Louise Prince MD, FACEP Chief Quality Officer September 11, 2012

DNV, NIAHO, ISO Why Do I Care?

Det Norske Veritas (DNV) • Originally a non governmental organization that

establishes and maintains technical standards for the construction and operation of ships and offshore structures. Also validates to ensure compliance with standards.

• Organized with the objective to “safeguard life, property

and the environment” • Ultimately a provider for the services of managing risk

The DNV

• Received CMS deeming authority to survey health care organizations utilizing the Medicare Conditions of Participation.

• Ultimately exceeds Medicare accreditation due to ISO 9001 standards.

• Slightly over 300 hospitals in the US have chosen DNV. • Only health care accreditation body that includes both

CMS standards and ISO 9001.

JCAHO, Healthcare Accreditation Facilities Program (HFAP), State Department of Health and direct CMS survey are all other options for acquiring deemed status from CMS.

The DNV in Health Care

• Annual surveys- adds accountability. • Not as prescriptive as to “how” to meet each requirement: We

determine the how and then need to perform in that manner. • Focus on interactions of processes. • Survey findings are reported in two categories

• Category 1 nonconformities: requires submission of an action plan within 10 days of receipt from final report and submission of performance measurement data to verify implementation of corrective action measure.

• Category 2 nonconformities: requires submission of an action plan within 10 days of receipt from final report and validation of effective implementation occurs at next annual survey.

What is this survey process?

AUDIT CYCLE FOCUS Initial survey Accreditation following NIAHO (2010) standards Year One NIAHO Surveillance (2011) ISO 9001 Readiness survey Year Two NIAHO Surveillance (2012) ISO 9001 Stage One Year Three NIAHO Recertification (2013) ISO 9001 Stage Two (full ISO

certification audit)

Survey Process

• National Integrated Accreditation for Healthcare Organizations standards (NIAHO).

• NIAHO is a combination of Center for Medicare and Medicaid Services Conditions of Participation (CoP’s) and ISO 9001 requirements.

• ISO 9001 requirements include a Quality Management System which consists of five main categories:

• Documentation • Management Responsibility (customer/patient focus,

planning) • Resource Requirements (Human Resources,

infrastructure, work environment) • Service Realization (Admit, Treat and Discharge) • Measuring and Monitoring (internal audits,

customer/patient satisfaction, corrective and preventive action, continual improvement)

NIAHO

Each of the previous categories is further subdivided

Quality Management System Governing Body Medical Staff Nuclear Medicine Services Nursing Services Rehabilitation Services Staff Management Obstetric Services Medication Management Emergency Services Outpatient Services Patient Rights Chief Executive Officer Dietary Services Discharge Planning Anesthesia Services Utilization Review Infection Control Laboratory Services Medical Records Service Respiratory Care Services Surgical Services Medical Imaging Physical Environment Organ, Eye and Tissue Procurement

NIAHO Requirements (Standards)

• Created by the International Organization for Standardization (ISO) its objective is to set standards that meets the following objectives:

• Consistency of patient care • Customer (patient) satisfaction • Continual Improvement

• Seen throughout the world as the “must have” certification for quality-driven organizations.

• Less than 50 DNV accredited hospitals have achieved either

compliance or certification to ISO 9001. Many are just beginning the process. In Syracuse, Crouse, St. Joseph’s and Upstate are all DNV accredited and in varying stages of ISO certification.

ISO 9001:2008

• ISO helps health care to develop standardized processes. Examples: improved communication hand offs, revisions to policies to reflect best practice, detection of problem-prone issues and standardization of documents for patient care.

• The key is finding those things that work well and then making them our standardized processes.

• ISO supports the “continual” improvement model and therefore ensures that we improve our practices and maintain the improvement.

• ISO 9001 is a system that is the base (the foundation) for the 3

C’s: Consistent delivery of care, Customer (patient) satisfaction and Continual improvement (Plan, Do, Study, Act: We Plan our system, Do the implementation, Study the effectiveness, and Act if further corrections are needed)

How does ISO work in Health Care?

