Quality Assessment / Quality Assurance Flashcards
What is the purpose of a quality assurance program?
assess and improve reliability and efficiency of the laboratory to ensure highest possible quality of service is provided AND to comply with regulatory requirements
What is the scope of the quality assurance plan?
comprehensive- must resolve known, identified or suspected problems that may have a negative effect on the provision of laboratory services
should focus on issues that may improve testing proceses
all phases - pre-analytical, analytical and post-analytical must be included
written policies and procedures detailing quality assurance process - WHO WHAT WHERE WHEN WHY HOW
What are the goals of quality assurance?
Ensure policies and procedures are effective and comply with lab laws and regulations
Ensure accurate, reliable and efficiency performance of tests and test reporting
improve overall quality and efficiency of the labs service by promoting effective, efficient and appropriate use of resources
ensure safe environment for patients and staff
meet needs of physicians in diagnosis and treatment of patients
What are the objectives of the quality assurance plan?
Provide organized, systematic process designed to accomplish the goals
1) identify, prioritize, monitor, evaluate act on, resolve issues that impact test management, performance or patient care
2) Evaluating personnel to assess competence and maintenance of skill
3) Implement effective solutions to problems
4) communicate findings to staff
5) follow up on all corrective actions to ensure improvements have been maintained
6) coordinate all lab QA activities
7) review on annual basis and update as necessary the QA plan
What are critical indicators?
processes or events that reveal how well the laboratory is functioning
monitoring critical indicators identifies problems significant enough to require review, analysis and implementation of appropriate corrective action
represent problems that would negatively impact lab testing or patient care
Critical indicators should be selected for which categories?
test management and performance
Appropriate utilization of services
proficiency testing
user satisfaction
safety
quality control
observed or reported incidents
competency of personel
What is the principle of QA program?
QA is achieved by regularly reviewing critical indicators in three major phases of lab testing: pre-analytical, analytical and post-analytical
Problems are acted upon to prevent future occurrence
observations that could provide opportunities for implementation are acted upon
What are the methods for QA review?
Must determine method used to collect data
data collected will be evaluated to determine whether critical indicator thershold or expectations have been met
choose method or combination that is most efficient or effective for the laboratory
Examples of methods: chart audits, lab test log reviews, corrective/remedial action log reviews, QC record reviews etc.
Method represents HOW
What are Elements in QA plan?
Elements are the policies and procedures associated with each phase of testing
used when determining which critical indicators will be evaluated
WHAT aspect of QA plan
Example: Element = patient preparation; critical indicator = non fasting specimens submitted for lipid profile
List elements of the pre-analytical phase
1)patient preparation,
2)specimen collection/labelling and accessioning
3) Specimen preservation/storage/transport
4) test requisitions
5) Relevance of test requests
6) specimen rejection criteria and actions initiated
7) confirmation of oral requests
8) Evaluation and verification of employee competence
9) Safety
10) Procedure updates and reviews
What are analytical phase elements?
1) INstrument monitoring, validation, operation functions, inspections, preventative maintanece, operational parameters
2) Calibration and calibration verification
3) Quality control evaluations
4) Proficiency test results
5) Comparative analysis for multiple analyze methodologies/locations
6) Quality management of lab supplies, reagents and materials
What are elements of post-analytical phase?
1)Appropriateness and acceptability of test results
2) completeness of test reports
3) timely reporting of all test results including STAT
4) Accuracy and reliability of test reporting systems
5) Appropriate storage and retrieval of records of test results
6) Problems in communicating with physicians or other workers
7) complaint investigation and evaluation and corrective actions
8) Compliance with regulatory requirements
9) User satisfaction monitors (physician and patient)
10) Incidence reports
11) Review of QA reports with staff
How do you select critical indicators?
Choose critical indicators for each element that may actually lead to identifying a problem or improving a process
Once indicator has been selected identify
1) Data that need to be collected
2) Time period to be covered
3) Limits of acceptability (Thresholds)
How long must quality assurance documents be retained?
2 years and must be easily revtreivable during on- site inspections
What should be included in documentation of QA activities?
Date,
Initials of person,
Scope or method of review,
Analysis of problem, Written documentation of any corrective action
Description of effectiveness of the corrective action, date for followup review
Documentation that QA review has been discussed with the lab director, staff and lab management
