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Practical Training and Research in Gynecologic Endoscopy

 Teaching and credentialing

J.F. Hulka M.D.
University of North Carolina
Chapel Hill, N.C.

B. Levy, M.D.
Franciscan Health System
Federal Way, WA.

I. History

Providing and documenting adequate training in laparoscopy has been an unsolved problem since laparoscopy became widespread in the 1970s. Part of the problem was the slow acceptance of the method in academic training programs compared to the enthusiastic acceptance in the private sector of medicine. In the United States, although there were thousands of private physicians providing laparoscopic sterilization to their patients by the mid 1970s, it was not until the fall of 1981 that the American Board of Obstetrics and Gynecology notified the directors of residency programs that they would be required to sign a verification as of 1982 that board candidates demonstrate the necessary technical skills to competently perform endoscopic procedures in the pelvis and indicate the number of laparoscopies performed in training1. Credentialing of physicians who learned laparoscopy out of residency had not been addressed at this time by any medical organization, even though laparoscopic complications, including sterilization failures, were the leading cause of lawsuits against practicing gynecologists.

The situation did not change with the advent of operative laparoscopy. Indeed, an editorial on the subject in Fertility and Sterility explained, "Credentialing a surgeon’s skills, particularly when they have not been acquired in residency, can be a political and legal hot potato"2.

Politically, the various medical organizations who could assume responsibility had avoided doing so for fear of the potential for being sued by an applicant whose request for credentialing would be rejected.

II. Credentialing a Local Matter

The Hospital Association of New York was early in reviewing laparoscopically assisted vaginal hysterectomies and other advanced laparoscopic procedures3 towards credentialing by hospitals.

The position of the American College of Obstetrics and Gynecology is that the process of credentialing for operative endoscopy is a local matter for the hospital in which these procedures are performed. Their "committee opinion" no. 106 and 107 of April 1992 offered guidelines for hospitals granting privileges to gynecologists in operative laparoscopy and hysteroscopy. In August 1994, the Committee on Gynecological Practice supplanted those with committee opinion #142 "Credentialing Guidelines for New Operative Procedures." Their current position is that the problem is a local matter.

The Society of Obstetricians and Gynaecologists of Canada drew up similar recommendations4, and in 1992 a committee (chaired by one of the authors [JH]) of the American Association of Gynecologic Laparoscopists (AAGL) issued similar guidelines reproduced here:

AAGL Credentialing Guidelines for Operative Endoscopy (1992)

The following guidelines are suggested for departmental qualifications of gynecologists requesting privileges to perform operative endoscopic procedures:

  1. Each applicant must be a member in good standing of the Institution and Department of Obstetrics and Gynecology.
  2. Each applicant should have extensive experience utilizing the laparoscope and hysteroscope for diagnostic or sterilization procedures or both. Experience should include the use of video monitors to direct procedures in addition to operating through the endoscope.
  3. Each applicant must have documented resident education and experience or didactic program experience, usually obtained by a course in operative endoscopy which has been approved for AMA category 1 credits or ACOG cognates. Training should include didactic sessions of 8-10 hours which cover theory, and review instruments and safety factors. Following didactic training a "hands-on" laboratory must be incorporated with each participant having at least 2 hours of actual experience. Tissue models should be used.
  4. The applicant should observe live surgery by other surgeons. Following this training experience, each surgeon should be supervised in the use of these techniques, preferably in the hospital where privileges are requested. The supervisor should make recommendations to the department in writing.
  5. Gynecologic surgeons should restrict their activities to equipment with which they are qualified and procedures for which they are credentialed.

In 1992 Azziz proposed5 a three level measure of skills:

  1. Ectopic, mild to moderate adhesiolysis, small to moderate endometriomas and endometriosis
  2. Large endometriomas, severe adhesiolysis, salpingostomy
  3. Innovative surgery: pre-sacral neurectomy, lymphadenectomy, colon resection.

He suggested level 1 be acquired in residency training, level 2 afterward in practice and after a training program like the one outlined above.

