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QUALITY IN THE LAB
Quality in the Clinical Laboratory
| Question | Answer |
|---|---|
| What is the definition of quality? | doing the right test, at the right time, for the right person |
| In order to perform quality work, we must... | - know the customer's need - meet their requirements - apply corrective action when mistakes happen in order to prevent future repetition of error - have all the resources and trained staffing necessary to do our job successfully |
| QMS stands for | Quality Management System |
| What is a QMS? | resources and structures within an organization to implement quality management via policies and procedures; these contribute to testing quality both directly and indirectly |
| What are the main components of an effective QMS? | - training/outgoing staff support - management of finances and budgeting - quality assurance/good communication - management of equipment/supplies - quality service to lab users |
| CQI= | Continuous Quality Improvement |
| TQM= | Total Quality Management |
| QA= | Quality Assurance |
| What is Quality Assurance? | A sequence of actions that are essential to be confident that services will satisfy customer needs |
| Record keeping, calibration, and proficiency testing are examples of actions done to ensure that | the results produced from the lab are reliable |
| What is in the Preanalytical Process? | - test ordering - specimen collection specimen transport - specimen processing |
| What is in the Analytical Process? | QC testing and result interpretation |
| The reporting and archival of specimen is part of which part of the QA cycle? | Postanalytical Process |
| What are the three stages of the QA Cycle? | Preanalytical/analytical/postanalytical |
| Where does the 70% majority of medical error occur? | In the preanalytical stage |
| "Management from the ground up" is associated with what Quality Program? | TQM |
| What is the function of a TQM program? | It encourages lower level techs to suggest quality improvement during committees; their voices are the closest to the customer base |
| What does the TQM program look like in action? | they collect data on a problem and draft a plan meant to improve it. this is then presented to the administration that approves the plan and collects new data from it to evaluate its effectiveness |
| CQI programs are meant to improve quality on a/an | ongoing basis |
| What does the CQI program look like in action? | they review data on a regular basis (daily to monthly), enact a plan, and change to act on it |
| DMAIC stands for | define measure analyze improve control |
| The DMAIC acronym is often associated with what QA program? | Six Sigma |
| DPM= | defects per million |
| Why must we maintain analytical quality? | it doesn't matter how fast a result is churned out, if the result is untrue |
| The uniform design of the SOPs was created by what organization? | Clinical Laboratory Science Institute (CLSI) |