I GOVERNANCE ^122

To provide effective and efficient women’s health care, a well-defined organizational structure must be in place. The organizational structure will facilitate compliance with operational, regulatory, risk management, and ethical guidelines.

The Department of Obstetrics and Gynecology

Open communication and a multidisciplinary approach to problem solving facilitate the growth and development of obstetric and gynecologic services within an institution, which enables it to better meet the needs of patients and the community. Administration and departmental leadership should strive to maintain such an approach in the management of these services. The departmental organization should fulfill the following functions:

• Clarify issues of accountability.

• Provide departmental representation in institutional policy-making decisions.

• Provide a system of governance for clinicians who provide obstetric and gynecologic services within an institution.

• Foster collaborative practice with other allied personnel engaged in the care of women (eg, certified nurse-midwives, nurses, physician assistants, nurse practitioners, technicians, therapists, clergy and others providing spiritual support, support personnel, clerical workers, and administrators).

• Foster collaborative practice with other medical specialists.

The ultimate goal of a department of obstetrics and gynecology is to pro­vide a mechanism that ensures the best possible patient care and treatment outcome.

The department of obstetrics and gynecology should be organized as an independent unit. In addition to ensuring the provision of quality patient care, the department also should address the prudent use of medical resources, liability issues, and equitable treatment of departmental mem­bers, and it should be responsive to the needs and policies of the parent institution. It should be responsible for education and research and should ensure regulatory compliance. At the same time, it should maintain a rela­tionship with the community. A sound organizational plan encourages the prevention of problems, monitors quality of care, and supports quality improvement. The plan should include processes for the early identifica­tion of problems and, using evidence-based medicine, address issues in a fair and nonpunitive manner as a teaching and learning experience. Errors and problems, once identified, should be dealt with quickly. A depart­ment’s structure should be evaluated in terms of improving the outcome of patient care.

The functional responsibility of the department of obstetrics and gyne­cology is delegated by the institution’s governing board. The duties, expec­tations, and authority of the department chair (and other departmental leadership, if any) should be delineated clearly. The chair is responsible for communicating and ensuring compliance with hospital and depart­mental policies and procedures. All individuals who are granted privileges in a department should be subject to the policies and procedures of that department and should respect them. When physicians accept leadership positions, such as a chief medical officer, chief of staff, or department chair, their primary purpose is to establish an environment in which quality improvements can thrive. As a corollary to the physician’s time commit­ment, the hospital should consider providing a stipend for these leadership positions.

The size and type of institution, together with the bylaws of the medical staff, determine the type of organization appropriate for the department of obstetrics and gynecology. The Joint Commission requires bylaws to address the medical staffs self-governance and its accountability to the governing board for the quality and safety of patient care and recognizes that the governing board, medical staff, and administration must collabo­rate to achieve this goal. The organizational needs of a department in an institution devoted exclusively to patient care may differ from those of a department with teaching and research responsibilities. Regardless, there are some basic components and key alliances that provide an organiza­tional approach to quality patient care.

Officers

Each department should have a designated head or chair, who may be elected or appointed. That individual should be chosen on the basis of professional ability, experience, management skills, and commitment to continued improvement of patient care.

The responsibilities and authority of the department leadership should be defined in writing by the medical staff and institution administration. They should be consistent with the general structure of the medical staff bylaws and other accepted external standards established for such facilities. Responsibilities of the department head generally include the following:

• Make recommendations on the appointment, reappointment, pro­motion, or suspension of staff.

• Make recommendations to grant or withdraw privileges as man­dated in the institution's bylaws.

• Periodically evaluate, in writing, the professional performance of each member of the department, and maintain confidential docu­ments appropriately.

• Delineate clinical privileges.

• Provide a system whereby substandard performance of any depart­ment member can be identified and corrected.

• Develop, institute, and oversee the quality assessment and quality improvement programs for the department.

• Integrate the department’s quality assessment and improvement activities with those of the institution.

• Establish committees with clear charges regarding purpose, tenure, and reporting responsibilities.

• Appoint committee members.

• Provide a mechanism for appointing committee chairs.

• Recommend and approve members of the department for appoint­ment to institutional committees.

• Provide a continuing education program for department members, and maintain records of attendance.

• Establish and monitor policies, procedures, and protocols.

• Collaborate with other professional health care providers when appropriate.

• Serve as a consultant or arbitrator for unresolved differences of opinion regarding patient care or questions of policy.

