making iso 9001 based hospital accreditation really work - some practical tips

Winning Strategies for ISO Based AccreditationHealthcare Financial Management Association

04/08/2023Chapman Medical Quality LLC, copyright 2014

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DNV Accreditation: The NIAHO COPS Survey & ISO 9001:2008 Quality

Management Systems –An Introduction

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Can New Accreditation Lower Cost & Improve Quality?

The Challenge of ISO 9001

Wes ChapmanChapman Medical Quality [email protected]

Chapman Medical Quality LLC, copyright 2014

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 statutorily-guaranteed accreditation authority for hospitals

2014: Nearly 500 US hospitals have or are pursuing DNV/ISO9001/NIAHO accreditation


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Accreditation Organizations

Accreditation Organizations with CMS Deeming AuthorityAccreditor Scope of Authority # of accredited

customers (CoPs)ISO connection

The Joint Commission

Hospitals, Labs, Durable Medical Equipment, Home Health, Hospice, other

Around 5,000 hospitals and over 10,000 other institutions

Affiliated with SGS to offer the option of ISO certification to members

DNV Healthcare Critical Access Hospitals (CAH), Acute Care Hospitals (ACH)

About 370 hospitals Requires ISO 9001 compliance / certification within three years

American Osteopathic Association (HFAP)

CAH, ACH, Ambulatory Surgical Center, Behavioral Health, Lab

Around 230 hospitals and 200 other institutions

No ISO relationship

ACHC Home Health, Hospice, Durable Medical Equipment (DMEPOS)

No hospitals, 8,700 DMEPOS, 1,400 Home Health, and 300 Hospices

ISO-certified itself but not offering ISO certification to clients

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


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


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


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

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See: CMS & ISO 9001 – The Impulse Toward Quality in Healthcare

Chapman Medical Quality LLC, copyright 2014

http://www.mwestonchapman.com/cms-iso-9001-the-impulse-toward-quality-in-healthcare/

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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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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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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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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ISO 9001 has NO explicit set of rules or procedures.The standard is composed of several elements.

Some can be exempted if not relevantIt 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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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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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 Action16Chapman Medical Quality LLC, copyright 2014

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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Documents flow from initial state through consistent filters into new document control System

Basic Flow Method – Documentation Review

Existing Policies & Procedures

Rational Document

Filters

ISO & NIAHO Organized Documents

Documents Initial State

Document Review Filters & Risk Rating

Revised Documents and Training


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

Audited records become

Data

Clinical or Other Processes

3 Required ISO Documents

Administrative Level Policies

Specific Dept. Level Policies

Process Specific PoliciesSpecific Procedure related to

Process

Span of Procedure

Order Sets, Check lists, Records

Training – Methods


Document Development & Transformation – Rational Filters, Systematically Applied

1. 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


Document System – Goals for 1st Generation

Lean Rules! Less is moreHierarchy of control clearly reflected in numbers of

documents Few control documents, more operational documents, most training

People can access the documents they needTraining & documents in rational balanceDocuments turn into records where data is requiredCAPA system, management review & internal audit function

smoothly inside document systemDocuments actually facilitate CI, improve work flow, reduce

waste


Internal Audit – Goals for 1st Generation

Make sure that people can audit to the StandardMake sure that audits tie: P&Ps to actual processesStart the data flowingTackle some major problems firstFeed the CAPA system with data from auditsAudit effectiveness as well as complianceIf you have a tiered CAPA system, power data to lower level

CAPAsFocus on process – not documents


Records – Goals for 1st Generation

Keep no record that you can’t useEMRs are great – but typically will not provide operational

dataMake your documents turn into records!Integrate training records and documentsFeed the CAPA system with data from recordsRecords prove compliance & professional standingIf you have a tiered CAPA system, power records to lower

level CAPAsRecords document process!


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 servicesCreate supplier ratings and reportsForce the examination of waste in the purchasing systemDefine what constitutes reportable clinical eventsTier 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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Corrective & Preventive ActionsCAPA System – Where Improvement

Happens


CAPA Type % of total

CAPAs

% of total Work Time

Type of Failure Addressed

Comments

SRE CAPAs

≤ 1% 30% Complex failure involving cascading events. High risk, cost and exposure.

This needs to be the area of senior management focus. Pro-active preventive action. Bow-tie risk analysis

Normal CAPAs

20-30% 40-50% Linear process failure or simple system upgrade.

Most LSS projects fit into this category. Most departmental projects fit here.

Penalty Box Tickets

70-80% 20-30% Recurring small problems

Simple and very valuable tool.

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Pros

Proven QMS standard

Adapts to your

organization

Grows with you

Locks in improvements

Data for decision-making

DNV is friendly & helpful

Change

Education

Commitment from the top

Focused effort to

implement

Cons

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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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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


http://www.iso.org/

http://www.mwestonchapman.com/medical-quality-systems-the-elusive-goal-of-quality-in-complex-medical-systems/

04/08/2023

THANK YOU!

Wes Chapman603 252 7340

[email protected]


making iso 9001 based hospital accreditation really work - some practical tips

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