Introduction to Laboratory Quality Management Audience – Local laboratory leaders

Learning Objectives At the end of this activity, you will be able to: Relate the importance of a laboratory quality system Define the principal terms used in the field of quality List the essential elements of a laboratory quality system Describe the development of quality principles during the last centuries STATE the objectives on the slide.

What is Quality? ASK the audience what quality is. EXPLAIN Quality Competition is the core of international market competition; Example made in Japan and made in China Quality is of paramount importance in health laboratories. Reliable results produced by laboratory improve the decision making capacity of clinicians as well as public health physicians. The consequence of poor quality could be serious and it could lead to inappropriate action or inaction leading to over treatment , over investigation or mistreatment, lack of treatment or inadequate investigations . Delayed or suboptimal response as a result of poor quality of laboratory services could adversely affect the credibility of the laboratory and may also invite legal action. For example , HIV

99%: High Quality level? Accepting 1% non-quality, means everyday in France : -- 14 minutes without water or electricity -- 50 000 parcels lost by postal services -- 4 bad landings at Orly Paris airport -- 20 newborns falling from midwives’ hands -- 600 000 lunches contaminated by bacteria ASK if 99% seems to the audience a high quality level. Is it acceptable? STATE what accepting 1% non-quality means.

1% of non quality?

A laboratory occurrence and its consequences A 83 year old male was admitted to hospital with fever, weight loss and cough being investigated for possible tumor. Sputum was reported to be positive for tuberculosis, but on later review, found to be false positive culture due to in-laboratory contamination. Further investigation found 14 additional patients with falsely positive TB culture Delay in correct diagnosis Unnecessary treatment Treatment complications. Pattern of other contaminations discovered Problem resolution required 6 months of investigation, contacting of more than 200 patients, many requiring culture and X-Ray re-examination. Revision of laboratory procedures eradicated the problem. Laboratory errors cost in time, energy, money personnel and patient outcomes STATE the case. EXPLAIN The consequences of this misdiagnosis are: a delay in correct diagnosis, an unnecessary treatment which has been given to the patient with, therefore, treatment complications. This has also enabled the discovery of other contaminations. To resolve the problem, it required 6 months of investigation, over 200 patients had to be contacted to check if they needed re-examination of their case: culture and/or X-ray. The whole procedures of the laboratory had to be revised to eradicate the problem. This is an example showing that laboratory errors cost time, energy, personnel and money. It is also very important for the patient’s outcome.

Laboratory Quality Management Coordinated activities to direct and control an organization with regard to quality ISO 9000:2000 STATE Laboratory quality management needs coordinated activities to direct and control an organization with regard to quality. This is required for the ISO 9000:2000 norms

Post- Examination Phase Pre- Examination Phase Path Of Workflow Post- Examination Phase Pre- Examination Phase EXPLAIN The patient is the centre of the process in the work of diagnostic laboratory. The different coordinated activities are represented on the slide. If we follow the workflow, we first start with the pre-examination phase, which includes the following activities: sampling, sample transport, sample distribution. Then the examination phase which includes the different activities for the laboratory analysis. Then the post-examination phase with the report creation, the report transport and the result interpretation. EMPHASIZE: these activities must all be directed and controlled to ensure a correct organization with regard to quality. Examination Phase

Why the Path of Workflow is essential to consider in health laboratories A sample that is damaged or altered as a result of improper collection, or without consideration of the effects of transport will always result in an inaccurate result. A medical report that is delayed, or lost, or sent to the wrong clinician, or written in a method that results in misinterpreted negates all the time and energy and finances that were spent in collecting, transporting and performing the examination properly EMPHASIZE All parts of the workflow are important for the success of the diagnostic

