CLINICAL PRIVILEGE WHITE PAPER

Transcription

1 Procedure 203 CLINICAL PRIVILEGE WHITE PAPER Capsule endoscopy Background Capsule endoscopy involves the use of a swallowable camera pill that creates a graphic representation of a patient s gastrointestinal (GI) tract to pinpoint the exact location of a detected pathology. The system allows physicians to locate small intestine diseases with increased precision and they can then provide more accurate and efficient treatment through either additional scope procedures or surgery. Prior to the development of the capsule endoscopy system, the standard method for detecting abnormalities in the small intestine was push endoscopy. In this procedure, physicians snake a flexible catheter carrying light, power, and the return video signal down the patient s throat. At the same time air is pumped in to inflate the GI tract. The procedure is so uncomfortable that sedation is required. With capsule endoscopy, the patient swallows a disposable capsule, which contains a miniature color video camera, a light source, a miniature transmitter, batteries, and an antenna. The capsule travels painlessly through the patient s stomach and intestines before being naturally expelled. During the procedure, the patient wears a wireless recorder that includes a sensor array on a belt around the waist. The video camera in the capsule captures images of the intestine and transmits them by radio frequency to the recorder. After approximately eight hours (or earlier, if the capsule has been excreted), the patient removes the belt and data recorder and returns them to the clinic. At the clinic, there is a computer workstation equipped with software that processes the images and data downloaded from the recorder into a short video film clip of the small intestine and additional relevant information from the digestive tract. Doctors can then examine the video to look for abnormalities. They can also edit and archive the video as well as save individual images and short video clips. The capsule endoscopy diagnostic system was developed by the Israeli company, Given Imaging, which has its American headquarters in Norcross, GA. The Given components consist of the ingestible M2A capsule, the Given data recorder, and the RAPID workstation. The system received marketing clearance from the U.S. Food and Drug Administration on August 1, A supplement to Briefings on Credentialing 781/ /02 1

2 Involved specialties Gastroenterologists, general surgeons, radiologists, and family practitioners Positions of societies and academies ASGE The American Society for Gastrointestinal Endoscopy (ASGE) publishes the statement Methods of Granting Hospital Privileges to Perform Gastrointestinal Endoscopy. In this statement, the ASGE states the following principles of initial credentialing: Credentials and privileges should be determined independently for each type of endoscopic procedure (sigmoidoscopy [flexible and rigid], colonoscopy, esophagogastroduodenoscopy [EGD], endoscopic retrograde cholangiopancreatography [ERCP], endoscopic ultrasonography) and any other endoscopic procedures. Credentialing for all procedures, except sigmoidoscopy, should require the ability to perform common associated therapeutic modalities. Competence in each endoscopic procedure requires both cognitive and technical components. Appropriate documentation should be required in the determination of competence in each procedure. This may include the completion of a formal training program (residency or fellowship) or documentation of equivalent training in other settings. Documentation of continued competence should be required for the renewal of endoscopic privileges. Following the successful completion of a gastrointestinal endoscopy training program, the trainee must - be able to integrate gastrointestinal endoscopy into the overall clinical evaluation of the patient - have sound general medical or surgical training - have a thorough understanding of the indications, contraindications, individual risk factors and benefit-risk considerations for the individual patient - be able to clearly describe an endoscopic procedure and obtain informed consent - have a knowledge of endoscopic anatomy; technical features of endoscopic equipment; and accessory endoscopic techniques, including biopsy, cytology, photography, and thermal and nonthermal endoscopic therapy - be able to accurately identify and interpret endoscopic findings - have a thorough understanding of the principles, pharmacology, and risks of sedation/analgesia 2 A supplement to Briefings on Credentialing 781/ /02

3 - be able to document endoscopic findings and therapy, and communicate with referring physicians - competently perform the procedures that were taught The ASGE further states that training in endoscopic techniques must be adequate for each major category of endoscopy for which privileges are requested. Performance of an arbitrary number of procedures does not guarantee competency. Whenever possible, competence should be determined by objective criteria and direct observation. The number of supervised procedures necessary to obtain competency will vary tremendously between trainees. Previously published required numbers of procedures were an estimate of the threshold number of procedures that must be performed before competency can be assessed. The number represents a minimum, and it is understood that most trainees will require more (never less) than the stated number. The current recommendation for the minimum number of procedures before competency can be assessed and the number of cases required include the following: Diagnostic EGD 130 Total colonoscopy 140 Snare polypectomy 30 Nonvariceal hemostasis (upper and lower, includes 10 active bleeders) 25 Variceal hemostasis (includes five active bleeders) 20 Esophageal dilation with guide wire 20 Flexible sigmoidoscopy 30 PEG (percutaneous endoscopic gastrostomy) 15 ERCP 200 The ASGE states that the above numbers may be too low but specific measures of competency have not yet been developed for all endoscopic procedures. These measures should be rapidly adopted in credentialing processes as they are developed. The ASGE does not currently publish credentialing or privileging criteria for capsule endoscopy but may recommend a minimum number of procedures before competency can be assessed in the future. A supplement to Briefings on Credentialing 781/ /02 3

