South Carolina Code of Regulations
(Unannotated)
Current through State Register Volume 33, Issue 9, effective September 25, 2009.
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CHAPTER 81.
DEPARTMENT OF LABOR, LICENSING AND REGULATION-- STATE BOARD OF MEDICAL EXAMINERS
(Statutory Authority: 1976 Code Sections 40-1-70, 40-47-20 and 40-47-80)
ARTICLE 1.
GENERAL PROVISIONS
81-1. Responsibilities of the State Board of Medical Examiners.
The State Board of Medical Examiners (Board) is empowered by Section 40-47-20, CODE OF LAWS OF SOUTH CAROLINA, 1976, as amended, to adopt and publish rules in its Annual Directory regulations for the practice of medicine and osteopathy. Accordingly, the Board outlines its specific responsibilities to include, but not be limited to, the duty to receive, entertain, inquire into, take proofs and make findings, as hereinafter provided:
(a) concerning complaints of misconduct, as hereinafter defined, on the part of any physician licensed to practice medicine or osteopathy in this State; and
(b) relating to petitions for reinstatement to the practice of medicine or osteopathy in this State.
All proceedings for the investigation of complaints and grievances involving alleged misconduct of any physician licensed in this State, all proceedings for the discipline of such physicians and all proceedings for reinstatement to the practice of medicine or osteopathy in this State shall be brought, conducted and disposed of in accordance with the provisions of Articles 1 through 4.
Misconduct, as the term is used herein, means any one or more of the following:
(a) violation of any of the provisions of Section 40-47-200, Section 40-47-630, or Regulation 81-100, Code of Laws of South Carolina, 1976, as amended; and
(b) violation of any of the principles of medical ethics as adopted by the Board.
Every licensee, registrant or holder of a certificate found guilty of misconduct shall be disciplined, in accordance with the seriousness of such misconduct by any one or more of the following:
(a) revocation of his license, registration, or certification in this State; or
(b) suspension of his license, registration, or certification for a specified period of time, subject to reinstatement only as hereinafter provided, when such suspension is for an indefinite period; or
(c) the issuance of a public reprimand; or
(d) the issuance of a private reprimand; or
(e) payment of a fine as provided by law; or
(f) any other reasonable action short of revocation or suspension, such as requiring the licensee, registrant, or holder of a certificate to undertake additional professional training subject to the direction and supervision of the Board.
A person whose license, registration, or certification has been revoked shall never be readmitted to practice in this State.
A person who, having voluntarily surrendered his license, registration or certification has been thereafter reinstated in the manner hereinafter provided, or who, having been suspended for an indefinite period, has been thereafter reinstated in the manner hereinafter provided, shall have his license, registration or certification revoked upon being found guilty of subsequent misconduct which would warrant a suspension of at least one year.
Whenever a license, registration or certification is suspended or any other action "short of revocation or suspension" is taken, the Board may require the licensee, registrant or holder of a certificate to give evidence of satisfactory compliance therewith before reinstating his license, registration or certification.
A person whose license, registration or certificate has been revoked shall, within fifteen days after the effective date of the revocation, surrender his or her wall certificate and wallet card to the Board Administrator. The wall certificate and wallet card shall be destroyed by the Board Administrator.
Initial complaint, as the term is used herein, means a brief statement which alleges misconduct on the part of a physician licensed to practice medicine or osteopathy in this State. The initial complaint may be made by (1) any individual, firm or corporation (2) any physician licensed to practice medicine or osteopathy in this State or (3) the Administrator of the Board as provided in 81-40. The initial complaint shall be dated, numbered, signed by the person making the complaint or the Administrator when appropriate, verified under oath and shall identify the subject of the complaint and contain a brief summary of the nature of the complaint. All initial complaints shall be filed with the Administrator of the Board who shall upon receipt of said initial complaint immediately cause a preliminary investigation to be made and promptly prepare the same for presentation to the Board. The identity of the person making the initial complaint shall remain privileged and confidential during the initial investigation of the complaint and shall not be disclosed in any event. If a formal complaint, as described in Regulation 81-13 is initiated, the identity of the initial complainant shall continue to remain privileged and confidential, and shall not be disclosed under any circumstances during the conduct of formal proceedings, upon administrative or judicial review, nor at any time thereafter, unless the initial complainant testified as a witness in the formal proceedings.
A formal complaint, as the term is used herein, means a formal written complaint alleging misconduct on the part of a physician licensed to practice medicine or osteopathy in this State who shall be designated therein as the respondent. A formal complaint shall issue only upon a finding by a majority of the Board that an initial complaint presented pursuant to 81-12.5 is meritorious and warrants a hearing before the Disciplinary Panel as provided in 81-15. If the Board finds that the initial complaint along with the investigative report does not state facts sufficient to charge misconduct, as herein defined, the said initial complaint shall be dismissed and the Executive Administrator shall notify the person initially complaining who may petition the Board for a reconsideration. Otherwise the Administrator shall forthwith cause to be sent to the respondent by certified mail a formal complaint setting forth in summary fashion the alleged misconduct together with the notice signed by the Administrator requiring that the respondent within thirty (30) days after mailing of such notice, file with the Board his answer to the formal complaint and to serve a copy of said answer upon the attorney appointed by the Office of General Counsel. The notice mailed to the respondent shall further state that if the respondent fails to answer, judgment by default may be taken against him. The answer shall be signed by the respondent or by his counsel or by both and may, but need not be, verified. If, after thirty calendar days from the date the notice and formal complaint were mailed to the respondent no answer has been filed, the allegations of the formal complaint shall be deemed admitted and the Board may proceed and render a default judgment against the respondent.
81-15. Hearing by Panel of Three Commission Members.
After the respondent's answer has been filed, or the time within which the respondent was required to file such answer has expired, a formal hearing shall be held upon thirty (30) days' notice to the complainant and the respondent or their counsel, by a panel of three (3) Board members appointed by the President of the Board, who shall designate one member of the panel as the chairman thereof. The President of the Board may, whenever he deems it advisable, request the Attorney General's Office to handle the prosecution of a claim before the hearing panel.
Upon an initial finding by the Board that a complaint is meritorious, the President or Vice President of the Board shall convene pursuant to Section 40-47-211 a panel of three (3) commission members, no two members of which shall have a major part of their practice in the same county as the respondent, to hear the complaint. The President or Vice President of the Board shall designate one member of the panel as chairman thereof. The Attorney General's Office shall prepare and present the prosecution before the panel. After the respondent's answer has been filed or the time within which the respondent was required to file such an answer has expired, a formal hearing shall be held by the Commission Panel upon thirty (30) days notice to the complainant and the respondent or their counsel.
(a) If the panel finds that the charges in the formal complaint are not supported by the evidence or do not merit the taking of a disciplinary action, the panel shall make a certified report of the proceedings before it, including its findings of fact and recommendation, and shall file the same with the Administrator of the Board.
(b) If the panel finds and determines that the respondent is guilty of misconduct meriting suspension or revocation, private or public reprimand or any other reasonable action short of suspension, it shall make a certified report of the proceedings before it, including its findings of fact, conclusions, and recommendations, and shall file the same together with a transcript of the testimony taken and such exhibits as may have been in evidence before it, with the Administrator of the Board.
Whenever the panel has filed its report, the Board, through its Administrator shall, before acting upon such report, notify the respondent and his counsel, if any, of the time and place at which the Board will consider the report for the purpose of determining its action thereon, such notice to be given not less than thirty days prior to such meeting. The respondent and his counsel shall have the right, and shall be so informed in said notice, to appear before the Board at said meeting and to submit briefs and be heard in oral argument in opposition to or in support of the recommendations of the panel. Like notice shall be given, and like opportunity to submit briefs and be heard in oral argument in support of or in opposition to the recommendations of the panel, shall be afforded to the complainant and his counsel, if any, to the Attorney General's Office where that office has participated in the hearing before the panel, and to the office of General Council.
Upon consideration of the report of the panel and of the showing made to the Board, the Board may:
(a) refer the matter back to the panel for further hearing; or
(b) order a further hearing before the said Board; or
(c) proceed upon the certified report of the prior proceedings before the panel.
Upon its final review, the Board may either dismiss the complaint or find that the respondent is guilty of misconduct. If the formal complaint is dismissed, the Administrator of the Board shall so notify the respondent, personally or through his counsel, the initial complainant and the Office of General Counsel.
If the Board shall determine that the respondent is guilty of misconduct meriting suspension or revocation, private or public reprimand or any other reasonable action short of suspension, it shall make a final certified report of the proceedings before it, including its findings of fact and decision of sanction, and shall file the same, together with a transcript of the testimony taken and such exhibits as may have been in evidence before it, with the Administrator of the Board and the Administrator shall forthwith notify the respondent, personally or through his counsel and the initial complainant, of such action, enclosing with such notice a copy of the Board's findings of fact and decision of sanction.
Any action by the Board relating to the suspension or revocation of a license to practice medicine or osteopathy in this State, or any other official action by the Board relating to the discipline of a physician licensed to practice medicine or osteopathy in this State shall be subject to review by an administrative law judge as provided under Article 5 of Chapter 23 of Title 1 upon petition filed by the licensee with an administrative law judge and a copy of the petition served upon the Administrator of the Board within thirty (30) days from the date of delivery of the Board's decision to the licensee. An appeal taken to an administrative law judge as provided under Article 5 of Chapter 23 of Title 1 has precedence on the calendar of an administrative law judge, is considered an emergency appeal if the Board has revoked, suspended, or restricted a license for more than six months, and should be heard not later than thirty (30) days from the date the petition is filed. The review is limited to the record established by the Board hearing.