• Make recommendations regarding policies for any obstetric or gyne­cologic care needed by women admitted to other services within the institution.

• Establish responsibilities of all department health care providers for teaching and patient care, and ensure that a schedule of assignments is established to carry out such activities.

• When responsible for medical student or resident education, ensure that standards for content, quality, and needs for supervi­sion are met in accordance with the Liaison Committee on Medical Education and the Accreditation Council for Graduate Medical Education.

• Serve as a voting representative of the department on the medical staff executive committee.

• Participate in any institutional planning for further development or changes that may affect the department.

Members of the department should be involved in the formulation of policies to improve the quality of patient care. A consensus should be achieved on these policies when possible, and they should apply to all members of the department. The department head should review all policies and procedures and ensure that they meet the standard of care.

Mechanisms by which these policies are formally adopted and reported should be established.

If there is a department staff fund, it is necessary to maintain accurate records of the use of that fund and to obtain an external audit at least annu­ally. If the fund’s size justifies it, a treasurer may be elected; alternatively, a departmental advisory committee can be made responsible for overseeing the fund. Access to, and management and disbursement of, department funds must conform to the standards set by the department, the institution, and generally accepted accounting principles.

Committees

The purpose of a committee is to address specific issues that relate to patient care. The extent to which a department will have committees for certain functions will depend on the size and complexity of the institution and the department. In some instances, the institution’s organizational structure may fill some of those needs and require only departmental participation. When an institution-wide committee performs any of these functions, the department of obstetrics and gynecology should have active membership on that committee.

The department head should be familiar with the institution’s commit­tee structure. Certain institutional committees make decisions that have substantial effects on patient care within the department of obstetrics and gynecology (see Box 1-1). The department should have representation on these committees. The representatives should report on the activities of these committees and convey their significance and importance to the other members of the department.

All department members should be strongly encouraged to participate in the activities of the department, including serving on committees. Such involvement encourages a better understanding of how the department functions and maintains the interest of the members.

Box 1-1. Items for Committee Review ^

The institutional governance structure should ensure, at a minimum, the ongoing function of the following activities:

• Medical staff credentials review

• Reappraisal and reappointment

• Medical records review

• Bylaws, rules, and regulations review

• Quality assessment and improvement and patient safety

• Infection and environmental control evaluation

• Pharmacy and therapeutics control

• Laser safety control

• Risk management review

• Hospital admissions and complications review

• Continuing education and performance standards review of all members of the health care team

• Operating room and tissue review

• Ethics review

of objectives, such as finance, managed care, and education. At least one committee should focus on assessment and improvement of the quality of patient care (see also the “Quality Improvement” section later in Part 1).

Committees may be ad hoc or standing. Ad hoc committees are estab­lished for a limited purpose and a limited duration. Standing committees are required to carry out basic departmental functions. The department head should appoint members of ad hoc committees. These committees should have the broadest representation possible to include individuals who might be affected and those who can contribute. An ad hoc committee should have a specific charge and should be given specific time require­ments for reporting. When the ad hoc committee has achieved its goal and submitted its report, it should be disbanded formally unless there is a compelling reason to continue its function or to convert it to a standing committee.

In departments with large numbers of staff members, an executive or advisory committee is desirable to expedite the decision-making process and to provide representation for all members of the staff. There should be appropriate representation from full-time, part-time, and volunteer staff in departments that have such a configuration.

Meetings

Regular meetings and conferences of the department should be held. A level of acceptable attendance for continued maintenance of privileges should be established. An agenda should be developed for each meeting. The number and complexity of these meetings will vary with the size and intricacy of the department:

• An administrative and business focus may address needs, changes, or problems within the department.

• Committee reports can keep the department members informed.

• Quality assessment, risk management, and quality improvement activities should be summarized and discussed when appropriate and are helpful in improving patient care.

• Minutes of departmental meetings should be documented. They provide continuity in the activities of the department and help keep the medical staff administration informed. Information and policy decisions that are applicable to the department should be distrib­uted to all staff members.

• Quality assessment and quality improvement activities are privi­leged and should have legal protection under state or federal laws. Legal counsel should be sought in establishing and maintaining such committees. Records of such activities are confidential and should be filed separately from the business minutes of the depart­ment in a secure location.

Education and Research

In addition to regular business meetings of the department, educational conferences should be held. These conferences should include continu­ing education activities provided by the members of the department, the institution, or visiting lecturers. Such activities create an opportunity to provide current information about evidence-based approaches to patient management, technological advances, and new technological develop­ments in the field. These conferences also can be used to discuss global issues identified in the quality assessment process.

