S.C. Code Regs. § § 61-108.100.101

Current through Register Vol. 48, No. 10, October 25, 2024

Section 61-108.100.101 - Definitions

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

A. Administering Medication. The direct application of a single dose of a medication to the body of a patient by injection, ingestion, or any other means.

B. Advanced Practice Registered Nurse. An individual who has official recognition to practice as an advanced practice registered nurse by the S.C. State Board of Nursing.

C. Anesthesiologist. A physician who has completed a residency in anesthesiology.

D. Anesthesiologist's Assistant. An individual currently authorized as such by the S.C. Board of Medical Examiners.

E. Anesthetic Agent. Any drug or combination of drugs administered parenterally or inhaled with the purpose of creating conscious (moderate) or deep sedation.

F. Cardiac Catheterization. The passage of a small catheter, usually through a blood vessel into chambers of the heart, under roentgenologic control, permitting the securing of blood samples, determination of intracardiac pressure, and detection of cardiac anomalies.

G. Certified Registered Nurse Anesthetist. A registered nurse who is authorized to practice as a certified registered nurse anesthetist by the S.C. State Board of Nursing.

H. Computerized Tomography (CT). The recording of internal body images in which an emergent X-ray beam is measured by a scintillation counter. The electronic impulses are recorded on a magnetic disk and then are processed by a mini-computer for reconstruction display of the body in cross-section on a cathode ray tube.

I. Conduction Anesthesia. The administration of anesthetic agents to interrupt nerve impulses without loss of consciousness. Major conduction blocks include regional nerve blocks (epidural, caudal, and spinal anesthesia). Minor conduction blocks include local infiltration, local nerve blocks, and nerve blocks by direct pressure and refrigeration.

J. Conscious (Moderate) Sedation. The administration of drugs to obtund or reduce the intensity of pain and awareness without the loss of defensive reflexes.

K. Controlled Substance. A medication or other substance included in Schedule I, II, III, IV, and V of the Federal Controlled Substances Act and the S.C. Controlled Substances Act.

L. Consultation. A visit by individuals authorized by the Department to provide information to the licensee to enable better compliance with these regulations.

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

N. Direct Care Staff Member. An individual who provides care, treatment, and/or services or performs procedures for a patient.

O. Existing Equipment. Equipment that was in operation prior to the promulgation of this regulation. The licensing standards governing new equipment apply if and when existing equipment is not continuously operated and licensed under this regulation.

P. Freestanding or Mobile Technology. Medical equipment which is to be used for diagnosis or treatment and is owned or operated by a person, other than a health care facility (as defined in S.C. Code Ann. Section 44-7-130 (1976, as amended)), for which the total cost is in excess of that prescribed by R.61-15 and for which specific standards or criteria are prescribed in the State Health Plan.

Q. Gamma Knife. Stereotactic radiosurgery by which intracranial lesions are treated with high dose, high energy photons, i.e., a non-invasive procedure utilizing narrow bands of radiant energy that are directed at a treatment target in the head.

R. Health Assessment. An evaluation of the health status of a staff member or volunteer by a physician, physician's assistant, or advanced practice registered nurse or by a registered nurse, pursuant to standing orders approved by a physician, as evidenced by the physician's signature in accordance with facility policy.

S. Host/Host Hospital. An acute care facility or other entity that leases or otherwise arranges for the provision of services of a mobile technology unit.

T. Ionized Radiation. Radiation that causes a neutral atom or molecule to acquire a positive or negative charge.

U. Inspection. A visit by an authorized individual(s) for the purpose of determining compliance with this regulation.

V. Investigation. A visit by an authorized individual(s) for the purpose of determining the validity of allegations received by the Department relating to this regulation.

W. Initial License. A license granted for new equipment.

X. Legally Authorized Health Care Provider. An individual authorized by law and currently licensed in S.C. to provide specific medical care, treatment, procedures, and/or services to patients. Examples of individuals who may be authorized by law to provide specific medical care, treatment, procedures, and/or services within the lawful scope of practice may include, but are not limited to, advanced practice registered nurses, radiological technicians, and physician's assistants.

Y. Legend Drug.

1. A drug required by federal law to be labeled with any of the following statements prior to being dispensed or delivered:

a. "Caution: Federal law prohibits dispensing without prescription";

b. "Rx only."

