Exam 1: Lecture 1- Quality Assurance, Urine Specimen Types Flashcards
Most labs are regulated under an act of the U.S. Congress called…
Clinical Laboratory Improvement Amendment of 1988 (CLIA’88)
How does CLIA ‘88 divide labs and laboratory tests? (What are the categories)
waived, moderate, and high-complexity categories
What are the two parts of a typical urinalysis?
-chemistry
-microscopic portion (automated)
chemistry profiles, complete blood count, urinalysis, urine drug screen, and automated immunoassays
are what type of complexity?
Moderate complexity
What type of tests has Little to no chance of error? Think home pregnancy kits.
Waived
cytology, flow cytometry, microbiology gram stains and cultures, blood banking, molecular testing
are what level of complexity?
High complexity – requires more training and experience and more quality control.
_______ is required for any healthcare organization that takes Medicare/Medicaid
CLIA
What is the prime objective of the Occupational Safety and Health Administration (OSHA)?
to ensure a safe workplace for every worker in the U.S.
In the lab, you have the right to a safe workplace and report unsafe practices to _______ without fear of reprisal by your employer.
OSHA
a regulatory agency that implements public health regulations and reporting requirements for the clinical lab.
Clinical and Public Health labs report many types of sexually transmitted disease, food borne and vector borne illnesses, viral infections, etc. to them
The Centers for Disease Control (CDC)
Who keeps track of reportable diseases?
CDC
-CDC also supports CLIA
What are the three agencies that certify labs? (necessary to receive Medicare/Medicaid payments.)
-College of American Pathologists (CAP)
-Commission on Office Laboratory Accreditation (COLA)
-The Joint Commission (TJC)
This professional organization has deemed status to provide this service for the federal government.
College of American Pathologists (CAP)
This commission is administered through the CMS. This office is under the HHS.
Commission on Office Laboratory Accreditation (COLA)
Accredits and certifies hospitals and laboratories.
(the hospital at large, not only for the laboratory)
The Joint Commission (TJC)
Will all labs have CAP, COLA, and TJC?
CAP or COLA (one or the other)
and TJC (all)
What two regulatory agencies inspect and accredit?
CAP and COLA
What does CLSI stand for?*
Clinical Laboratory Standards Institute
CLSI was formerly…
NCCLS
Publishes national and international standard documents on a variety of laboratory testing procedures and policies for guidance on achieving better testing outcomes.
CLSI (Clinical Laboratory Standards Institute)
Quality ___________: proactive; involves implementing a process. May be modified due to QC issues.
QUALITY ASSURANCE (QA):
Quality ____________ – collecting and analyzing data to ensure standards have been met
assessment
Quality _________: Assure accuracy compared to a standard in the testing process
Control (QC)
Quality assurance is divided into what three components?
-Preanalytical
-Analytical
-Post analytical
Quality assurance:
before testing. Think specimens and orders.
Preanalytical
Quality assurance:
actual testing. Think instruments and reagents (and you!)
Analytical
Quality assurance:
Think interpreting and reporting results
Post analytical
Making sure a pt. sample is properly labeled is an example of what component of quality assurance?
Preanalytical
Preanalytical, Analytical, or Post-analytical?
-Make sure test is appropriate and not duplicated
-Make sure there was not a delay in getting the specimen to the lab – affects quality of specimen and turn around time (TAT)
-Assure Specimen integrity
Preanalytical
Preanalytical, Analytical, or Post-analytical?
-how old the sample is?
-how long to get the results?
-proper transportation
Preanalytical
Specimen labels should be placed on the container and not on the…
lid
Preanalytical, Analytical, or Post-analytical?
-Assure testing instruments and reagents are working within established parameters…daily, each shift, each test. Besides doing the QC check, there will be a list of preventative maintenance for each instrument.
-Reagents are checked upon receipt and when we do QC
-Documented. Needed for inspections.
Analytical
Reagents are checked upon receipt and when we do QC.
What are the reagents run against?
a control or set of standards
True or False:
QC can also test the lab scientist’s technique.
true
Preanalytical, Analytical, or Post-analytical?
