International 15189-2012 Standard Medical laboratories -Requirements for quality and competence “This International Standard, based upon ISO/IEC 17025 and ISO 9001, specifies requirements for quality and competence that are particular to medical laboratories. “The medical laboratory services are essential to patient care and therefore have to be available to meet the needs of all patients and the clinical personnel responsible for the care of those patients”. “A medical laboratory's fulfillment of the requirements of this International Standard means the laboratory meets both the technical competence requirements and the management system requirements that are necessary for it to consistently deliver technically valid results”. (iso 15189:2012(E) introduction Page) Training Roadmap 4 Components of an 1SO-based QMS QMS 1: Management Responsibility Resource Management Path of Workflow Evaluation and Continual ImprovementIlluminating the Path to 18015189 Accreditation B practical approach to understanding and implementing| 18015109) QMS 1: Management Responsibility - OVERVIEW QMS 1: Management Responsibi PURPO: * Management responsibility requires a commitment to quality and making a quality management system (QMS) a strategic goal. * Because a QMS is comprised of numerous interrelated or interacting processes, the standard encourages a process-based approach (i.e. the identification and interactions of these processes and their management). * IN QMS 1, participants will learn how to manage processes through the use of quality tools; manage documents and records and establish an internal communication plan. Illuminating the Path to 18015189 Accreditation practical approach to understanding and implementin, 18015109) 1.1 Management Responsibi' Introduction ctivity: Introduction PURPOSE: To strengthen laboratory management towards accreditation, leaders must develop an understanding of quality and quality management principles. a A ISO Quality Basics = A Quality Management Principles Commit to making quality a priority. A Strengthening Laboratory Management Toward (iso) Accreditation (Understand ) Apply quality management principlest set of inherent characteristics fulfills requirements iso1sia93.8 = It must be related to customer requirements and needs Everything in business needs to be focused from the perspective of the customer which is who an organization isin business to serve. No customer = No business It has a measurable component The product produced either fulfills a requirement or not. Nonconformity ~ nonflflment ofa requirement Defects (nonconformances) can be counted.sing [pp |The lab must be responsible for understanding ai Decision-™ the clinical needs and interpreting these Cinic _sourcome® needs in terms of analytical performance cainies! goals. That is the labs responsibility for 7 “implied needs” Information + Accurate [To meet the needs and requirements of Request report * Reliable the customers (e.g. patients and users), + Timely medical laboratory testing must: + Interpretable Clinical Decision Points ina Healthcare System provide cl Preventing disease * Quality is the degree to which a set of inherent value at the er eee haracteristics fulfills requirement non - dpi eee characteristics fulfills requirements. rer ar apr sean Slecting the right treatment STE) ‘Avoiding delays in treatment Facilitating recovery Reducing disability Preventing relapse Inhibiting progression +The 2 important characteristics of Quality. a) it must be related to customer requirements and peers needs and BETUWGETO b) it has a measurable component EC * Lab results must be Accurate, Reliable, Timely and ner ; ; Interpretable . A Variability is the Enemy of Quality * If the laboratory can’t produce quality lab results, it Variation reduces quality, increases risk of defects becomes a liability to the healthcare system. ISO system is implemented as a tool for continual i Basic QC Practices 3“ Edition by Westgardp.4- J improvement and process standardization. Whatis Quality? Whatis Qualit The basis for continuous improvement is in the QUALITY = MuLHDMensionm _! conapeg of eartaton, *CDC 1986. “The quality of a laboratory The central problem in management and in testing service depends on providing the leadership...is failure to understand the information in *totality of features and characteristics that —{{ variation. w. Edward Deming conform to the stated or implied needs of 2 users or customers”. * Lab results must be Accurate, Reliable, Timely and Interpretable ~ QUALITY is multi-dimensional K Basic QC Practices 3" Edition by Westgard p.5 Whatls Quality? * The lab is responsible for understanding the clinical Whats Quality? needs and interpreting these needs in terms of *CDC 1986. “The quality of a laboratory analytical performance goals. testing service depends on providing the Lab must CONSISTENTLY provide quality lab results to] totality of features and characteristics that add value to the healthcare system. *conform to the stated or implied needs of a + Variability is the enemy of quality users or customers”. +150 system is implemented as a tool for continual “conformance to the stated or implied needs i.e. improvement and process standardization goals, objectives or requirements, is the key to making quality a quantitative and measurable characteristic A & ISO 15189 is based upon TURN-AROUND-TIME. which two other ISO ia Basic QC Practices 3‘ Edition by Westgard p.5 standards? Whatis Quality? “Analytical quality is not as easy to understand. How should the requirements be ISO/IEC 17025 and stated? Should it be in the form of allowable Iso 9001 bias, allowable imprecision, or allowable total error?”ISO 9001:2008 Principles of Quality Management understanding customers’ current and future needs and expectations managing interrelated processes as a system understanding the complex relationship between cause and effect Strategic Leadership| ~creatinga unity of purpose anda quality culture through action and example Operational Leadership - providing people with the required resources, training and authority to act with accountability. continually seeking better ways of doing things striving for perfection Quality Management developing and motivating the people enables their abilities to be used for the organization’s benefit. providing greater objectivity and confidence with decisions when based on the analysis and evaluation of data and information » fundamental principles behind the ISO quality requirements ensuring repeatability of the process and consistency in quality which conform to specified requirements managing relationships with interested parties, such as suppliers creating strong partnershipsManagement commitment to making quality a priority 1SO 15189 4.1.2.1 Management Commitment “Laboratory