2. A drug required by federal or state law to be dispensed pursuant to a prescription drug order or restricted to use by practitioners only;

3. Any drug products designated by the S.C. Board of Pharmacy to be a public health threat; or

4. Any prescribed compounded prescription within the meaning of the Pharmacy Act.

Z. License. A certificate issued by the Department to freestanding or mobile technology that authorizes equipment operation subject to the provisions of this regulation.

AA. Licensed Nurse. An individual authorized by the S.C. State Board of Nursing to practice as a registered nurse or licensed practical nurse.

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

CC. Magnetic Resonance Imaging (MRI). A diagnostic procedure used to create cross-sectional images of the body by the use of magnetic fields and radio frequency fields. It can also show certain biochemical activity and is non-invasive.

DD. Monitoring. The observation of a patient using instruments to measure, display, and/or record (continuously or intermittently) the values of certain physiologic variables such as pulse, blood pressure, oxygen saturation, and respiration.

EE. New Equipment. Equipment that is:

1. Being licensed for the first time;

2. Providing a different service that requires a change in the type of license;

3. Being licensed after the previous licensee's license has been revoked, suspended, or after the previous licensee has voluntarily surrendered the license and the equipment has not been continuously operated.

FF. Nonlegend Medication. A medication that may be sold without a prescription and that is labeled for use by the consumer in accordance with the requirements of the laws of this State and the federal government.

GG. On-Site Manager. The individual designated by the licensee to have the authority and responsibility to manage/operate the equipment. This person, or an individual designated to act in his/her absence, is the main contact with Department personnel.

HH. Pharmacist. An individual currently registered as such by the S.C. Board of Pharmacy.

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

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

KK. Positron Emission Tomography (PET). A procedure that allows the study of metabolic processes, such as oxygen consumption and utilization of glucose and fatty acids, by capturing images of cellular activity or metabolism by tracking the movement of radioactive tracers throughout the body.

LL. Procedure Room. A room where procedures not requiring general anesthesia can be safely performed.

MM. Quality Improvement Program. The process used to examine methods and practices of providing care, treatment, procedures, and/or services, identify the ways to improve performance, and take actions that result in higher quality of care, treatment, procedures, and/or services for patients.

NN. Radiation Therapist. A person, other than an individual licensed to practice within the lawful scope of practice of medicine in this State, who applies radiation to humans for therapeutic purposes.

OO. Radiation Therapy. The use of a stream of high-energy particles or waves such as X-rays, gamma rays, and alpha and beta particles to destroy or damage cancer cells.

PP. Radiographer. A person, other than an individual licensed to practice, medicine, dentistry, podiatry, chiropractic, or osteopathy in this State, who applies radiation to humans for diagnostic purposes, including, but not limited to, mammography, cardiovascular-interventional technology, and computed tomography.

QQ. Radiologic Technologist. A person who is a limited practice radiographer, radiographer, podiatric limited practice radiographer, limited chest radiographer, radiation therapist, or nuclear medicine technologist certified by the American Registry of Radiologic Technologists or who is certified by the S.C. Radiation Quality Standards Association (SCRQSA) or who has obtained a certificate acceptable to the SCRQSA.

RR. Registered Nurse Anesthetist. A registered nurse who is authorized to practice as a registered nurse anesthetist by the S.C. State Board of Nursing.

SS. Repeat Violation. The recurrence of any violation cited under the same section of the regulation within a 36-month period. The time-period determinant of repeat violation status is not interrupted by ownership changes.

TT. Responsible Party. A person who is authorized by law to make decisions on behalf of a patient, including, but not limited to, a court-appointed guardian or conservator or person with a health care power of attorney or other durable power of attorney.

UU. Revocation of License. An action by the Department to cancel or annul a license by recalling, withdrawing, or rescinding its authority to operate.

VV. Staff Member. An individual who is 18 years or older and is a compensated employee on either a full or part-time basis.

WW. Suspension of License. An action by the Department requiring a licensee to cease operation for a period of time until such time as the Department rescinds that restriction.

XX. Vendor. A person who owns and/or operates mobile technology and contracts with acute care hospitals or other hosts for the purpose of providing diagnostic or therapeutic services.

YY. Volunteer. An individual who performs tasks at the direction of the on-site manager or his or her designee without compensation.

S.C. Code Regs. § 61-108.100.101

Added by State Register Volume 28, Issue No. 5, eff May 28, 2004.