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BOS Document/DNV-ISO9000 for Healthcare

Speaker: Mickey Christensen ­ President - TQM Systems Contact Info:

­ 12382 Mollylea Drive, Baton Rouge, LA 70815 ­ [email protected] ­ 225-273-4972

Time and Location: 2:45 pm ­ 3:25 pm ­ Assembly Hall Presentation Title: BOS Document/DNV-ISO9000 for Healthcare

­ ISO 9000 use in hospitals in the USA really began with the American Legion Hospital in Crowley, LA getting certified in Jan. 1996. Since then about 20 hospitals, some clinics, some labs, and some physician offices have been certified. ISO 9000 is used in healthcare quite extensively in Europe, Mexico, Australia/New Zealand, and other countries. The BOS document combines the Baldrige Health Care criteria and ISO 9001. DNV Healthcare, Inc. has combined the Centers for Medicare and Medicaid Services hospital criteria and ISO 9001. DNV Healthcare, Inc. has recently been granted deeming authority by CMS to accredit hospitals. ­ Benefits of using ISO 9001 in health care will be pointed out.

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Mickey Christensen

Mickey Christensen is President of TQM Systems, a quality management consulting firm that focuses on healthcare and manufacturing. Mickey spent the first 31 years of his career working in the petrochemical industry. He had 28+ years with The Dow Chemical and the last seven years as the quality and productivity manager for the Louisiana operations. After taking early retirement from Dow, Mickey started QMS consulting with manufacturing and then with healthcare. He also is co-owner (with his son) of a fish farm that spawns, hatches, and grows-out Koi and goldfish for use in ponds. Mickey is a past chair of the ASQ Healthcare Division and has taught classes for ASQ on the use of ISO 9000 in healthcare. Along with Dan Reid, Mickey co-authored the AIAG document, HC-1, that was processed to become the first ISO IWA guideline. This document utilized ISO 9004 and had healthcare text added to aid use in healthcare. Mr. Christensen then co-authored, with Dan Reid, the AIAG document "Business Operating Systems (BOS) for Health Care - - Requirements for Process Improvements to Achieve Excellence". This document combines Baldrige and ISO 9001. He graduated from LSU in 1961 with a BSME and in 1965 with a MSME and was recognized as a 2008 AIAG Volunteer Achievement Award recipient. He has given talks on the use of ISO 9000 in healthcare in the USA, Mexico, Brazil, Canada, and Finland.

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March 9, 2009

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Good Afternoon... Standards talk again?

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Summary of points

­ Briefly describe the AIAG guideline for healthcare operating systems, BOS ­ Briefly describe DNV Healthcare, Inc. accreditation of hospitals program ­ Give a few examples of benefits healthcare organizations have seen from implementing ISO 9001

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BOS Document

Business Operating System (BOS) for Health Care Organizations - - Requirements for Process Improvements to Achieve Excellence An Alternative/complimentary Document To The ISO IWA-1 Guideline For Health Care BOS Is Based On 2006 Malcolm Baldrige National Quality Award Health Care Criteria and ISO 9001:2000 (basically fits 2008 version too) BOS Has The MBNQA Criteria Format And All Of ISO 9001, Some IWA-1 Text (Health Care Speak) And Reviewers' Comments Inserted The Document Is Published By The Automotive Industry Action Group (AIAG), Southfield, MI

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ISO 9001 and Malcolm Baldrige

ISO 9001 Key Principles

Customer Focus Process Approach System Approach to Management Continual Improvement Leadership Involvement People Involvement Factual Approach to Decision Making Mutually Beneficial Supplier Relationships

Malcolm Baldrige Criteria

Leadership Strategic Planning Focus on Patients, other Customers, and Markets Measurement, Analysis and Knowledge Management Human Resource Focus Process Management Results (Outcomes)

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BOS Document, continued Implementing a Quality Management System

QMS in place

Standardization (maintain / control) Kaizan Process Improvement Improvement gap

Breakthrough (Lean/Six Sigma)

No QMS in place

Improvement Time

The Improvement Gap

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BOS Document, continued

How the Criteria Fit

e.g. diagnostics, care provided, bills correct

Baldrige, EQFM (stretch goal?)

