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© Det Norske Veritas AS. All rights reserved Slide 2 February 15, 2010

DNV

 Established in 1864

  Independent, self supporting Foundation

 Tax paying entity (in every country it operates)

 300 Offices in 100 Countries

 9000 Employees (locally employed)

 Operating in the U.S. since 1898


The DNV Purpose

Safeguarding

life, property and

the environment


The DNV Vision

Global impact

for a safe and

sustainable future


DNV Values

We build trust

and confidence

We never compromise

on quality or integrity

We are committed to

teamwork and innovation

We care for our customers

and each other


Emergence of “Hospital Accreditation”

  Hospital Accreditation – increased use of the term globally -  An increasingly accepted term to denote a formal independent review to

national regulations that carries with it a monetary return to the accredited organizations

-  Formal exclusive use in the US for the last 50 years -  Other nations are adopting a similar approach

  DNV’s Focus in Hospital Accreditation -  Approved by the US Centers for Medicare & Medicaid Services (CMS) to

deem hospitals in compliance with the Medicare Conditions of Participation for Hospitals (42 C.F.R. §482)

-  Also a a “Risk partner” to the UK National Healthcare Services (NHS) in assessing hospitals, developing standards and training hospital staff in enhancing patient care

The need for DNV’s new accreditation alternative


  Evidence is present to indicate that medical errors are still occurring at an alarming rate despite current efforts to impact reduction

  Fear of legal ramifications and other protections under the law have created reporting barriers for hospitals

  Hospitals feel compelled to implement measures to address these events, yet are struggling with managing their effectiveness

  Poorly designed and ineffective processes that lack consistency are the primary cause for these outcomes


  Processes in healthcare organizations are very complex and require a great deal of communication and validation to be effective.

  Processes become more difficult to manage and control when they become more decentralized.

  The improvement of quality, performance and outcomes is directly related to the accountability for the processes.

  Hospitals struggle with introducing new methodologies to focus their efforts and abandon one methodology only to replace it with another producing the same results


  Limit the focus to primarily clinical settings and associated activities

  Pay less attention to important non-clinical processes such as management and support processes that play a vital role in the overall effectiveness of the healthcare delivery system that impact quality

  Represent only a snapshot of the hospital with a fair amount prepared just prior to the on-site visit, and does not represent standard operating procedure


1951 Joint Commission established

1964 CMS established

-  Accreditation or State Survey required to received for CMS reimbursement

-  TJC has statutory privilege – no accountability to CMS

1999 IOM report on medical errors

12/19/2007 DNV applies to CMS to become an approved AO for hospitals

7/15/2008 HR 6331 becomes public law #110-275 -  Removing TJC’s special statutory privileges as AO -  TJC will have to receive CMS approval within 2 years

9/26/2008 DNV granted CMS approval as an AO for hospitals 10/13/2008 IJC survey reports “19% of respondents stated their hospitals were

considering switching to DNV”

DNV Healthcare Inc.

Hospital Accreditation: Integration of NIAHO℠ Standards with ISO 9001 Quality Management System Standards


ISO 9001:2000 Quality Management System (Infrastructure of QMS)

NIAHO℠ Accreditation Requirements (Consistent with CMS CoPs - Requirement for ISO

Compliance/Certification)

CMS (CoPs) (Accreditation Oversight)


Why NIAHO℠

 Meets and exceeds CoP requirements

  Includes ISO 9001:2000 QMS (proven basis for continual improvement)

 No additional staff required to implement NIAHO℠

 Annual visits – added accountability

 Focus on sequence and interactions of processes throughout the hospital

 Leads to improvement of patient safety and reduction in hospital’s internal cost of accreditation


DNV Accreditation Progression

  1st visit: -  Get Accredited to NIAHO℠ - meet the requirements of CMS -  Get a gap analysis to ISO 9000 with the road map to achieving it within a

maximum of 2 years

  2nd visit – 1 year after accreditation -  Continue accreditation by undergoing an survey to NIAHO℠ -  Survey for progress in implementing ISO 9001 -  If in compliance with ISO 9001 – a statement included in Certificate of

Accreditation -  May choose to demonstrate compliance by obtaining a separate ISO 9001

certificate

  3rd visit – -  Continue accreditation by undergoing survey to NIAHO℠ -  Be in compliance with ISO 9001


What can hospital gain from implementing ISO 9001?