management shall provide evidence of its commitment to the development and implementation of the quality management and continually improve its effectiveness. “strategic Leadership” “create a unity of purpose and quality culture through action and example” Management commitment to making “quality a priority” Value = Quality Cost The Cost of Quality is NOT the cost of creating a quality product or service. Instead, the Cost of Quality is a FAILURE to create a quality product or service. [Cost of Quality (lob aid 2: Cost of Quality 4-37) _| PREVENTION cosr | |2St of developing and implementing quality mahagement system Cost of activities associated with measuring, evaluating or auditing to assure processes are fit-for-purpose and conformance to quality standards. APPRAISAL COST Cost of rework (sample recollection, repeat testing) and material or consumable losses. Internal FAILURE cost External FAILURE | | Cost of failure at customer site, including | cost | misdiagnosis or mistreatment. PREVENTION COST CORRECTION COST FAILURE COST WHY commit to making Quality a Priori Laboratory??? in Your Information + Accurate + Reliable + Timely + Interpretable Path of Workflow =» Request Report cian thinks about a patient. ‘test result can change the way acl i the way the clinician manages the patient. his change in thinking ca This change in patient management can affect the clinical . mortaltyimorbicity). Cogs} + Quality has a measurable component. +The principles of quality management serve as the underlying foundation for the ISO quality requirements. +The laboratory must fully commit to making quality a priority. Responsibility 1.2 Management Tools Techniques and methods used for ualty planning and improvement Management Tools > Process Mapping — A graphic representation of a (Procesused to bring forth a clearer understanding ‘and clarity. PDSA (Plan-Do-Study-Act) — A scientific method used to improve Grocesse3)a continuous improvement ———o Quality Indicator/ Balanced Scorecard — Data used to monitor the effectiveness and efficiency of ‘Management Calendar ~The scheduling of essential tasks that are necessary to achieve quality in routine laboratoryIf you cannot describe what you are doing as a process, then you do not know what you are doing. W. Edwards Deming In order to audit a process, you must first understand what it is. J.P. Russell Process — set of interrelated or interacting activitieg 'so151893.17 which transform inputs into outputs Output! ISO 9001:2008 Introduction 0.2 Process approach This International Standard promotes the adoption of a when developing, implementing and improving the effectiveness of a quality management system, to enhance customer satisfaction by meeting customer requirements. The application of a system of processes within an organization, together with the identification and interactions of these processes, and their management to} produce the desired outcome, can be referred to as the om tat re xynical yalue ISO 9001:2008 Introduction 0.2 Process approach This international Standard nes ele when de improving the effectiveness system, to enhance custome customer requirements. - pea » Reliable ely The application of a system ofp ® ww ret organization, together with the |_« interactions of these processes, z .u wneir management to produce theldesired butcome, can be referred to as the ISO 15189:2012 (v2003/2007/2012) ISO 9001:2008 - ISO 17025:2005 uolity systems Management General Requirements for Requirements the Competence of Testing ‘This international standard applies Gnd Calibration ‘oindustries which produce: ise eee + This international standard pear addresses requirements for Hardware, tee the competence to cary Service (medicallaboraton). Sur tent andor 180 9001:2015 was considered 2 ESiations including ‘major revision, sampling. ‘Risk became an integral aaa component of the standard aioe ame (November 2017, v3) is the current version. Improve an organization. = ISO 15189 adapts industry's quality management approach to the clinical laboratory * The ISO standards are presented in Element #4: Management Requirements and Element #5: Technical Requirements = ISO 15189 takes a when developing, implementing, and improving the effectiveness and} efficiency of a quality management system (QMS). World Health ‘Organization mcrae Ae Stee abort Gonty Inpro rece Tord Arai ui a SLIPTA checklist is based on compliance o with = ISO 15189:2008 = ISO 15190:2003 Medical Laboratories — Requirements for Safety. ISO 15189:2012 4.2 Quality management system. 4.2.1 General requirements, The quality management system shall provide forthe integration of all required to full ts quality policy and objectives and meet the needs and requirements of the users. The laboratory shal! a) determine the needed for the quality management system and ensure their application throughout the laboratory; b) determine the sequence and interaction of these 3 /c) determine criteria and methods needed to ensure that both the ‘operation and control of these are effective; 1d) ensure the availabilty of resources and information necessary to support the operation and monitoring of these Je) monitor and evaluate these 1 implement actions necessary to achieve planned resuits and ‘continual improvement of theseISO 9001:2008 Introduction 0.2 Process approach For an organization to function effectively, it has to determine and manage numerous linked activities. An activity or set of activities using resources, and managed in order to enable the transformation of inputs into outputs, can be considered as a process. Often the output from one process forms the input to the next. Process — 2 Set of activities that are interrelated or that interact with one another. Processes use resources to transform inputs into outputs. oA interconnected because the output from one process... ‘Output DESIRED Information + Accurate Ip Fath of Worktlo + Reliable (Pow) ene ization © PROCESS MAPPING “A series of actions or steps taken in order to achieve a particular end” PROCESS “Visual depiction of a sequence of events to build a product or produce an outcome”. MAPPING THE PROCESS Mapping the Process rocess Mapping Part | - Order the Steps ‘What wit you do? ee "Work indvdualy to arrange the phases of Werkfiow. To use this mapping tool to increase the productivity and efficiency ofthe laboratory. testing (phase cards) and the process steps ( step’ cards), fom beginning to end inthe order that they occur inthe ab (please refer to ppt for Homework) ‘ Place Testing Phase Cards above the ‘sep ards 4 Place Process Step Cards in order from left to right horizontally across the wall submit asignment 48 hours before lve session (Please refer to Homework Uist for ive dete) > Estimated tine for activity: 30 minutes (Ch at will you need? Testing