SEATTLE CHILDREN S RESEARCH INSTITUTE OPERATING POLICIES / PROCEDURES. Effort Certification and Compliance

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Effort Certification and Compliance ORF-002 Page 1 of 10 SEATTLE CHILDREN S RESEARCH INSTITUTE OPERATING POLICIES / PROCEDURES DEPARTMENT: Office of Research Finance (ORF) POLICY NUMBER: ORF-002 REPLACES: New Policy EFFECTIVE DATE: January 1, 2009 REVISION DATE: POSTED FROM: TITLE: Effort Certification and Compliance SUMMARY: Seattle Children s Research Institute is committed to compliance in research effort reporting, recording and certification. APP is comprised of two procedures: Effort Initiation and Adjustment (EIA), and Effort Certification and Compliance (ECC). This policy outlines Effort Certification and Compliance only and explains how to certify quarterly research effort as well as the repercussions of noncompliance. The aim of this policy is to clarify the expectations of investigators, Center Business Managers (CBMs) and research staff in certifying research effort on awards in order to achieve Seattle Children s goal of research effort certification and compliance. Policy ORF-001 compliments policy ORF-002 and standardizes effort initiation and adjustments. The following terms will be used throughout the Affiliate Processing Policies: 1. Affiliate Individual - the individual whose research effort is being reported (includes faculty, investigators and staff belonging to an Affiliate Group). 2. Affiliate Groups - the employers of record for groups of professionals who engage in and support research at Seattle Children s. Billing services are conducted on behalf of the groups members. Affiliate groups include Children s University Medical Group (CUMG) and the University of Washington (UW). 3. Project Principal Investigator (Project PI) - the PI whose project is being worked on by the Affiliate Individual. 4. Sponsored Research (research effort) - Activity spent conducting clinical trials, basic science and other sponsored activities that directly contribute toward the objectives of a single, identifiable project which are externally funded. These activities are typically characterized by two or more of the following: a) a defined work statement; b) a line item budget identifying expenditures by activity, function and project period; c) a specific commitment regarding deliverables and level of personnel effort devoted to the project; and d) a formal report that summarizes results or conclusions.

Effort Certification and Compliance ORF-002 Page 2 of 10 Research faculty and staff at Seattle Children s Research Institute shall conform to the below policy outlining effort certification and compliance. A streamlined process for affiliates to certify their effort and a standard method to track certified effort represents the research institute s commitment to comply with federal regulations in order to secure current and future funding. (See CFR-45, Part 74, Appendix E or A-122 for clarification on federal regulations) POLICY/PROCEDURE: 002-1 Each Affiliate Individual is required to submit a Salary Composition Detail Form (SCD) with the help of their CBM to ORF and the associated Affiliate Group (see the Effort Initiation and Adjustment Policy ORF-001). 002-2 ORF uses the information obtained in the SCDs to generate Effort Certification Forms. 002-3 Every fiscal quarter, ORF updates effort reports in the Lawson System and generates Effort Certification Forms. Seattle Children s fiscal quarters are: Fiscal quarter 1 Fiscal quarter 2 Fiscal quarter 3 Fiscal quarter 4 Oct-Dec Jan-Mar April-June July-Sept 002-4 By the end of the fiscal quarter, ORF informs CBMs via e-mail that Effort Certification Forms are available in Lawson to run. 002-5 Starting the first day of the new quarter, CBMs run the Effort Certification Forms from Lawson and distribute the Effort Certification Forms to each Affiliate Individual. 002-6 Affiliate Individuals review their Effort Certification Form and sign it. If changes to effort are required, the Affiliate Individual makes the corrections directly on the Effort Certification Form. Affiliate individuals and CBMs work together to return the Effort Certification Form to be received by ORF by the 40 th day after the fiscal quarter s end. Please note: At Seattle Children s Research Institute, there is a 5% (+/-) margin regarding effort reported. Therefore, if an affiliate s effort on their Effort Certification Form is within 5% (+/-) of their total actual effort, it does not warrant an adjustment and the form can be certified as is. 002-7 If the Effort Certification Form has changes marked on it by the Affiliate Individual, ORF and the CBM will collaborate to determine next steps to rectify the affiliate individual s reported effort (e.g. a Retro-SCD). Changes to certified effort can be made on a case by case basis. However, once effort is certified, ORF/CBMs can not move that effort/costs onto a federal award. 002-8 ORF scans in and saves signed Effort Certification Forms to the shared location, Research Affiliate Payroll Process (RAPP) SharePoint, at http://sps.hospital.childrens.sea.kids/sites/rapp/default.aspx in the Effort Certification Forms-Fiscal Year XX folder.