  Improve the quality “system” to reduce errors and improve performance

  Improve the effectiveness and efficiency of processes that enable errors and are hindered with complexity

  Increase patient satisfaction

  Learn from and benefit from the success ISO 9001 QMS has produced in other sectors, especially the service industry


Quality Policy = Mission, Vision

Quality Objectives = Organization’s Quality Goals & Objectives

Corrective Action = CQI/PI Process – RCAs

Preventive Action = FMEA Process

Internal Audit = Review of departmental & organization processes and outcomes; individual performing cannot come from area being audited

Document Control = Sundown provision

Management Representative = Quality Director

Management Review = Enlarged Quality Council Function


Process Map Example


Ensuring that Quality and Patient Safety is Managed, Not Just Measured!!


  Quality Management System

  Governing Body

  Chief Executive Officer

  Medical Staff

  Nursing Services

  Staffing Management

  Medication Management

  Surgical Services

  Anesthesia Services

  Laboratory Services

  Respiratory Care Services

  Medical Imaging

  Nuclear Medicine Services   Rehabilitation Services

  Obstetric Services

  Emergency Department

  Outpatient Services

  Dietary Services

  Patient Rights

  Infection Control

  Medical Records Service

  Discharge Planning

  Utilization Review

  Physical Environment

  Organ, Eye and Tissue Procurement

© Det Norske Veritas AS. All rights reserved Slide 22

CUSTOMER

INPUT OUTPUT

4.0 Quality Management System 4.1 4.2

4.1 General 4.1.f Continual Improvement* 4.2 Document requirements 4.2.2 Quality Manual Justification & process flow diagram* 4.2.3 Documentation 4.2.4 Records

5.1 Management commitment (4.1) 5.2 Customer focus* 5.3 Quality Policy* 5.4 Planning (objectives) 5.5 Responsibility & authority 5.5.3 Internal Communication* 5.6 Management review

5.1 5.2 5.3 5.4 5.5 5.6

5.0 Management responsibility

6.1 Resources 6.2 Human Resources 6.3 Infrastructure 6.4 Work environment

6.1 6.2 6.3 6.4

6.0 Resource management

7.1 Planning and product realization 7.2 Customer related 7.2.1 Determine requirements* 7.2.2 Review requirements 7.2.3 Customer requirements* 7.3 Design & development 7.4 Purchasing 7.5 Production 7.6 Calibration

7.0 Product realization 7.1 7.2 7.3 7.5 7.4 7.6

8.1 8.2 8.3 8.4 8.5

8.0 Measurement, analysis and improvement

CUSTOMER

8.1 General 8.2 Monitor & measure 8.2.1 Customer Satisfaction* 8.2.2 Internal audit 8.2.3 Processes* 8.2.4 Product 8.3 Nonconforming product 8.4 Analysis of data * 8.5 Improvement 8.5.1 Continual* 8.5.2 Corrective 8.5.3 Preventive


Crosswalk CoP – NIAHO℠ - ISO 9001 Sec. 482.11 Condition of participation: Compliance with Federal, State and local laws.

GOVERNING BODY (GB) GB.1 LEGAL RESPONSIBILITY 5.1, 5.5.1, 5.5.2

Sec. 482.12 Condition of participation: Governing body.

GOVERNING BODY (GB) GB.1 LEGAL RESPONSIBILITY

MEDICAL STAFF (MS) MS.2 ELIGIBILITY MS.7 MEDICAL STAFF BYLAWS MS.3 ACCOUNTABILITY MS.8 APPOINTMENT MS.11 GOVERNING BODY ROLE