Phase Cards (PPT) Process Step Cards (PPT) (ie Requisition complated & coded byPRE-ANALYTICAL Tips for Using the Mapping Process to Improve Your Lab PDSA- the standard for making continuous improvements. to processes and systems. Activity: Process Mapping Part Il - Complete the Table Purpose What will you do? To complete the process table by * Work Individually to sort and order Beir oi Tieroces ¢ ey ae cae Srwcreel category) to correspond to the 1 Wes spenaie « Completa ee, aging to + hat procedure are ead Ce rfels corresponding step (Refer fo ppt slides: Process Mepping What will you need? Homework Part I) (ne category (se above) of proces table espe omens rods Nring PROCEDURES NEEDEDThe Model for Improvement ‘What are na to 1so1s109) QMS 1: Management §f When you Tow wal we know Gut + ., combine change i an improvement? Responsibility the 3 aunts mae questions ( with the... 1.2 Management Tools ae Techniques and methods used for quality planning and improvement 1.2.1 Using The Model for Improvement Data is the key ACTIVITY: USING THE MODEL FOR |Aim Statement Example: IMPROVEMENT PDSA cycle, you get... Soy | ame roblem: High incidence of Central line-associated Activity: The Model for |e bloodstream Infection (CLABS))Inineonatal CUE] Improvement + Aim: To decrease the CLABSI rate in the NICU from 11s) PURPOSE: infections per 1,000 catheter days to fewer than 5 This activity introduces participants to the infections per 1000 catheter in nine(9) months Model for improvement — a structured approach to achieving rapid and significant [Mj Strong Aim or Weak Aim | improvements through small tests of change. Participants will get an opportunity i] —- 5. Hematiogy EGA resume have been to practice the model by addressing a unsatisfactory for the past 3 oycles. typical managementissue. + Aim: To do better on EQA testing What is the best way to track and display quality improvement metrics over time? 2° Question’ inten Metrics (Measures) Evidence-based; to quantify problem; objective gauge of successor failure Run Chart [Why are metries important? ‘What ae the two key components of a metric? Why is baseline data To understand the magnitude of the important? problem; to know the current status. Numerator and DenominatorFamily of Measures Outcome measures Measures you ultimately want to move Indication of how the system is performing (ie. the ultimate result) Process measures: Tell you if the parts or steps in the process are performing as planned to affect the outcome measure. Balancing Measures: + often not directly related to the aim + assess whether the changes or intervention implemented are introducing problems elsewhere + Also called “side effect” Whattype na Fi i Bienen jutcome, Process Balancing im: To decrease the CLABSI rate in the NICU from 11 infections per 1,000 atheter days to fewer than S infections per 1000 catheter in ine months. ‘A. How often ICU staff were actually doing the things they were asked to do to prevent infection i.e. improve hand hygiene and checking the lines daily Process [B.Rateat which babies are gettingcLABsi.] Outcome C. Number of minutes spent by nurses on each babies with central line. Balancing What type of measure? Outcome, Process Balancing [Aim: To reduce the average waiting time in the phlebotomy department for blood draw from 1 hour to less than 30 minutes by March 2019. |A. How often the staff assigned at Urinalysis comes to cover phlebotomy area while phlebotomist is in the ward, Process B. How often phlebotomist is unavailable i.e. gone to ward for sample re-draw. Process (c. Average waiting time at phlebotomy Outcome department. Balancing Treo) If you keep doing what you've always been doing, you'll keep getting what you've always got D. Increased in Urinalysis TAT. 3'¢ Question: Every system hieve exactly the result it achieves’ ‘Although not all changes leads to improvement, ALL improvement requires change CHANGE IS NEEDED!!! SLOW DOWN: “if had an hour to solve a problem, I'd spend 55 minutes thinking ‘about the problem and five minutes thinking about solutions.” Albert Einstein Techniquesin coming up with good ideas for CHANGE. * Critical thinking about the current system - Understand the process first before asking Why. * Analyze baseline data/information by Fishbone diagram, 5 Whys, Pareto Diagram. Handout 3: Tools for Analysis XC 06 * Use change concepts - list the type of changes that often lead to improvement. Handout 4: Using Change Concepts for Improvement The Model for Improvement Wists ns ayo When you combine the 3 questions with the. sarees Sansome > PDSA cycle, you get.. =..the Model for Taeain Teieoeeoron =e improvement. A Model for Learning and Changei Worksheet 2: Quality Improvement Project Plan PLAN Plan the test, including a plan for collecting data. Quality Improvement Project Pian je ___Proet Summary 1. State the objective of the test ‘03p (Problem) Statement (Sno ras) » 2. Developa plan to test the change (WhO? [fc sitenent: roa a What? When? Where?) ‘tom _(baseneyto___eargeby. soe) 3. Make predictions about what will wane: Numerator= happen when you implement the ee aaa change. i amet Worksheet 2: Quality Improvement Project Plan collec |. Define and understand the problem and identify the Try out the test on a small scale Foot cause. A. Collect baseline data/information: r Fi B. Analyze the baseline data Put your plan into action for a pre- 7 C. Identify root cause (Use Process Map and Tools for established amount of time. & Analysis) 2. Monitor progress of implementation at Il, Identify possible changes/interventions: specific time periods (e.g., weekly, monthly or whatever applies to your improvement Ill, Select the change/intervention that you want to test. project). using PDSA 3. Monitor and document problems & PDSA: Test the Change/Intervention observations. —————————E—EeEEees| 4. Record results and chart data im Statement: (Project Summary Section] STUDY Analyze the eaeand study the |. List the tasks needed to set up this test of change. Il, Select additional metrics to monitor effectiveness of aRVAt the end Gta predetermined ume: implemented actions (if applicable) Outcome Measure; Process Measure; Balancing Measure 2. Check if changes are achieving desired results/outcomes as expected during the PLAN phase. Describe the measured results and how ieee oeecnor aed they compare to the predictions. 3. Check for unseen consequences. This information is very useful for the next phase where you will act on the findings. ‘4, Summarize and reflect on what you learned. Implement Action Plan 1. Collect data on element to be measured ACT Refine the change, based on what | ff 11. Display data in Run Chart (if applicable). you learned from the test Ill. Monitor how the plan is being executed. IV. Document problems and unexpected observations 1. Determine what modifications you should make * ADOPT (test the change on a larger scale), ‘STUDY. Analyze the results and compare * ADAPT (make modification and run another them to your aim. eae + Describe the measured results and how * ABANDON (don’t do another test on this they compare to the aim. | change idea). 