Key Takeaways
- CLIA (Clinical Laboratory Improvement Amendments) classifies lab tests into three categories: waived, moderate complexity, and high complexity
- CLIA-waived tests can be performed by medical assistants with minimal training — examples include rapid strep, urine dipstick, blood glucose, and urine pregnancy tests
- Quality control (QC) must be performed on all lab equipment according to manufacturer instructions and documented in a QC log
- A complete blood count (CBC) measures red blood cells (RBCs), white blood cells (WBCs), hemoglobin, hematocrit, and platelets
- Normal adult WBC count is 4,500-11,000/mcL; elevated WBC (leukocytosis) suggests infection; decreased WBC (leukopenia) suggests immunosuppression
- Urinalysis includes physical examination (color, clarity, specific gravity), chemical analysis (dipstick), and microscopic examination
- Normal fasting blood glucose is 70-100 mg/dL; diabetes is diagnosed at fasting glucose of 126 mg/dL or higher on two occasions
- Hemoglobin A1C reflects average blood glucose over the past 2-3 months — normal is below 5.7%, prediabetes is 5.7-6.4%, and diabetes is 6.5% or higher
Laboratory Procedures
Medical assistants perform a variety of laboratory procedures in the clinical setting. Understanding CLIA regulations, quality control, normal lab values, and proper specimen handling is essential for safe and accurate laboratory testing.
CLIA (Clinical Laboratory Improvement Amendments)
CLIA was enacted in 1988 to ensure quality laboratory testing. It classifies tests into three categories:
| Category | Complexity | Who Can Perform | Examples |
|---|---|---|---|
| Waived | Minimal complexity, low risk of error | Medical assistants, trained office staff | Rapid strep, urine dipstick, blood glucose, pregnancy test, hemoglobin, INR (point-of-care) |
| Moderate complexity | Requires more training and skill | Lab technicians, trained personnel | CBC (automated), urinalysis (microscopic), Gram stain |
| High complexity | Requires advanced training and expertise | Medical technologists, pathologists | Cytology, histopathology, flow cytometry |
CLIA Requirements for Medical Offices
- Must have a CLIA certificate appropriate for the testing complexity level performed
- Certificate of Waiver (CoW) allows only waived tests — most common for physician offices
- Must follow manufacturer's instructions for all testing procedures
- Must perform and document quality control (QC) as specified
- Records must be maintained for at least 2 years
Quality Control (QC)
Quality control ensures laboratory test results are accurate and reliable:
| QC Component | Description |
|---|---|
| Control samples | Known-value samples run alongside patient samples to verify accuracy |
| Calibration | Adjusting instruments to ensure accurate readings |
| Proficiency testing | External evaluation by a reference lab to verify accuracy |
| QC log | Written record of all QC results, dates, and corrective actions |
| Levey-Jennings chart | Graph tracking QC results over time to identify trends or shifts |
Key QC Rules
- Run controls at the beginning of each day testing is performed (or per manufacturer instructions)
- Controls must fall within the acceptable range before patient samples can be run
- If controls are out of range: Do NOT run patient samples — troubleshoot, repeat controls, document
- Document all QC results, including out-of-range values and corrective actions taken
- Reagent management: Check expiration dates, store properly, do not use expired reagents
Hematology
Complete Blood Count (CBC)
The CBC is one of the most commonly ordered blood tests:
| Component | Normal Adult Range | Clinical Significance |
