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U.S. Department of Health and Human Services

Animal & Veterinary

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THE ROLE OF THE OMBUDSMAN IN CVM

FDA Veterinarian Newsletter May/June 2000 Volume XV, No III

By Marcia K. Larkins, D.V.M.

Definition of an Ombudsman

Ombudsman is a Scandinavian term meaning literally "administrative man." It describes a special kind of grievance-handling official -- one who investigates citizen’s complaints against administrative agencies.

An ombudsman is an individual who is skilled in dealing with reported complaints, operating in a neutral and confidential role, to help achieve equitable solutions. Although the terms are frequently used interchangeably, ombudsman generally refers to a function while ombudsperson or practitioner refers to the individual performing the function. The ombudsperson is a designated neutral who reports to the top of an agency/organization outside of normal management channels. This distinction helps to preserve the independence and contributes to the overall effectiveness of the function. The two basic types of ombudsman are the classical ombudsman and the organizational ombudsman. The organizational ombudsman is the more prevalent of the types defined below, and in practice, has the most functions that any dispute resolution practitioner can have.

The classical ombudsman is a function that is created by law and appointed by legislative bodies. Classical ombudspeople receive complaints about the administrative acts of government agencies. They may have jurisdiction over all agencies or only certain agencies of a local or state government. They may also "specialize" by focusing on the needs of a defined population such as the elderly or the disabled. Classical ombuds practitioners can do formal investigations and have subpoena power. They make recommendations to an agency that they have investigated and can publish public reports that include the findings on whether a complaint is justified. There are strong legal safeguards in place to preserve their independence and the confidentiality of their records.

The organizational ombudsman is a complaint-handler and dispute-resolver, communications channel, confidential and informal information resource, and a person who helps an organization work for change. The organizational ombudsperson helps to achieve resolution and then helps an organization to avoid reoccurrence of the same problems. This aspect of the ombudsman function differs from that of a formal mediator who leaves after a dispute has been resolved. Public and private institutions, agencies and corporations employ organizational ombudspeople. They are further classified as being either "internal" or "external." An internal ombudsperson is an employee of the organization who is paid to be neutral, whereas the external ombudsperson is a service provider by contract. Otherwise the function is the same.

What an Organizational Ombudsman Does

An organizational ombudsperson may serve internal staff or customers of the organization or both. He or she helps to find solutions to problems and concerns expressed by customers, that meet the needs of both the customer and the organization. Ombudsman intervention is accomplished through informal investigation, shuttle diplomacy or third party intervention and informal mediation. Rather than choosing for a complainant how a complaint will be handled, the ombudsperson thinks of options or helps the complainant develop new options.

Additionally, the organizational ombudsperson 1) provides feedback to the organization on issues, 2) acts as a safety-net for those issues that are not addressed through normal channels and 3) serves as an "early warning" channel for new issues by identifying trends, thus allowing the organization to be proactive. For example, the ombudsperson might notice a pattern or multiple incidents of the same kind, which may indicate an organizational need for a new policy, or procedure or structure. While the ombudsperson is not a decision-maker, he or she does make insightful recommendations that can help effect positive change in the organization.

The ombuds practitioner is a point of contact who provides information about an organization to callers by 1) advising them on how the system works and how they can best access it, 2) clarifying the meaning of and/or providing them with a copy of a policy and 3) providing or helping them to find information (names, phone numbers, etc.) that enables them to go directly to the person who can best address their concern, or resolves their problem in one or two contacts. Due to the protection provided by the practice of confidentiality, the ombudsperson may also serve an important role in receiving information from callers that is useful to an organization. Typically, organizational ombudspeople do not answer questions or voluntarily disclose information regarding anyone that they may have spoken to, and maintain that privacy unless they have permission to do so, for the purpose of informal dispute resolution.

It should be noted that the CVM Ombudsman does not intervene for or replace the functions of the Equal Employment Opportunity (EEO) program or the National Treasury Employees Union (NTEU). The issues that are handled by the Ombudsman whether initiated internally or externally, involve disputes over science and/or policy decisions and the administrative procedures used in making those decisions.

Knowledge and Skills of the Organizational Ombudsman

An organizational ombudsperson should know the values and ethics and the policies and procedures of an organization, and should understand the structure, processes and resources within that organization. For example, about 3 years ago the National Institutes of Health (NIH) appointed its first Ombudsman and Director of the Center for Cooperative Resolution based on his scientific background, personal qualities and his familiarity with the NIH research environment.

