Transcript Introduction to DNV - Services for Managing Risk

Introduction to DNV Healthcare and
NIAHO℠
A New Choice for Hospital Accreditation
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
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07 July 2015
Slide 2
The DNV Purpose
Safeguarding
life, property and
the environment
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07 July 2015
Slide 3
The DNV Vision
Global impact
for a safe and
sustainable future
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07 July 2015
Slide 4
DNV Values
We build trust
We never compromise
and confidence
on quality or integrity
We are committed to
We care for our customers
teamwork and innovation
and each other
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07 July 2015
Slide 5
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
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07 July 2015
Slide 6
The need for DNV’s new
accreditation alternative
Medical Errors/Adverse Events…

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
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Slide 8
Lack of quality management
system infrastructure

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
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Slide 9
Other accreditation models….

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
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Slide 10
New Face for Hospital Accreditation
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”
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07 July 2015
Slide 11
DNV Healthcare Inc.
NIAHOSM and ISO 9001 Quality
Management System
Hospital Accreditation: Integration of NIAHO℠ Standards with
ISO 9001 Quality Management System Standards
Infrastructure and Accreditation
CMS (CoPs)
(Accreditation Oversight)
NIAHO℠ Accreditation Requirements
(Consistent with CMS CoPs - Requirement for ISO
Compliance/Certification)
ISO 9001:2000 Quality Management System
(Infrastructure of QMS)
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Slide 13
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
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07 July 2015
Slide 14
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
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Slide 15
Applying ISO 9001 QMS in Healthcare
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
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Slide 16
Terminology …
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
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07 July 2015
Slide 17
ABC Regional Hospital
Inpatient Treatment
Cross Functional Flowchart
Physician/ED
Registration
Inpatient Unit
Writers admit
orders
Process Map Example
Pt registered
Transfer to another
hospital
Assessed.
Treatment initiated
Reassesses.
Develops plan/
orders
Physician
Pharmacy
Transfer back to
Nursing Home
Medication orders
processed &dispensed
Discharged home
Physical Therapy
Provides
therapy
Respiratory Care
Laboratory
Diagnostic
testing
Radiology
Cardiology
Infection Control
Social Services
Assesses IC
needs
Assesses
discharge
needs
Environmental Service
Room cleaned
Purchasing/Distribution
Supplies restocked
Medical Records
Transcription. Chart
assembly, coding
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07 July 2015
Slide 18
Introduction of a New Accreditation Model
Ensuring that Quality and Patient
Safety is Managed,
Not Just Measured!!
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Slide 19
NIAHO℠ Standards - Chapters

Quality Management System

Medication Management

Governing Body

Surgical Services

Chief Executive Officer

Anesthesia Services

Medical Staff

Laboratory Services

Nursing Services

Respiratory Care Services

Staffing Management

Medical Imaging

Rehabilitation Services

Nuclear Medicine Services

Obstetric Services

Discharge Planning

Emergency Department

Utilization Review

Outpatient Services

Physical Environment

Dietary Services

Patient Rights

Organ, Eye and Tissue Procurement

Infection Control

Medical Records Service
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07 July 2015
Slide 20
QUALITY MANAGEMENT SYSTEM
(CONTINUAL IMPROVEMENT)
C
U
S
T
O
M
E
R
R
E
Q
U
I
R
E
M
E
N
T
S
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C
U
S
T
O
M
E
R
Management
Responsibility
Resource
Management
INPUTS
Measurement
Analysis &
Improvement
Product /
Service
Realization
07 July 2015
OUTPUTS
S
A
T
I
S
F
A
C
T
I
O
N
Slide 21
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
5.0 Management responsibility
5.1 5.2 5.3 5.4 5.5 5.6
C
U
S
T
O
M
E
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6.0 Resource management
6.1
6.2
6.3
6.1 Resources
6.2 Human Resources
6.3 Infrastructure
6.4 Work environment
INPUT
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6.4
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
7.0 Product realization
7.1 7.2 7.3 7.4 7.5 7.6
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
8.0 Measurement, analysis
and improvement
8.1
8.2
8.3
8.4
8.5
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 *OUTPUT
8.5 Improvement
8.5.1 Continual*
8.5.2 Corrective
8.5.3 Preventive
C
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T
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Slide 22
Crosswalk CoP – NIAHO℠ - ISO 9001
Sec. 482.11 Condition
of participation:
Compliance with
Federal, State and local
laws.
GOVERNING BODY (GB)
Sec. 482.12 Condition
of participation:
Governing body.
GOVERNING BODY (GB)
5.1, 5.5.1, 5.5.2
GB.1 LEGAL RESPONSIBILITY
5.1, 5.5.1, 5.5.2
GB.1 LEGAL RESPONSIBILITY
MEDICAL STAFF (MS)
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
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
5.1, 5.5.1, 5.5.2
MEDICAL STAFF (MS)
6.2.1, 6.2.2
MS.15 ADMISSION REQUIREMENTS
GOVERNING BODY (GB)
GB.2 INSTITUTIONAL PLAN AND BUDGET
GB.3 CONTRACTED SERVICES
5.4, 6.1
7.4.1, 7.4.2, 7.4.3
EMERGENCY DEPARTMENT (ED)
ED.3 EMERGENCY SERVICES NOT PROVIDED
ED.4 OFF-CAMPUS DEPARTMENTS
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7.5.1, 7.5.2, 8.2.3
5.5.1, 6.2.1, 6.2.2, 6.3
Slide 23
ISO 9001 As the Infrastructure for
NIAHO℠ Accreditation

