Quality Assurance and Performance Improvement
What is a comprehensive set of policies and procedures, and practices necessary to make sure that
the overall operation of the health care facility provides the yes possible management of the patient?
- ANSWER-Quality assurance.
What is a set of laboratory procedures designed to ensure that the test method is working properly
and that results meet diagnostic needs of the physician? - ANSWER-Quality control.
Includes
Control samples
Charting results
Analyzing results statistically
Laboratories Role in QA - ANSWER-Ensure that results are reliable
Provide ranges called reference ranges that indicate what is "normal"
Have ongoing QA process for monitoring analytic results
Ensure reliability (accuracy and reproducibility) of results
Centers of Medicare and Medicaid Services (CMS) - ANSWER-Replaced Health Care Financing
Administration (HCFA)
Established regulations to implement the Clinical Laboratory Improvement Act of 1988 (CLIA)
Any facility performing quantitative, qualitative, or screening tests on materials derived from the
human body are regulated by CLIA
Regulations depend on complexity of testing performed
CLIA 88 - ANSWER-Complexity determined by
Risk of harm to patient
Likelihood of erroneous results
Type of testing method
Degree of independent judgment required
Interpretation and availability of home use for the test
Public Service Act - ANSWER-Lab receiving Medicare or Medicaid must be licensed under this act
Responsibility of CMS
Laboratory Standards - ANSWER-Set by Clinical and Laboratory Standards Institute (CLSI)
Formerly called NCCLS
Components of QA - ANSWER-Facilities and resources
Technical competence
QA procedures in the laboratory
Specimen procurement and labeling
Specimen transportation and processing
Quality control
Procedure manuals
Problem solving mechanisms
Instrumentation, turn-around times, accuracy of results, documentation, & record keeping
Facilities and Resources - ANSWER-Physical lab site must be conducive to good performance
Must be safe
Adequate, properly maintained equipment and supplies
Technical Competence - ANSWER-Well-trained, competent personnel
Able to perform tests, QC, maintain instruments, keep accurate & systematic records
Thoroughly oriented on lab policies and procedures
, Continuing education for upgrading skills
Competency evaluated regularly
Supervisors monitor all analytic reports and evaluate for errors
Quality Assurance Procedures - ANSWER-Specimen procurement and labeling
Specimen transportation and processing
Quality control
Procedure manuals
Problem solving mechanisms
Instrumentation, turn-around times, accuracy of results, documentation, & record keeping
Test Requesting Procedures - ANSWER-Must include patient identification data, time and date of
collection, source of specimen, test requested
Complete form must accompany specimen
Specimen Procurement and Labeling - ANSWER-Information on specimen must be matched with
laboratory test(s) request form
Accessible handbook of specimen requirements (must be current)
Emphasis on universal precautions
All specimens must be labeled by person collecting specimen
Analytic result is only as good as specimen received
Specimen Transportation & Processing - ANSWER-Specimens must be transported to lab in safe,
timely manner
Specimen arrival must be documented and status in the laboratory determined at any time
Quality Control - ANSWER-Includes monitoring the performance of lab instruments, reagents,
products, and equipment
Must be carefully documented
Deviation from normal results
Problems or failures in instrument function
Corrective action taken in response to problems
QC - ANSWER-Includes preventive maintenance records, temperature charts, QC charts for
procedures
Reagents and products must be checked before use in patient testing
Use of QC samples, proficiency testing and standards
Procedure Manuals - ANSWER-Must be complete for all analytic procedures performed
Should contain patient preparation, specimen requirements, test request information, criteria for
performing test, procedural information including reagents and controls used, instrument calibration,
maintenance checks performed, QC data, reference values, how to report results
Procedure Manual - ANSWER-Must be reviewed and updated regularly by the supervisor
Clinical and Laboratory Standards Institute (CLSI)
Formerly National Committee for Clinical Laboratory Standards (NCCLS)
Sets guidelines for writing procedure manuals
Problem Solving Mechanisms and Performance Improvement - ANSWER-Any problem or situation
that might affect the outcome of a test must be recorded and reported
Corrective action must be taken to address problems
Corrective action must be documented
Any problem in the overall operation of the laboratory must be addressed, corrected, and
documented to improve performance of the laboratory
Other QA Procedures - ANSWER-Determining turnaround times
What is a comprehensive set of policies and procedures, and practices necessary to make sure that
the overall operation of the health care facility provides the yes possible management of the patient?