Effort Certification and Compliance ORF-002 Page 3 of 10 002-9 If Effort Certification Forms are not received by ORF for an Affiliate Individual by the 35 th day after the fiscal quarter s end, ORF will send a reminder to CBMs/Affiliate Groups/Affiliate Individuals notifying them of the upcoming deadline. A list of affiliates who have yet to certify their effort will be maintained by ORF and sent to the Chief of Research Operations. 002-10 Affiliate individuals and CBMs work together to return the Effort Certification Form to be received by ORF by the 40 th day after the fiscal quarter s end. 002-11 On the 41 st day after the fiscal quarter s end, individuals who have yet to certify their effort will enter Level 1 of the Non-Certifier Escalation Procedure (Appendix C). Continual noncompliance will progress to actions described in Levels 2 and 3 of the escalation procedure. 002-12 If effort is not certified by the 51 st day after the fiscal quarter s end, affiliate individuals will enter level 2 of the escalation procedure and ORF will reduce future payments to Affiliate Groups to recover non-certified effort previously paid and will withhold future payment until affiliate becomes current in effort certifications. 002-13 If Affiliate Individuals enter level 3 of the Non-Certifier Escalation Procedure, actions by the affiliate are required to recommence payment to Affiliate Groups. NOTES: 1. Appendix A is matrix of responsibilities. 2. Appendix B is a visual depiction of the ECC process. 3. Appendix C explains the Non-Certifier Escalation Procedure. 4. Appendix D lists the timeline of actions and calendar deadlines. 5. Appendix E lists common practices associated with effort certification and compliance. 6. All deadlines refer to calendar days, not business days. If a deadline falls on a weekend or a holiday, the new deadline is the following business day by 5 p.m. 7. All questions and concerns regarding the affiliate payroll process can be sent to effortreporting@seattlechildrens.org. Submitting Office: Office of Research Finance Approved by: \s\ Patrick Bassett, Director, Research Finance and Strategic Analysis, December 24, 2008 \s\ John Streck, Chief, Research Operations, December 29, 2008

Effort Certification and Compliance ORF-002 Page 4 of 10 \s\ Erik Lausund, VP, Research Operations & Logistics, December 30, 2008 \s\ Dr. Jim Hendricks, President, Seattle Children s Research Institute, Jan. 5, 2009

Effort Certification and Compliance ORF-002 5 of 10 Appendix A: Responsibility Matrix ROLE Operation of Lawson System Form Distribution Review and sign Form Send effort certification form to ORF Reminders to collect forms Track returned forms and late returns Record keeping of Non- Certifiers Office of Research Finance (ORF) Center Business Managers (CBMs) Affiliate Individual Responsible for maintenance of Lawson System and data entry from SCDs Notify CBMs via e-mail when Effort Certification Forms are available to run in Lawson Run and distribute Effort Certification Forms to affiliates for their signature Required Work with Affiliate Individual to return form Work with CBM to return form Send reminders to CBMs, Affiliate Groups and Affiliate Individuals on the 35 th day after the fiscal quarter s end Follow-up with affiliates to ensure they sign their forms. Send signed forms to ORF to be received by the deadline. Keep a running list of who has turned in their form and who has not Send list of non-certifiers on day 35 to Chief of Res. Ops. Track non-certifiers through escalation procedure.

