I. Key terms
A. Review the terms listed in the terminology section.
B. Spell the listed terms accurately.
C. Pronounce the terms correctly.
D. Use the terms in their proper context.
II. Clinical laboratory testing
A. Reasons to perform clinical tests
1. Diagnose or rule out disease process
2. Establish treatment plans
3. Monitor treatment plans
B. Purpose of physician office laboratory (POL)
1. Diagnostic testing on site
a. Screening test for diabetes
b. Establish dietary or insulin related treatment plans.
c. Monitor effectiveness of treatment plan using Point of care (POC) glucose monitors.
2. Convenience for patient
3. Cost-effective (managed care)
III. The medical assistant’s duties in a physician’s office laboratory
i. Logs
ii. Record keeping
iii. Proficiency testing
5. Quality assurance
6. Preventative maintenance
7. Documentation
8. Laboratory safety
i. Chemicals
ii. Physical
iii. Personnel
iv. Patient
9. Hazardous waste disposal
10. Patient education/instruction
IV. Regulatory controls under Clinical Laboratory Improvement Amendment (CLIA)
A. Laboratory regulations for physician office lab
1. CLIA
a. Categories of testing
b. Testing personnel
c. Documentation
d. Proficiency testing
e. Fees
B. State
1. Laws and regulations
2. Inspections
3. Fees
V. Quality control and quality assurance programs
A. Quality control
1. Definition
2. Quality of work
3. Accuracy of testing
4. Documentation/logs
B. Quality control programs
1. Set up
2. Review
C. Documentation
VI. Common reference materials used for the performance standards of a test
A. Performance standards
1. Accuracy
2. Precision
3. Calibration
4. Control samples
5. Relevance
B. Reference materials
1. Package inserts
2. Manufacturer’s user guide
3. Clinical laboratory technical procedure manuals
4. OSHA standards
5. CLIA’88 requirements
VII. Safety rules, accidents, hazardous waste
A. Standard Precautions
1. Infection control
2. Body surface isolation
B. OSHA Bloodborne Pathogen Standard
C. Hazard Communications Standard
1. Material Safety Data Sheets (MSDS)
2. Biohazard symbol
3. Hazard labels
4. Record keeping
D. Accident Prevention Guidelines
1. Physical safety
2. Fire and electrical safety
3. Biologic safety
4. Sharps safety (no recapping needles)
5. Accident reporting
6. Housekeeping
E. Hazardous Waste Operations and Emergency Response Final Rule
F. Hazardous Waste Disposal (OSHA regulations)
1. What is considered hazardous waste?
2. Proper disposal
a. Chemicals
b. Biohazardous
c. Medical Sharps
3. Proper storage prior to pickup
4. Disposal companies
5. Record keeping
VIII. The composition and function of blood
A. Composition of blood
1. Erythrocytes
2. Leukocytes
3. Thrombocytes
4. Fluid or plasma
B. Production of blood
1. Hematopoiesis
a. Bone marrow
b. Liver
c. Spleen
C. Function of blood
1. Oxygen transportation
a. Hemoglobin
b. Hematocrit
2. Infection control
a. Leukocytes total
b. Lymphocytes
c. Monocytes
d. Neutrophils
e. Eosinophils
f. Basophils
3. Transport chemical components
a. Electrolytes
b. Proteins
c. Glucose
d. Hormones
e. Enzymes
4. Remove waste products
IX. Common fears and concerns of patients
A. Common fears
1. Physical harm/injury
2. Emotional/test results
3. Misunderstanding
B. Reducing fears
1. Explanation of procedure
2. Knowledge of equipment
3. Assessment of patient age, emotional and physical condition
4. Language barriers addressed
5. Professional attitude
6. Compassion
X. Common blood tests and their purpose
A. Common blood tests
1. Complete blood count (CBC)
2. Chemistry panels
a. Glucose
b. BUN
c. Creatinine
d. Proteins
e. Electrolytes
f. Cardiac enzymes
g. Liver enzymes
h. Lipids
3. Tests for hormone levels
XI. The basic characteristics of urine
A. Urine formation
1. Urinary system
2. Organs
3. Filtering process
a. Urine composition 25% water
