Current through Register Vol. 46, No. 3, March 25, 2022
For the purpose of these standards, the following definitions
Abuse. Physical abuse
or psychological abuse.
1. Physical Abuse. The
act of intentionally inflicting or allowing infliction of physical injury on a
patient by an act or failure to act. Physical abuse includes, but is not
limited to, slapping, hitting, kicking, biting, choking, pinching, burning,
actual or attempted sexual battery, use of medication outside the standards of
reasonable medical practice for the purpose of controlling behavior, and
unreasonable confinement. Physical abuse also includes the use of a restrictive
or physically intrusive procedure to control behavior for the purpose of
punishment except that of a therapeutic procedure prescribed by a licensed
physician or other legally authorized healthcare professional. Physical abuse
does not include altercations or acts of assault between patients.
2. Psychological Abuse. The deliberate use of
any oral, written, or gestured language or depiction that includes disparaging
or derogatory terms to a patient or within the patient's hearing distance,
regardless of the patient's age, ability to comprehend, or disability,
including threats or harassment or other forms of intimidating behavior causing
fear, humiliation, degradation, agitation, confusion, or other forms of serious
Administering Medication. The acts of preparing and giving a single dose of a
medication to the body of a Patient by injection, ingestion, or any other means
in accordance with the orders of a physician or other Authorized Healthcare
C. Administrator. The
staff member designated by the Licensee to have the authority and
responsibility to manage the Facility and oversees all functions and activities
of the Facility.
D. Annual. A time
period that requires an activity to be performed at least every twelve (12)
E. Assessment. A procedure
for determining the nature and extent of the problems and needs of a Patient,
or potential Patient, to ascertain if the Facility can adequately address those
problems and needs, and to secure information for use in the development of the
Individual Plan of Care.
Authorized Healthcare Provider. An individual authorized by law and currently
licensed in South Carolina as a physician, advanced practice registered nurse,
or physician assistant to provide specific treatments, care, or services to
G. Consultation. A
meeting with a licensed Facility and individuals authorized by the Department
to provide information to Facilities to enable/encourage Facilities to better
comply with the regulations.
Continuous Ambulatory Peritoneal Dialysis. A continuous manual exchange of
dialysate into and from the peritoneal cavity (usually every four to six
I. Continuous Cycling
Peritoneal Dialysis. The use of a machine to warm and cycle the dialysate in
and out of the peritoneal cavity (usually every four hours).
J. Controlled Substance. A medication or
other substance included in Schedule I, II, III, IV, and V of the Federal
Controlled Substances Act or the South Carolina Controlled Substances
K. Department. The South
Carolina Department of Health and Environmental Control. L. Designee. A staff
member designated by the Administrator to act on his or her behalf.
M. Dialysis. A process by which dissolved
substances are removed from a Patient's body by diffusion from one fluid
compartment to another across a semipermeable membrane.
N. Dietitian. An individual currently
licensed as a Dietitian by the South Carolina Department of Labor, Licensing
O. Direct Care
Staff. Those individuals who are employees (full- and part-time) of the
Facility providing direct treatment, care, and services to Patients, and those
individuals contracted to provide treatment, care, and services to
P. Discharge. The point
at which treatment, care, and services in a Facility are terminated and the
Facility no longer maintains active responsibility for the treatment, care, and
services of the Patient.
End-Stage Renal Disease . That stage of renal impairment that appears
irreversible and permanent and requires a regular course of dialysis or kidney
transplantation to maintain life.
R. End-Stage Renal Disease Service. The type
of care or services furnished to an End-Stage Renal Disease Patient. Such types
of care are: transplantation service; Dialysis service and Home Dialysis
1) Causing or requiring a Patient to engage
in an activity or labor that is improper, unlawful, or against the reasonable
and rational wishes of a patient. Exploitation does not include requiring a
patient to participate in an activity or labor that is a part of a written
Individual Plan of Care or prescribed or authorized by the patient's attending
2) an improper,
unlawful, or unauthorized use of the funds, assets, property, power of
attorney, guardianship, or conservatorship of a patient by an individual for
the profit or advantage of that individual or another individual; or
3) causing a patient to purchase goods or
services for the profit or advantage of the seller or another individual
through undue influence, harassment, duress, force, coercion, or swindling by
overreaching, cheating, or defrauding the patient through cunning arts or
devices that delude the patient and cause him or her to lose money or other
Assessment. An evaluation of the health status of a staff member or volunteer
by a Physician, other Authorized Healthcare Provider, or a registered nurse, A
registered nurse may complete the Health Assessment pursuant to standing orders
approved by a Physician as evidenced by the Physician's signature. The standing
orders shall be reviewed annually by the physician, with a copy of the review
maintained at the Facility.
Dialysis. Dialysis performed by a Patient and/or individuals who assist
Patients at home. The Patient and individuals who assist patients are trained
and supervised by licensed nurses to do dialysis treatments on their
V. Home Dialysis Training. A
program that trains and provides support services to End-Stage Renal Disease
Patients and individuals who assist them in performing Home Dialysis with
little or no professional assistance.
