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Making ISO 9001 Based Hospital Accreditation Really Work - Some Practical Tips

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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. …

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.

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  • 1. Winning Strategies for ISO Based Accreditation Healthcare Financial Management Association 1 Chapman Medical Quality LLC, copyright 2014 1/25/2014
  • 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 Chapman Medical Quality LLC, copyright 2014 1/25/2014
  • 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 Chapman Medical Quality LLC, copyright 2014 3 1/25/2014
  • 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) Chapman Medical Quality LLC, copyright 2014 Around 230 hospitals and 200 other institutions 4 ISO-certified itself but not offering ISO certification to clients 1/25/2014
  • 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 Chapman Medical Quality LLC, copyright 2014 5 1/25/2014
  • 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 Chapman Medical Quality LLC, copyright 2014 6 1/25/2014
  • 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 Chapman Medical Quality LLC, copyright 2014 7 1/25/2014
  • 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 Chapman Medical Quality LLC, copyright 2014 8 1/25/2014
  • 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 Chapman Medical Quality LLC, copyright 2014 9 1/25/2014
  • 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. Chapman Medical Quality LLC, copyright 2014 10 1/25/2014
  • 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. Chapman Medical Quality LLC, copyright 2014 11 1/25/2014
  • 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 Chapman Medical Quality LLC, copyright 2014 12 1/25/2014
  • 13. What is the ISO 9001 Approach? Chapman Medical Quality LLC, copyright 2014 13 1/25/2014
  • 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. Chapman Medical Quality LLC, copyright 2014 14 1/25/2014
  • 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 Chapman Medical Quality LLC, copyright 2014 15 1/25/2014
  • 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 Chapman Medical Quality LLC, copyright 2014 16 1/25/2014
  • 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! Chapman Medical Quality LLC, copyright 2014 17 1/25/2014
  • 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 Chapman Medical Quality LLC, copyright 2014 Document Review Filters & Risk Rating Rational Document Filters 18 Revised Documents and Training ISO & NIAHO Organized Documents 1/25/2014
  • 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 Chapman Medical Quality LLC, copyright 2014 Training – Methods 19 1/25/2014
  • 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. Chapman Medical Quality LLC, copyright 2014 20 1/25/2014
  • 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 Chapman Medical Quality LLC, copyright 2014 21 1/25/2014
  • 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 Chapman Medical Quality LLC, copyright 2014 22 1/25/2014
  • 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! Chapman Medical Quality LLC, copyright 2014 23 1/25/2014
  • 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)! Chapman Medical Quality LLC, copyright 2014 24 1/25/2014
  • 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 Chapman Medical Quality LLC, copyright 2014 25 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. 1/25/2014
  • 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 Chapman Medical Quality LLC, copyright 2014 26 1/25/2014
  • 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 Chapman Medical Quality LLC, copyright 2014 27 1/25/2014
  • 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 Chapman Medical Quality LLC, copyright 2014 28 1/25/2014
  • 29. THANK YOU! Wes Chapman 603 252 7340 wes@chapmanmedqual.com Chapman Medical Quality LLC, copyright 2014 29 1/25/2014

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