Assuring the Quality of Testing: A Systems Approach to Quality (ISO 15189:2012) Module 4

Assuring the Quality of Testing:A Systems Approach to Quality

(ISO 15189:2012)

Module 4

Learning Objectives

At the end of this module, you will be able to:

• Explain the systems approach to lab quality and its benefits.

• Identify the essential elements of a lab quality system.

• Recognize key factors that may compromise the quality of laboratory testing.

Learning Objectives

At the end of this module, you will be able to:

• Compare the Quality Essentials in a Quality Management System to the ISO 15189 Checklist sections

• Apply each Quality Essential in review, revision or development of a Laboratory Quality Manual

Content Overview

• The approach we take to achieve quality

• Essential elements of a lab quality system

• Quality assurance procedures in the medical laboratory testing site

• How the laboratory documents its program of quality for all phases of testing - before, during and after testing

What is “Quality?”

• The ability of a product or service to satisfy stated or implied needs of a specific customer

• In the lab: accuracy, precision and timeliness

• Achieved by conforming to established requirements and standards

Discussion – Dining Out: A Quality Experience

• Think about your expectations for quality

• What might you expect for a quality experience at a restaurant?

Why Quality?

Test Site

QualityAccurate, ReliableTesting

Quality in All Aspects

of Health Care

A Systems Approach to Quality

• Considers all components within a system– Such as organs working

together as a system in

the body

• To produce quality service in the laboratory, all facets are needed to work together

A System...

• Identifies the connection and relationship (e.g., cause and effect) among the components

• Example of cause and effect: Anemia may be caused by many reasons including lack of iron; but lack of energy and fatigue is often the effect

Definition of a Lab Quality System

• A system with an organizational structure of management and staff who carry out their responsibilities using good laboratory practices and procedures including the resources necessary for providing quality laboratory test results.

• In other words…all activities which contribute to quality tests, directly or indirectly.

Benefits of a Quality System

• Patient benefits with accurate results for the clinician to diagnose, treat and monitor their health

• Proactively detects and reduces errors before results are released

• Improves consistency of results between testing sites and increases clinician confidence

• Ultimately is the most cost effective

Interactive Opportunity

• What does a Quality System mean for the laboratory?

• How is a quality laboratory established?

Lab Quality Systems:The 12 Quality Essentials

Organization Personnel Equipment

Purchasing & Inventory

Documents & Records

Process Improvement

Customer Service

Occurrence Management

Facilities & Safety

Assessment

Information Management

Process Control Quality Control &

Specimen Management

Activity

Break into four groups and define the specificlaboratory needs that each of the

Quality Essentials include.

Secondly, relate the Quality Essentials toThe ISO 15189 Checklist Sections. Are they

essentially the same?

1. Documents and Records2. Management Reviews3. Organization and Personnel4. Client Management & Customer Service5. Equipment6. Internal Audit7. Purchasing & Inventory8. Process Control and Internal and External Quality Assessment9. Information Management10. Corrective Action11. Occurrence/Incident Management & Process Improvement12. Facilities and Safety

ISO 15189 Aligns with WHO Checklist Sections

ISO 15189:2012

• Based upon ISO/IEC 17025 and ISO 9001, specifies requirements for competence and quality particular to medical laboratories

• A country could have its own specific regulations or requirements applicable to its professional personnel, their activities, & responsibilities

• Medical laboratory services are essential to patient care and must meet the needs of all patients and the clinical personnel responsible for the care of those patients.

ISO 15189:2012

Such services include:• Arrangements for examination requests, patient

preparation, patient identification, collection of samples, transportation, storage, processing and examination of clinical samples, with interpretation, reporting and advice, in addition to the considerations of safety and ethics in medical laboratory work

Documents and Records• Quality Manual - Describes YOUR Quality System

• Document Control with Master Index and ensures they are current by annual review

• System for Document Archive, Retrieval and Record Retention

• SOP for all Laboratory Processes and Procedures

Requirements for a Quality Laboratory

Management Reviews• Laboratory Manager and/or Quality Officer:

• Review of all Quality and Technical Records

• Review and Improvement of Quality Management System

• Developed Laboratory Workplan and Budget


Organization & Personnel• Organization authority hierarchy - internal and

external

• Lab Manager & Quality Officer assigned with roles and responsibilities

• Commitment to Quality - by entire facility

• Adequate Staff

• Personnel Files


Organization & Personnel• Tasks Defined - Duty Roster

• Job Descriptions

• Orientation and Training

• Competency Checks

• Staff Communication


• Qualified and Available Staff for Customer Advice

• Handbook for Clients

• Communication with Clients and Patients

• Customer Survey & Improvement


Client Management/Customer Service

Equipment •Equipment Installation• Correlations• Linearity studies• Method validation


• Book of Life• Routine maintenance• Repair records• Equipment failure

• Operator manual available

• Calibration as necessary

Internal Audit What is happening inside your own laboratory:•Personnel competency•Cross-checking results within a department•Checking that instrument maintenance is performed each day & that logs are initialed each day•Are all staff following SOPs?•Are temperature charts completed each day?•Are safety policies in place & do staff use PPE?