No stay or supersedeas may be granted pending appeal from a decision by the Board to revoke, suspend, or restrict a license for more than six months.
Service of notice shall be conclusively presumed thirty days after mailing by registered or certified mail to such licensee of such notice at such person's last known address.
Unless and until otherwise ordered by the Board, all proceedings and documents relating to formal complaints and hearings thereon and to proceedings in connection therewith shall be private, unless the respondent shall in writing request that they be public. The Board may, in its discretion open the proceedings, however, in no case will the identity of the initial complainant be disclosed, unless the initial complainant testified as a witness in the formal proceedings. All formal complaints shall be captioned "In the Matter of -----" (name of respondent to be inserted).
No persons whomsoever in any way connected with a matter before the Board, including witnesses, counsel, counsel's secretaries, the respondent, Board members, Board employees, reporters or investigators, shall mention the existence of any such proceeding, or disclose any information pertaining thereto or discuss any testimony or evidence therein except to persons directly involved, and then only to such extent as necessary for a proper disposition of the proceedings before the Board. Provided, however, any proceeding before the Board may be made public upon written request of the respondent. All persons attending any proceedings or taking part in any matter hereunder shall be advised of this provision upon the commencement thereof. All records and correspondence held by members of the Board at the conclusion of their respective terms of office shall be carefully screened by them. They shall deliver all essential records and correspondence so held to the Administrator for filing with the permanent records of the Board and destroy all nonessential records having no permanent or continuing effect.
A majority of the members of the Board or of a hearing panel shall constitute a quorum for all purposes; and the action of a majority of those present comprising such quorum shall be the action of the Board or of such hearing panel.
Wherever in these Regulations provision is made for the service of any notice, order, report or other paper or copy thereof upon any complainant, respondent or petitioner in connection with any proceeding involving a complaint or a petition for reinstatement, service may be made upon counsel of record for such complainant, respondent or petitioner, either personally or by registered mail.
81-23. Administrator is Agent for Service of Notices on Non-resident Physicians.
Service of any notice provided for in these Regulations upon any non-resident respondent who has been admitted to the practice of medicine or osteopathy, or upon any resident respondent who, having been so admitted, subsequently becomes a non-resident or cannot be found at his usual abode or place of business in this State, may be made by leaving with the Administrator a true and attested copy of such notice and any accompanying documents and by sending to the respondent, by registered mail, a like true copy, with an endorsement thereon of the service upon the said Administrator , addressed to such respondent at his last known address. The postmaster's receipt for the payment of such registered postage shall be attached to and made a part of the return of service of such notice. The panel or Board before which there is pending any proceeding in which notice has been given as provided in this section may order such continuance as may be necessary to afford the respondent reasonable opportunity to appear and defend. The Administrator shall keep a record of the day and hour of the service upon him of such notice and any accompanying documents.
For the purpose of any investigation or proceeding under the provisions of this chapter, the Board or any person or persons designated by it may administer oaths and affirmations, subpoena witnesses, take evidence and require the production of any documents or records which the Board or panel deems relevant to the inquiry. In the case of contumacy by, or refusal to obey a subpoena issued to any person, an administrative law judge, as provided under Article 5 of Chapter 23 of Title 1, may issue an order requiring the person to appear before the board or the person designated by it and produce documentary evidence and to give other evidence concerning the matter under inquiry.
Whenever the Board has reason to believe that any person is violating or intends to violate any provision of this chapter, it may, in addition to all other remedies, order such person to immediately desist and refrain from such conduct. The Board may apply to an administrative law judge, as provided under Article 5 of Chapter 23 of Title 1, for an injunction restraining the person from such conduct. An administrative law judge may issue a temporary injunction ex parte, and upon notice and full hearing may issue any other order in the matter it deems proper. No bond shall be required of the Board by an administrative law judge as a condition to the issuance of any injunction or order contemplated by the provisions of this section.
The Administrator of the Board shall keep a docket of each complaint and of all proceedings thereon, and the same shall be retained permanently as a part of the records of the Board.
81-26. Confidentiality of Disciplinary Proceedings.
All proceedings and documents relating to formal complaints and hearings thereon and to disciplinary proceedings in connection therewith shall be private unless the respondent or his counsel files a written request with the Administrator that they be made public. Upon request by the respondent for the proceedings to be made public the Board may, in its discretion open the proceedings, however, in no case will the identity of the initial complainant be disclosed, unless the initial complainant testified as a witness in the formal proceedings. The Administrator of the Board shall keep secure in the Board's offices in all written records and documents pertaining to Disciplinary Procedures. All proceedings and records pertaining to any disciplinary proceedings, except final orders of the Board, which orders are not designated as private reprimands or dismissals, shall be the private records of the Board as provided in Section 30-4-40, Code of Laws of South Carolina, 1976, provided that upon an appeal under Section 40-47-200, Code of Laws of South Carolina, 1976, such documents as necessary to constitute the record established by the Board's hearings shall be filed with the Administrative Law Judge Division.
Final orders of the Board in any disciplinary proceeding shall be issued upon approval of the Board as provided in Section 40-47-200 and Regulation 81-18. All final orders shall be kept on file in the Board's office, but only final orders not designated as private reprimands or dismissals, shall be public. All final orders, except those orders designated as private reprimands or dismissals shall be promptly filed with the Federation of State Boards of Medical Examiners, and the Board through its Administrator shall cause to be published in South Carolina a biannual summary of its disciplinary actions. All final orders of the Board, except those designated as private reprimands or dismissals, shall be served upon the County Medical Society of the respondent, all South Carolina hospitals in which the respondent enjoys staff privileges and upon the President and Executive Director of the South Carolina Medical Association.
Final orders of the Board which are designated as private reprimands as provided for in Section 40-47-200, Code of Laws of South Carolina, 1976, and Regulation 81-11 shall be sent by means of registered mail from the President or Vice-President of the Board to the respondent. Any such letters or final orders of the Board so designated shall be entered as a part of the Board's final report and shall be treated as a part of the disciplinary proceedings and therefore private and not subject to public disclosure as provided in Regulation 81-26.
A. It is unprofessional conduct for a physician to initially prescribe drugs to an individual without first establishing a proper physician-patient relationship. A proper relationship, at a minimum, requires that the physician make an informed medical judgment based on the circumstances of the situation and on his/her training and experience. This will require that the physician:
(1) Personally perform an appropriate history and physical examination, make a diagnosis, and formulate a therapeutic plan. This process must be documented appropriately; and
(2) Discuss with the patient the diagnosis and the evidence for it, and the risks and benefits of various treatment options; and
(3) Insure the availability of the physician or coverage for the patient for appropriate follow-up care.
B. Prescribing for a patient whom the physician has not personally examined may be suitable under certain circumstances. These may include, but not be limited to, admission orders for a newly hospitalized patient, prescribing for a patient of another physician for whom the prescriber is taking call, prescribing for a patient examined by a licensed advanced practice registered nurse, a physician assistant or other physician extender authorized by law and supervised by the physician, or continuing medication on a short-term basis for a new patient prior to the patient's first appointment.
C. Prescribing drugs to individuals the physician has never met based solely on answers to a set of questions, as is common in Internet or toll-free telephone prescribing, is inappropriate and unprofessional.
D. Section 40-47-200(F)(8) of the South Carolina Medical Practice Act authorizes the Board to discipline a licensed South Carolina physician who is guilty of engaging in dishonorable, unethical or unprofessional conduct that is likely to deceive, defraud, or harm the public.
Subject to the foregoing restrictions, any person who has been indefinitely suspended from the practice of medicine or osteopathy and who wishes to be reinstated may file with the Administrator his verified petition, and thirteen (13) copies thereof, setting forth:
(a) the date when indefinite suspension was ordered and, if there was a reported opinion concerning the same, the volume and page of the official reports of the court where such opinion appears;
(b) the dates upon which any prior petitions for reinstatement were filed, denied or granted;
(c) the name of the county in which he resides at the time of the filing of the petition, and of each county in which he proposes to maintain an office if reinstated; and
(d) the facts upon which he relies to establish by clear and convincing proof that he has rehabilitated himself.
The Board shall, with all convenient dispatch, proceed to hold a hearing or hearings, take evidence concerning the petitioner's character and his claim of rehabilitation and make findings of fact and a decision. Reasonable notice of all such hearings before the Board shall be given to the petitioner or his counsel and to the President of the local medical association or associations in the county or counties in which the petitioner resides and in which he proposes to maintain an office in the event of his reinstatement. Such hearings may, in the discretion of the Board, be public and shall be public if the petitioner so requests in writing. Any interested person, any physician and any member of the local medical association or associations may appear before the Board in support of, or in opposition to, the petition.
81-33. Board's Report to be Filed; Procedure Thereupon.
The report of the Board and six (6) copies of the Board's findings of fact and recommendations shall be filed in the office of the Administrator, who shall thereupon notify the petitioner or his counsel and the Office of General Counsel of such filing and shall with such notice enclose a copy of the Board's findings of fact and decisions. If the Board denies the petition, the petitioner shall have the right of judicial review as provided in Regulation 81-19.