SERVICE/ PRODUCT · COMPANYSPECIFIC

e.g. Agreed services

e.g. purchaser, patient, consumer

· BOS criteria

· Baldrige for HC Health Service Accreditation (e.g. JC, DNV HC, HFAP, NCQA, CCHA, URAC)

Integration recommended

Many have to meet CMS conditions of participation

FUNDAMENTAL ISO 9001 Basic Quality System

Problemsolving "tools": Lean, Six Sigma, SPC, FMEA, QFD, Sarbanes-Oxley ASQ Symposium on Improving Healthcare Quality & Costs

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BOS Document, continued

Why include ISO 9001?

­ The primary objective for healthcare is: » Achieving customer/patient satisfaction by preventing nonconforming service delivery at all stages of the healthcare delivery process from admission through discharge and aftercare. » Reduce the year over year cost increases for health care products & services by assisting healthcare providers in their adoption of quality and process improvement tools and methodologies » Build a good quality management system to address all functions that are necessary to meet all customer requirements.

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BOS Document, continued

­BOS:2008 Requirements

» Introduction Focuses On:

Requirements Are Complementary To Other Accreditation Requirements. ISO 9001 Can Be Used For Third Party Certification Process Approach, Identify And Manage All Linked Activities Description Of Document Format To Distinguish Different Standards Used.

» Four Basic Support Sections in the Criteria:

O Introduction P Preface Organizational Descriptions Organizational Challenges 8 Glossary 9 Appendices

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BOS Document, continued

Seven Criteria Focusing On System:

1 Leadership

Senior Leadership Governance And Social Responsibilities

2 Strategic Planning

Strategy Development Strategy Deployment

3 Focus On Patients, Other Customers And Markets

Patient, Other Customers, and Health Care Market Knowledge Patient and Other Customer Relationships and Satisfaction

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BOS Document, continued

4 Measurement, Analysis, And Knowledge Management

Measurement, Analysis, And Review Of Organizational Performance Information And Knowledge Management

5 Human Resources

Work Systems Staff Learning And Motivation Staff Well-Being And Satisfaction

6 Process Management

Health Care Processes Support Processes And Operational Planning Corrective And Preventive Action Disaster Planning

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BOS Document, continued

7 Results

Health Care And Service Delivery Outcomes Patient And Other Customer-Focused Outcomes Financial And Market Outcomes Human Resource Outcomes Organizational Effectiveness Outcomes Leadership And Social Responsibility Outcomes

8 Glossary

A Number Of Definitions Added

9 Appendices

Crosswalk Between ISO 9001 And Baldrige Crosswalk Between Baldrige And ISO 9001

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BOS Document, continued

Core Values And Concepts

­ ­ ­ ­ ­ ­ ­ ­ ­ Visionary Leadership Patient Focused Excellence Organizational & Personal Learning Valuing Staff And Partners Agility Focus On The Future Managing For Innovation Management By Fact Social Responsibility And Community Health ­ Focus On Results & Creating Value ­ Systems Perspective

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Example of format and text of BOS

1. Leadership 1.1 Senior Leadership a. Vision and Values 1. Senior leaders shall set the organizational vision and values. Senior leaders shall deploy the organization's vision and values through the leadership system to all staff, key suppliers, partners, patients, other customers, and stakeholders as appropriate. Senior leaders' personal actions shall reflect a commitment to the organization's values. NOTE 1. Senior leaders include the head of the organization and his/her direct reports. In health care organizations with separate administrative/operational and health care provider leadership, "senior leaders" refers to both sets of leaders and the relationships among those leaders. NOTE 2. Organizational vision should set the context for strategic objectives and action plans (see 2.1, 2.2). The vision and / or mission of the organization should provide for a focus on the patient / customer and the need for continual improvement.

