Agency for Toxic Substances and Disease Registry:

Policies and Procedures for Public Health Product Preparation Should Be Strengthened

GAO-10-449: Published: Apr 30, 2010. Publicly Released: May 20, 2010.

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The Agency for Toxic Substances and Disease Registry (ATSDR) has faced concerns related to the quality of some of the public health products it publishes. ATSDR investigates community exposures related to certain hazardous chemical sites and releases; assesses associated health effects; and recommends actions to stop, prevent, or minimize harmful effects. ATSDR publishes many types of products, including public health assessments, health consultations, exposure investigations, and health study reports. GAO was asked to examine the extent to which ATSDR's policies and procedures for product preparation, including work initiation, product development, and review and clearance, provide reasonable assurance of product quality. GAO reviewed ATSDR policies and procedures and interviewed agency officials and employees.

The policies and procedures that ATSDR has established for public health product preparation lack some of the critical controls to provide reasonable assurance of product quality. To provide reasonable assurance that agency objectives are being met, federal internal control standards call for agencies to establish policies and procedures, assess risks associated with achieving agency objectives, ensure effective information sharing throughout the organization, monitor agency activities, and establish key areas of authority and responsibility for management and staff. While ATSDR has established some policies and procedures to guide the preparation of its public health products, the policies and procedures do not establish how information is to flow between management and staff during initiation. Absent such policies and procedures, ATSDR generally relies on various meetings to inform management and staff about new work. The agency is also implementing a new database, which may improve information flow. Furthermore, ATSDR does not comprehensively evaluate and categorize the risk of work being initiated. While the agency used to officially classify some hazardous chemical sites as "high-priority" or "focus sites," and require any products resulting from those sites to undergo a higher level of review and clearance, it no longer does so. Because ATSDR does not comprehensively assess and categorize the risk of work being initiated at the agency, management cannot ensure that they have consistently managed the risk related to new work. Additionally, many of ATSDR's policies and procedures that guide product development do not clearly define management roles and responsibilities and do not consistently require that management monitor the development of key components of these products. These deficiencies may lead management to be unclear about their responsibilities, and may result in problems that occur during product development not being identified or addressed until review and clearance, if at all. For example, ATSDR and Institute of Medicine reports show that because scientific concerns were not identified during development of an ATSDR report regarding chemical releases in the Great Lakes region, the document underwent several years of review, and a final report was not issued until more than 4 years after the first draft was written. Moreover, because some review and clearance policies do not reflect current practices, ATSDR staff cannot rely on these policies to accurately or consistently determine review and clearance procedures. Furthermore, review and clearance policies and procedures direct management and staff to use discretion to identify products that require higher levels of review, rather than making this determination through a comprehensive risk assessment process. While ATSDR policy sets out criteria for when additional review may occur, such as when a document could have a high degree of visibility, there is no required point during a product's preparation when management and staff collectively determine whether a product meets the criteria, and whether additional review is warranted. Thus, the agency cannot ensure that all products consistently receive the appropriate level of review.

Recommendations for Executive Action

  1. Status: Closed - Implemented

    Comments: In response to our recommendation, ATSDR finalized and implemented the "ATSDR Policies and Procedures" document on March 22, 2011 in order to update selected internal controls (e.g. prioritization of site work and management controls) to help the agency focus resources on mission-related public health problems that can be effectively managed. By finalizing and implementing this document, ATSDR can provide reasonable assurance that its products have undergone the appropriate level of monitoring and review. Specifically, ATSDR can use this document to determine the proper level of scrutiny throughout the initiation, development, and review and clearance phases, including whether or not a product should undergo external peer review, thereby ensuring that this determination is made consistently across the agency.

    Recommendation: To strengthen the ATSDR's policies and procedures, and ensure that they provide reasonable assurance of public health product quality, the director of ATSDR should develop policies and procedures to ensure that a risk assessment is conducted at the time site-specific work is initiated, and that any assigned risk level be reevaluated throughout product preparation to ensure that it remains appropriate.

    Agency Affected: Department of Health and Human Services: Public Health Service: Centers for Disease Control and Prevention: Agency for Toxic Substances and Disease Registry

  2. Status: Closed - Implemented

    Comments: In response to our recommendation, as of March 2011, ATSDR had included revisions to its policy for the clearance of products for public use to include documented direction for various levels of management on their roles and responsibilities in the monitoring of all products prior to review and clearance. Additionally, ATSDR created a policies and procedures manual that details management controls of the agency's work. By revising its policy for the clearance of products for public use and creating a policy that addresses management controls, ATSDR has a reasonable assurance that its management has a clear understanding of the role they are supposed to play in supervising a product?s preparation, and that product errors are caught and significant publication delays do not occur during the review and clearance phase.

    Recommendation: To strengthen ATSDR's policies and procedures, and ensure that they provide reasonable assurance of public health product quality, the director of ATSDR should revise existing policies and procedures, or develop new guidance, to provide documented direction for various levels of management on their roles and responsibilities in the monitoring of all products prior to review and clearance, such as requirements for management monitoring and approval of key components of these products.

    Agency Affected: Department of Health and Human Services: Public Health Service: Centers for Disease Control and Prevention: Agency for Toxic Substances and Disease Registry

 

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