ARTICLE 4.
DISCIPLINE AT THE INITIATIVE OF BOARD OR COMMISSION MEMBERS
81-40. Investigation at Instance of Board or Commission Members; Procedure Thereunder.
Whenever any Board or Commission member learns from sources deemed by him to be reliable that a physician licensed to practice medicine or osteopathy in this State is engaging in practices in violation of his duty or in violation of applicable ethical standards, and the member concludes that an investigation should be made, he shall designate the Administrator in writing to have an investigation made. The Administrator shall cause an investigation to be made and for this purpose he may call upon the services of any State agency. Following the investigation, a report should be made to the Board for its determination as to whether or not a formal complaint shall be forwarded to a designated panel pursuant to 81-13 and 81-15 above for a hearing.
The process and procedure under Articles 1 through 4 shall be as summary as reasonably may be. Amendments to any complaint, notice, answer, objection, return, report or order may be made at any time prior to final order of the Board. Any party affected by such amendment shall be given reasonable opportunity to meet any new matter presented thereby. No investigation or procedure shall be held to be invalid by reason of any non-prejudicial irregularity or for any error not resulting in a miscarriage of justice. Articles 1 through 4 shall be liberally construed for the protection of the public and the medical profession and shall apply to all pending complaints, investigations and petitions whether the conduct involved occurred prior or subsequent to the effective date of Articles 1 through 4. To the extent that application of Articles 1 through 4 to such pending proceedings may not be practicable, the procedure in force at the time Articles 1 through 4 became effective shall continue to apply.
Every communication, whether oral or written, made by or on behalf of any complainant to the Board or any hearing panel or member thereof pursuant to Articles 1 through 4, whether by way of complaint or testimony, shall be privileged; and no action or proceeding, civil or criminal, shall lie against any such person, firm or corporation by or on whose behalf such communication shall have been made by reason thereof.
A. A physician shall be dedicated to providing competent medical service with compassion and respect for human dignity.
B. A physician shall deal honestly with patients and colleagues, and strive to expose those physicians deficient in character or competence, or who engage in fraud or deception.
C. A physician shall respect the law and also recognize a responsibility to seek changes in those requirements which are contrary to the best interests of the patient.
D. A physician shall respect the rights of patients, of colleagues, and of other health professionals, and shall safeguard patient confidence within the constraints of the law.
E. A physician shall continue to study, apply and advance scientific knowledge, make relevant information available to patients, colleagues, and the public, obtain consultation, and use the talents of other health professionals when indicated.
F. A physician shall, in the provision of appropriate patient care, except in emergencies, be free to choose whom to serve, with whom to associate, and the environment in which to provide medical services.
G. A physician shall recognize a responsibility to participate in activities contributing to an improved community.
A. Interns, residents and other physicians (M.D., D.O.) approved for limited practice situations may apply for a Limited License if they do not meet the requirements for a Permanent License. An applicant for a Limited License must write the Board to request an application stating: Mailing address, type of training, and name of hospital or institution, and intended plans after expiration of Limited License.
B. Applicants must furnish to the Board a copy of a position contract or submit a recommendation letter for a training program from the institution. Applicants who practice before they are approved are subject to a late fee of $25 and charges of violation of the Medical Practice Laws and Regulations.
C. Limited Licenses are issued only for medical training or limited practice approved by the Board. A Limited License will entitle the holder to apply for individual controlled substance registration through DHEC for a training program or any practice that is approved by the Board. Each Limited License is for one fiscal year or part thereof. Renewal may be considered upon approval of the Board.
D. An applicant must be a graduate of an approved medical school located in the United States or Canada; graduates of a medical school located outside the United States or Canada may be considered on an individual basis.
E. Section VI of the Limited License application is to be completed by the dean of the applicant's medical school or as approved by the Board.
F. Graduates of medical schools located outside of the United States or Canada must complete Section VI of the Limited License application and present approved copies of a medical diploma from schools approved by the Board. If the diploma is not in English, an approved translation must be provided. Graduates of medical schools located outside of the United States or Canada must also (1) document successful completion of a Fifth Pathway program, or (2) furnish copies of current ECFMG certificate and documentation of all postgraduate training completed in the United States. All copies must be initialed by the physician in charge of the applicant's program.
G. The Fifth Pathway or ECFMG certificate requirement may be waived if the applicant has a full-time academic faculty appointment at the rank of assistant professor or greater in an A.C.G.M.E. accredited medical school in the United States.
H. Physicians remaining in South Carolina after the expiration of their Limited License may apply for a Permanent License by written examination or by endorsement at least 90 days before their Limited License expires annually on June 30th. No parts of a Limited License application shall be applied to an application for examination or endorsement. Each application is filed separately. The fee for each Limited License is $150.
81-75. Waiver of Fees and Special Volunteer License.
The fundamental purpose of the State Board of Medical Examiners is to protect the public. This is accomplished by insuring that only competent, qualified physicians are licensed to practice medicine in South Carolina. Such public protection is best afforded by a permanent, unrestricted license to practice medicine in South Carolina.
The State Board of Medical Examiners wishes to remove any financial impediments that might inhibit physicians otherwise eligible for unrestricted licensure from providing medical services to the indigent and needy citizens of our State. Therefore, this Board shall waive all application fees, examination fees and annual reregistration fees for any physician who otherwise meets all permanent licensure requirements if the physician documents, to the satisfaction of the Board, that his practice is to be exclusively and totally devoted to providing medical care to the needy and indigent in South Carolina. To be eligible for the waiver of such fees, a physician must acknowledge that there shall be no expectation of payment or compensation for any medical services rendered, or any compensation or payment to the physician, either direct or indirect, monetary or in-kind, for the provision of medical services.
The Board also hereby establishes a Special Volunteer License for physicians meeting the requirements for such license. This License shall be issued for a fiscal year, or a part thereof, renewable annually upon approval by the Board. It will limit practice to a specific site(s) and practice setting(s). There will be no licensure or other fees associated with this Special Volunteer License. Requirements for this Special Volunteer License shall be as follows:
1. Satisfactory completion of a Special Volunteer License Application, including documentation of medical/osteopathic school graduation and practice history;
2. Documentation of specific proposed practice location(s);
3. Documentation that applicant has been previously issued an unrestricted license to practice medicine in another state of the United States and that applicant has never been the subject of any disciplinary action in any jurisdiction;
4. Documentation that the applicant shall only practice under the supervision of a supervising physician(s) approved by the Board. In order to insure that public health, safety and welfare are protected, the Board will review the proposed supervisory relationship to insure that the physician supervisor(s) is competent to supervise the Special Volunteer Licensee. Factors the Board shall consider will include, but not be limited to the training and practice experience of the supervising physician, the current nature and extent of the supervising physician's practice, the existence of any recent demonstration of the supervising physician's clinical competency and the number of Special Volunteer Licensees the physician proposes to supervise.
5. Documentation of the name(s) of supervising physician(s) and that such physician(s) has agreed to accept this supervisory responsibility. All supervising physicians must possess an active, unrestricted permanent license to practice medicine in South Carolina. An approved supervising physician must physically be on the premises whenever a Special Volunteer Licensee is practicing medicine.
6. Documentation and acknowledgement that the applicant shall receive no payment or compensation, either direct or indirect or have any expectation of payment or compensation for medical services rendered. Moreover, the supervising physician shall not receive any compensation or payment as the result of the Special Volunteer Licensee's provision of medical services.
ARTICLE 8.
REQUIREMENTS FOR THE WRITTEN EXAMINATION (FLEX)
81-80. Requirements to Take Step 3 of the United States Medical Licensing Examination.
The State Board of Medical Examiners of South Carolina shall administer Step 3 of the United States Medical Licensing Examination (USMLE). Applicants wishing to take Step 3 of the USMLE must satisfy the following requirements.
A. Educational Requirements:
(1) Graduation from medical school located in the United States, its territories or possessions, or Canada which is accredited by the Liaison Committee on Medical Education or other accrediting body approved by the Board, or
(2) Graduation from a school of osteopathic medicine located in the United States, its territories or possessions, or Canada accredited by the American Osteopathic Association or other accredited body approved by the Board, or
(3) Graduation from a medical school located outside the United States or Canada.
(a) Graduates of medical schools located outside of the United States of Canada must possess a Standard Certificate from the Education Commission for Foreign Medical Graduates (ECFMG), or
(b) Document successful completion of a Fifth Pathway program and be currently Board certified by a Specialty Board recognized by the American Board of Medical Specialties or the American Osteopathic Association.
B. Prior Examination Requirements:
(1) To be eligible to take Step 3 of the USMLE, an applicant must document successful completion of Step 1 and Step 2 of the USMLE, (A score of 75 or better shall be considered a passing score on each Step), or
(2) Document successful completion of the combination of the examinations of the National Board of Medical Examiners, Federation Licensing Examination (FLEX) and USMLE acceptable to the Composite Committee of the USMLE and approved by the Board.
C. Other Requirements:
(1) To be eligible to take Step 3 of the USMLE in South Carolina, an applicant must
(a) possess a current South Carolina license, or
(b) document acceptance into a post-graduate residency training program in South Carolina, or
(c) document satisfaction of all other requirements for permanent license but for successful completion of Step 3 of the USMLE.
(2) To be eligible to take Step 3 of the USMLE, an applicant must file a completed application for Step 3, with the required fee, prior to the application deadline established by the Board. The non-refundable fee for Step 3 of the USMLE shall not exceed $600.
