ISO 9001:2000 Basics for Health Care with NIAHO Requirements

Introductions
Barry Julian

Agenda
Status of NIAHO Overview of NIAHO Requirements Overview of ISO 9001:2000 Requirements

NIAHO
NIAHO refers to DNVs National Integrated Accreditation for Healthcare Organizations NIAHO represents a blend between the ISO 9001:2000 Quality Management Systems requirements and the Center for Medicare and Medicaid Services Conditions of Participation (COPs) Requirements. Administered by DNV Registrars

NIAHO Status
DNV applied to CMS for deeming authority for NIAHO in mid March of 2008. CMS is required to respond within a 210 day review period. This review period was completed as of 9/29/08 and CMS granted authority to DNV for the NIAHO Hospital Accreditation program. Represents the first new deemed authority program in over 40 years. JCAHO, HFAP, NIAHO, State Agency and direct survey by CMS are now all methods for gaining deemed status.

NIAHO Requirements
Unlike other deeming programs, NIAHO requires the healthcare organization to be registered to the ISO 9001:2000 Quality Standard within two years after undergoing their deeming survey. In addition to the Quality Management Systems requirements, NIAHO is divided into 25 additional requirements as outlined by CMSs COPs. NIAHO will require an annual survey to be performed instead of tri-annual review.

COPSs
All accreditation programs must meet the basic requirements of CMSs conditions of participation. Due to this fact, most of the requirements of NIAHO will be very familiar to hospitals currently accredited by one of the other methods. Four major differences in NIAHO
Not as prescriptive in how each requirement is met Additional requirement for Quality Management System Surveyed on an annual basis versus tri-annual Must be registered to ISO 9000 within two years after initial survey

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

NIAHO Requirements
Healthcare organizations currently deemed under either the Joint Commission schema or the HFAP schema should have very little difficulty in converting to the requirements of NIAHO. All three standards address the CMS requirements as outlined under the COPs. Major addition is the requirement to become registered to the ISO 9001:2000 standard. Hospitals must maintain ISO 9001:2000 registration in order to be eligible for deeming under the NIAHO schema.

Quality Management System Requirements

Quality Management System ISO 9001:2000 Certified QMS Quality Outline Management Representative Documentation and Management Reviews Systems Requirements Measuring, Monitoring, Analysis Patient Safety System

Sticking To The Basics

The IOM recently stated:
Develop one program with basic guidelines for improving care and effectiveness without overwhelming providers

This is the fundamental premise behind how ISO 9001:2000 functions

One universally applied standard Focuses on customer requirements and improving processes Requires only six documented procedures

Premise of ISO 9001:2000

ISO 9001:2000 is the compilation of more than 28 control points designed to ensure healthcare processes are delivered in the same manner each and every time. The intent of the ISO 9001:2000 standard is to reduce variation in the delivery and outcomes of healthcare processes. It achieves this by establishing a closed loop measuring and monitoring system designed to provide essential feedback to management. ISO 9001:2000 has as its foundation the Plan, Do, Check, Act (PDCA) cycle of continuous improvement.

How a Quality Management System Works

P-D-C-A
Quality Management System

PLAN
Continuous Improvement

ACT

DO

A hospital PLANS its system, DOES the implementation, CHECKS for effectiveness and ACTS to make corrections.

CHECK

Basic Requirements
ISO 9001:2000 is divided into five main categories, each of which is subdivided into more defined requirements. The main categories are:
Documentation Top management responsibility Resource requirements Process realization Measuring and monitoring

Documentation Requirements
Quality Manual Control of policies Control of records

Quality Manual
The intent of developing a quality manual is for senior management to define the application of the ISO 9001:2000 standard to their institution and describe the method of interaction among the different departments within the hospital. Serves as a guidance document to navigate the entire management system.

