The game has changed in hospital accreditation, and ISO 9001 based NIAHO system from DNV is changing the landscape. This is a big change for any hospital, and making it work is an art and a science. Here are some practical considerations for organizations considering taking the plunge.

1. Winning Strategies for ISO Based Accreditation
Healthcare Financial Management Association
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2. Can New Accreditation Lower Cost
& Improve Quality?
The Challenge of ISO 9001
2
DNV Accreditation: The NIAHO COPS
Survey & ISO 9001:2008 Quality
Management Systems –
An Introduction
Wes Chapman
Chapman Medical Quality LLC
wes@chapmanmedqual.com
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3. Accreditation – A New Hat in the Ring
 1965: The Joint Commission (TJC) receives deeming
status from Medicare
 2008: CMS changes the rules, DNV granted deeming
status, removed The Joint Commission's statutorilyguaranteed accreditation authority for hospitals
 2014: Nearly 500 US hospitals have or are pursuing
DNV/ISO9001/NIAHO accreditation
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4. Accreditation Organizations
Accreditation Organizations with CMS Deeming Authority
Accreditor
Scope of Authority
# of accredited
customers (CoPs)
The Joint
Commission
ISO connection
Hospitals, Labs, Durable
Medical Equipment,
Home Health, Hospice,
other
DNV Healthcare
Critical Access Hospitals
(CAH), Acute Care
Hospitals (ACH)
American
CAH, ACH, Ambulatory
Osteopathic
Surgical Center,
Association (HFAP) Behavioral Health, Lab
Around 5,000 hospitals
and over 10,000 other
institutions
Affiliated with SGS to
offer the option of ISO
certification to members
About 370 hospitals
Requires ISO 9001
compliance / certification
within three years
No ISO relationship
ACHC
No hospitals, 8,700
DMEPOS, 1,400 Home
Health, and 300 Hospices
Home Health, Hospice,
Durable Medical
Equipment (DMEPOS)
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Around 230 hospitals and
200 other institutions
4
ISO-certified itself but
not offering ISO
certification to clients
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5. 2008 – DNV Starts a Revolution
 CMS grants “deeming status” to DNV’s NIAHO® Survey
• Requires annual surveys (vs. 3 year) and ISO 9001
certification/compliance
• Three year process for ISO
• NIAHO certification year 1
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6. NIAHO®
 National Integrated Accreditation of Healthcare
Organizations (NIAHO®)
 Used to accredit hospitals under CMS’ Conditions of
Participation (CoPs) @ CFR Part 482
 Healthcare providers must meet the CoPs quality and safety
standards in order to be reimbursed for treating patients
under Medicare and Medicaid, Medicare Provider #
 Surveys Unannounced
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7. What is DNV?
 Det Norske Veritas – Norwegian,
http://www.dnv.com/

A classification society organized as a foundation, with the objective of
"Safeguarding life, property, and the environment". The organization's history
goes back to 1864, when the foundation was established in Norway to inspect
and evaluate the technical condition of Norwegian merchant vessels.

300 offices, 10,000 employees, 70,000 QMSs around the world

Around 2,200 healthcare organizations, 500 US hospitals
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8. What is ISO 9001?
• A quality system standard, designed to work across industries
• The most widely implemented on the planet
• Helps you do what you say you want to do
• Specifies the types of components a quality system must have in order
to improve processes and increase value
• Based on eight principles that underlie effective quality management
See: CMS & ISO 9001 – The Impulse Toward Quality in Healthcare
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9. The 8 Principles of ISO 9001
1.
Customer focus – A great tool for Patient Centric Care
2.
Top Management Involvement & Direction
3.
Involvement of people
4.
Process approach
5.
System approach to management
6.
Continual improvement
7.
Factual approach to decision making
8.
Mutually beneficial supplier relationships
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10. What is ISO 9001?



A quality management system designed to help
organizations ensure they meet the needs of customers and
other stakeholders
International and Generic in application
 “It is not the intent of this International Standard to
imply uniformity in the structure of quality
management systems or uniformity of
documentation.”
It easily incorporates best practices like Lean, Six Sigma,
A3 etc.
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11. What is the ISO 9001 Approach?

ISO 9001 utilizes a process approach to quality.
 Process: “An activity or set of activities using
resources, and managed in order to enable the
transformation of inputs into outputs.”
 The output from one process often forms the input to
the next process and, ultimately, to the customer.
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12. What is the ISO 9001 Approach?


Such an approach emphasizes the importance of:
a) understanding and meeting requirements,
b) the need to consider processes in terms of added
value,
c) obtaining results of process performance and
effectiveness, and
d) continual improvement of processes based on
objective measurement.
Plan – Do – Check – Act
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13. What is the ISO 9001 Approach?
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14. What is the ISO 9001 Approach?
ISO
9001 has NO explicit set of rules or procedures.
The standard is composed of several elements.

