Phlebotomy book- Chapter 15 Flashcards
CLIA 88 ID 3 levels of complexity for-
medical lab tests
Provider-performed microscopy was added to CLIA 88 in 1997 as a-
subcategory of moderate complexity tests
high complexity tests require- (3)
-close attention to detail
-specialized training & substantial experience
-interpretation & troubleshooting skills
high complexity tests involve-
manual manipulation of complex equipment & reagents
Examples of high complexity tests- (3)
-Manual DNA extraction procedures
-Special staining procedures
-Complex analyzers that require detailed setup or operator interaction
moderate complexity tests require- (4)
-formal training
-little manual manipulation
-may require direct supervision
-personnel required to have proper training & experience
ex of moderate complexity tests-
Tests that involve running simple automated instruments
Provider-performed microscopy procedures are a subcategory of-
moderate complexity testing that allows healthcare providers to perform certain tests only for their own patients
ex of provider performed microscopy procedures- (9)
-Direct wet mounts.
-Potassium hydroxide (K O H) preparations.
-Pinworm examinations.
-Fern tests.
-Post-coital qualitative tests
-Urine sediment examinations
-Nasal smears for granulocyte
-Fecal leukocyte examinations
-Qualitative semen evaluation
Waived tests-
FDA-approved laboratory tests that are minimally complicated and pose little risk of harm to the patient
Examples of waived tests- (6)
-Blood glucose levels by glucose monitoring devices cleared by the FDA specifically for home use
-Erythrocyte sedimentation rate
-Fecal occult blood
-Spun microhematocrit
-Urine chemical testing
-Urine pregnancy tests
Erythrocyte sedimentation rate-
non-automated
Spun microhematocrit-
manual procedure for determining hematocrit that requires only a small amount of blood
urine pregnancy tests- (2)
-visual color comparison tests
-the testing of urine for the presence of human chorionic gonadotropin, indicating pregnancy
waived tests require-
less training than higher complexity tests, on-the-job training possible
all medical labs must comply with-
CLIA 88
A Certificate of Accreditation (COA) is awarded to laboratories that perform-
moderate & high complexity testing & meet the standards of a private not-for-profit accreditation program. These labs must be surveyed every other year.
A Certificate of Compliance (COC) is awarded to laboratories that perform-
moderate & high complexity testing after inspectors find that the lab is in compliance with all applicable CLIA requirements. These labs must also be surveyed every other year.
A Certificate of Registration (COR) is granted to laboratories that have- (2)
-applied for either COA or COC
-enables the lab to perform moderate & high complexity testing until it has been inspected & verified to meet all requirements for COA or COC.
A Certificate for Provider-Performed Microscopy Procedures is granted to labs at facilities where-
physicians, mid-level practitioners, or dentists perform only certain microscopy procedures.
The Clinical Laboratory Improvement Advisory Committee (CLIAC) has made several recommendations for-
good practice in a Certificate of Waiver laboratory.
A Certificate of Waiver must be granted before-
a laboratory can perform waived tests. These labs must submit to random inspections & investigation if indicated.
ESR-
Rate at which RBCs settle in whole blood.
SOP post-exam guidelines- (3)
-Report test results to the physician in a timely manner.
-Follow package insert recommendations for follow-up or confirmatory testing.
-Follow OSHA regulations for disposing of biohazardous waste.
Standard operating procedure (SOP) requires the person performing waived testing to follow-
designated steps during all phases of the testing process (pre-examination, examination, post-examination)
waived testing regulations- (9)
-Follow federal, state, and local regulations.
-Perform waived tests only.
-Follow manufacturer instructions.
-Do not modify instructions.
-Allow random inspections.
-Establish lab safety plan that follows OSHA guidelines.
-Have a designated area with adequate space & conditions.
-Have enough personnel & train them appropriately.
-Have written documentation of each test performed.
Facilities that perform waived lab tests must have a designated person-
usually a physician or experienced lab supervisor that is responsible for lab supervision. All personnel must follow the guidelines, regulations, & requirements
SOP pre-examination guidelines- (6)
-Confirm written test orders.
-Establish procedure for patient ID.
-Give pre-test instructions and determine whether patients followed them.
-Collect specimens according to package insert instructions.
-Label specimens appropriately.
-Never use expired reagents or test kits
SOP examination guidelines- (6)
-Perform quality control testing.
-Correct problems discovered during QC testing before testing patient samples.
-Establish policy for control testing frequency.
-Follow test-timing recommendations.
-Interpret test results as directed.
-Record test results according to office policy
To help ensure the quality of testing, Certificate of Waiver laboratories are also required to participate in-
quality assurance/assessment programs for each test they perform.
ESR screens for-
inflammation
ESR is measured as-
distance, in millimeters, that RBCs fall in one hour when allowed to settle in a calibrated tube
when inflammation is present in ESR-
plasma proteins such as albumin and globulin are increased.
increased plasma proteins cause RBCs to-
come closer & may result in rouleaux formation, in which the RBCs stick to each other.
elevated sedimentation rate indicates inflammation-
Several cells sticking together sink faster than a single RBC does
ESR methods- (3)
-wintrobe
-westergren
-modified westergren
The equipment needed for a simple ESR test include- (5)
-Specimen transfer pipettes
-ESR kit
-ESR vials containing a premeasured amt of diluent (usually saline)
-Calibrated ESR tubes
-ESR testing rack
The amount of blood needed for ESR test varies by-
kit manufacturer. Be sure to fill the diluent vial to the mark on the vial
factors affecting ESR results- (5)
-Time from collection to testing.