Key Elements of ISO 9001:2000

Control of Documents Intent is to establish administrative level control mechanism to ensure relevant policies, procedures, and protocols are approved prior to use, revision levels are controlled, documents are periodically reviewed, documents are available at points of use, and documents of external origin are controlled.
QWI-ED-01
Revision Date: 3/21/06 Revision: 0 Review Date:

Procedure:

Admissions to the Emergency Department

Approved by:_______________________ Reviewed by:_______________________

Revision History Log

Revision Description Revision Level Revision Date

Initial issue of procedure

3/21/06

Document Master List

Document Name
Admissions to the Emergency Dept.

Document Number
QWI-ED-01

Current Revision Level

0-3/21/06

Key Elements of ISO 9001:2000

Control of Records Intent is to establish administrative level control mechanism to ensure records that attest to the fulfillment of requirements are stored, retained, protected, and destroyed when necessary.

Record Retention Registry

Record Name Training Internal Audits Incident Reports CARS/PARS Storage Location Departmental Office Specific PI Office Risk Management Office Retention Period (maximum) As required by law Current year + 1 year Current year + 1 year Disposal Method Shred Shred Shred

Management Responsibility
Management Commitment Customer Focus Quality Policy Planning Responsibility, Authority, and Communication Management Review

Key Elements of ISO 9001:2000

Management Responsibility
Intent of the management responsibility requirement is to ensure that senior management sufficiently resources the hospital in terms of people, buildings, and equipment.

Key Elements of ISO 9001:2000

Customer Focus
Intent is for management to have a formal process in place for the establishment of a long range planning process that reflects the needs of the community it serves. Examples:
Development of Certificate of Need Offering of new services such as Catherization Labs, Heart ORs, and Womens Clinics Physician recruitment Purchasing of new equipment such as PET/CT scanners, Digital Mammography List of statutory and regulatory requirements
DHEC, CMS, JCAHO, OIG, etc.

Key Elements of ISO 9001:2000

Quality Policy
Intent is for Top Management to establish a mission and vision statement that relates to the community and services it provides.
Our Vision Believing in our future, we strive to be the regions best medical center. Through the dedicated efforts of our board of directors, medical staff, administration and employees, we are committed to developing and providing the finest health services for our patients, families, physicians, and communities. We will access, plan, and provide services based on changing needs. Mission Statement RBMC, a non-profit healthcare organization, is committed to providing professional, compassionate, and quality health care to all patients and to meeting the changing healthcare needs of our community.

Key Elements of ISO 9001:2000

Planning-Objectives
Intent is for top management to establish a strategic management process where high level objectives are developed based on the community it serves, and to deploy these objectives throughout the organization.
Strategic objective: Improve the overall customer satisfaction rating of the hospital to a minimum score of 88% as evidenced by the Press Ganey scorecard. Operational Objective: Improve the overall patient wait time in the ED to no more than 1 hour 95% of the time. Program: Implement Fast Track program in the ED to better serve incoming patients.

40,000 foot view

6 foot view

Method

Key Elements of ISO 9001:2000

Management Review
Intent of requirement is for management to establish a cross functional review process to review the performance of the organization against key measures. Inputs to Management Review are:
Press Ganey/Gallup Results Internal Customer Satisfaction Survey Results Audit Results such as Joint Surveys, Internal Audits, CMS audits Process Performance Measures such as turnaround times Product-Outcomes Measures such as wrong medications Status of Corrective Actions such as incident reports Status of Preventive Actions such as FMEAs

MRM should be attended by all senior management as well as directors and departmental managers. Outputs of MRM will be assignment of responsibilities and allocation of resources.

