Clinical Laboratory Improvement Amendments (CLIA)
Federal standards that regulate laboratory testing, handling, and processing
Random urine:
A urine specimen collected in a clean container for screening purposes; no preparation is required
Clean-catch midstream:
a urine specimen that is collected in the middle of the urinary stream in a sterile container after perineal cleaning
What is the most common collected specimen in ambulatory care setting
urine
First morning specimen:
the patient collects the first specimen of the morning in a clean container. This specimen is more concentrated and used for pregnancy testing, or when other analytes (proteins, nitrites) need to be evaluated
Clean-Catch midstream
the patient performs perineal cleaning using moist wipes, begins to urinates, and then collects the specimen midstream in a sterile urine container. This specimen is used for cultures or when a nonctomtaimined specim is desired.
24-hour:
this method uses a container with preservatives. The patient discards the first morning specimen and collects all specimens for the next 24 hr, including the first void of the second day. This type of collection is important in quantitative analysis of components such as protein when analyzing kidney function
Catheterized collection:
this method is used when a sterile urine sample is needed or if patients are unable to provide a specimen on their own. It involves insertion of a sterile tube through the urethra into the bladder. This procedure is performed by the provider or nurse, with the medical assistant preparing the patient and assisting.
Quantitative:
analysis that identifies quantity or actual number counts
Fecal Occult Blood:
evaluation of a stool specimen for hidden blood
What does a fecal occult blood test require:
a stool specimen collection to screen for the presence of blood, which can indicate a disease process or gastrointestinal bleeding
Why are correct patient instructions imperative?
to ensure that false positive do not occur
Before collection specimen, patients should avoid food and medication for how many days?
3
What is the tape test used for?
detect pinworms
What are stool specimens for:
collected for parasites or to evaluate for bacterial infections
What does the ova and parasites test detect:
presence of parasites and their eggs
What are sputum specimens collected in?
sterile containers
What is important in obtaining a sputum specimen?
patient to produce deep, producitve cough
When are sputum specimens best collected?
in the early morning before eating or drinking
What should patients avoid prior to sputum collection?
mouthwash
Where are specimens for cultures collected in?
always sterile containers
What happens if the specimen is not properly collected?
the identification of the causative agent will not occur and proper treatment cannot be started
What are the 5 reminders for specimen collection?
-collect the specimen at appropriate time
-collect the specimen from the site of suspected infection
-minimize transport time to a reference lab
-collect the appropriate quantity
-use the appropriate containers and label them accordingly
What does the FDA require:
that all testing meet federal guidelines and determines the complexity of the tests performed in the laboratory
Qualitative:
analysis that identifies quality or characteristics of components such as size, shape, and maturity of cells; typically reported as positive or negative
Pregnancy testing:
urine is screened for the presence of human chorionic gonadotropin antibodies
Rapid streptococcus testing:
throat swabs are obtained to screen for Group A streptococcus
Dipstick, tablet, or multi-stick urinalysis:
The urinalysis is a screening tool for analytes that are excreted in the urine
Hemoglobin:
a machine is used to screen for the oxygen-carrying protein in whole blood, performed using capillary blood from a fingerstick
Spun hematocrit
Fingerstick collection of blood in microcapillary tubes is centrifuged and evaluated for the percentage of red blood cells
Blood glucose:
whole blood is analyzed in a glucometer for quantitative glucose level and is a screening test for diabetes, performed using capillary blood from a finger stick
Hemoglobin A1c
This capillary blood test shows diabetes control over an approximate 3 month period
Cholesterol testing:
Lipids are evaluated using capillary blood
Helicobacter pylori:
a blood sample screens for H. pylori, which is the main cause of gastric ulcers
Mononucleosis screening:
this screening tool tests for the presence of the Epstein-Barr virus in capillary blood
Nasal smear for influenza types A and B
This screening is a qualitative test for influenza antigens using a swab that is inserted into the nostril
Drug testing:
Substances can be detected in urine and blood samples
Fecal Occult Blood:
this test is performed to screen for hidden blood in the stool
The CLIA was established in 1988 to:
ensure quality of diagnostic testing through laboratory regulations
How many designations are there for laboratory testing based on complexity?
