1. Aligning Accreditation and Quality – The DNV Perspective
The Maryland Association for Healthcare Quality
The corporate presentation is DNV’s common, standard presentation. It does not contain confidential information.
Please do not change the layout/design of the presentation, but feel free to cut slides that are not relevant, and add others that are relevant for your presentation.
DNV Healthcare
Rebecca Wise, Chief Operating Officer
Patrick Horine, Executive Vice President, Accreditation

2. 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
Here the key is on the fact that we are an independent self supporting tax-paying foundation that has been in the US since 1898
© Det Norske Veritas AS. All rights reserved
19 September 2018

3. Safeguarding life, property and the environment The DNV Purpose
SUSTAINABLE 1 able to continue over a period of time: 2 causing little or no damage to the environment and therefore able to continue for a long time:
The expression SUSTAINABLE DEVELOPMENT was first used by former Norwegian Prime Minister GRO HARLEM BRUNDTLAND in Brundtland’s definintion of sustainable development is:
Sustainable development is development that meets the needs of the present without compromising the needs of future generations to meet their own needs.
SEE ALSO:
© Det Norske Veritas AS. All rights reserved
19 September 2018

4. Global impact for a safe and sustainable future The DNV Vision
SUSTAINABLE 1 able to continue over a period of time: 2 causing little or no damage to the environment and therefore able to continue for a long time:
The expression SUSTAINABLE DEVELOPMENT was first used by former Norwegian Prime Minister GRO HARLEM BRUNDTLAND in Brundtland’s definintion of sustainable development is:
Sustainable development is development that meets the needs of the present without compromising the needs of future generations to meet their own needs.
SEE ALSO:
© Det Norske Veritas AS. All rights reserved
19 September 2018

5. DNV Values We build trust and confidence We never compromise
on quality or integrity
We are committed to
teamwork and innovation
We care for our customers
and each other
© Det Norske Veritas AS. All rights reserved
19 September 2018

6. 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
The new risk reality is a statement that illustrates the increased complexity of society.
Picture 1: (Prestige sinking) Extreme environmental focus. Compliance, or lack of compliance? A symbol of a shipping accident.
Picture 2: (Enron USA) Expectations on ethical standards in business. Demonstrates consequences of poor ethics. A symbol of corporate failure.
Picture 3: (microphones) Requirements on transparency from media and non-governmental organisations (NGO) on the rise.
Picture 4: (security guard) Illustrating increasing security needs in the world – which is a part of the new risk reality.
© Det Norske Veritas AS. All rights reserved
19 September 2018

7. DNV Main Industries Maritime Health Care IT & Telecom Finance
Automotive
Food & Beverage
Transport
Energy
© Det Norske Veritas AS. All rights reserved
19 September 2018

8. 300 offices in 100 countries Head office Local offices
DNV has about 7000 employees in close to 300 offices in about 100 countries. These are approximate figures for DNV in November At present the growth is quite high, and the number of employees is probably even higher, but the numbers will be updated once or perhaps twice a year to avoid confusion.
Background.
The historical growth of DNV followed the coastline, then gradually expanded.
Head office
Local offices
© Det Norske Veritas AS. All rights reserved
19 September 2018

9. 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
© Det Norske Veritas AS. All rights reserved
19 September 2018

10. NIAHOSM and ISO 9001 Quality Management System
DNV Healthcare Inc.
NIAHOSM and ISO 9001 Quality Management System
Hospital Accreditation: Integration of NIAHO℠ Standards with ISO 9001 Quality Management System Standards

11. 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)
© Det Norske Veritas AS. All rights reserved
19 September 2018

12. 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
© Det Norske Veritas AS. All rights reserved
19 September 2018

13. 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
© Det Norske Veritas AS. All rights reserved
19 September 2018

14. Introduction of an Accreditation Alternative
Ensuring that Quality and Patient Safety is Managed,
Not Just Measured!!
At TÜV America through TÜV Healthcare Specialists – we have created an accreditation model that will hold hospitals accountable for creating and sustaining a quality management system that will also meet the requirements for participation in the Medicare and Medicaid Program.
© Det Norske Veritas AS. All rights reserved
19 September 2018

