[1S] UNIT 2: Quality Assurance for Diagnostic Laboratories Flashcards
It is defined as accuracy, reliability and timeliness of reported test results.
Quality Assurance (QA)
The set of planned and systematic activities focused on providing confidence that quality requirements will be fulfilled.
Quality Assurance (QA)
Can be defined as “coordinated activities to direct and control an organization with regard to quality”. This definition is used by the International Organization for Standardization (ISO) and by the Clinical and Laboratory Standards Institute (CLSI).
Quality Management System
A widely used quality management system model organizes all of the laboratory activities into twelve quality system essentials, which are a set of coordinated activities that serve as building blocks for quality management.
Quality Management System (QMS) Model
GENERAL ADMINISTRATIVE GUIDELINES
It monitors and regulates all procedures for continuous measurement and improvement of laboratory performance by ensuring all laboratory processes follow Standard Operating Procedures (SOPs) validated at predefined parameters.
Internal Quality Assurance (IQA) system
GENERAL ADMINISTRATIVE GUIDELINES
known as proficiency testing (PT), are inevitable for monitoring of performance. It is necessary to periodically assess the analytical performance of molecular tests by inter-laboratory comparison.
External Quality Assurance (EQA) programs
SPECIMEN HANDLING
is the consequence of erroneous or misleading results caused by events that occur prior to sample analysis. The Clinical and Laboratory Standards Institute (CLSI) provides recommendations for the collection of specimens under standardized conditions.
Preanalytical error
SPECIMEN HANDLING
T/F: Specimen collection, transport and handling in the laboratory require careful attention, whereas the age, type and condition of the specimens are vital to the success of a clinical laboratory experiment.
T
SPECIMEN HANDLING GUIDELINES CLSI
T/F: 1. A requisition or electronic order should accompany the specimen.
T
SPECIMEN HANDLING GUIDELINES CLSI
T/F: The condition of the specimen, and the chain of custody (if necessary) isn’t reviewed on receipt of the laboratory.
F; is reviewed
SPECIMEN HANDLING GUIDELINES CLSI
T/F: 3. No specimen is accepted without proper labeling and identification on the specimen tube or container.
T
SPECIMEN HANDLING GUIDELINES CLSI
T/F: 4. The test requisition includes the type of specimen material (blood or bone marrow), ordered test, date and time of collection, reason for testing and the contact information of the ordering physician.
T
SPECIMEN HANDLING GUIDELINES CLSI
T/F: 5. The laboratory should have written procedures for documentation of specimen handling and accession.
T
SPECIMEN HANDLING GUIDELINES CLSI
T/F: 6. If a specimen is unacceptable, the disposal or retention of the specimen is not recorded in the patient report or laboratory quality assurance records.
F; is recorded
SPECIMEN HANDLING GUIDELINES CLSI
T/F: 7. If not processed immediately, specimens are maintained in secure areas with limited access under the appropriate conditions for the analyte being tested.
T
SPECIMEN HANDLING GUIDELINES CLSI
T/F: Biohazard stickers are required for cabinets, freezers that contain potentially hazardous specimens.
T
EXAMPLES OF SPECIMEN HANDLING TECHNIQUES
- Nucleic acid-based testing on specimens on buccal cell suspensions and cerebrospinal fluids (CSF) must be performed.
- The entire specimen is not used during isolation of nucleic acid to avoid cross-contamination during pipetting.
Routine Molecular Amplification lab setup
EXAMPLES OF SPECIMEN HANDLING TECHNIQUES
Specimens received in the lab should be inspected for visual signs of hemolysis. Buffers and resins have been designed to sequester anticoagulants or hemoglobin for more rapid nucleic acid isolation.
DNA and RNA isolation procedures
EXAMPLES OF SPECIMEN HANDLING TECHNIQUES
T/F: Solid tissues are best analyzed from heated samples. Highly recommended protocol before performing southern blot or polymerase chain reactions (PCR) methodologies that require high quality DNA.
