Quality Assurance and Improvement Program
Objectives of the Program
The Quality Assurance and Quality Improvement (QA/QI) Program is a function within the Office of Research Integrity under the Office of Research and Economic Development. The QA/QI Program was developed to strengthen animal subjects’ protections at FIU and to demonstrate FIU’s commitment to continuous improvement in research compliance. Identifying the strengths and weaknesses of protection efforts is essential to maintaining a quality program and enables the ORI and the Institutional Animal Care and Use Committee (IACUC) to continue FIU’s tradition of excellence.Implementation of the QA/QI Program at FIU serves to evaluate animal research, teaching and training protections at varying levels, increase awareness of existing processes, operating procedures, educational programs, and acquire information necessary for enhancing protections. The QA/QI Program provides a means to assess FIU’s level of compliance with federal, state, and institutional regulations, and the Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC) guidelines, which is a key element in meeting the highest standards for animal subject protections.
Components of the program focus on educating the University’s researchers on the ethical and regulatory responsibilities by which animal subjects are protected. It also allows researchers, ORI staff, and IACUC members the opportunity to improve animal research, teaching and training protections performance. The QA/QI Program can provide useful information to identify educational/training initiatives for researchers, their staff, ORI staff, and IACUC members.
The goal of the QA/QI Program is to review active animal protocols to ensure animal based research, teaching and training is being conducted in accordance with what is written and approved. Additionally, the Program:
- Enhances the current IACUC Semiannual Site Visits which occur in June and December of each year, which provides an ongoing mechanism for ensuring compliance with applicable animal care and use policies, guidelines and laws.
- Serves as an opportunity for constructive interaction and education for the PI, PI staff and animal care personnel.
- Helps prepare for visits by outside evaluators, such as USDA inspectors, the Office of Laboratory Animal Welfare (OLAW) staff, and the Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC) International site visitors.
The visit is as informal as possible and is an opportunity for the PIs and their staffs to request any help they may need, and to provide feedback on the protocol process. Protocols are selected both randomly or for-cause.
Mechanisms of Review
Selection Criteria for Identifying Projects to be Reviewed Randomly
- Projects may be selected randomly or by risk-based assessment to ensure adequate coverage of complex protocols (i.e., those involving surgical procedures or field studies) and USDA-covered species.
- Major Multiple Survival Surgery – Every approved Animal Care and Use Protocol that involves multiple major survival surgery will be reviewed at least once after the protocol is approved and is active.
- Protocols approved with a condition (stipulation) – Every Animal Care and Use Protocol that has been approved with a condition will have the condition reviewed at least once with the PI or the PI’s designee.
Selection Criteria for Directed and For-Cause Reviews of Projects
- The reviews can be requested by the FIU IACUC, the Vice President for Research, the Attending Veterinarian or, the University Compliance Officer.
- The reviews are typically implemented due to unusual circumstances, significant risks to animals, routine failure of an investigator to comply with federal and/or institutional requirements, allegations or concerns about the conduct of the study brought to the IACUC’s attention, or any case requiring further scrutiny as deemed appropriate.
Once a protocol is selected, the ORI office schedules a visit with the PI and PI staff. The QA/QI Coordinator will visit the laboratory or animal facility, discuss the procedures on the selected protocol(s) with the PI and PI staff and/or observe them, review experimental treatment and medical records, and note any drift away from the approved protocol. The PI then has the opportunity to correct any deviations by improving techniques or by submitting an amendment to the protocol. Serious deviations that constitute non-compliance with IACUC policies will be reported as Incidents to the IACUC.
Areas Reviewed during the Site Visit
Areas covered during the review may include the following components:
- Examination of Surgical, Procedural and Housing Areas including anesthetic equipment
- Review of Animal Records
- Controlled Substances
- Observation of laboratory practices and procedures
- Occupational Health & Safety Program
- Adverse Events
- Project Personnel (Qualifications and IACUC Training)
- Continuing Review
- Protocol Adherence (Violations/Deviations)
- Other areas as determined by the review
Outcome of Reviews
Following completion of the QA/QI review, ORI will prepare a written report for the PI. The report may include recommendations for aligning the research protocol, if necessary, with institutional policies and regulatory requirements and/or specify corrective actions, if any.
- If the quality improvement review identifies a need for revision of the protocol, the PI is responsible for submitting an amendment/modification to the current approved protocol in accordance with IACUC requirements.
- If the quality improvement review identifies serious or continuing noncompliance, ORI and the PI will adhere to established processes of the FIU Office of Research and Economic Development and IACUC for the investigation, correction and reporting of any material noncompliance, as may be required or appropriate.
Preparing for a Schedule QA/QI Review
Investigators should review over the information listed below prior to initiating a new research study as it will help to ensure regulatory compliance and good clinical practices.
- Confirm the date and time for the audit, as well as the anticipated duration of the QA/QI Review. Ascertain whether the QA/QI team will require the use of any specific equipment.
- Ensure that all research team members are aware of the upcoming QA/QI Review.
- Ensure that the principal investigator and senior study coordinator are available for the QA/QI Review.
- Ensure that the following documents will be available and accessible during the review in hard copy and/or electronic format (copies are not necessary unless the QA/QI team specifically requests them during the review):
- IACUC Letters and Documents including, but not limited to:
- Initial Review
- Continuing Reviews
- Adverse or Unanticipated Event Reports
- Deviation Reports
- Lab Documents including, but not limited to:
- Surgical records
- Husbandry Logs
- Sanitation Log
- Lab books
- Disaster/Emergency Plan
- Standard Operating Procedures
- Pest Management Notebook