Unit 18 Objectives- QA and QC in the Molecular Laboratory
Textbook Chapter 16
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
State the most common cause of cross contamination of clinical specimens.
State the reason for never returning an aliquot to the original sample
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
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 quantitative
State the organization which publishes guidelines for forensic testing.
State the frequency for periodic review of the laboratory procedure
State the length of time a retired procedure must be kept by the clinical
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
List and describe the processes and/or procedures to 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
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
State the organization which monitors workers who are exposed to radioactive
List the special safety precautions required when working with radioactive
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 Analyte specific reagents
Describe how test results must be reported out.
Describe why the confidentiality of molecular diagnostic testing is
Discuss the challenges in the area of standard reagent sets and instrumentation,
especially when changes occur.