Guidelines for Institutions Granting Privileges Utilizing Laparoscopic and/or Thoracoscopic Techniques

This statement was reviewed and approved by the Board of Governors of the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) on Jun 2010.

I.PRINCIPLES OF PRIVILEGING

PREAMBLE

The Society of American Gastrointestinal Endoscopic Surgeons (SAGES) recommends the following guidelines for privileging qualified surgeons in the performance of surgical procedures utilizing laparoscopy and/or thoracoscopy alone, or in a hybrid fashion with hand or robotic assistance. The basic premise is that the surgeon(s) must have the judgment and training to safely complete the procedure as intended, as well as have the capability of immediately proceeding to a traditional open procedure when circumstances so indicate. As a basic premise, surgical privileging should be based on training, surgical board certification, and ongoing practice experience[1].

DISCLAIMER:

Guidelines for clinical practice are intended to indicate preferable approaches to medical problems as established by experts in the field. These recommendations will be based on existing data or a consensus of expert opinion when little or no data are available. Guidelines are applicable to all physicians who address the clinical problem(s) without regard to specialty training or interests, and are intended to indicate the preferable, but not necessarily the only acceptable approaches due to the complexity of the healthcare environment. Guidelines are intended to be flexible. Given the wide range of specifics in any health care problem, the surgeon must always choose the course best suited to the individual patient and the variables in existence at the moment of decision.

Guidelines are developed under the auspices of the Society of American Gastrointestinal and Endoscopic Surgeons and its various committees, and approved by the Board of Governors. Each clinical practice guideline has been systematically researched, reviewed and revised by the guidelines committee, and reviewed by an appropriate multidisciplinary team. The recommendations are therefore considered valid at the time of its production based on the data available. Each guideline is scheduled for periodic review to allow incorporation of pertinent new developments in medical research knowledge, and practice.

A. PURPOSE

The purpose of this statement is to outline principles and provide practical suggestions to assist healthcare institutions when granting privileges to perform procedures utilizing laparoscopy and/or thoracoscopy. In conjunction with the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) guidelines for granting hospital privileges, implementation of these methods should help hospital staffs ensure that laparoscopic and/or thoracoscopic surgery is performed in a manner assuring high quality patient care and proper procedure utilization.

B. UNIFORMITY OF STANDARDS

Uniform standards should be developed which apply to all medical staff requesting privileges to perform procedures utilizing laparoscopy and/or thoracoscopy. Criteria must be established which are medically sound, but not unreasonably stringent, and which are universally applicable to all those wishing to obtain privileges. The goal must be the delivery of high quality patient care. Surgical proficiency should be assessed for every surgeon, and privileges should not be granted or denied solely based on the number of procedures performed.

C. RESPONSIBILITY FOR PRIVILEGING

The privileging structure and process remain the responsibility of the institution at which privileges are being sought. It should be the responsibility of the department of surgery, through its chief, to recommend privileges for individual surgeons to perform laparoscopic and/or thoracoscopic procedures. These recommendations should then be approved by the appropriate institutional committee, board, or governing body.

D. DEFINITIONS

MUST/SHALL – Mandatory recommendation

SHOULD – Highly desirable recommendation

MAY/COULD – Optional recommendation; alternatives may be appropriate

DOCUMENTED TRAINING AND EXPERIENCE[2] – Case list that must specify the applicant’s role (primary surgeon, co-surgeon, first assistant, chief resident, junior resident or observer). Complications, outcomes, and conversion to traditional techniques should be included if known. The applicant must specify if these details are not known[3]. Summary letter from preceptor and/or program director and/or chief of surgery (should state if applicant can independently and competently perform the procedure in question).

PRIVILEGING – The process whereby a specific scope and content of patient care services (that is, clinical privileges) are authorized for a health care practitioner by a health care organization based on evaluation of the individual’s credentials and performance.

COMPETENCE OR COMPETENCY – A determination of an individual’s capability to perform up to defined expectations.

CREDENTIALS – Documented evidence of licensure, education, training, experience, or other qualifications.

COMPLETE PROCEDURAL CONDUCT – Competency of the applicant and/or institution regarding patient selection, peri-procedural care, conduct of the operation, technical skill and equipment necessary to safely complete procedure using laparoscopic and/or thoracoscopic techniques, and the ability to proceed immediately with the traditional open procedure.

LAPAROSCOPY AND THORACOSCOPY – Specialized areas within the field of surgery, which require unique knowledge and set of skills related to the equipment, physiology, and operative technique, whether the procedure is performed inside or outside of the traditional operating room.

FUNDAMENTALS OF LAPAROSCOPIC SURGERY (FLS) – FLS is a comprehensive web-based education module that includes a hands-on skills training component and assessment tool designed to teach the physiology, fundamental knowledge, and technical skills required in basic laparoscopic surgery. It is a joint educational offering of the American College of Surgeons and the Society of American Gastrointestinal and Endoscopic Surgeons SAGES). It is required for certification by the American Board of Surgery beginning in July 2009. FLS alone is not appropriate training to begin performing a procedure independently.

