Introduction to quality laboratory management systems, international standards and the GLI Tool

Transcription

1 Introduction to quality laboratory management systems, international standards and the GLI Tool Prof. Paul Klatser PhD Royal Tropical Institute (KIT)/University of Amsterdam KIT Biomedical Research* Amsterdam, The Netherlands *ISO15189 accredited

2 Would you accept 1% of non-quality? Slide from Antoine Pierson

3 1% of non quality? Slide from Antoine Pierson

4 Quality assurance through guilds* in the Middle- Ages (up to 18 th century) Protection of the worker and of the consumer Only a fully qualified master could become a member of the guild. Goods and services were inspected Members of guilds were expected to undertake long apprenticeships The Governors of a Guild of painters in 1675 *A guild is a society of persons united by a particular aim or occupation (craftsmen).

5 The Sampling Officials (Dutch: De Staalmeesters) - Syndics of the Drapers Guild, 1662 Quality control (inspection): they controlled the quality of dyed ' laken' cloth, a fine woollen fabric.

6 Development of standards for quality and of thinking about quality requirements 1) Standards developed for products, procurement and suppliers ( ) Forerunners: US military industry, Japanese manufactory industry and Aeronautics and Space program 2) Thinking about quality management developed Phil Crosby, W.Edwards Deming, Joseph M. Juran,

7 Edward Deming If you can't describe what you are doing as a process, you don't know what you're doing. Does experience help? NO! Not if we are doing the wrong things. The emphasis should be on why we do a job. Quality is everyone's responsibility. "It is not enough to just do your best or work hard. You must know what to work on."- Our customers should take joy in our products and services.

8 Levels of quality implementation 5) Quality management coordinated activities to direct and control an organization with regard to quality activities and techniques to achieve and maintain the quality of a product, process or service. 4) Quality system is the organizational structure, resources, processes and procedures 3) Quality assurance is the prevention of quality problems through planned and systematic activities around processes. 2) Quality control steps taken during the generation of a product or service to ensure product/service quality. 1) Inspection determining whether product or service has the required quality required specified standards

9 Quality of labs is essential in health laboratories and health care systems Reliable results by laboratories improve the decision making capacity of the clinicians/health workers as well as public health authorities. The consequences of poor quality are serious: inappropriate treatment, investigation and responses.

10 Quality is most of all The right test result, at the right time, on the right specimen, from the right patient, with result interpretation based on correct reference data, and at the right price. Summarized: Doing the right things right!!

11 The emphasis should be on why we do a job. Doing the right things right? What are the right things in a laboratory? How do you know if you do them right? Quality Management Standards may help: A standard is a document that provides requirements, specifications, guidelines or characteristics that can be used consistently to ensure that materials, products, processes and services are fit for their purpose (definition by ISO).

12 Standards Organizations ISO International Organization for Standardization Guidance for quality in manufacturing and service industries Broad applicability; used by many kinds of organizations Uses consensus process in developing standards A standard is a document that provides requirements, specifications, guidelines or characteristics that can be used consistently to ensure that materials, products, processes and services are fit for their purpose.

13 ISO 15189: The international standard for medical laboratory quality and competence Broad consensus document. ISO is not laboratory discipline specific. Amsterdam, The Netherlands

14 Definitions Certification (ISO/IEC 17000) Procedure by which a third party gives written assurance that a product, process or service conforms to specific requirements. Accreditation (ISO 15189) Procedure by which an authoritative body gives formal recognition that a body or person is competent to care out specific tasks. Licensure (Wikipedia) Granting of ability to practice provided most often by a local governmental agency, usually based on demonstrated knowledge, training and skills.

15 Accreditation Provided by an accreditation body South African National Accreditation System (SANAS) Organismo Argentino de Acreditacion (OAA) Dutch Accreditation Council (RvA) Etc. They all have to be accredited themselves to ISO Conformity assessment -- Requirements for bodies providing audit and certification of management systems

16 Goal of a QM System For the laboratory: To operate efficiently and effectively, meeting regulatory requirements To be managed with the interests of the patients To ensure that everyone understands who is responsible for doing what, when, why, where and how To continually strive for improvement

17 Stated simply Say what you do (document) Do what you say State of the art (professionally) Standardize, standardize, standardize Measure and monitor those things that are important to your customer Focus on the process Assess

18 ISO15189 specifies requirements for each step Specific instructions for proper collection of samples shall be documented and implemented by laboratory management and made available to those responsible for sample collection (ISO:5.4.2) shall shall shall shall shall shall shall shall shall shall shall shall but not how!