Some can be exempted if not relevant
It
is up to the organization to develop processes and
procedures that best address the elements FOR THAT
ORGANIZATION.
What are those elements?
Note: There
is nothing revolutionary here. Many
organizations already do a lot of the elements of ISO 9001 but
do not document what they do.
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15. Elements of ISO 9001






Sections 1-3, Introduction and ties to previous standards
4.1 General requirements
5.X Management Responsibilities
6.X Resources and Environment
7.X Product & Service Realization
8.X Measurement, Data, Audits, CAPAs
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16. Six Required Procedures of ISO 9001
1. Document Control
2. Record Control
3. Internal Audit
4. Control of Non-conforming Product
5. Corrective Action
6. Preventive Action
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17. The Problem with ISO – It Looks too
Easy
Most
hospitals have:
 vast documents in the P&P controls.
 vast numbers of records.
 many different types of audits
 many different purchasing and failure reporting
systems
 several types of process improvements systems
 The problem with ISO – It makes you bring them all
together to function effectively – and prove it with data
 If you want to do ISO – You must Lean out your System!
Start with your P&Ps!
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18. Basic Flow Method – Documentation Review
Documents flow from initial state through consistent filters into new
document control System
Documents
Initial State
Existing Policies
& Procedures
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Document Review
Filters & Risk Rating
Rational
Document
Filters
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Revised Documents
and Training
ISO & NIAHO
Organized
Documents
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19. Basic Flow Method – The Hierarchy of
Documents
 Documents grade from general




to Specific
Procedures define required
Action on a process
Train to Procedures
Documents become
Records
Records Are audited
3 Required ISO Documents
Administrative Level Policies
Specific Dept. Level Policies
Process Specific Policies
Specific Procedure related to Process
Span of
Procedure
Clinical or Other Processes
 Audited records become
Order Sets, Check lists, Records
Data
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Training – Methods
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20. Document Development & Transformation –
Rational Filters, Systematically Applied
3 Required Documents & 6 Required Policies in place
2. Policies, Procedures, Forms, Signage and Training clearly identified and
separated - hierarchy established
3. Application to ISO & NIAHO requirements identified, requirements
considered
4. Process maps as applicable
5. 3rd party documents identified and incorporated
6. Responsible parties identified for each document, training and activity
7. Risk and safety considerations identified
8. Notifications, work listing, timing identified
9.
Effectiveness, validation, data requirements identified
10. Identifiers – numerical & language assigned
1.
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21. Document System – Goals for 1st Generation
 Lean Rules! Less is more
 Hierarchy of control clearly reflected in numbers of
documents

Few control documents, more operational documents, most training
 People can access the documents they need
 Training & documents in rational balance
 Documents turn into records where data is required
 CAPA system, management review & internal audit function
smoothly inside document system
 Documents actually facilitate CI, improve work flow, reduce
waste
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22. Internal Audit – Goals for 1st Generation
 Make sure that people can audit to the Standard
 Make sure that audits tie: P&Ps to actual processes
 Start the data flowing
 Tackle some major problems first
 Feed the CAPA system with data from audits
 Audit effectiveness as well as compliance
 If you have a tiered CAPA system, power data to lower level
CAPAs
 Focus on process – not documents
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23. Records – Goals for 1st Generation
 Keep no record that you can’t use
 EMRs are great – but typically will not provide operational






data
Make your documents turn into records!
Integrate training records and documents
Feed the CAPA system with data from records
Records prove compliance & professional standing
If you have a tiered CAPA system, power records to lower
level CAPAs
Records document process!
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24. Non-Conforming Product – Goals for 1st Generation
 Definition is really important:


Mistakes that you buy
Clinical issues – be really clear in the definition!
 Really examine purchasing – both products and services
 Create supplier ratings and reports
 Force the examination of waste in the purchasing system
 Define what constitutes reportable clinical events
 Tier the events to reflect severity and risk
 Define what to do with reportable clinical events (non-
conforming outcomes or processes)
 Control, document, correct (CAPA)!
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25. Corrective & Preventive Actions
CAPA System – Where Improvement
Happens
CAPA Type
% of
total
CAPAs
≤ 1%
% of total
Type of Failure
Work
Addressed
Time
30%
Complex failure
involving cascading
events. High risk,
cost and exposure.
20-30%
40-50%
Linear process
failure or simple
system upgrade.
Penalty Box 70-80%
Tickets
20-30%
Recurring small
problems
SRE
CAPAs
Normal
CAPAs
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Comments
This needs to be the area
of senior management
focus. Pro-active
preventive action. Bow-tie
risk analysis
Most LSS projects fit into
this category. Most
departmental projects fit
here.
Simple and very valuable
tool.
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26. Pros
 Proven QMS standard
 Change
 Adapts to your
 Education
organization
 Commitment from the top
 Grows with you
 Focused effort to
 Locks in improvements
implement
 Data for decision-making
 DNV is friendly & helpful
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27. To make it work:
 Commit to monitoring, controlling, and improving quality
 Create a quality system designed for your organization
 Implement effective auditing and process improvement
 Ensure an understanding of the system up & down the chain
 Address all stakeholder processes in order to improve the customer
experience
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28. Suggested Reading




International Organization for Standardization www.ISO.org
The Checklist Manifesto: How to Get Things Right – Atul
Gawande, Metropolitan Books, 2009, ISBN -10:
9780805091748
Management Lessons from Mayo Clinic: Inside One of the
World’s Most Admired Service Organizations, Leonard
Berry, McGraw-Hill, 2008, ISBN - 10: 9780071590730
Wes Chapman's Blog
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29. THANK YOU!
Wes Chapman
603 252 7340
wes@chapmanmedqual.com
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