Transcript Introduction to DNV

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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16 July 2015
Slide 2
The DNV Purpose
Safeguarding
life, property and
the environment
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Slide 3
The DNV Vision
Global impact
for a safe and
sustainable future
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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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16 July 2015
Slide 5
The need for DNV’s new
accreditation alternative
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
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
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16 July 2015
Slide 7
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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16 July 2015
Slide 9
Why NIAHO℠

Meets and exceeds CoP requirements

Includes ISO 9001:2000 QMS (proven basis for continual
improvement)
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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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16 July 2015
Slide 10
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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16 July 2015
Slide 11
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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16 July 2015
Slide 12
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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16 July 2015
Slide 13
NIAHO℠ Standards - Chapters

Quality Management System

Medication Management

Governing Body

Surgical Services

Chief Executive Officer

Anesthesia Services

Medical Staff

Laboratory Services
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Nursing Services
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Respiratory Care Services
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Staffing Management
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Medical Imaging
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Rehabilitation Services
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Nuclear Medicine Services
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Obstetric Services
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Discharge Planning
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Emergency Department
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Utilization Review
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Outpatient Services
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Physical Environment
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Dietary Services
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Patient Rights

Organ, Eye and Tissue Procurement

Infection Control

Medical Records Service
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Slide 14
QUALITY MANAGEMENT SYSTEM
(CONTINUAL IMPROVEMENT)
C
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Q
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C
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Management
Responsibility
Resource
Management
INPUTS
Measurement
Analysis &
Improvement
Product /
Service
Realization
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OUTPUTS
S
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F
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Slide 15
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
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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
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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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16 July 2015
Slide 17
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 18
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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Slide 21
Conducting Survey Activities
Survey activities are carried out 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 visits 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
since its beginning.
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Slide 22
NONCONFORMITIES
Classification of Findings
The surveyor shall categorize the findings to:
Nonconformity (NC)- (Category 1) – 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.
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16 July 2015
Slide 23
NONCONFORMITIES
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.

Corrective Action Plan in 10 days – documented objective evidence of
correction due to DNVHC in 60-90 days
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16 July 2015
Slide 24
NONCONFORMITIES
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.

Corrective Action Plan required in 10 days – follow-up at next annual
survey
© Det Norske Veritas AS. All rights reserved
16 July 2015
Slide 25
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16 July 2015
Slide 26
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
16 July 2015
Slide 27
Question & Answer
Session
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16 July 2015
Slide 28
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
16 July 2015
Slide 29