2. Prepare a plan for the next PDSA cycle. pjoumnnraarize the esult ofthe tested change/intervention.| ADOPT (It worked! Let’s test it on a larger scale) ADAPT (It needs modification. ABANDON (It did not work!) Plan & implement cycle I! of the improvement Project: + Proposed date to begin Cycle Il of improvement project: * Signature of Reviewer * Laboratory Director. ACTIVITY: MANAGING PERFORMANCE — THE BALANCED SCORECARD luality Assurance |; Focus on the needs of the users Principles Customer focus Process and system approach Focus on processes to increase the productivity of work Use data to improve services Use teams to improve quality Improve communication Factual approach to decision making Involvement of people Which guiding principle of QA and quality management principle supports this activity? Use data to improve services Factual approach to decision degree to which a set of © \')\ 5 9)" inherent characteristics fulfills requirements 15015189 3.17] "ss" Indicator-measure of the degree to which a set of inherent characteristics fulfills requirements 15015169 3.19 Quality Indicators (Qi) Monitoring and Measurement of Processes ‘Measurement is the first step that leads to control and eventually to improvement. If you can’t measure something, you can’t understand it. If you can’t understand it, you can’t control it. If you can’t control it, you can’t improve it. James Harrington Quality Indicator measurements can provide... * Early detection of unfavorable trends and patterns {preventative action) + Rapid Remediation ‘measure of the degree to which a set of inherent characteristics fulfils requirements NOTE 1 Measure can be expressed, for example, as % yield (% within specified requirements), % defects (% outside specified requirements), defects per million occasions (DPMO) or on the Six Sigma scale. NOTE 2 Quality indicators can measure how well an organization meets the needs and requirements of users and the quality of all operational processes. True or False The contaminated urine} is a nonconformity? Which Qh measurement value reflects the worst level of quality? Rejection Rate in % 1 17 1223 The best level? NOTE 2 Quality indicators c= EXAMPLE requirement -receive all urine /samples in the laboratory uncontaminated measure of the quality of the process: the number of contaminated urine samples received as a % of all urine samples received The laboratory shall establish quality indicators to monitor and evaluate performance throughout critical aspects of pre-examination, examination and post- examination processes.The process of monitoring quality indicators shall be planned, which includes establishing the objectives, methodology, interpretation, limits, action plan and, duration of measurement. The indicators shall be periodically reviewed, to ensure their continued appropriateness. ISO 15189 4.15 Management Review 4.15.2 Review Input f. use of quality indicators| The laboratory, in consultation with the users, shall establish turnaround times for each of its examinations that reflect clinical needs. The laboratory shall periodically evaluate whether or not it is meeting the established turnaroun lypes of Process Quality Indicators eee 1) quality Control indicator 2) Quality Assurance Indicator + Monitors specific equipment checks + Monitors complex processes that has numerous inputs and sequential activity steps (e.g POW) + When thresholds ae exceeded The deviation prompts further investigation rather than bringing the process to an immediate hak. The cause of variation is Unclear and consequences are uncertain involving normally stable functions (ve refrigerator temperature) + Involves repeated measurements + Has well defined action thresholds + When thresholds are exceeded, production is halted until the cause of the deviation is resolved B) Quality improvement indicator + Monitors the effectiveness of a planned Project + Confirms solutions have been correctly implemented and are achieving the desired Quality Indicators Equipment Down Time Stock Outs ‘Test Statistics ‘Turn Around Time External Quality Assessment Results Specimens Rejected Customer Satisfaction Service Interruptions due to Staffing Issues Technologist Productivity Activity: managing Performance- The Balanced Scorecar Part I - Introducing Quality Indicators What will you do? * Answer the questions in Worksheet 1 Participate in classroom discussion regarding Worksheet 1 Purpose * To monitor the performance of the laboratory using uality indicators + Todefine the chosen quality indicators ‘What will you need? + Worksheet 1: Quality Indicator Quiz 0miutes ‘ey Quatty neieators ‘How Bo You Measure? Seve eruption doe to Quantity oumber of doy er ‘month that ny specie pce of euipment mot foetoning Turn Arcund Time CAT) ‘Quontty orally umber of ‘ona narey (Dependent om f03! hed for exezsment) Testing Sates ‘Quantity umber af especie fe prfrmed pe tecootoge Stock Outs Quantity number of days tat Starr i ue for Nein (a tore t,o Hines) Analyze aliyiweciy! monthly est Fnuipent Down Tine uontiy number of dye Boe month ent ny space reagent ‘supp stocked out Erternat Guay Asesment an Rests iensiy oumber af specimens reason for rejection econ ‘Quantify amber ofeach test Performed per month, ue. [Number of EBCs per month Incite eer Fes oF Fal for tach EQA rogrer in which the {Shovoton Is engeses Spocimen Rejection “Techtogit prodvctvty Measure time from specimen ecietog into reese of. Activity: Part Il - Assessing What Quality Indicators Monitor ‘What wi you do? * Relate quality indicators othe Process Map by pacing the ‘rows at appropiate paces on the process map + Parcipatein classroom séscussion regarding Qls with the debit, Purpose proces ath motos + completes process map tar the Process Mapping Ati. QMS 1: Management Responsibility 15015109) 4.2 Management)Tools' 1.2.4 :MANAGEMENT CALENDAR Conscious use of time will assist a manager to be well organized and well prepared. ACTIVITY: MANAGEMENT CALENDARThe Calendar Allows a Manager to: ‘sorsse, QIVIS 1: Management Balance and prioritize tasks seca Responsibility * Coordinate and schedule these tasks *Communicate task assignments 1.3 Quality Management System Job Aid 1: ree a ecu calendal Activity: Designing a sonatas Continuously Improving QMS PURPOSE: Dish ose + To achieve a QMS that is repeatable, measurable, and constantly improving, ISO 15189 requires laboratories to take a process-based approach towards quality a management. In this session, participants