1. Regulatory Compliance & Quality Management
April 15, 2011
Rebecca Carson, RN, MSN
Psychiatric Facilities Coordinator
DMH-MIMH LEADERSHIP TRAINING INSTITUTE

2. WHY regulate Mental Health Facilities and Service Providers?
Regulatory Compliance: Why Regulate?
WHY regulate Mental Health Facilities and Service Providers?

3. Insure safety of vulnerable citizens
Regulatory Compliance: Why Regulate?
Insure safety of vulnerable citizens
Insure safety of the general public
MONEY
Insure we are getting the service for which we paid
Insure we are getting reasonable quality of service for which we paid

4. Regulatory Compliance: Who Regulates?
Federal Government
U.S. Code (Public Laws)—Establish intent & authority
Federal Code of Regulations (FCRs)
Interpret & Provide Operational Instructions
State Government
Revised Statutes of Missouri (RSMo)—Establish intent & authority
State Code of Regulations (CSRs)
County/Municipal Ordinances
Usually life safety; Zoning issues

5. Regulatory Compliance: Learning the “Lingo”
Licensure
Minimum requirements to do business
To perform a services, such as a professional license
To provide a service/function, such as operate a residential facility
Certification
Requirements to participate in a particular service or program
Usually required for reimbursement
Can reflect a special designation or achievement
Can give you “deemed status” for some licenses
Accreditation
Most often VOLUNTARY , with rare exceptions
Goal=Quality; “Good Housekeeping Seal”
Can give you “deemed status” for some licenses &/or certifications
“Deemed Status”—Determined to be equivalent; able to substituted for other requirement

6. Regulatory Compliance: Learning the “Lingo”
Accreditation continued…………
Major Players---
The Joint Commission (TJC)
CMS grants deeming status for hospitals (5000), PRTC
Hospitals, Behavioral Health Organizations
Home Care, Laboratory, LTC
Commission on Accreditation of Rehab Facilities Inter’l (CARF)
CMS acknowledged accreditor for DME
Council on Accreditation (COA)
Largely “kid” and family serving agencies
Det Norske Vertas Healthcare Inc. (DNV)
CMS grants deeming status for hospitals (27)
Healthcare Facilities Accreditation Program (HFAP)
Division of AOA, American Osteopathic Association
CMS grants deeming status for hospitals (200)
The Council on Quality & Leadership (CQL)
Used to be known as Accreditation Council for MR or other DD Persons

7. Regulatory Compliance: Learning the “Lingo”
Accreditation continued…………
How to compare—What has meaning for your organization---Not all created equal
Organizational Focus
Clinical/Administrative
Outcomes/Process
Organizational Structure; Governance Leadership
Non-for-Profit/ For Profit
Accreditation Requirements
Participation requirements, General
Standards
Survey Process/Frequency
Annual/Triennial
Announced/Unannounced
Paper/Onsite
Complaint process
Surveyors (Qualifications)
Employees or volunteers
Scoring Process/Decision Process
Status of Accreditation
Satisfies other standards (Deeming)
Public/Professional Reputation
Accreditation Categories
Programs covered
Cost
Usually based on size of organization, but can vary $10K-$15 K/yr.
Patient Safety
Continuous Improvement
TQM, CQI
ISO
Lean Six Sigma

8. Regulatory Compliance: Special Oversight-Complaint Driven
Federal
HIPAA
EMTALA
Department of Justice Investigations/Litigation
ADA –Olmstead Decision
Telecommunications, Fair Housing, Voting Accessibility Acts
Air Carrier Access, Architectural Barriers, Rehabilitation Acts
Individuals w/ Disabilities Education Acts
Civil Rights of Institutionalized Persons Act (CRIPA)
State
DHSS-Vulnerable Person Protection
RSMo &
DHSS/DMH/DSS Memo of Understanding – Facilities Only
DSS-Children’s Division—Abuse/Neglect
RSMo ; 13 CSR &

9. Regulatory Compliance: Hospital: Licensure
Missouri Hospital License—RSMo Chapter 197
Survey/Determination Responsibility=Dept of Health & Sr. Services (DHSS)
Applies to all hospitals, BUT DHSS has elected not to survey DMH operated hospitals; DMH views regulations as Standard of Practice
DMH does not license psychiatric hospitals, DHSS does
Hospitals: 19 CSR thru
Psych Hospitals: 19 CSR thru

