Transcript Aligning Accreditation and Quality – The DNV Perspective

Aligning Accreditation and Quality
– The DNV Perspective
The Maryland Association for Healthcare Quality
DNV Healthcare
Rebecca Wise, Chief Operating Officer
Patrick Horine, Executive Vice President, 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)

50,000 clients worldwide

85,000 Certificates world-wide

Operating in the U.S. since 1898
- Corporate Headquarters in Houston, Texas
- Operational Office in Cincinnati, Ohio

DNV received CMS deeming authority on September 26, 2008
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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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17 July 2015
Slide 5
Today’s risk reality

Organizations today are operating in an increasingly more global,
complex and demanding risk environment

Society at large is adopting a zero-tolerance for failure

Increased demands for transparency and business sustainability

Stricter regulatory requirements

Global and instant media coverage
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Slide 6
DNV Main Industries
Maritime
Automotive
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Health Care
Food & Beverage
17 July 2015
IT & Telecom
Finance
Transport
Energy
Slide 7
300 offices in 100 countries
Head office
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Local offices
Slide 8
DNV Certification Clients by City
Note: Nearly 900,000 organizations in 170 countries have adopted the ISO 9001 Quality Management
System standard - International Organization for Standardization, The ISO Survey of Certifications
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17 July 2015
Slide 9
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 9001:2008 Quality Management System
(Infrastructure of QMS)
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Slide 11
Advantages to DNV Healthcare Accreditation

Meets and exceeds CoP requirements

Includes ISO 9001Quality Management System (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

Demeanor of the Survey Team

No survey findings “tipping” point

Accreditation as a strategic business asset
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Slide 12
DNV Accreditation Progression

1st visit:
- Get Accredited to NIAHO℠ - meet the requirements of CMS
- Get a gap analysis to ISO 9001 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 13
Introduction of an Accreditation Alternative
Ensuring that Quality and Patient
Safety is Managed,
Not Just Measured!!
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Slide 14
ISO 9001 as part of NIAHO℠
Accreditation Requirements
What Is ISO?

Greek acronym for “all sides being equal”

International Organization for Standardization

Headquartered in Geneva, Switzerland

Over 120 countries worldwide are members

USA is represented by American National Standards Institute
(ANSI)

ISO first published its ISO 9001 Standard in 1987
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Slide 16
ISO 9001 As the Infrastructure for
NIAHO Accreditation

Meets the requirements of the CMS Conditions of
Participation within improved processes to generate
good outcomes

Holds the hospital accountable through the mechanisms
required in ISO 9001 for Internal Audits, Management
Review and Corrective / Preventive Action

Is less prescriptive in many areas, and leaves up to the
hospital the “how” to assure that effective systems are in
place to manage quality and that outcomes support this
approach
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Slide 17
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
17 July 2015
OUTPUTS
S
A
T
I
S
F
A
C
T
I
O
N
Slide 18
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
R
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
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
U
S
T
O
M
E
R
Slide 19
Some Examples of Hospital Processes

Inpatient Care

Outpatient Care

Ambulatory Surgery

Emergency Care

Critical Care Delivery

Medication Delivery

Transfusion and Blood Product Administration
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Slide 20
Applying a Process Approach

Define and develop processes

Understanding the relationship between processes is a
key to success

Analyze all aspects of a process to identify those critical
characteristics that are a key to success