will integrate and align ISO 15189's management and technical requirements into a process-based model, thus allowing participants to design a high-level outline for an effective and efficient Ms. ISO 15189: 4.2 Quality management system 4.2.1 General requirements The laboratory shall establish, document, implement and maintain a quality management system and continually improve its effectiveness in accordance with the requirements of this International Standard. The quality management system shall provide for the wereernons Integration of all processeDrequired to fulfil its quality ssren"™* | policy anc objectives and meet the needs and ‘cusneryintentyotine | PEQuIrements of the users. Process (system) approach ere Quality Management System (QMS) ISO Definition - Amanagement system to direct and control an organization with regard to quality. soissan 20 ene ena taste Purpose - to define the organizational structure and essential tasks that are necessary to achieve quality in routine laboratory Services. wnurveweiitet NOTE 1 ~The term “quality management MERTON. 60 sony ose [aes gan | system” referred to in this definition relates to: rma Mmm V general management activities, FEBRUARY 2020 soy loa ¥ the provision and management of ieee ema .. | the pre-examination, examination and post examination processes and ¥ evaluation and continualimprovement.ISO 15189 - Management and Technical Requirements near! et 4.1 Organization and managem sibility 5.1 Personnel QMS - a management system to direct and control an Aa tug magento 3.2Accommodatonsand organization with regard to QUALITY geneween ee 5.3 Laboratory equipment, Purpose - to define the organizational structure and Reese edna aimatensanaconsumabier Tl) essential tasks that are necessary to achieve QUALITY ease 5.5 Examination processes Sidecar ston fone, SSEnurngcuaty of “The lab shail establish, document, implement and 4 0Correctve action examination results maintain a QMS... integrate ALL processes... in estrone Sakeoortngotreaie fg {accordance to the 15 Management Requirements and 10 4.13Control of records 5,9 Release of results Technical requirements of this standard” 4114€valuation and audits 5.10 Laboratory information 4.35Managementreview ‘management Quick Review [Is there a template somewhere for a process-based QMS?) 4.2.1... Continually | Continual Improvement of the Quality Management System improve its (QMS) effectiveness "| Management 7 Ee Responsibility & 4.2.1 meet Ub the needs j and us Measurement, F | requirements Reece Analysis, and eee te a esosoemert!| | imeem) Se ~ CUSTOMER CUSTOMER Satistacton or Requirements > Product Dissatisfaction Realization. a ee = rat” |_|ISO standards promote the adoption of a approach when developing, implementing and improving the effectiveness of a quality management system. PROCESS — (For Example). Management Responsity (>, Measurement, Analysis, {and Improvement seme] >) Path of Wortiow aa a aD |e Di Port-eamination (For Example). anagement ae Maa 2 ieume Wiveasirement, Anais, | = The lab shall establish, document, rocesses... in accordance to the of this standard” a. Qs. integrate ALL Management unperiy tivity: Designing a Continuously Improving QMS Pur ‘Whatwall you do? Tomanage processes Working individually, refer to Handout: Model effectively itisimportantto Overview and 50 15189 sta Ce ee Using the Worksheet, ceorzanize the 15 intereelationsipe, Inthis __anagement Requirements and 10 Technical activity, * requirements by assigning them into 1 of chatagectent ahd tec! the 4 elements (Management Responsibility; Resource Management; Path of Workflow; Measurement, Analysis and improvement) requirements are organized What will you need? + Handout: Model Overview + 1015189 standards + Worksheet: Process- based Model 1-114 ; ae amme | \S)) __ Pathot Workflow EE: esac Preesomination = a ED | snes sors, QMS 1: Management Responsibility 4.3 Quality Management System 1.3.1 Designing a Continuously Improving QMS Activity: Designing a Fit-for- Purpose Processes URPOSE: Alllaboratory work is a series of connected processes. Therefore, to adequately perform root cause analysis and| riskassessment, management must first identify and understand the processes involved. In this activity, document control processes are used to explore the benefits of applying processes in problem resolution efforts. Working with the document control process, participants will be better prepared to support their QMS improvements and the accompanying, documentation changes at their site.iso 15189:2012 4.2 Quality management system (QMS) .2.1 General requirements The QMS shall provide for the integration of all required to fulfil its quality policy and objectives and meet the needs and requirements of the users. The laboratory shalt Ja) determine the needed for the OMS system and ensure their application throughout the laboratory lb) determine the sequence and interaction of these {) determine criteria and methods needed to ensure that both the operation and control of these are effective; 1) ensure the availabilty of resources and information necessary to ‘support the operation and monitoring of these Je) monitor and evaluate these 1 implement actions necessary to achieve planned results and continual improvement of these Establishing a process is good, but it could be either agood process (Fit-for-Purpose) or a bad process. (Fit-for-Compliance)} There could be = Unnecessary steps, = Wrong steps, *Not understood steps rm Fit-for-Purpose Process Designed to achieve the quality objectives under normal operating conditions. Designed for performance not just conformance Efficient and effective Saves time instead of consuming time Less stressful Can be sustained and remains compliant Compliance is planned into the process. As works being done, compliance is being met. Compliance is no longer EXTRA work. QUALITY-ORIENTED PROCESSES \-....0. =» QUALITY ry Quality Planning — a management activity that focuses on setting quality objectives and specifying necessary operational and related resources to fulfill quality objectives. Develop and document QUALITY PLAN H document Sn, 8 age Staff Control Verification Pee ear] chaos during the change to a minimum. Quality Plan (action plan, implementation plan) specific plan (road map) for achieving the quality objectives What actions will be performed? For each action: ‘© What resources will be required? © Whowill be involved? (assigned accountabilities and defined deliverables) © Whatis the timeline? ISO 15189:2012— 4.1.2.4 Quality objectives and planning Laboratory management shall ensure that planning of the quality management system is carried out to meet the requirements (see 4.2) and the quality objectives, Laboratory management shall ensure that the integritypf the quality management system is, maintained when to the quality management system are planned and implemented. Risk-based thinking [= Identifying that may impact QMS Fran tne proces cocfe (oxen of plonnine R depends on RISK), Do~Carryautthe Jourrurs process o \_ study - monitor / measure ——— process performance 395500014 TOU WM VORDEIDIUT Interaction with other processes ISO 9001:2015 introduction 0.5 “Risk-based thinking” Riskis the effect of uncertainty on an expected result and the concept of risk-based thinking has always} been implictin ISO 9001. This International Standard makes risk- based thinking more explicit and incorporates it in requirements for the establishment, implementation, maintenance and continual improvement ofthe quality management system. 