Skills Competency Education
for
New PI Directors and Coordinators
Session Six
March 28, 2006
Sponsored by: The MT Rural Healthcare PI Network
Co-Sponsored by: The Mountain Pacific Quality Health Foundation
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.
MHREF
NOVEMBER 18-19, 2003
DRAFTING POLICIES AND
PROCEDURES
Michelle A. Williams, J.D.
Alston & Bird LLP
404-881-7594
[email protected]
Gary McClanahan, J.D.
Alston & Bird LLP
404/881-7632
[email protected]
I.
WHAT ARE POLICIES AND
PROCEDURES?
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
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
INTENDED USES
• Manuals Are Used
 To Teach
 To Evidence Compliance with Law
 To Document / Defend
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
INTENDED USES
• Contractually Required
 Hospital-Based Physician Agreements
 Transfer Agreements
 Corporate Integrity Agreements
INTENDED USES
• “Voluntary” Requirements
 Accreditation
 OIG Hospital Compliance Guidance
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).
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.
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.
UNINTENDED USES
• Discoverable
 Surveys
• Part of Plan of Correction
 Lawsuit Defense
• Define Standard of Care
EXAMPLES OF
POLICY MANUALS
•
•
•
•
•
•
•
•
•
Administrative
Credentialing
Human Resources
Purchasing
Nursing
Privacy
Infection Control
Compliance
Disaster
• Departmental Level
■ Laboratory
■ Radiology
■ Medical Records
POLICY MANUAL TYPE
DOCUMENTS
•
•
•
•
•
•
•
Hospital Bylaws
Medical Staff Bylaws
Medical Staff Rules and Regulations
Employee Handbook
Compliance Plan
Quality Improvement Plan
Code of Conduct
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
INVENTORY
Manuals
Bylaws/Plans/Other
II. ELEMENTS OF
A POLICY AND PROCEDURE
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
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
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?
III. PRACTICE POINTERS
DRAFTING DON’Ts
• “Must”/“Shall”
• Use of Abbreviations
• Assume the “Subject”
• Time Designations
 “Dr. Called”
• Forms Without Policies
• Use of Negative Statements
 “Never”
 “Do Not”
 Immediately / ASAP
• Use of Jargon
DRAFTING DO’s
• Use of the Word “May”
• Use of the Word “Should”
• Read Aloud
• Test on Users Before Adoption
USE OF DEFINED TERMS
• Definition
• Consistent Use of Defined Term
• Capitalize
“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
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
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
READING COMPREHENSION
• Grade Level: 4th and 8th 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
QUESTIONS
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GHA TELNET DRAFTING POLICIES AND PROCEDURES