(3) A score of 75 or better shall be considered a passing score on Step 3.
(4) In order to be eligible to apply for permanent licensure, an applicant must complete all steps of the USMLE within seven years.
81-81. Oral and/or Written Examinations for Graduates of Medical Schools Located Outside the United States or Canada.
All applicants for licensure graduating from medical schools located outside the United States or Canada must satisfactorily complete oral and/or written examinations (in addition to the current ECFMG, FLEX, and/or National Board Examinations) as required by this Board. This requirement is necessary to ensure that the applicant is familiar with United States medical practices, procedures and policies. A completed application must be returned to this Board at least ninety (90) days prior to the date of the oral and/or written examinations. Any expense of the oral and/or written examinations shall be borne by the applicant.
This requirement is in addition to those licensure requirements set forth in Regulations 81-80 and 81-90 of the State Board of Medical Examiners.
Requirements for a permanent license to practice medicine in South Carolina include the following educational, examination, postgraduate residency training and other requirements:
A. With respect to the educational requirements for licensure, applicants must document to the satisfaction of the Board:
(1) Graduation from a medical school located in the United States, its territories or possessions, or Canada which is accredited by the Liaison Committee on Medical Education or other accrediting body approved by the Board, or
(2) Graduation from a school of osteopathic medicine located in the United States, its territories or possession, or Canada accredited by the American Osteopathic Association or other accrediting body approved by the Board, or
(3) Graduation from a medical school located outside the United States or Canada.
(a) Graduates of medical schools located outside of the United States or Canada must possess a Standard Certificate from the Education Commission on Foreign Medical Graduates (ECFMG), or
(b) Document successful completion of a Fifth Pathway program and be currently Board Certified by a Specialty Board recognized by the American Board of Medical Specialties or the American Osteopathic Association.
(c) Notwithstanding 81-90 A(3)(a) or (b), the ECFMG or Fifth Pathway requirement may be waived at the discretion of the Board if the applicant is to have full time academic faculty appointment at the rank of assistant professor or greater at a medical school in South Carolina.
B. With respect to the examination requirements for licensure, applicants must document to the satisfaction of the Board:
(1) Successful completion of all parts of the National Board of Medical Examiners; or
(2) Successful completion of all parts of the National Board of Osteopathic Medical Examiners; or
(3) Successful completion of the Federation Licensing Exam (FLEX) based on standards established by the Board; or
(4) Successful completion of the United States Medical Licensing Examination (USMLE) based on standards established by the Board; or
(5) Successful completion of a written state examination of another State Medical, osteopathic, or Composite Board prior to 1976 if applicant also meets additional requirements approved by the Board, such as certification by a Specialty Board recognized by the American Board of Medical Specialties or the American Osteopathic Association; or
(6) Successful completion of combinations of the FLEX, National Board and USMLE acceptable to the Composite Committee of the USMLE and approved by the Board.
C. In addition to the examination requirements set forth in 81-90 B, if an applicant has not documented within ten years of the date of a completed application to the Board the passing of one of the following:
(1) National Board of Medical Examiners examination; or
(2) National Board of Osteopathic Examiners examination; or
(3) FLEX; or
(4) SPEX; or
(5) Certification or recertification by a Specialty Board recognized by either the American Board of Medical Specialties or the American Osteopathic Board, then the applicant, in addition to meeting all other licensure requirements, must pass the Special Purpose Examination (SPEX). A passing score on this examination is 75 or better. The SPEX requirement is in addition to all other requirements. The fee for the SPEX examination shall not exceed $500.00.
D. The additional examination required set forth in 81-90 C shall be waived if the applicant is to be employed full time by the South Carolina Department of Corrections, South Carolina Department of Health and Environmental Control, South Carolina Department of Mental Health or South Carolina Department of Mental Retardation. A license issued pursuant to this waiver is revoked immediately if the individual leaves that full-time employment or acts outside the scope of employment within the Department. This waiver of the additional examination requirement of 81-90 C does not apply where the applicant is to provide services under a contract for the State, or if the applicant is to provide services for which there is an expectation of payment, is payment for services, or should have been payment from a source other than the salary the physician receives from the State.
E. For FLEX examinations taken prior to June 1, 1985, the applicant, in one sitting, must have attained a score of at least 75 each day and a FLEX weighted average of 75 or better; applicants licensed in other states who have a FLEX weighted score of 75 or more and no daily score below 70 may be considered on a discretionary basis by the Board if they are currently certified by an A.O.A. or A.B.M.S. recognized Specialty Board and meet all other requirements for licensure.
F. For FLEX examinations taken after June 1, 1985, the applicant must pass both FLEX Component I and FLEX Component II. A score of 75 or better is a passing score. An applicant must achieve a score of 75 or better on both FLEX Component I and FLEX Component II. An applicant must pass both Component I and Component II within five years of the applicant's first taking of any FLEX examination.
G. For the United States Medical Licensing Examination, the applicant must pass Step 1, Step 2 and Step 3. A score of 75 or better on each Step is considered passing.
(1) All Steps of the USMLE must be passed within seven years of taking Step 1 for the first time.
(2) The results of the first three takings of each Step examination will be considered by the Board. The Board has discretion whether to consider the results from a fourth taking of any Step. It is the burden of the applicant to present special and compelling circumstances why a result from a fourth taking should be considered. Such circumstances may include, but are not limited to the applicant's additional medical education or training, the applicant's score on the third taking or other special or compelling circumstances. Under no circumstances shall the Board consider results received after the fourth taking of any Step.
H. With respect to postgraduate residency training requirements, the following standards shall apply:
(1) Graduates of approved medical or osteopathic schools located in the United States or Canada must have a minimum of one year of postgraduate residency training approved by the Board.
(2) Graduates of medical schools located outside of the United States or Canada must have a minimum of three years of progressive postgraduate residency training approved by the Board, except that such graduates who have been licensed in another state for ten years or more need only document one year of postgraduate residency training approved by the Board.
(3) The Board has the discretion of accepting a full time academic appointment at the rate of assistant professor or greater in a medical or osteopathic school in the United States as a substitute for, and in lieu of postgraduate training. Each year of this academic appointment may be credited as one year of postgraduate training for purposes of the Board's postgraduate training requirements.
(4) For purposes of satisfying postgraduate training requirements, the Board accepts postgraduate training in the United States approved by the Accreditation Council on Graduate Medical Education, and postgraduate training in Canada approved by the Royal College of Physicians and Surgeons.
I. An applicant shall be denied licensure if the individual has committed acts or omissions which are grounds for disciplinary action as set forth in Section 40-47-200, Code of Laws of South Carolina, 1976, as amended.
J. An applicant must file a completed application, with required supporting documentation, on forms provided by the Board.
K. The non-refundable application fee for a permanent license shall not exceed $500.00.
ARTICLE 9.
5. ELECTION PROCEDURES
81-91. Election Procedures for the State Board of Medical Examiners and the Medical Disciplinary Commission.
Notice of the election of Board Members shall be mailed to each physician possessing a permanent license and eligible to vote, according to records of the Board. Physicians wishing to offer their candidacy for the Board must submit a written petition signed by not less than fifty (50) physicians possessing a permanent license and eligible to vote in the particular election contest which the petitioner seeks to enter; provided however, this provision does not apply to the election for the doctor of osteopathy at-large. All signatures must be on petitions provided by the Board; physicians eligible to vote in the election may sign the petition of more than one candidate. Petitions must be received by the Board within thirty-five days of the date of the notice announcing the election. Any person submitting the required number of petition signatures may subsequently withdraw his name upon written notice to the Board. If only one candidate receives the required number of petition signatures, he shall be declared the winner in that particular contest, and certified as nominee to the Governor. If more than one candidate submits the required number of petition signatures, ballots shall be prepared with the names of the candidates in alphabetical order. Ballots and return envelopes shall be mailed to every physician possessing a permanent license and qualified to vote in that particular election. The candidate receiving a majority of the ballots received by the Board in the allotted time period shall be certified as nominee to the Governor. If no candidate receives a majority of the votes cast, a run-off election involving the two candidates receiving the most votes will be held. Voters shall be allowed fifteen days to return their ballots to the Board.
Notice of the election of the Medical Disciplinary Commission Members shall be mailed to each physician possessing a permanent license and eligible to vote, according to records of the Board. Physicians wishing to offer their candidacy for the Commission shall submit a written petition signed by not less than twenty-five (25) physicians possessing a permanent license and eligible to vote in that particular congressional district. All signatures must be on petitions provided by the Board; physicians eligible to vote in the election may sign the petition of more than one candidate. Petitions must be received by the Board within thirty-five (35) days of the date of the notice announcing the election. Any person receiving the required number of petition signatures may subsequently withdraw his name upon written notice to the Board. If only one physician from a particular congressional district submits the required number of petition signatures, that physician shall be declared the winner. If more than one candidate from a particular congressional district submits the required petition signatures, ballots shall be prepared with the names of the candidates in alphabetical order. Ballots and return envelopes shall be mailed to every physician possessing a permanent license and qualified to vote in the congressional district. The candidate receiving a majority of the ballots received by the Board in the allotted time period shall be declared the winner. If no candidate receives a majority of the votes cast, a run-off election involving the two candidates receiving the most votes shall be held. Voters shall be allowed fifteen days to return their ballots to the Board.