2. Senior leaders shall promote an environment that fosters and requires legal and ethical behavior (see 7.6). 3.Senior leaders shall create a sustainable organization. They shall also create an environment for: o performance improvement, o accomplishment of the organization's mission and strategic objectives, o innovation, o organizational agility, o organizational and staff learning o customer satisfaction. Senior leaders shall personally participate in succession planning and the development of future organizational leaders. NOTE 3. A sustainable organization is capable of addressing current organizational needs and possesses the agility and strategic management to prepare successfully for its future organizational and market environment. In this context, the concept of innovation includes both technological and organizational innovation to succeed in the future. 4. Senior leaders shall create and promote a culture of patient safety.

Top management shall provide evidence of its commitment to the development and implementation of the quality management system and continually improving its effectiveness by

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BOS Document, continued

BOS can be used as a guide for implementing:

­ ­ ­ ­ ­ ­ An ISO 9001 based management system A Baldrige based management system A guide to assist in applying for the Baldrige Award Process Improvement A system including all criteria of Baldrige and ISO 9001 Assist with incorporating quality/problem solving tools so the gains are institutionalized ­ BOS is written so it could be used for a third party certification if an accreditation scheme for registrars is developed.

­ To cure insomnia try reading BOS when having trouble going to sleep.

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Benefits Seen by Health Care From Adopting A Quality Management System

· Improved documented procedures and reduced volume · Better interdepartmental communications · Less risk management resources consumed · Better document & data control and records control · Equipment traced better (especially mobile) · Less wasted work by all functions · Cost savings in material management & pharmacy

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Benefits Seen by Health Care From Adopting A Quality Management System

· Quality attitude of personnel is largely positive · Variation in work practices, treatment methods and ways to organize services has decreased · Number of compensation cases against treatment errors paid by insurance has reduced · Statistical follow up on quality indicators has improved · Measurement devices are under control & calibrated · Reduced patient complaints

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ISO 9001 in Healthcare

So, What Is Happening To Drive ISO 9001 in Healthcare?

­ AIAG is promoting the BOS ­ AIAG is meeting with healthcare organizations to promote adopting ­ ASQ is focusing on healthcare and QMS use in HC ­ CEN in Europe published new documents on the use of ISO 9001 in HC ­ Department of State embassy clinics are pursuing certification to ISO 9001 ­ CMS has granted deeming authority to DNV Healthcare, Inc. ­ Several hospital associations are considering DNV HC criteria for their member hospitals

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DNV Healthcare, Inc.

Who is DNV Healthcare, Inc.?

­ DNV is a 140-year old international foundation whose purpose is to Safeguard Life, Property and the Environment. ­ With over 7,000 employees in 100 countries, DNV utilizes local resources that brings many best practices from its global activities and experience. Being a leader in third party assessment, verification and certification, DNV has issued nearly 70,000 accredited management system certificates of compliance with various ISO and other international standards. ­ These include 1,200 certificates to healthcare facilities including hospitals, outpatient clinics, diagnostics centers, laboratories, nursing homes and homecare centers.

DNV Healthcare, Inc is headquartered in Houston, TX, with offices in Cincinnati, OH The CMS allows Det Norske Veritas Healthcare to accredit U.S. hospitals, a move that puts the company in a small group of "deeming" organizations and could bring an increased focus on international standards, most notably ISO 9001, to hospitals across the country.

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DNV Healthcare, Inc.

DNV Healthcare integrated criteria contain:

­ The CMS conditions of participation for hospitals ­ The ISO 9001 quality management system standard criteria

National Integrated Accreditation for Healthcare Organizations (or NIAHO for short) is their criteria that was approved by CMS DNV Healthcare can accredit hospitals for compliance to the CoP's (approximately 14-15 are accredited now) DNV Healthcare will require (and can certify) compliance to ISO 9001 at the time of accreditation or within two years.

­ Compliance may be certification

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DNV Healthcare, Inc.