4 SAGES The Society of American Gastrointestinal Endoscopic Surgeons publishes Granting of Privileges for Gastrointestinal Endoscopy. In this publication, SAGES states that credentialing for the performance of EGD and diagnostic and therapeutic colonoscopy should be based on prior demonstration of proficiency in the performance of these techniques. Proficiency should be substantiated by documentation provided by the applicant from prior mentors/supervisors. Eligible members/supervisors include residency program directors, chiefs of services, and other members of the teaching faculty. Individuals applying for privileges for EGD and colonoscopy should have demonstrated satisfactory completion of an Accreditation Council for Graduate Medical Education (ACGME) accredited training program in gastroenterology, general surgery, colorectal surgery, or pediatric surgery. Attestation to competency in the performance of these techniques should therefore be provided by the program director and, if deemed necessary, by the Credentialing and Qualifications Committee at the institution at which these privileges are being sought by other prior teaching faculty from the applicant s residency program. In the case of applicants who already have credentialing to perform these procedures and are applying for similar privileges at another facility or for renewal of privileges at the same facility, attestation as to competency should be provided by the applicant s respective chief of service. Maintenance of continued competency is the responsibility of the respective Credentialing and Qualifications Committee and should be based on ongoing review of the applicant s performance by their respective chief of service. SAGES also states that uniform standards that apply to all hospital staff requesting privileges to perform endoscopy, and to all areas where endoscopy is performed within a given institution should be developed. Criteria that are medically sound, not unreasonably stringent, and applicable in common to all those wishing to obtain privileges in each specific endoscopic procedure must be established. The goals must be the delivery of high-quality patent care. In addition, privileges should be granted for each major category of endoscopy separately. The ability to perform one endoscopic procedure does not imply adequate competency to perform another. Associated skills generally considered to be 4 A supplement to Briefings on Credentialing 781/ /02

5 an integral part of an endoscopic category may be required before privileges for that category can be granted. In regard to training, SAGES requires formal fellowship or residency training in gastroenterology or surgery. The ACGME mandates that the program must provide experience to each resident in the performance of a variety of rigid and flexible endoscopic procedures, including laryngoscopy, bronchoscopy, esophagoscopy, gastroscopy, colonoscopy, as well as the study and performance of new and evolving endoscopic techniques. For determination of competence, SAGES requires the following: Completion of a residency program that incorporates structured experience in gastrointestinal endoscopy. Competence should be documented by the instructor(s). Proficiency in endoscopic procedure(s) and clinical judgment equivalent to that obtained in a residency program. Documentation and demonstration of competence is necessary. Participation in gastrointestinal endoscopic training until competence in the specific procedure(s) is equivalent to the structured experience in gastrointestinal endoscopy that is acquired in the residency program. The training director s opinion and recommendation should be considered prima facie evidence for the trainee s acceptance as an individual qualified in gastrointestinal endoscopy. Likewise, attendance at short endoscopy courses, which do not provide supervised hands-on training with patients is not an acceptable substitute in the development of equivalent competency. SAGES makes the following statements regarding competency: Training and experience outside of a formal fellowship or residency program. Equivalent training/experience obtained outside a formal program is recognized, but must be at least equal to that described above. Certification of experience by a skilled endoscopic practitioner must include a detailed description of the nature of informal training, the number of procedures performed with and without supervision and the actual observed competency of the applicant for each endoscopic procedure for which privileges are requested. It is generally no longer acceptable for physicians to acquire equivalent endoscopic experience by performing unsupervised procedures when skilled endoscopists are available in A supplement to Briefings on Credentialing 781/ /02 5

