ISO 9001:2015 CoxHealth Implementation

Leadership Development Institute

December 15, 2016

Arlo Stallion

Objectives

• Create better understanding of what ISO 9001 is and is not

• Brief overview of ISO 9001 & accreditation relationship

• Launch the CoxHealth ISO 9001 model

• Define leadership expectations

• Overview of CoxHealth ISO 9001 requirements in breakout sessions

Personal Story

ISO 9001 Transformation

• Don’t be intimidated with the unknown

• Learn everything you can

• Participate

• Embrace the challenge

• Leaders and the organization will both reap the rewards

“The secret of change is to focus all of your energy, not on fighting the old, but on building the new”

Socrates

Common ISO 9001 Misconceptions

ISO 9001 is:

• A journey – not a destination

• A business management system – not a quality initiative, pillar, or a compliance model

• About continual improvement – not perfection

• Separate from accreditation – but required

• Applicable to all settings – not just hospital

A framework that provides leadership with the structure and tools to focus on what is important.

Accreditation & ISO 9001 Connection• NIAHO Hospital Accreditation requires ISO 9001 conformance by

the 4th year.

• ISO 9001 conformance is a condition of accreditation

• DNV-GL is our accrediting body and our ISO 9001 Registrar – two separate roles.

• Accreditation requirements are built into the key processes.

• Enables concurrent assessment of accreditation & ISO 9001 conformance.

• Accreditation assesses base requirements/industry standards.

• ISO 9001 assesses business practice performance to meet customer requirements.

Highest level of assessment

Planning

System Development

Implementation

Conformance

Certification

Y 3Y 1 Y 4

NIAHO® Accreditation

NIAHO® Accreditation + ISO Pre-assessment

NIAHO® Accreditation + ISO Initial Visit Stage 1

NIAHO® Reaccreditation + ISO Certification Stage 2

Continual Improvement

Y 2YR 1 YR 2 YR 3 YR 4

Transformation Path from Accreditation to ISO 9001 Certification

ISO 9001 Business Management SystemC

ust

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ire

me

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Cu

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er Satisfactio

n (V

alue

)

Input Output

ManagementResponsibility

Resources & Facilities

Measure & Improvement

Delivery of Patient Care

The ISO 9001 Mantra

• Deliver care & services

• Measurement

• Analyze results

• Records & Audit

• Planning

• Policies

• Procedures

• Continual Improvement

Improve it

Say what you do

Do what

you sayProve it

D

P

C

A

Ever Feel Like This?

ISO 9001 Creates Alignment Standardization & Enables Integration

Working Smarter

Baldrige/MagnetISO 9001

Business

Management

System

Performance Management

Baldrige/Magnet

Studer

Integration/Growth

MVV

ObjectivesPopulation Health

ISO 9001 Implementation Team• Frank Romero, MD - VPMA

• Arlo Stallion, System Director Regulatory Affairs

• Vicki Good, System Director Quality & Patient Safety

• Tracy Mitchell, System Director Population Health

• Scott Rogers, System Director Performance Integration & Innovation

• Jim Brown, System Director Health Care Analytics

• Gina Ellerbee, System Director Clinical Education

• Shawn Snider, System Director Radiology

• Shelly Hillhouse, PI Manager

• Ad Hoc Leaders

4Context

4.1Understanding

Context

4.2 Interested

Parties

4.3 Scope

4.4 QMS

5Leadership

5.1Leadership &Commitment

5.2 Quality Policy

5.3 Organizational

roles, responsibilities,

& authorities

6Planning

6.1Actions to

address risks & opportunities

6.2 Quality

objectives & planning

6.3 Planning of

change

7Support

7.1 Resources

7.1 .2 People

7.1 .3 Infrastructure

7.1 .4 Environmentfor operation of processes

7.1 .5 Monitoring &

measuring resources

7.1 .6 Organizational

Knowledge

7.2Competence

7.3Awareness

7.4Communication

9Performance &

evaluation

9.1Monitoring,

measurement, analysis, & evaluation

9.1.2Customer

Satisfaction

9.1.3 Analysis & evaluation

9.2 Internal Audit

9.3 Management

Review

10 Improvement

10 .1 General

10 .2 Nonconformity

& corrective action

10 .3 Continual

Improvement

8.2 Requirementsfor products &

services

8.3 Design &

Development

8.4 Control of externallyprovided

products & services

8.5 Production &

service provision

8.6 Release of products &

services

8.7 Control of

nonconforming products &

services

7.5 Documented Information

8Operation

8.1 Operational Planning &

control

PLAN DO CHECK ACTIS

O9

00

1:2

01

5

Act Plan

DoCheck

ISO 9001 Gap Analysis

Painful essential first stepISO 9001 Clause 3/2016 10/2016

4: Quality Management System 37.5% 84%

5: Management Responsibility 54.2% 69%

6: Resource Management 91.6% 91.6%

7: Product Realization (Healthcare delivery) 94.4% 94.4%

8: Measurement, Analysis, Improvement 68.8% 77.7%

2015 Transition clauses 70% 72.5%

Total Conformance 71% 83%

Top Priorities

National Networking

ISO 9001 Certified

• Sentara Healthcare - Virginia

• Advocate Health Care - Chicago

• Lee Memorial Health System - Florida

• Florida Hospital

• Houston Methodist

CoxHealthBusiness Management System

Quality Policy – Mission/Vision/Values– Quality is the ability to deliver, through a consistent and

efficient system, healthcare that meets or exceeds the customer’s rational value expectations.

