Objectives To provide information on implementation of a quality management system including: • An implementation plan • Quality manager • Document and records • Policies, processes and procedures • Quality system essentials • Quality policy statement • Quality manual • Continual quality improvement
Implementing a Quality Management System: Some Tips • QMP-LS does not dictate how a facility must approach the task of implementing processes or their QMS • Our program requirements lay out the basic elements of a quality management system • How a facility develops its QMS is up to facility management • OLA assesses the end result, not the manner in which your system was implemented • CLSI (NCCLS) outlines one approach in HS1-A and GP26-A • The following slides lay out a simplified version
Implementation of a Quality Management System 1. Get commitment from top management 2. Communicate your intent to all staff 3. Appoint a responsible individual (“quality manager”) 4. Review OLA requirements 5. Prepare an implementation plan 6. Prepare quality policy statement 7. Prepare quality manual: a compendium of policies* 8. Map processes as they are now * 9. Determine the gaps in processes and associated documentation * Note: Steps 7 and 8 can be reversed
Implementation of a QMS (continued) 10. Prioritize the redesign of processes 11. Plan and document the new processes 12. Verify the new processes 13. Plan and document the associated procedures 14. Communicate and train staff 15. Implement the processes 16. Measure the effectiveness of the processes 17. If problems are identified, modify the processes and go back to step 11
Quality Manager • An individual responsible for ensuring compliance with the quality management system; director retains ultimate responsibility • Can be either a full-time or part-time activity • Ensures the quality manual is kept up to date • Plans internal audits • Reports directly to the level of management where decisions are made on laboratory policy and resources
Define and Document What is Done • Take a systematic approach to address all operations in the path of workflow: pre-analytical, analytical and post-analytical • This is an enormous task, and will not take less than a year • Define what you currently do, then move toward improvement • Laboratory management should set priorities based on which processes most directly affect outcomes to patient results, and improve those first • Input from the people actually doing the work is essential • Input from users of the service is essential • Process mapping is essential
Documents and Records: Definitions • Documents: any information that provides direction • Policies, processes, procedures • Specifications • Plans • Regulations and standards • Records: any information that produces evidence • Requisitions • Examination results and reports • Quality Control and EQA records • Incident/Accident reports
Documenting the System • There are three types of documents used to describe laboratory protocols: • Policies • Processes • Procedures • The means of documentation can be electronic or paper • The next ten slides describe policies, processes, and procedures in detail
Policies Processes Procedures Documenting the System
Policies • Statements describing what is done and why • Define goals, briefly state the intent and direction • If your laboratory chooses to follow the CLSI model, typically, there is one policy for each Quality System Essential as listed on slide #24 • The twelve QSE policies form the basis for the Quality Manual • There may be additional “operational” policies that require documentation • Refer to supporting processes, procedures or other documentation, i.e. a list of related documents should be included
Processes • A series of inter-related steps involved in an activity or examination that uses resources and is managed to transform inputs into outputs • Usually displayed as flowcharts and illustrate the path of workflow and who is responsible • They do not include step-by-step instructions for individuals wanting to know exactly how to do something • Example: Process for Specimen Reception and Accessioning (a flow chart to show the steps involved in specimen reception and accessioning, involves more than one individual, but does not give detailed work instructions)
Processes • CLSI (NCCLS) documents HS1-A and GP26-A have some excellent examples of processes in both table and flow chart formats. • Typical processes for a laboratory service include those that follow a test from the time a health-care professional decides the test is needed through to the receipt of the test report: test ordering, specimen collection, specimen transport, specimen receipt, specimen referral, testing, interpretation, reporting. That is, pre-analytical, analytical and post-analytical processes. • Note that half of these processes do not occur within the laboratory itself, but that the laboratory still has a responsibility to document them.
Processes • Beyond these obvious processes all of the 12 Quality System Essentials (QSE) listed on slide #24 require process mapping • Examples of all of these can be found in CLSI (NCCLS) HS1-A and GP26-A • Each of the quality system essentials requires one or more processes, most of which will be linked • The output of one process is often the input to the next • Rarely is there a process that is not linked to another
Mapping Processes: Step One Map the BASIC process: • Identify and map the primary process in your facility • Begin at the highest and simplest level possible: a simple flow chart that traces a laboratory examination from physician order to the reported result • Identify the input (physician order) and the output (reported result) and all of the major steps that transform the physician order into a reported reported result • Begin with the “AS IS” process, i.e. what you are doing right now. This will allow you to identify problems and revise the process • You need to know where you are at, before you can determine where you are going!