10. Regulatory Compliance: Hospital: Certification
Certification— “qualified, eligible for reimbursement”
Most important = Hospital Certification from CMS [A-tags]
US Department of Health & Human Services, Centers for Medicare & Medicaid Services
MO DHSS serves as contracted surveyors for CMS
Must be certified/”deemed” certified to bill/collect Medicare or Medicaid dollars
Some private insurances tie their reimbursement to CMS certification as well
Psych Hospitals treated differently ! ! !
Must also meet Special Conditions of Participation [B-tags]
Allowed to designate “Distinct Part” of hospital for certification
IMD Rule [“Institutions for Mental Disease”]
> 16 beds; care=primarily MH; Ages 22-64
Correctional institutions vs Hospitals

11. Regulatory Compliance: Hospital: Accreditation
Accreditation — “Voluntary” standards compliance
Most important
Deemed Status for Hospital Certification from CMS [A-tags]
Deemed Status for Special Psych CoPs [B-tags] NEW ! ! !
Considered Standard of Practice for hospitals
All DMH hospitals achieved in 1990; all now except for SWPRC
Other benefits
Credibility; “good housekeeping seal”
Requirement to be “training/practicum” sites for professionals
Recruitment/Retention
Helps us “keep up” with changing/improving practice
Leverage with Legislature/Governor
Psychiatric Residential Treatment Centers: [Cottonwood & Hawthorn Residential] Youth, Medicaid reimbursable, must accredited + CMS [N-tags]

12. Regulatory Compliance: Community Providers: Residential
Community Residential –[Non-Hospitals]
Licensure
MO DHSS Licensed
Skilled Nursing Facilities (SNF), Intermediate Care Facilities (ICF; ICFMR) Residential Care Facilities (RCF), Assisted Living Facilities (ALF) [CSR Title 19 Division 30]
MO DMH Co-Licensed DHSS
RCFs that have 1 MRDD consumer and/or 50% or greater MI consumers [CSR Title 9 Division 40 Chapter 3]
DMH Standards focus=treatment program
MO DMH Licensed Only [CSR Title 9 Division 10 & 40]
Psychiatric Group Homes
Therapeutic Foster Homes

13. Regulatory Compliance: Community Providers: Residential
Community Residential [Non-Hospital]
Certification
MO DHSS Only
Skilled Nursing Facilities (SNF), Intermediate Care Facilities (ICF; ICFMR) Residential Care Facilities (RCF), Assisted Living Facilities (ALF) [CSR Title 19 Division 30 Chapter 81]
Title XIX-Medicaid; Title XVIII-Medicare – Federal/State reimbursement for long term care
MO DMH Only
Intensive Community Psychiatric Rehabilitation [9 CSR Amended 2/24/2011]
Amendment permits the necessary supports for Intensive Residential Treatment Services (IRTS) NEW !!!
Inpatient Redesign effort to move long term hospitalized individuals into the community
Accreditation— Available, but not big role as yet

14. Regulatory Compliance: Community Providers: Outpatient
Community Outpatient
Licensure
Individual Practitioners—Professional Licensure
DIFP-Department of Insurance, Financial Institutions and Professional Registration
Division of Professional Registration--
Business Registration
Secretary of State--
MO DHSS Licensed Only
Adult Day Care; Child Day Care (May or may not impact our MH Community Providers) [CSR Title 19 Division 30]
MO DMH Licensed Only [CSR Title 9 Division 40]
MI & DD Day Programs – Non Medicaid Certified
Certified Programs are “deemed” to have met licensure requirements

15. Regulatory Compliance: Community Providers: Outpatient
Community Outpatient
Certification
MO DMH Only
Usually tied to Medicaid reimbursement, ADA exception
ADA & CPS “Core Rules” --- Combined 2001
9 CSR 10-Chapter 7
Division Specific
9 CSR 30-Chapter 3, Alcohol & Drug Abuse Programs
9 CSR 30-Chapter 4, Mental Health Programs
MSAPCB- Substance Abuse Professional Credentialing;
Accreditation
Available, but not big role as yet but growing
Increase with large hospital acquisition of CMHCs
CMHCs seeking “deemed status” for licensure/certification requirements
Contract & Billing Audits --- Although not “regulatory”, intertwined

16. General Constructs & Overview Only
Regulatory Compliance: Disclaimer & Last Thoughts
General Constructs & Overview Only
Do not assume everyone speaks the same language
The devil is in the details ! ! !
If you’re responsible for it, do your homework
Regulatory compliance does not automatically assure quality ! ! !