CHIEF EXECUTIVE OFFICER (CE) CE.1 QUALIFICATIONS

MEDICAL STAFF (MS) MS.15 ADMISSION REQUIREMENTS

GOVERNING BODY (GB) GB.2 INSTITUTIONAL PLAN AND BUDGET GB.3 CONTRACTED SERVICES

EMERGENCY DEPARTMENT (ED) ED.3 EMERGENCY SERVICES NOT PROVIDED ED.4 OFF-CAMPUS DEPARTMENTS

5.1, 5.5.1, 5.5.2

5.5.1, 7.2.1, 7.2.2 5.5.1, 6.3, 8.5.2 5.5.1 6.2.2, 8.1, 8.2.2, 8.2.3, 8.2.4, 8.4, 8.5.1, 8.5.2, 8.5.3 5.5.1, 6.3

5.1, 5.5.1, 5.5.2

6.2.1, 6.2.2

5.4, 6.1 7.4.1, 7.4.2, 7.4.3

7.5.1, 7.5.2, 8.2.3 5.5.1, 6.2.1, 6.2.2, 6.3


 The inherent requirements for process improvement result in good outcomes specified in the CMS Conditions of Participation

 Hospitals are held accountable through the mechanisms required in ISO 9001 for Internal Audits, Management Review and Corrective / Preventive Action

 Allows hospital innovation to determine HOW assures sustainable and safe best practices that support this approach


Implementation plan for ISO 9001:2000

NIAHO℠ Survey Activities


  Survey teams consist of individuals educated in the health sciences (physicians, nurses, administrators, quality managers), academically qualified specialists experienced in the Life Safety Code, and IT Specialists.

  All survey team members are trained as ISO 9001 QMS Lead Auditors (Quality Management System)

  All Life Safety Specialists are also trained as ISO 14001 EMS Lead Auditors (Environmental Management System)

  Many surveyors will be cross-trained as ISO 27001 Lead Auditors (Information Security Management System)


Generalist Surveyor   Quality Management Review

  Medication Management

  Medical Staff and Human Resources Review

  Ancillary / Support Services Review (Laboratory, Medical Imaging, Rehab, etc.)

Clinical Surveyor   Operational Review Activities

-  Patient Care Unit Visits (Clinical Settings) -  Med-Surg, ICU, CCU, Obstetrics, Emergency Department

Physical Environment / Life Safety Specialist   Physical Environment aspects and review of management plans

  Physical Environment / Life Safety Tour

  Biomedical Engineering (Equipment)


Conducting the Survey - Arrival

  Survey team arrives on-site together

  The team leader provides identification and the Announcement letter to the Receptionist at the information (front) desk and a request is made to contact the hospital representative

  Hospital will typically request that the survey team sign-in and be provided with necessary identification as required by the hospital

  The survey team is escorted to a conference room and makes preparations with the hospital representative to conduct the survey

-  A copy of the survey schedule is provided to the hospital representative to make the desired copies and assemble the appropriate parties for the opening meeting


Opening Meeting   Explanation of the purpose, scope of the survey, and provide a schedule of survey activities to the

organization (the schedule may be adjusted as necessary)

  Brief explanation of the survey process;

  Introduction of survey team members,   Clarification of all organization areas and locations, departments, and patient care settings under the

hospital provider number and/or scope statement that will be surveyed, including any contracted patient care activities or patient services located on organization campuses or organization provider based locations

  Discuss the location (e.g., conference room) where the team may meet privately during the survey

  A telephone and internet connection for team communications (or access to these services if needed), preferably in the team meeting location

  Determine how the facility will ensure that surveyors are able to obtain the photocopies of material, records, and other information as they are needed

  Obtain the names, locations, and telephone numbers of key staff to whom questions should be addressed

  Discuss the approximate time, location, and possible attendees of any meetings to be held during the survey

  Discuss the proposed date and time for the Closing Meeting.

  During the Opening Meeting, the Team Leader will request that the organization provide the survey team with the documents requested for Document Review as listed.


Initial Survey Team Meeting & Document Review

  Review the scope of hospital services

  Identify hospital locations to be surveyed, including any off-site locations

  Adjust surveyor assignments, as necessary, based on information provided

  Discuss issues such as change of ownership, adverse events, construction activities, and disasters, if they have been reported

  Make an initial patient sample selection (The patient list may not be available immediately after the opening meeting and the team may delay completing the initial patient sample selection a few hours as meets the needs of the survey team) – this is reviewed during the document review session

Document Review List


Survey activities are carried out through as follows:

  A comprehensive review includes observation of care/services provided to the patient, patient and/or family interview(s), staff interview(s), and medical record review.

