oversight

Certification Requirements: Guidance Governing Agency Actions Is Limited

Published by the Government Accountability Office on 1999-09-09.

Below is a raw (and likely hideous) rendition of the original report. (PDF)

                        United States General Accounting Office

GAO                     Testimony
                        Before the Subcommittee on Benefits
                        Committee on Veterans' Affairs
                        House of Representatives


Not to be Released
Before 10:00 a.m. EDT   CERTIFICATION
Thursday
September 9, 1999       REQUIREMENTS

                        Guidance Governing
                        Agency Actions Is Limited
                        Statement for the Record of L. Nye Stevens
                        Director, Federal Management and Workforce Issues
                        General Government Division




                        -GAO      Accountability * Integrity * Reliability

GAOrT-GGD-99-166
                             2,2-'1lp7~~
Statement

Certification Requirements: Guidance
Governing Agency Actions Is Limited

                  Mr. Chairman and Members of the Committee:

               I am pleased to provide some preliminary results from our ongoing review
               for the House Committee on Small Business of federal agencies'
               certification requirements. The term "certification" generally refers to a
               process of providing written assurance that a product, process, service,
               organization, or individual conforms to specified requirements or
               standards, and includes activities such as accreditation, registration, and
               conformity assessment. The Committee on Small Business asked us to
               describe (1) the extent and variety of certification activities in the federal
               government; (2) the extent to which any policies, procedures, or guidance
               exist governing those activities, either governmentwide or within selected
               agencies; and (3) an agency certification practice that could serve as an
               example or "best practice" for other agencies. At the Committee's request,
               the Department of Veterans Affairs (VA) was one of the agencies that we
               contacted during our review.'

              In brief, our preliminary results indicate that federal agencies engage in a
              large number and wide variety of certification-related activities. These
              activities vary across multiple dimensions, such as the targets of the
              certifications, the types of organizations that actually do the certifications,
              and whether the certifications are mandatory or voluntary. Although there
              are some limits in federal procurement law and within certain programs on
              the use of certification requirements, there is currently no
              governmentwide or, within the agencies we contacted, agencywide
              guidance to direct or assist agencies in the development, selection, or
              implementation of all types of certification requirements. However, the
              Department of Commerce's National Institute of Standards and
              Technology (NIST) has prepared draft guidance for agencies on
              conformity assessment activities, including certification. 2 NIST plans to
              publish that guidance for public comment later this year. Finally, we
              believe that transparency, or describing the basis of agencies'
              decisionmaking, is a certification best practice. We concluded that some
              agencies' certification decisions were very transparent, clearly
              documenting the criteria used to select a particular requirement or
              certification body. However, in other cases-including one at VA-the

              'The other agencies that we contacted were the Department of Transportation (DOT); and, within the
              Department of Health and Human Services, the Centers for Disease Control and Prevention (CDC), the
              Food and Drug Administration (FDA), and the National Institutes of Health (NIH).
              2
               Congress established NIST (formerly the National Bureau of Standards) in 1901 to support industry,
              commerce, scientific institutions, and all branches of the government. It is an agency of the
              Department of Commerce, and its primary mission is to promote United States economic growth by
              working with industry to develop and apply technology, measurements, and standards.




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                        Certification Requirements: Guidance Governing Agency Actions Is Limited




                        reasons agencies selected specific certifying bodies were not as
                        transparent, and organizations that were not selected to provide
                        certifications raised questions about the criteria the agencies used.

                        There is no official definition of "certification" that is applicable to the
Background              activities of all federal agencies. A NIST official told us that there are
                        almost as many definitions of a federal certification program as there are
                        agencies. Different organizations may use other terms to refer to the
                        concept, such as accreditation, registration, approval, or listing, and may
                        use the terms interchangeably. 3 Federal certification requirements can be
                        imposed with regard to a variety of topics and in many different forms. An
                        agency might require a physician to be board certified in his or her medical
                        specialty. Before purchasing certain types of equipment, an agency might
                        require that prospective sellers obtain a certification from a testing
                        laboratory indicating that their product is safe. Federal agencies may
                        establish certification requirements as prerequisite for federal contracting
                        opportunities, as part of a regulatory provision, or for other purposes.
                        Certifications can also have some troubling effects on affected parties.
                        Businesses or individuals that wish to provide a particular product or
                        service to the government might need to obtain multiple certifications to
                        meet the requirements of different agencies. Also, an agency might select a
                        particular certifying organization while not accepting certifications in the
                        same subject area from other organizations with similar qualifications.

                        We did not attempt to develop a compendium of every federal certification
Agencies Engage in a    or certification-related activity and requirement. However, it is clear from
Wide Variety of         the information we obtained that federal agencies engage in a large
Certification-Related   number and wide variety of certification-related activities. For example,
Activities              NIST publishes directories listing more than 200 federal government
                        procurement and regulatory programs in which agencies are actively
                        involved in providing or requiring certification, accreditation, listing, or
                        registration. The NIST directories provide only a partial inventory of
                        agencies' certification activities, though, because they are primarily limited
                        to certifications of products, processes, and services. Also, the directories
                        do not cover individual procurement opportunities in which agencies
                        require a vendor or contractor to have particular certifications or
                        accreditations in order to participate.