• The difference between “Continual Improvement” and “continuous improvement”? Continual improvement asks that you constantly raise the benchmark to improve (what we should strive to be); continuous improvement is when you focus your resources on the issue and it improves while you are focused and once you change your focus it deteriorates and you are continually restarting the process

• Quality Management System and 6 Required Procedures. These procedures are:

– Control of Documents – Control of Records – Internal Audits – Control of Nonconforming Product – Corrective Action – Preventive Action

ISO

• Purpose of the Quality Manual is to define how ISO 9001 fits in the organization (defines our scope and who we are)

• Includes the six required procedures • Describes the interaction between the processes of what

we do (admit-treat-discharge and all the supporting departments)

• Ours was developed in June 2012

Quality Manual

• A procedure (Policy) that establishes the level of control for all documents to ensure documents are periodically reviewed, approved prior to use, and available at points of use. This needs to include external documents and how they effect our processes (changes in state laws and regulations to practice)

• Examples of documents we would need to control are:

policies, procedures, protocols, forms, job descriptions, and competency checklists

Control of Documents

• A procedure (Policy) that ensures that records (a document that is filled in and shows history) are stored, retained, protected and destroyed when appropriate.

Examples would be: Medical records, temperature logs for refrigerators, crash cart logs, any document that is completed to provide us information of what happened.

Control of Records

• Audits come in three types: Internal (auditing our process), supplies and patients (auditing satisfaction), and external (audits by regulatory bodies for compliance)

• Five required Audits:

– Environment of care – Clinical (our core business, treating patients) – Infection Control – ISO 9001 audits (the quality management system) – Utilization Review

• Internal audits are performed by individuals who have no

responsibility for the area/process being audited to ensure impartiality. There will be a schedule of areas to be audited and recurrent time frames.

Internal Audits

• A procedure (policy) that addresses our practice when a product or service does not meet the intended original requirements

Examples: Out of date supplies or medications, equipment not functioning as required, wrong site surgeries or procedures and patient complaints

Control of Nonconforming Product

• A procedure (policy) that defines if data/results fall below the established benchmark, then the organization would establish a corrective action.

• A correction is a quick fix to a specific action • A corrective action includes a root cause analysis were the

organization investigates the “why “ of the problem/issue to prevent it from re occurring

• When the organization takes a corrective action they must always adhere to the following

• Review the identified problem (including customer complaints) • Determine the cause • Evaluate the need for action to prevent a re occurrence • Determine and implement the action needed • Record the results of the action • Review the effectiveness of the corrective action

Corrective Action

• A procedure (policy) that addresses if data reveals a negative trend, then the organization would take a preventive action to “prevent” the situation from re occurring or getting worse.

• Example would be Failure Mode Effects Analysis (FMEA) where we review the “what if’s” prior to implementation to determine that we are “preventing” errors, when we determine a potential problem may exist be performing a risk assessment (infection control does this annually, environment of care rounds, clinical engineering preventive maintenance checks on equipment), risk management reports such as PSN events that may show us of potential system/process issues that need to be changed to prevent bad outcomes or redundancy.

Preventive Action

According to the ISO standard definition organizations “shall appoint a member who will have the responsibility and authority that includes: • Ensure the quality management system processes are

established, implemented and maintained • Reports to senior management on the performance of

the system and any need for improvement • Ensures engagement of employees

• Our representative is Julie Briggs

Top Management Representative

ISO 9001 Management system is not JUST compliance, it should be seen as an organizational initiative to improve patient care. You may be asked to participate in an audit (infection control, care of patients, document or record control)- always keep information secure, know that our policies are on line on the intranet, and know how and who to speak with to improve patient care and satisfaction-Chief of Service, CEO, the nurse manager, the Quality Officer or the ISO top management representative

What Can You Do?