W. Individual Plan of Care. A documented
regimen of appropriate care and services or written action plan prepared by the
Facility for each Patient, based on the Patient's needs and preferences, and
which is to be implemented for the benefit of the Patient.
X. Interdisciplinary Team. A group designated
by the Facility to provide or supervise care and services provided by the
facility. The group may include the following persons: physician or other
Authorized Healthcare Provider, licensed nurse, dietary, social services, and
direct care staff members.
Inspection. A visit by Department representatives for the purpose of
determining compliance with current statutes and regulations.
Z. Investigation. A visit by Department
representatives to a licensed Facility or unlicensed entity for the purpose of
determining the validity of allegations received by the Department relating to
statutory and regulatory compliance.
A drug when, under federal law, is
required, prior to being dispensed or delivered, to be labeled with any of the
a. "Caution: Federal law
prohibits dispensing without prescription";
b. "Rx only";
2. A drug which is required by any applicable
federal or state law to be dispensed pursuant only to a prescription drug order
or is restricted to use by practitioners only;
3. Any drug products considered to be a
public health threat, after notice and public hearing as designated by the S.C.
Board of Pharmacy; or
prescribed compounded prescription drug within the meaning of the S.C. Pharmacy
License. The authorization to operate a Facility as defined in this regulation
and as evidenced by a current certificate issued by the Department to a
CC. Licensed Capacity.
The number of dialysis stations that the Facility is authorized to operate to
include chronic hemodialysis and home hemodialysis training stations.
DD. Licensed Nurse. A person to whom the
South Carolina Board of Nursing has issued a license as a registered nurse or
licensed practical nurse, or a person granted multi-state licensing privileges
by the South Carolina Board of Nursing and who may practice nursing in any
Facility or activity licensed by the Department subject to the provisions and
conditions as indicated in the Nurse Licensure Compact Act.
EE. Licensee. The individual, corporation,
organization, or public entity that has received a license to provide care and
services at the Facility and with whom rests the ultimate responsibility for
compliance with the current regulation.
FF. Medical Director. A physician currently
licensed in South Carolina who is responsible for the medical direction of the
End-Stage Renal Disease Services.
GG. Medication. A substance that has
therapeutic effects including, but not limited to, Legend, Non-Legend, herbal
products, over-the counter, nonprescription, vitamins, and nutritional
HH. Neglect. The
failure or omission of a direct care staff member to provide the care, goods,
or services necessary to maintain the health or safety of a Patient including,
but not limited to, food, clothing, medicine, shelter, supervision, and medical
services. Failure to provide adequate supervision resulting in harm to
patients, including altercations or acts of assault between patients, may
constitute neglect. Neglect may be repeated conduct or a single incident that
has produced or could result in physical or psychological harm or substantial
risk of death. Noncompliance with regulatory standards alone does not
Drug. A drug that may be sold without a prescription and that is labeled for
use by the consumer in accordance with state and federal law.
JJ. Patient. A person who receives care,
treatment, or services from a Facility licensed by the Department.
KK. Physical Examination. An examination of a
Patient that meets the requirements set forth in Section 1100 of this
regulation by an Authorized Healthcare Provider.
LL. Quality Improvement Program. The process
used by a Facility to examine its methods and practices of providing care and
services, identify the ways to improve its performance, and take actions that
result in higher quality of care and services for the Facility's
MM. Quarterly. A time
period that requires an activity to be performed every three (3)
NN. Registered Health
Information Administrator. An individual who holds a professional certification
as a Registered Health Information Administrator from the American Health
Information Management Association.
OO. Registered Health Information Technician.
An individual who holds a professional certification as a Registered Health
Information Technician from the American Health Information Management
Association in the United States.
PP. Renal Dialysis Equipment Technician. An
individual who cleans, sterilizes, sets up, monitors, adjusts, and tests
dialysis machines and accessory equipment used in the treatment of Patients
with End- Stage Renal Disease.
Renal Dialysis Facility (Facility). An outpatient Facility which offers
staff-assisted Dialysis or Home Dialysis Training and support services to
-End-Stage Renal Disease Patients. A Facility may be composed of one or more
fixed buildings, mobile units, or a combination.
RR. Revocation of License. An action by the
Department to cancel or annul a Facility License by recalling, withdrawing, or
rescinding the Facility's authorization to operate.
SS. Social Worker. A person licensed as a
social worker by the South Carolina Board of Social Work Examiners.
TT. Station. An individual Patient treatment
area that provides sufficient space to accommodate the dialysis equipment and
supplies needed for Dialysis. Includes Stations specifically for chronic
Hemodialysis, Home Hemodialysis Training, and Peritoneal Dialysis.
UU. Suspension of License. An action by the
Department requiring a Facility to cease operations for a period of time or to
require a Facility to cease admitting Patients, until such time as the
Department rescinds that restriction.
VV. Tuberculosis Risk Assessment. An initial
and ongoing evaluation of the risk for transmission of Mycobacterium
tuberculosis in a particular healthcare setting.