III. Credentialing a State’s Obligation

In June 1992, seven deaths in New York State after laparoscopic cholecystectomies performed by general surgeons, prompted the New York State Health Department to issue guidelines specifying "that surgeons must perform at least 15 laparoscopies under supervision" before a hospital could issue privileges permitting a doctor to perform this procedure independently. This, to our knowledge, was the first instance in the U.S. of a state imposing training guidelines in surgery. Hitherto physicians imposed these guidelines on themselves. (New York State also issued similar guidelines for laparoscopic hysterectomies and other endoscopic procedures and has recently offered guidelines for techniques of abdominal entry.)

Medicine was suddenly reminded that it is a State’s obligation to protect its citizens from poor surgical training if surgeons or their societies would not assume the responsibility of doing so. The hot potato was now in medicine’s hands.

In England the death of the wife of a prominent citizen following laparoscopy in 1994 prompted her grief-stricken husband to inquire into the experience and qualifications of the performing surgeon. The results were sufficiently disturbing to prompt the Royal Colleges of Surgery and of Obstetrics and Gynaecology to form work parties to come up with recommendations for training and credentialing in operative laparoscopy, an effort currently in progress (see below). In effect, it was necessary for the State to remind us of our obligation to control and regulate surgical training and certification.

IV. Current Credentialing Efforts in Medicine

A. The United States

After exhaustive efforts to convince the American Board and the American College of Obstetrics and Gynecology of our obligation, an independent organization, the Accreditation Council for Gynecologic Endoscopy was established in 1994 to establish criteria for documenting the experience and qualifications of gynecologists performing advanced endoscopic surgery. This effort is currently directed by one of the authors (BL). Gynecologists wishing to be "grand-fathered" (accredited without the future testing process) have been invited to submit certified hospital lists of difficult operative endoscopic cases (50 laparoscopies and/or 20 hysteroscopies). Dictated operative notes of the procedures on these lists as well as pathologic reports and a discharge summary in questionable cases are currently being reviewed under close scrutiny by the Council members. The National Practitioner Data Bank is queried and each applicant must demonstrate adequate continuing medical education (CME) credits as well as good standing in the community as evidenced by letter of recommendation. Almost 1,000 gynecologists have submitted such lists, and the review process is more burdensome then had been anticipated.

Before beginning the process of outside reviews, the seven council members carefully reviewed all of each others applications. Any discrepancies were clarified.

From those accredited, a committee will prepare a written examination in endoscopy, similar to American Specialty Board Part I examinations, with the aid and supervision of the Educational Testing Service at Princeton. This is being designed as a self-assessment program. In addition, unique tests of surgical skills may be devised, including hand-eye coordination utilizing television, as well as specific laparoscopic skills such as knot-tying, haemostasis and adhesiolysis using non-viable tissue models. Applicants granted certification in operative laparoscopy and/or hysteroscopy are being encouraged to participate in an ongoing case registry to support outcomes research in endoscopic surgery. The Council is particularly interested in complications of advanced procedures.

Among general surgeons, a newly-formed society of American Gastrointestinal Endoscopic Surgeons (SAGES) commented on privileges6, and the American College of Surgeons issued a statement concerning evaluation of credentials7.

B. United Kingdom

A working party of the Royal College of Obstetricians and Gynaecologists of London8 noted that "whether surgeons should be required to submit to a form of certification may be a point of dispute. ... HOWEVER...THIS WOULD BE AN APPROPRIATE DEVELOPMENT AND OUR COLLEGE SHOULD LEAD THE WAY IN THIS RESPECT. (Capital letters in the original)" After a review of what they termed Minimal Access Surgery (MAS) procedures, current training, and complications, they recommended a classification of degrees of skill required. Similar to Azziz in 1992, they have established four levels of laparoscopic procedures:

Level 1: Diagnostic Laparoscopy

Level 2: Minor procedures

  • Sterilization
  • needle aspiration of small cysts
  • ovarian biopsy
  • adhesiolysis not involving bowel
  • ventro-suspension
  • coagulation of endometriosis, AFS stage I

