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Compliance Developments. Jeff Newman. Overview. A continued (and increased ) focus on compliance Recent developments Industry-by-industry coverage Development of a code of conduct and internal controls Key implementation steps. Industry Update. Pharma IT Education
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Compliance Developments Jeff Newman
Overview • A continued (and increased) focus on compliance • Recent developments • Industry-by-industry coverage • Development of a code of conduct and internal controls • Key implementation steps
Industry Update • Pharma • IT • Education • Defense & Security • Financial
Development of a Code of Conduct and Internal Controls • FAR Clause 52.203-13 and revisions to FAR Subpart 9.4 require formal compliance programs. • FAR 52.203-13 applies to prime contracts & subcontracts > $5 million (base + options)/performance 120 days+. • Requirement must be flowed down in all subcontracts that exceed $5 million and whose performance period is greater than 120 days.
Development of a Code of Conduct and Internal Controls • FAR Subpart 9.4 applies to all contracts and subcontracts, regardless of type, size or duration, and has a three-year “look back” provision • FAR 52.203-13 requires: • Written Code of Business Ethics and Conduct (Code) implemented and available to each employee engaged in the contract within 30 days after contract award.
Development of a Code of Conduct and Internal Controls • Awareness Program and Internal Control System (for non-small businesses and non-commercial item contracts) established within 90 days after contract award • As a practical matter, all contractors need internal control mechanisms because FAR Subpart 9.4 now includes, as a basis for suspension and debarment, a “knowing failure” by a principal to timely disclose....
Key Implementation Steps • Take the appropriate steps NOW • Where is your Code? • Ensure that the components of your Code are suitable to the size of the company and extent of its involvement in government contracting. • Evaluate and incorporate the appropriate internal controls into your Code.
Key Implementation Steps • Maintaining effective compliance practices • Contracting 101… • Tone from the top • Training • Compliance should be more than avoiding unlawful conduct … compliance should extend to all aspects and avenues of government contracting practices.
Key Implementation Steps • Take advantage of audits, mini-audits or periodic reviews • Some initial steps: • Establish audit team • Contractor performed or outsourced reviews/audits should be performed by “detached” evaluators, e.g., principal investigators under a R&D contract should not be performing the only, or formal, corporate compliance audit/evaluation. • Define scope of audit and objectives to be achieved (e.g., areas to cover and “visions” of company compliance) • Develop deliverables (e.g., matrix of problem areas and related risk rating)
Key Implementation Steps • Conducting the audit – top-level steps: • Paper and personnel (and welcome to the 21stcentury) • Honest assessment • Random sampling • Toot your horn! • Final deliverable and recommendations