-  Using Tracer methodology, department/patient unit audits to include staff interviews and open medical record review as appropriate (both clinical and support departments)

-  identify performance issues -  handoff between steps -  Tracer methodology has been in place with ISO 9001 long before it

was adopted by any accreditation organization.


Surveyors will pay particular attention to the following:

  Patient care, including treatments and therapies in all patient care settings;

  Staff member activities, equipment, documentation, building structure, sounds and smells;

  People, care, activities, processes, documentation, policies, equipment, etc.,

  Integration of all services to determine that the facility is functioning as one integrated whole

  Whether quality improvement is a organization-wide activity, incorporating every service and activity of the organization

  Interaction between various hospitals departments and activity reports to assure quality management oversight, facilitating the organization-wide quality management system.

  Awareness and the effectiveness of the hospital’s quality management system

  Storage, security and confidentiality of medical records.


Review documentation (written and electronic) and include the following:   Patient’s clinical records and its validation by interviews

  Plans of care and discharge plans, review of the pre-surgical assessment, informed consent, operative report, and pre-, inter-, and post-operative anaesthesia notes.

  Personnel files, competency/performance assessments, and licenses (as required)

  Physician and allied health credential files

  Maintenance and calibration records to determine if equipment is periodically attested and/or calibrated to determine if it is in good working order and if environmental requirements have been met

  Staffing documents to determine if adequate numbers of staff are provided

  Policy and Procedure Manuals

  Contracts, if applicable

  Organization activities minutes as requested


Closing Meeting

  The Team Leader is responsible for organization of the presentation of the exit.

  The facility determines which hospital staff will attend the closing meeting.

  The Team Leader will explain how the team will conduct the closing meeting and any associated ground rules.

  The surveyor will present the findings of Nonconformity, explaining why the finding is a non-compliance issue.

  The team will assure that all findings are discussed at the closing conference.


Post-Survey Activities

  An oral report of the findings will be provided by the Survey Team at the closing meeting of each survey and provide the opportunity for the organization to discuss any of the findings prior to survey team ending the survey.

  The Team Leader will submit the Preliminary Report to DNVHC offices after the survey has concluded.

  DNVHC will forward the Final Survey Report to the organization within 10 days of the last date of the survey.


Nonconformities Handling

Classification of Findings The surveyor shall categorize the findings to:

Nonconformity (NC)- (Category 1)   Objective evidence exists that a requirement has not been addressed (intent), a practice

differs from the defined system (implementation), or the system is not effective (effectiveness).

  The absence of one or more required system elements or a situation which raises significant doubt that the services will meet specified requirements.

  A group of category 2 non-conformities indicating inadequate implementation or effectiveness of the system relevant to requirement of the standard.

  A category 2 non-conformity that is persistent (or not corrected as agreed by the customer) shall be up-graded to category 1, OR a situation, that, on the basis of available objective evidence, would have the capability to cause patient harm or does not meet a standard of care.

  Condition Level Finding- A Condition Level Finding is a Category 1 Nonconformity in which the customer is determined to be completely or substantially out of compliance with the standard. Such finding is made on a case-by-case basis in DNV Healthcare Inc.’s sole discretion. A Condition Level Finding will be identified as a Category 1 Nonconformity- Condition Level Finding. All Condition Level Findings will require a follow-up survey prior to the next annual survey.


Nonconformities Handling

Nonconformity (NC)- (Category 2)

  A lapse of either discipline or control during the implementation of system/procedural requirements, which does not indicate a system breakdown or raise doubt that services will meet requirements. Overall system requirement is defined, implemented and effective.

  As applicable a finding as a Category 2 nonconformity may be:

  An isolated non-fulfillment of a standard requirement that is otherwise properly documented and implemented, or,

  Inconsistent practice compared to other areas of the customer, or,

  Significant enough to warrant the customer to take action to prevent future occurrence and/or has the potential for becoming a Category 1 nonconformity.