-When you run a laboratory test, a report is generated that will be sent to the patient chart.
-If there are critical values, you should be alerted and will respond appropriately, but you are responsible for noting any irregularities.
Post-analytical
“the testing of urine with procedures commonly performed in an expeditious, reliable, safe, and cost-effective manner”
CLSI Urinalysis definition
What is the Importance of urine tests?
-Readily available and easily collected specimen
-Urine contains information, which can be obtained by inexpensive laboratory tests, to assess many metabolic functions
Reasons to perform a urine test?
Aid disease diagnosis, screen for asymptomatic diseases, monitor disease progress and therapy effectiveness and more.
What are the different urine specimen types?
-First morning (best for monitoring things that are normally in low concentrations)
-Random
-Timed
-CCMS (clean catch mid-stream)
-cath
-12-24 hour collection
Which urine specimen type?
-Alternative to catheterized specimen
-Less traumatic method
-Less contaminated than routine collection*
-Do not touch or contaminate inside of container
Midstream Clean-Catch Specimen
What is the most common test that is done for catheterized urine samples?
bacterial culture
Which urine sample type?
-For creatine clearance test
-Patient receives container and instructions for collection. Specimen must be refrigerated .
-At the end of collection period, patient delivers full jug.
-In lab, mix and combine if there are more than one containers. Refrigerate.
24-Hour Specimen
Which urine sample type?
-Completely free of contamination for culture and cytology
-External introduction of needle for aspiration from the bladder
-Possible pediatric specimen
Suprapubic Aspiration
What urine sample type?
-Soft, clear, plastic bags, with hypoallergenic tape applied to genital area
-Monitor bag frequently
-Clean-catch method with sterile bag can be used
Cleaning for microbiology specimens
-Bags with tubes to a larger container are available for timed specimens
Pediatric Specimens
Changes in urine composition take place not only in vivo but also in _____.
vitro
How quickly must a urine specimen be tested?
within 2 hours
-Refrigerate or chemically preserve if testing is delayed
-Most problems are caused by bacterial multiplication
What changes occur in a urine specimen over time?
Increased: color, turbidity, pH, nitrite, bacteria, odor
Decreased: glucose, ketones, bilirubin, urobilinogen, RBCs, WBCs, casts (due to breakdown or oxidation)
What is the routine way to preserve a urine specimen?
refrigeration at 2°C to 8°C
-Decreases bacterial growth and metabolism
-Must return to room temperature for chemical testing
What are the most common chemical preservatives for urine specimen preservation?
boric acid or tartaric acid
Specimen Preservation:
Commercial transport tubes are available, but they must be…
compatible with tests
What are the advantages and disadvantages of refrigerating a
urine specimen?
advantages: Does not interfere with chemical tests
Disadvantages: Precipitates amorphous phosphates and urates
Refrigerating a urine sample prevents bacterial growth for ____ hours.
24
What are the advantages and disadvantages of BD Preservation Tube (Becton Dickinson, Rutherford, NJ)?
Advantages: Good for UA. Can hold 72 hours
Disadvantages: Not acceptable for culture
What color top is BD Preservation Tube (Becton Dickinson, Rutherford, NJ)?
What chemical is used?
yellow/cherry marble top
*chlorhexidine
What are the advantages and disadvantages of the BD vacutainer preservation tubes?
Advantages: Good for UA. Can hold 96 hours
Disadvantages: Not acceptable for culture
What color top are BD vacutainers?
What chemical is used?
Yellow cap
*Formaldehyde (formaldehyde) or no preservative
What are the advantages and disadvantages of BD Preservation tubes (C&S tube)?
Advantages: Sample stable at room temperature (RT) for 48 h; prevents bacterial overgrowth and metabolism
Disadvantages: Cannot use for UA
Interferes with drug and hormone analyses
What color top are BD Preservation tubes (C&S tube)?
What chemical is used?
Gray top
*Boric Acid
Keeps pH at about 6.0
Best for culture
Do not use if urine is below the minimum fill line.
What is very commonly ordered together?
Urinalysis and culture. One tube for each.