Resource Management
Human Resources Infrastructure Work Environment

Key Elements of ISO 9001:2000

Human Resources
Intent of requirement is for organization to be staffed in critical-to-care processes with employees who are appropriately trained in their respective disciplines, aware of the importance of their activities, and competent at the tasks they are required to performed. Examples
Annual competency evaluations Staff education events Board certifications Concurrent training events Monitoring of processes Chart reviews

Key Elements of ISO 9001:2000

Infrastructure
The intent of the infrastructure requirement is to ensure the organization has provided sufficient building and equipment necessary to provide the services required. Examples:
Preventive maintenance by engineering of key infrastructure items such as beds, HVAC systems, etc. Maintenance of elevators Communications systems Infection control systems in ED Tube transport systems in Laboratory Med Gas System

Key Elements of ISO 9001:2000

Work Environment
The intent of the work environment requirement is to ensure the organization has provided a work environment adequate to perform the necessary services. Examples:
Clean room environment in IV makeup area of the pharmacy Laboratory exhaust ventilation systems in histology area IC rooms in the ED EOC

Service Realization
Planning of care delivery process Customer-related processes Design and development of care delivery processes Purchasing requirement Delivery of care
Special Processes Patient and Doctor Supplied Property Identification and Trace Ability

Control of Measuring and Monitoring Devices

Key Elements of ISO 9001:2000

Planning of Service Realization
The planning requirement is a transition requirement from top level resource allocation to the delivery of the care giving services. The intent of the planning requirement is to ensure that organizational planning has taken place in order to have adequate resources in place at the time the service is required. Any changes to the organization such as personnel, equipment, buildings, process, outcomes, JCAHO requirements, or CMS requirements should be carried out under the guidance of a quality plan.

Key Elements of ISO 9001:2000

Determination and review of requirements related to the procedure prior to delivery of care
Intent of this requirement is for the hospital to develop and implement a process to ensure checks have been put in place to ensure the correct care is being provided to the correct patient at the correct time and that all resources are in place prior to the delivery of care.

Customer Communication
Intent of this requirement is for the hospital to develop and implement a process for effective communication with the patient, doctor and care giver concerning the delivery of care requirements.

Key Elements of ISO 9001:2000

Purchasing
The intent of the purchasing requirement is to ensure that purchased product is purchased from a qualified vendor, the product purchased is adequately sourced, the received product is correct and free from damage, and vendors are continuously monitored for their performance. Examples:
Detailed criteria for the selection of vendors Detailed POs stating the product to be purchased Incoming inspection of material received Annual evaluation of vendors for continuing suitability to supply product

Key Elements of ISO 9001:2000

Service Realization
Errors are typically the result of variation in processes. The intent of the service realization process is to ensure that sufficient controls are in place to ensure the process is carried out exactly by the same method each time it is performed. Examples:
Protocols stating how a procedure is to be performed Engineering controls that allow the procedure to be performed only in one manner Monitors to detect when variation from the correct method occurs

Key Elements of ISO 9001:2000

Identification and Trace Ability
The intent of this requirement is for the organization to establish controls necessary to ensure that items requiring identification are properly determined and that processes are in place where the ability to determine origin is required. Examples:
Patient IDs Biomed equipment Medications Blood Implantable devices

Key Elements of ISO 9001:2000

Customer Property
The intent of the requirement is for the organization to establish sufficient controls over property that is supplied by either doctors or patients to prevent the loss of or damage to this property. In the event the property is lost or damaged, the customer must be notified. Examples:
Eye glasses Hearing aids Watches, rings, jewelry Doctor supplied instruments Medications from home Therapy units supplied by patient

Key Elements of ISO 9001:2000

Control of Measuring and Monitoring Devices
The intent of this requirement is to ensure devices utilized in the hospital which require calibration are calibrated and/or verified on a periodic basis in accordance with regulatory requirements. Examples:
EKGs Manometers Sphygmomanometers Pulseoximeters Pulmonary Function Calibration Cylinders Biomed test instruments Refrigerator Thermometers Pipettes

System should ensure all devices requiring calibration are located and calibrated.