Judge both effectiveness and efficiencies of processes
since both have a significant bearing on customer
satisfaction and meeting patient needs
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Slide 21
Customer Relationships – Internal – External
(Product/Service Realization Processes)
Pt. Needs Hip
Replacement
INPUT
3
1
2
5
6
7
4
OUTPUT
Pt. Has Hip
Replaced and
returns home
1 Physician’s Office
5 Operating Room
2 Scheduling
6 Med/Surg IP Unit
3 Admitting
7 Home Care
4 Pre-Admission Testing
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Slide 22
All Other Processes (Management and Support) Must Complement Patient
Care
Budget
INPUT
Information Services
Patient Care
HR
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Purchasing
OUTPUT
Infection Control Social Services
17 July 2015
Slide 23
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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Slide 24
Process Mapping
4.2 Documentation Requirements
5.0 Management Responsibility
6.1 Provision of Resources
6.2 Human Resources
6.3 Infrastructure
6.6 Work Environment
7.4 Purchasing
8. Measurement, Analysis & Improvement
Referral
Organizational Structure
Management & Support
Resources Staff &
Equipment ( Including
Training)
Support Services
(Dietary, Housekeeping,
Buildings & Grounds)
Performance Monitoring
& Review
Pre-Admission
Review of Service
Capabilities
5.2 Customer Focus
7.2 Customer Related Processes
Admission (Assessment /
Diagnosis)
5.2 Customer Focus
5.4 Planning
7.2 Customer Related Processes
6.2 Human Resources
6.3 Infrastructure
6.4 Work Environment
5.2 Customer Focus
7.2 Customer Related Processes
7.3 Design & Development (Research Hospital)
6.3 Infrastructure
6.4 Work Environment
7.1 Planning and Service Realization
7.5 Production & Service Provision
7.6 Control of Monitoring & Measuring Devices
8.2.3 Monitoring & Measurement of Processes
8.2.4 Monitoring & Measuring of Service
Development of Care /
Treatment Plan
Delivery of Care
Service
Improvement
External Input:
DOH
CMS (COPs)
HFAP
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On-going Monitoring and
Measurement
7.1 Planning & Service Realization
7.4.3 Verification of Purchased Product
7.5.1 Control of Product & Service Provision
8. Measurement, Analysis &Improvement
Change Care / Treatment
Plan as Appropriate
8.3 Control of Non-Conforming Service
8.4 Analysis of Data
8.5 Improvement
Discharge / Long Term
Care
17 July 2015
4.2.4 Control of Records
8.2.1 Customer Satisfaction
Slide 25
Hospital Sequence and Interaction of Processes
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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 9001:2008 Quality Management System
(Infrastructure of QMS)
Hospital Patient Care Processes and Supporting Operations
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Slide 27
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)
MS.15 ADMISSION REQUIREMENTS
6.2.1, 6.2.2
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
7.5.1, 7.5.2, 8.2.3
5.5.1, 6.2.1, 6.2.2, 6.3
See Handout Document - Crosswalk
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Slide 28
NIAHO℠ Accreditation
Requirements
Quality Management System (QM)

QM.1 Quality Management System

QM.2 ISO 9001 Quality Management System

QM.3 Quality Outline

QM.4 Management Representative

QM.5 Documentation and Management Reviews

QM.6 System Requirements

QM.7 Measurement, Monitoring, Analysis

QM.8 Patient Safety System
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Slide 30
Quality Management System (QM)
QM.2 ISO 9001 QUALITY MANAGEMENT SYSTEM

SR.1 Compliance with the ISO 9001 standard:

must occur within two (2) years after the initial deemed NIAHO℠
accreditation.

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 NIAHO℠ Accreditation.
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Slide 31
Quality Management System (QM)

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 QM.6 SR.1 as well as top management for
review and analysis during a management review process.
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Slide 32
Governing Body (GB)

GB.1
Legal Responsibility

GB.2
Institutional Plan and Budget

GB.3
Contracted Services
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Slide 33
Chief Executive Officer (CE)

CE.1
Qualifications

CE.2
Responsibilities
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Slide 34
Medical Staff (MS)

MS.1 Organized Medical Staff

MS.2 Eligibility

MS.3 Accountability

MS.4 Responsibility

MS.5 Executive Committee

MS.6 Medical Staff Participation

MS.7 Medical Staff Bylaws

MS.8 Appointment

MS.9 Performance Data
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Slide 35
Medical Staff (MS)

MS.10
Continuing Education

MS.11
Governing Body Role

MS.12
Clinical Privileges

MS.13
Temporary Clinical Privileges

MS.14
Corrective or Rehabilitation Action

MS.15
Admission Requirements

MS.16
Medical Records Maintenance

MS.17
History and Physical

MS.18
Consultation

MS.19
Autopsy
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Slide 36
Nursing Services (NS)

NS.1 Nursing Service

NS.2 Nurse Executive

NS.3 Plan of Care
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Slide 37
Staffing Management (SM)

SM.1 Licensure or Certification

SM.2 Professional Scope

SM.3 Department Scope of Service

SM.4 Determining and Modifying Staffing

SM.5 Job Description

SM.6 Orientation

SM.7 Staff Evaluations
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Slide 38
Medication Management (MM)

MM.1 Management Practices

MM.2 Formulary

MM.3 Scheduled Drugs

MM.4 Medication Orders

MM.5 Review of Medication Orders

MM.6 Oversight Group

MM.7 Available Information
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Slide 39
Surgical Services (SS)

SS.1 Organization

SS.2 Staffing and Supervision

SS.3 Practitioner Privileges

SS.4 History and Physical

SS.5 Available Equipment

SS.6 Operating Room Register

SS.7 Post-Operative Care

SS.8 Operative Report

SS.9 Immediate Post-Operative Note
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Slide 40
Anesthesia Services (AS)

AS.1
Organization

AS.2
Administration

AS.3
Policies and Procedures
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Slide 41
Laboratory Services (LS)

LS.1Organization

LS.2Infectious Blood and Products

LS.3Patient Notification

LS.4General Blood Safety
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Slide 42
Respiratory Care Services (RC)

RC.1
Organization

RC.2
Physician Order

RC.3
Policies or Protocols

RC.4
Tests Outside the Lab
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Slide 43
Medical Imaging (MI)