The continued professional competency of physicians holding a permanent license shall be assured in the following manner:
A. For renewal of a permanent license initially issued during a biennial renewal period, compliance with all educational, examination, and other requirements for the issuance of a permanent license shall be deemed sufficient for the first renewal period following initial licensure.
B. For renewal of an active permanent license biennially, documented evidence of at least one of following options during the renewal period:
1. forty (40) hours of Category I continuing medical education sponsored by the American Medical Association, American Osteopathic Association, or other organization approved by the Board as having acceptable standards for courses it sponsors, at least thirty (30) hours of which are directly related to the licensee's practice area; or
2. certification of added qualifications or recertification after examination by a national specialty board recognized by the American Board of Medical Specialties or American Osteopathic Association or other approved specialty board certification; or
3. completion of a residency program or fellowship in medicine in the United States or Canada approved by the Accreditation Council on Graduate Medical Education or American Osteopathic Association; or
4. passage of the Special Purpose Examination (SPEX) or Comprehensive Osteopathic Medical Variable Purpose Examination (COMVEX); or
5. successful completion of a clinical skills assessment program approved by the Board, such as the Institute for Physician Evaluation (IPE), the Post-Licensure Assessment System (PLAS), or the Colorado Personalized Education Program (CPEP).
C. For reinstatement of a permanent license from lapsed or inactive status of less than four years, documented evidence of at least one of the following options within the preceding two years:
1. forty (40) hours of Category I continuing medical education sponsored by the American Medical Association, American Osteopathic Association, or other organization approved by the Board as having acceptable standards for courses it sponsors, at least thirty (30) hours of which are directly related to the licensee's practice area; or
2. certification of added qualifications or recertification after examination by a national specialty board recognized by the American Board of Medical Specialties or American Osteopathic Association or other approved specialty board certification; or
3. completion of a residency program or fellowship in medicine in the United States or Canada approved by the Accreditation Council on Graduate Medical Education or American Osteopathic Association; or
4. passage of the Special Purpose Examination (SPEX) or Comprehensive Osteopathic Medical Variable Purpose Examination (COMVEX); or
5. successful completion of a clinical skills assessment program approved by the Board, such as the Institute for Physician Evaluation (IPE), the Post-Licensure Assessment System (PLAS), or the Colorado Personalized Education Program (CPEP).
D. For reinstatement of a permanent license from lapsed or inactive status of four years or more, documented evidence of at least one of the following options:
1. certification of added qualifications or recertification after examination by a national specialty board recognized by the American Board of Medical Specialties or American Osteopathic Association or other approved specialty board certification; or
2. completion of a residency program or fellowship in medicine in the United States or Canada approved by the Accreditation Council on Graduate Medical Education or American Osteopathic Association; or
3. passage of the Special Purpose Examination (SPEX) or Comprehensive Osteopathic Medical Variable Purpose Examination (COMVEX); or
4. successful completion of a clinical skills assessment program approved by the Board, such as the Institute for Physician Evaluation (IPE), the Post-Licensure Assessment System (PLAS), or the Colorado Personalized Education Program (CPEP).
The purpose of this regulation is to promote patient safety in the non-hospital office-based setting during procedures that require the administration of local anesthesia, sedation/analgesia, or general anesthesia, or minor or major conduction block. Moreover, this regulation has been developed to provide physicians performing office-based surgery (including cryosurgery and laser surgery), that requires anesthesia (including tumescent anesthesia), analgesia or sedation, the benefit of uniform professional standards regarding qualification of practitioners and staff, equipment, facilities and policies and procedures for patient assessment and monitoring. Level I procedures as defined in (B)(13) are excluded from this regulation.
B. Definitions
For the purpose of this regulation, the following terms are defined:
1. "Advanced resuscitative technique" means current certification in Advanced Trauma Life Support (ATLS), Advanced Cardiac Life Support (ACLS), or Pediatrics Advanced Life Support (PALS) as appropriate for the individual patient and surgical situation involved. For example, for those licensees treating adult patients, training in advanced cardiac life support (ACLS) is appropriate; for those treating children, training in pediatric advanced life support (PALS) is appropriate.
2. "Anesthesiologist" means a physician who has successfully completed a residency program in anesthesiology approved by the Accreditation Council of Graduate Medical Education (ACGME) or the American Osteopathic Association (AOA), or who is currently a diplomate of either the American Board of Anesthesiology or the American Osteopathic Board of Anesthesiology, or who was made a Fellow of the American College of Anesthesiology before 1982.
3. "Anesthesiologist's assistant (AA)" means a person licensed by the Board as an anesthesiologist's assistant who is an allied health graduate of an accredited anesthesiologist's assistant program who is currently certified by the National Commission for Certification of Anesthesiologist's Assistants and who works under the direct supervision of an anesthesiologist who is immediately available in the operating suite and is physically present during the most demanding portions of the anesthetic including, but not limited to, induction and emergence.
4. "Board" means the South Carolina State Board of Medical Examiners.
5. "Certified registered nurse anesthetist (CRNA)" means a person licensed by the South Carolina State Board of Nursing as an Advanced Practice Registered Nurse in the category of Certified Registered Nurse Anesthetist.
6. "Complications" means untoward events occurring at any time within 48 hours of any surgery, special procedure or the administration of anesthesia in an office setting including, but not limited to, any of the following: paralysis, malignant hypothermia, seizures, myocardial infarction, renal failure, significant cardiac events, respiratory arrest, aspiration of gastric contents, cerebral vascular accident, transfusion reaction, pneumothorax, allergic reaction to anesthesia, unintended hospitalization for more than 24 hours, or death.
7. "Deep sedation/analgesia" means the administration of a drug or drugs that produce sustained depression of consciousness during which patients cannot be easily aroused but respond purposefully following repeated or painful stimulation. The ability to independently maintain ventilatory function may be impaired. Patients may require assistance in maintaining a patent airway, and spontaneous ventilation may be inadequate. Cardiovascular function is usually maintained.
8. "DHEC" means the S.C. Department of Health and Environmental Control.
9. "General anesthesia" means a drug-induced loss of consciousness during which patients are not arousable, even by painful stimulation. The ability to independently maintain ventilatory function is often impaired. Patients often require assistance in maintaining a patent airway, and positive pressure ventilation may be required because of depressed spontaneous ventilation or drug-induced depression of neuromuscular function. Cardiovascular function may be impaired.
10. "Health care personnel" means any office staff member who is licensed or certified by a recognized professional or health care organization such as but not limited to a professional registered nurse, licensed practical nurse, physician assistant or certified medical assistant.
11. "Hospital" means a hospital licensed by the state in which it is situated.
12. "Immediately available" means being located within the office and ready for immediate utilization when needed.
13. "Level I Surgery" means minor procedures in which p.o. preoperative medication and/or unsupplemented local anesthesia is used in quantities equal to or less than the manufacturer's recommended dose adjusted for weight and where the likelihood of complications requiring hospitalization is remote. No drug-induced alteration of consciousness other than preoperative minimal p.o. anxiolysis of the patient is permitted in Level I Office Surgery; the chances of complications requiring hospitalization must be remote.
14. "Local anesthesia" means the administration of an agent that produces a transient and reversible loss of sensation in a circumscribed portion of the body.
15. "Major conduction block" means the injection of local anesthesia to stop or prevent a painful sensation in a region of the body. Major conduction blocks include, but are not limited to, axillary, interscalene, and supraclavicular block of the brachial plexus, spinal (subarachnoid), epidural and caudal blocks.
16. "Minimal sedation" (anxiolysis) means the administration of a drug or drugs that produces a state of consciousness that allows the patient to tolerate unpleasant medical procedures while responding normally to verbal commands. Cardiovascular or respiratory function should remain unaffected and defensive airway reflexes should remain intact.
17. "Minor conduction block" means the injection of local anesthesia to stop or prevent a painful sensation in a circumscribed area of the body (that is, infiltration or local nerve block), or the block of a nerve by direct pressure and refrigeration. Minor conduction blocks include, but are not limited to, intercostal, retrobulbar, paravertebral, peribulbar, pudendal, sciatic nerve, and ankle blocks.
18."Moderate sedation/analgesia" means the administration of a drug or drugs, which produces depression of consciousness during which patients respond purposefully to verbal commands, either alone or accompanied by light tactile stimulation. Reflex withdrawal from painful stimulation is NOT considered a purposeful response. No interventions are required to maintain a patent airway, and spontaneous ventilation is adequate. Cardiovascular function is usually maintained. This includes dissociative anesthesia, which does not meet the criteria as defined under sustained deep anesthesia or general anesthesia.
19. "Monitoring" means continuous visual observation of a patient and regular observation of the patient as deemed appropriate by the level of sedation or recovery using instruments to measure, display, and record physiologic values such as heart rate, blood pressure, respiration and oxygen saturation.
20. "Office" means a location at which medical or surgical services are performed and which is not subject to regulation by DHEC.
21. "Office-based practice" means procedures performed under this regulation that occur in a physician's office or location other than a hospital or facility licensed by DHEC.
22. "Office-based surgery" means the performance of any surgical or other invasive procedure requiring anesthesia, analgesia, or sedation, including cryosurgery and laser surgery, which results in a necessary patient stay of less than twenty-four consecutive hours and is performed by a physician in a location other than a hospital or a diagnostic treatment center, including free-standing ambulatory surgery centers.