17. Regulatory Resources ACCREDITATION
Commission on Accreditation of Rehab Facilities Inter’l (CARF);
Council on Accreditation (COA);
Det Norske Vertas Healthcare Inc. (DNV);
Healthcare Facilities Accreditation Program (HFAP);
The Council on Quality & Leadership (CQL);
REVISED STATUTES OF MISSOURI (RSMo);
Department of Mental Health, Chapter 630 RSMo
Division of Alcohol & Drug Abuse, Chapter 631 RSMo
Division of Comprehensive Psychiatric Services, Chapter 632 RSMo
Division of Developmental Disabilities, Chapter 633 RSMo
Department of Social Services; Chapter 660 RSMo
Public Health & Welfare; Chapters 188, 189, 190, 191, 192, 194, 195,196, 197
MISSOURI CODE OF STATE REGULATIONS ( CSR)
Department of Mental Health, Title 9
Department of Health & Senior Services, Title 19
Department of Social Services, Title 13

18. Regulatory Resources FEDERAL LAW; http://www.gpoaccess.gov/uscode/
FEDERAL CODE OF REGULATIONS;
HIPAA;
EMTALA;
Department of Justice; Division of Civil Rights;
Civil Rights of Institutionalized Persons;
Olmstead Decision;
CMS REGULATIONS & INTERPRETATIVE GUIDELINES
Hospitals, A Tags;
Psych Hospitals, B Tags;
Psych Residential Treatment Facilities, N-Tags;

19. QM starts with asking the right questions ! ! !
Quality Management
QM starts with asking the right questions ! ! !
[and it never stops……….continuously seeking to improve !]

20. WHAT constitutes Quality?
Quality Management
WHAT constitutes Quality?

21. “I can’t define it, but I know it when I see it”
Quality Defined
“I can’t define it, but I know it when I see it”
You better know how to define it if you want to stay employed or stay in business
“Common person” standard
Licking, Missouri
“Political” reality
A.K.A “How does it play out in the headlines?”
Established criteria
Published standards
“Evidence Based Practices”

22. Key Responsibilities Identified
What are my key responsibilities; what am I responsible to produce; for what am I accountable?

23. Example : Areas of Responsibility in Health Care
Consumer and Employee Safety
Elimination/Reduction in physical Plant Hazards
Infection Control
Disaster Preparedness
Consumer Satisfaction
Comfort
Staff Responsiveness
Appropriate & Efficient Admissions
Triage and screening processes
Appropriate & Effective Care & Treatment
Right Treatment Program
Right Medications
Consumer Progress/Outcome Measures
Utilization Review
Appropriate & Effective Discharges
Readmissions
Post discharge complications/Suicides
Cost Effective Fiscal Management
Budget outliers
Price increases/decreases
Optimal Utilization of Human Resources
Right number and right mix of employees
Right and up to date employee competencies

24. How do know if I am meeting my key responsibilities?
Meeting Key Responsibilities
How do know if I am meeting my key responsibilities?
Was what I produced satisfactory?

25. Your job is to acquire and take care of 20 ducks.
Ask More Questions---Duck Exercise
Your job is to acquire and take care of 20 ducks.
You want to be successful at your job.
How do you keep your job?

26. Your owner/boss (taxpayers) Your VP of Finance (legislature)
Duck Exercise: Roles
YOU (manager of ducks)
Your owner/boss (taxpayers)
Your VP of Finance (legislature)
The vendor (he who has ducks to sell)
The competition (he who also cares for ducks)

27. What are my key responsibilities?
QM of Ducks
What are my key responsibilities?
What questions should I ask to determine if I’m meeting my responsibilities?

28. Performance Measurement
QM = Asking the Right Questions
QUESTIONS
QM Technology
Did we get that for which we paid?
Contact Compliance
Does what we purchased or what we perform meet minimum standards?
Quality Assurance
Is what we’re doing healthy and/or safe?
Have we mitigated against loss or damage?
Risk Management
Can we get better performance or better product? Can we exceed standards or move towards “best practices”?
Quality Improvement
Is what we purchased or what we’re doing achieving the outcomes we sought?
Performance Measurement
How do we compare? Do we achieve similar outcomes as that of our peers? Are we competitive in the market
Benchmarking
What can we learn from an extremely good experience or an adverse event?
Sentinel Event
Analysis

29. Identify key responsibilities to monitor
Basic Tools of QM—A Plan
Need a plan:
Identify key responsibilities to monitor
Methods to monitor
Think sample
Think intermittent sampling
Areas for improvement focus
Think strategic
Fix existing problems
Prevent problems
Change system to address root cause of problem
Manage innovation
Quality improvement approach
CQI, TQM, Lean Six Sigma, ISO