Education is of key importance in all institutions. The medical staff and other health care providers achieved their degrees, certifications, and licensure through a formal education process. Continuing education is required to maintain and update these skills and knowledge. It is a respon­sibility of the institution and each department to have an organized educa­tional program appropriate to its needs. The medical and nursing staff who provide gynecologic care at any level should become knowledgeable about current practices through in-service training programs. Such educational programs should be sensitive and responsive to any deficiencies that have been identified by either the institution or the department. These programs are an excellent forum for introducing new technology and treatment methods.

An educational program provides the opportunity to exchange useful information with others, including clinicians, risk managers, ethicists, or guest speakers. The sponsorship of guest speakers should be reviewed to avoid any actual or implied impropriety by linking program financing to sales of drugs or equipment (see also the “Human Resources” section later in Part 1).

Educational programs must take into account ethical obligations to the patient. Specific consent should be obtained for some procedures included in such programs, such as pelvic examinations under anesthesia for educa­tional purposes. Although alternatives to using patients under anesthesia to teach pelvic examination exist, such as the use of professional patients, the examination of actual patients under anesthesia before surgery allows for increased relaxation of the pelvic floor muscles, which may be beneficial to the education process. Because this examination offers no personal ben­efit to the patient, it should be performed only with the patient’s specific informed consent (see also the “Ethical Issues” section later in Part 1, the “Information Management” section in Part 2, and Appendix A.)

Only certain institutions have active research programs. Most of these institutions are teaching hospitals, which also offer residency programs for specialty training. Research experience is a special requirement for resi­dents, as defined by the Residency Review Committee for Obstetrics and Gynecology. When research is clinical and affects patients, institutional rules should be in place to protect the welfare of each patient. In general, this function is best served by an institutional review board (IRB), which reviews research proposals and has the authority to approve or reject them based on their implications for patients’ rights and safety. The role of an IRB is to review and monitor biomedical research involving human partici­pation, with the goal of ensuring the protection of the rights and welfare of the participants. Federal guidelines have been established for research con­ducted, supported, or otherwise regulated by the federal government (see Resources). The IRB should have written policies that are consistent with federal guidelines. Its members should be selected to reflect expertise in science, ethics, and the sensitivities of the community. Research that affects patients must not be done without such review and written approval. An IRB review is required for all clinical investigations. Additionally, many journals require IRB review as a condition of publication, even for studies that would not otherwise need IRB review.

In the recruitment of participants for research, women should be pre­sumed eligible for all studies except those that solely target the health concerns of men. Female participants should be included in sufficient numbers so that the analysis of data is valid for both sexes and so that sex differences can be detected. In addition, research on women should con­form to general scientific standards and requires informed consent, without inducements to influence participation. It is appropriate for investigators and sponsors, with the approval of the IRB, to require a negative pregnancy test result and effective birth control measures for women of reproductive capacity as criteria for participation in research when the research may pose more than minimal risk to the fetus. The health care needs of the woman always take precedence over research interests.

Involvement of adolescent participants in research is important to improve adolescent health care and to aid in health policy decisions. Researchers should be familiar with, and adhere to, current federal regu­lations and federal and state laws that affect research. They include laws regarding age of majority and emancipation, minor consent statutes, con­fidentiality, and reporting of abuse, as well as a federal educational law that governs certain research conducted in schools (see also the “Human Resources” section later in Part 1 and the “Adolescents” section in Part 3). More detailed guidance is available to assist researchers in understanding these laws and in determining when parental permission is required and when it may be waived (see Resources).

Ambulatory Surgical Facilities

A freestanding ambulatory care surgical facility should have a governing board similar to a hospital’s board of trustees. This governing board should have final authority and responsibility for the following:

• Patient care

• Facilities

• Services

• Appointment of the medical staff

• Delineation of clinical privileges

• Administrative regulations

A policy similar to that used in a hospital must be established for grant­ing privileges. A hospital-based facility usually functions under the hospi­tal’s governing board. Hospital regulations determine the staff privileges for such a facility.

Some ambulatory surgical facilities offer a wide variety of procedures, whereas other facilities limit their services to a particular surgical spe­cialty. If obstetric and gynecologic services are provided, obstetrician­gynecologists should be included in the process of developing policies related to overall operations, quality assessment activities, and patient care. Physicians should check state and federal laws and regulations on self-referral prohibitions before referring a patient for health care services in which the physician or a member of the physician’s immediate family has a financial interest. These laws and regulations continue to evolve, and current requirements should be reviewed (see also the “Human Resources” section later in Part 1).

