S.C. Code Regs. 61-102.A - Definitions, Interpretations and Penalties

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

(1) Definitions:

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

(a) Administrator means the person who is delegated the responsibility for interpreting, implementing, and applying policies and programs established by the governing authority. He/she is delegated responsibility for the establishment of safe and effective administrative management, and the control and operation of the services provided.
(b) Birthing center means a facility or other place where human births are planned to occur. This does not include the usual residence of the mother or any facility which is licensed as a hospital or the private practice of a physician who attends the birth.
(c) Birthing room means a room and environment designed, equipped and arranged to provide for the care of a woman and newborn and to accommodate her support person(s) during the process of vaginal birth.
(d) Board means the South Carolina Board of Health and Environmental Control.
(e) Certified Nurse Midwife (CNM) means a person licensed by the South Carolina State Board of Nursing as a Registered Nurse with official recognition as a Certified Nurse Midwife.
(f) Clinical staff means the physicians, certified nurse midwives and lay midwives appointed by the governing authority to practice within the birthing center and governed by rules approved by the governing body.
(g) Department means the South Carolina Department of Health and Environmental Control (DHEC).
(h) Governing body means an individual or group which is legally responsible for the operation and maintenance of the birthing center.
(i) Lay Midwife means an individual so licensed by the Department.
(j) Licensing agency means DHEC.
(k) Low risk means normal, uncomplicated prenatal course as determined by adequate prenatal care and prospects for a normal, uncomplicated birth as defined by reasonable and generally accepted criteria of maternal and fetal health.
(l) Midwifery means the application of scientific principles in "with woman" care during uncomplicated pregnancy, birth, and puerperium including care of the newborn, support of the family unit, and gynecologic health care.
(m) Person means a natural individual, private or public organization, political subdivision, or other governmental agency.
(n) Personnel means individual(s) in training and/or employed by the birthing center.
(o) Physician means a doctor of medicine or osteopathy with training in obstetrics or midwifery and licensed by the South Carolina State Board of Medical Examiners to practice medicine.
(p) Recovery means that period or duration of time starting at birth and ending with the discharge of a client from the birthing center.
(q) Registered Nurse means a person licensed by the South Carolina State Board of Nursing as a registered nurse.
(2) Interpretations:
(a) No person shall establish, conduct or maintain a birthing center without first obtaining a license from the Department.
(b) The license shall be posted in a conspicuous place in a public lobby or waiting room. The issuance of a license does not guarantee adequacy of individual care, treatment, personal safety, fire safety or the well-being of any occupant of a facility. A license is not assignable or transferable and is subject to revocation by the Department for failure to comply with the laws and regulations of the State of South Carolina.
(c) Any birthing center which is in operation at the time of promulgation of these regulations shall be given a reasonable time, not to exceed one year from date of such promulgation, within which to comply with such regulations.
(d) Effective Date and Term of License: A license shall be effective for a 12-month period following the date of issue and shall expire one year following such date; however, a facility that has not been inspected during that year may continue to operate under its existing license until an inspection is made.
(e) Separate Licenses: Separate licenses are required for facilities not maintained on the same premises. Separate licenses may be issued for facilities maintained in separate buildings on the same premises.
(f) Licensing Fees: Each applicant shall pay an annual license fee prior to issuance of the license. The annual fee shall be $200.00.
(g) Inspections: Each facility submitting an application for licensing or re-licensing shall be inspected prior to initial licensure and at least annually by authorized representatives of the Department. All licensed and prospective licensed facilities are subject to inspection at any time. All facilities to which these requirements apply shall permit entrance to all properties and access to every area, object and records and reports by representatives of the Department.
(h) Initial License: A new facility or one that has not been continuously licensed under these Standards, shall not provide birthing center services until it has been issued an initial license. Section L sets forth the prerequisites for initial license.
(i) Noncompliance: When noncompliances with the Licensing Standards are detected, the applicant or licensee will be notified of the violations and at the same time requested to provide information as to how and when such items will be corrected. If an item of noncompliance is of a serious nature and is not promptly corrected, a penalty may be invoked or a license may be denied, suspended or revoked.
(j) Exceptions to Licensing Standards: The Department reserves the right to make exceptions to these Standards where it is determined that the health and welfare of the community requires the services of the facility and that the exception, as granted, will have no significant impact on the safety, security or welfare of the facility's occupants.
(k) Change of License: A facility shall request issuance of an amended license, by application to the Department, prior to any of the following circumstances:
(1) Change of ownership by purchase or lease.
(2) Change of facility's name or address.
(3) Addition or replacement of a birthing room or any part thereof.
(3) Penalties:

Facilities shall be subject to a penalty for violating Licensing Regulations. When the Department determines that a facility is in violation of any statutory provision, rule or regulation relating to the operation or maintenance of such facility, the following conditions shall apply:

(a) Class I violations are those which the Department determines present an imminent danger to the patients or other occupants of the facility or a substantial probability that death or serious physical harm could result therefrom. A physical condition, one or more practices, means, methods or operations in use in a facility 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 shall exist after expiration of said time shall be considered a subsequent violation.
(b) Class II violations are those, other than Class I violations, which the Department determines have a direct or immediate relationship to the health, safety or security of the facility's patients or other occupants. The citation of a Class II violation shall specify the time within which the violation is required to be corrected. Each day such violation shall exist after expiration of said time shall be considered a subsequent violation.
(c) Class III violations are those which are not classified as serious in these regulations or those which are against the best practices as interpreted by the Department. The citation of a Class III violation shall specify the time within which the violation is required to be corrected. Each day such violation shall exist after expiration of said time shall be considered a subsequent violation.
(d) Class I and II violations are indicated by notation after each applicable section, e.g., (I) or (II). Violations of sections which are not annotated in that manner will be considered as Class III violations.
(e) The Department may deny, suspend, or revoke licenses or assess a monetary penalty for violations of provisions of law or departmental regulations. The Department shall exercise discretion in arriving at its decision to take any of these actions. The Department will consider the following factors: specific conditions and their impact or potential impact on health, safety or welfare; efforts by the facility to correct; overall conditions; history of compliance; any other pertinent conditions.
(f) If a decision is made to assess monetary penalties, the following schedule will be used as a guide to determine the dollar amount.

Frequency of violation of standard within a 24-month period

MONETARY PENALTY RANGES

Class I

Class II

Class III

1st

$ 200-1000

$ 100-500

0

2nd

500-2000

200-1000

100-500

3rd

1000-5000

500-2000

200-1000

4th

5000

1000-5000

500-2000

th

5000

5000

1000-5000

6th and more

5000

5000

5000

Notes

S.C. Code Regs. 61-102.A

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