Effect of regulations and guidelines on gastroenterology programs.

Lutheran General Hospital is a 712-bed community hospital with a residency program in internal medicine that started in 1976. A two-procedure room gastrointestinal endoscopy and bronchoscopy laboratory was established in 1975. In 1982, it was expanded to four procedure rooms. In 1985, the endoscopy center moved from the basement to the first floor to provide easier access to outpatients. Because of the increase in volume, particularly outpatient procedures, our present four procedure rooms and three recovery beds are inadequate. The hospital is proceeding with an expansion to six procedure rooms and eight recovery beds. The increase in biliary tract diagnostic and therapeutic procedures and the difficulty of the radiology department in meeting the demand has necessitated the development of our own fluoroscopy unit as part of this expansion.

In 1978, the Division of Gastroenterology had a full-time medical director and five voluntary medical staff gastroenterologists, a nurse director of the laboratory, two gastrointestinal assistants, and a secretary. In 1993, the division included 5 full-time faculty members and 15 voluntary medical staff gastroenterologists. The endoscopy center personnel includes a nurse director, a nurse coordinator, 12 staff nurses and assistants, and 2 secretaries. ACGME approved a two-year gastroenterology fellowship at Lutheran General Hospital, which began in July 1993 with two first-year fellows.

Space and Equipment

The activities of the gastrointestinal endoscopy center are affected by numerous government agencies. The Centers for Disease Control (CDC), through the Center for Infectious Diseases,[1] sets guidelines for prevention and control of infectious diseases in health care facilities. The Occupational Safety and Health Administration (OSHA) establishes guidelines for cleaning and sterilizing endoscopes to prevent the spread of infectious disease. The U.S. Food and Drug Administration (FDA) may initiate the process of product recall where equipment or devices used in endoscopy (endoscopes, biopsy forceps, brushes, mono and bipolar cautery, cutting devices, laser, etc.) represent a hazard to patients or other individuals.[1] The addition of a fluoroscopy unit to our endoscopy center requires that we comply with standards of the U.S. Nuclear Regulatory Commission (NRC) and hire a radiology technician.

A specific compliance problem arose in our expansion with the need to obtain new washers for endoscopes. The washers in use did not meet current Joint Commission for Accreditation of Healthcare Organizations (JCAHO) standards. For the new cleaning room, we acquired washers that are in compliance with current JCAHO regulations.

The gastrointestinal endoscopy center has to comply not only with federal regulations, but also with multiple state regulatory agencies. Endoscopy centers have to be in compliance with state fire codes and standards for use of electrical devices and equipment that may differ from federal regulations. Because construction costs were under $1 million, we were not required to obtain a certificate of need from the State of Illinois.

Quality of Care

In addition to regulations pertaining to the physical plan of the gastrointestinal endoscopy center, multiple external regulations and guidelines govern the quality of procedures and patient care and set standards for behavior and clinical and technical expertise by physicians, nurses, and support personnel in the center.

Endoscopy center employees are primarily registered nurses. Their performance is subject to JCAHO standards for nurses detailed in the Accreditation Manual for Hospitals.[2] Standards set by the JCAHO for patient and family education need to be considered, and compliance needs to be ensured. The gastrointestinal endoscopy center must comply with regulations for orientation, training, and education of staff, as stipulated in the Accreditation Manual for Hospitals: "The new staff members need to be oriented regarding the organization's missions, governance, policies, and procedures to be performed. The new staff members also need to be given specific information about job description, performance, expectations, infection control, and quality assessment of the organization."[2]

The Society for Gastrointestinal Nurses and Associates (SGNA), a national organization, recently published standards for practice by gastroenterology nurses and associates in a monograph that outlines the activities and levels of proficiency required of gastroenterology nurses and gives examples of standards of care that pertain to all activities.[3] SGNA has also developed a certifying examination to ensure that nurses have the required cognitive skills.

Multiple outside agencies regulate the activities of gastroenterologists. Attending physicians are members of the medical staff and are subject to regulations, described in the Accreditation Manual for Hospital,[2] that define the standards of licensure and privileges for physicians to practice and that charge the hospital with developing mechanisms for reviewing the medical staff's privileges and ensuring that staff members have appropriate skills. These functions are delegated to the medical staff by the executive committee of the hospital.

To comply with recent JCAHO regulations, we developed a working relationship with the department of anesthesia, which is now charged with supervising sedation, "with or without analgesia, for which there is a reasonable expectation that in the manner used, the sedation-analgesia will result in the loss of protective reflexes for a significant percentage of a group of patients."[2] The standards for conscious sedation had to be reviewed by the nurse and physician directors of the endoscopy center and the chairman of the department of anesthesia, who is ultimately responsible. Once the standards were agreed upon, the chairman of anesthesia delegated day-to-day supervision of compliance to the physician and nurse directors. Compliance with JCAHO guidelines establishes standards for safety of the individual patient and ensures the hospital's participation in the Medicare program.

The American Society for Gastrointestinal Endoscopy (ASGE), often in concert with other digestive disease societies such as the American Gastroenterological Association (AGA) and the American College of Gastroenterology (ACG), has developed standards of care in endoscopy to ensure high-quality care is provided by physicians. Because gastrointestinal endoscopy is also performed by surgeons, the Society for Surgery of the Alimentary Tract (SSAT), formed by surgeons with an interest in digestive diseases and skills in gastrointestinal endoscopy, works with other professional societies to maintain similar quality of care standards.

