodialyzers that comply with the
regulations for end stage renal disease services contained in
42 C.F.R.
494.50 (October 1, 2009) and are consistent
with the association for advancement of medical instrumentation (AAMI)
standards;
(7) Develop and follow
policies and procedures for direct care staff to notify appropriate health care
professionals of problems related to the provision of dialysis care;
(8) Develop and follow emergency plans to
include patient self disconnect;
(9) Provide each patient with both verbal and
written instructions for post treatment care and procedures for obtaining
emergency care; and
(10) Develop
and follow policies and procedures for documenting and responding to adverse
events. The policies and procedures shall include the course of action to be
taken by staff to respond to adverse events, including patient care and
evaluation of equipment, water, or dialysate solution. Each dialysis center
shall report to the director all adverse events involving the following:
(a) An event requiring emergency treatment,
or hospitalization;
(b) An
involuntary discharge of a patient;
(c) Contamination of the water or
dialysate;
(d) Development of
infection or communicable disease; and
(e) An event having a direct or immediate
impact on the health, safety, or security of a patient or staff
member.
(B)
Each dialysis center shall utilize a coordinated and integrated
interdisciplinary team working in conjunction
with the patient, to develop and
implement a written, individualized, comprehensive patient care plan. The care
plan shall:
(1)
Be based upon an
evaluation of the nature of the patient's illness, the treatment modality
prescribed, and an assessment of the patient's needs;
(2)
Address the
patient's physical, medical, dietary, psychosocial, functional, and
rehabilitation needs
(3)
Be reviewed at least semi-annually if the patient is
stable and monthly if the patient is not stable.
(C) Each dialysis center shall provide the
necessary ancillary and support services to meet the dialysis needs of patients
and in accordance with the patients' care plans.
(D) No dialysis center may set up dialysis
stations for patient use which exceed the authorized maximum number of licensed
dialysis stations.
(E) No dialysis
center shall provide dialysis services for hepatitis B positive patients unless
the facility has an in-house isolation room, a designated station or
area.
(F) Each dialysis center
shall provide the patient or the patient's representative in writing the
following:
(1) Information regarding the
policies, procedures, and mission statement of the dialysis center and the
services provided at the facility;
(2) Information concerning the services to be
performed;
(3) Information about
the complaint policies and procedures required by rule
3701-83-13 of the Administrative
Code; and
(4) Information regarding
the center's policy on advanced directives and
do-not-resuscitate orders, if applicable.
(G) Each dialysis center shall maintain
operational records for:
(1) The dialysate
solution delivery system;
(2) The
reuse of hemodialyzers and bloodlines;
(3) The reprocessing system;
(4) The water treatment system; and
(5) The water treatment quality.
(H) Each dialysis center shall
maintain records of water test results and necessary treatment for two
years.
(I) Each dialysis center
shall maintain an appropriately stocked emergency tray or cart consistent with
the types of services being provided.
(J) Each dialysis center shall ensure that
all drugs and supplies have not exceeded the expiration date.
(K) Each dialysis center shall develop and
follow procedures to respond to medical emergencies that may arise in the
provision of services to patients, including emergency cardiac care.
Effective: 7/1/2016
Five Year Review
(FYR) Dates: 02/16/2016 and
02/15/2021
Promulgated
Under: 119.03
Statutory Authority: 3702.13, 3702.30
Rule
Amplifies: 3702.12, 3702.13, 3702.30
Prior Effective Dates:
9/5/2002, 6/29/09, 4/24/11, 6/20/13
