4 - QA IN CC AND HEMA

Question 1

ISO 15223

Answer 1

provides the list of symbols in medical devices.

Question 3

provides the list of symbols in medical devices.

Answer 3

ISO 15223

Question 4

• The scientific medical study of blood and blood-forming tissues
• Microscopic identification of
  the different blood cells and their inclusions, blood abnormalities, indices and coagulation.

Answer 4

HEMATOLOGY

Question 5

Hema Tests

Answer 5

CBC, Hematocrit, coagulation test (thromboplastin test)

Question 6

is not yet centrifuged blood;

Answer 6

Whole blood

Question 7

Level 1

Answer 7

Red

Question 8

Level 2:

Answer 8

Green / White

Question 9

Level 3:

Answer 9

Black

Question 10

• QC material for whole blood is color red
• Invert gently the controls before using them

Answer 10

HEMATOLOGY CONTROLS

Question 11

Characteristics of an Ideal QC Material

Answer 11

1. Resembles human sample
2. Inexpensive and stable for long periods
3. NO communicable diseases
4. NO matrix effect / known matrix effects
5. With known analyte concentrations
6. Convenient packaging for easy dispensing and storage

Question 12

HIGH levels

Answer 12

Red

Question 13

LOW levels

Answer 13

Blue

Question 14

normal levels

Answer 14

Green

Question 15

Storage of controls (with close cap):

Answer 15

2-8C

Question 16

• Must be protected from freezing
• Check expiration date
• Opened vials stability depends on product type
• Always check packaging for specific instructions

Answer 16

Transportation, Storage Condition, and Shelf Life

Question 17

1. Remove the vial from the refrigerator and equilibrate with RT (15-30C) for at least 15 minutes before use
2. Roll each vial between the palms of your hand for 15 seconds
3. Holding the vial from end to end between the thumb and forefinger, invert the vial 20 times using a very quick turning motion of your wrist during mixing. Details can be seen in a video on the CD-ROM or USB stick accompanying each QC lot.
4. Analyze the QC material on the instrument according to the instructions for use. The piercable septum in the vial cap allows sampler analysis
5. Subsequent analyses during this test period may be performed by inverting the vial 5 times prior the instrument analysis
6. Return the vial to the refrigerator (2-8C) for storage.

Answer 17

PREPARATION OF XN-CLASS QC MATERIALS BEFORE MEASUREMENT

Question 18

• Deals with the quantitative measurement and examination of substances present normally or in abundance in biological fluids such as:
  o Blood
  o Urine
  o Cerebrospinal Fluid
  o Peritoneal Fluid
  o Pleural Fluid
  o Analysis or renal stone to provide important information for the diagnosis, treatment, and management of diseases.

Answer 18

CLINICAL CHEMISTRY