180 9001:2015 was considered a major revision. 1SO 15189:2012 4.14.6 Risk management The laboratory shall evaluate the impact of work processes and potential & failures on and shall ‘modi processes to reduce or eliminate the identified risks and document decisions and actions taken. aThe identification of risk (i.e. pitfalls) and the analysis of its effects on the process allows sites to prepare for and reduce the chances of an occurrence. Simple Steps to Identify Risks 1.Create a process map 2.\dentify potential failures in each process step 3.Determine mechanisms in place to prevent or detect a failure 4.Design process steps or procedures (specific work instructions) so that they provide the mechanisms to prevent or detect errors. Tobit inaeagiarpret Risk Management Risk management attempts to answer 4 questions: 1) 2) 3) 4) What can go wrong? How bad is it? How often? What should be done to reduce the risk? What is the point? The purpose of risk management is to lower the risk of potential hazardous situations (problems) to an acceptable level. Risk-based thinking allows laboratories to prioritize and use their limited resources wisely by targeting the areas that hurt the laboratory the most. The time to begin considering risk is during quality design phase | Quality planning is time well spent as part of a the laboratory's risk reduction and management strategy. A specific plan (road map) for achieving the quality objectives. QUALITY PLAN QUALITY PLANNING Itisa laboratory management activity that translates quality policy into measurable objectives, Laboratory management leadership and commitment are essential to guarantee the QUALITY in all processes in the laboratory, IF laboratory management did not pay enough attention to reliability and sustainability during the planning (design) process. Badly designed process =m = Unnecessary steps = Wrong steps 4 aNotunderstocdstens| | (ENEMEORQUAUTY) cnaiasydeuas ov documens De ROGSEstrat wil be ble tomes established goals. VARIATION + Analyze ‘Common Approaches * Perform a gap analysis + Collect and analyze baseline metrics for the objective + Dicectly observe current actions by staff and potential risks, + Use any and all availabe information + Design Job Aid 1: Oe tea [7 Process Control ify Ifthe process works as expe pea For aboratory managementto controla proces itmustestabish a ‘Steps for Controllinga Process (Process Control Process) ACT Neer sew ote ors PLAN (“yasmmmnrgecuma (Procedufes and toms are processs validated o veriied fetes and approved. ye competency assessments conducted Cesta DO, TUBYWhat is a PROCESS? and timing that transforms inputs into outputs An activity or set of activities using resources, and inputs into outputs, can be considered as a forms the input to the next. |SO 9001:2008 Processes define * The activities necessary to accomplish the intent of the policy (i.e. how is the requirement metiin the laboratory). * The correct sequencing of the activities for the successful outcome of the process = Which entities (e.g. sections, departments) or job titles are responsible for each activity in the process WHO DOES WHAT & WHEN depiction of a sequence of events to build a product or produce an outcome MAPPING THE PROCESS Clinical labs should weave the requirements of ISO 15189 into their organizational fabric. This includes designing high-level process maps for the entire lab, as well as more detailed maps tailored to individual departments and [functions. These maps allow staff members to understand how they contribute to quality and patient safety (oss Navigating $0 15188, 201) When to Use a Process Map (Flowchart, = To understand how a process works. = To study a process for improvement. = To documenta process. = When planning a project. = To communicate to others howa process is done. = When better communicationis needed between people involved with the same process. Answer: A series of activities specific in sequence managed in order to enable the transformation of process. Often the output from one process directly esigning Fit-for-Purpose Processes Part | - Quickly Comprehended Communication Purpose ‘wnat youd? Working individually you wil * After hearing the facilitator ay, Ready, Set, Gol, review the projected PowerPoint side for 30, seconds Toeaplre how process mapping promotes better and ‘quicker understanding and ‘What will you need? PowerPoint Side “Interpret the PowerPoint side information being communicated toyou How to Play Pictionary members of the team tryto gues whats Being rn an therfore he word onthe car. 2: the drwerisnt allowed to verbally communicate withthel team nether are hey alowedto gstclate. The nl thing they re allowed todos DRAW! QMS 1: Management Responsibility 1.4 Documents and Records 1.4.1 Introduction to documentation System, 1.4.2 Documents Process Map 1.4.3 Why Was the Outdated Version Used? 1.44 Records Process Map section e) ‘The laboratory shall establish and maintain a quality manual that includes: /e) A description of the structure and relationships of the documentation used in the quality management ‘system;Job Aid 3: Document Structure 14 Standards & Specific Quality Policies e.g. QSEs or ISO 15189 Sub. iclauses) Quality Processes (eg Handling of External to the site TECHNICAL Internal to the site (Path of Workflow — PoW) Policies ‘States what the site does and why (intent) Defines how the site fulfills the extemal requirements Quality Plan and Objectives : Technical Processes Processes + Pre-exam (e.g, phlebotomy) Describes how thappens a this ste + Exam(eg instrument set-up) Nonconformities) Defines howshe ste tums its polcyinienonsiniolaboraen actions | ost evar (e.g cial Quality Procedures Quality Forms ‘Need to designs document system is identified Document hierarchy is defined Identification system is created Document formats are created Document control processes are defined Responsibilities tocreate documents are assigned notification) Technical Procedures Procedures and Job Aids + Pre-exam + Exam ‘Stepwise work instnictions on how to