                        3
                         Adding to the confusion over terminology, certification is also used in a completely different sense to
                        refer to many routine contract clauses and solicitation provisions, such as the Certification of Final
                        Indirect Costs;, that are not related to conformance with technical or professional standards. Those
                        clauses and provisions were outside the scope of our review. See 41 U.S.C. 425(c) for limitations on the
                        use of requirements for certification by offerers or contractors in the Federal Acquisition Regulation.




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                           Certification Requirements: Guidance Governing Agency Actions Is Limited




                           Like the standards on which they are based, agencies' certification
                           activities vary across multiple dimensions, including (1) the origin of the
                           requirements (e.g., statutory versus agency-initiated); (2) which entity or
                           entities do the certifying (e.g., governmental versus private sector agents);
                           (3) whether certifications are mandatory or voluntary; and (4) the extent
                           to which there is reciprocity with or recognition of other certifications or
                           other organizations' requirements. Some of the requirements differ on
                           multiple dimensions. For example, the Department of Commerce's
                           National Marine Fisheries Service has a voluntary Seafood Inspection
                           Program for inspection and certification of both seafood products and
                           processing operations. The program is carried out pursuant to the
                           Agricultural Marketing Act of 1946, as amended; involves inspection by
                           licensed federal and state agents; and provides certification recognized by
                           other federal, state, and foreign government agencies, as well as some
                           private and international organizations. Some other certification programs
                           are mandatory in nature, originate with the agencies themselves, are
                           performed by nongovernmental personnel, and/or may not be universally
                           recognized by other agencies, countries, or the private sector.

                           The Competition in Contracting Act of 1984 provides that a solicitation for
Little Governmentwide      a government contract may include a restrictive provision only to the
Guidance Covering          extent the provision is authorized by law or is necessary to satisfy the
Certification Activities   agency's needs. Some agency-specific acquisition regulations mirror the
                           act's general limitation against restrictive provisions. 4 In our bid protest
                           decisions, we have generally not objected to a requirement that an item
                           conform to a set of standards adopted by a nationally recognized
                           organization in the field or a requirement for independent laboratory
                           certification that such standards are met. However, we have found
                           requirements unduly restrictive if they require approval by specific
                           organizations without recognition of equivalent approvals. 5 The absence of
                           an endorsement by a particular private organization should not
                           automatically exclude offers that might otherwise meet a procuring
                           agency's needs.

                           Neither the agency officials that we interviewed nor agency documents
                           that we reviewed identified any governmentwide guidance or, for the
                           selected agencies we reviewed, agencywide guidance focused specifically
                           on certification activities. Agency officials we contacted said that their
                           certification activities are driven more by the particular profession,

                           'See, for example, VA's acquisition regulations at 48 CFR 852.211-75.

                           SSee, for example, Aegis Analytical Laboratories. Inc., B-252511, July 2, 1993.




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  industry, or market sector involved than by federal government
  considerations. For example, officials from VA and NIH said that their
  agencies often use "nationally recognized" or "industry standard"
  certifications for a given sector. NIST officials said that a common finding
  from their meetings and workshops is that people tend to use the
  certification or accreditation program with which they are most familiar.

  NIST has taken a first step toward governmentwide guidance in this area,
  preparing draft guidance for federal agencies on certification and other
  conformity assessment activities. This guidance is currently under review
  at the Office of Management and Budget (OMB), and NIST expects to
  publish it in the Federal Register for public comment later this year. NIST
  officials explained that the guidance would apply to all agencies that set
  policy for, manage, operate, or use conformity assessment activities and
  results, both domestic and international, except for activities carried out
  pursuant to treaties. NIST expects the guidance to define agency
  responsibilities in a number of areas, such as

* identifying appropriate private sector conformity assessment practices and
  programs and considering use of the results of such practices or programs
  as appropriate in new or existing regulatory and procurement actions;
* using relevant guides or recommendations for conformity assessment
  practices published by domestic and international standardizing bodies as
  appropriate; and
* working with other agencies to avoid unnecessary duplication and
  complexity in federal conformity assessment activities.

  However, NIST officials pointed out that the guidance will not preempt the
  agencies' authority and responsibility to make regulatory or procurement
  decisions authorized by statute or required to meet programmatic
  objectives and requirements. They also said that the guidance would not
  suggest that agencies explain why they selected one certification
  requirement or organization over other possible candidates.

  Agency officials also identified some related policies, procedures, and
  guidance that affect their certification activities. For example, OMB
  Circular A-119 provides guidance on agencies' participation in the
  development and use of voluntary consensus standards and in conformity
  assessment activities. The circular directs agencies to use voluntary
  consensus standards in lieu of government-unique standards except where
  inconsistent with law or otherwise impractical. Agency officials also noted
  that their general procedures and regulations governing rulemaking and
  procurement play an important role in certification activities. In particular,


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                       they noted that such procedures provide valuable opportunities for an
                       agency to inform the public and solicit feedback on proposed certification
                       requirements.