MI.1
Organization

MI.2
Radiation Protection

MI.3
Equipment

MI.4
Order

MI.5
Supervision

MI.6
Staff

MI.7
Records

MI.8
Interpretation and Records
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Slide 44
Nuclear Medicine Services

NM.1
Organization

NM.2
Radioactive Materials

NM.3
Equipment and Supplies

NM.4
Interpretation
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Slide 45
Rehabilitation Services (RS)

RS.1
Organization

RS.2
Management and Support

RS.3
Treatment Plan
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Slide 46
Obstetric Services (OB)

OB.1
Compliance

OB.2
Anesthesia Services
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Slide 47
Emergency Department (ED)

ED.1
Organization

ED.2
Staffing

ED.3
Emergency Services Not Provided

ED.4
Off-Campus Departments
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Slide 48
Outpatient Services (OS)

OS.1
Organization

OS.2
Staffing

OS.3
Scope of Service
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Slide 49
Dietary Services (DS)

DS.1
Organization

DS.2
Services and Diets

DS.3
Diet Manual
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Slide 50
Patient Rights (PR)

PR.1 Specific Rights

PR.2 Advance Directive

PR.3 Language and Communication

PR.4 Informed Consent

PR.5 Grievance Procedure

PR.6 Restraint or Seclusion

PR.7 Restraint or Seclusion: Staff Training Requirements

PR.8 Restraint or Seclusion Report of Death
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Slide 51
Infection Control (IC)

IC.1 Infection Control System
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Slide 52
Medical Records Services (MR)

MR.1 Organization

MR.2 Complete Medical Record

MR.3 Retention

MR.4 Confidentiality

MR.5 Record Content

MR.6 Identification of Authors

MR.7 Required Documentation
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Slide 53
Discharge Planning (DC)

DC.1
Written Policies

DC.2
Discharge Planning Evaluation

DC.3
Plan Implementation

DC.4
Evaluation
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Slide 54
Utilization Review (UR)

UR.1
Documented Plan

UR.2
Sampling

UR.3
Medical Necessity Determination

UR.4
Extended Stay Review
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Slide 55
Physical Environment (PE)

PE.1 Facility

PE.2 Life Safety Management System

PE.3 Safety Management System

PE.4 Security Management System

PE.5 Hazardous Material (Hazmat) Management System

PE.6 Emergency Management System

PE.7 Medical Equipment Management System

PE.8 Utility Management System
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Slide 56
Organ, Tissue and Eye Procurement (TO)

TO.1 Process

TO.2 Organ Procurement Organization (OPO) Written Agreement

TO.3 Alternative Agreement

TO.4 Respect for Patient Rights

TO.5 Documentation

TO.6 Organ Transplantation

TO.7 Transplant Candidates
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17 July 2015
Slide 57
ISO 9001:2008
Quality Management System
Requirements
Crosswalk CoP – NIAHO℠ - ISO 9001
Sec. 482.51
Condition of
participation:
Surgical services.
SURGICAL SERVICES (SS)
SS.1 ORGANIZATION
SS.2 STAFFING AND SUPERVISION
SS.3 PRACTITIONER PRIVILEGES
SS.4 HISTORY AND PHYSICAL
SS.5 AVAILABLE EQUIPMENT
SS.6 OPERATING ROOM REGISTER
SS.7 POST-OPERATIVE CARE
SS.8 OPERATIVE REPORT
SS.9 IMMEDIATE POST-OPERATIVE NOTE
6.1, 6.2.1, 6.2.6
6.2.1, 6.2.2
5.5.1
4.2.4, 6.3, 6.4, 7.1, 7.2.3, 7.5.1, 7.5.2
6.3, 7.1, 7.5.1, 7.5.2. 7.5.3, 8.2.3, 8.2.4
5.5.3
7.2.1, 7.2.2, 7.5.1, 7.5.1
4.2.4
4.2.4
Sec. 482.52
Condition of
participation:
Anesthesia
services.
ANESTHESIA SERVICES (AS)
AS.1 ORGANIZATION
AS.2 ADMINISTRATION
AS.3 POLICIES AND PROCEDURES
5.5.1, 6.1, 6.2.1, 6.2.2
6.2.2, 7.1, 7.2.1, 7.5.1, 7.5.2
4.2.3, 4.2.4, 7.1, 7.2.1, 7.5.1
See Handout Document - Crosswalk
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17 July 2015
Slide 59
Structure of the 9001 Standard

Clause 1 – Scope

Clause 2 – Normative Reference

Clause 3 – Terms and Definitions

Clause 4 – Quality Management System

Clause 5 – Management Responsibility

Clause 6 – Resource Management

Clause 7 – Service Realization

Clause 8 – Measurement, Analysis, and Improvement
© Det Norske Veritas AS. All rights reserved
17 July 2015
Slide 60
4 Quality Management System
4.1
General