Measurement, Analysis and Improvement

Monitoring and measurement
Patient and doctor satisfaction Management System Processes Outcomes

Control of nonconforming product/service Analysis of data Improvement

Corrective Action-RCA Preventive Action-FMEA

Key Elements of ISO 9001:2000

Measuring and Monitoring-Customer Satisfaction
The purpose of this requirement is to establish a feedback loop to allow the organization to determine the extent to which it has met the customers requirements. It is not intended to be a measure of customer dissatisfaction. Examples:
Press Ganey Report Gallup Survey Internal customer satisfaction surveys

Key Elements of ISO 9001:2000

Measuring and Monitoring-System Performance
The intent of this requirement is for the organization to establish a mechanism to internally assess its performance against the organizational requirements. Internal assessments should be performed with such frequency to ensure all performance requirements are being met. Internal audits are performed by personnel with no responsibility for the function being audited, to ensure impartiality in the audit process.

Key Elements of ISO 9001:2000

Measuring and Monitoring-Processes Processes are the day-to-day activities conducted in the care giving process. The intent of this requirement is to measure how well the organization is controlling the individual processes. (Operations Controls)
Objective Improve average TAT times for Troponins to less than 50 minutes
70 60 50 40 30 20 10 0

Troponin Turnaround Times

Minutes

Troponin Turn Around Times Target

50

45

45

Ja n Fe b M ar A pr il M ay Ju ne Ju ly Au g Se pt O ct No v D ec
Dates

Average Troponin Turn Around Times

50

55

48

60

45

65

60

62

49

50

Key Elements of ISO 9001:2000

Measuring and Monitoring-Outcomes Outcomes are the direct result of the processes. The less variation in processes, the better the outcomes.
The intent of this requirement is to ensure the organizations processes are generating the desired outcomes.
ED Hemolysis Rate % o f H em o lysis 8 6 4 2 0 T arget F eb J une M ar May O ct J an N ov Sept April Aug D ec J uly

Objective Improve Average ED Hemolysis Rate to less than 4.5%

ED Hemolysis Rate Target

Date

Average ED Hemolysis Rate

4.5

3.50

2.75

3.00

5.00

5.50

5.75

4.50

6.00

6.25

6.50

5.00

5.25

Key Elements of ISO 9001:2000

Nonconforming product can also be nonconforming service. Nonconforming product or service is product or service that does not meet the original requirements. The standard requires that this product or service be controlled in such a manner that it is rendered unusable unless it is approved for use by a relevant authority. Examples:
Incorrect MARS Incorrect med records Incomplete forms Out-of-date supplies or medications Equipment calibration dates out-of-date Equipment not functioning as required Wrong-site surgeries Out-of-date manuals (PDRs), Merck Manuals, Lippencotts, etc.

Key Elements of ISO 9001:2000

Data Analysis
The intent of this requirement is to ensure that analysis of data takes place on the key attributes of the operations. Information from data should then be utilized to improve the management systems, processes, and outcomes. Example: In the two previous slides, several monthly averages were above target. These out of control data points should be analyzed for root cause and resources allocated for corrective action.

Key Elements of ISO 9001:2000

Continual Improvement-Corrective Action
The intent of this requirement is for the organization to establish systematic processes for the determination of root cause and the implementation of sufficient actions to ensure the problem does not recur. Steps in RCA
Identify the problem Gather data/information about problem Analyze the data Determine Root Cause Determine Corrective Action Apply Corrective Action to Root Cause Examine similar processes for same problem

Key Elements of ISO 9001:2000

Continual Improvement-Preventive Action
The intent of this requirement is for the organization to establish systematic processes for the determination of potential problems and the implementation of sufficient actions to ensure the potential problems do not occur. Steps in FMEAs
Flow chart the processes Determine where in the process failure could occur Determine the impact if failure did occur Determine actions necessary to prevent failure from occurring Monitor the processes for the effectiveness of the preventive action

Healthcare Example

Adequate Hand Hygiene

Hand Hygiene Example

Variability in Standards of Care

Limits of SOC acceptability

Caregivers Patient Interaction

Hand Hygiene Example

Procedures/Methods Equipment Materials People Environment Miscellaneous

Assuring the Adequacy of Hand Hygiene Sanitary Hands

Hand Hygiene Example-Methods

Procedures/Methods
Policies for decontaminating hands: If moving from a contaminated body site to a clean site Prohibition of artificial nails Before donning gloves If soiled with proteinaceous material Prior to patient contact After patient contact Prior to inserting indwelling urinary catheter After contact with body fluids After removing gloves Before eating or after restroom

