MLAB 2378 Fundamentals of Molecular Diagnostics Links

MLAB 2378 Fundamentals of Molecular Diagnostics

Unit 19 Objectives- QA and QC in the Molecular Laboratory

Describe the purpose of the Clinical Laboratory Improvement Act (CLIA) of 1988.
List 5 items which are specified by CLIA which must be met to document quality testing for moderate and/or high complexity tests..
List three aspects of a specimen utilized for molecular testing which may affect the success of the procedure.
Name the organization which has set recommendations for collection of specimens under standardized conditions.
Describe the information which must be submitted, including information on the sample itself, for acceptance by the laboratory.
List 5 additional pieces of information which may be required for samples submitted for genetic and parentage testing.
List three items which must be included in documenting in the specimen accessioning record.
State the most common cause of cross contamination of clinical specimens.
State the reason for never returning an aliquot to the original sample tube.
State the affects of hemoglobin and/or coagulants present in the sample on the results obtained.
State the purpose of buffers and resins utilized in sample preparation.
State the preservation method of choice for tissue samples which cannot be analyzed immediately.
State why paraffin embedded tissues are less desirable than fresh or alternatively preserved tissues.
List three additives frequently used for phlebotomy collection tubes for molecular testing and the two which are the most popular.
State the problems encountered using heparin as an additive.
State the reason the use of disodium EDTA should be avoided.
State the advantages of using a plasma preparation tube (PPT) and list 4 types of analyses for which this tube is utilized.
State the challenges and solutions for obtaining samples for RNA testing.
List additional PPE required for processing frozen tissue samples.
State why gloves are essential in a molecular laboratory.
List two molecular reagents that are at highest risk at being contaminated.
State the precautions which must be in place to prevent RNA and DNA from enzyme exposure.
State why fresh samples are required for fluorescent in-situ hybridization (FISH) and karyotyping procedures.
State the name of the organization which accredits clinical laboratories.
State the preferred material for samples which must be stored long term for molecular testing.
List the shipping conditions for blood, bone marrow and tissue samples sent to a reference laboratory for testing.
List the storage conditions and accepted storage times for isolated and purified DNA.
State the reason that refrigeration is preferred for a frequently used clean DNA sample.
State the reason that a frost-free freezer is not recommended for storage.
State the storage conditions and length of storage for RNA samples.
Briefly state the validation methods for: new, predeveloped, FDA approved and/or test modification procedures.
List the items which must be included in qualitative and quantitave written procedures.
State the organization which publishes guidelines for forensic testing.
State the frequency for preiodic review of the laboratory procedure manual.
State the length of time a retired procedure must be kept by the clinical laboratory.
List and describe the controls used for qualitative and quantitative procedures and the purpose of each.
State the purpose of internal controls and how they are used in the test procedure.
List and describe the processes and/or procedures tho ensure controls and standard curves are valid.
State why frozen controls must be tested with old aliquots of controls.
Describe the elements of a quality assurance plan for molecular testing.
Describe the instrument maintenance and monitoring process required for: instruments, refrigerators, freezers, thermometers, thermocyclers, centrifuges, automatic pipettors, electrophoresis equipment, photographic equipment, spectrophotometers, instruments used for background measurements, fume hoods and laminar flow hoods. Include the appropriate intervals for monitoring, documentation and action to take when malfunctions occur.
State the recommendations for performing instrument calibration verification and instrument recalibration, include the time interval if appropriate.
List and describe three materials which may be used for instrument calibration.
Describe procedures for validation and use of primers and probes.
State four descriptive items of information which must be documented for probes used in the laboratory.
Describe quality assurance procedures for multi-plex reactions.
Describe the types of analyte-specific reagents available for home-brew testing and state the ASR used most commonly in the routine molecular laboratory and blood banks.
State the organization which developed the chemical safety warning labels.
State the organization which monitors workers who are exposed to radioactive reagents.
List the special safety precautions required when working with radioactive reagents.
Describe and state the purpose of proficiency testing in the molecular laboratory, including the frequency of testing required.
State how laboratories can perform proficiency testing when a commercial product is not available.
Explain documentation and reporting of results, including gene sequencing.
Describe the disclaimer required for class I Aanalyte specific reagents (ASR).
Describe how test results must be reported out.
Describe why the confidentiality of molecular diagnostic testing is so important.
Discuss the challenges in the area of standard reagent sets and instrumentation, especially when changes occur.
Define or describe the terms listed in the "Unit 19 Vocabulary".