# Presentation: 036340

## Quality Systems in theClinical Laboratory 

**Susan Blonshine RRT, RPFT, FAARC**

## Why Quality Systems?

- Consistent services
- High quality
- Cost-effective

## Selected Key Definitions

- _ISO:_  International Standards Organization
- _Quality System:_  The organizational structure, resource, processes, procedures needed to implement quality management
- _Quality System Essentials_ - those elements which must be applied to all operations in the service’s path of workflow

## Selected Key Definitions 

- _Path of Workflow_ - as it relates to the  processes involved in the pre-, during and post- phases of delivery of services with the laboratory as an example
- Policy:  _What to do_ - states intent and direction
- Process:  How it happens - describes activities that transform intent into action
- Procedure:  What To Do - work instructions

## Stages of QualityNCCLS Approved Guideline - GP26A

- Quest Diagnostics Incorporated

## Origins	

_**ISO 9000**_** - “Family of Quality Standards”**
- ISO 9001 - defines 20 quality system elements that any business should use to manage its operations:
- Manufacturers and Service Industries
- GMP - International

## Origins 

**FDA Mandate for Blood Banks - CGMP:**
- ISO 9001:
- Standards Applications
- Model for Quality Assurance
**Segue To Laboratory Applications  **
- ISO/IEC DIS 17025
- [General Requirement for Competency of testing and calibration]
- ISO/DIS 15189
-  [Quality Management in the Clinical Laboratory]

## Healthcare ApplicationNCCLS GP 26-A

- Harmonization/Standardization
- JCAHO Interest
- Infrastructure - Launching Pad:
- ISO 9000 Quality System Certification

## Quality System Essentials

**Organization**
**Personnel**
**Equipment**
**Purchasing and Inventory**
**Process Control**

**Documents and Records**
**Occurrence Management**
**Internal Assessment**
**Process Improvement**
**Service and Satisfaction**

## Comparison:  NCCLS Quality System Model to ISO 9001

## Comparison:  NCCLS Quality System Model to ISO’s 17025 and 15189

## Subsequent Quality ModelsApplications

- NCCLS HS4-P A Quality System Model for Respiratory Care
- A Quality System Model for Imaging Services

## Model for a Quality System

- Quality system essentials
- Path of workflow
- Adding the patient to the system
- Documentation
- Policies
- Processes
- Procedures

## Model Structure For a Quality System

- Organization
- Personnel
- Equipment
- Purchasing and Inventory
- Process Control
- Documents/Records
- Occurrence Management
- Internal Assessment
- Process Improvement
- Service and Satisfaction

## The Laboratory Service As An Example

- Laboratory Path of Workflow

## Slide 16

## Slide 17

## Slide 18

## Slide 19

## Integrated Path of Workflow

## Slide 21

## Adding the patient to the Quality System

## Linking Quality System To The Patient

## Path of Workflow

- Pre-analytical
- Analytical
- Post-Analytical
- Information Management

## HIV TestingPath of Workflow

## InitialPhases of Implementation

- Establishment of management commitment
- Identification of the laboratory service's path of workflow
- Development of the quality manual

## QSE: Organization

- Establishment of management commitment
- Identification of the laboratory service's path of workflow
- Development of the quality manual

## QSE: Documents & Records

- Development of the system for controlling documents and records
- Analysis and validation of processes, development of SOPs and implementation of process controls

## Quality System Documentation Hierarchy

## Document Control

**THIS MEANS -**
- 	There is defined document structure
- 	There are defined formats
- 	There is a defined document revision process
- 	There is a defined review process
- 	There is a defined retention process

- Quest Diagnostics Incorporated

## QSE : Equipment

- The Equipment Management Plan
- Equipment Selection
- Equipment Installation

## Equipment Selection

- Management Plan
**List of acceptable vendors**
**Develop product-evaluation matrix**
**Evaluate equipment**
**Determine acceptable limits of accuracy and precision**

## Equipment Selection

- Management Plan
**Consider database options**
**Consider quality control and calibration routines**
**Consider computer standards**
**Identify warranty and service agreements**
**Perform on-site evaluation**
**Correlate old and new equipment**

## EquipmentInstallation

**Develop installation manual**** **
**Validate equipment function**** **
**Perform biomedical checks**** **
**Validate reference values selected**** **

## QSE : Process Control

- Develop flowcharts for processes
- Process Validation
- Identify and Write Standard Operating Procedures
- Process Control
**Quality Control**
**Proficiency Testing**

## AdditionalPhases of Implementation

- QSE: Personnel
**Training and competence assessment programs**
- QSE: Purchasing and Inventory

## AdditionalPhases of Implementation

- QSE: Occurrence Management
- QSE: Internal Assessment
- QSE: Process Improvement
- QSE: Service and Satisfaction

## QSE : Personnel

- Job qualifications and descriptions
- Training and Competence Assessment Programs

## QSE: Personnel

## Training and Competence Assessment Programs

- Orientation and Training
- Training Guides
- Competence Assessment
- Documentation of Training and Competence Assessment

## QSE:Purchasing and Inventory

- Purchasing
- Inventory

## QSEOccurrence Management System

- Uniform documents for capturing information
- Immediate action and investigation
- Investigation and corrective action

## QSE : Internal Assessment

- Quality Indicators
**GP-26 appendix**
**Key elements**** **
- Internal Auditing
- The Quality Audit

## QSE: Process Improvement

- Identification of Opportunities for Improvement
- Problem resolution process
- Periodic reporting

## QSE : Service and Satisfaction

- Internal
**Physicians**
**Staff**
**Nurses**
**Other caregivers**

## QSE : Service and Satisfaction

- External
**Patients**
**Physicians**
**Clinics**
**Accrediting bodies**
**Regulatory groups**
**Public Health**

## Quality System Essentials

**Organization**
**Personnel**
**Equipment**
**Purchasing and Inventory**
**Process Control**

**Documents and Records**
**Occurrence Management**
**Internal Assessment**
**Process Improvement**
**Service and Satisfaction**

## Staff Benefits

- Staff are more process focused
- (think globally)
- Increased accountability
- (clear definitions)
- Improved training
- (customer/employee satisfaction)
- Develops team attitude
- (removes departmental barriers)

## Keys to Success

- Ability
- Agility
- Skating to where the puck is going to be
- 					*Wayne Gretzky*
*	**	**	**	**	**Hockey Star*
*	**	**	**	**	**New York Rangers*

## NCCLS Documents

- NCCLS
- 940 West Valley RoadSuite 1400Wayne, PA  19087-1898610-688-0100