Mapping Processes: Step Two Map the processes down to greater detail • Map processes for each of the essential elements of a quality management system: these are discussed in greater detail in unit 5 • Determine the sequence and interaction of the processes • Usually the output from one process will form the input to the next, but the relationship may be far more complex in some cases • Clarify the start and stop of each process to avoid creeping beyond the boundaries of the process being defined • Identify the personnel position responsible for each step of a process • Be sure to involve these individuals when mapping • Remember to map the processes AS THEY ARE NOW to allow you to identify problems and improve the processes
Implementation of Processes Define the criteria for determining that the process is effective. • This involves setting goals for quality performance, for example: • The Westgard rules for the quality control of quantitative results • The criteria for an acceptable and an unacceptable specimen • Target turnaround times Ensure that there are adequate resources available to implement the process • A primary function of laboratory management is to ensure that there is adequate staff and that the staff have the materials they need to do the job right Train staff and implement the process. • Effective communication and training is the key to success
Procedures • A procedure is the written work instructions that specify a way to carry out an activity, examination or step in a process. It is a set of step-by-step instructions that each individual follows • Form the classical procedure manual • Example: Procedure for performing an ABO group (the step-by-step instructions for a technologist to follow when performing the test)
Procedures • These should be written so that any individual who has a role in a process has detailed instructions to follow. • There must be step-by-step instructions available for a good number of tasks beyond technical procedures, such as responding to complaints from users of the laboratory service, validating equipment before use, accessioning specimens, entry of results into a laboratory information system. • The process flowcharts will prove to be invaluable tools to help pinpoint activities for which written procedures aremissing. • CLSI document GP2—A: Laboratory Documents: Development and Control is an excellent resource for procedure templates.
What is required for formatting? • Laboratories have the latitude to write their manuals in keeping with their own unique situation and scope of practice. • Laboratories are NOT required to revise manuals to conform to a specific template. • Assessors do not need to look for any particular format. • We do require that that appropriate document control procedures for review, identification, revision, etc. as described in section II.F (summarized on slide 21) are followed. • All analytical procedures must have the elements as described in program requirement VI.3. • The templates provided in CLSI GP26-A, and GP2-A meet our expectations and are an excellent resource.
Identification of Documents All quality management system documents must have an identification in the form of a header or footer that contains the following information: • Date of issue • Edition and/or current revision date and/or revision number • The number of pages within • Authority for issue • An electronic identification, if applicable
Document and Record Control • All documents must be approved prior to use • Changes to documents must be approved by authorized personnel • May be on any appropriate medium • Available at all locations • Reviewed periodically • For obsolete documents • Remove promptly or assure against inadvertent use • Retain for a defined length of time • Identify the document as obsolete
Documentation Hint • Since a major goal of implementing a QMS is CONTINUAL IMPROVEMENT, be sure that the system documenting policies, processes, and procedures can be easily modified by authorized personnel. • The expectation is that laboratory management will respond to opportunities for improvements, possibly by modifying protocols.
Organization Personnel Equipment Purchasing and inventory Process control Documents and records Information management Investigation of non-conformities Assessment Process improvement Service and satisfaction Facilities and safety The Quality System Essentials (QSE) • The QMS must encompass all management activities and processes relating to quality assurance. • These can be categorized into twelve essentials:
Quality Policy Statement • A document that defines the overall intentions and direction of the quality management system • Demonstrates the facility’s commitment to quality with clear leadership by top management • Leaders shape the culture of the lab: their commitment is the key to success
QMP-LS Quality Policy Statement • QMP-LS commits to maintain a quality management system to support high quality laboratory accreditation, external quality assessment and education services that: • Meet all clients’ needs; applicable regulatory, statutory and contractual requirements; and relevant national/international standards. • Evaluates and continually improves the effectiveness of the services provided. • Ensures this policy is communicated to and understood by all employees. • Provides a process for establishment, review and modification of quality objectives. • Reviews and modifies this policy for continued suitability.
Quality Manual • A compendium of policies to describe the laboratory’s quality management system • Format can vary, usually will be contained in a single volume • Can be electronic or paper • Must be easy to update • All personnel given instructions on its use • Maintained and reviewed by the quality manager
Quality Manual • Includes a description of the laboratory • Includes quality policy statement • Defines policies of the laboratory • Makes references to supporting processes and procedures, but does not include them • If a policy is documented and included in the quality manual, it must reflect actual laboratory practice • Validation of policies will be sought during the assessment visit
Quality Manual Review • Prior to each assessment visit, laboratories are asked to submit the results of a self-assessment of their quality manual. • Self-assessment form includes an evaluation of the physical aspects of the manual (i.e. table of contents, introduction, glossary, identification). • In addition, the form provides a pre-assessment of the facility’s policies as defined by the requirements and serves as a guide for assessors to locate laboratory documents when on-site
Continual Quality Improvement • Once your Quality Management system is fully documented, do not expect it to stay static for long. • The next phase is continual improvement through the use of quality indicators, internal auditing, investigation of non-conformities, and management review. • This is a primary objective of the QMS. • Continual improvement is a never-ending loop wherein a facility : • plans for a policy/process/ procedure (PLAN); • communicates it and implements it (DO); • monitors it to see if it works (CHECK) and • if a problem is identified, formulates a new or revised plan (ACT).