ISO 9001:2000 Applicable Requirements Assuring the Adequacy of Hand Hygiene Document Control Records Control Process realization

Sanitary Hands
Measuring and Monitoring of Process Measuring and Monitoring of Outcomes/Product Control of Nonconformances Data Analysis Preventive Action Corrective Action

Hand Hygiene Example-Equipment

Equipment
Adequate, type, number and location of sinks Adequate type, number and location of cleaning agents Adequate type, number and location of hand drying devices

ISO 9001:2000 Applicable Requirements Assuring the Adequacy of Hand Hygiene Records Control Infrastructure Planning Purchasing Process Realization Identification and Traceability Control of Measuring and Monitoring Devices

Sanitary Hands
Measuring and Monitoring of Process Measuring and Monitoring of Outcomes/Product Control of Nonconformances Data Analysis Preventive Action Corrective Action

Hand Hygiene Example-Materials

Materials
Antimicrobial soap agent Sterile gloves Alcohol-based hand rub agent Non-sterile gloves Compatible emollient lotions Initial soaps with/without antimicrobial agent Disposable paper towels Antimicrobial soaps for washing visibly soiled hands

ISO 9001:2000 Applicable Requirements Assuring the Adequacy of Hand Hygiene Records Control Planning Purchasing Identification and traceability

Sanitary Hands
Measuring and Monitoring of Process Measuring and Monitoring of Outcomes/Product Control of Nonconformances Data Analysis Preventive Action Corrective Action

Hand Hygiene Example-People

People
Adequate job descriptions Competency checks available for hand hygiene Adequate Personnel Training Adequate, monitoring and feedback for nonNICU personnel entering NICU Adequate monitoring and feedback Adequate staffing levels to enable all recommended processes to be completed in available time

ISO 9001:2000 Applicable Requirements Assuring the Adequacy of Hand Hygiene Records Control Quality policy Training, awareness and competency

Sanitary Hands
Measuring and Monitoring of Process Measuring and Monitoring of Outcomes/Product Control of Nonconformances Data Analysis Preventive Action Corrective Action

Hand Hygiene Example-Environment

Environment
Adequate cultural environment to support compliance Adequate physical environment to support compliance Multidisciplinary focus to hand hygiene policies Location of hand hygiene dispensers

ISO 9001:2000 Applicable Requirements Assuring the Adequacy of Hand Hygiene Control of records Control of workplace environment Calibration of measuring and monitoring devices

Sanitary Hands
Measuring and Monitoring of Process Measuring and Monitoring of Outcomes/Product Control of Nonconformances Data Analysis Preventive Action Corrective Action

Hand Hygiene Example-Miscellaneous

Miscellaneous
Top management commitment to providing adequate resources (time, people, buildings and equipment) Hand hygiene policy adopted by top management Strategic, functional and operational objectives established Robust communications systems in place Frequent periodic reviews of management system by top management

ISO 9001:2000 Applicable Requirements Assuring the Adequacy of Hand Hygiene Top management commitment Patient focused organization Quality Policy Objectives deployment Internal and external communications Management Review Customer satisfaction Internal assessments

Sanitary Hands
Measuring and Monitoring of Process Measuring and Monitoring of Outcomes/Product Control of Nonconformances Data Analysis Preventive Action Corrective Action

Hand Hygiene Example

Variability in Standards of Care

Limits of SOC acceptability

Caregivers Patient Interaction

Summary
By effectively developing, implementing and maintaining a management system meeting the requirements of ISO 9001:2000, the hospital will have the ability to create a system that is completely transparent between departments, accountable at all functions, and sustainable across the entire organization.