S.C. Code Regs. § ch. 61, 61-125, 61-125.100, 61-125.101

Current through Register Vol. 48, No. 11, November 22, 2024

Subsection 61-125.101 - Definitions

For the purpose of this regulation, 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. Administrator. The staff member designated by the licensee to have the authority and responsibility to manage the facility, and is in charge of all functions and activities of the facility.

C. Adult. A person eighteen (18) years of age or older.

D. Annual. A time period that requires an activity to be performed at least every twelve to thirteen (12 to 13) 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, meet those needs, and to secure information for use in the development of the individual plan of care ("IPC").

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. Blood Assay for Mycobacterium tuberculosis ("BAMT"). A general term to refer to in vitro diagnostic tests that assess for the presence of tuberculosis ("TB") infection with M. tuberculosis. This term includes, but is not limited to, IFN-[GAMMA] release assays ("IGRA").

H. Contact Investigation. Procedures that occur when a case of infectious TB is identified, including finding persons (contacts) exposed to the case, testing and evaluation of contacts to identify Latent TB Infection ("LTBI") or TB disease, and treatment of these persons, as indicated.

I. 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.

J. Consultation. A visit by Department representatives who will provide information to the licensee with the goal of facilitating compliance with these regulations.

K. Crisis Stabilization Unit Facility ("CSU"). A facility, other than a health care facility, operated by the Department of Mental Health, or operated in partnership with the Department of Mental Health that provides a short-term residential program, offering psychiatric stabilization services and brief, intensive crisis services to individuals eighteen (18) years of age or older, twenty-four (24) hours a day, seven (7) days a week.

L. Department. The S.C. Department of Health and Environmental Control ("DHEC").

M. Designee. A staff member designated by the administrator to act on his or her behalf.

N. Direct Care Staff. Those individuals who are employees (full- and part-time) of the facility who provide direct treatment, care, and services to patients, and those individuals contracted to provide treatment, care, and services to patients.

O. 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.

P. Dispensing Medication. The transfer of possession of one (1) or more doses of a medication or device by a licensed pharmacist or individual as permitted by law, to the ultimate user or his or her agent pursuant to a lawful order of a practitioner in a suitable container appropriately labeled for subsequent administration to, or use by a patient.

Q. Elopement. An instance when a patient who is physically, mentally, or chemically impaired wanders, walks, runs away, escapes, or otherwise leaves the CSU unsupervised or unnoticed.

R. 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.

S. Facility. A Crisis Stabilization Unit Facility licensed by the Department.

T. Health Assessment. An evaluation of the health status of a staff member or volunteer by a physician, other authorized healthcare provider, or registered nurse, pursuant to written standing orders and protocol approved by a physician's signature. The standing orders and protocol shall be reviewed annually by the physician, with a copy maintained at the facility.

U. Incident. An unusual unexpected adverse event in the facility or on facility grounds, including any accidents, that could potentially cause harm, injury, or death to patients or staff members.

V. Individual Plan of Care ("IPC"). 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 to be implemented for the benefit of the patient.

W. Inspection. A visit by Department representatives for the purpose of determining compliance with this regulation.

X. Investigation. A visit by Department representatives to a licensed or unlicensed entity for the purpose of determining the validity of allegations received by the Department relating to statutory and regulatory compliance.

Y. Latent TB Infection ("LTBI"). Infection with M. tuberculosis. Persons with Latent TB Infection carry the organism that causes TB but do not have TB disease, are asymptomatic, and are noninfectious. Such persons usually have a positive reaction to the tuberculin skin test and/or positive BAMT.

Z. 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" or;

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.

AA. 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.

BB. Licensed Nurse. A person to whom the S.C. Board of Nursing has issued a license as a registered nurse or licensed practical nurse or an individual licensed as a registered nurse or licensed practical nurse who resides in another state that has been granted multi-state licensing privileges by the S.C. Board of Nursing 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.

CC. Licensee. The individual, corporation, organization, or public entity that has received a license to provide care and services at a facility and with whom rests the ultimate responsibility for compliance with this regulation.

DD. 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.

EE. 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.

FF. Non-legend Drug. A drug which may be sold without a prescription and which is labeled for use by the consumer in accordance with state and federal law.

GG. Patient. Any individual, other than staff members, volunteers or owners and their family members, who resides in a facility.

HH. Physical Examination. An examination of a patient by a physician or other authorized healthcare provider that meets the requirements set forth in Section 1100 of this regulation.

II. Physician. An individual currently licensed to practice medicine by the S.C. Board of Medical Examiners.

JJ. Physician Assistant. An individual currently licensed as such by the S.C. Board of Medical Examiners.

KK. 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.

LL. Quarterly. A time period that requires an activity to be performed at least four (4) times a year within intervals ranging from eighty-one to ninety-nine (81 to 99) days.

MM. Restraint. Any means by which movement of a patient is inhibited, whether physical, mechanical, or chemical. In addition, devices shall be considered a restraint if a patient is unable to easily release from the device.

NN. Revocation of License. An action by the Department to cancel or annul a facility license by recalling, withdrawing, or rescinding the facility's authority to operate.

OO. Screening. The process by which the facility, prior to admission, determines a prospective patient requires the level of services and active treatment provided by the CSU.

PP. Self-Administration. A procedure by which any medication is taken orally, injected, inserted, or topically or otherwise administered by a patient to himself or herself without prompting. The procedure is performed without assistance and includes removing an individual dose from a previously dispensed and labeled container (including a unit dose container), verifying it with the directions on the label, taking it orally, injecting, inserting, or applying topically or otherwise administering the medication .

QQ. Staff Member. An adult, to include the administrator, who is a compensated employee of the facility on either a full- or part-time basis, including those in partnership or contracted with the S.C. Department of Mental Health ("SCDMH").

RR. 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.

SS. Tuberculosis Risk Assessment. An initial and ongoing evaluation of the risk for transmission of M. tuberculosis ("TB") in a particular healthcare setting. To perform a risk assessment, the following factors shall be considered: the community rate of TB, number of TB patients encountered in the setting, and the speed with which patients with TB disease are suspected, isolated, and evaluated. The TB risk assessment determines the types of administrative and environmental controls and respiratory protection needed for a setting.

TT. Volunteer. An individual who performs a task at the facility at the direction of the administrator or his or her designee without compensation.

S.C. Code Regs. ch. 61, 61-125, 61-125.100, 61-125.101

Added by State Register Volume 43, Issue No. 05, eff. 5/24/2019.