Laboratory environment There are many factors that influence whether laboratory tests will be performed accurately and in a timely manner. Laboratory environment Reagents and equipment Quality control Knowledgeable staff Communications Competent staff EXPLAIN Many factors can influence the results of a test: if the staff isn’t competent or doesn’t know how to do a test, if the equipment is damaged, if the reagents are lost or out of date, if instructions for performing a test are missing, if quality controls are not followed correctly or out of control, if the technicians are not informed of the use of a new lot of reagents or of a malfunctioning equipment, if tubes get lost or if no one knows who is working and who is responsible for the technique, if records are not correctly kept. If these different factors are not correct then the likelihood of an accurate and timely test result is markedly reduced. EMPHASIZE This damages patient’s safety. Process Management Occurrence Management Records keeping

Quality system essentials Twelve Quality System Essentials Process Control (Quality Control & Specimen Management) Purchasing & Inventory Assessment Occurrence Management Information Management Process Improvement Customer Service Facilities & Safety Organization Personnel Equipment Documents & Records Quality system essentials Set of coordinated activities that function as building blocks for quality management. EXPLAIN When these issues are organized into an understandable and workable structure, the opportunity to ensure that quality is dealt with properly increases. This is often referred to as working with quality system essentials. STATE these twelve essentials. Details of these quality system essentials will be dealt with in detail at a later time.

Path of Workflow Equipment Information Management Documents & Records Process Control (Quality Control & Specimen Management) Purchasing & Inventory Assessment Occurrence Management Information Management Process Improvement Customer Service Facilities & Safety Organization Personnel Equipment Documents & Records Path of Workflow EXPLAIN For a good quality management, each of the quality essentials should be considered throughout the path of workflow. If equipment works properly within the laboratory, but failed during specimen transport, then the faulty test result is still due to a laboratory’s error. Similarly if the sample is collected properly and analyzed properly, but never reported because the report never got mailed, then the patient suffers from a laboratory’s error. This will be considered in more detail later.

The Laboratory shall be legally identifiable Name Address Medical Director Contact Information Telephone Facsimile Electronic Path of Workflow STATE All standards require the laboratory to be legally identifiable so that customers and workers know who is responsible and where and how they can be contacted. Workers know to whom to complain about late salary cheques Clinician know to whom to call about late reports Patients know to whom to complain about inconvenience

Laboratory Quality Management A Brief History of Laboratory Quality Management

Quality Management is not new Walter Shewhart W. Edwards Deming Joseph Juran EXPLAIN The Giants of Quality (Shewhart, Deming, Juran, Crosby, and Galvin) were all focussed primarily on quality for manufacturing and shop processes. Despite this, the lessons of these men, apply to the medical laboratory today. Robert Galvin Phillip Crosby

A Short History of Quality Management Innovator Date Cycle Walter A Shewhart 1920’s Statistical Process Control W Edwards Deming 1940’s Continual Improvement Joseph Juran 1950’s Quality Toolbox Phillip Crosby 1970’s Quality by Requirement Robert Galvin 1980’s Micro Scale Error Reduction EXPLAIN The very first ideas on quality were for improvement of quality and productivity in industry such as automobile production. This was a concern for the quality of production as opposed or complementary to concerns for quantity of production addressed by Ford and Taylor in car industry.

Walter Shewhart Statistical Process Control Chart EXPLAIN Walter Shewart paved the way for laboratorians such as Levey and Jennings. Shewart described the Statistical Process Control Chart in 1931. S. Levey and E.R. Jennings suggested the use of Dr. Shewhart’s control chart in the clinical laboratory in 1950.

W. Edwards Deming The Deming Cycle EXPLAIN The Plan-Do-Check-Act cycle, is the central core of all continual improvement programs, however they are named.

Joseph Juran Juran Cost of Quality Curve EXPLAIN Joseph Juran developed many models to monitor success in implementing quality. One tool was the graphic relationships between quality improvement, expenditure of avoidable costs (such as the costs of repeating test, discarding defective products, and investigations for error remediation) and expenditure of unavoidable costs such as costs of wages, and system improvements.

Joseph Juran COSTS DEFECTS EXPLAIN Juran’s quality model can be interpreted as when laboratories start to move towards quality through reduced errors or defects, the total costs markedly reduces. But at a certain point, if one wants to have better quality, the costs for quality start to rise. This occurs at the end of the improvement cycle when the number of errors or defects is very low, and much increased energy and activity drives towards zero defects. EMPHASIZE You need good quality but you must admit that if you want to reach high quality it will cost too much. Example: on an ELISA test, no controls is cheap but bad quality, 3 controls for 1 sample is high quality but too expensive. COSTS DEFECTS

Philip Crosby Absolutes of Quality Quality is defined as conformance to requirements, not as 'goodness' or 'elegance'. The system for causing quality is prevention, not appraisal. The performance standard must be Zero Defects, not "that's close enough". The measurement of quality is the Price of Nonconformance, not indices. EXPLAIN Phillip Crosby defined the essence of modern quality management. Quality is clearly defined by meeting the specific needs of the client, not by extravagant attributes or actions. Quality is not a philosophy but conformance to requirements. Quality is improved more through prevention of error than through correction of error. Quality improvement that results in reduced error saves money. Setting targets should be for highest quality, recognizing that zero defects may be unobtainable.

6∑ Robert Galvin Six Sigma EXPLAIN Six sigma is a valuable quality management tool and approach to problem solving. Projects for improvement are carefully selected and the opportunities for improvement are defined and the methods for measuring success developed and applied. A phase of project for improvement is implemented and then monitored to examine for measured success. Opportunities for changes and fine tune are implemented. Six Sigma

Six Sigma A modern tool that blends statistical process control and structured project planning Total Error Percent Process Sigma 1,000,000 100,000 10% 2.78 10,000 1% 3.83 5,000 0.5% 4.08 1,000 0.1% 4.59 500 0.05% 4.79 100 0.01% 5.22 50 0.005% 5.39 10 0.001% 5.76 5 0.0005% 5.92 1 0.0001% 6.25 EXPLAIN Six sigma calculations help put error rates in large scale facilities, including medical laboratories into perspective. A 99.5% error-free rate sounds very good, until you realize that it still allows for 5000 errors in many intermediate and large sized laboratories.

The March of Quality Management 1942-52 US Military develop requirements for contractors for shell, aircraft, missile suppliers (Quality without 100% inspection) 1959 US Department of Defense established MIL-Q-9858 quality management 1963 MIL-Q-9858 is internationalized as an ABCA standard 1968 NATO adopts MIL-Q-9858A as Allied Quality Assurance Publication 1 (AQAP-1) 1979 British Standards Institute (BSI) developed AQAP-1 for civilian use BS 5750 1987 ISO modifies and adopts BC5750 for international civilian use ISO 9000 1994-2000 ISO issued ISO 9000:1994 and follows with ISO 9000:2000. STATE The march of quality management has evolved over 60 years.

The 30 year March of Quality Management 2004 US Military Replaces Mil-Q-9858 with ISO 9000:2000 MIL-Q-9858 1959 1967, 1988 NATO AQAP-1 1968 EXPLAIN MIL-Q-9858 was developed to assess the quality and competence of companies wanting to be material suppliers to the US Military. All NATO countries later adopted it as the basis for military procurement. In 1979 the British Standards Institute adopted it for civilian commercial use. In 1987 it formed the foundation of the international quality management standard ISO 9000. ISO 9000 was revised in 1994 and again in 2000, but remained consistent in its core to Mil-Q-9858. BSI 5750 1979 ISO 9000 1987

ISO 15189:2003 today’s cornerstone of international Medical Laboratory Quality Management Medical laboratories –Particular requirements for quality and competence STATE ISO 15189:2003 today’s cornerstone of international Medical Laboratory Quality Management. EXPLAIN It is being used in medical laboratories as the basis for quality and competence both within and without a framework for laboratory accreditation.

Development of ISO 15189 ISO 17025:1999 ISO 15189:2003 ISO 9001:2000 Argentina Australia Austria Belgium Brazil Canada Chile China Czech Republic Denmark Finland France Germany   Iran, Ireland Israel Italy Jamaica Japan   Korea  Mexico Netherlands New Zealand   Norway   Portugal Singapore   Spain  Sweden  Switzerland  Turkey United Kingdom United States ISO 9001:2000 Quality Management Systems EXPLAIN ISO 15189 was developed through the proposal made by the American National Standards Institute to the International Organization for Standardization in 1995. The new standard ISO 15189 Medical Laboratory was developed through the active participation of countries around the world and molded from other standards on quality. Particular requirements for quality and competence were first published in 2003. ISO 17025:1999 ISO 15189:2003 General requirements for the competence of testing and calibration laboratories Medical laboratories – Particular requirements for quality and competence

ISO 15189:2003 Management Requirements Technical Requirements Organization Quality Management System Document control Contract review Referral laboratories Supplier review Complaint resolution Identification of Nonconformities Control of Nonconformities Preventive Actions Corrective Actions Management review Continual Improvement Technical Requirements Personnel authorities and responsibilities Accommodation and Environment Equipment and supplies Testing Cycle Events Pre-Examination procedures Examination procedures Standard Operating Procedures Quality Control External Quality Assessment Post-Examination procedures Reporting EXPLAIN ISO 15189 is a valuable compilation of statements and standards written to assist laboratorians in understanding and implementing quality management systems. ISO 15189 has become the international foundation for medical laboratory accreditation.

ISO 15189 Family of Documents ISO 15189:2003Medical laboratories -- Particular requirements for quality and competence ISO 15190:2003Medical laboratories -- Requirements for safety ISO 22870:2006Point-of-care testing (POCT) -- Requirements for quality and competence ISO/TR 22869:2005Medical laboratories -- Guidance on laboratory implementation of ISO 15189: 2003 ISO/WD TS 22367Medical laboratories -- Reduction of error through risk management and continual improvement STATE the different ISO on the slide. EXPLAIN Point-of-Care Testing trial (PoCT) is pathology testing performed by or on behalf of a medical practitioner at the time of consultation, allowing the results to be used to make immediate, informed decisions about patient’s care.

CLSI Essential Documents National Committee for Clinical Laboratory Standards Clinical and Laboratory Standards Institute HS01-A2 2004 A Quality Management System Model for Health Care GP26 – A3 Application of a Quality Management System Model for Laboratory Services; EXPLAIN CLSI documents are valuable descriptive guidelines written to assist laboratorians in understanding and implementing quality management systems. CLSI’s documents do not form the foundation of accreditation.

CLSI Beginning Started in 1967 31 clinicians and laboratory scientists representing 15 organizations met: to discuss ways of improving patient care to develop a formal consensus process for standardization.  

CLSI Today Today, 40 years later A committed forum for laboratory improvement through consensus, guidelines, and standardization. International in scope and participation World Health Organization Collaborating Centre Secretariat – ISO Technical Committee2.12 Ten area committees addressing the full range of laboratory activities. Current catalogue contains over 180 titles that address the quality and competence of practice in the medical laboratory.

ISO and Medical Laboratory Quality Quality and Competence Laboratory Safety Point of Care Testing Risk Management EXPLAIN To fulfil ISO norms and have a medical laboratory quality one must have requirements on the quality and competence, on the laboratory safety, on point-of-care testing and on the risk management. CLSI documents give you guidelines, and then the laboratory has to go through accreditation.

Summary Quality management is not new. Quality management grew from the good works of innovators who defined quality over a spam of 80 years. Quality management is applicable for the medical laboratory as it is for manufacturing and industry.

Summary Through the good works of organizations including WHO, ISO, CLSI, and others… Laboratories benefit Health care benefits Patients benefit