ASGE has published numerous statements and guidelines for practicing gastrointestinal endoscopists and endoscopy centers,[4,5] including ethical issues.[6] These guidelines are not mandatory, but they may be used to evaluate performance if questions of quality of care are raised.

The recent emergence of short endoscopy training courses and the performance of endoscopies by relatively untrained physicians has resulted in publication of position papers by digestive disease societies opposing the performance of endoscopy by undertrained physicians. ACG requested a legal opinion from a Washington, D.C., law firm and circulated it to interested parties in November 1992.[7] These position papers and legal opinions should be used by hospitals and their credentialing bodies to ensure performance of endoscopy only by qualified physicians and thus help prevent the occurrence or recurrence of complications that may lead to increased morbidity and mortality and/or to litigation.

Educational Programs

Because of the development of a gastroenterology fellowship at the hospital, we need to comply with guidelines for training in gastrointestinal endoscopy established by ASGE, which has determined the minimum number of procedures that a physician should perform to assess competence.[8] The quality of the performance of the procedures by trainees needs to be established.[9] In addition to proficiency in procedures and expertise as a consultant, humanistic qualities such as those put forth by the American Board of Internal Medicine[10] (ABIM) need to be considered.

The regulatory body charged with accreditation of training programs is the Residency Review Committee for Internal Medicine (RRC-IM), sponsored by the Accreditation Council for Graduate Medical Education (ACGME). RRC-IM accredits new postgraduate educational programs in internal medicine and evaluates them with periodic site visits. Special requirements are available both for internal medicine and gastroenterology programs.[11] RRC-IM has the power, during a site visit, to cite a program for deficiencies and, if they are not corrected, to initiate a process leading to loss of accreditation of a program in a manner similar to the government agency's ability to demand compliance from a hospital and to recommend closing of the facility if the situation warrants.

Another outside agency that participates in the regulation postgraduate medical training is the Educational Commission for Foreign Medical Graduates (ECFMG). Because there is a significant number of physicians training in the United States who are not graduates of a medical school in this country (one of our two current fellows is a foreign medical graduate), the program and hospital have to ensure appropriate visa status and have to comply with specific educational requirements for foreign medical graduates.

The relationship of regulatory agencies and professional organizations with gastroenterology functions are summarized in the table on left. An environment that fosters physician participation and encourages the physician's executive role has accompanied the growth of the gastroenterology division and endoscopy center. Understanding of and compliance with regulations and standards of care may have been instrumental in the approval of the gastroenterology fellowship in our hospital.

Regulatory Agencies and Professional Organizations Affecting
Gastroenterology
Agency/         Gl Lab Operations    Professional Staff   Fellowship
Organization     and Equipment      Physicians   Nurses   Program
CID                   +                 +          +         x
OSHA                  +                 x          x         x
FDA                   +                 x          x         x
NRC                   +                 x          x         x
JCAHO                 +                 +          +         +
SGNA                  -                 -          +
ASGE                                    +                    +
ABIM (RRC-IM)         -                 x          -         +
ECFMG                 -                 -          -         +

+ = Direct Effect   x = Indirect Effect   - = No Effect

References

[1.] Regulatory and Voluntary Compliance Agencies. Safe Guide for Health Care Institutions, 4th Edition. Chicago, Ill.: AHA Publishing, Inc. p. 11-25, 1989. [2.] Accreditation Manual for Hospitals. Chicago, Ill.: Joint Commission on Accreditation for Healthcare Organizations, 1993, Sections N.C. 1 to N.C.5, P.F. 1, G.1., M.S.1. to M.S.5, .A.1. [3.] SGNA Standards for Practice for Gastroenterology Nursing. Chicago, Ill.: Society for Gastrointestinal Nurses and Associates, 1992, pp. 1-8. [4.] "ASGE Publication on Statements and Guidelines Developed by the Standards of the Training and Practice Committee of the ASGE." Gastrointestinal Endoscopy 34(Suppl.): 1S-40S, May-June 1988. [5.] American Society for Gastrointestinal Endoscopy publications 1019 (1/88), 1020 (1/88), 1022 (1/88), and 1024 (4/91). [6.] ASGE Ethics Document, adopted August 1992. [7.] Legal memorandum to American College of Gastroenterology from law offices of Williams & Connolly, Nov. 1992. [8.] Principles of Training in G.I Endoscopy. Manchester, Mass.: American Society for Gastrointestinal Endoscopy, 1991. [9.] Cass, O., and others. "Objective Evaluation of Endoscopic Skills during Training." Annals of Internal Medicine 118(1):40-3, Jan. 1993. [10.] Guide to Awareness and Evaluation of Humanistic Qualities in the Internist; 1992-1995. Portland, Ore.: ABIM, 1992. [11.] Directory of Graduate Medical Programs. Chicago, Ill.: American Council on Graduate Medical Education, 1992-1993, pp. 44-9, 54.

Juan J. Engel, MD, is Director, Division of Gastroenterology Department of Medicine, Lutheran General Hospital, Park Ridge, Ill. The author thanks William J. Arnold, MD, Chairman, Department of Medicine, for his review of this manuscript and his suggestions; Norah Connelly, RN, Nursing Director, and Linda Michl, Secretary, Gastroenterology Laboratory, for their assistance in securing part of the references used; and Dawne Ideker-Sowle, Gastroenterology Administrative Secretary, for typing this manuscript