F; fresh or frozen samples
COLLECTION TUBES FOR MOLECULAR TESTING
Chemistry, serum, viral antibody studies
Red top
COLLECTION TUBES FOR MOLECULAR TESTING
Immunology, virology studies
Sodium heparin (Freeze-dried) (Green)
COLLECTION TUBES FOR MOLECULAR TESTING
Cytogenetic & molecular studies
Sodium Heparin (Brown)
- Lithium is toxic to the cell
COLLECTION TUBES FOR MOLECULAR TESTING
Virology, molecular biology studies
Tripotassium EDTA (7.5-15%) (Lavender)
COLLECTION TUBES FOR MOLECULAR TESTING
Molecular biology studies
Acid Citrate Dextrose Solution (Yellow)
COLLECTION TUBES FOR MOLECULAR TESTING
T/F: Blood or bone-marrow specimens collected in EDTA or ACD tubes are preferred.
T
PRECAUTIONS IN SPECIMEN HANDLING
According to Centers for Disease Control and Prevention, ALL specimens must be handled by _______ ______________ using Personal Protective Equipment (PPE).
standard precautions
PRECAUTIONS IN SPECIMEN HANDLING
Include respirators that are used with airborne or contact-transmissible agents.
Transmission-based precautions
PRECAUTIONS IN SPECIMEN HANDLING
These are designed for direct patient care where there is a potential for direct exposure to infectious agents on or from the patients.
Contact precautions
T/F: In general, gloves, face masks, eye protection and gowns are standard precautions (PPE) used by molecular biologists and medical technologists when in direct contact with patients. These are necessary when performing nucleic acid isolation procedures to prevent contamination with nucleases
T
EQUIPMENT MAINTENANCE
must exist to demonstrate and provide evidence that all instrumentation and equipment are validated, operated, inspected, maintained, tested and standardized to ensure optimal quality of assay results.
SOPs and supporting documentations
EQUIPMENT MAINTENANCE
documents and reviews the equipment performance and maintenance consistently and on a routine basis.
Laboratory personnel
EQUIPMENT MAINTENANCE
must review, sign, and date all documentation of equipment maintenance at least monthly. All laboratory equipment should be listed on the inventory.
Supervisory staff member
SPECIFIC SERVICE GUIDELINES PER EQUIPMENT
Check for volumetric accuracy and reproducibility, and recalibrate as necessary at specific defined intervals, at least once every 6 months.
Adjustable and fixed-volume automatic pipettors
SPECIFIC SERVICE GUIDELINES PER EQUIPMENT
Test against a standardized thermometric device annually.
Thermometers
SPECIFIC SERVICE GUIDELINES PER EQUIPMENT
Establish tolerance limits for temperatures which must reflect the most stringent needs of all reagents, supplies and specimens stored within it.
Refrigerators and freezers
SPECIFIC SERVICE GUIDELINES PER EQUIPMENT
Establish tolerance limits for temperatures, carbon dioxide levels and humidity as applicable.
Incubators and water bath
SPECIFIC SERVICE GUIDELINES PER EQUIPMENT
Measure operating speeds periodically with a tachometer.
Centrifuges
SPECIFIC SERVICE GUIDELINES PER EQUIPMENT
Verify content processing using heat sensitive tape with each autoclave batch. Verify effective sterilization with an appropriate biological indicator weekly.
Autoclave
SPECIFIC SERVICE GUIDELINES PER EQUIPMENT
Check accuracy with standard weights and class at a predetermined frequency.
Analytical balances
SPECIFIC SERVICE GUIDELINES PER EQUIPMENT
Verify air intake grills are not obstructed. Certify cabinets/hoods annually by a trained service
technician, certified maintenance department or company.
Biosafety cabinets/laminar flow hoods
SPECIFIC SERVICE GUIDELINES PER EQUIPMENT
Any equipment that is out of service for any reason should be clearly identified and removed from the laboratory.
Out of service equipment