6 the medical community. New procedures. Self-Training in new techniques in gastrointestinal endoscopy must take place on a background of basic endoscopic skills. The endoscopist should recognize when additional training is necessary. Proctoring. Recognizing the limitations of written reports, proctoring of applicants for privileges in gastrointestinal endoscopy by a qualified, unbiased staff endoscopist may be desirable, especially when competency for a given procedure cannot be adequately verified by submitted written material. The procedural details of proctoring should be developed by the credentialing body of the hospital and provided to the applicant. Monitoring of endoscopic performance. To assist the hospital credentialing body in the ongoing renewal of privileges, there should be a mechanism for monitoring each endoscopist s procedural performance. This should be done through existing quality assurance mechanisms or, alternatively, through a multi-disciplinary endoscopy committee. This should include monitoring endoscopic utilization, diagnostic and therapeutic benefits to patients, complications, and tissue review in accordance with previously developed criteria. Continuing education. Continuing medical education related to endoscopy should be required as part of the periodic renewal of endoscopic privileges. Attendance at appropriate local, national, or international meetings and courses is encouraged. Renewal of privileges. For the renewal of privileges, an appropriate level of continuing clinical activity should be required, in addition to satisfactory performance as assessed by monitoring of procedural activity through existing quality assurance mechanisms as well as continuing medical education relating to gastrointestinal endoscopy. Positions and other interested parties ABIM In addition to the primary certificate in internal medicine, the American Board of Internal Medicine (ABIM) offers a subspecialty certificate in gastroenterology. Physicians who are awarded the certificate must hold certification in internal medicine by the ABIM, and must have completed the requisite subspecialty training, demonstrated clinical competence in the care of patients, and passed the subspecialty examination. 6 A supplement to Briefings on Credentialing 781/ /02

7 Requisite training requirements The ABIM requires 36 months of gastroenterology training, of which a minimum of 18 months is clinical training. Requisite diagnostic and therapeutic procedures Proctoscopy/flexible sigmoidoscopy Diagnostic upper gastrointestinal endoscopy Colonoscopy, including biopsy and polypectomy Esophageal dilation Therapeutic upper and lower gastrointestinal endoscopy Liver biopsy Clinical competence requirements The ABIM requires substantiation that candidates for certification in the subspecialties are competent in clinical judgment, medical knowledge, clinical skills (medical interviewing, physical examination, and procedural skills), humanistic qualities, professionalism, provision of medical care, and continuing scholarship. Through its tracking process, the ABIM requires verification of the subspecialty fellows clinical competence from both the director of the subspecialty-training program and the chair of the department of medicine. All fellows must receive a satisfactory rating of overall clinical competence, humanistic qualities, and moral and ethical behavior in each of the required years of training. Given Imaging Inc., Norcross, GA According to Scott Fraser, director of marketing at Given Imaging, physicians use the capsule endoscopy system to diagnose conditions that include the following: Obscure bleeding Crohn s disease Inflammatory bowel disease Celiac disease Unexplained abdominal pain The physicians using the system are mainly gastroenterologists. In addition, there are some surgeons and radiologists who also use the system. To provide practical training and instruction in the use of the A supplement to Briefings on Credentialing 781/ /02 7

8 software, Given sends out a company representative to the physician s hospital or clinic. The representative works with the physicians until they are comfortable with the system. It usually only requires two or three cases because most of the gastrenterologists who are trained by Given representatives have already done hundreds of endoscopy procedures and are highly skilled at them. Essentially, says Fraser, what we ve done is remove the work from the procedure. All that s required with capsule endoscopy is the interpretation of the video, and when physicians use the system they aren t involved with the mechanics of operating a scope. Instead they re operating a software package on the computer to view what they used to view with the endoscopy scope. What they re really learning, he adds, is how to move a mouse. St. Elizabeth s Medical Center, Boston, MA It is not difficult for physicians to learn the mechanics of the capsule endosopy system, says David Cave, MD, chief of gastroenterology at St. Elizabeth s Medical Center, Boston. But that doesn t mean they can interpret what they re seeing. This is particularly true because the system is producing results that are more sensitive and specific than those that physicians have seen before. For physicians to be qualified to interpret capsule endoscopy results, Cave says the current prerequisite is completion of a fellowship program in gastrenterology. Then the physicians should have performed a significant number of endoscopic procedures that allowed them to interpret images in the small bowel. Because the capsule endoscopy procedure is so new, Cave says it is difficult to pinpoint the number of cases needed for competence. It s probably not a long learning curve for experienced endoscopic physicians, he says, because there is a finite number of clinical patterns that people will have to get used to. But, he adds, the number has proven to be bigger than he anticipated. For maintaining competence, Cave thinks physicians eventually will begin to specialize in small bowel procedures, much as they do with biliary track procedures. Then they will build up a large enough repertory of experience so that they ll know what they re looking at and can develop the sophistication to 8 A supplement to Briefings on Credentialing 781/ /02

