The Role of CVM’s Ombudsman

by Marcia K. Larkins, D.V.M., Ombudsman
FDA Veterinarian Newsletter 2006 Volume XXI, No V

The Center for Veterinary Medicine (CVM), like most government agencies, has an ombudsman function assigned to a key staff member. The ombudsman helps stakeholders who may have a complaint or concern, and has broader responsibilities for serving as a confidential channel for communications to the Center. This article explains the functions, the legal underpinnings for the job, and the limits of the authority of CVM’s ombudsman.

The term “ombudsman,” Scandinavian in origin, and sometimes referred to as “ombud” or “ombudsperson,” is a special kind of grievance-handling official—one who investigates citizens’ complaints against administrative agencies. It describes a person authorized to receive and investigate complaints, report the findings, and help to achieve equitable settlements.

The basic types of ombudsmen are the classical ombudsman, the advocate ombudsman, and the organizational ombudsman. Classical ombudsmen are created by law and appointed by legislative bodies, do formal investigations, have subpoena power, and can publish public reports. Advocate ombudsmen (American Bar Association Standards) are established by legislation, serve a designated population, and can initiate action in formal forums. Organizational ombudsmen function by informal processes, conduct independent and impartial investigations, and issue reports, but do not publish public reports on the details of their investigations. CVM has an organizational ombudsman.

Knowledge, skills of the organizational ombudsman

An organizational ombudsman requires skills that include being able to listen impartially to a complainant, being sensitive to fairness, and being able to work with others to resolve a dispute. The ombudsman should also have a good working knowledge of the regulations, guidance documents, and administrative policies and procedures relevant to the organization and its customers, as well as those that specifically involve dispute resolution.

The role of an ombudsman within an organization will depend on the culture of that organization. In order to be effective, the ombudsman must:

• Have the support of top management;
• Have access to any individual manager within the organization;
• Act and be perceived as neutral; and
• Be able to offer confidentiality and anonymity to those who contact him or her for informal problem -resolution.

Due to the protection provided by the practice of confidentiality, the organizational ombudsman may also serve an important role in receiving information from callers that is useful to an organization. Typically, organizational ombudsmen do not answer questions or voluntarily disclose information regarding anyone that they may have spoken to, and they maintain that privacy unless they have permission to disclose information for the purpose of informal dispute resolution.

The ombudsman enhances his or her skills and knowledge through personal experience in an organization and from training courses, conferences, and workshops sponsored by professional organizations. The International Ombudsman Association is a non-profit organization that provides a forum for practicing organizational ombudsmen. CVM’s Ombudsman is a member. The knowledge and experiences shared in discussions with other ombudsmen can also provide valuable information, insight, and professional support. The Coalition of Federal Ombudsmen is based in Washington, DC, and meets every 2 months. The membership includes ombudsmen from FDA and many other Federal organizations.

CVM Ombudsman

CVM’s Ombudsman not only handles complaints and helps to resolve disputes, but also serves as a communications channel, a confidential and informal information resource, and a person who helps the organization work for change.

The CVM Ombudsman serves both its employees and customers, assisting in resolving disputes with affected persons and groups both inside and outside the Center. The CVM Ombudsman investigates complaints involving science and science-based policy decisions made by individuals inside and outside the organization, reports the findings, and helps to achieve equitable solutions. The ombudsman also handles complaints concerning the way in which the Center’s science-based regulatory policies and certain administrative policies and procedures are implemented, and works to ensure that these are being applied fairly and equitably. The objective is to help find solutions to problems and concerns expressed by customers that meet the needs of both the customer and the organization.

Dispute resolution by the CVM Ombudsman is generally accomplished through informal investigation, shuttle diplomacy, or third-party intervention and informal mediation. Rather than choosing for a complainant how a dispute will be handled, the CVM Ombudsman provides options or helps the complainant develop new options.

The CVM ombudsman knows the values, ethics, policies, and procedures of the organization and understands the structure, processes, and resources within CVM. That knowledge helps the ombudsman to resolve issues and to work toward avoiding recurrence of the same problems.

The FDA dispute resolution procedures for employees and customers requesting review of a scientific controversy is found under 21 Code of Federal Regulations (CFR) 10.75 “Internal agency review of decisions.” http://www.washingtonwatchdog.org/documents/cfr/title21/part10.html#10.75

In addition, CVM has a process for employees to bring critical information that may be controversial or precedent-setting to the ombudsman and ultimately to the CVM Leadership Team, outside of normal supervisory channels. Procedures for Internal CVM Review of Science or Policy Issues Related to Significant Decisions of High Impact can be found at http://www.fda.gov/cvm/Policy_Procedures/2115.pdf.

Consistent with typical organizational ombudsmen, the CVM ombudsman does not conduct formal investigations for adjudication, nor does she adjudicate. However, the ombudsman can advise its stakeholders on fair process and assist in facilitating appeals related to regulated products effectively and fairly. The ombudsman’s role in CVM’s formal appeal process is described in Guidance #79 “Dispute Resolution Procedures for Decisions on Products Regulated by the Center for Veterinary Medicine”.

The CVM’s Ombudsman also:

• Provides feedback to the organization on systemic issues;
• Acts as a safety net for those issues that are not addressed through normal channels; and
• Serves as an “early warning” channel for new issues by identifying trends, thus allowing the organization to be proactive.

The CVM Ombudsman is also a point of contact that provides information about an organization to callers by:

• Advising them on how the system works and how they can best access it;
• Clarifying the meaning of and/or providing a copy of a policy; and
• Providing or helping to find information (names, phone numbers, etc.) that enables callers to go directly to the person who can best address their concern or resolve their -problem.

Current issues unique to Federal ombudsmen

Confidentiality, whether communication with an ombudsman constitutes notice to an organization, and record retention are three issues that are ongoing with regard to the rights and responsibilities of organizational ombudsmen. These issues have been discussed in the International Ombudsman Association training courses and annual conferences as to how they apply to all ombudsmen and in Coalition of Federal Ombudsmen meetings with specific regard to Federal ombudsmen in light of current Federal regulations.

Confidentiality, and notice: One of the ombudsman’s most important tools is the ability to ensure the confidentiality of any dispute resolution communication. In order to safeguard both the practice and appearance of neutrality and confidentiality, organizational ombudsmen do not do formal investigations or keep formal case records. Simply contacting an ombudsman generally does not constitute legal notice to the organization.

Records retention: Under 21 CFR §10.70, documentation of significant FDA decisions on any matter under Federal law must be provided in an administrative file. However, communications that are made with regard to an informal dispute resolution are not “records” within the meaning of 44 U.S.C. 3301 and are, therefore, not submitted to or received by an ombudsman under Federal law. An ombudsman does not keep case records containing identifying information on behalf of the -organization.

Summary

Like most Federal ombudsman, the CVM ombudsman is available to investigate problems and provide options, and also to follow up on resolutions to determine if they were effective. In addition, the ombudsman tracks and monitors issues to determine if repetitive patterns exist and advises CVM’s Center Management Team on possible preventative measures.

Finally, the ombudsman at CVM works hard to foster an environment in the organization of fairness, equity, and respect.

Contact the CVM Ombudsman at: CVMOMBUDSMAN@fda.hhs.gov; 7519 Standish Place, Rockville, MD 20855; (240) 276-9015.