Exam 1: Lecture 1- Quality Assurance, Urine Specimen Types

Question 1

Most labs are regulated under an act of the U.S. Congress called…

Answer 1

Clinical Laboratory Improvement Amendment of 1988 (CLIA’88)

Question 2

How does CLIA ‘88 divide labs and laboratory tests? (What are the categories)

Answer 2

waived, moderate, and high-complexity categories

Question 3

What are the two parts of a typical urinalysis?

Answer 3

-chemistry
-microscopic portion (automated)

Question 4

chemistry profiles, complete blood count, urinalysis, urine drug screen, and automated immunoassays
are what type of complexity?

Answer 4

Moderate complexity

Question 5

What type of tests has Little to no chance of error? Think home pregnancy kits.

Answer 5

Waived

Question 6

cytology, flow cytometry, microbiology gram stains and cultures, blood banking, molecular testing
are what level of complexity?

Answer 6

High complexity – requires more training and experience and more quality control.

Question 7

_______ is required for any healthcare organization that takes Medicare/Medicaid

Answer 7

CLIA

Question 8

What is the prime objective of the Occupational Safety and Health Administration (OSHA)?

Answer 8

to ensure a safe workplace for every worker in the U.S.

Question 9

In the lab, you have the right to a safe workplace and report unsafe practices to _______ without fear of reprisal by your employer.

Answer 9

OSHA

Question 10

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

Answer 10

The Centers for Disease Control (CDC)

Question 11

Who keeps track of reportable diseases?

Answer 11

CDC

-CDC also supports CLIA

Question 12

What are the three agencies that certify labs? (necessary to receive Medicare/Medicaid payments.)

Answer 12

-College of American Pathologists (CAP)
-Commission on Office Laboratory Accreditation (COLA)
-The Joint Commission (TJC)

Question 13

This professional organization has deemed status to provide this service for the federal government.

Answer 13

College of American Pathologists (CAP)

Question 14

This commission is administered through the CMS. This office is under the HHS.

Answer 14

Commission on Office Laboratory Accreditation (COLA)

Question 15

Accredits and certifies hospitals and laboratories.
(the hospital at large, not only for the laboratory)

Answer 15

The Joint Commission (TJC)

Question 16

Will all labs have CAP, COLA, and TJC?

Answer 16

CAP or COLA (one or the other)

and TJC (all)

Question 17

What two regulatory agencies inspect and accredit?

Answer 17

CAP and COLA

Question 18

What does CLSI stand for?*

Answer 18

Clinical Laboratory Standards Institute

Question 19

CLSI was formerly…

Answer 19

NCCLS

Question 20

Publishes national and international standard documents on a variety of laboratory testing procedures and policies for guidance on achieving better testing outcomes.

Answer 20

CLSI (Clinical Laboratory Standards Institute)

Question 21

Quality ___________: proactive; involves implementing a process. May be modified due to QC issues.

Answer 21

QUALITY ASSURANCE (QA):

Question 22

Quality ____________ – collecting and analyzing data to ensure standards have been met

Answer 22

assessment

Question 23

Quality _________: Assure accuracy compared to a standard in the testing process

Answer 23

Control (QC)

Question 24

Quality assurance is divided into what three components?

Answer 24

-Preanalytical
-Analytical
-Post analytical

Question 25

Quality assurance: before testing. Think specimens and orders.

Answer 25

Preanalytical

Question 26

Quality assurance: actual testing. Think instruments and reagents (and you!)

Answer 26

Analytical

Question 27

Quality assurance: Think interpreting and reporting results

Answer 27

Post analytical

Question 28

Making sure a pt. sample is properly labeled is an example of what component of quality assurance?

Answer 28

Preanalytical

Question 29

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

Answer 29

Preanalytical

Question 30

Preanalytical, Analytical, or Post-analytical? -how old the sample is? -how long to get the results? -proper transportation

Answer 30

Preanalytical

Question 31

Specimen labels should be placed on the container and not on the...

Answer 31

lid

Question 32

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.