Documented, implemented quality management system

processes need for the QMS

sequence and interaction of processes

methods to ensure operation and control of processes

availability of resources and information

monitor, measure and analyze processes

implement actions to achieve planned results
© Det Norske Veritas AS. All rights reserved
17 July 2015
Slide 61
4.2 Documentation Requirements
4.2.1 General

quality policy, quality objectives, quality manual, documented procedures,
documents needed by the organization (P/P), records
4.2.2 Quality Manual

scope of the QMS

documented procedures for QMS

description of interaction of the processes
© Det Norske Veritas AS. All rights reserved
17 July 2015
Slide 62
4.2.3 Control of Documents *

approval prior to use

review and update as necessary

changes and current revisions are identified

relevant versions applicable at point of use

legible and readily identifiable

documents of external origin

prevention of unintended use of obsolete documents
© Det Norske Veritas AS. All rights reserved
17 July 2015
Slide 63
4.2.4 Control of Records *

documented procedure

legible, identifiable and retrievable

storage, protection, retrieval, retention and disposition of records
© Det Norske Veritas AS. All rights reserved
17 July 2015
Slide 64
5 Management Responsibility
5.1
Management Commitment

effectiveness of communication throughout the organization

establishing the quality policy

ensuring quality objectives are established

conducting management reviews

ensuring availability of resources
5.2 Customer Focus

ensure customer requirements are met
© Det Norske Veritas AS. All rights reserved
17 July 2015
Slide 65
5.3 Quality Policy

appropriate to the organization

commitment to comply with requirements and continually improve the
QMS

provide framework for establishing and reviewing quality objectives

communicated and understood

reviewed for continuing suitability
© Det Norske Veritas AS. All rights reserved
17 July 2015
Slide 66
5.4 Planning
5.4.1 Quality Objectives

objectives are established at relevant functions and levels within the
organization

measurable and consistent with the quality policy
5.4.2 Quality management system planning

planning of the QMS is carried out

integrity of the QMS is maintained when changes are implemented
© Det Norske Veritas AS. All rights reserved
17 July 2015
Slide 67
5.5
Responsibility, authority, and
communication
5.5.1 Responsibility and authority

responsibilities and authorities are defined and communicated within the
organization
5.5.2 Management representative

appointed by top management

ensure processes needed for QMS are established, implemented and maintained

reporting to top management on performance of the QMS

ensure promotion and awareness of customer requirements
5.5.3 Internal communication

appropriate communication channels are established re: the QMS and other
issues
© Det Norske Veritas AS. All rights reserved
17 July 2015
Slide 68
5.6 Management Review
5.6.1 General

top management review of the QMS

conducted at planned intervals

review of opportunities for improvement for changes to the QMS,
including the quality policy and quality objectives
© Det Norske Veritas AS. All rights reserved
17 July 2015
Slide 69
5.6 Management Review
5.6.2 Review input

results of audits

customer feedback

process performance and conformance

status of preventive and corrective actions

follow-up from previous management review

changes affecting the QMS

recommendations for improvement
5.6.3 Review output

improvement of the effectiveness of the QMS

improvement of services related to customer requirements

resource needs
© Det Norske Veritas AS. All rights reserved
17 July 2015
Slide 70
6 Resource Management
6.1 Provision of Resources

determine and provide resources needed

implement and maintain the QMS and continually improve its
effectiveness

enhance customer satisfaction by meeting customer requirements
© Det Norske Veritas AS. All rights reserved
17 July 2015
Slide 71
6.2 Human Resources
6.2.1 General

Personnel shall be competent on the basis of appropriate education,
training, skills, and experience
6.2.2 Competence, awareness, and training

determine the necessary competence for personnel

provide training or take other actions to satisfy these needs

evaluate effectiveness of actions taken

ensure personnel are aware of the relevance and importance of their
activities and how they contribute to the quality objectives

maintain appropriate records of their education, training, skills, and
experience
© Det Norske Veritas AS. All rights reserved
17 July 2015
Slide 72
6.3 Infrastructure / 6.4 Work Environment
6.3 Infrastructure

determine need, provide and maintain the infrastructure to achieve
conformity to service requirements

buildings, workspace and associated utilities

process equipments (both hardware and software)

supporting services (such as transport and communication)
6.4 Work Environment

determine and manage the work environment to achieve conformity to
service requirements
© Det Norske Veritas AS. All rights reserved
17 July 2015
Slide 73
7
Product (Service) Realization
7.1 Planning of Product (Service) Realization

plan and develop processes needed for service realization

determine quality objectives and requirements

need to establish processes, documents and provides resources

required verification, validation, monitoring, inspection and test activities

records needed to provide evidence
© Det Norske Veritas AS. All rights reserved
17 July 2015
Slide 74
7.2 Customer-Related Processes