FORMAL COURSE – This is a limited period of instruction that should offer Category I Continuing Medical Education (CME) credits that meet American Medical Association (AMA) standards. The course should be taught by instructors with appropriate clinical experience, and have a curriculum that includes didactic instruction as well as hands on experience utilizing inanimate and/or animate models. The course director and/or instructor should provide a written assessment of the participant’s mastery of course objectives. Documentation for certain courses consisting of only didactic instruction may consist of verification of attendance.

II. MINIMUM REQUIREMENTS FOR GRANTING PRIVILEGES

Part II.A is mandatory, and must be accompanied by either part II.B or a combination of II.C and at least one component of part II.D.

A. FORMAL RESIDENCY TRAINING IN GENERAL AND/OR THORACIC SURGERY

Prerequisite training must include satisfactory completion of an accredited surgical residency program. The residency program must be recognized by the Accreditation Council for Graduate Medical Education or the equivalent body if the program is based outside the United States or Canada. Board certification by the organization with appropriate jurisdiction is recommended, and is required by many institutions.

B. FORMAL TRAINING IN LAPAROSCOPYAND/OR THORACOSCOPY

For surgeons who successfully completed a residency and/or fellowship program that incorporated a structured experience in laparoscopic and/or thoracoscopic surgery, the applicant’s program director, and if desired other faculty members, should supply the appropriate documentation of training.

C. NO FORMAL RESIDENCY TRAINING IN LAPAROSCOPY OR THORACOSCOPY

For those surgeons without residency and/or fellowship training that included structured experience in laparoscopic and/or thoracoscopic surgery, or for those without documented prior experience in these areas, a structured training curriculum is required. The curriculum should be defined by the institution, and may include a formal course and/or FLS certification. Other teaching aids may include video review and interactive computer programs. The curriculum should include didactic sessions and hands-on experience with inanimate and/or animate models. The curriculum should include an appropriate number of opportunities for the applicant to observe, assist, and serve as primary operator for the procedure for which privileges are being sought.

D. PRACTICAL EXPERIENCE

  1. Applicant’s Experience – Documented experience that includes an appropriate volume of cases equivalent to the procedure in question in terms of complexity. The chief of surgery should determine the appropriateness of this experience. (Two surgeons, already skilled in laparoscopy and/or thoracoscopy working together may be more appropriate in this situation rather than a single surgeon working with an inexperienced assistant.)
  2. Complementary Experience – Two surgeons (applicant and first assistant or co-surgeon) with combined expertise in the complete procedural conduct. (i.e. one surgeon skilled in laparoscopy and/or thoracoscopy, the other surgeon skilled in the traditional open technique).
  3. Experience with Preceptor and/or Proctor – The specific role and qualifications of the preceptor and/or proctor, if required, must be determined by the institution. Criteria of competency for each procedure should be established in advance, and should include evaluation of: familiarity with instrumentation and equipment, competence in their use, appropriateness of patient selection, clarity of dissection, safety, and successful completion of the procedure. The criteria should be established by the chief of surgery in conjunction with the specific specialty chief where appropriate. It is essential that proctoring be provided in an unbiased, confidential, and objective manner.

III. INSTITUTIONAL SUPPORT

If the particular procedure in question requires a significant amount of supporting infrastructure vital to the complete procedural conduct of the operation in question, it is incumbent on the institution to have this support in place prior to beginning the procedure (e.g., bariatric, cardiac, and transplant surgery).

IV. MAINTENANCE OF PRIVILEGES

A. PROVISIONAL PRIVILEGES

Once competence has been determined, a period of provisional privileges may be appropriate. The time frame and/or number of cases required during this period should be determined by the chief of surgery and/or the appropriate institutional committee, board, or governing body.

B. MONITORING OF PERFORMANCE

Once privileges have been granted, performance should be monitored through existing quality assurance mechanisms at the institution. These mechanisms may be modified as appropriate, and should evaluate outcomes, as well as competency in the complete procedural conduct.

C. CONTINUING MEDICAL EDUCATION

Continuing medical education related to laparoscopic and/or thoracoscopic surgery should be required as part of the periodic renewal of privileges. Attendance at appropriate local, national or international meetings and courses is encouraged.

D. RENEWAL

The American Surgical Association has recently recommended that surgical privileges be time-limited and be reviewed on a 3-5 year time cycle[1]. This should include review of quality assurance data, as well as appropriate CME activity, in addition to existing mechanisms at the institution designed for this purpose.

E. DENIAL OF PRIVILEGES

Institutions denying, withdrawing, or restricting privileges should have an appropriate mechanism for appeal in place. The procedural details of this should be developed by the institution, and must satisfy the institution’s bylaws and JCAHO recommendations.