Effort Certification and Compliance ORF-002 6 of 10 Appendix B: Flowchart of ECC Process

Effort Certification and Compliance ORF-002 7 of 10 Appendix C: Non-Certifier Escalation Procedure All dates refer to after the fiscal quarter s end. Level 1: Level 2: Level 3: Day 41 - Affiliate Individuals, who have yet to certify their effort by the 40 th day after the fiscal quarter s end, receive a notification e-mail from ORF alerting the individual that their Effort Certification Form is past due. Affiliate Individuals have 10 days to submit their signed Effort Certification Form to ORF before future payments to Affiliate Groups are reduced/withheld. The Vice President of Research, the Chief of Research Operations, the Manager of Research Finance, the Affiliate Group Administrator and the appropriate CBM are cc d on the e-mail. The link to the ECC Policy is included in the e- mail for the individual s review. Additional discussions are available through ORF to acquaint Affiliate Individuals with the APP policies. Day 51 - Affiliate Individuals, who have yet to certify their effort by the 50 th day after the fiscal quarter s end, receive a notification e-mail from the Vice President of Research stating that ORF will reduce future payments to Affiliate Groups to recover non-certified effort previously paid and will withhold future payment until affiliate becomes current in their effort certifications. The President of the Research Institute, the Chief Academic Officer, the Vice President of Finance, the Chief of Research Operations, the Affiliate Group Administrator, the appropriate Center Director, and the appropriate CBM are cc d on the e-mail. The link to the ECC policy is included in the e-mail for the individual s review. Additional discussions are available through ORF to acquaint Affiliate Individuals with the APP policies. Day 61 - Affiliate Individuals, who have yet to certify their effort by the 60 th day after the fiscal quarter s end, receive a notification e-mail and a hard copy letter from the President of the Research Institute stating that they are still not compliant with the Effort Certification and Compliance Policy. The Chief Academic Officer, the Vice President of Research, the Vice President of Finance, the Chief of Research Operations, the Affiliate Group Administrator, the appropriate Center Director, and the appropriate CBM are cc d on the e-mail. The link to the ECC Policy is included in the e-mail as well as delivered as a hard copy with the hard copy letter for the individual s review. In order for ORF to repay Affiliate Groups for the Affiliate Individual s previous effort as well as recommence future payment to Affiliate Groups, non-certifiers must: 1. Sign and submit their Effort Certification Form to ORF; and 2. Develop a corrective action plan that adequately addresses the compliance violation (including the steps they will take to be compliant in the future) and submit the plan to the Director of Research Finance/Vice President of Research Operations for review/approval; or

Effort Certification and Compliance ORF-002 8 of 10 3. Meet with the Director of Research Finance to discuss the violation and the Effort Certification and Compliance Policy. *Once Affiliate Individuals in level 3 submit their signed Effort Certification Forms to ORF, and either develop, submit and receive approval for their corrective action plan or meet with the Director of Research Finance, payment to Affiliate Groups will resume.

Effort Certification and Compliance ORF-002 9 of 10 Level 3: 61 days after fiscal quarter s end Level 2: 51 days after fiscal quarter s end LEVEL 1: 41 days after fiscal quarter s end

Effort Certification and Compliance ORF-002 10 of 10 Appendix D: ECC Timeline of Actions and Calendar Deadlines Dates below describe time after the fiscal quarter s end. End of quarter: ORF notifies CBM s via e-mail that Effort Certification Forms are available to run through Lawson. Day 1: Day 35: Day 40: Day 41: Day 51: Day 61: CBM s run Effort Certification Forms in Lawson and distribute to Affiliate Individuals. Research Finance sends reminders to CBMs/Affiliate Groups/Affiliate Individuals for affiliates who have yet to certify their effort (the Chief of Research Operations is given a list of non-certifiers). Affiliate Individuals are required to sign Effort Certification Forms. Affiliate individuals and CBMs work together to return the Effort Certification Form to be received by ORF by the 40 th day after the fiscal quarter s end. Deadline for signed Effort Certification Forms to be returned to ORF. Non-certifiers enter Level 1 of the Non-Certifier Escalation Procedure. Non-certifiers enter Level 2 of the Non-Certifier Escalation Procedure. ORF to reduce payment to Affiliate Groups to recover costs previously paid for non-certified effort and will withhold future payment until affiliate becomes current in their effort certifications. Non-certifiers enter Level 3 of the Non-Certifier Escalation Procedure. A corrective action plan or a meeting with the Director of ORF are now required of Affiliate Individuals. Appendix E: Common Practices Associated with Effort Certification and Compliance At Seattle Children s Research Institute, there is a 5% (+/-) margin regarding effort reported. Therefore, if an affiliate s effort on their Effort Certification Form is within 5% (+/-) of their total actual effort, it does not warrant an adjustment.