15. ISO 9001 as part of NIAHO℠ Accreditation Requirements

16. 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
© Det Norske Veritas AS. All rights reserved
19 September 2018

17. 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
In an effort to create a more accountable accreditation model for hospitals, ISO 9001 is the foundation for NIAHO
© Det Norske Veritas AS. All rights reserved
19 September 2018

18. © Det Norske Veritas AS. All rights reserved
19 September 2018

19. CUSTOMER 4.0 Quality Management System 5.0 Management responsibility
4.1
4.2
4.1 General
4.1.f Continual Improvement*
4.2 Document requirements
4.2.2 Quality Manual Justification & process flow diagram*
4.2.3 Documentation
4.2.4 Records
5.1
5.2
5.3
5.4
5.5
5.6
5.0 Management responsibility
CUSTOMER
8.1
8.2
8.3
8.4
8.5
8.0 Measurement, analysis and improvement
CUSTOMER
6.1
6.2
6.3
6.4
6.0 Resource management
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
8.1 General
8.2 Monitor & measure
8.2.1 Customer Satisfaction*
8.2.2 Internal audit
8.2.3 Processes*
8.2.4 Product
8.3 Nonconforming product
8.4 Analysis of data *
8.5 Improvement
8.5.1 Continual*
8.5.2 Corrective
8.5.3 Preventive
6.1 Resources
6.2 Human Resources
6.3 Infrastructure
6.4 Work environment
Emphasize that the red “clauses” are those who are most crucial to the continual improvement, and that when we are viewing hospitals adherence to CoP, we ensure hospitals employs the generic structure specified in ISO 9001.
7.0 Product realization
7.1
7.2
7.3
7.5
7.4
7.6
INPUT
OUTPUT
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
© Det Norske Veritas AS. All rights reserved

20. Some Examples of Hospital Processes
Inpatient Care
Outpatient Care
Ambulatory Surgery
Emergency Care
Critical Care Delivery
Medication Delivery
Transfusion and Blood Product Administration
© Det Norske Veritas AS. All rights reserved
19 September 2018

21. 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
© Det Norske Veritas AS. All rights reserved
19 September 2018

22. © Det Norske Veritas AS. All rights reserved
19 September 2018

23. © Det Norske Veritas AS. All rights reserved
19 September 2018

24. Process Map Example © Det Norske Veritas AS. All rights reserved
19 September 2018

25. Process Mapping Pre-Admission 25 Referral
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
Process Mapping
Referral
Organizational Structure Management & Support
Pre-Admission
Review of Service Capabilities
5.2 Customer Focus
7.2 Customer Related Processes
Resources Staff & Equipment ( Including Training)
5.2 Customer Focus
5.4 Planning
7.2 Customer Related Processes
6.2 Human Resources
6.3 Infrastructure
6.4 Work Environment
Admission (Assessment / Diagnosis)
Support Services (Dietary, Housekeeping, Buildings & Grounds)
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
Performance Monitoring & Review
Delivery of Care
Service
Improvement
7.1 Planning & Service Realization
7.4.3 Verification of Purchased Product
7.5.1 Control of Product & Service Provision
8. Measurement, Analysis &Improvement
On-going Monitoring and Measurement
External Input:
DOH
CMS (COPs)
HFAP
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
4.2.4 Control of Records
8.2.1 Customer Satisfaction
© Det Norske Veritas AS. All rights reserved
19 September 2018 25

26. Hospital Sequence and Interaction of Processes
© Det Norske Veritas AS. All rights reserved
19 September 2018

27. 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
© Det Norske Veritas AS. All rights reserved
19 September 2018

