Entities generally met Federal Select Agent Program internal inspection requirements, but CDC could do more to improve effectiveness
- Collection:
- Health Policy and Services Research
- Series Title(s):
- Report in brief
- Contributor(s):
- United States. Department of Health and Human Services. Office of Inspector General. Office of Evaluation and Inspections, issuing body.
- Publication:
- [Washington, D.C.] : U.S. Department of Health and Human Services, Office of Inspector General, June 2018
- Language(s):
- English
- Format:
- Text
- Subject(s):
- Biohazard Release -- prevention & control Toxins, Biological Guideline Adherence Laboratories Safety Humans United States United States. Department of Health and Human Services. Centers for Disease Control and Prevention (U.S.)
- Genre(s):
- Technical Report
- Abstract:
- Why OIG Did This Review. Select agents and toxins are potential bioweapons that can cause significant loss of life and economic damage. Incidents of mishandling of select agents and toxins by some entities registered with the FSAP have raised questions about DSAT's ability to oversee entities' responsible handling of select agents and toxins. Entities' internal inspections are one critical safeguard to help protect public health and safety. In this review, OIG examines entities' and DSAT's roles in implementing and overseeing these internal inspections. This builds on a companion review in which OIG examined DSAT's inspections of entities. How OIG Did This Review. We reviewed DSAT data, survey data, and documentation from a purposive sample of 24 DSAT inspectors and 21 entities registered with the FSAP from 2013 through 2015. We determined whether entities reported conducting internal inspections during this timeframe and whether DSAT cited those entities that did not conduct them. We asked DSAT inspectors about their challenges in overseeing entities' compliance with the internal inspection requirement and asked entities about their challenges in conducting internal inspections. What OIG Found. Eighteen of the 21 entities registered with the Federal Select Agent Program (FSAP) and that were included in our review reported to us that they conducted internal inspections annually for all areas where select agents were used or stored, as required, from 2013 to 2015. In nearly all cases, the Centers for Disease Control and Prevention's (CDC) Division of Select Agents and Toxins (DSAT) had identified and cited those few entities that reported to us they did not conduct these inspections as required. During their internal inspections, most entities cited observations (i.e., instances of potential regulatory noncompliance) for the Select Agents Regulations' Biosafety section (14 entities) or Security section (6 entities). This is consistent with the types of observations that DSAT most commonly found in its inspections, according to a previous HHS OIG report. However, the DSAT inspectors whom we surveyed in our review also reported that in their experience, entities' internal inspections are not always sufficiently thorough (15 of 24 inspectors) or sufficiently documented (7 of 24 inspectors), which may hinder the effectiveness of these inspections. Data that we collected from DSAT inspections for registration renewals support these claims. DSAT inspectors also raised concerns that unclear inspection requirements and insufficient training challenge both DSAT's ability to oversee entities' internal inspections and entities' ability to conduct them. Some entities reported similar concerns. These challenges may partially explain why entities' internal inspections are not always sufficiently thorough or sufficiently documented. What OIG Recommends and How the Agency Responded. We recommend that CDC take steps to strengthen the effectiveness of entities' internal inspections by clarifying the FSAP internal inspection requirements and the procedures for assessing entity compliance, and developing and providing additional training both to DSAT inspectors and entities on these requirements and procedures. CDC concurred with all four of our recommendations.
- Copyright:
- The National Library of Medicine believes this item to be in the public domain. (More information)
- Extent:
- 1 online resource (1 PDF file (40 pages))
- Illustrations:
- Illustrations
- NLM Unique ID:
- 101738040 (See catalog record)
- Permanent Link:
- http://resource.nlm.nih.gov/101738040