23. "Operating room" means that location in the office or facility dedicated to the performance of surgery or special procedures.
24. "Physical status classification" means a description of a patient used in determining if an office surgery or procedure is appropriate. The American Society of Anesthesiologists (ASA) enumerates classification: I - Normal, healthy patient; II - a patient with mild systemic disease; III- a patient with severe systemic disease limiting activity but not incapacitating; IV- a patient with incapacitating systemic disease that is a constant threat to life; and V- Moribund, patients not expected to live 24 hours with or without operation.
25. "Physician" means an individual holding an M.D. or D.O. degree who is authorized to practice medicine in accordance with the South Carolina Medical Practice Act.
26. "Practitioner" means a physician or anesthesiologist assistant, registered nurse or CRNA licensed and practicing within the scope of practice pursuant to South Carolina law.
27. "Recovery area" means a room or limited access area of an office dedicated to providing medical services to patients recovering from surgery or anesthesia.
28. "Special procedure" means patient care which requires entering the body with instruments in a potentially painful manner, or which requires the patient to be immobile, for a diagnostic or therapeutic procedure requiring anesthesia services; for example, diagnostic or therapeutic endoscopy, invasive radiologic procedures, pediatric magnetic resonance imaging; manipulation under anesthesia or endoscopic examination with the use of general anesthetic.
29. "Sufficient knowledge" means a physician holds staff privileges in a South Carolina hospital or ambulatory surgical center which would permit the physician to supervise the anesthesia, or the physician must be able to document certification or eligibility by a specialty board approved by the American Board of Medical Specialties or American Osteopathic Association, or the physician must be able to demonstrate comparable background, formal training, or experience in supervising the anesthesia, as approved by the Board.
30. "Surgery" means any operative or manual procedure performed for the purpose of preserving health, diagnosing or treating disease, repairing injury, correcting deformity or defects, prolonging life or relieving suffering, or any elective procedure for aesthetic or cosmetic purposes. This includes, but is not limited to, incision or curettage of tissue or an organ, suture or other repair of tissue or an organ, extraction of tissue from the uterus, insertion of natural or artificial implants, closed or open fracture reduction, or an endoscopic examination with use of local or general anesthetic. This also includes, but is not limited to, the use of lasers and any other devices or instruments in performing such procedures.
31. "Topical anesthesia" means the effect produced by an anesthetic agent applied directly or indirectly to the skin or mucous membranes, intended to produce a transient and reversible loss of sensation to a circumscribed area.
C. Office Administration
Each office-based practice, at a minimum, must develop and implement policies and procedures on the topics listed below. The policies and procedures must be periodically reviewed and updated. The purpose of the policies and procedures is to assist in providing safe and quality surgical care, assure consistent personnel performance, and promote an awareness and understanding of the inherent rights of patients.
1. Emergency Care and Transfer Plan: A plan must be developed for the provision of emergency medical care as well as the safe and timely transfer of patients to a nearby hospital, should hospitalization be necessary.
a. Age appropriate emergency supplies, equipment and medication must be provided in accordance with the scope of surgical and anesthesia services provided at the physician's office.
b. In an office where anesthesia services are provided to infants and children, the required emergency equipment must be appropriately sized for a pediatric population, and personnel must be appropriately trained to handle pediatric emergencies (e.g. PALS certified).
c. A practitioner who is qualified in resuscitation techniques and emergency care must be present and available until all patients having more than local anesthesia or minor conduction block anesthesia have been discharged from the operating room or recovery area.
d. In the event of untoward anesthetic, medical or surgical complications or emergencies, personnel must be familiar with the procedures and plan to be followed, and able to take the necessary actions. All office personnel must be familiar with a documented plan for the timely and safe transfer of patients to a nearby hospital. This plan must include arrangements for emergency medical services, if necessary, or when appropriate, escort of the patient to the hospital or to an appropriate practitioner. If advanced cardiac life support is instituted, the plan must include immediate contact with emergency medical services.
2. Medical Record Maintenance and Security: The practice must have a written procedure for initiating and maintaining a health record for every patient evaluated or treated. The record must include a procedure code or suitable narrative description of the procedure and must have sufficient information to identify the patient, support the diagnosis, justify the treatment and document the outcome and required follow-up care. For procedures requiring patient consent, there must be a documented, informed consent in the patient record. If analgesia/sedation, minor or major conduction block or general anesthesia are provided, the record must include documentation of the type of anesthesia used, drugs (type and dose) and fluids administered, the record of monitoring of vital signs, level of consciousness during the procedure, patient weight, estimated blood loss, duration of the procedure, and any complications related to the procedure or anesthesia. Procedures must also be established to assure patient confidentiality and security of all patient data and information.
3. Infection Control Policy: The practice must comply with state and federal regulations regarding infection control. For all surgical procedures, the level of sterilization must meet current OSHA requirements. There must be a written procedure and schedule for cleaning, disinfecting and sterilizing equipment and patient care items. Personnel must be trained in infection control practices, implementation of universal precautions, and disposal of hazardous waste products. Protective clothing and equipment must be available.
4. Performance Improvement:
a. A performance improvement program must be implemented to provide a mechanism to periodically review (minimum of every six months) the current practice activities and quality of care provided to patients, including peer review by members not affiliated with the same practice. Performance improvement (PI) can be established by:
(1) Establishment of a PI program by the practice; or
(2) A cooperative agreement with a hospital-based performance or quality improvement program; or
(3) A cooperative agreement with another practice to jointly conduct PI activities; or
(4) A cooperative agreement with a peer review organization, a managed care organization, specialty society, or other appropriate organization dedicated to performance improvement approved by the Board.
b. PI activities must include, but not be limited to review of mortalities, review of the appropriateness and necessity of procedures performed, emergency transfers, surgical and anesthetic complications, and resultant outcomes (including all postoperative infections), analysis of patient satisfaction surveys and complaints, and identification of undesirable trends, such as diagnostic errors, unacceptable results, follow-up of abnormal test results, and medication errors and system problems. Findings of the PI program must be incorporated into the practice's educational activity.
5. Reporting of Adverse Events: Anesthetic or surgical events requiring resuscitation, emergency transfer, or resulting in death must be reported to the South Carolina Board of Medical Examiners within three business days using a form approved by the Board. Such reports shall be considered initial complaints under the S.C. Medical Practice Act.
6. Federal and State Laws and Regulations: Federal and state laws and regulations that affect the practice must be identified and procedure developed to comply with those requirements. The following are some of the key requirements upon which office-based practices must focus:
a. Non-Discrimination (see Civil Rights statutes and the Americans with Disabilities Act)
b. Personal Safety (see Occupational Safety and Health Administration information)
c. Controlled Substance Safeguards
d. Laboratory Operations and Performance (CLIA)
e. Personnel Licensure Scope of Practice and Limitations.
7. Patients' Bill of Rights: Office personnel must recognize the basic rights of patients and understand the importance of maintaining patients' rights. A patients' rights document must be immediately available upon request.
D. Credentialing
1. Facility Accreditation: Practices performing office-based surgery or procedures that require the administration of moderate or deep sedation/analgesia, or general anesthesia (Level II and III facilities as defined below) must be accredited within the first year of operation by an accreditation agency, including the American Association of Ambulatory Surgery Facilities (AAASF); Accreditation Association for Ambulatory Health Care (AAAHC); the Joint Commission on Accreditation of Healthcare Organizations (JCAHO); or the Healthcare Facilities Accreditation Program (HFAP), a division of the American Osteopathic Association; or any other agency approved by the South Carolina Board of Medical Examiners. The accrediting agency must submit a biannual summary report for each facility to the South Carolina Board of Medical Examiners. Any physician performing Level II or Level III office surgery must register with the South Carolina Board of Medical Examiners. Such registration must include each address at which Level II or Level III office surgery is performed and identification of the accreditation agency that accredits each location (when applicable). Rule of Thumb: The capacity of the patient at all times to retain his/her life-protective reflexes and to respond to sensory stimuli (i.e., the depth of sedation or anesthesia), rather than the specific procedure performed, lies at the core of differentiating Level II from Level III surgery.
a. Scope of Level II Office Surgery: Level II office surgery includes any procedure which requires the administration of minimal or moderate intravenous, intramuscular, or rectal sedation/analgesia, thus making post-operative monitoring necessary. Level II office surgery must be limited to procedures where there is only a moderate risk of surgical and/or anesthetic complications and the likelihood of hospitalization as a result of these complications is unlikely. Level II office surgery includes local or peripheral nerve block, minor conduction block, and Bier block.
b. Scope of Level III Office Surgery: Level III office surgery includes any procedure that requires, or reasonably should require, the use of deep sedation/analgesia, general anesthesia, or major conduction block, and/or in which the known complications of the proposed surgical procedure may be serious or life threatening.
2. Practitioners:
a. The specific office-based surgical procedures and anesthesia services that each respective practitioner involved is qualified and competent to perform must be commensurate with each practitioner's level of training and experience. Criteria to be considered to demonstrate competence include:
(1) State licensure.
(2) Procedure-specific education, training, experience and successful evaluation appropriate for the patient population being treated (e.g. pediatrics).
(3)(a) For physicians, staff privileges in a hospital to perform the same procedure or service as that being performed in the office setting or board certification, board eligibility or completion of a training program in a field of specialization recognized by the ACGME for expertise and proficiency in that field, or comparable background, formal training, or experience as approved by the Board. Board certification is understood as American Board of Medical Specialists (ABMS), American Osteopathic Association (AOA), or equivalent board certification as determined by the Board.