3
What is the most common designation of ambulatory care and is the lowest level of complexity
CLIA-waived
What test are considered nonwaived:
Moderate-and High-complexity
Provider-performed microscopy procedure:
a CLIA term for microscopic examinations that require the expertise of a physician or mid level proivder qualified in micrsocpic examination; falls under CLIA's moderate compelxity category
Commission on office laboratory accreditation (COLA)
an independent firm that provides accreditation for laboratories and has a goal of meeting CLIA standards
quality assurance:
policies and procedures to maximize patient safety and ensure reliability related to laboratory testing
Quality control:
measures incorporated to maximize reliability and accuracy of results while recognizing and eliminated errors in testing
Forced expiratory volume:
the amount of air that can be forcibly exhaled
Radioallergosorbent test (RAST)
A blood test used to detect antibodies associated with allergens
Ishihara test:
A set of templates with patterns or numbers embedded within them to test for color blindness
Tympanometry:
The process of recording the movement of the tympanic membrane through pressure variances in the external ear canal
Critical value:
A laboratory result that is outside of the established reference range and presents potential health risks to a patient
Hyperopia
difficult seeing things up close; farsightedness
Myopia
difficult seeing things far away; nearsightedness
Presbyopia:
a gradual, age-related loss of they eyes' ability to focus actively on nearby objects
Chain of custody:
A series of processes and procedures used to ensure security and accuracy
Panel:
a group of tests that are connected to one particular body system; profile
Controls:
specific tools used in the laboratory with a known result, used to compare with results of a patient sample to confirm validity of the test and specimen
What information is required when labeling specimens;
-patients name
-date and time of collection
-patients DOB
-providers name
-initials of person collecting specimen
What are the safety measures when transporting non blood specimens:
padding and protection from leakage
-when transported via mail, use a biohazard identification on the outside of the package
How to use a near vision acuity chart:
Ask patients to read printed materials 14 to 16 inches away from eyes without corrective lenses, testing each eye separately and then together. The result is the level at which the patient reads the smallest print clearly.
Normal adult hearing:
Should hear up to 25 decibels
Normal child hearing
Should hear up to 15 decibels
Catheterized urine collection:
Nurse or provider inserts a sterile tube through the urethra into the bladder.
How to perform a tape test:
Provide parents with slide with a piece of tape. Tape is placed over child's anus before getting up in the morning, then back on slide
Tympanometry
The process of recording the movement of the tympanic membrane through pressure variances in the external ear canal
What are the two most common noninvasive methods:
spirometry and peak flow meter testing
What can the peak flow test:
monitor lung function in the home, especially for patients who have chronic respiratory diseases such as asthma
What does the peak flow meter measure:
the forced expiratory volume, which indicated the effectiveness of airflow out of the lungs
Spirometry:
An automated test that produces graphic result
How should the patient take a spirometry test:
-wear loose clothing
-sit in an upright or standing position
-breath through the mouth
-pursing the lips around mouthpiece
What should the patient do during the spirometry test to reduce breathing resistance?
the patient should lift the chin slightly and extend the neck
What is required in pretest preparation:
-no large meals 2 hours before the test
-no smoking 1hr before test
-discontinuing the use of bronchodilators or other breathing therapies for at least 6hrs before the test
How to take the Peak Flow test
-wear nonrestrictive clothing
-begin with marker at the bottom of the scale on the meter
-upright or standing position, take a deep breath and blow out the mouth
-record the # where the marker is located
-repeat test 2-3 times
Challenge testing is used to:
detect specific allergies, such as food allergies
What happens during food challenges test
the patient receives increasing amounts of food suspected of causing an allergy
What test requires a blood draw, but safer regarding avoiding a potential allergic reaction
Radioallergosorbent
What can be indetified as an allergen
if a wheal becomes infected with induration (raised, hard area)
The _____the wheal, the more significant the allergy
larger
Where is skin testing usually performed
forearm or the back
how far do patients stand from a chart at eye level during a distance vision test:
20 feet
How many items can a patient miss and still pass that line during an eye test?
one
what is normal vision:
20/20