doit a coh + Postexam Technical Forms Forms, Labels, oes Teas . ‘Become records providing evidence of completion of ‘our Documentation System ISO 15189 requires your QMS be documented. description of the structure and general relationships of the documentation used inthe QMS Level {Ata minimum, a unique ttle must be given to each document f Consider how forms wil be linked back to its respective procedure of document Detail create a numbering system that does not requte a secondary index to decipher the document type and purpose. Templates for. + Policies and Processes + Procedures ~1SO 15189 defines specific elements for technical procedures + Forms ied doco orl piconet ; ‘Docume derieaionand contro specific Docamentcrvton, review, ae approval Making changes to documents Patodc wie of docimena erie heise All documents must be legible and written in language commonly understood by staffWhich type of laboratory documents provides statements of overall intentions and directions, as defined by the laboratory or institution? POLICIES aes which become Records QMS 1: Management Responsibility 15015189) 1.4 Documents and Records 1.4.2 Documents Process Map Activity: Document Process Map PURPOSE: + Through process mapping, the activity steps and their linkages will be discussed so that participants will better understand the ISO 15189 sub-clause and how to achieve the| intended quality output and minimizes the risks of unintended (e.g. defective, nonconforming) outputs. Gaining] clarity, the participants will be better able to effectively lead the quality planning at their site. + in this activity, participants will explore the numerous interrelated or interacting processes of ISO 15189 4.3 Document control, a QMS sub-system — SO 15189 - 4.3 Document Control The lab shall control documents....prevent use of obsolete document. The lab shall have a documented procedure to ensure the following: All documents ...reviewed and approved, »b. Alldocuments are identified to include Current authorized editions and their distributions are identified by means of alist (e.g. document register log or master index) Only current, authorized editions are availabe at points of use procedures and authorities are defined when amendments of documents by hand are allowed. Changes to documents are identified Documents remain legible Documents are periodically reviewed and updated ‘Obsolete controlled documents are dated and marked, retain a copy of an obsolete controlled document ‘Step creating a Fit for Purpose process is to define the purpore| or go: 4.3 Document Control - Goal *Controlling all documents so that only current and approved versions are available to users in all locations where they are needed. *Retrieve appropriate versions of the document for investigative purposes. ink is clearer than the best memory. "Not documented — Not done! You document because "The If your documents are NOT correct, you will ALWAYS have problems. Documents serve as the virtual infrastructure External tothe laboratory mere eeoos ReentrySS fod document control proces Document isetifeation and conto! + Document creation, review, nd approval Making changes to documents Periodic review of documents “ocazent chia storage, and ete I = = ee] ‘Saree : a ES =) se Competency, NO We raning YES Tang = 1 ~r Process: Le Sa — : seal se — Prommen | | Smarts Seesotere | a aaa) =a) =O Activity: Document Process Map ISO 15189 4.3 Document Control Parpese ‘Whatwitt you do? Toldentiy and understandthe Working individually, you wil, azrtystepsand "= Create a map(tonehert) ofthe curcent interelatinshipswithother Document Process of you laboratory. Bousieosub-dauebeing *Indkatebeside the appropriate steps, studied the applicable sub-lauses of 4.3, document control (see example) ‘What wityouneet? + submit completed process map ‘Map. Document Process «Be ready to present your flowchart and + 18015189 standard participate in the discussion, + obAid: Document Process Map Steps Example for indicating beside the step in your process map applicable ISO 15189 4.3 Document Control requirements sub- clauses ato j 1 ‘Approval is ‘blaine 1.4 : Document and Record Control 1.4.3 Why Was the Outdated Procedure Used? EnsuriEsse Create a pros davees the ress involving document ‘contol. For each tep inthe process determine the procedires needed and laster Index ~ a document og o spreadsheet ured to track ALL documents nus inthe laboratory ganization by nating thelr elective dates and lesions. ps, and procedures inthe Quality age ares forthe andtags ly on the current version, kept confi silable snd acces needed 1 cre cime upemsone ecg gee ee ‘New examination Master File document is Index entinnd Demonstration Documents — Maintained Information Each document evolves over time. It must be maintained and updated when necessary. anne ge Mane 4 206 z sae ‘current documents Pevodialy reviewed. Decision keep ss.Activity: Why was the Outdated Version Used? Purpese To perform document control for ‘three common laboratory scenarios involving: a current procedure, a revised procedure, and a new procedure ‘What will you need? + Worksheet 1: Master File Index Worksheet 2: Scenario + Worksheet 3: Scenario A (AFB) Worksheet 4: Scenario B (Critical) Worksheet 5: Scenario C (Heb) ‘What will you do? Working individually, you wil: + Assessall3 scenarios + Answer the questions relating tothe scenario found on Worksheet 2 * Update the Master File Index (Worksheet ) and the appropriate procedure coversheets (Worksheets 3-5) as necessary. * Submit assignment 48 Hours before tive Session (See homework ist for submission deadline). * Participant inthe plenary discussion to debrief and conclude actity sso, QMS 1: Management Responsibility 1.4 Documents and Records 1.4.4 Records Process Activity: Document Process Map PURPOSE: + Through process mapping, the activity steps and their linkages will be discussed so that participants will better understand the ISO 15189 sub-clause and how to achieve the intended quality output and minimizes the risks of unintended (e.g. defective, nonconforming) outputs. Gaining clarity, the participants will be better able to effectively lead the quality planning at their site. +n this activity, participants will explore the numerous interrelated or interacting processes of ISO 15189 4.13 Control of Records, a QMS sub-system — ISO 15189 - 4.13 Control of Records The lab shall have a documented procedure for identification, collection, Indexing, access, storage, maintenance, amendment and safe disposal of quality and technical records. Records shall be created concurrently with performance of each activity that affects the quality of examination. The date and time of amendments shall be captured + personnel making the amendments, define time period that recordsare to be retained. !provide sultable environment for storage to prevent damage, loss or Unauthorized access. Records shall include, at least the following: a) tov) All of these records (quality and technical) shal be available for lab ‘management review. 