NIAHO℠ Report and Corrective Action Submittal

  Using the NIAHO℠ Report Template – The findings are noted according the findings categories

-  The NIAHO℠ Standard Number, -  Description -  Applicable Standard Requirement (SR statement), -  Applicable Interpretive Guidelines for clarification (if necessary)

-  For the Physical Environment – related LSC Code and other appropriate codes may be indicated

-  Finding statement (stating of applicable objective evidence)


Organization Response – Corrective Action

  The organization is required to respond with the Corrective Action Plan(s) to address any nonconformities and/or observations to DNVHC

  Example of Corrective Action Submittal Form – Response

  A review is conducted for acceptance and approval of the corrective action plan(s) and noted on the form.

  Once the corrective action plans have been accepted and approved, a copy of the survey schedule, NIAHO℠ Report and Corrective Action Response is submitted for review by members of the Accreditation Committee with a Accreditation Committee Action Form


Accreditation Committee Review/Decision

  There are a minimum of two accreditation committee members required to approve/deny accreditation of an organization based on review of the documentation

  The members reviewing the report packages will have the following qualifications:

-  Knowledge of processes/functions within the hospital setting -  Experience in a leadership and/or clinical role within the hospital

setting -  Knowledge of the NIAHO℠ Standards and Accreditation Process -  Knowledge of the ISO 9001 QMS Requirements

It is not necessary that each member have all qualifications but all requirements listed above must be covered by the members conducting the review.


Accreditation Committee Review/Decision

  If the Accreditation Committee approves the issuance of an Accreditation Certificate, the Executive Vice President of Accreditation or designee will verify all appropriate information and approvals and will print the certificates and send it to the Accredited Organization.

  If the Accreditation Committee does not approve the issuance of an Accreditation Certificate, the reasons must be documented in writing and sent to the affected hospital.


Appeal Process

  Appeals received by DNV Healthcare Inc. shall be:

  Registered in a log to record the progress to completion;

  Acknowledged by DNV Healthcare Inc. without undue delay; and, Reviewed and answered.

  The appeal is not bound to a particular form or content. However, the appeal shall be submitted in writing stating the basis of the appeal and the relief being requested. The appeal can be faxed, e-mailed or sent by US mail to:

Darrel J. Scott, Senior Vice President, Regulatory & Legal Affairs DNV Healthcare Inc. 463 Ohio Pike, Suite 203 Cincinnati, Ohio 45255 Fax: (513) 947-1250 Email: [email protected]


Appeal Process   The appellant shall be informed of the right to:

-  Present its case in person.

-  Appeal to the President of DNV Healthcare Inc. if the appellant does not accept the decision of the Executive Vice President, Accreditation.

  The following applies for all appeals: -  The decision reached by the Executive Vice President, Accreditation or

President shall be communicated to the appellant in writing

-  If the appellant still remains dissatisfied with the decision of the Executive Vice President, Accreditation or President, the appellant is entitled to one (1) appeal to the Standards and Appeals Board. The appeal will be conducted in accordance with the Standards and Appeals Board Procedures in Appeals.

-  Any appellant notice that it will pursue a remedy beyond DNV Healthcare Inc. shall be reported to DNV Corporate Legal Affairs through the Vice President, Regulatory Affairs.

  Corrective Action The Executive Vice President of Accreditation and President, if appropriate, shall review the final outcome of all appeals to determine the need for any change in DNV Healthcare Inc. procedures.


Certificate Issuance

 Upon conformation that any nonconformities noted have been corrected and closed

 Upon approval of the Accreditation Committee, the NIAHO℠ Accreditation Certificate is created and issued to the hospital.

 Example of a NIAHO℠ Accreditation Certificate


Hospital Patient Care Processes and Supporting Operations

ISO 9001:2000 Quality Management System (Infrastructure of QMS)

NIAHO℠ Accreditation Requirements (Consistent with CMS CoPs - Requirement for ISO

Compliance/Certification)

CMS (CoPs) (Accreditation Oversight)

Improved patient care and safety


Yehuda Dror, President [email protected]

Rebecca (Becky) Wise, COO [email protected] 513-388-4866

Patrick (Pat) Horine, EVP [email protected] 513-388-4888

Darrel Scott, SVP [email protected] 513-388-4862

www.dnvaccreditation.com

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