Compliance Process Reviews
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1 Compliance Process Reviews Developing and Implementing a Systematic Approach to Evaluating Ethics and Compliance Programs Anna E. Ward, JD, CHC Eva Maria Wood, JD HCCA s 16 th Annual Compliance Institute April 30, 2012, Session 107 Presentation Overview Ethics and Compliance Program Structure Compliance Process Review (CPR) Summary Systematic Approach: Creating Consistency 2 1
2 HCA E&C Program Structure 3 CPR Mission and Goals Assess ECO s performance and engagement Review and test program elements Serve as a tutorial and supplemental training Share best practices Increase awareness 4 2
3 Review Documents Compliance Process Questionnaires Ethics & Compliance Officer Facility Privacy Official Facility Information Security Official Health Information Management Director Pharmacy Director Records Management Clinical Research Document Request 5 Example Topics ECO Visibility Code of Conduct Training Gifts and Entertainment Conflict of Interest Privacy Controlled Substances Physician Relationships Ineligible Persons Licensure Verification EMTALA Coding Processes Antitrust 6 3
4 Methodology Questionnaires test knowledge, compliance Questions based on what ECO should know Document review tests processes/procedures Three months data shows current status Interviews resolve issues and raise awareness 7 Timeline Questionnaires completed Documents uploaded to secure, online teamroom Questions for discussion prepared Onsite visit with interviews and additional document review Exit conference with ECO and others Three month process from review initiation to Corrective Action Plan (CAP) approval 8 4
5 Reports to Facility Report of Findings Details of issues Policy requirements for reference Corrective Action Plan Root cause Responsible person Completion date Three weeks to put plan together for approval Follow up on plan until completed Executive Summary to CEO, Division, Group 9 Self Assessment Option Questionnaires and Document Requests are available on intranet for ECOs ECOs can conduct whole or partial review FECC members should assist Review tools available to Division ECOs for mock reviews Updated Questionnaires and Document Request are posted on external HCA website:
6 Key to Success: Consistency 11 Annual Review of Scope 12 6
7 Document Request Example 13 Document Review Structure 14 7
8 Creating Checklists Hard copy and/or electronic checklists One checklist for each document type Template has required compliance elements Rules and regulations Policy and procedures Guidance documents Corresponding envelopes for organization Example policies: 15 Data Collection Options Excel spreadsheet tracks issues found Access database for more accurate data entry and streamlined reporting SharePoint database Real time, multi user workspace virtual office Secure and backed up on a network server More than a database calendars and teamrooms 16 8
9 SharePoint Advantages Online access while traveling Document collection in secure teamrooms Data entry more efficient and accurate Track issues from discovery to resolution More professional and detailed reports More timely reporting Helps identify potential systemic issues 17 Key to Success: Consistency 18 9
10 Exit Conference Report Presents entire scope of the review Green, yellow, red, gray coding indicates compliance for each topic No Issue, Issues, Opportunities, Questions 19 Scoring Tool Example Allows Flexibility Standard Grading Scale 20 10
11 Scoring Tool Development Organized by topic Most common issues anticipated Issues match Exit Conference report Annually, each issue is assigned a risk factor Low = 1, medium = 2, high = 3 Severity level assigned for actual issues found Minor Issues yellow Systemic orange Egregious red 21 Scoring Tool Example Example Formula: Total minor issues reduces score by 0.4% Total systemic issues reduces score by 0.9% Total egregious issues reduces score by 1.9% Predetermined Weight 22 11
12 Scoring Tool Development Start with 100% Score reduced for each finding based on weight and severity Flexibility to adjust for less common or more specific issues Grading scale converts score to a 1 5 rating Calibrate tool using historical data and ratings 23 Rating Descriptions 24 12
13 Scoring Validation Review Reviewers and manager meet Recommend in person, could be virtual Review line by line report issues Ensure severity is consistent for similar issues Discuss ECO engagement Final reality check of CPR rating 25 Trending and Additional Reports Real time reporting to address company wide issues Periodic Reporting As needed by issue or division to track trends Assists Division ECOs with focus areas Share with other departments Annual Reporting Trending by year and issue Distribution to field to raise awareness FECC review required 26 13
14 Communication Weekly reviewer meetings to collaborate Share new/complex issues encountered Discuss approach Raise facility implementation challenges Obtaining Responsible Executives guidance for issues not directly addressed by policy Add guidance notes on reviewer checklists Add guidance notes to SharePoint teamroom Quality Control Evaluation feedback from ECO 27 Systematic Evaluation Approach 28 14
15 Questions? Anna Ward, JD, CHC Eva Maria Wood, JD
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