28. Crosswalk CoP – NIAHO℠ - ISO 9001
Sec Condition of participation: Compliance with Federal, State and local laws.
GOVERNING BODY (GB)
GB.1 LEGAL RESPONSIBILITY
5.1, 5.5.1, 5.5.2
Sec Condition of participation: Governing body.
GB.1 LEGAL RESPONSIBILITY
MEDICAL STAFF (MS)
MS.2 ELIGIBILITY
MS.7 MEDICAL STAFF BYLAWS
MS.3 ACCOUNTABILITY
MS.8 APPOINTMENT
MS.11 GOVERNING BODY ROLE
CHIEF EXECUTIVE OFFICER (CE)
CE.1 QUALIFICATIONS
MS.15 ADMISSION REQUIREMENTS
GB.2 INSTITUTIONAL PLAN AND BUDGET
GB.3 CONTRACTED SERVICES
EMERGENCY DEPARTMENT (ED)
ED.3 EMERGENCY SERVICES NOT PROVIDED
ED.4 OFF-CAMPUS DEPARTMENTS
5.5.1, 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
6.2.1, 6.2.2
5.4, 6.1
7.4.1, 7.4.2, 7.4.3
7.5.1, 7.5.2, 8.2.3
5.5.1, 6.2.1, 6.2.2, 6.3
See Handout Document - Crosswalk
© Det Norske Veritas AS. All rights reserved
19 September 2018

29. NIAHO℠ Accreditation Requirements

30. 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
© Det Norske Veritas AS. All rights reserved
19 September 2018

31. 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.
© Det Norske Veritas AS. All rights reserved
19 September 2018

32. 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.
© Det Norske Veritas AS. All rights reserved
19 September 2018

33. Governing Body (GB) GB.1 Legal Responsibility
GB.2 Institutional Plan and Budget
GB.3 Contracted Services
© Det Norske Veritas AS. All rights reserved
19 September 2018

34. Chief Executive Officer (CE)
CE.1 Qualifications
CE.2 Responsibilities
© Det Norske Veritas AS. All rights reserved
19 September 2018

35. 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
© Det Norske Veritas AS. All rights reserved
19 September 2018

36. 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
© Det Norske Veritas AS. All rights reserved
19 September 2018

37. Nursing Services (NS) NS.1 Nursing Service NS.2 Nurse Executive
NS.3 Plan of Care
© Det Norske Veritas AS. All rights reserved
19 September 2018

38. 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
© Det Norske Veritas AS. All rights reserved
19 September 2018

39. 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
© Det Norske Veritas AS. All rights reserved
19 September 2018

40. 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
© Det Norske Veritas AS. All rights reserved
19 September 2018

41. Anesthesia Services (AS)
AS.1 Organization
AS.2 Administration
AS.3 Policies and Procedures
© Det Norske Veritas AS. All rights reserved
19 September 2018

42. Laboratory Services (LS)
LS.1 Organization
LS.2 Infectious Blood and Products
LS.3 Patient Notification
LS.4 General Blood Safety
© Det Norske Veritas AS. All rights reserved
19 September 2018

43. Respiratory Care Services (RC)
RC.1 Organization
RC.2 Physician Order
RC.3 Policies or Protocols
RC.4 Tests Outside the Lab
© Det Norske Veritas AS. All rights reserved
19 September 2018

44. 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
© Det Norske Veritas AS. All rights reserved
19 September 2018

45. Nuclear Medicine Services
NM.1 Organization
NM.2 Radioactive Materials
NM.3 Equipment and Supplies
NM.4 Interpretation
© Det Norske Veritas AS. All rights reserved
19 September 2018

46. Rehabilitation Services (RS)
RS.1 Organization
RS.2 Management and Support
RS.3 Treatment Plan
© Det Norske Veritas AS. All rights reserved
19 September 2018

47. Obstetric Services (OB)
OB.1 Compliance
OB.2 Anesthesia Services
© Det Norske Veritas AS. All rights reserved
19 September 2018

48. Emergency Department (ED)
ED.1 Organization
ED.2 Staffing
ED.3 Emergency Services Not Provided
ED.4 Off-Campus Departments
© Det Norske Veritas AS. All rights reserved
19 September 2018

49. Outpatient Services (OS)
OS.1 Organization
OS.2 Staffing
OS.3 Scope of Service
© Det Norske Veritas AS. All rights reserved
19 September 2018

50. Dietary Services (DS) DS.1 Organization DS.2 Services and Diets
DS.3 Diet Manual
© Det Norske Veritas AS. All rights reserved
19 September 2018

51. 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
© Det Norske Veritas AS. All rights reserved
19 September 2018