9 do the procedure quickly and effectively on the appropriate patients. I would hate the idea of people trying to do just one or two of these procedures per year, he says. CRC draft criteria Minimum threshold criteria for requesting core privileges in capsule endoscopy The following draft criteria are intended to serve solely as a starting point for the development of an institution s policy CRC draft criteria regarding this procedure. Basic education: MD or DO Minimum formal training: Applicants must have completed an ACGME/American Osteopathic Association (AOA) accredited program in gastroenterology, general surgery, or radiology that included training in standard upper GI endoscopy and colonoscopy or have completed equivalent training under the supervision of an experienced endoscopic physician. Applicants must also have completed capsule endoscopy training by a Given Imaging company representative. Required previous experience: Applicants must be able to demonstrate that they have performed at least 100 capsule endoscopy procedures in the past 12 months. Note: A letter of reference should come from the director of the applicant s endoscopy training program as well as from the director of the applicant s capsule endoscopy training program. Alternatively, a letter of reference regarding competence should come from the chief of gastroenterology at the institution where the applicant most recently practiced. Reappointment Reappointment should be based on unbiased, objective results of care according to the organization s existing quality assurance mechanisms. Applicants must be able to demonstrate that they have maintained competence by showing evidence that they have performed at least 100 capsule endoscopy procedures annually over the reappointment cycle. In addition, continuing education related to capsule endoscopy should be required. A supplement to Briefings on Credentialing 781/ /02 9

10 For more information For more information regarding this procedure, contact: American Board of Internal Medicine 510 Walnut Street, Suite 1700 Philadelphia, PA Telephone: 215/ Fax: 215/ Web site: American Society for Gastrointestinal Endoscopy Thirteen Elm Street Manchester, MA Telephone: 978/ Fax: 978/ Web site: Given Imaging Inc. Oakbrook Technology Center 5555 Oakbrook Parkway, #355 Norcross, GA Telephone: 770/ Fax: 770/ Web site: Caritas Gastroenterology Group St. Elizabeth s Medical Center 736 Cambridge Street Brighton, MA Telephone: 617/ Fax: 617/ Web site: Society of American Gastrointestinal Endoscopic Surgeons 2716 Ocean Park Boulevard, Suite 3000 Santa Monica, CA Telephone: 310/ Fax: 310/ Web site: 10 A supplement to Briefings on Credentialing 781/ /02

11 Privilege request form Capsule endoscopy In order to be eligible to request clinical privileges for capsule endoscopy, an applicant must meet the following minimum threshold criteria: Basic education: MD or DO Minimum formal training: Applicants must have completed an ACGME/AOA-accredited program in gastroenterology, general surgery, or radiology that included training in standard upper GI endoscopy and colonoscopy or have completed equivalent training under the supervision of an experienced endoscopic physician. Applicants must also have completed capsule endoscopy training by a Given Imaging company representative. Required previous experience: Applicants must be able to demonstrate that they have performed at least 100 capsule endoscopy procedures in the past 12 months. References: A letter of reference should come from the director of the applicant s endoscopy training program as well as from the director of the applicant s capsule endoscopy training program. Alternatively, a letter of reference regarding competence should come from the chief of gastroenterology at the institution where the applicant most recently practiced. Reappointment: Reappointment should be based on unbiased, objective results of care according to the organization s existing quality assurance mechanisms. Applicants must be able to demonstrate that they have maintained competence by showing evidence that they have performed at least 100 capsule endoscopy procedures annually over the reappointment cycle. In addition, continuing education related to capsule endoscopy should be required. I understand that by making this request I am bound by the applicable bylaws or policies of the hospital, and hereby stipulate that I meet the minimum threshold criteria for this request. Physician s signature: Typed or printed name: Date: A supplement to Briefings on Credentialing 781/ /02 11

12 Clinical Privilege White Papers Advisory Board James F. Callahan, DPA Executive vice president and CEO American Society of Addiction Medicine Chevy Chase, MD Sharon Fujikawa, PhD Clinical professor, Dept. of Neurology University of California, Irvine Medical Center Orange, CA John N. Kabalin, MD, FACS Urologist/Laser surgeon Scottsbluff Urology Associates Scottsbluff, NE Publisher/Vice President: Suzanne Perney Executive Editor: Dale Seamans John E. Krettek Jr., MD, PhD Neurological surgeon Vice president for medical affairs Missouri Baptist Medical Center St. Louis, MO Michael R. Milner, MMS, PA-C Senior physician assistant consultant Phoenix Indian Medical Center Phoenix, AZ Managing Editor: Edwin B. Niemeyer Beverly Pybus President The Beverly Group Georgetown, MA Richard Sheff, MD Practice director Quality and credentialing The Greeley Company Marblehead, MA The information contained in this document is general. It has been designed and is intended for use by hospitals and their credentials committees in developing their own local approaches and policies for various credentialing issues. This information, including the materials, opinions, and draft criteria set forth herein, should not be adopted for use without careful consideration, discussion, additional research by physicians and counsel in local settings, and adaptation to local needs. The Credentialing Resource Center does not provide legal or clinical advice; for such advice, the counsel of competent individuals in these fields must be obtained. Reproduction in any form outside the recipient s institution is forbidden without prior written permission. Copyright 2002 Opus Communications, a division of HCPro, Marblehead, MA A supplement to Briefings on Credentialing 781/ /02