- ANSWER-Quality assurance.
What is a set of laboratory procedures designed to ensure that the test method is working properly
and that results meet diagnostic needs of the physician? - ANSWER-Quality control.
Includes
Control samples
Charting results
Analyzing results statistically
Laboratories Role in QA - ANSWER-Ensure that results are reliable
Provide ranges called reference ranges that indicate what is "normal"
Have ongoing QA process for monitoring analytic results
Ensure reliability (accuracy and reproducibility) of results
Centers of Medicare and Medicaid Services (CMS) - ANSWER-Replaced Health Care Financing
Administration (HCFA)
Established regulations to implement the Clinical Laboratory Improvement Act of 1988 (CLIA)
Any facility performing quantitative, qualitative, or screening tests on materials derived from the
human body are regulated by CLIA
Regulations depend on complexity of testing performed
CLIA 88 - ANSWER-Complexity determined by
Risk of harm to patient
Likelihood of erroneous results
Type of testing method
Degree of independent judgment required
Interpretation and availability of home use for the test
Public Service Act - ANSWER-Lab receiving Medicare or Medicaid must be licensed under this act
Responsibility of CMS
Laboratory Standards - ANSWER-Set by Clinical and Laboratory Standards Institute (CLSI)
Formerly called NCCLS
Components of QA - ANSWER-Facilities and resources
Technical competence
QA procedures in the laboratory
Specimen procurement and labeling
Specimen transportation and processing
Quality control
Procedure manuals
Problem solving mechanisms
Instrumentation, turn-around times, accuracy of results, documentation, & record keeping
Facilities and Resources - ANSWER-Physical lab site must be conducive to good performance
Must be safe
Adequate, properly maintained equipment and supplies
Technical Competence - ANSWER-Well-trained, competent personnel
Able to perform tests, QC, maintain instruments, keep accurate & systematic records
Thoroughly oriented on lab policies and procedures
, Continuing education for upgrading skills
Competency evaluated regularly
Supervisors monitor all analytic reports and evaluate for errors
Quality Assurance Procedures - ANSWER-Specimen procurement and labeling
Specimen transportation and processing
Quality control
Procedure manuals
Problem solving mechanisms
Instrumentation, turn-around times, accuracy of results, documentation, & record keeping
Test Requesting Procedures - ANSWER-Must include patient identification data, time and date of
collection, source of specimen, test requested
Complete form must accompany specimen
Specimen Procurement and Labeling - ANSWER-Information on specimen must be matched with
laboratory test(s) request form
Accessible handbook of specimen requirements (must be current)
Emphasis on universal precautions
All specimens must be labeled by person collecting specimen
Analytic result is only as good as specimen received
Specimen Transportation & Processing - ANSWER-Specimens must be transported to lab in safe,
timely manner
Specimen arrival must be documented and status in the laboratory determined at any time
Quality Control - ANSWER-Includes monitoring the performance of lab instruments, reagents,
products, and equipment
Must be carefully documented
Deviation from normal results
Problems or failures in instrument function
Corrective action taken in response to problems
QC - ANSWER-Includes preventive maintenance records, temperature charts, QC charts for
procedures
Reagents and products must be checked before use in patient testing
Use of QC samples, proficiency testing and standards
Procedure Manuals - ANSWER-Must be complete for all analytic procedures performed
Should contain patient preparation, specimen requirements, test request information, criteria for
performing test, procedural information including reagents and controls used, instrument calibration,
maintenance checks performed, QC data, reference values, how to report results
Procedure Manual - ANSWER-Must be reviewed and updated regularly by the supervisor
Clinical and Laboratory Standards Institute (CLSI)
Formerly National Committee for Clinical Laboratory Standards (NCCLS)
Sets guidelines for writing procedure manuals
Problem Solving Mechanisms and Performance Improvement - ANSWER-Any problem or situation
that might affect the outcome of a test must be recorded and reported
Corrective action must be taken to address problems
Corrective action must be documented
Any problem in the overall operation of the laboratory must be addressed, corrected, and
documented to improve performance of the laboratory
Other QA Procedures - ANSWER-Determining turnaround times