7.2.1 Determination of requirements related to product (service)

requirements specified by the customer

requirements not stated by the customer but necessary for specified or
intended use

statutory and regulatory requirements

any additional requirements determined by the organization
7.2.2 Review of requirements related to product (service)

define product (service) requirements

contract or order requirements differing from those previously expressed
are resolved

organization has the ability to meet requirements
© Det Norske Veritas AS. All rights reserved
17 July 2015
Slide 75
7.2.3 Customer communication

determine and implement effective arrangements for communicating with
customers on

product (service) information

enquiries, contracts or order handling, including amendments

customer feedback, including complaints
© Det Norske Veritas AS. All rights reserved
17 July 2015
Slide 76
7.3 Design and Development
7.3.1 Design and development planning

plan and control design

design and development stages

review, verification and validation are appropriate

responsibilities and authorities for design and development
7.3.2 Design and development inputs

functional and performance requirements

applicable statutory and regulatory requirements

information derived from previous designs

other requirements essential to design
© Det Norske Veritas AS. All rights reserved
17 July 2015
Slide 77
7.3 Design and Development
7.3.3 Design and development outputs

meet the input requirements for design and development

provide appropriate information for purchasing, production and service
provision

contain or reference product acceptance criteria

specify the characteristics of the product essential for safe use
© Det Norske Veritas AS. All rights reserved
17 July 2015
Slide 78
7.3 Design and Development
7.3.4 Design and development review

evaluate the ability of the results of design and development to meet
requirements

identify any problems and propose necessary actions
7.3.5 Design and development verification

to ensure that the design and development outputs have met the design
and development inputs
© Det Norske Veritas AS. All rights reserved
17 July 2015
Slide 79
7.3 Design and Development
7.3.5 Design and development verification

to ensure that the design and development outputs have met the design
and development inputs
7.3.6 Design and development validation

ensure the resulting product (service) is capable of meeting the
requirements for the specified application or intended use

validation shall be completed prior to delivery where practicable
7.3.7 Control of design and development changes

changes shall be reviewed, verified and validated, as appropriate and
approved before implementation
© Det Norske Veritas AS. All rights reserved
17 July 2015
Slide 80
7.4 Purchasing
7.4.1 Purchasing process

ensure that purchased product (service) conforms to specified purchase
requirements

evaluation and selection of suppliers based upon their ability to supply
product (service) in accordance with the organization’s requirements

criteria for selection, evaluation and re-evaluation shall be established
7.4.2 Purchasing information

requirements for approval of product, procedures, processes, and
equipment

requirements for qualification of personnel

QMS requirements
© Det Norske Veritas AS. All rights reserved
17 July 2015
Slide 81
7.4 Purchasing
7.4.3 Verification of purchased product

Establish and implement the inspection and other activities necessary for
ensuring that the purchased product (service) meets the specified
purchase requirements
© Det Norske Veritas AS. All rights reserved
17 July 2015
Slide 82
7.5 Production and service provision
7.5.1 Control of production and service provision

Planning and carrying out production and service provision under these
controlled conditions

Availability of information that describes the characteristics of the product
(service)

Availability of work instructions, as necessary

Use of suitable equipment

Availability and use of monitoring and measuring devices

Implementation of monitoring and measurement

Implementation of release, delivery and post-delivery activities
© Det Norske Veritas AS. All rights reserved
17 July 2015
Slide 83
7.5 Production and service provision
7.5.2 Validation of processes for production and service provision

Validation shall demonstrate the ability of these processes to achieve
planned results by the established arrangements including

Defined criteria for review and approval of these processes

Approval of equipment and qualification of personnel

Use of specific methods and procedures

Requirements for records

Revalidation
© Det Norske Veritas AS. All rights reserved
17 July 2015
Slide 84
7.5 Production and service provision
7.5.3 Identification and traceability

Identify the product status with respect to monitoring and measurement
requirements

Control and record the unique identification of the product
© Det Norske Veritas AS. All rights reserved
17 July 2015
Slide 85
7.5 Production and service provision
7.5.4 Customer property

Identify, verify, protect and safeguard customer property provided for use
or incorporation into the product (service)

Lost, damaged or otherwise found to be unsuitable for use – shall be
reported to the customer and records maintained
7.5.5 Preservation of product

Preserve the conformity of product during internal processing and
delivery to the intended destination

This includes identification, handling, packaging, storage and protection
© Det Norske Veritas AS. All rights reserved
17 July 2015
Slide 86
7.6 Control of monitoring and measuring
devices

Be calibrated or verified at specified intervals against measurement
standards traceable to international or national measurement standards

Be adjusted or re-adjusted as necessary

Be identified to enable the calibration status to be determined

Be safeguarded from adjustments that would invalidate the measurement
result

Be protected from damage and deterioration during handling,
maintenance and storage
© Det Norske Veritas AS. All rights reserved
17 July 2015
Slide 87
8
Measurement, analysis and
improvement
8.1 General

