waived testing

Question 1

What are waived testing procedures

Answer 1

• at home
• using kits that ae availalbe from number of manufactureres
• includes easy to follow isntruction and most come with b uilt in control
• includes:
  ● erythrocyte sedimentation rate (ESR)
  ● fecal occult blood testing
  ● microhematocrit
  ● strep screening
  ● urine pregnancy testing
  ● urine chemical screening
  ● point-of-care testing (POCT)

Question 2

what are the levels of lab testing designated by the CLIA in 1988`

Answer 2

• waived tests, moderate complecity tests and high complixty testing, provider-performed microscopy

Question 3

what are high complexity tests

Answer 3

• tests that require close attention to details
• require manual manpulation of high complexd equipment and reagenets (lab test chemicals) and that require interpretation and troubleshoot skills
• manual dna extraction procedures intricate special staining procuedre and operation of complex analyzer that require detailed setup or ieator interactions

Question 4

what are moderate complexity tests

Answer 4

• faled btwn waived and high compleicty
• a few orcoedural step that aer not highly complexy but requre some forma training to perform
• include running automated instruments (little manual manipulatio of specimen or reagenet with minimal interpretation and tourbleshooting skiills)

Question 5

what is certificate of accrediation?

Answer 5

• moderate and or high complex testing
• private not for profit accreditation program

Question 6

what are certificate of compliance

Answer 6

moderate and or high complex testing
lab is in compliance with all applicable CLIA requirements
- labs r surveyed every other year

Question 7

certificate of registration

Answer 7

• lab that applied for COA COC
• lab can perform moderate and or high complex testing until inspected for COA or COC

Question 8

Certificate for Provider-Performed Microscopy Procedures

Answer 8

• lab where physician midlevel practitioner or dentist perform only microscopy procuedres q

Question 9

certificate of waiver

Answer 9

• lab performs only waived tests
• must ably to department of health and human services, centers for medicare and medicaid services (CMS)
• submit to randsom inspection and investigatoon
• recommended to follow Clinical Laboratory Improvement Advisory Committee (CLIAC) suggestions for lab managements during before and after test

Question 10

provider-performed microscopy procedures
(PPMPs)

Answer 10

● direct wet mounts
● potassium hydroxide (KOH) preparations
● pinworm examinations
● fern tests
● post-coital qualitative
● urine sediment examinations
● nasal smears for granulocytes
● fecal leukocyte examinations
● qualitative semen evaluation

Question 11

what is lab management and personnel need to adher to ?

Answer 11

● Follow all applicable federal, state, and local regulations.
● Perform waived tests only.
● Follow the manufacturer’s instructions in the package insert.
● Do not make modifications to the instructions.
● Allow random inspections by authorized agencies, such as the CMS.
● Establish a laboratory safety plan that follows OSHA guidelines.
● Have a designated area that has adequate space and conditions.
● Have enough personnel in the lab and train them appropriately.
● Have written documentation of each test performed.
- follow standard operating procedures (SOPs)

Question 12

what is ESR?

Answer 12

• rate at which RBC settle in whole blood
• measures distance in mL that RBC fall in 1 hr when allowed to settle in a calibrate dtube
• screens for presence of any inflammation
• number of plasma proteins such as albumin and globulin increases
• increase in plasma proteins may = rouleaux formation (RBC sticks together)
• several cells sticking together settls faster than a single RBC

Question 13

What are the different methods to perform ESR

Answer 13

• Wintrobe
• Westergren
• Modified Westergren

Question 14

tube and testing for ESR

Answer 14

• requires light blue top tube or their own speciality tube usually with a black stopper or top
• ESR procedure are done in less than 4 hours but if refrigerated up to 12 hours

Question 15

what is required for ESR

Answer 15

● Specimen transfer pipets
● ESR kit
● ESR vials containing a premeasured amount of diluent (usually 0.9%
sodium chloride)
● Calibrated ESR tubes
● ESR testing rack

Question 16

how to test ESR

Answer 16

1. Transfer the mixed blood from an appropriate specimen to the diluent vial and fill it
   to the mark on the vial (amounts vary by manufacturer).
2. Replace the vial cap and gently mix the blood with the diluent by inversion.
3. Insert a calibrated ESR tube through the vial cap and into the blood–diluent mix-
   ture; adjust the tube until the blood is even with the 0-mm mark.
4. Place the ESR tube in the testing rack (it should be absolutely level).
5. Label the ESR tube or vial with the patient’s identification.
6. Allow the blood to settle for 1 hour.
7. After 1 hour, read the level to which the red blood cells have fallen and record this
   information as millimeters per hour.
8. Consult the manufacturer’s instructions for proper interpretation of the results. Nor-
   mal values vary by method and may vary by gender.