|---|---|---|
| RBC (Red Blood Cells) | M: 4.5-5.5 million/mcL; F: 4.0-5.0 million/mcL | Low = anemia; High = polycythemia |
| WBC (White Blood Cells) | 4,500-11,000/mcL | High (leukocytosis) = infection; Low (leukopenia) = immunosuppression |
| Hemoglobin (Hgb) | M: 13.5-17.5 g/dL; F: 12.0-16.0 g/dL | Oxygen-carrying capacity; low = anemia |
| Hematocrit (Hct) | M: 38-50%; F: 36-44% | Percentage of blood volume that is RBCs |
| Platelets | 150,000-400,000/mcL | Low (thrombocytopenia) = bleeding risk; High (thrombocytosis) = clotting risk |
| MCV | 80-100 fL | Size of RBCs: low = microcytic; high = macrocytic |
WBC Differential
The WBC differential breaks down the types of white blood cells:
| WBC Type | Normal % | Function |
|---|---|---|
| Neutrophils | 55-70% | Fight bacterial infections (most abundant) |
| Lymphocytes | 20-40% | Immune response (T cells, B cells); increased in viral infections |
| Monocytes | 2-8% | Phagocytosis (engulf pathogens and debris) |
| Eosinophils | 1-4% | Fight parasites; increased in allergic reactions |
| Basophils | 0.5-1% | Release histamine and heparin; involved in allergic responses |
Memory aid: "Never Let Monkeys Eat Bananas" (Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils — in order from most to least abundant)
Urinalysis
A complete urinalysis has three components:
1. Physical Examination
| Parameter | Normal | Abnormal Findings |
|---|---|---|
| Color | Pale yellow to amber | Red/brown (blood), dark amber (dehydration), orange (bilirubin), cloudy (infection) |
| Clarity | Clear to slightly hazy | Turbid/cloudy (infection, crystals, mucus) |
| Specific gravity | 1.005-1.030 | High = concentrated (dehydration); Low = dilute (overhydration, diabetes insipidus) |
2. Chemical Analysis (Dipstick)
| Reagent Pad | Normal | Clinical Significance of Abnormal |
|---|---|---|
| pH | 4.5-8.0 (avg 6.0) | Acidic: high-protein diet, DKA; Alkaline: UTI, vegetarian diet |
| Protein | Negative | Positive: kidney disease, preeclampsia, UTI |
| Glucose | Negative | Positive: diabetes mellitus (renal threshold ~180 mg/dL) |
| Ketones | Negative | Positive: DKA, starvation, low-carb diets |
| Blood | Negative | Positive: infection, stones, trauma, menstrual contamination |
| Bilirubin | Negative | Positive: liver disease, bile duct obstruction |
| Leukocyte esterase | Negative | Positive: UTI (presence of WBCs) |
| Nitrite | Negative | Positive: UTI (bacteria convert nitrate to nitrite) |
3. Microscopic Examination (Moderate Complexity)
| Finding | Significance |
|---|---|
| RBCs | Bleeding, trauma, stones, infection |
| WBCs | Infection (>5 per HPF is abnormal) |
| Bacteria | Urinary tract infection |
| Casts | Kidney disease (specific type indicates cause) |
| Crystals | Kidney stones, metabolic disorders |
| Epithelial cells | Contamination (large numbers) or kidney disease |
Blood Chemistry
Common Blood Chemistry Values
| Test | Normal Range | Clinical Use |
|---|---|---|
| Fasting blood glucose | 70-100 mg/dL | Diabetes screening (>126 = diabetes) |
| Hemoglobin A1C | <5.7% | 2-3 month glucose average (>6.5% = diabetes) |
| BUN (Blood Urea Nitrogen) | 7-20 mg/dL | Kidney function |
| Creatinine | 0.7-1.3 mg/dL | Kidney function (more specific than BUN) |
| Total cholesterol | <200 mg/dL | Heart disease risk |
| LDL ("bad") | <100 mg/dL | Heart disease risk — lower is better |
| HDL ("good") | >40 mg/dL (M), >50 mg/dL (F) | Heart disease protection — higher is better |
| Triglycerides | <150 mg/dL | Heart disease risk |
| TSH | 0.4-4.0 mIU/L | Thyroid function (high = hypothyroid; low = hyperthyroid) |
Specimen Handling
Key Rules
- Label at the time of collection — never pre-label specimens