Plan, monitor and implement the monitoring, measurement and analysis
and improvement processes needed to

Demonstrate conformity of the product

Ensure conformity of the QMS

Continually improve the effectiveness of the QMS
8.2 Monitoring and Measurement
8.2.1 Customer satisfaction

Organization shall monitor information relating to customer perception as
to whether the organization has met customer requirements
© Det Norske Veritas AS. All rights reserved
17 July 2015
Slide 88
8.2 Monitoring and Measurement
8.2.2 Internal audit *

Organization shall conduct internal audits at planned intervals to
determine whether the QMS

Conforms to the planned arrangements to the requirements of the
International standard and to the QMS requirements of the organization

Is effectively planned and implemented
© Det Norske Veritas AS. All rights reserved
17 July 2015
Slide 89
8.2 Monitoring and Measurement
8.2.3 Monitoring and measurement of processes

Organization shall apply suitable methods for monitoring and, where
applicable, measurement of the QMS processes.

Take corrective action when planned results are not achieved
8.2.4 Monitoring and measurement of product (service)

Organization shall monitor and measure the characteristics of the product
(service) to verify that product (service) requirements have been met
© Det Norske Veritas AS. All rights reserved
17 July 2015
Slide 90
8.3 Control of nonconforming product *

Organization shall deal with nonconforming product (service) by one or
more of the following ways

By taking action to eliminate the detected nonconformity

By authorizing its use, release or acceptance under concession by a
relevant authority and, where applicable, by the customer

By taking action to preclude its original intended use or application
© Det Norske Veritas AS. All rights reserved
17 July 2015
Slide 91
8.4 Analysis of data

Analysis of data shall provide information relating to

Customer satisfaction

Conformity to product requirements

Characteristics and trends of processes and products including
opportunities for preventive action and

Suppliers
© Det Norske Veritas AS. All rights reserved
17 July 2015
Slide 92
8.5 Improvement
8.5.1 Continual improvement

Organization shall continually improve the effectiveness of the QMS
through the use of the quality policy, quality objectives, audit results,
analysis of data, corrective and preventive actions and management
review
© Det Norske Veritas AS. All rights reserved
17 July 2015
Slide 93
8.5 Improvement
8.5.2 Corrective Action *

Documented procedure to define requirements for

Reviewing nonconformities (including complaints)

Determining causes of nonconformities

Evaluating need for action to ensure that nonconformities do not recur

Determining and implementing action needed

Records of results of the action taken (see 4.2.4)

Reviewing corrective action taken
© Det Norske Veritas AS. All rights reserved
17 July 2015
Slide 94
8.5 Improvement
8.5.3 Preventive Action *

Documented procedure to define requirements for

Determining potential nonconformities and their causes

Evaluating need for action to ensure prevent occurrence of
nonconformities

Determining and implementing action needed

Records of results of the action taken (see 4.2.4)

Reviewing preventive action taken
© Det Norske Veritas AS. All rights reserved
17 July 2015
Slide 95
Establishing the ISO QMS
Appointment of a Management Representative
• Responsibility and authority for all aspects of
implementation
• Selection of implementation team – comprised of
management and staff; establish budget; develop
written implementation plan
Selection of a Consultant and Registrar
• Consultant is not required – but can help to help
facilitate the implementation and education process
• Registrar is the Certification Body that is going to
conduct the audits and evaluate the organization
© Det Norske Veritas AS. All rights reserved
17 July 2015
Slide 96
Establishing the ISO QMS
Educate management and staff about the development of the
Quality Management System
• ISO 9001:2000 Requirements
• Documentation Requirements
• Identification and description of processes
Map the path of workflow and basic processes
• Identify key processes within the organization
• This can first be done at high-level (40,000 feet)
© Det Norske Veritas AS. All rights reserved
17 July 2015
Slide 97
Establishing the ISO QMS
Develop quality manual for the organization
• Outline of how the organization meets the
international standard (ISO 9001:2008)
Review and identify control mechanism for documents,
policies, procedures, work instructions, etc.
• How documents are controlled
• Prevention of use of obsolete documents
© Det Norske Veritas AS. All rights reserved
17 July 2015
Slide 98
Establishing the ISO QMS
Define the following for the organization
• Describe Document Control Program
• Records Management Program
• Training/Competency Assessment Program
• Process Control System (Analysis and evaluation)
• Equipment Management Program
• Purchasing and Inventory Control Program
• Nonconformance (Occurrence) Detection & Analysis
• Monitoring of Customer Satisfaction and Complaints
• Internal and External Auditing (assessment)
• Continuous Improvement (monitoring and measurement)
© Det Norske Veritas AS. All rights reserved
17 July 2015
Slide 99
Six Documented Procedures Are Required