Offices

Medical office practices, especially any facility in which outpatient surgi­cal procedures are performed, should have a designated medical direc­tor. In a solo practice, the physician should assume the role of medical director. In a group practice, one of the partners should be designated as medical director. In very large practices, other individuals may assume some of the responsibilities (eg, Director of Quality Assurance, Director of Credentialing). The medical director verifies the qualifications and safety of people, equipment, space, and supplies, which requires a full understand­ing of all the elements necessary for the safe completion of any planned procedure. Involving the collective efforts of all stakeholders should help ensure a safe environment for the delivery of care. Stakeholders include all participants: the patient, the receptionist, nursing staff, physicians, mid­level health care providers, and outside participants, such as laboratory, pathology, and vendor services.

Regular meetings should be held for all office staff. These meetings can be useful in improving staff communication and in exploring ways to enhance patient relations and communication. The office staff meeting is the ideal setting to discuss quality assessment issues and risk management and provide continuing medical education for clinical and nonclinical staff members. Staff should be encouraged to make suggestions for improving office procedures.

Office staff should be reminded periodically of the need for maintaining strict confidentiality of all patient contacts, treatment, and records, includ­ing those that pertain to adolescents. A written personnel policy should exist that states that any violation of patient confidentiality is grounds for employee dismissal (see also the “Compliance With Government Regulations” section later in Part 1). Specific policies (eg, sexual harass­ment, conflict of interest, grievances and complaints, and faculty leave) should be established, and all personnel should be made aware of them. Discussion with staff should include the use of chaperones when either male or female health care providers perform physical examinations (see also the “Human Resources” section later in Part 1).

Bibliography

American College of Obstetricians and Gynecologists. Guidelines for adolescent health care [CD-ROM]. 2nd ed. Washington, DC: American College of Obstetricians and Gynecologists; 2011.

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Santelli JS, Smith Rogers A, Rosenfeld WD, DuRant RH, Dubler N, Morreale M, et al. Guidelines for adolescent health research. A position paper of the Society for Adolescent Medicine. Society for Adolescent Medicine. J Adolesc Health 2003; 33:396-409. [PubMed] [Full Text]

Resources

Accreditation Association for Ambulatory Health Care. 2014 Accreditation hand­book for ambulatory health care. 2014 ed. Skokie (IL): Accreditation Association For Ambulatory Health Care; 2014.

American College of Obstetricians and Gynecologists. Code of professional ethics of the American College of Obstetricians and Gynecologists. Washington, DC: American College of Obstetricians and Gynecologists; 2011. Available at: http:// www.acog.org/~/media/Departments/National%20Officer%20Nominations% 20Process/ACOGcode.pdf?dmc=1&ts=20130715T1226302728. Retrieved July 15, 2013.

American Medical Association. Organized Medical Staff Section: helpful resources. Available at: http://www.ama-assn.org/ama/pub/about-ama/our-people/member- groups-sections/organized-medical-staff-section/helpful-resources.page?. Retrieved July 10, 2013.

American Medical Association. Physician’s guide to medical staff organization bylaws. 5th ed. Chicago (IL): AMA; 2012.

CONSORT Group. Consolidated Standards of Reporting Trials (CONSORT) Statement. Available at: http://www.consort-statement.org. Retrieved July 10, 2013. Food and Drug Administration. Information sheet guidance for institu­tional review boards (IRBs), clinical investigators, and sponsors. Available at: http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/ GuidancesInformationSheetsandNotices/ucm113709.htm. Retrieved July 10, 2013. Institutional review boards. 21 C.F.R. part 56 (2013). Available at: http://www. gpo.gov/fdsys/pkg/CFR-2013-title21-vol1/pdf/CFR-2013-title21-vol1-part56.pdf. Retrieved September 20, 2013.

MedPage Today. Guide to biostatistics. New York (NY): MedPage Today; 2007. Available at: http://www.medpagetoday.com/lib/content/Medpage-Guide-to-Bio statistics.pdf. Retrieved July 10, 2013.

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Protection of human subjects. 45 C.F.R. part 46 (2012). Available at: http://www. gpo.gov/fdsys/pkg/CFR-2012-title45-vol1/pdf/CFR-2012-title45-vol1-part46.pdf. Retrieved September 20, 2013.

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