                       As noted previously, agency certification actions are numerous and vary
Transparency of        substantially. Therefore, specification of a certification "best practice"
Agency Certification   would likely depend on the context of the certifications. Rather than
Requirements Varies    attempting to develop criteria for selecting the best among these
                       procedures, we want to highlight one that we have supported in the
                       regulatory arena-transparency, or clearly describing the basis for agency
                       decisionmaking. Transparency in certification decisionmaking is important
                       because those decisions can have significant implications for affected
                       parties.

                       Our review of agency certification activities indicates that the
                       transparency of these actions can vary dramatically. The criteria that
                       agencies used or planned to use to select particular requirements or
                       certifying organizations appeared to be very clear in some instances and
                       not well documented in others. FDA's mammography program provides a
                       good example of transparency in certification decisionmaking. Making
                       extensive use of the public rulemaking process, FDA established detailed
                       procedures and criteria for certification of personnel and facilities
                       providing mammography services, as well as the approval of accreditation
                       bodies under the act. In other certification requirements, though, the
                       agencies did not provide clearly documented explanations for their
                       actions. In these cases, certification organizations that were not selected
                       or designated raised questions about the criteria the agencies used.
                       However, agency officials were able to explain to us the reasons for their
                       actions.

                       One such example was VA's implementation of new procedures, effective
                       July 1, 1997, requiring newly-hired physicians to be board certified in the
                       clinical specialty in which they will practice, unless they have the written
                       approval of the Chief Patient Care Services Officer prior to appointment.
                       In a subsequent information letter, the VA Undersecretary for Health
                       specified that certifying bodies recognized for purposes of this issue are
                       the American Board of Medical Specialties (ABMS) for allopathic
                       physicians and the Bureau of Osteopathic Specialists (BOS) for
                       osteopathic specialists. In a series of letters, the American Association of
                       Physician Specialists, Inc. and this Committee questioned why only ABMS
                       and BOS certification were recognized, and requested that VA provide the
                       criteria used to evaluate and select those two organizations. In its response
                       to this Committee, VA stated that certifying groups vary widely in their


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               requirements and that ABMS and BOS are "the standard certifying
               organizations recognized throughout American medicine." However, VA
               did not further describe how it selected these two certifying organizations.

               VA officials told us that the Department does not have specific written
               criteria or guidance on certification decisionmaking, and said they rely on
               consensus practices and standards of the health care profession. They said
               VA's use of ABMS and BOS certifications can be traced back to a 1980
               decision by the Chief Medical Director to accept ABMS and BOS physician
               board certifications for Incentive Special Pay purposes. In 1997, VA
               extended those same certifications that were required for special pay
               purposes to employment, "grandfathering" currently employed physicians.
               VA officials also noted that they had canvassed other federal agencies
               involved in health care-including the Department of Defense, the Public
               Health Service, NIH, CDC, and the Bureau of Prisons-and found that
               essentially all recognized ABMS and BOS as the two accepted
               organizations for accreditation purposes. Finally, they pointed out that, by
               law, the Secretary for Veterans Affairs has special authority to make
               personnel decisions.

               Federal agencies' certification requirements are an invaluable tool in
Concluding     helping to ensure product quality, process reliability, and professional
Observations   competence in a variety of venues. Without those requirements, federal
               agencies would have to independently evaluate the safety of products,
               whether certain procedures will yield the desired results, and whether
               individual workers possess the skills required to perform a given task.

               Agencies have broad latitude in the selection of certification requirements
               and certifying organizations, which can result in what appear to be
               inconsistencies of application. These apparent inconsistencies are
               exacerbated when the reasons behind the agencies' certification decisions
               are unclear. Transparency of these decisions can improve their perceived
               legitimacy, and that transparency can be achieved in a variety of ways. For
               example:, if an agency's certification requirement is related to a
               procurement action, the agency can make clear the basis of that
               requirement in the request for proposals. If prospective contractors
               believe the justification provided is insufficient, mechanisms are available
               in the contracting process to appeal the agency's determination. Some
               agencies have also used the rulemaking process to delineate the rationale
               behind their certification requirement decisions. Again, those who believe
               the justifications are insufficient can file comments with the agency as part
               of the notice and comment process. Although these contracting and
               rulemaking processes are convenient mechanisms for certification


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Certification Requirements: Guidance Governing Agency Actions Is Limited




transparency, they are not universally applicable because some
certification requirements do not arise in either environment. The
diversity of these requirements suggests that a governmentwide mandate
for certification transparency would be difficult to implement. However,
regardless of the venue in which the requirements arise, multiple channels
are available for agencies that want to clearly explain their certification
decisions.



Contacts and Acknowledgement
For further contacts regarding this testimony please contact L. Nye
Stevens or Tim Bober at (202) 512-8676. Individuals making key
contributions to this testimony included Curtis Copeland, Alan Belkin,
Victor B. Goddard, and John Brosnan.




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