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
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07 July 2015
Slide 24
Implementation plan for ISO 9001:2000
IMPLEMENTATION PLAN FOR ISO 9001:2000
Month
PROCESS
Pre-Assessment (Readiness)
Assign Management Representative
Identify Implementation Team
Educate Management and Staff
Map Organization Processes
Document Control
Control of Records
Management Responsibility
Competence, Awareness and Training
Infrastructure
Planning of Service Realizations Processes
Customer Related Processes
Design and Developed (unless excluded)
Purchasing
Control of Production and Service Provision
Identification and Traceability
Customer Property
Preservation of Product
Control of Monitoring and Measuring Devices
Monitoring, Measuring and Analysis
Internal Audits
Control of Nonconforming Product (Service)
Corrective Action / Preventive Action
Train Internal Audit Team
Conducting Internal Audits
Completion of Management Review
Compliance Verification / Certification
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Slide 25
NIAHO℠ Survey Activities
Survey Team
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)
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07 July 2015
Slide 28
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
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Slide 29
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.
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Slide 30
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
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07 July 2015
Slide 31
Conducting Survey Activities
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.
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07 July 2015
Slide 32
Conducting Survey Activities
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.
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Slide 33
Conducting Survey Activities
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
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Slide 34
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.
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07 July 2015
Slide 35
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.
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Slide 36
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 NonconformityCondition Level Finding. All Condition Level Findings will require a follow-up survey prior to
the next annual survey.
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07 July 2015
Slide 37
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.
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07 July 2015
Slide 38
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)
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Slide 39
DNV HEALTHCARE INC
16340 Park Ten Pl.,
Suite 100,
Houston, Texas 77084
(281) 721-6869
Nonconformity Notes /
Corrective Action Plan Submittal
463 Ohio Pike,
Suite 203,
Cincinnati, Ohio 45255
(513) 947-8343
Organization:
NC
Number
Process or
Department
Finding
Category
Number of Requirement/
Clause
(Requirement / SR)
CoP/CFR Number(s):
 NC-1 Condition Level
 NC-1
 NC-2
Requirement (Description):
The requirement was NOT MET as evidenced by the following:
Corrective Action Due Date:
ORGANIZATION RESPONSE
Cause that led to the nonconformity:
Organization Corrective Plan:
Person/Function Responsible for Implementation of Corrective Action Plan:
Date for Implementation of Plan*:
Hospital Method for Follow-Up **:
DNVHC USE ONLY
Date C/A Plan Accepted:
DNV Rep:
Date C/A Plan Rejected:
DNV Rep:
Reason for rejection:
Date C/A Plan Verified and Closed:
DNV Follow-Up and Closure of NC:
* Implementation of corrective action plan will generally be within 60 days
** Measurable evidence of sustained compliance and frequency of monitoring
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07 July 2015
Slide 40
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
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07 July 2015
Slide 41
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.
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07 July 2015
Slide 42
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.
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07 July 2015
Slide 43
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]
© Det Norske Veritas AS. All rights reserved
07 July 2015
Slide 44
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.
© Det Norske Veritas AS. All rights reserved
07 July 2015
Slide 45
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
© Det Norske Veritas AS. All rights reserved
07 July 2015
Slide 46
© Det Norske Veritas AS. All rights reserved
07 July 2015
Slide 47
Infrastructure and Accreditation
Improved patient care
and safety
CMS (CoPs)
(Accreditation Oversight)
NIAHO℠ Accreditation Requirements
(Consistent with CMS CoPs - Requirement for ISO
Compliance/Certification)
ISO 9001:2000 Quality Management System
(Infrastructure of QMS)
Hospital Patient Care Processes and Supporting Operations
© Det Norske Veritas AS. All rights reserved
07 July 2015
Slide 48
Question & Answer
Session
© Det Norske Veritas AS. All rights reserved
07 July 2015
Slide 49
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
© Det Norske Veritas AS. All rights reserved
07 July 2015
Slide 50