Commitment Statement– CoxHealth aims to enhance customer value through the

effective application of the Business Management System, including processes for continual improvement and the assurance of conformity to customer, statutory, & regulatory requirements.

CoxHealth Key Strategies

CoxHealth Operational Objectives and Goals

Mission, Vision, Values

Our Patient

Create one Patient Experience

Coordinating Care & Reducing per Capita Cost

Attract, Grow, &Retain Talent

Blanket our Region with appropriate services

In the right places

Top Decile in Patient Experience

Top Decile inEmployee Satisfaction

Top Decile in Quality & Safety Outcomes

Top Decile in Financial Metrics

Top Decile in Employee Giving

Strategic Direction

CoxHealth Parent Board

Board Quality & Safety

Medical Executive

Committee

Medical Center

Management Review

Medical Staff Issues QMS Monitoring &

Improvement Activities

Communication Q & S issues

Functional Integration

CMC BoardSystem Management

Review

HospitalManagement Review Structure

Administration

Clinical

Operations

Support Operations

Medical Staff

System

Entity

Safe

Timely

Effective

ST

E

E

EP

Efficient

Equitable

Patient Centered

Customer Requirements = Inputs

Quality Service

Cost

Output = Customer Value

Key Management Processes

Management Review

Planning

Revenue Cycle

Measurement Analysis

Improvement

Top Management System level & Entity Level

Strategic, Financial, & Business Planning

Registration, billing, collections, accounting, billing & audit

HCA, Quality, CQI, audits, Regulatory, Patient Safety, Innovation, PI

Core Operational Processes

• Patient Centered

• Designed for all healthcare delivery systems

– Emergency

– Inpatient

– Outpatient

– Post acute care

– Ambulatory

Cycle of care is continuous

Key Support ProcessesDevelop & Manage

Care Force

Manage Information

Manage Supplies, materials, & products

Environmental Health & Safety

Manage Facilities

Manage Equipment

Employees, Volunteers, Students, Contracted, Medical Staff, Training and Development

EMR, Information Technology, HIPAA, Communication, Customer Service, Health Information Management

Medical Equipment, Imaging Equipment, Laboratory

Employee Safety (OSHA), Emergency Management, Hazardous Materials, Radiation Safety, Security, Employee Health, Infection Prevention

Engineering, Utilities, Construction, Maintenance, Environmental Services

Materials Management, Blood Products, Medications, Food Services, Sterilization, Linen

MissionImprove the health of the communities we serve

through quality health care, education, & research

Vision: To be the best for those who need us Values: safety, compassion, respect, integrity

Cu

sto

mer

Req

uir

emen

tsSa

fe, T

imel

y, E

ffec

tive

, Ef

fici

ent,

Eq

uit

able

, Pa

tien

t C

ente

red

Cu

stom

er Valu

eQ

uality, Service, C

ost

Management Review

Planning Revenue CycleMeasurement

Analysis & Improvement

Manage Supplies, Materials, Product

Manage Information

Develop/Mgt Careforce

Environmental Health & Safety

Manage Facilities

Manage Equipment

Key Management Processes

Key Support Processes

Inputs

Business Management SystemKey Process Interaction

Core Operational Processes

Outputs

Process Approach – Matrix Management

Plan & Manage Process Change

• Change is carried out in a planned manner

• Consider purpose and potential consequences

• Impacts to the business management system

• Availability of resources

• Allocation and reallocation of responsibilities

• Changing knowledge needs

• Control both planned and unintended change

Planning & Controlling Change

Planning

Control

Ho

urs

/day

s

d

ays/

wee

ks

mo

nth

sm

on

ths

yea

rs

Significance of planning & control

• Long Range – objectives

• Medium – determine resources

• Short Range –interventions to control deviations from the plan to still meet requirements

Examples: Triage system, scheduling

ISO 9001 Expected Results

• Customer focus enables meeting customer needs

• Create consistency and greater efficiencies

• Process standardization and integration

• Leader and employee engagement

• Sustainability in an uncertain environment

• Continual improvement to be the best for those who need us

ISO 9000: Leadership Statement

• “Leaders at all levels establish unity of purpose and direction and create conditions in which people are engaged in achieving the organization’s objectives”.

• “Creation of unity of purpose and the direction and engagement of people enable an organization to align its strategies, policies, processes, and resources to achieve its objectives”.

Leadership Expectations

• You are the key ingredient to success

• Active participation

• Develop an understanding of the need to move from a department or entity mindset to a system

• Embrace the process approach to management and continual improvement

• Communicate, communicate, communicate…

Leadership Commitment

• Excellence does not happen by accident

• It requires a well thought-out, well communicated plan that is embraced by everyone.

• Join us on this journey to excellence

Questions