|
|
UCSB Semiannual Program Evaluation
Facility Inspection Process
Generation of the Semiannual Report
| 1) Semiannual Program Evaluation and Facility Inspection occurs at least once every six months. There are two components. First is an evaluation of the UCSB program for humane care and use of animals, using "The Guide for the Care and Use of Laboratory Animals" as a basis for evaluation. The second component is an inspection of all of the institution's animal facilities, including satellite facilities, using the Guide as a basis for evaluation. The IACUC procedures for conducting semiannual program evaluations utilize the OLAW Semiannual Program and Facility Review Checklist, which has been customized for the UCSB Animal Care and Use Program. |
a. The Semiannual Program Evaluation and Facility Inspection occurs during Fall (October) and Spring (April) each year to best accommodate the academic calendar and the IACUC meeting hiatus during July and August. The exceptions are the Santa Cruz Island Reserve (SCIR) and Valentine Eastern Sierra Reserve (VESR). These locations are inspected only once during the year due to the distance away from the main campus and travel requirements. Animals are not housed on SCIR; they are in the process of transportation or removal from the island. Ancillary function areas are inspected annually. At VESR, vertebrate animal work occurs only during the late spring and summer months (less than 6 months of the year). The VESR inspection is routinely scheduled during the last half of May when a majority of the vertebrate animal researchers are present on site.
b. Semiannual Program Evaluation and Facility Inspection subcommittees are selected with a minimum of two IACUC members to perform the Semi-annual Program Evaluation and Facility Inspection for each Animal Care and Use Program (ACUP) unit. The IACUC Coordinator coordinates the subcommittees and inspection times and locations. No IACUC member is excluded from the opportunity to participate in a facility inspection; however, the reserve site inspections for SCI and VESR are typically performed by a single IACUC member and the Reserve Director.
c. IACUC members are provided with background materials and access to appropriate resources to assist them in understanding and evaluating the issues involved with the Semiannual Program Evaluation and Facility Inspection. New IACUC members are expected to participate in all or part of the semiannual as a component of their IACUC member training. Each Semiannual subcommittee will have available:
|
i. Semiannual Program Evaluation and Facility Inspection instructions
ii. "The Guide for the Care and Use of Laboratory Animals"
iii. The IACUC Guidebook
iv. Semiannual checklists for the Program and Facility
v. Past Program and Facility records
vi. Animal Care and Use Program description
vii. Animal Care and Use Program SOPs, which should also be available in the facility.
|
d. Conducting the semiannual program review and facility inspection: The subcommittee will review both Program and Facility compliance with the Guide. The subcommittee will verify the current status of previously reported deficiencies during this review. Major deficiencies would be immediately addressed on discovery and reported to the Campus Veterinarian, IACUC Chair and the Institutional Official. Minor deficiencies are recorded on the Checklist. Issues and deficiencies associated with institutional policies and responsibilities are identified and presented to the full committee for follow-up. The responsible parties of facility and animal study areas are informed of deficiencies and a correction schedule and/or interim status report is requested by the IACUC Office. During the inspection the IACUC members are responsible for reporting findings on the semiannual checklists (recorded by the IACUC Coordinator), stating why there is a concern, and suggesting a timeline for correction.
e. The IACUC Coordinator is responsible for using the data collected on the semiannual checklist to draft inspection letters. (Follow-up gathering of information and discussion of a correction plan and schedule should occur after the inspection letters have been typed up and formatted by the IACUC Coordinator.)
f. After the letters have been drafted, they will be returned to the subcommittee for review via email. The subcommittees will be responsible for the drafts of only those inspections they conducted with the exception of the IACUC Program letter. The subcommittee should come to an agreement on resolutions and timelines and email their decision to the IACUC Coordinator to complete the draft inspection letter. If the sub-committee elects to meet with the responsible party to discuss the findings or the timeline for correction, it should not delay the letter of notice more than 7 days following the facility inspection.
g. After all timelines and resolutions have been received from the subcommittees, the IACUC Coordinator finalizes the draft inspection letters and coordinates a meeting with the IACUC to approve the draft letters within 14 days following the facility inspection. Each subcommittee is responsible for approving their drafts, while the entire Committee should approve the IACUC Program draft. After approval, the IACUC Coordinator emails the inspection letters to the responsible parties.
h. Semiannual Program Evaluation and Facility Inspection letters: Letters will be sent to all responsible parties.
|
i. The letter will follow the Semiannual Program Evaluation and Facility Inspection letter template.
ii. The letter will include the facility inspection date.
iii. Each finding will be described as an item. The compliance concern regarding that finding or a group of findings will be stated, followed by an acceptable plan of action for correcting the item of concern.
iv. The draft letter will be sent to the subcommittee for review via email unless other arrangements have been made with the IACUC Coordinator.
v. The reviewed letters will be sent via email, unless other arrangements have been made with the IACUC Coordinator.
vi. The letters will be sent to the responsible parties, who are PIs, some Co-PIs, Facility Directors, Facility Managers or Facility Supervisors.
vii. The letters will be copied to the next level of oversight. These are identified in the Animal Care and Use Program Unit Overview.
|
i. Response timeline: Responsible parties will have a default time of 14 working days to respond to the letter of findings; if they want to modify the response and/or plan. Specific deadlines will be listed in the body of the letter, and supercede the 14-day rule.
j. Response review: The subcommittee will review the response from the responsible party, and make decisions regarding the plan.
k. Compliance: Any rebuttal or failure to comply will result in full committee action.
|
2) The IACUC Office will inform all responsible parties, PIs, and facility users of the semiannual program review and facility inspection process. The Semiannual checklists will be made available for Animal Care and Use Program units to perform a self-evaluation before the IACUC subcommittee inspects their facility.
3) Semiannual Report: The IACUC will prepare reports of the IACUC evaluations as set forth in the PHS Policy at IV.B.3., and submit the reports to the Institutional Officer (Vice Chancellor for Research). The IACUC process for developing reports and submitting them to the Institutional Official involves reviewing the Semiannual Program and Facility Inspection letters of findings where the deficiencies and other issues are identified and listed. A correction plan and schedule is included in the letter. Any alterations in the correction plan and schedule are handled as described above. The letters and any changes requested by the responsible parties are collected by the IACUC Office and used to generate a Semiannual Report similar to the sample OLAW Semiannual report from the OLAW website. The Semiannual Report includes a cover letter (see attached report cover letter template), and copies of the Semiannual Program Review and Facility Inspection letters. In addition, letters from responsible parties and parts of the Semiannual Checklist may also be included in the Semiannual Report. The Semiannual Report is distributed to the entire IACUC. Each member may approve, disapprove or submit a minority view. A majority of the IACUC members must sign the Semiannual Report. The signed Semiannual Report and any minority IACUC opinions are forwarded to the Institutional Official.
|
|