Bill 2634

                    Current Status

Bill Number:               2634
Ratification Number:       395
Act Number:                368
Introducing Body:          House
Subject:                   To provide for the licensing and
                           regulation of renal dialysis centers and to
                           provide a penalty for violations

(A368, R395, H2634)

AN ACT TO AMEND CHAPTER 39 OF TITLE 44, CODE OF LAWS OF SOUTH CAROLINA, 1976, BY ADDING SECTIONS 44-39-5 AND 44-39-40 THROUGH 44-39-80 SO AS TO PROVIDE FOR THE LICENSING AND REGULATION OF RENAL DIALYSIS CENTERS AND TO PROVIDE A PENALTY FOR VIOLATIONS, AND TO AMEND SECTION 44-39-20, RELATING TO THE RENAL DIALYSIS ADVISORY COUNCIL, SO AS TO INCREASE THE MEMBERSHIP FROM TWELVE TO FOURTEEN PERSONS AND TO REQUIRE THE COUNCIL REVIEW REGULATIONS BY THE STATE BOARD OF HEALTH AND ENVIRONMENTAL CONTROL AFFECTING RENAL DIALYSIS.

Be it enacted by the General Assembly of the State of South Carolina:

Definitions

SECTION 1. Chapter 39 of Title 44 of the 1976 Code is amended by adding:

"Section 44-39-5. As used in this chapter:

(1) 'Board' means the South Carolina Board of Health and Environmental Control.

(2) 'Department' means the South Carolina Department of Health and Environmental Control.

(3) 'Dialysis' means 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.

(4) 'End-stage renal disease' means that stage of renal impairment that appears irreversible and permanent and requires a regular course of dialysis or kidney transplantation to maintain life.

(5) 'Person' means a natural individual, private or public organization, political subdivision, or other governmental agency.

(6) 'Renal dialysis center' means an outpatient facility which offers staff assisted dialysis or training and support services for self-dialysis.

(7) 'Council' means the Renal Dialysis Advisory Council."

"Section 44-39-40. No person may establish, conduct, or maintain a renal dialysis center without first obtaining a license from the department. This license is effective for a twelve-month period following the date of issue but is subject to suspension or revocation at any time for failure to comply with the provisions of this chapter. The license shall specify the maximum number of stations allowed in the center.

A person desiring to obtain a license shall file with the department an application on a form prescribed, prepared, and furnished by the department. Fees sufficient to cover the cost of administering this chapter are established by the board through regulations promulgated pursuant to the Administrative Procedures Act.

Section 44-39-50. The department shall require reports from, and regulate and inspect all renal dialysis centers and records of these facilities as necessary and promulgate regulations with the advice of the Council, in accordance with the Administrative Procedures Act to carry out the purposes of this chapter. The regulations shall provide that any renal dialysis center which is in operation at the time of promulgation of the regulations must be given a reasonable period of time, not to exceed one year from the date of the promulgation to comply.

Section 44-39-60. Information received by the department through inspection or as otherwise authorized may not be disclosed publicly so as to identify individuals, facilities, or programs except in a proceeding involving the question of licensing or the revocation of a license or unless ordered to do so by a court of competent jurisdiction.

Section 44-39-70. A. The department, upon proper notice and opportunity for hearing in accordance with the Administrative Procedures Act and department regulations, may deny, suspend, or revoke licenses or assess a monetary penalty for:

(1) failure to establish or maintain proper standards of care and service as prescribed by the department;

(2) conduct or practice detrimental to the health or safety of residents or employees of any center or program; this provision does not apply to any healing practices authorized by law;

(3) violations of any provisions of this chapter or regulations promulgated under this chapter.

B. If a facility has conditions or practices which provide an immediate threat to the safety and welfare of the patients served, the department may immediately suspend the license of the facility. After the suspension, proper notice and opportunity for hearing must be provided.

C. An applicant or licensee may appeal a final decision on a hearing by the department to the appropriate court for judicial review as provided in the Administrative Procedures Act.

Section 44-39-80. The department, in accordance with the laws of the State governing injunctions and other processes, may maintain an action in the name of the State against any person for establishing, managing, or operating any renal dialysis center without obtaining a license.

Any person violating the provisions of this chapter is guilty of a misdemeanor and, upon conviction, must be fined not more than one hundred dollars for a first offense and not more than five hundred dollars for each subsequent offense. Each day the facility or program operates without a license after notice is a subsequent offense."

Department to appoint council

SECTION 2. Section 44-39-20 of the 1976 Code is amended to read:

"Section 44-39-20. The Department of Health and Environmental Control shall appoint the Renal Dialysis Advisory Council to consult with and advise the department in the administration of this chapter. The council is composed of a minimum of fourteen persons, one member recommended by the Palmetto Chapter of the American Nephrology Nurses Association; one member recommended by the S.C. Chapter of the National Association of Patients on Hemodialysis and Transplants; three physicians specializing in nephrology recommended by the S.C. Renal Physicians Association; two administrators of facilities certified for dialysis treatment or kidney transplant services; one member recommended by the S.C. Kidney Foundation; one member recommended by the S.C. Hospital Association; one member recommended by the S.C. Medical Association; one member of the general public; one member representing technicians working in renal dialysis facilities; one member recommended by the Council of Nephrology Social Workers; and one member recommended by the Council of Renal Nutritionists. The directors of dialysis programs at the Medical School of the University of South Carolina and the Medical University of South Carolina, or their designees, are ex officio members of the council. Present members of the council shall serve out the unexpired portions of their terms. Members shall serve four year terms and until their successors are appointed and qualify. No member of council shall serve more than two consecutive terms. The council shall meet as frequently as the board considers necessary, but not less than twice each year. Members shall receive no compensation but are reimbursed for actual expenses incurred in carrying out their duties as members of the council. The council shall provide professional and technical advice in the administration of the State Renal Program, including matters relating to: (a) franchising, licensing, and comprehensive health planning review relative to dialysis and kidney transplant facilities and services; (b) the design of a network system for end stage renal disease care incorporating the full scope of diagnostic and therapeutic services, including training and education of patients and their families; and (c) the development of a state plan encompassing the provisions of this chapter. The Council must be consulted and have the opportunity to review all regulations promulgated by the Board affecting renal dialysis prior to submission of the proposed regulations to the General Assembly."

Time effective

SECTION 3. This act shall take effect upon approval by the Governor.