-Testing time.
-Temperature.
-Tilting.
-Vibrations.
Hematocrit-
percentage of whole blood that is made up of red blood cells
microhematocrit measured as-
packed cell volume (PCV).
microhematocrit can be performed directly from- (2)
-puncture
-EDTA tube
in microhematocrit, blood is placed in _____ tubes-
capillary
centrifuge microhematocrit to-
pack RBCs
hematocrit is determined by using-
reading device
hematocrit is used as a screen test for-
anemia
Microhematocrit procedure uses capillary tubes, which are narrow-diameter tubes that take up blood using ___ action-
capillary action
avoid air bubbles in microhematocrit procedures because they may cause-
erroneous results
for microhematocrit procedures Fill the capillary tubes Directly from dermal puncture- (3)
-Wipe away first drop.
-Touch a red-tipped capillary tube to the edge of the next blood drop without touching the skin.
-Keep the capillary tube angled upward to avoid air bubbles.
for microhematocrit procedures Fill the capillary tubes From EDTA tube- (4)
-Remove the cap from an EDTA tube filled with blood.
-Tilt the specimen tube slightly & insert one end of the capillary tube.
-Keep the capillary tube angled upward to avoid air bubbles.
-fill 2 capillary tubes 3/4 full
Some microhematocrit tubes are self-sealing and do not require-
sealing clay
A microhematocrit centrifuge is used to spin the capillary tubes, the packed cell volume is read using-.
microhematocrit reading device, many microhematocrit centrifuges have these reading devices built in
reading microhematocrit- (3)
-Place bottom of RBC layer at 0% mark.
-Adjust scale so top of plasma layer is at 100% mark.
-Read hematocrit value at top of RBC layer on scale
Tests available by RDT methods include- (3).
-Infectious mononucleosis.
-Human immunodeficiency virus (HIV).
-Syphillis
Strep screening is used to determine if-
patient’s sore throat is caused by the bacteria Group A Streptococcus
Detection for strep screening is important because-
untreated Streptococcus infections can lead to rheumatic fever and autoimmune disease.
RDT Testing devices contain- (3)
-Antibodies to Group A Strep
-A color developer
-Built-in controls
General procedure for the test kits used in Certificate of Waiver laboratories- (5)
-Swab specimen is taken from back of throat.
-Swab is placed in a vial that contains premeasured amounts of extraction reagent to remove the bacteria from the swab.
-Vial is set onto a testing device treated with antibodies to the bacterial antigens and color developers.
-Results are read after a specified period of time, usually less than 10 minutes.
-For the results to be valid, the control (“C” in the tests shown on this slide) must show a positive result.
RDTs for respiratory infections are tests to rapidly identify infectious diseases, such as- (4)
-Influenza virus.
-Respiratory syncytial viruses (RSV).
-Corona virus.
-group A streptococcus (strep A)
urine pregnancy tests confirms/rules out-
pregnancy
urine pregnancy test tests for-
hCG
hCG-
hormone produced by placenta
General procedure for pregnancy test kits used in Certificate of Waiver laboratories- (3)
-Place required number of drops of urine onto the testing device.
-Read the results according to the manufacturer’s directions. (The test shown on this slide is negative.)
-Built-in control verifies that the test has been performed correctly.
urine chemical screening Physical Components- (2)
-Color
-Clarity
urine chemical screening Microscopic Components- (3)
-Casts
-Cells
-Crystals
Urine chemical screening-
testing of urine for various chemicals, most not normally present in the urine; part of a urinalysis
Urinalysis-
testing of urine for physical, chemical, and microscopic characteristics
urine chemical screenings Chemical Components- (10)
-pH
-Specific gravity
-Blood
-Bilirubin
-Glucos.
-Ketones
-Leukocytes
-Nitrite
-Protein
-Urobilinogen
Fecal occult blood-
blood found in the feces/stool & may not be visible (occult)
Guaiac-
chemical that turns blue when blood (hemoglobin) is present
Several portions of the stool sample are usually processed in order to-
maximize blood detection
False-positive fecal occult blood results may occur if patients have ingested- (4)
-Fish
-Heme-laden meat (such as beef and lamb)
-Fruits that contain peroxidase (bananas, cantaloupe, pears, plums)
-Vegetables that contain peroxidase (broccoli, cauliflower, horseradish, turnips)
POCT is designed to- (2)
-Reduce healthcare costs
-Enhance patient care
Typical POCT tests- (12)
-Glucose
-Hemoglobin
-Electrolytes (sodium, potassium, chloride, bicarbonate)
-Ionized calcium
-Cholesterol
-Blood ketones
-Blood gases
-Coagulation studies (such as prothrombin time)
-Urine dipstick (plastic strip with reagent pads containing chemicals for urine or blood testing)
-Urine pregnancy
-Fecal occult blood
-Strep screening
POCT samples tested-
immediately after collection at patient’s side
POCT typically requires-
small amount of blood from dermal puncture
Glucose testing-
Screening for abnormal glucose levels and to monitor glucose levels in patients with diabetes mellitus