The ombudsman function 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 the dispute. A publication put out by The Ombudsman Association (TOA) on organizational ombudsmen states that "The cost effectiveness of good communications, of raising problems on a timely basis, and of fair conflict management should be understood and communicated by ombuds practitioners." The ombudsperson should also have a good working knowledge of the regulations and guidance documents relevant to the organization and to its customers including those involving dispute resolution.

The ombudsperson can enhance his or her skills and knowledge through personal experience in an organization and from training courses, conferences and workshops sponsored by professional organizations. The Ombudsman Association (TOA) is a non-profit organization that provides a forum for practicing organizational ombudspeople while the United States Ombudsman Association (USOA) is for classical ombuds practitioners. The knowledge and experiences shared in discussions with other ombudspeople can also provide valuable information, insight and professional support. The Coalition of Federal Ombudsmen (CFO) is based in Washington D.C. and meets every two months. The membership includes the FDA and many other organizations such as the National Institutes of Health (NIH), the Environmental Protection Agency (EPA), the U.S. Secret Service, the U.S. House of Representatives, the Federal Deposit and Insurance Corporation (FDIC), the Securities and Exchange Commission (SEC), U.S. Customs Service, the Department of Energy (DOE), the Federal Reserve, the Bureau of Alcohol, Tobacco and Firearms (ATF) and the Capitol Police.

The Role of the Organizational Ombudsman in the FDA

The role of an ombudsman within an organization will depend on the culture of that organization. In order to be effective, the ombudsman must 1) have the support of top management, 2) have access to any individual manager within the organization, 3) act and be perceived as neutral, and 4) be able to offer confidentiality and anonymity to those who contact him or her for informal problem resolution.

Ombudsmen employed by federal government agencies are classified as internal organizational ombudsmen. The significance of this function within FDA is demonstrated by the existence of the Office of the Ombudsman (OO) in the Office of the Commissioner. The Office is staffed with a Chief Ombudsman, a Deputy Ombudsman, and two staff lawyers serving as Regulatory Counsels. The function of this Office is defined in the Federal Register publication dated February 27, 1997 (Vol. 62 No.39) which states:

"The Ombudsman reports directly to and acts on behalf of the FDA Commissioner in investigating and resolving issues and problems that affect products under FDA’s jurisdiction. The office was created to investigate industry complaints about FDA’s regulatory processes, identify deficiencies about those processes, respond to problems affecting a product under FDA’s jurisdiction, and ensure that FDA policy is fairly and evenly applied throughout the agency. The Ombudsman also mediates disputes or issues between FDA and the regulated industry that have not been resolved through other means."

The Ombudsman’s Office receives and handles external complaints about the review process primarily from private industry. The Office is there to assure that the process by which decisions are made in the Centers is legal. The Chief Ombudsman is also the product jurisdiction officer and is authorized to determine whether the Center for Drug Evaluation and Research (CDER), the Center for Biologics Evaluation and Research (CBER), or the Center for Devices and Radiological Health (CDRH) has primary responsibility for premarket review and regulation of combination products based on their established informal intercenter agreements. For products where the Center with primary jurisdiction is either unclear, not covered in the formal intercenter agreements, or in dispute [as per 21 CFR §3.7(a), and §5.32], the Chief Ombudsman works with the Centers to get a consensus before making a final decision on requests for designation on product jurisdiction.

Three other Centers (CDER, CBER and CDRH) have ombudsmen in place to handle dispute resolution including appeals. One quarter of the disputes handled by CDER’s Ombudsman originate internally and three quarters are initiated externally. Those handled by the CBER and CDRH Ombudsmen are all external. The contact for appeals at the Center for Food Safety and Applied Nutrition (CFSAN) is the Industry Activities Staff, as it does not have an ombudsman. The Office of the Ombudsman supports the Center ombudsmen but reserves certain functions to that Office such as 1) inter-Center inconsistencies and coordination issues, 2) issues that have gone through the Center Director and the complainant seeks further agency review and 3) when the caller or complainant has reasonable concerns about raising an issue with the Center. Public awareness of and accessibility to the FDA Ombudsmen in OO, CDER and CBER are enhanced by information provided via web pages linked to their respective agency and Center home pages.