30. Basic Tools of QM— Improvement Process
Identify the problem, issue or opportunity for improvement
Gather relevant data and information
Brainstorm possible solutions
Select a solution to trial
Develop an implementation plan
Establish a baseline to measure against
Implement the plan
Evaluate the results of the solution against the baseline
If solution fails to resolve problem or render improvement, REPEAT THE ABOVE STEPS
If solution is somewhat successful, consider fine tuning or modifying solution; implement and re-evaluate
If problem resolved or improvement achieved, adopt the solution as final practice…..and move on to new problems or opportunities for improvement

31. Check whether the test worked; achieved the desired result.
Basic Tools of QM— PDCA Cycle
PDCA Cycle:
Plan to improve your operations by first finding what things are going wrong.
Do changes designed to solve the problems on a small scale first; test to minimize disruption.
Check whether the test worked; achieved the desired result.
Act to implement changes on a larger scale if test is successful.
Plan Do
Check
Act
Shewhart Cycle
Deming Wheel

32. Quality improvement is a continuous effort.
Basic Tools of QM— QI According to Marty Martin-Forman
Quality is, first of all, leadership responsibility; it cannot be delegated to the “Quality Department.”
Quality improvement is a continuous effort.
QI is dependent on leadership at all levels of the organization.
Quality planning must begin with a clear delineation of customers, what they need or want from the organization, and what quality characteristics will be adopted as the most important.

33. Basic Tools of QM— QI According to Marty Martin-Forman
In health care or mental health, the definition of quality is shared by the customer or client and by the experts or specialist.
QI requires discipline to go through the PDCA cycle. All levels of management and organizations resist the check and act phases.
Data will free employees. Data that supports improvement plans drives out fear and empowers managers and employees.
QI is not a democratic process. QI is leader driven and requires a vision of how things must be.

34. Basic Tools of QM— QI According to Marty Martin-Forman
QI is not a democratic process. QI is leader driven and requires a vision of how things must be.
QI requires repetitive education and training. One shot education is insufficient. Key concepts and tools need to be integrated into multiple learning opportunities.
Quality is a function of everyone in the organization; team work is basic to QI efforts.

35. Five Mistakes That Commonly Doom Quality Improvement
Basic Tools of QM— QI According to Marty Martin-Forman
Five Mistakes That Commonly Doom Quality Improvement
Lack of:
Top Management Involvement
Middle Management Leadership
Integration
Continuous Training

36. Ten Pillars of Continuous Improvement……………
Basic Tools of QM— QI According to Marty Martin-Forman
Ten Pillars of Continuous Improvement……………
1. Management Vision and Commitment
2. Accountability
3. Measurement and Feedback
4. Problem-Solving and Process Improvement
Communication
6. Staff Development and Training
7. Physician Involvement
8. Reward and Recognition
9. Employee Involvement and Empowerment
10. Reminders and Refreshers

37. Basic Tools of QM— Root Cause Analysis
RCA Goal: What happened --Why did it happen -- What to do to prevent it from happening again
Root Cause Analysis is a tool for identifying prevention strategies. It is a process that is part of the effort to build a culture of safety and move beyond the culture of blame.
Root Cause Analysis is:
Inter-disciplinary, involving experts from the frontline services
Involving of those who are the most familiar with the situation
Continually digging deeper by asking why, why, why at each level of cause and effect.
A process that identifies changes that need to be made to systems
A process that is as impartial as possible

38. Basic Tools of QM— RCA continued……
To be thorough, a Root Cause Analysis must include:
Determination of human & other factors
Determination of related processes and systems
Analysis of underlying cause and effect systems through a series of why questions
Identification of risks & their potential contributions
Determination of potential improvement in processes or systems
To be credible, a Root Cause Analysis must:
Include participation by the leadership of the organization & those most closely involved in the processes & systems
Be internally consistent
Include consideration of relevant literature
A Bazooka not a BB gun !

