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Guidelines for Institutions Granting Bariatric Privileges Utilizing Laparoscopic Techniques

Privileging Guidelines published on: 03/2003
by the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES)

GUIDELINES FOR INSTITUTIONS GRANTING BARIATRIC PRIVILEGES UTILIZING LAPAROSCOPIC TECHNIQUES

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 bariatric surgical procedures. 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. Moreover this assumes the surgeon practices as part of a bariatric team to provide adequate preoperative teaching and long term follow up.

A. PURPOSE

The purpose of this statement is to outline principles and provide practical suggestions to assist healthcare institutions when granting privileges to perform bariatric procedures utilizing laparoscopy. 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 bariatric 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 laparoscopic bariatric surgery. 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 based solely 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 bariatric surgery. 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

  1. 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. The applicant must specify if these details are not known.
  2. 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 a bariatric surgical procedure using laparoscopic techniques, and the ability to proceed immediately with the traditional open procedure.

LAPAROSCOPY- 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.

CATEGORIES OF BARIATRIC SURGICAL PROCEDURES – For the purposes of this document, bariatric surgery will be divided into two broad categories: those that are reconstructive (require an intestinal anastomosis) and those that are non-reconstructive (e.g. gastric banding procedures).

FORMAL COURSE - A formal course alone is not appropriate training to begin performing a procedure independently. 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 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. The curriculum should include didactic sessions and hands-on experience with inanimate and/or animate models. Other teaching aids may include video review and interactive computer programs. 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 and II F are mandatory for all candidates

Candidates who fall into Category II B must accomplish E3 and must also accomplish E2 or E4.

Candidates who fall into Category II C must accomplish E1 and should accomplish E2.

Candidates who fall into Category II D must accomplish E3 and E4 and should accomplish E2.

A. FORMAL RESIDENCY TRAINING IN GENERAL SURGERY

Prerequisite training must include satisfactory completion of an accredited surgical residency program, with subsequent certification by the American Board of Surgery, or its equivalent, as required by the institution.

B. FORMAL TRAINING IN OPEN BARIATRIC SURGERY

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

C. FORMAL TRAINING IN LAPAROSCOPIC BARIATRIC SURGERY.

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

D. NO FORMAL RESIDENCY TRAINING IN LAPAROSCOPIC OR OPEN BARIATRIC SURGERY

For those surgeons without residency and/or fellowship training, which included structured experience in laparoscopic and/or open bariatric surgery, or without documented prior experience in these areas, a structured training curriculum is required.

E. PRACTICAL EXPERIENCE

1. Applicant’s Experience – Documented training experience that includes an appropriate volume of cases (open and / or laparoscopic) in the category of bariatric surgical procedure for which privileges are being considered (reconstructive versus non-reconstructive, Section I D above). The chief of surgery should determine the adequacy of this experience.

2. Complementary Experience - Two surgeons (applicant and an experienced laparoscopic or bariatric surgeon) supporting one another who demonstrate combined expertise in the complete procedural conduct. (must include one surgeon skilled in laparoscopy and the other surgeon skilled in the traditional open technique for the specific category of bariatric procedure for which privileges are being sought).

3. Applicant must complete a formal course for the specific category of bariatric procedure for which privileges are being sought.

4. 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.

F. FOLLOW-UP

It is necessary to document that the surgeon is working with an integrated program for the care of the morbidly obese patient that provides ancillary services such as specialized nursing care, dietary instruction, counseling, support groups, exercise training, and psychological assistance as needed. Document that there is a process in place to minimize, monitor and manage short-term and long-term complications, as well as to provide follow-up for all patients.

III. Institutional Support

Bariatric procedures require a significant amount of supporting infrastructure (both equipment and staff training) vital to the complete procedural conduct for bariatric procedures. It is incumbent on the institution and surgeon to have this infrastructure in place prior to initiating a program. Appropriate support aspects are delineated in the Bulletin of ACS, Vol. 85, No. 9, Sept. 2000.

Many laparoscopic bariatric operations require the presence of two skilled surgeons for their safe and efficient performance. In order to conform with these requirements the surgeon should choose a skilled first assistant, and the surgeon and the institution should use the assistant when required. Guidelines for the first assistant are given in the SAGES Statement on First Assistant.

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 bariatric surgery should be required as part of the periodic renewal of privileges. Attendance at appropriate local, national or international meetings and courses is encouraged to satisfy these requirements.

D. RENEWAL

An appropriate level of continuing clinical activity should be required. 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. It is recommended that the local facility review the surgeon's outcome data within 6 months of initiation of a new program and at regular intervals thereafter, to evaluate patient safety comparable to published outcome benchmarks.

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. Dent T.L.: Clinical privileges for laparoscopic general surgery. American Journal of Surgery, 161:399- 403 March 1991
  2. E.A.E.S. Guidelines: Training and Assessment of Competence- Surgical Endoscopy, 8:721-722, 1994
  3. Greene, F.L.: Training Credentialing and Privileging for minimally invasive surgery. Problems in General Surgery 8:502-506, 1991
  4. Jakimowicz, J.: The European Association for Endoscopic Surgery, Recommendations for Training in Laparoscopic Surgery- Annals Chirugiae at Gynaecologiae, 83:137-141, 1994
  5. JCAHO 2001 Automated Comprehensive Accreditation manual for hospitals, Update 2-May 2001.
  6. Laparoscopic surgery, New York State Department of Health Memorandum- Series 92-20, Albany, New York, June 12, 1992
  7. Ooi, L.L.P.J.: Training in Laparoscopic Surgery- Have we got it right yet?- Annals Academy of Medicine, 25:732-736, September, 1996
  8. 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
  9. 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
  10. Society of American Gastrointestinal Endoscopic Surgeons: Framework for post-residency surgical education and training: A SAGES guideline. Publication #0017, printed January, 1994, Published in SURGICAL ENDOSCOPY 8:9 (SEPT/94) P.1137-1142
  11. Society of American Gastrointestinal Endoscopic Surgeons: Granting of Privileges for Laparoscopic General Surgery, American Journal of Surgery 161:324-325, 1991
  12. Society of American Gastrointestinal Endoscopic Surgeons. SAGES Position Statement – Statement on First Assistants. Printed April, 2001.
  13. 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
  14. 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

This statement was prepared by the SAGES Guidelines Committee in conjunction with the SAGES Bariatric Task Force and was reviewed and approved by the Board of Governors of the Society of American Gastrointestinal Endoscopic Surgeons (SAGES), May 2003.


Requests for Reprints should be sent to:

Society of American Gastrointestinal Endoscopic Surgeons (SAGES)
11300 West Olympic Boulevard, Suite 600
Los Angeles, CA 90064
Tel: (310) 437-0544
Fax: (310) 437-0585
E-mail: sagesweb@sages.org

SAGES Publication #0031


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