Control of Documents

Control of Records

Internal Audit

Control of Non-Conforming Product

Corrective Action

Preventive Action
© Det Norske Veritas AS. All rights reserved
17 July 2015
Slide 100
Establishing the ISO QMS
Standardize format for internally created forms
• Numbering and identification process for each form
• Authorization process prior to use – and removal of obsolete
forms
• Education of staff – communication of current version
Establishing a records management program
• Retention period for records (onsite and offsite)
• Location of where records are stored (onsite and offsite)
• Indexing and Retrieval
© Det Norske Veritas AS. All rights reserved
17 July 2015
Slide 101
Establishing the ISO QMS
Educate staff regarding the Quality Management System
• Quality Policy
• Quality Objectives
• Process for Review (Audit)
• Quality Manual
Train a team of internal auditors
Establish at least one indicator or benchmark for each process
© Det Norske Veritas AS. All rights reserved
17 July 2015
Slide 102
Establishing the ISO QMS
Undergo a ISO 9001:2008 Pre-Assessment after the Quality
Management System has been implemented
• You may do this concurrently with the implementation
or wait until this is completed
Make corrections and adjustments to the quality
management system
• Based upon the findings from the pre-assessment
© Det Norske Veritas AS. All rights reserved
17 July 2015
Slide 103
Establishing the ISO QMS
Conduct an Internal Audit for the Organization to cover all
aspects of the organization
• Identify which issues need to be addressed through
corrective and preventive action
Hold at least one Management Review to discuss findings
from pre-assessment and internal audit(s)
Undergo the Certification Audit
© Det Norske Veritas AS. All rights reserved
17 July 2015
Slide 104
Benefits of ISO 9001

Provide a common framework for coordination and
communication between departments/units

Improve systems, processes, efficiency and effectiveness

Consistently meet patient’s stated and implied needs

Provide evidence of a safe environment for patients

Increase productivity and financial performance

Improve consistency

Increase patient satisfaction
© Det Norske Veritas AS. All rights reserved
17 July 2015
Slide 105
Sample Implementation Plan for ISO 9001
PROCESS
Undergo Pre-Assessment
Assign Management Representative
Identify Implementation Team
Educate Management and Staff
Map Organization Processes
* Document Procedure for Document Control
* Document Procedure for Control of Records
Define Management Responsibility
Validate Competence, Awareness and Training of Staff
Assess Infrastructure
Method for Evaluating & Planning of Service/ Product Realization Processes
Define Customer Related Processes
Create Mechanism for Design & Development (excluded unless a research hospital)
Create Purchasing Process (criteria & methods to evaluate vendors)
Create Mechanism for Control of Production and Service Provisions
Create Mechanism for Identification and Traceability (people, equipment, meds, etc.)
Create Mechanism for Protection of Customer Property
Create Mechanism to Ensure Preservation of Product (labs, meds, sterile field, etc)
Create Mechanism for Control of Monitoring and Measuring Devices
Create Mechanism for Monitoring, Measuring and Analysis of Processes & Outcomes
* Document Procedure for Conducting Internal Audits
* Document Procedure for Control of Nonconforming Service or Product
* Document Procedure for Developing Corrective Actions
* Document Procedure for Developing Preventive Actions
Train Internal Audit Team
Conduct Internal Audits
Conduct Management Review
Ready to Undergo Compliance / Certification Survey
1
2
3
Month
4
5
6
7
8
* The six required documented ISO 9001 procedures
© Det Norske Veritas AS. All rights reserved
17 July 2015
Slide 106
NIAHO℠ Accreditation
Process
Initial Inquiry/Information

Required information to prepare a quote is collected through the Inquiry
process and specifically by gathering all of the applicable information on
the formal DNVHC Application
- For new hospitals seeking accreditation: Application / Questionnaire
- For currently accredited hospitals: Application / Questionnaire (Annual Update)

An agreement is also provided and returned to proceed with the accreditation
survey
© Det Norske Veritas AS. All rights reserved
17 July 2015
Slide 108
Review of Application Information

Determination of surveyors and survey team members considers several
factors, most notably, this includes, but is not limited to, the following:
• Size of the facility to be surveyed, based on average daily census and number
of employees
• Complexity of services offered, including outpatient services
• Type of survey to be conducted
• Any off-site locations, ambulatory sites, physician’s offices, long term care,
home care, volume information at the various sites, etc;
© Det Norske Veritas AS. All rights reserved
17 July 2015
Slide 109
Survey Frequency

Surveys shall be planned at least annually

Surveys will be unannounced to the hospital
© Det Norske Veritas AS. All rights reserved
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Slide 110
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
© Det Norske Veritas AS. All rights reserved
17 July 2015
Slide 111
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.
© Det Norske Veritas AS. All rights reserved
17 July 2015
Slide 112
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
© Det Norske Veritas AS. All rights reserved
17 July 2015
Slide 113
Conducting Survey Activities
Survey activities are carried out through the means of the following:

A comprehensive review of care and services received by patients in the
sample will be part of the survey. A comprehensive review includes
observations 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)
- The Tracer methodology process may identify performance issues as
a result of reviewing an individual patient’s case, in one or more steps
in the process or perhaps the interfaces between steps that affect the
care of the patient/family as well as staff and organization
performance.
© Det Norske Veritas AS. All rights reserved
17 July 2015
Slide 114
Conducting Survey Activities
Gathering Information and Investigation

The surveyors will focus attention on actual and potential patient outcomes, as
well as required processes.

