Download presentation
Presentation is loading. Please wait.
Published byLiani Hermawan Modified over 6 years ago
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
Similar presentations
© 2025 SlidePlayer.com Inc.
All rights reserved.