39. Defensiveness = The Enemy
Basic Tools of QM—Benchmarking
Benchmarking is the process of measuring your current products, services and processes against other products, services and processes to identify opportunities for improvement.
Against yourself - Past performance; or other units/disciplines within organization
Against those outside the organization closest in comparison to your “business”
Against those outside that are similar, but somewhat different to your “business”
Against “Best Practice”
Defensiveness = The Enemy

40. A Quality Scorecard or Dashboard :
Basic Tools of QM— Scorecards/Dashboards
A Quality Scorecard or Dashboard :
An Executive or Top Management tool
brief document, usually 1 page
Summarizes critical operations and performance
Can be a “snapshot” of current operations and performance [DASHBOARD]
Can be a comparison of measures over a specific time [SCORECARD]
Can offer comparison to a set standard
Can monitor one complex process or multiple

41. Dashboard Example: Airline Company

42. Basic Tools of QM— CPS Facility Scorecard

43. Good quality management leads to good decision making !
QM: Parting Shots
Investigation vs. Quality Improvement Activity
Investigation seeks to assign culpability; who did what when
QI seeks to understand why, and to create systems that prevent mistakes
A “just culture” recognizes that people makes mistakes, and seeks ways to help them avoid mistakes in the future; engineers success.
CLOSE the LOOP ! ! ! --- Did your solution really solve the problem or improve the process?
Good quality management leads to good decision making !

44. Quality Management Raw Data Relevant Other Data Trend Analysis
TASKS/TOOLS/ACTIVITIES
QUALITY PROCESSES & TECHNOLOGY
Benchmarks
Certification
Investigations
Audits
Contract Monitoring
Hearings/Appeals
Outcome Measures
Consumer Grievances
Standards
Regulations
Best Practices
Consumer Satisfaction Surveys
Drills
Policies/Procedures
HR Exit Interviews
Accreditation
ORYX
Treatment metrics
Scorecards
Budgets
Injury reports
Environmental Rounds
CQI, TQM
Lean Six Sigma
RCA
Etc.
Risk
Management
Contract
Compliance
Quality
Assurance
Quality
Improvement
Performance
Measurement
Sentinel
Event
Analysis
DATA
INFORMATION PRODUCTS
Raw Data
Recommendations
Relevant Other Data
Trend Analysis
Opportunity Identification
Critical Decision Points
Right Person
Right Service
Right Time
Right Amount
Resulting in
RIGHT
OUTCOMES
ACTION
Treatment or Management
DECISIONS
(Clients, Families, Staff, Providers)
RECOVERY &
SELF DETERMINATION
of CONSUMER
TRACKING and OVERSIGHT
(Executive Function)
4/2011

45. ISO
International Organization for Standardization (ISO)- When an organization's quality system has been assessed against ISO standards by an accredited independent certification body, then the quality system is registered, and can be used as evidence of quality assurance in tendering for contracts. Quality systems produced in accordance with these quality system requirements are subject to regular third party assessment based on documented, objective evidence of compliance;

46. Lean Six Sigma
Lean Six Sigma -- builds on the knowledge, methods and tools derived from decades of operational improvement research and implementation. Lean approaches focus on reducing cost through process optimization. Six Sigma is
about meeting customer requirements and stakeholder expectations, and improving quality by measuring and eliminating defects. The Lean Six Sigma approach draws on the philosophies, principles and tools of both.

47. TQM
Total Quality Management -- is an approach to the art of management that originated in Japanese industry in the 1950's and has become steadily more popular in the West since the early 1980's. Total Quality is a description of the culture, attitude and organization of a company that aims to provide, and continue to provide, its customers with products and services that satisfy their needs. The culture requires quality in all aspects of the company's operations, with things being done right first time, and defects and waste eradicated from operations.

48. Quality Management Resources
Agency for Healthcare Research and Quality (AHRQ)--
American Health Quality Association (AHQA)--
Baldrige Performance Excellence Program (Baldrige Award, Healthcare Section) --
Institute for Healthcare Improvement (IHI)--
Institute of Medicine, Quality & Patient Safety --
Crossing the Quality Chasm: A New Health System for the 21st Century, 2001
Improving the Quality of Health Care for Mental & Substance Use Conditions: Quality Chasm Series, 2006
“Just Culture” Community --
Leadership Response to a Sentinel Event, IHI Toolkit --

49. Quality Management Resources
Miller, Ken; The Change Agent’s Guide to Radical Improvement. ASQ Quality Press: Milwaukee, WI, 2002
Missouri Center for Patient Safety (MOCPS) –
Missouri Quality Award –
Osborne, David & Gaebler, Ted – Reinventing Government
Peters, Tom –
In Search of Excellence;
Thriving on Chaos: Handbook for a Management Revolution;
Excellence in the Public Sector
Root Cause Analysis –
VA --
Human Services Research Institute --
Quality Management Resources

50. Quality Management Resources
Senge, Peter – The Fifth Discipline
Sluyter, GV & Mukherjee – Total Quality Management for Mental Health and Mental Retardation Services: A Paradigm for the 90’s. Annandale, VA: National Association of Private Residential Resources
Quality Management Resources