Answer 32

Analytical

Question 33

Reagents are checked upon receipt and when we do QC. What are the reagents run against?

Answer 33

a control or set of standards

Question 34

True or False: QC can also test the lab scientist's technique.

Answer 34

true

Question 35

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.

Answer 35

Post-analytical

Question 36

“the testing of urine with procedures commonly performed in an expeditious, reliable, safe, and cost-effective manner”

Answer 36

CLSI Urinalysis definition

Question 37

What is the Importance of urine tests?

Answer 37

-Readily available and easily collected specimen -Urine contains information, which can be obtained by inexpensive laboratory tests, to assess many metabolic functions

Question 38

Reasons to perform a urine test?

Answer 38

Aid disease diagnosis, screen for asymptomatic diseases, monitor disease progress and therapy effectiveness and more.

Question 39

What are the different urine specimen types?

Answer 39

-First morning (best for monitoring things that are normally in low concentrations) -Random -Timed -CCMS (clean catch mid-stream) -cath -12-24 hour collection

Question 40

Which urine specimen type? -Alternative to catheterized specimen -Less traumatic method -Less contaminated than routine collection* -Do not touch or contaminate inside of container

Answer 40

Midstream Clean-Catch Specimen

Question 41

What is the most common test that is done for catheterized urine samples?

Answer 41

bacterial culture

Question 42

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.

Answer 42

24-Hour Specimen

Question 43

Which urine sample type? -Completely free of contamination for culture and cytology -External introduction of needle for aspiration from the bladder -Possible pediatric specimen

Answer 43

Suprapubic Aspiration

Question 44

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

Answer 44

Pediatric Specimens

Question 45

Changes in urine composition take place not only in vivo but also in _____.

Answer 45

vitro

Question 46

How quickly must a urine specimen be tested?

Answer 46

within 2 hours -Refrigerate or chemically preserve if testing is delayed -Most problems are caused by bacterial multiplication

Question 47

What changes occur in a urine specimen over time?

Answer 47

Increased: color, turbidity, pH, nitrite, bacteria, odor Decreased: glucose, ketones, bilirubin, urobilinogen, RBCs, WBCs, casts (due to breakdown or oxidation)

Question 48

What is the routine way to preserve a urine specimen?

Answer 48

refrigeration at 2°C to 8°C -Decreases bacterial growth and metabolism -Must return to room temperature for chemical testing

Question 49

What are the most common chemical preservatives for urine specimen preservation?

Answer 49

boric acid or tartaric acid

Question 50

Specimen Preservation: Commercial transport tubes are available, but they must be...

Answer 50

compatible with tests

Question 51

What are the advantages and disadvantages of refrigerating a urine specimen?

Answer 51

advantages: Does not interfere with chemical tests Disadvantages: Precipitates amorphous phosphates and urates

Question 52

Refrigerating a urine sample prevents bacterial growth for ____ hours.

Answer 52

24

Question 53

What are the advantages and disadvantages of BD Preservation Tube (Becton Dickinson, Rutherford, NJ)?

Answer 53

Advantages: Good for UA. Can hold 72 hours Disadvantages: Not acceptable for culture

Question 54

What color top is BD Preservation Tube (Becton Dickinson, Rutherford, NJ)? What chemical is used?

Answer 54

yellow/cherry marble top *chlorhexidine

Question 55

What are the advantages and disadvantages of the BD vacutainer preservation tubes?

Answer 55

Advantages: Good for UA. Can hold 96 hours Disadvantages: Not acceptable for culture

Question 56

What color top are BD vacutainers? What chemical is used?

Answer 56

Yellow cap *Formaldehyde (formaldehyde) or no preservative

Question 57

What are the advantages and disadvantages of BD Preservation tubes (C&S tube)?

Answer 57

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

Question 58

What color top are BD Preservation tubes (C&S tube)? What chemical is used?

Answer 58

Gray top *Boric Acid Keeps pH at about 6.0 Best for culture Do not use if urine is below the minimum fill line.

Question 59

What is very commonly ordered together?

Answer 59

Urinalysis and culture. One tube for each.