(b) For non-physician practitioners, certification that is appropriate and applicable for the practitioner, as recognized by the practitioner's licensing board or this Board.
(4) Professional misconduct and malpractice history.
(5) Participation in peer and quality review proceedings.
(6) Participation in continuing competency activities consistent with the statutory requirements and requirements of the practitioner's professional organization.
(7) Malpractice insurance coverage adequate for the specialty.
(8) Procedure-specific competence (and competence in the use of new procedures/technology), which encompasses education, training, experience and evaluation, and which includes:
(a) Adherence to professional society standards;
(b) Hospital and/or ambulatory surgical privileges for the scope of services performed in the office-based setting at Levels II and III or must be able to document satisfactory completion of training such as board certification or board eligibility by a specialty board approved by the American Board of Medical Specialties, American Osteopathic Association, or comparable background, formal training, or experience as approved by the Board;
(c) Credentials approved by a nationally recognized accrediting/credentialing organization;
(d) For physicians, didactic course complemented by hands-on, observed experience. Training is to be followed by a specified number of cases supervised by a practitioner already competent in the respective procedure, in accordance with professional society standards and guidelines.
b. Unlicensed or uncertified personnel may not be assigned duties or responsibilities that require professional licensure or certification. Duties assigned to unlicensed or uncertified personnel must be in accordance with their training, education and experience and under the direct supervision of a qualified, licensed practitioner.
E. Standards for Office Procedures
1. Level II Office Procedures:
a. Training Required:
(1) The physician must have staff privileges in a hospital to perform the same procedure as that being performed in the office setting or must be able to document satisfactory completion of training such as board certification or board eligibility by a specialty board approved by the American Board of Medical Specialties, American Osteopathic Association, or must demonstrate comparable background, formal training, or experience as approved by the Board. The physician must maintain current certification in advanced resuscitative techniques as appropriate (e.g. ATLS, ACLS, or PALS).
(2) One assistant or other health care personnel that is immediately available (immediately available is defined as being located within the office and not necessarily the person assisting in the procedure) must be certified in advanced resuscitative techniques as appropriate (e.g. ATLS, ACLS, or PALS).
b. Equipment and Supplies Required:
(1) Emergency resuscitation equipment and a reliable source of oxygen must be current and immediately available.
(2) Monitoring equipment must include a continuous suction device, pulse oximeter, and noninvasive blood pressure apparatus and stethoscope. Electrocardiographic monitoring must be available for patients with a history of cardiac disease. Age-and size-appropriate monitors and resuscitative equipment must be available for patients.
c. Assistance of Other Personnel Required:
(1) Supervision of the sedation/analgesia component of the medical procedure should be provided by a physician who is immediately available, who possesses sufficient knowledge, and who is qualified in accordance with law supervise the administration of the sedation/analgesia or minor conduction block. The physician providing supervision must:
(a) ensure that an appropriate pre-sedation/analgesia or anesthesia examination and evaluation is performed proximate to the procedure;
(b) order the sedation/analgesia or anesthesia;
(c) ensure that qualified health care personnel participate;
(d) remain immediately available until discharge criteria are met; and
(e) ensure the provision of indicated post-sedation/analgesia or anesthesia care.
(2) Sedation/analgesia or anesthesia must be administered or supervised only by a duly licensed, qualified and competent physician. CRNAs, AAs, or other qualified practitioners who administer sedation/analgesia or anesthesia as part of a medical procedure must have training and experience appropriate to the level of sedation/analgesia or anesthesia administered and function in accordance with their scope of practice. Such personnel must have documented competence to administer sedation/analgesia or anesthesia and to assist in any support or resuscitation measures as required. The individual administering sedation/analgesia or anesthesia and/or monitoring the patient must not play an integral role in performing the surgical procedure. This is not intended to restrict or limit the physician's ability to delegate medical tasks to other qualified practitioners in Level II office procedures.
(3) A registered nurse or other licensed health care personnel practicing within the scope of their practice who is currently certified in advanced resuscitative techniques must monitor the patient postoperatively and have the capability of administering medications as required for analgesia, nausea/vomiting, or other indications. Monitoring in the recovery area must include pulse oximetry and non-invasive blood pressure measurement. The patient must be assessed periodically for level of consciousness, pain relief, or any untoward complication. Each patient must meet discharge criteria as established by the practice, prior to leaving the operating room or recovery area.
d. Transfer and Emergency Protocols: The physician must have a transfer protocol in effect with a hospital within reasonable proximity.
e. Facility Accreditation: The physician must obtain and maintain accreditation of the office setting by an approved accreditation agency.
2. Level III Office Procedures
a. Training Required:
(1) The physician must have documentation of training to perform the particular surgical procedure(s). The physician must have staff privileges in a hospital to perform the same procedure as that being performed in the office setting or must be able to document satisfactory completion of training such as board certification or board eligibility by a specialty board approved by the American Board of Medical Specialties, American Osteopathic Association, or comparable background, formal training, or experience as approved by the Board. In the event the physician is supervising the administration of anesthesia by a CRNA, the physician must have sufficient knowledge of the anesthesia specified for the procedure to provide effective care in the case of emergency. If the physician does not possess the sufficient knowledge of anesthesia, the anesthesia must be administered by or under the supervision of a qualified physician. The physician must maintain current certification in advanced resuscitative techniques as appropriate (e.g. ATLS, ACLS, or PALS).
(2) One assistant or other health care personnel that is immediately available (immediately available is defined as being located within the office and not necessarily the person assisting in the procedure) must be currently certified in advanced resuscitative techniques as appropriate (e.g. ATLS, ACLS, or PALS).
b. Equipment and Supplies Required:
(1) Emergency resuscitation equipment, a continuous suction device, and a reliable source of oxygen must be current and immediately available. At least 12 ampules of dantrolene sodium must be immediately available. Age-and size-appropriate monitors and resuscitative equipment must be available for patients.
(2) Monitoring equipment must include:
(a) blood pressure apparatus and stethoscope
(b) pulse oximetry
(c) continuous EKG
(d) capnography
(e) temperature monitoring for procedures lasting longer than 30 minutes.
(3) Facility, in terms of general preparation, equipment and supplies, must be comparable to a free standing ambulatory surgical center, have provisions for proper record keeping, and the ability to recover patients after anesthesia.
c. Assistance of Other Personnel Required:
(1) Supervision of the sedation/analgesia component of the medical procedure should be provided by a physician who is immediately available, who possesses sufficient knowledge, and who is qualified in accordance with law to supervise the administration of the sedation/analgesia or minor conduction block. The physician providing supervision must:
(a) ensure that an appropriate pre-sedation/analgesia or anesthesia examination and evaluation is performed proximate to the procedure;
(b) order the sedation/analgesia or anesthesia;
(c) ensure that qualified health care personnel participate;
(d) remain immediately available until discharge criteria are met; and
(e) ensure the provision of indicated post-sedation/analgesia or anesthesia care.
(2) Sedation/analgesia or anesthesia must be administered or supervised only by a duly licensed, qualified and competent physician. CRNAs or AAs who administer sedation/analgesia or anesthesia as part of a medical procedure must have training and experience appropriate to the level of sedation/analgesia or anesthesia administered and function in accordance with their scope of practice. Such personnel must have documented competence to administer sedation/analgesia or anesthesia and to assist in any support or resuscitation measures as required. The individual administering sedation/analgesia or anesthesia and/or monitoring the patient must not play an integral role in performing the surgical procedure.
(3) A registered nurse or other licensed health care personnel practicing within the scope of their practice who is currently certified in advanced resuscitative techniques must monitor the patient postoperatively and have the capability of administering medications as required for analgesia, nausea/vomiting, or other indications. Monitoring in the recovery area must include pulse oximetry and non-invasive blood pressure measurement. The patient must be assessed periodically for level of consciousness, pain relief, or any untoward complication. Each patient must meet discharge criteria as established by the practice, prior to leaving the operating room or recovery area.
d. Transfer and Emergency Protocols: The physician must have a transfer protocol in effect with a hospital within reasonable proximity.
e. Facility Accreditation and Inspection. The physician must obtain and maintain accreditation of the office setting by an approved accreditation agency.
F. Patient Admission and Discharge
1. Patient Selection. The physician must evaluate the condition of the patient and the potential risks associated with the proposed treatment plan. The physician is also responsible for providing a post-operative plan to the patient and ensuring the patient is aware of the need for the necessary follow-up care. Patients with pre-existing medical problems or other conditions, who are at undue risk for complications, must be referred to an appropriate specialist for pre-operative consultation. Patients that are considered high risk or are a physical classification status III or greater and require a general anesthetic for the surgical procedure must have the surgery performed in a hospital setting or in ambulatory surgery centers. Patients with a physical status classification of III or greater may be acceptable candidates for moderate sedation/analgesia. ASA Class III patients must be specifically addressed in the operating procedures of the office-based practice. They may be acceptable candidates if deemed so by a physician qualified to assess the specific disability and its impact on anesthesia and surgical risks. Acceptable candidates for deep sedation/analgesia, general anesthesia, or major conduction block in office settings are patients with a physical status classification of I or II, no airway abnormality, and possess an unremarkable anesthetic history.