Analysis of Indicators • Term used to describe ways of measuring how well the quality system is working. • The analysis of daily quality control charts is the indicator most familiar to laboratory personnel, but there are measures of the pre- and post-analytical phases as well. • OLA does not dictate the use of any specific indicators. • Facilities are expected to choose indicators to reflect critical issues to outcome, or problematic issues. • Facilities should include all aspects of the service, pre-analytical, analytical and post-analytical, inpatients and outpatients, referral labs, point-of-care tests
Analysis of Indicators • Analysis is conducted by comparing against a “benchmark” where available • Lab’s own experience • Practice guidelines • Published references • Trend analysis • Remember that something must be done with the data gathered: identify opportunities for improvement and formulate an action plan.
Analysis of Indicators • Examples of pre-analytic indicators: • Specimen transport times • Wrist band checking • Quality of phlebotomy • Specimen acceptability rates • Examples of analytic indicators: • QC and EQA results • Computer downtimes • Correlation of tests e.g. POCT vs lab based results • Examples of post-analytic indicators: • Critical value reporting • Reflexive testing • Turnaround times • Reporting errors
Non-conformities • Non-fulfillment of any requirement in the performance of a laboratory examination or test. Identified from many sources, including audits, quality control, staff comments and clinician complaints. • Instances where something has gone wrong in a process. • Laboratories are expected to keep records of non-conformities and corrective actions taken. • Non-conformance reports are the biggest and best source of information for continual improvement.
Internal Audits • Recommend conducting once per year • Planned by the quality manager • Personnel should not audit their own work • Reviewed by management • Corrective or preventive actions identified, documented, and measured
Management Review • Recommend that the quality management system documentation be reviewed and signed periodically by laboratory management. • Review: reports from managerial/supervisory personnel, internal audits, external assessments, non-conformity reports, indicator analyses, feedback, etc. • Recommend that action plans for improvement are appropriately identified, developed, implemented and monitored.
Final Comments • Everyone is responsible for ensuring that the protocols of the QMS are followed. • This includes top management, directors, managers, MLTs, laboratory assistants and clerical staff. • All personnel need to be aware of what is expected of them as individuals. • It is NOT ENOUGH just to write down a series of protocols—they must be followed and they must be proven to WORK. • Each laboratory should be able to provide evidence that its processes are effective in meeting the goals defined in their policies. • It is up to the laboratory to define what records and documentation are necessary to provide this supporting evidence.
Question 1 Which of the following statements is correct? • A process states the goals of the facility. • Processes do not include step-by-step instructions. • A process only involves one individual. • Processes should always be discrete and never linked.
Question 1 The correct answer to question 1 is b) Processes do not include step-by-step instructions, these are PROCEDURES.
Question 2 Which of the statements regarding procedure manuals is correct? • Laboratories have the latitude to write their manuals in keeping with their own unique situation and scope of practice. • Laboratories are required to revise manuals to conform to the templates in CLSI GP2-A • Assessors must ensure that all manuals conform to the QMP-LS format. • Procedure manuals do not fall under the rules for document control.
Question 2 The answer to question 2 is a) Laboratories have the latitude to write their manuals in keeping with their own unique situation and scope of practice. While GP2-A is an excellent resource for those looking for a template, we do not require every facility to revise their manuals to conform to it.
Question 3 A suitable plan for continual improvement can be summarized as: • CHECK PLAN DO ACT • DO ACT CHECK PLAN • PLAN DO CHECK ACT • PLAN ACT CHECK DO
Question 3 The answer to question 3 is c)
Question 4 To be in compliance with OLA program requirements, each facility must designate a full-time “Quality Manager” • TRUE • FALSE
Question 4 The correct answer to question 4 is b) FALSE The responsibility for quality management must be assigned to an individual (quality manager or otherwise titled), but this can be either a full-time or part-time activity given in addition to other responsibilities.
Question 5 Which of the following statements is incorrect? • OLA assesses the manner in which each facility implemented their QMS. • Policies define goals and briefly state the intent and direction of the facility. • There must be step-by-step instructions for tasks other than technical procedures in the analytical phase. • The quality manual makes references to supporting processes and procedures, but does not include them.
Question 5 The answer to question 5 is a). OLA assesses the end result, not the manner in which a facility’s QMS was implemented.
Additional Optional Resources • ISO 9000:2005. Quality management systems—Fundamentals and vocabulary. • ISO 9001:2000. Quality management systems—Requirements. • ISO 9004-2000. Quality management systems—Guidelines for performance improvements • ISO 17025. General Requirements for the Competence of Testing and Calibration Laboratories.