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Quality Assurance/Quality Improvement

The Quality Assurance/Quality Improvement Program (QA/QI) is a unit within the Office of Research independent of the Institutional Review Board ( IRB), the Institutional Animal Care and Use Committee ( IACUC), and all research related departments. The objectives of this group in no way conflicts with those of IRB, The Office of Human Research Protection (ORHP), IACUC, U.S. Department of Agriculture (USDA), or the Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC, Intl).and/or other regulatory agencies.

The QA/QI aims to promote a culture of compliance with the highest legal and ethical standards for the conduct of research. It is also committed to education of the Drexel and affiliates research community and outreach to collaborating institutions striving for research excellence.

QA/QI has free, unlimited and unrestricted access to all books, records, files, equipment, materials, property, systems and personnel of Drexel University and its subsidiaries during reviews of research related activities. To the degree that audit rights have been established, affiliates, partnerships, joint ventures, licensees, contractors, vendors, distributors, third parties or other operations are also subject to quality assurance/quality improvement review. The QA/QI team has the authority to recommend improvements, to monitor the implementation of approved recommendations and has the duty to report findings to the appropriate compliance committee, Institutional Official, and/or regulatory oversight agencies when deemed applicable.

QA/QI's animal research objective is twofold:

  1. To support institutional animal welfare regulatory compliance
  2. To assist investigators in the humane use of animals in their research

QA/QI for animal use in laboratory research complements the regulatory oversight provided by internal and external animal welfare regulators, but functions independently of them.  This is accomplished through a mechanism called Post Approval Monitoring (PAM).

PAM is a continuing program to review IACUC approved animal use protocols to ensure compliance with approved activities. This improves communication between investigators and regulatory agencies by giving a personalized review of relevant internal and external regulatory requirements and best practices. The process involves a thorough evaluation of individual animal procedure areas, observation of procedures performed, record keeping, personnel training, and laboratory safety.

SUPPORTING and ENSURING INSTITUTIONAL REGULATORY COMPLIANCE BY:

  • Conducting Routine/Random PAM reviews to assess animal welfare regulatory compliance and protocol adherence
  • Conducting Directed (for-cause) reviews at the request of the IACUC, Veterinarian, or Institutional Officials. Directed PAM reviews focus on areas of concern identified or reported by the requesting party
  • Investigating allegations and findings of non-compliance
  • Identifying opportunities for improvements and making recommendations to individuals involved in the care and use of laboratory animals and/or  Institutional Officials
  • Providing support for implementation of an improvement plan as requested
  • Conducting follow-up and continuing PAM reviews to ensure sustained regulatory compliance