DNV Healthcare is an alternative to other accreditations, such as The Joint Commission and the AOA program HFAP. DNV HC is focused on driving more efficient processes in hospitals without an over burden of criteria. DNV HC will come on site at least annually to survey/audit the facility. This aids in the maintenance of the management system since it will be checked often for suitability. DNV HC is competitive on costs even though they will come in more often.

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DNV Healthcare, Inc.

National Integrated Accreditation for Healthcare Organizations (NIAHOSM) Accreditation Requirements ISSUE 307-6

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DNV Healthcare, Inc.

TABLE OF CONTENTS Topic Page Use of NIAHOSM Accreditation Requirements ................................................. 8 Definitions ................................................................................................ 9 QUALITY MANAGEMENT SYSTEM (QM) QM.1 Quality Management System............................................................... 10 QM.2 ISO 9001 Quality Management System................................................. 10 QM.3 Quality Outline ................................................................................. 11 QM.4 Management Representative .............................................................. 11 QM.5 Documentation and Management Reviews ............................................ 11 QM.6 System Requirements ....................................................................... 11 QM.7 Measuring, Monitoring, Analysis .......................................................... 12 QM.8 Patient Safety System ....................................................................... 13 GOVERNING BODY (GB) GB.1 Legal Responsibility ............................................................................ 13 GB.2 Institutional Plan and Budget ................................................................ 13 GB.3 Contracted Services ........................................................................... 14 CHIEF EXECUTIVE OFFICER (CE) CE.1 Qualifications ................................................................................... 14 CE.2 Responsibilities ................................................................................ 14

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DNV Healthcare, Inc.

Topic Page MEDICAL STAFF (MS) MS.1 Organized Medical Staff .................................................................... 14 MS.2 Eligibility ........................................................................................ 14 MS.3 Accountability ................................................................................. 14 MS.4 Responsibility ................................................................................. 15 MS.5 Executive Committee ....................................................................... 15 MS.6 Medical Staff Participation ................................................................. 15 MS.7 Medical Staff Bylaws ........................................................................ 15 MS.8 Appointment .................................................................................. 15 MS.9 Performance Data ........................................................................... 16 MS.10 Continuing Education ....................................................................... 16 MS.11 Governing Body Role ....................................................................... 17 MS.12 Clinical Privileges ............................................................................. 17 MS.13 Temporary Clinical Privileges .............................................................. 17 MS.14 Corrective or Rehabilitation Action ........................................................ 18 MS.15 Admission Requirements .................................................................... 18 MS.16 Medical Records Maintenance ............................................................. 18 MS.17 History and Physical ........................................................................... 19 MS.18 Consultation ...................................................................................... 19 MS.19 Autopsy ............................................................................................ 19 NURSING SERVICES (NS) NS.1 Nursing Service .................................................................................. 19 NS.2 Nurse Executive ................................................................................. 20 NS.3 Plan of Care ....................................................................................... 20

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DNV Healthcare, Inc. QM.1 QUALITY MANAGEMENT SYSTEM

The governing body (or organized group or individual who assumes full legal authority and responsibility for operations of the hospital), medical staff, and administrative officials are responsible and accountable for ensuring that the organization implements and maintains an effective quality management system. This quality management system shall ensure that corrective and preventive actions taken by the organization are implemented, measured and monitored. In addition to any other Quality Management System standard, the organization is required to comply with QM.1 at all times as a part of its Quality Management System. Until the organization achieves ISO 9001:2000 Certification, the organization shall follow at a minimum the ISO 9001:2000 methodology specified in QM.2, SR.3 (below).

SR.1 The organization must develop, implement and maintain an ongoing system for managing quality and patient safety.

SR.1(a) As a part of the Quality Management System for addressing performance improvement and patient safety, the organization must select projects or similar activities that focus attention on various processes, functions and areas of the organization. SR.1(a)(1) The number and scope of these projects or similar activities will be conducted annually and be proportional to the scope and complexity of the organization's operations and services offered. SR.1(a)(2) These projects or similar activities will be documented to include the rationale for selection and measurable progress achieved. SR.1(a)(3) If the organization participates in a Quality Improvement Organization (QIO) cooperative project, the organization must demonstrate that information and supporting documentation is provided to the QIO. If the hospital does not participate in a QIO, the projects and activities are required to be of comparable effort.