52. Infection Control (IC)
IC.1 Infection Control System
© Det Norske Veritas AS. All rights reserved
19 September 2018

53. 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
© Det Norske Veritas AS. All rights reserved
19 September 2018

54. Discharge Planning (DC)
DC.1 Written Policies
DC.2 Discharge Planning Evaluation
DC.3 Plan Implementation
DC.4 Evaluation
© Det Norske Veritas AS. All rights reserved
19 September 2018

55. Utilization Review (UR)
UR.1 Documented Plan
UR.2 Sampling
UR.3 Medical Necessity Determination
UR.4 Extended Stay Review
© Det Norske Veritas AS. All rights reserved
19 September 2018

56. 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
© Det Norske Veritas AS. All rights reserved
19 September 2018

57. 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
© Det Norske Veritas AS. All rights reserved
19 September 2018

58. ISO 9001:2008 Quality Management System Requirements

59. Crosswalk CoP – NIAHO℠ - ISO 9001
Sec 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, , 8.2.3, 8.2.4
5.5.3
7.2.1, 7.2.2, 7.5.1, 7.5.1
4.2.4
Sec 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
© Det Norske Veritas AS. All rights reserved
19 September 2018

60. 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
19 September 2018

61. 4 Quality Management System
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
19 September 2018

62. 4.2 Documentation Requirements
4.2.1 General
quality policy, quality objectives, quality manual, documented procedures, documents needed by the organization (P/P), records
Quality Manual
scope of the QMS
documented procedures for QMS
description of interaction of the processes
© Det Norske Veritas AS. All rights reserved
19 September 2018

63. 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
19 September 2018

64. 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
19 September 2018

65. 5 Management Responsibility
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
19 September 2018

66. 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
19 September 2018

67. 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
19 September 2018

68. 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
19 September 2018

69. 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
19 September 2018

70. 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
19 September 2018

71. 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
19 September 2018

72. 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
19 September 2018

73. 6.3 Infrastructure / 6.4 Work Environment
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
19 September 2018

74. 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
19 September 2018

75. 7.2 Customer-Related Processes
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
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
19 September 2018

76. 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
19 September 2018

77. 7.3 Design and Development
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
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
19 September 2018

78. 7.3 Design and Development
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
19 September 2018

79. 7.3 Design and Development
Design and development review
evaluate the ability of the results of design and development to meet requirements
identify any problems and propose necessary actions
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
19 September 2018

80. 7.3 Design and Development
Design and development verification
to ensure that the design and development outputs have met the design and development inputs
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
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
19 September 2018

81. 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
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
19 September 2018

82. 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
19 September 2018

83. 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
19 September 2018

84. 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
19 September 2018

85. 7.5 Production and service provision
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
19 September 2018

86. 7.5 Production and service provision
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
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
19 September 2018

87. 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
19 September 2018

88. 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
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
19 September 2018

89. 8.2 Monitoring and Measurement
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
19 September 2018

90. 8.2 Monitoring and Measurement
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
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
19 September 2018

91. 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
19 September 2018

92. 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
19 September 2018

93. 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
19 September 2018

94. 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
19 September 2018

95. 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
19 September 2018

96. 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
19 September 2018

97. 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
19 September 2018

98. 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
19 September 2018

99. 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
19 September 2018

100. 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
19 September 2018

101. 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
19 September 2018

102. 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
19 September 2018

103. 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
19 September 2018

104. 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
19 September 2018

105. 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
19 September 2018

106. Sample Implementation Plan for ISO 9001
* The six required documented ISO 9001 procedures
© Det Norske Veritas AS. All rights reserved
19 September 2018

107. NIAHO℠ Accreditation Process

108. 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
19 September 2018

109. 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
19 September 2018

110. Survey Frequency Surveys shall be planned at least annually
Surveys will be unannounced to the hospital
© Det Norske Veritas AS. All rights reserved
19 September 2018

111. 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
19 September 2018

112. 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
19 September 2018

113. 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
19 September 2018

114. 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
19 September 2018

115. 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
19 September 2018

116. 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
19 September 2018

117. 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
19 September 2018

118. 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
19 September 2018

119. 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
19 September 2018

120. Conducting Survey Activities
Example of a Survey Schedule (Agenda)
© Det Norske Veritas AS. All rights reserved
19 September 2018