1 Step in creating or goal 4.13 Control of Records - Goal | Ti-forPurpoze ‘todefine the purpose Retained documented information is easily, readily and completely retrievable within the timeframe consistent with patient care needs. External tothe laboratory ternal tothe laboratory oes ea eee sear Records « Aspecialkind of documentstatingresuts achieved or providing evidenced! activities performed AN + Created bythe staff who performed the work atthe time the werk seonducted + Subject $0 15189 4.13 Contolof Records Wan designing forms that become recor, Tabortory management should ei 1) Why do we need to create a record? 2) For how long do we need to retain the record? b What Makes for a Good Form Record? Forms must be easy to use. Ifyou have too many forms, the records will be harder to manage. Keep the number of records toa minimum. which can still adequately document the process The more specific you guide the user, the better likelihood youwill get the information you are seeking, Forms must be easily accessible to the responsible person, Forms may be created for the entire process or for Individual activities in a process. ‘A.common place to begin a new form is when responsibilities byob ttle changes.n the process .Activity: Document Process Map ISO 15189 4.13 Control of Records Purpose Whatwill you do? To identify and understandthe Working individually, you will: activity steps and Create a map(flowchart) of the interrelationships with other Records Management Process of your processes for the respective ISO 15189 sub-clause being own laboratory. studied. * Submit completed process map. | " Be ready to present your flowchart and What will youneed? participate in the discussion. * Job Aid: Record Process Map. * 18015189 Standard * Job Aid: Record Process Map Steps.sos) QIMS 1: Management Responsibility Planning and Condu Staff Me ISO 15189: 4.1.2.6 Communication Laboratory management shall ensure that ropriate communication processes are established between the laboratory and its stakeholders and that communication takes place regarding the effectiveness of the laboratory's pre-examination, ‘examination and post-examination processes and quality management. Laboratory management shall have an effective means for communicating with staff (see also 4.14.4). Records shall be kept of items discussed in communications and meetings. ISO 15189: 4.14.4 Staff suggestions Laboratory management shal encourage staff to make suggestions forthe improvement of any aspect of the laboratory service. Suggestions shall be evaluated, implemented as appropriate and feedback provided to the staff. Records of suggestions and action taken by the management shal be maintained Plan for 2-way Communication. Laboratory management shall have an effective means for communicating with staff. Records shall be kept of items discussed in communications and meetings P Hospital Medical || ceo.” | {Hospital ie CFO Bncitary)(_ Staff ) Department Y( Al Users of Nursing || Laboratory |{ Patients } Managers "statt’ || Services )— (Laboratory Director Laboratory {_Manager_} Safety Officer si Activity: Planning and Conducting A Staff Meeting PURPOSE; *Establishing an Internal Communications Plan requires laboratory managementto plan for quality and effective communications with their staff. +In this activity, participants will develop an Internal Communications Plan. Without structured communication, a laboratory director cannot expect employees to act as 3 coordinated unit. STAFF MEETINGS Tobe effective, meetings MUST. *Have a clear purpose *Have a facilitator *Have a firm start and stop time *Produce decisions and/or actions *Record minutes *Require participants to be preparedCommunication Requirements = Whois the target audience? + Define the audience you want to communicate to and influence. * Whatinformation is communicated? Information “Lora 2 (writen) ‘= Hows it communicated (mechanism)? *+ Consider a combination of oral and written (e.g. posting or emailing minutes). ‘+ Ensure your infrastructure can accommodate the chosen mechanisms, = When sit communicated frequency)? How often? * Who communicates the information? + Plan fr 2-way communication Whatis a communication plan? ‘A road map for sharing information with the team and key stakeholders eee Tocreatean effective plan ‘ot proces, the purpose mst leary be Understood, ‘A communication plan better ensures that the right information gets to the right people Inthis activity, participants at the right time panier ‘ill develop an internal ‘communiestions plan Wnatwil youneed? + Job Aid: Internal ‘Communications Plan + Worksheet: Internal ‘communication Plan Consistency, transparency, and timeliness of information are key factors in developing trust. ‘Job Aid 1: Internal Communications Plan 2° Purpose: To keep staff informed about the effectiveness of the QMS and quality-rolated informationia s clear, consistent and timely manner. Downward Communications Audience Information Mechanism Frequency Sender hemectngtscoverihe neato decatewen re call A sunmarfthemesteg as each ‘Section Supervisors 4. (oral) 2. (written) Laboratory Manager andlor Quality Officer Edecaiog and noting thefts taean playapnetalem Laboratory Manager andlor Quality Oficer Al Staff Departmental ‘Section eg sateen, Doctemny Staff TIWAYS coo feedback epacdeg ‘molenentaton pace ol anew orchangedprocess lean sewetodetectunantcpated changes or unforeseen coneenuances ery the pha, whch thencanleadio ata, peaciveconectve efor Downvard Communications Mechanism Upward ‘Communications Frequency Sender_(FeedbackMechanism) 1) Eectvenes of communication mechanism(s) used 2) "Staffing Recorded Information TY Efecveness of communication ‘mechanism(s) used 2) "Staffnpat| Activity: Planning and Conducting A Staff Meeting ‘Wnatwil you do? Working individually, you will, using Job Aid 1 35 3 guide, develop an internal ‘communication plan for your own laboratory using the provided worksheet: * Submit completed worksheet * Be prepared to share your internal communication plan to the large group. to provide essenti: Upward Communications Feedback Mechanism 1) Effectiveness of communication mechanisms) used 2) Staff Input Effectiveness of communication mechanism(s) used y 2) Staff Input 1) Effectiveness of communication mechanism(s) used Staff Input, > Ifa meetings held where great suggestions are discussed but NO action comes of it,then the time spenton the meeting is essentially wasted > Consistency, transparency, and timeliness of information are key factors in developing trust with your staff,