NHA Labs + Clinical Tests

Clinical Laboratory Improvement Amendments (CLIA)

Clinical Laboratory Improvement Amendments (CLIA)

a 1988 amendment that regulates federal standards that apply to all clinical laboratory testing performed on humans in the United States

clinical laboratory testing

testing used in conjunction with health history and physical examination to provide essential data for the diagnosis and management of a patient’s condition.

CLIA-waived testing

this category includes blood glucose testing, urine pregnancy tests, rapid strep screening, etc

urinalysis

this category includes the physical, chemical, and microscopic examination of urine

hematology

this category includes blood cell counts that determine RBCs, WBCs, and platelets of a blood specimen

chemistry

this category includes chemicals found in blood, cerebrospinal fluid, urine, joint fluid, lipid profiles (such as triglycerides, total cholesterol, HDL, and LDL), and fasting glucose

microbiology

this category includes studying bacteria, fungi, parasites, yeasts, and viruses; specimens can include urine, blood, sputum, cerebrospinal fluid, stool, and wound material

cytology

this category includes microscope examination of cells for diagnostic purposes

blood bank

this category includes processes and stores blood and blood products for transfusion and blood disorder treatments

requisition form

the following information should be included on this:

• Patient name

• Address

• Date of birth

• Sex

• Telephone number

• Insurance information

• Provider information

• Diagnosis code or indications for testing

  • Order date

specimen sample container label

the following information should be included on this:

• Patient’s name

• Patient’s date of birth

• Date and time of collection

• Medical assistant’s initials

pregnancy testing

test in which urine is screened for the presence of human chorionic gonadotropin (hCG) antibodies

rapid strep testing

throat swabs are obtained to screen for group A streptococcus.

dipstick, tablet, or multi-stick urinalysis

test used as a screening tool for analytes that are excreted in the urine

hemoglobin test

test in which a machine is used to screen for the oxygen-carrying protein in whole blood, performed using capillary blood from a fingerstick (capillary puncture)

spun hematocrit test

test in which fingerstick collection of blood in microcapillary tubes is centrifuged and evaluated for the percentage of red blood cells.

blood glucose test

test in which whole blood is analyzed in a glucometer for a quantitative glucose level and is a screening test for diabetes, performed using capillary blood from a fingerstick (capillary puncture)

hemoglobin A1C test

capillary blood test that shows blood sugar control over an approximate 3-month period

cholesterol testing

test in which lipids are evaluated using capillary blood

Helicobacter pylori testing

test in which a blood sample is screened for a bacterium which is the main cause of gastric ulcers

mononucleosis screening

screening tool that tests for the presence of the Epstein-Barr virus in capillary blood

nasal smear for influenza types A and B

a qualitative test for influenza antigens using a swab that is inserted into the nostril

drug testing

the detection of substances in urine and blood samples

fecal occult blood test

test performed to screen for hidden blood in stool

human chorionic gonadotropin (hCG)

hormone secreted by the placenta during pregnancy

analytes

substances or chemicals that are being identified and measured

quantitative test

a test that is related to measuring the amount of something

qualitative test

a test that is performed by identifying or measuring by the qualities and visible/measurable properties of something

quality control

action is performed to ensure the reliability of test results by detecting and eliminating error

quality assurance

maintenance of a desired level of quality related to a service or piece of equipment

factors that could lead to false positive fecal occult blood tests

• Red meats

• Red dye

• Aspirin and associated products

• Vitamin C supplements

• Iron supplements

Male: 13.5 to 17.5 g/dL

Female: 12 to 16 g/dL

normal result for hemoglobin (Hgb) test

Male: 41% to 53%

Female: 36% to 46%

normal result for hematocrit (Hct) test

4,500 to 11,000/mm3

normal result for white blood cell count in complete blood count (CBC) test

Male: 4.5 to 5.9 million/mm3 

Female: 4 to 5.5 million/mm3

normal result for red blood cell count in complete blood count (CBC) test

150,000 to 400,000/mm3

normal result for platelet count in complete blood count (CBC) test

50% to 70% (of all white blood cells)

normal result for granulocyte ratio in complete blood count (CBC) test

value score of 80 to 95

normal result for MCV in complete blood count (CBC) test

70-100 mg/dL, fasting

normal result for blood glucose test

<5.7%

normal result for hemoglobin A1C test

130-200 mg/dL

normal results for total cholesterol in lipid profile

<100 mg/dL

normal results for LDL in lipid profile

>60 mg/dL

normal results for HDL in lipid profile

40 to 150 mg/dL

normal results for triglycerides in lipid profile

preanalytical phase of clinical lab testing

• The provider orders a test to screen, monitor, or diagnose a patient’s condition.

• A written or electronic requestion is filled out, showing the requested tests to be ordered, the specimen required, and where the specimen will be tested.

• The specimen is collected, labeled, and processed.

• The specimen is transported to the laboratory or properly prepared for offsite laboratory pickup.

errors that affect results during preanalytical phase

• Inappropriate test request

• Order entry error

• Misidentification of the patient

• Inappropriate container

• Improperly labeling of specimen

• Inadequate sample collection

• Inadequate sample/anticoagulation ratio

analytical phase of clinical lab testing

• Instruments are maintained and calibrated.

• Controls are run and analyzed for each testing method.

• The specimen is tested, and the results are compared with reference ranges.

• The test results are logged and documented in the patient’s health record.

errors that affect results during analytical phase

• Equipment malfunctions (Personnel are required to perform calibration on laboratory equipment. Preventive maintenance schedules must be followed and documented.)

• Sample mix-up

• Unindicated failure of quality controls

• Procedures not properly followed

postanalytical phase of clinical lab testing

• Specimens are properly discarded.

• Analyses of control results are compared over time.

• Patient reports from outside laboratories are logged or documented.

• The provider interprets and signs all lab reports.

• The patient is notified of the results in the office or is contacted by laboratory personnel.

• The final report and all communication with the patient are documented in the patient’s health record.

errors that affect results during analytical phase

• Failure to report

• Improper data entry (Accurate recording is a key responsibility of the medical assistant.)​​​​​​​

• Excessive turnaround time

specialty testing

tests performed in the medical office that do not fall under point-of-care testing or CLIA-waived tests

Snellen chart

chart used to evaluate distance vision

Ishihara test

test used to assess for color deficiency (colorblindness)

tympanometry

records the movement of tympanic membrane in order to assess for hearing loss

normal tympanogram results

tympanometry produces a peak on the graph

abnormal tympanogram results

tympanometry produces a flat line on the graph

25 decibels

An adult who has normal hearing should be able to hear below _______.

15 decibels

A child who has normal hearing should be able to hear below ___________.

scratch allergy test

Test in which a diluted allergen is applied to a scratch or prick that has been made on the surface of the patient’s skin. The testing is usually conducted on the forearm or upper back. If a wheal occurs in the first 15 minutes, the allergist can identify the substance as a possible allergen and consider further allergy testing to be conducted intradermally.

intradermal allergy test

Test in which a diluted allergen is injected intradermally, and the patient is observed. An initial wheal is expected. If the wheal becomes inflamed with induration (raised, hard area), the substance can be identified and confirmed as an allergen.

80-120%

expected value for FEV₁ , FVC, and TLC during a pulmonary function test (with 95% confidence)

75-120%

expected value for FRC and RV during a pulmonary function test (with 95% confidence)

within 5% of predicted value

expected value for absolute FEV₁/FVC ratio during a pulmonary function test (with 95% confidence)