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

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Regulatory Compliance &

Quality Management

April 15, 2011Rebecca Carson, RN, MSN

Psychiatric Facilities Coordinator

DMH-MIMH LEADERSHIP TRAINING INSTITUTE

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Regulatory Compliance: Why Regulate?

WHY regulate Mental Health Facilities and Service

Providers?

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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

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Regulatory Compliance: Who Regulates?

Federal Government U.S. Code (Public Laws)—Establish intent & authority

o Federal Code of Regulations (FCRs) Interpret & Provide Operational Instructions

State Government Revised Statutes of Missouri (RSMo)—Establish intent

& authorityo State Code of Regulations (CSRs)

Interpret & Provide Operational Instructions

County/Municipal Ordinances Usually life safety; Zoning issues

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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

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Regulatory Compliance: Learning the “Lingo”

Accreditation continued………… Major Players---

o The Joint Commission (TJC) CMS grants deeming status for hospitals (5000), PRTC Hospitals, Behavioral Health Organizations Home Care, Laboratory, LTC

o Commission on Accreditation of Rehab Facilities Inter’l (CARF) CMS acknowledged accreditor for DME

o Council on Accreditation (COA) Largely “kid” and family serving agencies

o Det Norske Vertas Healthcare Inc. (DNV) CMS grants deeming status for hospitals (27)

o Healthcare Facilities Accreditation Program (HFAP) Division of AOA, American Osteopathic Association CMS grants deeming status for hospitals (200)

o The Council on Quality & Leadership (CQL) Used to be known as Accreditation Council for MR or other DD

Persons

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Regulatory Compliance: Learning the “Lingo”

o Accreditation Categories Programs covered

o Cost Usually based on size of

organization, but can vary $10K-$15 K/yr.

o Patient Safetyo Continuous Improvement

TQM, CQI ISO Lean Six Sigma

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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 660.250 & 570.145 DHSS/DMH/DSS Memo of Understanding – Facilities Only

DSS-Children’s Division—Abuse/Neglect RSMo 210.109-196; 13 CSR 35-20.010 & 31.025

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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 30-20.001 thru 30-20.142

Psych Hospitals: 19 CSR 30-24.010 thru 30-24.040

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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

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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]

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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

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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 30-4.045-

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

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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-- http://pr.mo.gov/ Business Registration

Secretary of State-- http://www.sos.mo.gov/business/corporations/

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

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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; http://www.msapcb.com/

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

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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 ! ! !

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Regulatory Resources

ACCREDITATION Commission on Accreditation of Rehab Facilities Inter’l (CARF); www.carf.org Council on Accreditation (COA); www.coanet.org Det Norske Vertas Healthcare Inc. (DNV); www.dnv.com/industry/healthcare Healthcare Facilities Accreditation Program (HFAP); www.hfap.org The Council on Quality & Leadership (CQL); www.thecouncil.org

REVISED STATUTES OF MISSOURI (RSMo); http://www.moga.mo.gov/statutesearch/

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) http://www.sos.mo.gov/adrules/csr/csr.asp Department of Mental Health, Title 9 Department of Health & Senior Services, Title 19 Department of Social Services, Title 13

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Regulatory Resources

FEDERAL LAW; http://www.gpoaccess.gov/uscode/FEDERAL CODE OF REGULATIONS; http://www.gpoaccess.gov/cfr/

HIPAA; http://www.hhs.gov/ocr/privacy/EMTALA; https://www.cms.gov/EMTALA/

Department of Justice; Division of Civil Rights; http://www.justice.gov/crt/about/drs/

Civil Rights of Institutionalized Persons; http://www.justice.gov/crt/about/spl/cripa.php Olmstead Decision; http://www.freedomclearinghouse.com/know/olmstead.htm

CMS REGULATIONS & INTERPRETATIVE GUIDELINES Hospitals, A Tags; http://cms.gov/manuals/Downloads/som107ap_a_hospitals.pdf Psych Hospitals, B Tags;

http://cms.gov/manuals/Downloads/som107ap_aa_psyc_hospitals.pdf Psych Residential Treatment Facilities, N-Tags;

http://www.cms.gov/CertificationandComplianc/13_PRTFs.asp; http://www.cms.gov/SurveyCertificationGenInfo/downloads/SCLetter04-13.pdf

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Quality Management

QM starts with asking the right questions ! ! !

[and it never stops……….continuously seeking to improve !]

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Quality Management

WHAT constitutes Quality?

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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”

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Key Responsibilities Identified

What are my key responsibilities; what am I responsible to produce; for

what am I accountable?

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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

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Meeting Key Responsibilities

How do know if I am meeting my key responsibilities?

Was what I produced satisfactory?

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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?

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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)

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QM of Ducks

1. What are my key responsibilities?

2. What questions should I ask to determine if I’m meeting my responsibilities?

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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

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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

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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

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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.

Shewhart CycleDeming Wheel

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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.

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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.

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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.

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Basic Tools of QM— QI According to Marty Martin-Forman

Five Mistakes That Commonly Doom Quality Improvement

Lack of:1.Top Management Involvement2.Middle Management Leadership3.Integration4.Continuous Training

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Basic Tools of QM— QI According to Marty Martin-Forman

Ten Pillars of Continuous Improvement……………1. Management Vision and Commitment2. Accountability3. Measurement and Feedback4. Problem-Solving and Process Improvement5. Communication6. Staff Development and Training7. Physician Involvement8. Reward and Recognition9. Employee Involvement and Empowerment10. Reminders and Refreshers

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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

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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 !

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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

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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

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Dashboard Example: Airline Company

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Basic Tools of QM— CPS Facility Scorecard

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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 !

Raw Data

Trend

Analysis

Recommendations

Critical D

ecision

Points

Relevant Other

Data

RiskManagement

Contract Compliance

QualityAssurance

Quality Improvement

PerformanceMeasurement

Sentinel Event

Analysis

Quality Management QUALITY PROCESSES & TECHNOLOGY

INFORMATION PRODUCTS

Opportunity Identification

Treatment or Management

DECISIONS(Clients, Families, Staff, Providers)

ACTIONACTION

• Right Person

• Right Service

• Right Time

• Right Amount

• Resulting in RIGHT OUTCOMES

RECOVERY &SELF DETERMINATION

of CONSUMER

TRACKING and OVERSIGHT(Executive Function)

TASKS/TOOLS/ACTIVITIES• 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.

4/2011

Benchmarks

DATA

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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; http://www.iso.org/iso/home.htm

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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 isabout 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. http://www.6sigma.us/six-sigma.php

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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.

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Quality Management Resources

Agency for Healthcare Research and Quality (AHRQ)-- http://www.ahrq.gov

American Health Quality Association (AHQA)-- http://www.ahqa.org

Baldrige Performance Excellence Program (Baldrige Award, Healthcare Section) -- http://www.nist.gov/baldrige/enter/health_care.cfm

Institute for Healthcare Improvement (IHI)-- http://www.ihi.org/ihi

Institute of Medicine, Quality & Patient Safety -- http://www.iom.edu/Reports• 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 -- http://www.justculture.org/algorithm.aspx

Leadership Response to a Sentinel Event, IHI Toolkit -- http://www.ihi.org/IHI/Results/WhitePapers/RespectfulManagementSeriousClinicalAEsWhitePaper.htm

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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) – http://www.mocps.org

Missouri Quality Award – http://www.mqa.org/qualityaward.htm

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 -- http://www.va.gov/ncps/CogAids/RCA/index.html#page=page-1

Human Services Research Institute -- http://www.hsri.org/publications/search-results/f48163a7e2236d30af8535ccbbe315aa/

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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. 1993