South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-108 - STANDARDS FOR LICENSING FREESTANDING OR MOBILE TECHNOLOGY › Sec2 61-108.300 - ENFORCEMENT ACTIONS › Section 61-108.300.302 - Violation Classifications

Current through Register Vol. 48, No. 6, June 28, 2024
Violations of standards in this regulation are classified as
				  follows:
A. Class I violations are
				those that the Department determines to present an imminent danger to the
				health, safety, or well-being of the patients for whom the equipment is used or
				a substantial probability that death or serious physical harm could result
				therefrom. A physical condition or one or more practices, means, methods or
				operations in use may constitute such a violation. The condition or practice
				constituting a Class I violation shall be abated or eliminated immediately
				unless a fixed period of time, as stipulated by the Department, is required for
				correction. Each day such violation exists after expiration of this time
				established by the Department may be considered a subsequent
				violation.
B. Class II violations
				are those, other than Class I violations, that the Department determines to
				have a negative impact on the health, safety, or well-being of patients for
				whom equipment is used. The citation of a Class II violation may specify the
				time within which the violation is required to be corrected. Each day such
				violation exists after expiration of this time may be considered a subsequent
				violation.
C. Class III violations
				are those that are not classified as Class I or II in these regulations or
				those that are against the best practices as interpreted by the Department. The
				citation of a Class III violation may specify the time within which the
				violation is required to be corrected. Each day such violation exists after
				expiration of this time may be considered a subsequent violation.
D. The notations "(I)" or "(II)", placed
				within sections of this regulation indicate that those standards are considered
				Class I or II violations if they are not met. Failure to meet standards not so
				annotated are considered Class III violations.
E. In arriving at a decision to take
				enforcement actions, the Department shall consider the following factors:
				specific conditions and their impact or potential impact on health, safety, or
				well-being of the patients; efforts by the licensee to correct cited
				violations; behavior of the licensee that reflects negatively on the licensee's
				character, such as illegal or illicit activities; overall conditions; history
				of compliance; and any other pertinent factors that may be applicable to
				current statutes and regulations.
F. When a decision is made to impose monetary
				penalties, the Department may invoke S.C. Code Ann. Section
				44-7-320(C)
				 (1976, as amended), to determine the dollar
				amount or may utilize the following schedule:
Frequency of violation of standard within a 36-month
				  period:
MONETARY PENALTY ACTIONS
FREQUENCY
CLASS I
CLASS II
CLASS III
1st
$500 - 1,500
$300 - 800
$100 - 300
2nd
1,000 - 3,000
500 - 1,500
300 - 800
3rd
2,000 - 5,000
1,000 - 3,000
500 - 1,500
4th
5,000
2,000 - 5,000
1,000 - 3,000
5th
7,500
5,000
2,000 - 5,000
6th and more
10,000
7,500
5,000
G.
				Any enforcement action taken by the Department may be appealed pursuant to the
				Administrative Procedures Act, S.C. Code Ann. Section
				1-23-310 (1976, as
				amended).