b. Urine composition 5% organic and inorganic waste products
4. Remaining urine composition
B. Physical properties
1. Color
2. Clarity
3. Odor
4. Specific gravity
C. Chemical properties
1. Albumin (protein)
2. Bacteria (nitrites)
3. Bilirubin
4. Blood (red blood cells, hemoglobin)
5. Blood (white blood cells)
6. Glucose
7. Ketone bodies
8. pH
9. Urobilinogen
10. Specific gravity
D. Formed elements
1. Red blood cells
2. White blood cells
3. Casts
4. Bacteria
5. Crystals
6. Artifacts
E. Purpose
1. To establish and/or rule out disease process.
2. To set up treatment program.
XII. OSHA Standards for Specimen Collection
1. When performing clinical procedures, before and after patient contact, before and after applying gloves, and after contact with blood or other potentially infections materials.
2. Gloves no substitute for hand washing
1. Infectious waste into these containers (closable and clearly marked).
2. Containers leak-proof and properly constructed to contain the contents during handling, transport, or shipping.
3. Urine specimen not qualified for placement into biohazard containers.
1. Worn when in contact with blood and other body fluids that are potentially infectious.
2. Examples: body fluids, mucous membranes, non-intact skin, and contaminated articles or surfaces.
1. Gown
2. Apron
3. Laboratory coat
4. Face shields or masks in combination with eye protection devices.
a. In case of splashes splatter, or droplets of blood.
b. Other potentially infectious materials
XIII. Maintain the chain of custody when processing urine specimens
A. Chain of custody
1. Specimen documentation form
2. Labels
3. Patient identification
B. Collection procedure
1. Preparation of restroom
2. Collection container
3. Patient instruction
XIV: Microorganisms cause disease
A. Pathogenic organisms
1. Used-up nutrients needed by cells and tissues for survival.
2. Reproduce within cells causing destruction of cells.
3. Body cells become targets of the body’s own defense mechanism.
4. Produce toxins which damage cells and tissues.
XV. Viruses, bacteria, fungi, and parasites differ
A. Bacteria
1. Single cell prokaryotic
2. Rapid reproduction Major cause of disease
3. Identified by gram stain
4. Identified by shape
5. Ability to grow in the presence or absence of oxygen
6. Presence of special groups
a. Mycobacteria
b. Rickettsia
c. Chlamydiae
d. Mycoplasms
B. Virus
1. Smallest known infectious organism
2. Not visible with regular microscope
3. Simpler life form than cell
4. Live and grow only within living cells of other organisms.
5. Diseases caused
a. Common cold
b. Influenza
c. Chicken pox
d. Hepatitis
e. Warts
f. AIDS
g. Mumps
h. Rubella
i. Encephalitis
j. Herpes
C. Fungi
1. Eukaryotic organism
2. Single celled organism
3. Budding reproduction (yeast)
4. Large fuzzy multi celled (molds)
5. Cause superficial infections
a. Athlete’s feet
b. Ringworm
c. Thrush
d. Vaginal yeast infections
6. Life-threatening illness possible if internal tissue invaded.
D. Parasites
1. Complete organism
2. Existence dependent on another organism for nourishment or some other advantage.
3. Examples of parasitic infections (“infestations”)
a. Worms
1) Round
2) Flat
3) Tape
b. Insects
1) Mosquitoes
2) Ticks
3) Lice
4) Mites
XVI. Transport specimens to outside laboratories
A. Specimen transportation
1. Follow the collection and packing directions from the laboratory that will receive and test the specimen.
2. Maintain the specimen in a state as close to original as possible.
3. Protect anyone who handles a specimen container from exposure to potentially infectious material.
B. Methods
1. Regularly-scheduled daily pick-ups by the reference laboratory.
2. As-needed pick up
3. Through the mail
a. CDC procedures based on U.S. Public Health Service regulations.