- Include: patient name, DOB, date/time of collection, collector initials, test requested
- Transport specimens to the lab promptly — most within 30-60 minutes
- Specimens requiring refrigeration: urine for culture (if delayed), some blood chemistries
- Never leave specimens in extreme temperatures (heat or direct sunlight)
- Maintain chain of custody for drug testing and forensic specimens
Microbiology Basics
Types of Microorganisms
| Type | Characteristics | Examples | Treatment |
|---|---|---|---|
| Bacteria | Single-celled prokaryotes; classified by shape and Gram stain | Staphylococcus, Streptococcus, E. coli | Antibiotics |
| Viruses | Non-living, require host cell to replicate | Influenza, HIV, COVID-19, hepatitis | Antivirals (limited), vaccines |
| Fungi | Eukaryotic; includes yeasts and molds | Candida (yeast), Tinea (ringworm) | Antifungals |
| Parasites | Organisms living in/on a host | Giardia, pinworm, malaria | Antiparasitics |
| Protozoa | Single-celled eukaryotes | Amoeba, Giardia, Plasmodium | Antiprotozoals |
Bacterial Classifications
| Classification | Shape | Examples |
|---|---|---|
| Cocci | Spherical/round | Staphylococcus, Streptococcus |
| Bacilli | Rod-shaped | E. coli, Clostridium |
| Spirilla | Spiral-shaped | Treponema (syphilis), Borrelia (Lyme) |
Gram Stain
- Gram-positive: Stain purple/blue; thick cell wall (e.g., Staphylococcus, Streptococcus)
- Gram-negative: Stain pink/red; thin cell wall with outer membrane (e.g., E. coli, Neisseria)
- Gram stain helps guide antibiotic selection before culture results are available
Specimen Collection for Cultures
- Use sterile technique to avoid contamination
- Throat culture: Swab posterior pharynx and tonsils (not tongue or cheeks); used for Group A Strep
- Wound culture: Collect from the wound margin (not surface discharge)
- Urine culture: Clean-catch midstream specimen to reduce contamination
- Blood culture: Collected in special blood culture bottles (yellow-top tubes); drawn from two separate sites
- Label all specimens immediately with patient name, DOB, date/time, source, and collector initials
- Transport to lab promptly — delayed transport may allow overgrowth of contaminants
Coagulation Studies
| Test | Normal Range | Purpose |
|---|---|---|
| PT (Prothrombin Time) | 11-13.5 seconds | Monitors warfarin (Coumadin) therapy; evaluates extrinsic pathway |
| INR (International Normalized Ratio) | 0.8-1.1 (normal); 2.0-3.0 (therapeutic on warfarin) | Standardized PT measurement for warfarin monitoring |
| PTT (Partial Thromboplastin Time) | 25-35 seconds | Monitors heparin therapy; evaluates intrinsic pathway |
| aPTT (Activated PTT) | 30-40 seconds | More sensitive version of PTT |
| Bleeding time | 2-7 minutes | Evaluates platelet function |
Key Coagulation Facts
- Warfarin is monitored with PT/INR (extrinsic pathway)
- Heparin is monitored with PTT/aPTT (intrinsic pathway)
- Elevated PT/INR = increased bleeding risk; may need to reduce warfarin dose
- Light blue top tubes (sodium citrate) are used for coagulation studies and must be filled to the exact line — underfilling causes inaccurate results
Which of the following is a CLIA-waived test that a medical assistant can perform?
A patient's fasting blood glucose is 134 mg/dL. This result suggests:
An elevated eosinophil count on a WBC differential is most commonly associated with:
Which of the following urinalysis dipstick results suggest a urinary tract infection (UTI)? (Select all that apply)
Select all that apply
Match each lab value to its normal adult range.
Match each item on the left with the correct item on the right
Hemoglobin A1C (HbA1c) reflects average blood glucose levels over the past - months.
