C - Lesson 9 Quality Assurance Flashcards
[?] of patient samples can be a complex procedure, depending on clinical analysis, microbiological stud y, or blood banking testing among other facets of the clinical laboratory.
Laboratory testing
is one of the most important impacts on laboratory testing — it ensures both precision and accuracy of patient sample results.
Quality control (QC)
The integrity of [?] is important to both management of overall quality as well as to meeting requirements of proficiency testing.
quality control samples
Addressing QC issues is critical to the identification of potential errors with patient results, including [?] as well as [?] of testing function.
reagent matrix effects
calibration misalignment
Maintaining [?] of laboratory sample testing through quality control is vital to ensuring that patient testing is done right and that it produces accurate results.
accurate and frequent checks
A program in which the overall activities conducted by the institution are directed toward assuring the quality of the products and services provided
Quality Assurance Program
The overall process of guaranteeing quality patient care
Quality Assurance Program
– focus on the monitoring of outcomes or indicators of care
Quality Assurance
– applied to activities directed toward the monitoring of the individual elements of care
Quality Control
Intralaboratory
Internal Quality Control
appropriate and standard laboratory methods, reagents, supplies and equipment
Internal Quality Control
proper maintenance and monitoring of all equipment.
Internal Quality Control
quality control reference materials.
Internal Quality Control
documented, continuous competency assessment program for all laboratory personnel
Internal Quality Control
Interlaboratory
External Quality Control
intended to monitor the delivery of the overall services of the laboratory as part of the health care team (indicators of quality performance)
External Quality Control
National Reference Laboratories
External Assurance Program (Proficiency testing)
Recognized reference laboratories.
External Assurance Program (Proficiency testing)
Everything that precedes actual test performance
Preanalytical
Test ordering by physician
Preanalytical
test ordering by nursing/clerical staff
Preanalytical
patient preparation
Preanalytical
patient identification
Preanalytical
specimen collection
Preanalytical
specimen transport
Preanalytical
specimen processing
Preanalytical
Everything related to the actual testing process
Analytical
Test analysis
Analytical
quality control reagents
Analytical
calibration
Analytical
preventive maintenance
Analytical
Everything that comes after test analysis
Verification of calculations and reference ranges
review of results
procedures for notification of critical values
result reporting
test interpretation by physician
follow patient care
All [?] are involved.
patients, laboratory personnel, laboratory equipment, and laboratory tests
Specific aspects include
patient preparation and identification, specimen collection, transportation and handling of the specimen, performance of the test, and the reporting of test results
The laboratory’s relation to other hospital departments - [?].
the nursing service, the admitting office, the outpatient department, public relations, purchasing, the storeroom, the pharmacy, surgical supplies, and the medical staff
should be collected in a manual to be revised at least once a year or when procedures are changed.
Laboratory policies and procedures
Copies of this manual should be available to other hospital departments
Laboratory policies and procedures
the main concern of this Q.C. system is the detection of a problem
Quality Surveillance System
offer education, realization of why errors happen, and program to remedy offer education, realization of why errors defects (equipment, technique, specimen procurement, storage of reagents, etc.)
Quality Control Corrective System
established to prove that corrective measures have actually brought results (Q.C. charts, S.D. calculations, etc.)
Objective Q.C. Parameters
Provide resources for independent assessment of the technical performance
External programs
Methods that are intended to monitor the delivery of the overall services of the laboratory as part of the health care team (indicators of quality performance)
Quality Monitoring & Assessment tools
eg. Validity of diagnosis & suitability of services provided
Quality Monitoring & Assessment tools
The Total Testing Process
requesting for the test
specimen collection
actual analysis
reporting of results
interpreting the result
Patient
Specimen Collection
Time of collection
Specimen Collection
Method of collection
Specimen Collection
Collection equipment
Specimen Collection
Technical & Physical facilities
Specimen Collection
Processing
Specimen Preparation
Centrifugation
Specimen Preparation
Separation
Specimen Preparation
Method/Procedure
Actual Analysis
Reagents
Actual Analysis
Standards and Controls
Actual Analysis
Glasswares/Equipment/Machines
Actual Analysis
Technical & Physical facilities
Actual Analysis
Method/Manner of Reporting
Reporting & Interpretation
Laboratory language (Communication)
o Laboratory interpretation
o Physician’s interpretation
Reporting & Interpretation
Professional Relationships within and outside the Laboratory
Reporting & Interpretation
o “There shall be a system of accurate recording to ensure quality results”
RA 4688
o “There shall be a provision for filing, storage and accession of all reports.
RA 4688
Laboratory records
Recording
Anatomic & Forensic records
Recording
Written policies and procedures
Quality Assurance Plan
Routine evaluation of staff performance
Quality Assurance Plan
Continuing education (documented)
Quality Assurance Plan
Safety program
Quality Assurance Plan
Specimen collection and handling
Quality Assurance Plan
Safety program (for staff and patients)
Quality Assurance Plan
Corrective action required if controls are out of range
Quality Assurance Plan
(to ensure that scheduled activities & duties are performed
Checklist
(specimens from PT sponsors should be treated exactly like the patients sample
Participation in proficiency testing
– gives official approval that the laboratory follows all of the guidelines set forth by the accrediting agency.
Accreditation by the appropriate agency
Factors affecting Quality Assurance Program (QAP)
✓ Staffing
✓ Physical facilities
✓ Equipment/Instruments
✓ Glasswares/Reagent/Supplies
✓ Waste Management/Biohazard practices
✓ Quality Control Programs
✓ Reporting
✓ Recording
✓ Patient
✓ Bench Space
✓ Methods/Procedures/tests
✓ Standards
✓ Controls
✓ Laboratory rules and regulations
✓ Professional Relationships within and outside the Laboratory
10 steps to a Quality Assurance Plan
- Assign responsibility
- Delineate scope of care
- Identify important aspects of care
- Identify indicators related to these aspects of care
- Establish thresholds for evaluation
- Gather and organize data
- Evaluate care when thresholds are reached
- Take corrective action
- Asses the effectiveness of actions; document improvement
- Communicate relevant information
is designed to detect, reduce, and correct deficiencies in a laboratory’s internal analytical process prior to the release of patient results, in order to improve the quality of the results reported by the laboratory.
Laboratory quality control
can be defined as accuracy, reliability and timeliness of reported test results.
Laboratory quality
The [?] must be as accurate as possible, all aspects of the [?] must be reliable, and [?] must be timely in order to be useful in a clinical or public health setting.
laboratory results
laboratory operations
reporting
In order to achieve the highest level of accuracy and reliability, it is essential to perform [?] in the laboratory in the best possible way.
all processes and procedures
The [?] is a complex system, involving many steps of activity and many people.
laboratory
The [?] of the system requires that many processes and procedures be performed properly.
complexity
Therefore, the [?], which looks at the entire system, is very important for achieving good laboratory performance
quality management system model
