1. Skills Competency Education for New PI Directors and Coordinators Session SixMarch 28, 2006 Sponsored by: The MT Rural Healthcare PI Network Co-Sponsored by: The Mountain Pacific Quality Health Foundation

2. Session Six Learning Goals  To understand the critical role that policies and procedures perform in organization communication;  To understand the role of policies and procedures in managing organization medical-legal risk;  To understand the difference between a policy and a procedure;  To share guidelines for policy and procedure development.

3. MHREF NOVEMBER 18-19, 2003 DRAFTING POLICIES AND PROCEDURES Michelle A. Williams, J.D.Gary McClanahan, J.D.Alston & Bird LLP 404-881-7594404/881-7632 mawilliams@alston.comgmcclanahan@alston.com

4. I.WHAT ARE POLICIES AND PROCEDURES?

5. WHAT ARE POLICIES AND PROCEDURES? Policies are a reflection of the Hospital’s mission and operations Procedures are a description of the steps necessary to accomplish a policy Policies and Procedures have intended uses and get used in unintended ways

6. WHAT ARE POLICIES AND PROCEDURES? Policy and Procedure Manual is first thing surveyors and investigators request regardless of what Agency they represent DPHHS for Hospital Licensure CMS for EMTALA OIG for Billing

7. INTENDED USES Manuals Are Used  To Teach  To Evidence Compliance with Law  To Document / Defend

8. INTENDED USES To Teach –Operationalize Communication –Minimize “Hand Me Down” Education Required By Law –CAH Conditions of Participation –State Hospital Licensure Law –Federal CLIA Law

9. INTENDED USES Contractually Required  Hospital-Based Physician Agreements  Transfer Agreements  Corporate Integrity Agreements

10. INTENDED USES “Voluntary” Requirements  Accreditation  OIG Hospital Compliance Guidance

11. OIG HOSPITAL COMPLIANCE GUIDANCE REQUIREMENTS  Risk Identification. The first element of a Compliance Plan is the development and distribution of written policies and procedures that identify specific areas of risk to the hospital.  Standards of Conduct. Hospitals should develop standards of conduct that:  include a clear commitment to compliance by the hospital’s senior management.  articulate the hospital’s commitment to comply with all Federal and State standards, with an emphasis on preventing fraud and abuse.  should be distributed to, and comprehensible by, all employees (e.g., translated into other languages and written at appropriate reading levels).

12. OIG HOSPITAL COMPLIANCE GUIDANCE  Risk Areas. The OIG Guidance focuses on specific areas of potential fraud and provides specific examples of policies that should be implemented to ensure compliance in these areas.  Claims Development and Submission Processes and Code Gaming (upcoding, DRG creep). There should be policies that create a mechanism for the billing or reimbursement staff to communicate effectively and accurately with the clinical staff.  Ensuring That Claims Are Submitted Only for services that are medically necessary and that were ordered by a physician or other appropriately licensed individual.

13. OIG HOSPITAL COMPLIANCE GUIDANCE  Anti-Kickback and Self-Referral Concerns. The hospital should have policies and procedures in place with respect to compliance with Federal and State anti-kickback statutes, as well as the Stark physician self-referral law.  Accurate and Timely Reporting of Bad Debts and Credit Balances to Medicare and other Federal health care programs.  Records System. There should be a records system which should establish policies and procedures regarding the creation, distribution, retention, storage, retrieval and destruction of documents.

14. UNINTENDED USES Discoverable  Surveys Part of Plan of Correction  Lawsuit Defense Define Standard of Care

15. EXAMPLES OF POLICY MANUALS Administrative Departmental Level Credentialing ■ Laboratory Human Resources ■ Radiology Purchasing ■ Medical Records Nursing Privacy Infection Control Compliance Disaster

16. POLICY MANUAL TYPE DOCUMENTS Hospital Bylaws Medical Staff Bylaws Medical Staff Rules and Regulations Employee Handbook Compliance Plan Quality Improvement Plan Code of Conduct

17. WHAT IS THE DIFFERENCE? Plans / Bylaws / Handbooks  Subject matter framework  Source of policies and procedures Policies and Procedures Operationalize Plans and Bylaws Who How Where When

18. INVENTORY ManualsBylaws/Plans/Other

19. II. ELEMENTS OF A POLICY AND PROCEDURE

20. POLICY AND PROCEDURE Review and Management Identify Criteria for When Needed Review Existing Manuals / Bylaws / Plans / Handbooks  Related Policies  Pre-existing Policies Which are Similar Draft / Proof / Consensus / Trial Read by Users Approval of Committee / Administrator / Board Publication To Proper User Group Inservice / Test Revisions

21. ELEMENTS OF A POLICY AND PROCEDURE What is a “Purpose”?  Goal  Objective  Aim  What do you want to achieve? What is a “Policy”?  Links the Purpose and Procedure  Describes How the Purpose will be Achieved

22. ELEMENTS OF A POLICY AND PROCEDURE What is a “Procedure”?  The Who, the What, the When, the Where  Applies the Policy  Series of Steps How is Policy Different from a Procedure?

23. III.PRACTICE POINTERS

24. DRAFTING DON’Ts “Must”/“Shall” Assume the “Subject”  “Dr. Called” Forms Without Policies Use of Negative Statements  “Never”  “Do Not” Use of Abbreviations Time Designations  Immediately / ASAP Use of Jargon

25. DRAFTING DO’s Use of the Word “May” Use of the Word “Should” Read Aloud Test on Users Before Adoption

26. USE OF DEFINED TERMS Definition Consistent Use of Defined Term Capitalize

27. “POLICIES AND PROCEDURES” POLICY How To Draft A Policy and Procedures How To Obtain Approvals How To Revise A Policy and Procedures How To Retain Old Policies and Procedures How To Document New Employee Training and Annual Training of Policies and Procedures How To Inservice New/Revised Policies and Procedures

28. PITFALLS Survey citations for “Not Following Hospital Policies on ________” Passive Voice Rather Than Active Voice “Prescriptive” Policies Drafts not marked “Draft”; Undated Drafts Use of terms “standards” “guidelines” “policy” “protocol” interchangeably or without definition

29. PITFALLS No Review and Revision Conducted Solitary Drafting and Annual Review versus “Qualified Group of Professionals” No Tracking and Retention of Policy Revisions Not Following Policy and Procedure No Monitoring to Confirm Policy and Procedure Being Followed or If Not, Why Not

30. READING COMPREHENSION Grade Level: 4 th and 8 th Grade Reading Level  SMOG - 10 consecutive sentences at the beginning of the document, 10 consecutive sentences in the middle, and 10 consecutive at the end. Count the number of multi-syllable words (3 or more) including repetitions. Then take the nearest perfect square root of that number and add 3. That gives you the reading level. Hyphenated words count as one; numbers and abbreviations: pronounce them aloud and count the number of syllables  Word Count Software: Voice and Grade Level

31. QUESTIONS