Lecture 1 Intro, QA & Specimen Types

Question 1

What government act regulates labs?

Answer 1

CLIA ‘88

Question 2

What does CLIA ‘88 do?

Answer 2

It mandates proficiency, quality assurance, inspections, minimum personnel qualifications, and divides lab tests into three categories. The categories are waived, moderate, and high - complexity.

Question 3

What describes tests that fall under waived lab tests?

Answer 3

Little to no chance of error. E.g. home pregnancy kit

Question 4

What describes tests under moderate complexity?

Answer 4

Chemistry profiles, complete blood count, urinalysis, urine drug screen, and automated immunoassays

Question 5

What describes tests under high complexity?

Answer 5

Tests that require more training and experience and more quality control. Think cytology, flow cytometry, micro gram stains, cultures, blood banking, and molecular testing (PCR).

Question 6

What is the primary objective of OSHA?

Answer 6

Assure a safe workplace for every worker in the U.S.; In the lab you are entitled to that. You have the right to report unsafe practices to OSHA without fear of retaliation.

Question 7

What does the CDC do?

Answer 7

They implement public health regulations, and reporting requirements for clinical labs. They also report many types of STDs, food borne, and vector borne illnesses, viral infections, and etc to the CDC.

Question 8

What are the three agencies that certify labs?

Answer 8

CAP, COLA, and TJC

Question 9

What does CAP stand for?

Answer 9

College of American Pathologists

Question 10

What does COLA stand for?

Answer 10

Commission on Office Laboratory Accreditation. Its administered through CMS. The office is under HHS.

Question 11

What does TJC stand for and what does it do?

Answer 11

It stands for The Joint Commission. It accredits and certifies hospitals and labs.

Question 12

What does the CLSI stand for and do?

Answer 12

Clinical Laboratory Standards Institute. It publishes national and international standard documents on a variety of lab testing procedures and policies for guidance on achieving better testing outcomes.

Question 13

What is quality assurance?

Answer 13

Proactive; involves implementing a process. May be modified due to QC issues.

Question 14

What is quality assessment?

Answer 14

Collecting and analyzing data to assure standards have been met.

Question 15

What is quality control?

Answer 15

Assure accuracy compared to a standard in the testing process.

Question 16

Preanalytical takes place where?

Answer 16

Before the specimen gets to the lab

Question 17

Where does analytical take place?

Answer 17

The process where the specimen is being tested. Think instruments, reagents, and controls + MLS.

Question 18

Where does post analytical take place?

Answer 18

The result of the tests ordered, interpreting, and reporting the results.

Question 19

What should you look out for in the preanalytical?

Answer 19

Patient identifiers, Is the specimen expired?, any test duplicated?

Question 20

What does specimen integrity mean?

Answer 20

Specimen is representative of patient’s condition. It did not sustain any kind of damage that would lead to erroneous lab results.

Question 21

What patient information should be on a specimen?

Answer 21

Patients name, ID#, DOB, Date, Time of collection

Question 22

As a you are checking in patient specimens, what should you be check?

Answer 22

Patient information matching on the requisition (Dr.’s order), time of collection (is it fresh?), location, healthcare provider’s name

Question 23

What are some reasons to reject a specimen?

Answer 23

1. Specimen unlabeled
2. Nonmatching labels & requisition forms
3. No orders in computer
4. Specimen contaminated
5. Insufficient amount of specimen
6. Specimen improperly transported
7. Labs must have written policies for rejection of specimens

Question 24

What is done during analytical to ensure results are valid?

Answer 24

1. Assure testing instruments and reagents within working parameters (daily)
2. Reagent expiration date checked
3. Document QC for inspection purposes

Question 25

What is done for postanalytical?

Answer 25

Lab results are formatted for patient chart usually by computer. If there are any critical values they are called in and documented. If you are not sure what to do it is in the procedure manual.

Question 26

How should any specimen or urine specimen should be treated?

Answer 26

Like they are infectious. Wear gloves!

Question 27

Reasons for urinalysis?

Answer 27

1. Aid disease diagnosis
2. Screen for asymptomatic diseases
3. Monitor disease progress
4. Monitor therapy effectiveness plus more
5. Cheap
6. Urine easy to collect & readily available

Question 28

List different types of urine specimens?

Answer 28

1. First morning
2. Timed (12 or 24 hr)
3. Random
   4, CCMS, Cath

Question 29

Advantages with midstream clean catch specimen?

Answer 29

1. Alternative to cath specimen (less traumatic)
2. Less contamination
   Note: Can be contaminated if a person touches the inside of container or urine.

Question 30

What is a catheterized specimen?

Answer 30

Specimen collected with a hollow tube. Its a common specimen for bacterial culture.

Question 31

What is a 24 hour specimen for?

Answer 31

For a creatine clearance test. If there are more than one container mix and combine then refrigerate.

Question 32

Describe a suprapubic aspiration.

Answer 32

External introduction of needle for aspiration from the bladder.
Free of contamination for culture and cytology. Sometimes the procedure is done on pediatric patients.

Question 33

Describe pediatric specimens

Answer 33

1. Comes in soft clear plastic bag with hypoallergenic tape applied to genital area.
2. They sometimes come with tubes to a larger container for timed specimen.
3. Clean - catch method with sterile bag can be used for microbiology specimens.

Question 34

What are changes a urine specimen undergoes if it doesn’t get refrigerated?

Answer 34

1. Increased color, turbidity, bacteria, pH, nitrite, and odor
2. Decrease in glucose, ketones, bilirubin, urobilinogen, RBCs, WBCs, and casts.

Question 35

When should urine specimens be refrigerated?

Answer 35

As soon as possible or within two hours of collection @ 2C to 8C

Question 36

Can a freshly refrigerated urine specimen undergo testing immediately?

Answer 36

No, it must return to room temperature for chemical testing.

Question 37

What is the common chemical preservative for a urine specimen?

Answer 37

Boric acid or tartaric acid

Question 38

Pro and cons of refrigerated urine specimens?

Answer 38

Pro - No interference with chemical tests & prevents bacterial growth for 24hrs
Con - Precipitates amorphous phosphates and urates

Question 39

Pro and con of BD preservation tube (Becton Dickinson,
Rutherford, NJ)?

Answer 39

Pro - Good for UA & viable for 72 hours b/c of chlorhexidine
Con - Not acceptable for cultures

Question 40

Pro and con of BD vacutainer?

Answer 40

Pro - Good for UA up to 96 hrs using formaldehyde or no preservative
Con - No good for cultures

Question 41

BD Preservation Tube (C&S Tube)

Answer 41

Pro - Stable at RT for 48 hrs, prevents bacterial overgrowth & metabolism, Good for cultures
Con - Cannot use for UA b/c boric acid interferes with drug and hormone analyses.
Note: pH @ 6.0, cannot use urine if under fill line.

Question 42

What happens if your parameters are out of range or a mistake occurs during analytical or post analytical?

Answer 42

Corrective action & documentation!