Level 3: More Extensive Procedures

  • Laser/coagulation of polycystic ovaries
  • Laser/coagulation of endometriosis AFS stage II or III
  • Utero-sacral nerve ablation
  • Salpingostomy
  • Salpingectomy, salpingo-oophorectomy
  • Moderate to severe adhesiolysis
  • Bowel adhesiolysis
  • Ovarian cystectomy
  • Laser management of endometrioma
  • Assisted vaginal hysterectomy without associated pathology

Level 4: Advanced Laparoscopy

  • Myomectomy
  • Endometriosis AFS stage III and IV
  • Pelvic lymphadenectomy
  • Pelvic side wall/ureteric dissection
  • Pre-sacral neurectomy
  • Dissection of obliterated pouch of Douglas
  • Incontinence reconstruction

Among their conclusions, they stated "The RCOG should set up a MAS Training and Certification Committee under the aegis of the Higher Training Committee... The Committee will identify a panel of gynaecologists already experienced in performing and teaching laparoscopic and hysteroscopic surgery and identify potential trainers to undertake the proctorships. (bold face in the original)".

In December 1994, a second RCOG publication9 noted that the Royal Surgical Colleges had agreed upon a common syllabus so that when medical school graduates are applying for basic training, "...any trainee who is found to be inept at the surgical skills training course will be advised that it is not appropriate for them to proceed with a career in surgery. ...However, procedure specific credentialing would not be introduced." Three laboratory centers for training had been established nationally (London, Leeds and Dundee).

The Royal College of Obstetricians and Gynaecologists would use these three centers also. After complying with the training requirements set forth {similar to those outlined above) the RCOG would issue a certificate of competence. This was true for any practicing gynaecologist applying for such a certificate "...following an assessment by identified trainers."

The implementation of the British plan is currently delayed by a problem similar to that in the U.S.: a review of the qualifications of potential preceptors to train and supervise other surgeons learning endoscopy.

C. Others Countries

Canada4 and Australia10 have begun similar efforts, and are experiencing similar delays, both qualification and political in nature. At the time of writing France and Switzerland are establishing credentialing requirements. Indeed, the purpose of this publication by the World Health Organization is to assist in this difficult process of establishing solid criteria for training of physicians wishing to provide the unfolding benefits of operative endoscopy to the patients in their countries.

References

  1. Hulka, J.F. Textbook of Laparoscopy, Grune and Stratton, Inc., Orlando Fla. 1985
  2. Azziz, R. Operative endoscopy: the pressing need for a structured training and credentialing process. Fertil and Steril 58:1100-2, 1992
  3. Hospital Association of New York State. Overview of ACOG/HANYS Considerations Regarding Laparoscopically Assisted Vaginal Hysterectomy and other Advanced Laparoscopic Procedures. 1991.
  4. Society of Obstetricians & Gynaecologists of Canada. Guidelines for Training in Operative Endoscopy in the Specialty of Obstetrics & Gynaecology. Dec 1992
  5. Azziz R. Training and certification in operative endoscopy. In: Azziz r, Murphy AA, editors. Practical manual of perative laparoscopy and hysteroscopy. New York: Springer-Verlag 1992:217-9
  6. Society American Gastrointestinal Endoscopic Surgeons. (SAGES) Granting of Privileges for Gastrointestinal Endoscopy by Surgeons. January 1992.
  7. American College of Surgeons. Statements on Emerging Surgical Technologies and the Evaluation of Credentials. Bulletin of the American College of Surgeons Vol. 79, No. 6: 40-41, June 1994.
  8. Report of the RCOG Working Party on Training in Gynaecological Endoscopic Surgery. RCOG Press, June 1994
  9. Implementation of the Recommendations of the Working Party in Gynaecological Endoscopy Surgery, RCOG Press, December, 1994
  10. Royal Australian College of Obstetricians and Gynaecolgists - Guidelines for training in advanced operative laparoscopy, July 1993