19 STANDARD STANDARD Proper collection Sputum quality collection s are properly collected, of good quality and stored in good, correctly labeled containers CRITERIA Outside or otherwise in area without risk of infection for others Patient has received the right instructions on how best to provide sputum Volume must be at least 1 ml, with purulent parts and not only saliva Sputum container Labeling container Clean Mulit-thread screw cap Wide mouth Clear and break resistent plastic Clearly, legible labeled with patient' s name, date and time of collection Lable on the container, not on the lid

20 The chain is as strong as the weakest link PRE-ANALYTICAL ANALYTICAL POST -ANALYTICAL request collection transport reception registration preparation processing examination Recording of results Reporting of results Storage of sample Disposal of sample Poor quality sample PRE-ANALYTICAL ANALYTICAL POST -ANALYTICAL request collection transport reception registration preparation processing examination Recording of results Reporting of results Storage of sample Disposal of sample PRE-ANALYTICAL ANALYTICAL POST -ANALYTICAL request collection transport reception registration preparation processing examination Recording of results Reporting of results Storage of sample Disposal of sample Reporting error

21 G g g g g g g G g g g g g g G g g g g g g H h h h h F f H h h h h F f H h h h h F f G g g g g g g H h h h h F f A a a a a a a X Y Z X Y Z E e e e e e e A a a a a a a X Y Z X Y Z E e e e e e e A a a a a a a X Y Z X Y Z E e e e e e e A a a a a a a X Y Z X Y Z E e e e e e e B b b b b b D d d d d d d B b b b b b D d d d d d d B b b b b b D d d d d d d B b b b b b D d d d d d d C c c c c c C c c c c c C c c c c c C c c c c c G g g g g g g H h h h G g g g g g g G g g g g g g h F f H h h h h F f H h h h h F f G g g g g g g H h h h h F f A a a a a a a X Y Z X Y Z E e e e e e e A a a a a a a X Y Z X Y Z E e e e e e e A a a a a a a X Y Z X Y Z E e e e e e e A a a a a a a X Y Z X Y Z E e e e e e e B b b b b b D d d d d d d C c c c B b b b b b D d d d d d d B b b b b b D d d d d d d c c C c c c c c C c c c c c B b b b b b D d d d d d d C c c c c c G g g g g g g G g g g H h h h h F f g g g G g g g g g g H h h h h F f H h h h h F f G g g g g g g A a a a a a a X Y Z X Y Z E e e e e e e H h h h h F f A a a a a a a X Y Z X Y Z E e e e e e e A a a a a a a X Y Z X Y Z E e e e e e e B b b b b b D d d d d d d A a a a a a a X Y Z X Y Z E e e e e e e B b b b C c c c c c b b D d d d d d d B b b b b b D d d d d d d C c c c c c C c c c c c B b b b b b D d d d d d d C c c c c c Each system consist of one or more sub systems ORGANIZATION and MANAGEMENT RESOURCES THE WORK MEASUREMENT AND IMPROVEMENT Personnel Safety Assessments Equipment Process Control Occurrence Management Purchasing & Inventory Document & Records Customer service Facilities & Safety Information management Process improvement PRE-ANALYTICAL ANALYTICAL POST -ANALYTICAL request collection transport reception registration preparation processing examination Recording of results Reporting of results Storage of sample Disposal of sample

22 Links to additional materials to prevent the laboratory from reinventing the wheel: Guidelines on specific topics (e.g. EQA) Course materials (LQMS + SLMTA) Document templates (KIT, GLI) Procurement software (GLI)

23 Many documents and tools available Roadmaps, guidelines, SOPs formats, training tool kits, roadmaps, checklists, etc. BUT: Operational translation of guidelines is missing: where to start and how to proceed? Little attention to management aspects. Shortage of harmonization/standardization. Not always addressing TB specific needs.

24 GLI Stepwise Process (