121. © Det Norske Veritas AS. All rights reserved
19 September 2018

122. © Det Norske Veritas AS. All rights reserved
19 September 2018

123. © Det Norske Veritas AS. All rights reserved
19 September 2018

124. 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
19 September 2018

125. 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
19 September 2018

126. Nonconformities Handling
Classification of Findings The surveyor shall categorize the findings to:
Nonconformity (NC)- (Category 1)
Objective evidence exists that a requirement has not been addressed (intent), a practice differs from the defined system (implementation), or the system is not effective (effectiveness).
The absence of one or more required system elements or a situation which raises significant doubt that the services will meet specified requirements.
A group of category 2 non-conformities indicating inadequate implementation or effectiveness of the system relevant to requirement of the standard.
A category 2 non-conformity that is persistent (or not corrected as agreed by the customer) shall be up-graded to category 1, OR a situation, that, on the basis of available objective evidence, would have the capability to cause patient harm or does not meet a standard of care.
Condition Level Finding- A Condition Level Finding is a Category 1 Nonconformity in which the customer is determined to be completely or substantially out of compliance with the standard. Such finding is made on a case-by-case basis in DNV Healthcare Inc.’s sole discretion. A Condition Level Finding will be identified as a Category 1 Nonconformity- Condition Level Finding. All Condition Level Findings will require a follow-up survey prior to the next annual survey.
© Det Norske Veritas AS. All rights reserved
19 September 2018

127. 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
19 September 2018

128. 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
19 September 2018

129. © Det Norske Veritas AS. All rights reserved
19 September 2018

130. 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
© Det Norske Veritas AS. All rights reserved
19 September 2018

131. 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.
© Det Norske Veritas AS. All rights reserved
19 September 2018

132. 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.
© Det Norske Veritas AS. All rights reserved
19 September 2018

133. 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, ed 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)
© Det Norske Veritas AS. All rights reserved
19 September 2018

134. 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
19 September 2018

135. 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
19 September 2018

136. © Det Norske Veritas AS. All rights reserved
19 September 2018

137. QMS Matures To Risk Management Approach In Partnership with DNVHC
DNV Accreditation
Risk Management
NIAHO℠ Standard
Identify
Analyze
Evaluate
Treat
Monitor and review
Record the process
In/Out Patient Care
Emergency Care
Medication Delivery
ISO 9001
Management review
Clinical Care
Internal Audits
Aggregate hospital data
Etc.
Corrective and Preventive Actions
This model is the vision for the second phase (recognizing DNV as a Risk Management partner in Accreditation of Hospitals.
Once a hospital is accredited by DNV and makes it sustainable by adopting ISO 9001 compliance, the next steps (already utilized in the UK NHSLA contract) is to evaluate it against a risk management model that is applied to the various hospital process and based on that, a rating is assigned to the hospital. For example, in England, the rating is on a 0-3 scale where a hospital that gets a 3 is awarde3d a 30% reduction on insurance poremium, 2 = 20%, 1 = 10% and 0 = 0% (with more frequent surveys). This is beginning to gain interest of US healthcare insurance companies. However, in the US it would require a collection of more aggregate data from hospital, which now is possible through the advent of the PSO (Patient Safety Organizations) concept where data is collected by these PSOs and elevated to a national level. The success of this concept depends on the success and acceptance of PSO data.
Once DNV establishes itself in Risk Management services to hospitals, we envision our participation in steering quality and patient safety and as we gain experience and momentum, we would increase also our own advisory members that would particpate in setting best practices, with that, it is entirely plausible to reach a point where we develop a universal “Rules” for Healthcare Risk management that would gain the recognition of all the relevant stakeholders, and facilitate an “incentive” system (in the form of insurance discounts) to those who adopt it.
Best Practices
© Det Norske Veritas AS. All rights reserved
19 September 2018

138. www.dnvaccreditation.com Yehuda Dror, President Yehuda.Dror@dnv.com
Rebecca (Becky) Wise, COO
Patrick (Pat) Horine, EVP
Darrel Scott, SVP
© Det Norske Veritas AS. All rights reserved
19 September 2018