Purchasing & Inventory• Forecasting needs and usage

• Adequate Budgeting with upper Management

• Tracking and documenting orders and receipts

• Inventory Control Management to prevent stockouts

• Adequate and monitored storage


Process Control and Internal & External Quality Assessment

• Written and available standard operating procedures

• Specimen management

• Quality control materials and rules


• Record Lot Numbers for reagents & test kits• Environmental Checks• Management review of records for all processes• EQA Proficiency Testing• Reference Specimen Tracking• Results cross checked before release


Process Control and Internal & External Quality Assessment

Information Management•Test report system with required information, cross checked and validated before release

•Organized archival system with retention of records, patient reports and all laboratory support documentation

•Timeliness of results to the clinician

•Patient privacy and confidentiality


Corrective Action• Written policies and procedures for addressing

errors

• Error resolution by root cause analysis

• All non-conformances reviewed and trackedfor trends


Occurrence Management & Process Improvement

• All occurrences recorded and addressed

• Ongoing Quality Indicators (QI) monitored

• QI monitors and/or trending occurrences usedfor improvements in operations and processes

• PDCA used to implement improvements


Process Improvement

On-Going Data Collection

Improvement Measures

Facilities & Safety

• Appointed Safety Officer

• Facility and environment adequate

• Workstations uncluttered

• Essential Safety Equipment available


Facilities & Safety

• Staff trained in safety policies and procedures

• Waste disposal to country standard

• Policies on staff exposure prevention and/or prophylaxis

• Accidents reported and followed up on


Quality Manual

• All Sections of the Checklist (and therefore the Quality Essentials) should be addressed in the Laboratory Quality Manual

• This details YOUR laboratory’s policies for YOUR Quality System

Policies verses ProceduresPolicies Procedures

Definition Policies are statements of WHAT the laboratory will do

Procedures are SOPs on HOW policies are implemented

Examples • The laboratory will maintain an orderly system for all documents and records so that all documents and records can easily be located, are current and available to staff, and are retained or disposed of according to law.

SOP for Document Control:• All procedures are

numbered• A master index is

maintained• All SOPs are reviewed

annually• Records are retained

for X years, etc……..

Writing YOUR Quality Manual

1. Begin with a Quality Statement or Objective for YOUR laboratory to have a commitment to a culture of Quality

2. Outline YOUR Scope of Service

3. Outline the roles and responsibilities of YOUR management and staff

4. Outline the organization of the Manual i.e. how the manual is arranged by addressing Quality Essentials.

*See ISO 15189: 4.2.3/4.2.4

Examples

Management Review:“It shall be the policy of xxxxxx Laboratory to establish an annual workplan and budget in coordination with and approval of upper management. This plan will be communicated to all laboratory staff.” (See File: Lab Workplan and Budget - Lab Manager Office)

“ At least annually, the laboratory manager will review with upper management (summary of items listed in ISO 15189:2012 (Meeting minutes) “

Management Review (cont)“There shall be an annual review of Laboratory Quality Improvement to ensure that data in the form of Quality Indicators are collected and Improvement Projects are identified and undertaken.”

“The Laboratory Manager or supervisor shall review monthly (or quarterly if more appropriate), the following quality and technical records: (see ISO 15189:2012 as it applies to your lab)”

Examples

Facilities and Safety“XXXXX Laboratory will provide, with the approval and oversight of upper management, a safe environment for its clients and staff. This includes the physical structure, the necessary safety equipment and supplies for specimen handling and testing, defined procedures for waste disposal, prophylaxis for staff upon specific exposure and training for all safety procedures.Reference: See Safety Manual Document #XXXX located in the LM office and all lab sections”

Another Example

• Divide in groups and with the Quality Essential you previously worked with, begin a plan on how to incorporate this essential into YOUR Quality Manual.

• Note: You should use the ISO 15189:2012 Checklist as your guide n

Activity and Homework

• Laboratory management and supervisory staff establish quality assurance policies procedures

• Test site personnel implement the quality assurance procedures

Who Is Responsible for Quality?

EVERYONE!

Why is the Quality System Important to Patient Sample

Testing? • Ensures that quality is the foundation of

everything we do

• Sets the standard for level of quality

• Meets/exceeds customer expectations

• Provides means to prevent, detect and correct problems

Why is the Quality System Important to Patient Sample

Testing? • Becomes the core of a monitoring, evaluation,

and improvement system

• Reduces costs

Even the simplest Rapid Test is not foolproof

SummaryAfter completing this module, the participant can:• Explain the systems approach to lab quality & its

benefits• Identify the essential elements of a lab quality system• Recognize key factors that may compromise the

quality of laboratory testing• Compare the 12 Quality Essentials in a Quality

Management System to the ISO 15189:2012 checklist sections

• Apply each Quality Essential in review, revision or development of a Laboratory Quality Manual