Current Issues Regarding Federal Organizational Ombudsmen

Confidentiality and record retention are 2 issues that are currently undergoing some scrutiny with regard to the rights and responsibilities of organizational ombudsmen employed by the federal government. The Office of the Ombudsman has taken the lead on examining the meanings and implications of both issues. The role of the federal ombudsman in light of the current regulations for dispute resolution and for record keeping has been discussed within FDA between the Office of the Ombudsman, the Office of the Chief Counsel, and the FDA Center ombudsmen. These issues are also being discussed in meetings of the Coalition of Federal Ombudsmen as to how they apply to all federal ombudsmen.

Confidentiality:

One of the ombudsman’s most important tools is the ability to assure the confidentiality of any dispute resolution communication. The Ombudsman Association’s (TOA) publication for organizational ombudspeople explains that they do not do formal investigations, keep formal case records or appear as witnesses in judicial or quasi-judicial proceedings in order to safeguard both the practice and appearance of neutrality and confidentiality. The Code of Ethics for TOA states:

"The ombudsman as a designated neutral, has the responsibility of maintaining strict confidentiality concerning matters that are brought to his or her attention unless given permission to do otherwise. The only exceptions, at the sole discretion of the ombudsman, are where there appears to be imminent threat of serious harm."

The conditions imposed on federal ombudsmen with regard to confidentiality prevents them from exercising strict adherence to TOA’s Code of Ethics and thereby denies them the right to full member status. They can apply for Associate status as long as they are willing to support and affirm the Code of Ethics. They cannot however, serve on the Board of Directors nor can they vote.

Generally, the right of the ombudsperson or designated neutral, to maintain confidentiality with regard to any form of communication with a complainant, and any records generated during a dispute or controversy is protected by the Administrative Dispute Resolution Act (ADRA). The recently amended ADRA now includes "the use of ombuds" in its definition of "alternative means of dispute resolution" as a procedure that is used to resolve issues in controversy. It also clarifies [as per 5 U.S.C. ( United States Code) §574(j)] that dispute resolution communications are not releasable under the Freedom of Information Act (FOIA). ADRA confidentiality protection for FDA ombudsmen however, is still unclear and open to interpretation regarding requests from Congress for access to information. A Congressional Research Service (CRS) Report for Congress (dated April 7, 1995) refers somewhat to this issue in that one section of the document (entitled the Effect of Statutory Prohibitions on Public Disclosure on Congressional Access) states:

"Upon occasion Congress has found it necessary and appropriate to limit its access to information it would normally be able to obtain by exercise of its constitutional oversight prerogatives. But where a statutory confidentiality or non-disclosure of information is not explicitly applicable to Congress, the courts have consistently held that agencies and private parties may not deny Congress access to such information on the basis of such provisions."

The document sites a couple of cases as examples to support the second statement. However, further research would have to be done to determine the best way to distinguish ADRA from the statutes at issue in these cases. There have not been any cases within FDA to date that required a direct interpretation of the ADRA provision.

Record 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. FDA ombudsmen may destroy certain informal dispute resolution communications when the dispute is resolved.

According to TOA, most organizational ombudspeople who serve internal staff and students look into problems much less formally, and never or almost never write a case report. However, the Association also acknowledges that all practicing ombudspeople do not follow this criterion, and that in fact, probably no statement about ombudspeople is true for all practitioners. Evidence of this is demonstrated even within the FDA as case records and files are not retained by all of the current ombudsmen. This practice complies with TOA’s Standards of Practice under section 3.3 which states:

"An ombudsman keeps no case records on behalf of the organization. If an ombudsman finds case notes necessary to manage work, the ombudsman should establish and follow a consistent and standard practice for the destruction of any such written notes."

Conclusion

The ombudsperson operates independently within an organization not only to investigate problems and provide options, but to follow-up on resolutions to determine if they were effective and to track or monitor issues to determine if repetitive patterns exist and advise management accordingly. The ombudsperson provides neutral facilitation for an appeals process by serving as the point of contact for all of the parties involved. Equally as important is the overall purpose of an organizational ombudsman, which is to foster values and decent behavior with respect to fairness, equity, justice, equality of opportunity and respect. These qualities are particularly relevant to CVM in light of the Center’s present quest to achieve goals that include behavioral and systems values, which will contribute to establishing it as a High Performance Organization (HPO).

Dr. Marcia Larkins became CVM's new and first Ombudsman in November of 1999. She gained experience by acting in this role beginning in 1997. Prior to this she held positions in the Center as a veterinary reviewer for 11 years from 1973 to 1984 and as a Branch Chief/Team Leader for 13 years from 1984 to 1997 in the Division of Drugs for Non-Food Animals.