REFERENCES

  1. Bass BL, et al.: Surgical privileging and credentialing: a report of a discussion and study group of the American Surgical Association. J Am Coll Surg, 209(3):396-404, Sep 2009
  2. Dent T.L.: Clinical privileges for laparoscopic general surgery. American Journal of Surgery, 161:399-403 March 1991
  3. E.A.E.S. Guidelines: Training and Assessment of Competence- Surgical Endoscopy, 8:721-722, 1994
  4. Greene, F.L.: Training Credentialing and Privileging for minimally invasive surgery. Problems in General Surgery 8:502-506, 1991
  5. Jakimowicz, J.: The European Association for Endoscopic Surgery, Recommendations for Training in Laparoscopic Surgery- Annals Chirugiae at Gynaecologiae, 83:137-141, 1994
  6. Laparoscopic surgery, New York State Department of Health Memorandum- Series 92-20, Albany, New York, June 12, 1992
  7. Wexner, S.D. & Weiss, E.G.: A Recommended Training Schema for Laparoscopic Surgery, – The Future of Laparoscopy in Oncology/Surgical Oncology Clinics of North America- Volume 3, No.4, 759-765, October 1994
  8. Wexner, S.D. & Weiss, E.G. : Training and Preparation for Laparoscopic Colectomy, – Seminars in Colon & Rectal Surgery, Volume 5, No.4, 224-227, December 1994
  9. SAGES: Granting of Privileges for Laparoscopic General Surgery, American Journal of Surgery 161:324-325, 1991
  10. Schwaitzberg, S.D.; Connolly, R.J.; Sant, G.R.; Reindollar, R. and Cleveland, R.J.; Planning, Development, and Execution of an International Training Program in Laparoscopy, Volume 6, No.1, 10-15, 1996
  11. See, W.A.; Cooper, C.S.; Fisher, R.J.; Predictors of Laparoscopic Complications after Formal Training in Laparoscopic Surgery- JAMA, Volume 270, No.22, December 8, 1993
  12. JCAHO 2001 Automated Comprehensive Accreditation manual for hospitals, Update 2-May 2001.
  13. Society of American Gastrointestinal Endoscopic Surgeons. Framework for post-residency surgical education and training a SAGES guideline. SAGES Publication #0017, printed January, 1994, Published in SURGICAL ENDOSCOPY 8:9 (SEPT/94) P.1137-1142
  14. Peters JH, Fried GM, Swanstrom LL, Soper NJ, Sillin LF, Schirmer B, Hoffman K and the SAGES FLS Committee. Development and validation of a comprehensive program of education and assessment of the basic fundamentals of laparoscopic surgery. Surgery 2004; 135: 21-27
  • Robert S. Fanelli, MD, Chair
  • William S. Richardson, MD, Co-Chair
  • Andrew S. Wright, MD
  • Raymond R. Price, MD
  • Keith N. Apelgren, MD
  • Ziad T. Awad, MD
  • David Earle, MD
  • Liane S. Feldman, MD
  • Erika K. Fellinger, MD
  • William W. Hope, MD
  • Thom E. Lobe, MD
  • Lisa R. Martin Hawver, MD
  • Summeet K. Mittal, MD
  • David W. Overby, MD
  • Jonathan R. Price, MD
  • John Scott Roth, MD
  • Alan A. Saber, MD
  • J.R. Salameh, MD
  • Dimitrios Stefanidis, MD
  • Kevin E. Wasco, MD
  • Marc Zerey, MD

This statement was reviewed and approved by the Board of Governors of the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) on Jun 2010.

This is a revision of SAGES publication #14 printed Jan 1992, revised Jun 2010.

For more information please contact:

SOCIETY OF AMERICAN GASTROINTESTINAL ENDOSCOPIC SURGEONS (SAGES)
11300 West Olympic Blvd., Suite 600
Los Angeles, CA 90064
Tel:
(310) 437-0544
Fax:
(310) 437-0585
Email:
publications@sages.org

Guidelines for clinical practice are intended to indicate preferable approaches to medical problems as established by experts in the field. These recommendations will be based on existing data or a consensus of expert opinion when little or no data are available. Guidelines are applicable to all physicians who address the clinical problem(s) without regard to specialty training or interests, and are intended to indicate the preferable, but not necessarily the only acceptable approaches due to the complexity of the healthcare environment. Guidelines are intended to be flexible. Given the wide range of specifics in any health care problem, the surgeon must always choose the course best suited to the individual patient and the variables in existence at the moment of decision.

Guidelines are developed under the auspices of the Society of American Gastrointestinal and Endoscopic Surgeons and its various committees, and approved by the Board of Governors. Each clinical practice guideline has been systematically researched, reviewed and revised by the guidelines committee, and reviewed by an appropriate multidisciplinary team. The recommendations are therefore considered valid at the time of its production based on the data available. Each guideline is scheduled for periodic review to allow incorporation of pertinent new developments in medical research knowledge, and practice.