b. Special mailing containers and labels
Lab:
I. Procedures for the collection of blood, urine, stool, sputum, throat and other bacteriological specimens
A. Collection procedures/types
1. Venous
a. Evacuated system
b. Syringe
c. Winged infusion sets
2. Capillary
3. Urine
a. Clean catch mid-stream
b. Random
c. 24 hour
d. Performance
1) Observe and record physical characteristics.
2) Perform chemical analysis (Multistix).
3) Record chemical analysis results.
4) Prepare aliquot for centrifugation.
5) Prepare slide with sediment for microscopic examination.
4. Stool / feces
a. Random
b. 24 hour
5. Sputum
a. First morning
b. Random
6. Throat
a. Random
b. Culturette
7. Microbiology (all other)
a. Random
b. Culturette
c. Transport media
II. The purpose of equipment found in a physician’s office laboratory
A. Basic equipment
1. Microscope
2. Centrifuge
3. Electronic
a. Photometers
b. Mechanical pipettes
c. Computerized cell counters
4. Equipment used for measurement
a. Glucose meters
b. Hemoglobin meters
c. Microhematocrit readers
5. Autoclave
B. Microscope parts
1. Oculars (eye pieces)
2. Objectives
3. Arm and focus controls
4. Stage and substage
5. Light source
6. Iris
7. Condenser
8. Slides and cover slips
C. Use of microscope
1. Set up
2. Adjusting eye pieces
3. Focusing
4. Slide preparation
5. Viewing the specimen
6. Cleaning
7. Storage
III. Clinical Laboratory Improvement Amendment (CLIA) waived tests
A. Hemoglobin
1. HemoCue
2. Copper sulfate drop
B. Hematocrit
1. Microhematocrit centrifuge
2. Microhematocrit reading device
C. Erythrocyte sedimentation rate (ESR)
1. Wintrobe tube
2. Transfer pipette
3. Timer
D. Blood glucose
1. Glucose meter (many types available)
2. Glucose reagent strips
E. Fecal occult blood
1. Hemoccult slides (other types are available)
2. Developer
F. Dipstick urinalysis
1. Mulitstix 10 SG reagent strips
2. Urinometer
G. Ovulation (visual comparison)
1. Over the counter test kit
2. Package insert
H. Pregnancy (visual comparison)
1. Over the counter test kit
2. Package insert
I. Cholesterol (visual comparison)
1. Over the counter test kit
2. Package insert
J. Rapid strep
1. Throat swab
2. Qtest strep for group A streptococcus
IV. The general guidelines for collection of bodily fluids for microbiological cultures
A. Collection guidelines
1. Collect specimens with care to avoid harm, discomfort or embarrassment to the patient.
2. If a patient is to collect specimen, give clear detailed instructions along with the proper container.
3. Collect a specimen from the area where organism is most likely to be found and contamination is least likely to occur.
4. Collect a specimen at a time when optimal recovery of the organism can be expected.
5. Use appropriate collection devices, specimen containers, transport systems and culture media.
6. Obtain appropriate quantity of specimen necessary to perform the requested procedures.
7. Obtain specimen before antimicrobial therapy begins. If patient is already on antimicrobial therapy, place note in chart.
8. Label the collection container or device.
a. Patient name and ID number
b. Source (collection site of specimen)
c. Date and time of collection
d. Physician name
e. Your first initial and last name
9. Fill out and include the appropriate requisition form.
a. Patient name
b. Patient address
c. Patient date of birth and sex
d. Patient billing information
e. Type and source of microbiological specimen
f. Date and time of specimen collection
g. Test requested
h. Medications patient is taking
i. Diagnosis
j. Physician name, address, and phone number
k. Special instructions