Question 17

what could affect ESR results

Answer 17

• colllection
• testing
• testing time
• temp (69-77F is opimtal)
• tilting (tilting = RBC to settle faster)
• vibration (settle faster - not same as centrifue_
• direct sunlight or drafts
• at room temp longer than 4 hours = lower than act
• sooner than 1 hr may = lower ESR or if after 1 hour than falsely high ESR

Question 18

what is fecal occult blood testing

Answer 18

• blood in stool that isnt visible
• fecal occult blood may be sign of infection, inflammatory conditions, trauma, ulcers, hemorrhods, colorectal cancer
• although high specific tests such as fecal immunohistochemical tests r availabe common waived methods may be used

Question 19

what is the waived method for occult blood

Answer 19

• cardboard holder with paper with guaiac (turn blue when blood is present)
• several portion of stool is sampled
• apply thin layer to front of guaiac card then few drops of hydrogen peroxide on back of card
• if sufficient amount of hemoglobin is present guaic paper (false neg if v small hemoglobin or not enough stool)
• most of times 3x stool sample

Question 20

false positivefecal occult blood

Answer 20

• fal positive if another type of peroxidase or pseudoperoxidase (enzyme present in
  some foods) is present
• could occur if pt injest fish, meat with lots of heme (beef and lamb), or food that contain peroxidaise (some fruits and vegetables - bananas, cantaloupe, pears, and
  plum and broccoli, tomatoes
  (including tomato sauce), cauliflower, horseradish, and turnips)
• avoid thesee footds and aspriirn and vitamin C

Question 21

what is microhematocrit ?

Answer 21

• screening for anemia and is measured as the packed cell volume (PCV) of RBC or percent of RBC in whole blood
• micro requires small amt of blood
• uses capillary tubes (narrow with red basnd arund one end, indicating theat tehy are coated with heparin) = blue band means no anticoagulants but could be used for microhematocrit if obtained from an EDTA tube

Question 22

how is microhematocrit testing done?

Answer 22

• directly on dermal puncutre or in microcollection container or evacuated tubes
• avoid air to enture tuve
• fill 2 capillaryt tuvbes 3/4 full
• dont remove tip from blodo source with tuvbe lower tha nblood as air will ender
• place gloved finger over dry end (not blood collection side) and hold horizontally - remove finger and embed clean end in clay sealent
• some microhematocrit tubes r self sealing
• place in larger tube
  microhematocrit centriufge is used to obtain packed RBC

Question 23

how to do strep screening?

Answer 23

• see if group A strep in throught
• immunoassay test that use antibodies to bacterial antigen to creat e a reaction such as a color change
• throat swab in testing vial that contains premeasured amt of extraction reagent
• set on device with antiobides to bacterial antigens and color developers
• letter t = indication of pt specimen
• c is contorl

Question 24

What is urine pergnancy testing ?

Answer 24

• tests human chorionic gonadotropin (hCG) which is detecatable in urine at 10 days after pregancy

Question 25

what is urine chemical screenign

Answer 25

- part of urinalysis - contains of a a physical component (color and clarity), a chemical component (pH, specific gravity, blood, bilirubin, glocuse, ketones, leukocytes, protein, nitries, and urobiligin), and a microscopic component (spinning urine to view sediment under microscope for various cells, crystals, microrganisms, and urine casts - no a waived test ) -

Question 26

What is a dipstick test?

Answer 26

- plastic strip wit hreagnet pads - pads have chemical that reactions with a paritcular substnacein urine and hcange color in a precise ways (indiacted presence, amt or concentration of sample) -

Question 27

what is Point-of-care testing (POCT)

Answer 27

- near pt testing - reduce heatlchare costs while enchaing pt care by making results avialbe quickly - collecting specimen and immediately testin on instrument by pt side - usually require small amt of blood from dermal puncture

Question 28

examples of POCT blood tests

Answer 28

glucose, hemoglobin, sodium, potassium, chloride, bicarbonate, ionized calcium, cholesterol, blood ketones, blood gases, and coagulation studies, such as prothrombin time (PT)

Question 29

other types of POCT tests?

Answer 29

urine dipstick, urine pregnancy and ovulation tests, fecal occult blood, and screening for infections, such as Group A Streptococcus.

Question 30

what is glucose POCT testing

Answer 30

- screnning for abn glucose levels and monitor glucose levels in DM pt - can do at home

Question 31

what is “B-Type Natriuretic Peptide”

Answer 31

- its a cardiac hormone produced by the heart in response to ventricular volume expansion and pressure overload - It is the first objective measurement for congestive heart failure (CHF). - helps differentiate (COPD) and CHF. - BNP blood concentrations increase with the increasing severity of CHF and have been shown to more accurately reflect final diagnosis than echocardiographic ejection fractions.