Type your answer below
A patient's CBC shows a hemoglobin of 9.0 g/dL and a hematocrit of 28%. These results are most consistent with:
Point-of-Care Testing (POCT)
Point-of-care testing refers to medical tests performed at or near the site of patient care (e.g., in the medical office) rather than in a reference laboratory. These tests provide rapid results for immediate clinical decision-making.
Common Point-of-Care Tests
| Test | Method | Turnaround | Clinical Use |
|---|---|---|---|
| Blood glucose | Glucometer (finger stick) | 5-10 seconds | Diabetes monitoring, hypoglycemia screening |
| Rapid strep | Throat swab with rapid antigen test | 5-10 minutes | Group A Streptococcus pharyngitis |
| Urine pregnancy (hCG) | Urine dipstick/cassette | 3-5 minutes | Pregnancy detection |
| Urine dipstick | Chemical reagent strip | 1-2 minutes | UTI screening, diabetes, kidney disease |
| INR (CoaguChek) | Finger stick with point-of-care device | 1 minute | Warfarin monitoring |
| Hemoglobin/Hematocrit | HemoCue or i-STAT | 1 minute | Anemia screening |
| Influenza rapid test | Nasal/throat swab | 15 minutes | Influenza A/B detection |
| COVID-19 rapid antigen | Nasal swab | 15 minutes | SARS-CoV-2 detection |
| Hemoglobin A1C (POCT) | Finger stick | 5 minutes | Diabetes monitoring |
| Fecal occult blood (FOBT/FIT) | Stool sample card | 1-5 minutes | Colorectal cancer screening |
Advantages of POCT
- Rapid results — enables immediate clinical decisions
- Convenience — testing at the point of care, no specimen transport
- Patient satisfaction — results before the patient leaves the office
- Cost-effective — reduced lab processing fees for simple tests
Limitations of POCT
- Less precise than reference laboratory testing
- Quality control still required (run controls per manufacturer instructions)
- Operator dependent — proper training is essential
- Confirmation needed — positive rapid tests may need laboratory confirmation (e.g., positive rapid strep confirmed with throat culture)
Hematology Additional Concepts
Erythrocyte Sedimentation Rate (ESR / Sed Rate)
- Measures how quickly RBCs settle in a test tube over 1 hour
- Normal: Males <15 mm/hr; Females <20 mm/hr
- Elevated: Indicates inflammation (not specific — elevated in infection, autoimmune disease, cancer, pregnancy)
- Used to monitor disease activity in conditions like rheumatoid arthritis and temporal arteritis
- Non-specific test — does not diagnose a specific condition
Blood Typing and Crossmatching
- ABO blood types: A, B, AB, O
- Rh factor: Positive (+) or negative (-)
- Universal donor: O negative (can donate to all blood types)
- Universal recipient: AB positive (can receive from all blood types)
- Rh incompatibility: Important in pregnancy — Rh-negative mother with Rh-positive fetus may develop antibodies (prevented with RhoGAM injection)
Complete Blood Count Reference Values Summary
| Component | Male | Female | Clinical Significance |
|---|---|---|---|
| RBC | 4.5-5.5 M/mcL | 4.0-5.0 M/mcL | Low = anemia; High = polycythemia |
| WBC | 4,500-11,000/mcL | 4,500-11,000/mcL | High = infection; Low = immunosuppression |
| Hemoglobin | 13.5-17.5 g/dL | 12.0-16.0 g/dL | Low = anemia |
| Hematocrit | 38-50% | 36-44% | Percentage of blood volume as RBCs |
| Platelets | 150,000-400,000/mcL | 150,000-400,000/mcL | Low = bleeding risk; High = clotting risk |
| MCV | 80-100 fL | 80-100 fL | Size of RBCs |
| ESR | <15 mm/hr | <20 mm/hr | Nonspecific inflammation marker |
When performing quality control on a lab instrument, the control sample result falls outside the acceptable range. The medical assistant should: