Understanding and implementing quality management system in medical laboratories
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The document outlines the importance of implementing a quality management system (QMS) in medical laboratories, emphasizing compliance with ISO standards such as ISO 15189 for accreditation. It details management responsibilities, resource management, service realization processes, and the necessity of continual improvement through measurement and analysis. Ultimately, the goal is to ensure consistent and accurate laboratory results while enhancing patient safety and organizational accountability.
![Pre analytical [examination]
• Most error prone phase
• Manual for sample collection must be available
• Phlebotomists must be trained & their competence monitored periodically
• Inventory used for sample collection must be controlled
• Systems used for transport specimens to the laboratory must be validated &
suitable
• Instructions provided outside laboratory must be document controlled and
must be reviewed by laboratory personnel
• Root cause of identified problems must bw corrected
• Laboratory must monitor pre analytical process with quality indicators & act on
data gathered
• Internal audit must include pre analytical processes
• Management reviews must include pre analytical elements](https://image.slidesharecdn.com/understandingandimplementingqualitymanagementsysteminmedicallaboratories-210208111256/85/Understanding-and-implementing-quality-management-system-in-medical-laboratories-43-320.jpg)
![Analytical [examination]
• All technical examination procedures must be documented &
available to staff who need it
• Can be either in electronic or paper form but must be controlled
• Staff must look at only the most current procedure
• Controlling of documents can be achieved by
• Distribution of printed copies is known & recorded
• Responsibility for printing of new & revised document is defined
• Responsibility for removal of obsolete printed document is defined](https://image.slidesharecdn.com/understandingandimplementingqualitymanagementsysteminmedicallaboratories-210208111256/85/Understanding-and-implementing-quality-management-system-in-medical-laboratories-44-320.jpg)
![Post-analytical [examination]
• Though most errors occur in pre and analytical phase, errors can
occur in post analytical phase too
• Report must spell the name correctly
• Sex and age of the patient too is important and must match
• Errors must be monitored, measured & analysed
• Internal audit and management review must include post analytical
process.](https://image.slidesharecdn.com/understandingandimplementingqualitymanagementsysteminmedicallaboratories-210208111256/85/Understanding-and-implementing-quality-management-system-in-medical-laboratories-45-320.jpg)
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Understanding and implementing quality management system in medical laboratories
- 1. Understanding & Implementing Quality Management System in Medical Laboratories Prof. Ashok Rattan, MD, MAMS, Common Wealth Fellow, INSA DFG Fellow, SEARO Temporary Advisor, WHO Lab Director (CAREC/PAHO) Advisor: Pathkind Labs Knowledge Forum, R & D and Quality
- 2. What is Quality ? • Quality is difficult to define, Invisible when GOOD, impossible to ignore when BAD • Doing the right thing right, the first time & every time • Meeting and exceeding expectations (STANDARDS)
- 3. Accreditation or Certification ? • Certification is the assessment of an organization to ensure that it is meeting the requirements of a required standard or regulation. • Certification is performed by certification bodies to meet the requirements of ISO 9001 • ISO DOES NOT GRANT Certification Bodies to assess for ISO 15189 • Accreditation is the assessment of an organization to ensure that it is performing in accordance with the requirements of a required standard or regulation • Accreditation is performed by accreditation bodies to meet the requirements of accepted documents including, but not limited against ISO 17025 and ISO15189. • ISO DOES GRANT accreditation Bodies to assess against ISO 15189
- 4. ISO 15189 : 2012 Requirements for Quality and Competence Medical Laboratories • Management requirements • Organization and management responsibility • Quality management system • Document control • Service agreements • Examination by referral laboratories • External services and supplies • Advisory services • Resolution of complaints • Identification and control of nonconformities • Corrective action • Preventive action Continual improvement • Control of records Evaluation and audits • Management review • Technical Requirements • Personnel • Accommodation and environmental conditions • Laboratory equipment, reagents, and consumables • Pre-examination processes • Examination processes • Ensuring quality of examination results • Post-examination processes • Reporting of results • Release of results
- 5. Benefits of Accreditation 1. Assurance of technical competence 2. Risk reduction 3. Staff confidence 4. Improve communication 5. International recognition 6. Peer review of laboratory operations 7. Demonstrates a commitment to quality and accountability 8. Continuous improvement 9. Different perspective 10. Volunteering as assessor
- 7. Test selection Test ordering Sample collection Transportation Sample Accessioning Analysis Reporting Interpretation ACTION 1. Has the right test been ordered ? 2. Errors between result receipt & action Preanalytical Preanalytical Preanalytical Pre Preanalytical Pre Preanalytical analytical Post analytical Post analytical Post post analytical Post post analytical
- 9. Use of 12 QSE would ensure 1. Reduction or elimination of medical error 2. Likelihood to meet customer satisfaction 3. Potential for successfully meet accreditation assessment 4. Sustained attainment of quality objectives
- 10. We never make any mistakes in our Laboratory, Mr. Sharma My name is Sunil Verma
- 11. To err is human 1999 (IOM report) • 44,000 to 98,000 Americans die each year from medical error • >8th leading cause of death • >motor vehicle deaths, breast cancer or AIDS • Laboratory tests errors: • 50 % : failure to use indicated tests • 32% : failure to act on results of test or findings • 55% : involved delay in diagnosis
- 12. Deaths in USA due to medical error are Equivalent to ONE Jumbo jet crashing every day of the year
- 13. OldParadigm Errors because of bad apple Name, Blame and Shame
- 14. • Deficiencies in design, organization, maintenance, training and management create conditions in which persons are more likely to make mistakes. • Deming Red beads experiment
- 15. Medical error is a failure of process • The concept that errors result largely from the failure of systems, not from individual carelessness or inadequacy, is fundamental to the new efforts to address safety and runs counter to the traditional focus of medical training on individual performance Process Input Output
- 16. Blunt and Sharp end model
- 17. Swiss Cheese model of error prevention
- 18. Goal of ISO 15189 is to create standardized processes to produce consistent results
- 19. Accepting 1% Error is equivalent to • Hotels in NCR can serve 600,000 lunches contaminated with bacteria • Postman can loose 50,000 parcels each day • Midwife can drop 22 newborns each day • Authorities can not supply water or electricity for 14 minutes each day • Pilots can make 3 bad landing each day Doing the Right Thing Right Every time From the First Time
- 21. QMS is a system designed to manage the continual improvement of all processes in an organisation in order to meet customer expectations
- 23. Four Components of QMS • 1. Management responsibility • 2. Resource Management • 3. Service Realization • 4. Measurement, Analysis and Improvement
- 24. 1. Management Responsibility • Management support is critical to success of a QMS • Management is responsible for strategic planning of a business • Creation of a quality policy which includes commitment to quality • Evaluating the success of QMS & areas that need to be improved • Ensuring customer requirements are both understood & met
- 25. 2. Resource Management • Top management must also ensure organization has enough • Staff to effectively carry out that strategy • Staff are provided with tools, supplies & resources to carry out their job, this includes • Suitable work environment • Laboratory Equipment from reliable suppliers
- 26. 3. Service Realization • This includes all three stages of investigations • Preanalytical • Analytical • Post analytical • Staff understand proper processes & procedures • Procedures are followed each & every time • Lab must document Each step • Controlling access to these documents is key to ensure staff is always viewing the latest version
- 27. 4. Measurement, Analysis & Improvement • A major goal of QMS is continual improvement • Achieved by measuring & analyzing performance of QMS & then acting on those findings • Determine which metrics to measure based on strategies of the organization • This process is repeated at regular interval
- 28. 1. Management Responsibilities • Without commitment from top management of an organization, QMS cannot succeed. • Management must take responsibility • Establish the Quality Policy • Establish the processes • Allocate resources to meet those goals • Quality Policy • Created with customer requirements in mind • Must help organization reach its strategic goals • Serve customer needs • Comply with statutory regulatory requirements • Management commitment to QMS must be ongoing not one off • Measuring & analysing success of QMS • Acting upon the finding • Continually improving quality
- 29. Quality Manager • Management must appoint a representative responsible for • Ensuring QMS processes are implemented & maintained • Report directly to the top management • Large labs can have full time QM • Can have other responsibilities in smaller labs • QM ensures everyone understands & complies with QMS • Reports to top management on state of compliance & • How it can be improved • Responsible for customer’s voice is heard & needs are met • Ensure that staff understand & respect customer requirements • Become a customer focused organization & not become preoccupied with internal processes & procedures alone.
- 30. Quality Policies in Quality Manual • Is the backbone of QMS • It is the framework on which QMS is founded • Responsibility of Top Management to lead creation of Quality Policy • Aligned with organizations goals & purposes • QP is not a static document • Must evaluate the effectiveness of its quality objectives & • Continually improve QMS • Must comply with all statutory & industry requirements • Must be communicate to & understood by all staff members
- 31. For Medical Laboratories Requirement spelled out in ISO 15189: 2012 clause 4.2.3 • a. Scope of service • b. Statement of the labs’s standard of practice • c. objectives of QMS • d. Requirements that personnel understand & comply with QMS • e. commitment to good practice & quality • F. commitment to comply with ISO 15189 • Quality Policy should be concise, defines the overall intentions & direction • Demonstrate the management’s commitment to quality & leadership’s support for a culture of quality • Detailed will be found in organism’s processes & procedures
- 32. Strategic Planning • It is a critical part of QMS • ISO 15189 states lab director shall “plan, set goals, develop & allocate resources appropriate to the medical environment” • Top management shall establish quality objectives for all • Relevant functions & • Levels within the organization • Objectives must meet product requirements and be • Measurable • Consistent with QP
- 33. Documentation of the system • Say what you do; do what you say & document both • Quality manual is the road map to QMS • Processes & procedures • Make sure staff • Understand & follows them • Knows where to find them • QM controls them • Why control the documents ? • So that only most recent document is available • Distribution list of where they have been distributed • All old documents must be withdrawn, labelled , filed or destroyed
- 35. Documents • Policies: • Statements that describe what is done & why • They define goals & state intent & direction • Strategic planning, Personnel, Inventory • Processes: • Interrelated steps in an activity that uses resources • transforms input output • Flow charts • Procedures: • Detailed step by step instructions • Detail not only technical but also activities such as respond to complaint from customer, instructions on how to use IT system, how to validate equipment before use. • Provides staff with clarification & transparency, should be readily accessible • Records: • History of what was done & cannot be changed • TRF, examination results & reports, instrument printouts
- 37. Common mistakes with documents • Organizations commonly document only technical procedures, but not management activities such as training & orientation of new staff & competency assessment • Ask a consultant to write their procedures or purchase a ready made set of pre- written policies. Such packages maynot reflect what actually happens Those who perform activities must play a role in drafting or reviewing the policies. • Policies & procedures should reflect what an organization actually does – not wished for outcomes & goals. Must reflect reality.
- 38. 2. Resource Management • Top management must provide resources necessary to both • Meet QMS requirements & Continually improve its effectiveness • Enhance customer satisfaction by meeting customer requirements • Managing resources means securing • enough people & • Ensuring their competence, awareness & training To meet those goals • Also to provide Right equipment, suitable infrastructure, work environment & supplies For personnel to do their job effectively
- 39. Personnel • Management must • Select personnel who are Competent based on education, skills & experience • Determine criteria for competence, • Provide appropriate Training • Evaluate effectiveness of training • Personnel understand • Why their competence is important to meet Quality objectives • Organization must provide evidence of personnel competence • Records of education, training, skills, experience, assessment
- 40. Accommodation & Environmental Conditions • Suitable work environment • Including workplaces, equipment & supplies • Supporting services like IT
- 41. Laboratory Equipment • All equipment required for providing services • Process for selecting equipment must be in place • Including process of evaluating suppliers • Records are maintained of these evaluations • On site inspection • External evaluation • Reviewing quality control records • Suppliers need not be ISO registered or accredited
- 42. 3. Service Realization • Process Flow for delivery of service • Pre Analytical Analytical Post analytical • Plan a workflow so everyone understands • how their task relates to others • Documenting all linked activities in the process map will help all staff understand the wider picture
- 43. Pre analytical [examination] • Most error prone phase • Manual for sample collection must be available • Phlebotomists must be trained & their competence monitored periodically • Inventory used for sample collection must be controlled • Systems used for transport specimens to the laboratory must be validated & suitable • Instructions provided outside laboratory must be document controlled and must be reviewed by laboratory personnel • Root cause of identified problems must bw corrected • Laboratory must monitor pre analytical process with quality indicators & act on data gathered • Internal audit must include pre analytical processes • Management reviews must include pre analytical elements
- 44. Analytical [examination] • All technical examination procedures must be documented & available to staff who need it • Can be either in electronic or paper form but must be controlled • Staff must look at only the most current procedure • Controlling of documents can be achieved by • Distribution of printed copies is known & recorded • Responsibility for printing of new & revised document is defined • Responsibility for removal of obsolete printed document is defined
- 45. Post-analytical [examination] • Though most errors occur in pre and analytical phase, errors can occur in post analytical phase too • Report must spell the name correctly • Sex and age of the patient too is important and must match • Errors must be monitored, measured & analysed • Internal audit and management review must include post analytical process.
- 46. 4. Measurement, Analysis & Improvement: Checking the process • ISO 15189 provides the ideal tool to implement continual improvement • Use quality indicators • Review non-conformatives • Internal & external quality audits • Regular management reviews
- 47. Focus on continual improvement • 1. Use of Quality indicators: Organization’s strategy will decide • What is important • What metrics to measure • What target to strive for • A Quality Indicator is a measurement and analysis to address how well the laboratory meets its customers’ needs • It is critical to gather & use reliable data • 2. Management of nonconformities: defined as “non fulfilment of a requirement” • Audit team should report any occurrence to the management
- 48. • 3. Internal & external quality audits: • A quality audit is a planned independent and documented assessment to determine whether agreed upon requirements are being met. • Audits are a means of gathering factual unbiased information about how well an organization’s quality system is functioning. • 4. Regular Management review of the QMS. • Gives Top Management a venue to evaluate and analyse practices for the purpose of improving the QMS • Review of policies & records • Result in action plan for improvement • Lead to change in strategy • Planned by QM • Conducted using Documented processes & detailed procedures & templates • So that management reviews are consistent year to year