Module 1 Flashcards
What is quality?
Meeting the needs and expectations of users and customers
What are the characteristics of quality lab test results?
Valid
Applicable
Timely
Cost efficient
Cause no patient harm
How are high quality test results ensured?
Ensuring best possible and realistic accuracy and precision
Detecting errors in a timely manner
Designing approaches to help prevent errors
Developing systems to provide applicable results in usable time frames
What is the clinical lab’s path of workflow?
The process that changes a physician’s order into lab info
What are the three phases of path of workflow? And what is involved with each?
Preanyalytical- test ordering, specimen collection, specimen transport, specimen receipt and processing
Analytical- test performance, review of test results, interpretation of test results
Postanalytical- test result reporting, specimen management
What is sample quality influenced by?
The completeness and correctness of all of the actions performed
What are preanalytical processes?
All activities that take place from the time the lab tests are ordered to the time the specimens are processed and delivered to the lab
What are the quality requirements for test ordering?
Req must be legible and include:
Correct patient info
Applicable clinical data or special requirements
Appropriate test
Type of specimen and anatomic site of origin (if applicable)
Correct destination location for results
What are the quality requirements for specimen collection?
Patient prep
Correct patient ID
Correct specimen collection technique
Correct tube
Adequate sample vol
Collected at right time
Specimen properly labelled
What are the quality requirements for specimen transport?
Transported within required timeframe
Accepted temp
Transported safely
What are the quality requirements for specimen receipt and processing?
Verification of correctness and completeness of req and specimen label
Specimen correctly accessioned into info system
Appropriate expedition of urgent specimens
What are analytical processes?
All the activities involved in performing a test, verifying the reliability of the test results and interpreting the findings
What are the quality requirements for test performance?
Comprehensive process, equipment and computer system validation
Equipment/systems maintained properly
Test is performed according to procedure instructions
Defined method/test specificity and sensitivity
Calibration and/or QC material prepared correctly
Test calibration performed correctly
Right tests run on right specimen
Adequate specimen vol
QC monitored and acted on appropriately
Processes in place for recognizing the presence of interfering substances
Established trouble shooting processes
What are the quality requirements for the review of test results?
Delta checks are performed when applicable
Follow up when results are significantly different (after delta check)
Auto verification processes are validated prior to use
What are the quality requirements for the interpretation of test results?
Available comparisons for interpreting data
Process in place to ensure test results correlate with patient’s diagnosis/symptoms
Recognize when results aren’t right (alert values)
What are postanalytical processes?
All activities involved in reporting and archiving results as well as retention of specimens
What are the quality requirements of test result reporting?
Report is legible, interpretive and without interpretive mistakes
Report includes patient, test and ordering location info
Report includes results with applicable reference ranges, interpretations and consultations
Process is in place to ensure all results are made available at the location they’ll be accessed
Established processes for notifying clinician of alert or critical test results and docs for notification
Timely delivery of results
Process in place for correcting reports
Method to archive and access previous test results
What are the quality requirements for specimen management?
Specimen storage conditions in place to maintain stability
Specimen retention in place for enough time that samples are available for follow up testing if required
Process in place to easily access stored specimen when required
What are the stages of quality?
Total quality management- organization, overall management of processes and outcomes
Quality management- focus on financial impact of processes
Quality system- maintenance and improvements of lab processes to meet quality goals, supervisor/tech II/III
Quality assurance- provides confidence that an organization fulfills quality requirements, monitors QC data and looks for opportunities to improve processes, review, identifies and eliminates problems, plans, policies and procedures
Quality control- regular operational activities that ensure high quality test results, everyday maintenance techs do
What does a QA program include?
Commitment
Facilities and resources
Technical competencies
Technical procedures
Problem solving mechanism
What is the purpose of the clinical lab?
Providing high quality patient test results