SR.2 The organization must implement hospital-wide quality assessment and performance improvement efforts to address priorities for improved quality of care and patient safety and that corrective and preventive actions are implemented and evaluated for effectiveness. SR.3 The organization will assure that adequate resources are allocated for measuring, assessing, improving, and sustaining the hospital's performance and reducing risk to patients.

ASQ Automotive Division

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DNV Healthcare, Inc.

QM.2 ISO 9001 QUALITY MANAGEMENT SYSTEM

SR.1 Compliance with the ISO 9001 standard must occur within two (2) years after the NIAHO accreditation that first occurs after DNVHC receives deeming authority from CMS. The Organization shall either demonstrate compliance with the ISO 9001 Quality Management System principles through a NIAHO accreditation survey or maintain Certification through an Accredited Registrar. Only certificates covered by an accreditation by an IAF MLA (International Accreditation Forum Multilateral Recognition Agreement) signatory shall be eligible. The organization shall maintain ISO 9001 compliance or formal Certification in order remain eligible for NIAHOSM Accreditation. SR.1a Failure to demonstrate compliance or certification with the ISO 9001 standard within two (2) years after the NIAHO accreditation that first occurs after DNVHC receives deeming authority from CMS shall result in NIAHOSM Jeopardy Status. SR.2 An Accredited Registrar recognized by the International Organization of Standardization shall meet the following minimum criteria: SR.2a. shall be accredited for IAF Scope 38; and, SR.2b. must have certified or conducted a pre-assessment at a minimum of twelve (12) hospitals. NIAHOSM Accreditation Requirements Issue 307-6 11 SR.3 The organization will initiate and continue implementation of the ISO 9001 methodology to achieve compliance or certification as stated in QM.1 SR.1. At a minimum the organization must be able to demonstrate at the time of the NIAHOSM Accreditation survey evidence of the following: SR.3a Control of Documents: the organization's documents (i.e. policies, procedures, forms) are structured in a manner to ensure that only the proper revisions are available for use; SR.3b Control of Records: the organization ensures that suitable records are maintained for the CoP and

NIAHO requirements;

SR.3c Internal Surveys (Internal Audits) ­ the organization conducts internal reviews of its processes and resultant corrective/preventive action measures have been implemented and verified to be effective; SR.3d The organization has established measurable quality objectives and the results are analyzed addressed; and SR.3f Appropriate information has been submitted to the oversight group for quality management as required in QM.6 SR.1 as well as top management for review and analysis during a management review process.

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Making Change Happen

Advice on Changing the System

"Don't be afraid to take a big step when one is indicated. You can't cross a chasm in two small steps."

David Lloyd George

Dr. Deming said: "You do not have to do any of this...

SURVIVAL is not mandatory!!!"

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Final summary

Final Summary

­ BOS is a guide for process and system improvement in healthcare organizations ­ The use of ISO 9001 in healthcare organizations has shown benefits ­ DNV HC has deeming authority and is actively accrediting hospitals ­ AIAG and ASQ are actively working to try and improve health care by collaborating with other healthcare organizations

» » » » American Medical Association Michigan Medical Group Managers Association that AIAG is involved with The IPIP program in MI that AIAG is involved with The IPIP program in PA that ASQ Healthcare Division members are pursuing » The Pfizer funded data collection and analysis from implementing the BOS that AIAG is involved with and is to be started soon » Meetings with CMS and HHS that AIAG arranged » Working with lobbyists through ASQ to attempt to influence the Obama transition team on the healthcare issues

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Any questions???

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Thank you for your time.

TQM Systems

®

12382 Mollylea Drive Baton Rouge, LA 70815-6616 Office Phone: 225-273-4972 Cell: 225-205-7559 E-mail: [email protected]

M. M. "Mickey" Christensen, BSME, MSME, P.E. Ret. RABQSA & IRCA registered QMS lead auditor

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