2. Informed Consent. The risks, benefits, and potential complications of both the surgery and anesthetic must be discussed with the patient and/or, if applicable, the patient's legal guardian prior to the surgical procedure. Written documentation of informed consent must be included in the medical record.
3. Preoperative Assessment. A specialty specific medical history and physical examination must be performed, and appropriate laboratory studies obtained within 30 days prior to the planned surgical procedure, by a practitioner qualified to assess the impact of co-existing disease processes on surgery and anesthesia. The physician must assure that a preanesthetic examination and evaluation is conducted immediately prior to surgery by the practitioner who will be administering or supervising the anesthesia. Monitoring must be available for patients with a history of cardiac disease. Age and size appropriate monitors and resuscitative equipment must be available for patients. The information and data obtained during the course of these evaluations must be documented in the medical record.
4. Discharge Evaluation. The physician must evaluate the patient immediately upon completion of the surgery and anesthesia. Care of the patient may then be transferred to qualified health care personnel in the recovery area. A qualified physician must remain immediately available until the patient meets discharge criteria. Criteria for discharge for all patients who have received anesthesia must include the following:
a. confirmation of stable vital signs
b. stable oxygen saturation levels
c. return to pre-procedure mental status
d. adequate pain control
e. minimal bleeding, nausea and vomiting
f. resolving neural block, resolution of the neuraxial block
g. discharged in the company of a competent adult.
5. Patient Instructions. The patient must receive verbal instruction understandable to the patient or guardian, confirmed by written post-operative instructions and emergency contact numbers. The instructions must include:
a. The procedure performed
b. Information about potential complications
c. Telephone numbers to be used by the patient to discuss complications or should questions arise
d. Instructions for medications prescribed and pain management
e. Information regarding the follow-up visit date, time and location
f. Designated treatment facility in the event of emergency.
G. Inapplicability to dentistry. These regulations shall not apply to an oral surgeon licensed to practice dentistry who is also a physician licensed to practice medicine, if the procedure is exclusively for the practice of dentistry.
ARTICLE 10.
PHYSICIAN ASSISTANTS
81-100. Repealed by State Register Volume 25, Issue No. 6, eff June 22, 2001.
81-110. Criteria for Physician Supervision of Nurses in Extended Role.
Any physician who supervises a Registered Nurse practicing in the extended role must be licensed in South Carolina, in possession of a permanent, active, unrestricted license to practice medicine in this State or, alternatively, be in possession of an active unrestricted academic license to practice medicine in this state and hold an appointment at the level of Associate Professor or above at an approved school of medicine. Such physicians must be currently engaged in the practice of medicine.
When the sponsoring physician is more than forty-five (45) miles from the nurse practitioner, when a physician is supervising more than three (3) nurse practitioners, or when otherwise deemed necessary, the State Board of Medical Examiners will review the nature and quality of physician supervision, on an individual basis, to insure that the public health, safety and welfare are protected. In making this evaluation, the Board's review will include, but not be limited to, the following criteria:
1. The training and practice experience of the physician;
2. The competency of the physician to supervise the "delegated Medical Acts" performed by the nurse;
3. The nature and complexity of the "delegated Medical Acts" being performed;
4. The geographic proximity of the supervising physician to the nurse practicing in the extended role;
5. The manner in which the physician intends to monitor the extended role practice and the extent to which the physician is available for consultation and advice; and
6. The number of other extended role nurses and/or Physician Assistants the physician is supervising. It is the physician's responsibility to insure that any "delegated Medical Act" being performed by the nurse is set forth in an approved written protocol, as defined by applicable law.
A copy of this approved written protocol, dated and signed by the nurse and the physician, shall be provided to the Board by the physician supervisor within seventy-two (72) hours of request by the Board.
The supervising physician shall be responsible and accountable to the Board for compliance with this regulation. Any violation of this regulation shall be considered an act of professional misconduct and subject the physician to sanctions pursuant to Section 40-47-200. A Physician Assistant is not authorized to supervise a nurse practicing in the extended role.
(1) "Qualified Physician Sponsorship" is defined as the existence of a physician permanently licensed in the State with special interest and knowledge in the diagnosis, treatment, and assessment of respiratory problems and assumes the responsibility for supervising all tasks and procedures performed by respiratory care practitioners in the home care of cardiopulmonary patients. The physician sponsor need not be physically present when the respiratory care practitioner is performing respiratory care but must be readily accessible and physically available to the respiratory care practitioner for appropriate consultation.
(2) "Public Notification" is defined as written communication conducted by the Department of Labor, Licensing and Regulation to all current and potential providers, employers, or consumers of respiratory care regarding the statutory and regulatory requirements for the practice of respiratory care. Public notification shall include communication with all health care facilities, hospitals, skilled nursing facilities, rehabilitation facilities, nursing homes, clinics, sleep laboratories, physicians offices, home care providers, and durable medical equipment suppliers. After notification through the State Register, entities will have ninety (90) days from the date of notification to provide written documentation regarding compliance with the statute and regulations.
(1) All respiratory care practitioners in this State certified as of January 1, 1999, will be issued a permanent license within ninety (90) days of the approval of regulations. Any pending disciplinary action, fines, or probationary status will carry forward and remain in effect until final disposition by the committee and board.
(2) Provisional licenses will be issued to individuals who provide evidence that they are practicing respiratory care in November and December of 1998 but cannot meet the professional education and examination requirements. Application for a provisional license must be made within ninety (90) days after public notification by the Department of Labor, Licensing and Regulation.
(3) A provisional license shall remain valid for a period not to exceed three (3) years from the date of issuance of the provisional license and be subject to annual renewal, continuing education and medical direction requirements. When a provisional licensee fails to meet statutory or regulatory requirements, the provisional license is immediately revoked by the board and the individual is no longer eligible to apply for further provisional licenses.
As a specific condition for the annual renewal of a permanent or provisional license, each licensed respiratory care practitioner must document the completion of at least fifteen (15) hours of continuing education within the twelve (12) month period prior to the March 1 annual renewal date. These continuing education hours must be approved or sponsored by one of the following organizations:
(1) American Association for Respiratory Care, Inc. or its sponsoring organizations;
(2) American Heart Association;
(3) the Society for Critical Care Medicine;
(4) American Lung Association;
(5) South Carolina Society for Respiratory Care;
(6) Allied Health Education Centers of the South Carolina Consortium of Community Teaching Hospitals; or
(7) Any other institution, educational medium or organization approved by the board.
HISTORY; Amended by State Register Volume 24, Issue No. 5, eff May 26, 2000.
81-203. Competency Requirements for the Provision of Respiratory Care by Non-RCPs.
(1) Non-RCP's providing respiratory care, regardless of care setting or demographics, shall successfully complete formal training and demonstrate initial competency prior to assuming those duties. Formal training is defined as a supervised, deliberate and systematic continuing educational activity intended to develop new proficiencies with an application in mind. Formal training shall be approved by the board and include supervised didactic, laboratory and clinical activities as well as documentation of competence through a post- testing mechanism. Qualifications of the faculty and educational program must be approved by the medical director. The board must be notified of the intent to medically delegate the practice of respiratory care to non-RCP's prior to implementation of the program or practice.
(2) Certified Nurse Anesthetists and Certified Paramedical and Emergency Medical Technicians (EMT's) are exempt from this regulation so long as they are certified or licensed by the State and do not hold themselves out as respiratory care practitioners or practice respiratory care.
(3) Registered Polysomnographic Technologists (RPSGT's) practicing in an accredited sleep medicine facility are exempt from this regulation so long as they are practicing under physician direction and do not hold themselves out as respiratory care practitioners or practice respiratory care.
(1) A respiratory care practitioner shall be dedicated to providing competent respiratory care with compassion and respect for human dignity.
(2) A respiratory care practitioner shall deal honestly with patients and colleagues, and strive to expose those respiratory care practitioners deficient in character or competence, or who engage in fraud or deception.
(3) A respiratory care practitioner shall respect the law and also recognize a responsibility to seek changes in those requirements which are contrary to the best interests of the patient.
(4) A respiratory care practitioner shall respect the rights of patients, of colleagues, and of other health professionals, and shall safeguard patient confidence within the constraints of the law.
(5) A respiratory care practitioner shall continue to study, apply and advance scientific knowledge, make relevant information available to patients, colleagues, and the public.
All employers of respiratory care practitioners shall report to the board, within thirty (30) days, any instances of misconduct leading to suspension or involuntary discharge. Misconduct is defined in "Grounds for Discipline" in Section 40-47-630.
81-206. Respiratory Care Practitioner Fees and Renewal.
(1) The following schedule of fees shall apply to Respiratory Care Practitioners:
(a) Application for permanent license ......................... $80
(b) Application for provisional license ....................... $80
(c) Annual renewal of permanent license ....................... $40
(d) Annual renewal of provisional license ..................... $40
(f) Renewal of limited license ................................ $40
(g) Upgrade of limited or provisional license to permanent .... $40
(2) All respiratory care practitioners with a permanent or provisional license must annually renew that license on or before March 1 of each year. If the respiratory care practitioner fails to timely renew, a penalty fee of ten dollars ($10) per month shall be levied in addition to the renewal fee. If the respiratory care practitioner has not renewed the license on or before May 31, that license shall be deemed inactive. A respiratory care practitioner may request and be granted inactive status if that individual is no longer practicing respiratory care in this State.
