S.C. Code Regs. 61-97.100.101 - Definitions

Current through Register Vol. 46, No. 3, March 25, 2022

For the purpose of these standards, the following definitions shall apply:

A. 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 emotional distress.
B. 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 Provider.
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) months.
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.
F. 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 Patients.
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.
H. Continuous Ambulatory Peritoneal Dialysis. A continuous manual exchange of dialysate into and from the peritoneal cavity (usually every four to six hours).
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 Act.
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 and Regulation.
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 Patients.
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.
Q. 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 training.
S. Exploitation.
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 physician;
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 property.
T. Health 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.
U. Home 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 own.
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.
Y. 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.
AA. Legend Drug.
1. A drug when, under federal law, is required, prior to being dispensed or delivered, to be labeled with any of the following statements:
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
4. Any prescribed compounded prescription drug within the meaning of the S.C. Pharmacy Practice Act.
BB. 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 Facility.
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 supplements.
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 constitute neglect.
II. Non-Legend 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 Patients.
MM. Quarterly. A time period that requires an activity to be performed every three (3) months.
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.
QQ. 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.


S.C. Code Regs. 61-97.100.101
Added by State Register Volume 44, Issue No. 06, eff. 6/26/2020.

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