The surveyors will assess the care and services provided, including the
appropriateness of the care and services within the context of the Standards.

The surveyors will visit patient care settings, including inpatient units, outpatient
clinics, anesthetizing locations, emergency departments, imaging, rehabilitation,
remote locations, satellites, etc.

The surveyors will observe the actual provision of care and services to patients
and the effects of that care, in order to assess whether the care provided meets
the needs of the individual patient.
© Det Norske Veritas AS. All rights reserved
17 July 2015
Slide 115
Conducting Survey Activities

During the survey, the 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., that
are present that should not be present as well as those that are not present that
should be present;

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

Whether every organization department and activity reports to and receives
reports from the organization’s 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.
© Det Norske Veritas AS. All rights reserved
17 July 2015
Slide 116
Conducting Survey Activities
Documents reviewed by the survey team may be both written and electronic and include the
following:

Patient’s clinical records to validate information gained during the interviews

Plans of care and discharge plans, review of the pre-surgical assessment, informed consent,
operative report, and pre-, inter-, and post-operative anesthesia notes.

Closed medical records may be used to determine past practice, and the scope or frequency of a
deficient practice. Closed records should also be reviewed to provide information about services
that are not being provided by the hospital at the time of the survey. (For example, if there are no
obstetrical patients in the facility at the time of the survey, the surveyors will review closed OB
records to determine care practices, or to evaluate past activities that cannot be evaluated using
open records.)

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 according to the
number and acuity of patients (typically compared to Scopes of Service)

Policy and Procedure Manuals

Contracts, if applicable

Organization activities minutes as requested
© Det Norske Veritas AS. All rights reserved
17 July 2015
Slide 117
Conducting Survey Activities
Clinical Surveyor

Operational Review Activities
- Patient Care Unit Visits (Clinical Settings)
- Inpatient Med/Surg, ICU/CCU, Obstetrics, Emergency Department,
Surgical Services, etc. (Open Medical Records)
- Ancillary Services Review
- Medical Record Review (Closed Medical Record)
- Medical Record Review Form
Life Safety Specialist

Physical Environment aspects and review of documentation

Physical Environment / Life Safety Tour

Biomedical Engineering (Equipment)
© Det Norske Veritas AS. All rights reserved
17 July 2015
Slide 118
Conducting Survey Activities
Generalist Surveyor

Quality Management Review

Patient Grievance Process

Medication Management

Medical Staff Review

Utilization Review, Discharge Planning and Case Management

Ancillary Services Review (Laboratory, Medical Imaging, Rehab, etc.)

Off-Site Clinics and Other Settings (if applicable)

Human Resources

Dietary Services

Organ, Tissue and Eye Procurement

Other Operational Areas (Patient Registration, Purchasing, etc)
© Det Norske Veritas AS. All rights reserved
17 July 2015
Slide 119
Conducting Survey Activities
Example of a Survey Schedule (Agenda)
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Slide 121
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Slide 123
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.
© Det Norske Veritas AS. All rights reserved
17 July 2015
Slide 124
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.
© Det Norske Veritas AS. All rights reserved
17 July 2015
Slide 125
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.
© Det Norske Veritas AS. All rights reserved
17 July 2015
Slide 126
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.
© Det Norske Veritas AS. All rights reserved
17 July 2015
Slide 127
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)
© Det Norske Veritas AS. All rights reserved
17 July 2015
Slide 128
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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Slide 129
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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17 July 2015
Slide 130
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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17 July 2015
Slide 131
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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Slide 132
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
17 July 2015
Slide 133
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
17 July 2015
Slide 134
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
17 July 2015
Slide 135
© Det Norske Veritas AS. All rights reserved
17 July 2015
Slide 136
QMS Matures To Risk Management Approach In
Partnership with DNVHC
Risk Management
DNV Accreditation
NIAHO℠ Standard
Corrective and Preventive Actions
Best Practices
© Det Norske Veritas AS. All rights reserved
17 July 2015
 Monitor
and
review
 Record
the
process
Medication Delivery
Etc.
Internal Audits
 Treat
Clinical Care
ISO 9001
 Evaluate
Emergency Care
Management review
Aggregate hospital data
 Analyze
In/Out Patient Care
 Identify
Slide 137
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
17 July 2015
Slide 138