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
Last updated: February 2026

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:

CategoryComplexityWho Can PerformExamples
WaivedMinimal complexity, low risk of errorMedical assistants, trained office staffRapid strep, urine dipstick, blood glucose, pregnancy test, hemoglobin, INR (point-of-care)
Moderate complexityRequires more training and skillLab technicians, trained personnelCBC (automated), urinalysis (microscopic), Gram stain
High complexityRequires advanced training and expertiseMedical technologists, pathologistsCytology, 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 ComponentDescription
Control samplesKnown-value samples run alongside patient samples to verify accuracy
CalibrationAdjusting instruments to ensure accurate readings
Proficiency testingExternal evaluation by a reference lab to verify accuracy
QC logWritten record of all QC results, dates, and corrective actions
Levey-Jennings chartGraph 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:

ComponentNormal Adult RangeClinical Significance
RBC (Red Blood Cells)M: 4.5-5.5 million/mcL; F: 4.0-5.0 million/mcLLow = anemia; High = polycythemia
WBC (White Blood Cells)4,500-11,000/mcLHigh (leukocytosis) = infection; Low (leukopenia) = immunosuppression
Hemoglobin (Hgb)M: 13.5-17.5 g/dL; F: 12.0-16.0 g/dLOxygen-carrying capacity; low = anemia
Hematocrit (Hct)M: 38-50%; F: 36-44%Percentage of blood volume that is RBCs
Platelets150,000-400,000/mcLLow (thrombocytopenia) = bleeding risk; High (thrombocytosis) = clotting risk
MCV80-100 fLSize of RBCs: low = microcytic; high = macrocytic

WBC Differential

The WBC differential breaks down the types of white blood cells:

WBC TypeNormal %Function
Neutrophils55-70%Fight bacterial infections (most abundant)
Lymphocytes20-40%Immune response (T cells, B cells); increased in viral infections
Monocytes2-8%Phagocytosis (engulf pathogens and debris)
Eosinophils1-4%Fight parasites; increased in allergic reactions
Basophils0.5-1%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

ParameterNormalAbnormal Findings
ColorPale yellow to amberRed/brown (blood), dark amber (dehydration), orange (bilirubin), cloudy (infection)
ClarityClear to slightly hazyTurbid/cloudy (infection, crystals, mucus)
Specific gravity1.005-1.030High = concentrated (dehydration); Low = dilute (overhydration, diabetes insipidus)

2. Chemical Analysis (Dipstick)

Reagent PadNormalClinical Significance of Abnormal
pH4.5-8.0 (avg 6.0)Acidic: high-protein diet, DKA; Alkaline: UTI, vegetarian diet
ProteinNegativePositive: kidney disease, preeclampsia, UTI
GlucoseNegativePositive: diabetes mellitus (renal threshold ~180 mg/dL)
KetonesNegativePositive: DKA, starvation, low-carb diets
BloodNegativePositive: infection, stones, trauma, menstrual contamination
BilirubinNegativePositive: liver disease, bile duct obstruction
Leukocyte esteraseNegativePositive: UTI (presence of WBCs)
NitriteNegativePositive: UTI (bacteria convert nitrate to nitrite)

3. Microscopic Examination (Moderate Complexity)

FindingSignificance
RBCsBleeding, trauma, stones, infection
WBCsInfection (>5 per HPF is abnormal)
BacteriaUrinary tract infection
CastsKidney disease (specific type indicates cause)
CrystalsKidney stones, metabolic disorders
Epithelial cellsContamination (large numbers) or kidney disease

Blood Chemistry

Common Blood Chemistry Values

TestNormal RangeClinical Use
Fasting blood glucose70-100 mg/dLDiabetes screening (>126 = diabetes)
Hemoglobin A1C<5.7%2-3 month glucose average (>6.5% = diabetes)
BUN (Blood Urea Nitrogen)7-20 mg/dLKidney function
Creatinine0.7-1.3 mg/dLKidney function (more specific than BUN)
Total cholesterol<200 mg/dLHeart disease risk
LDL ("bad")<100 mg/dLHeart disease risk — lower is better
HDL ("good")>40 mg/dL (M), >50 mg/dL (F)Heart disease protection — higher is better
Triglycerides<150 mg/dLHeart disease risk
TSH0.4-4.0 mIU/LThyroid 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

TypeCharacteristicsExamplesTreatment
BacteriaSingle-celled prokaryotes; classified by shape and Gram stainStaphylococcus, Streptococcus, E. coliAntibiotics
VirusesNon-living, require host cell to replicateInfluenza, HIV, COVID-19, hepatitisAntivirals (limited), vaccines
FungiEukaryotic; includes yeasts and moldsCandida (yeast), Tinea (ringworm)Antifungals
ParasitesOrganisms living in/on a hostGiardia, pinworm, malariaAntiparasitics
ProtozoaSingle-celled eukaryotesAmoeba, Giardia, PlasmodiumAntiprotozoals

Bacterial Classifications

ClassificationShapeExamples
CocciSpherical/roundStaphylococcus, Streptococcus
BacilliRod-shapedE. coli, Clostridium
SpirillaSpiral-shapedTreponema (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

TestNormal RangePurpose
PT (Prothrombin Time)11-13.5 secondsMonitors 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 secondsMonitors heparin therapy; evaluates intrinsic pathway
aPTT (Activated PTT)30-40 secondsMore sensitive version of PTT
Bleeding time2-7 minutesEvaluates 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
Normal WBC Differential (Approximate Percentages)
Test Your Knowledge

Which of the following is a CLIA-waived test that a medical assistant can perform?

A
B
C
D
Test Your Knowledge

A patient's fasting blood glucose is 134 mg/dL. This result suggests:

A
B
C
D
Test Your Knowledge

An elevated eosinophil count on a WBC differential is most commonly associated with:

A
B
C
D
Test Your KnowledgeMulti-Select

Which of the following urinalysis dipstick results suggest a urinary tract infection (UTI)? (Select all that apply)

Select all that apply

Positive leukocyte esterase
Positive glucose
Positive nitrite
Positive ketones
Presence of blood
pH of 5.5
Test Your KnowledgeMatching

Match each lab value to its normal adult range.

Match each item on the left with the correct item on the right

1
Fasting blood glucose
2
Hemoglobin A1C (normal)
3
WBC count
4
Platelet count
5
Total cholesterol (desirable)
Test Your KnowledgeFill in the Blank

Hemoglobin A1C (HbA1c) reflects average blood glucose levels over the past - months.

Type your answer below

Test Your Knowledge

A patient's CBC shows a hemoglobin of 9.0 g/dL and a hematocrit of 28%. These results are most consistent with:

A
B
C
D

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

TestMethodTurnaroundClinical Use
Blood glucoseGlucometer (finger stick)5-10 secondsDiabetes monitoring, hypoglycemia screening
Rapid strepThroat swab with rapid antigen test5-10 minutesGroup A Streptococcus pharyngitis
Urine pregnancy (hCG)Urine dipstick/cassette3-5 minutesPregnancy detection
Urine dipstickChemical reagent strip1-2 minutesUTI screening, diabetes, kidney disease
INR (CoaguChek)Finger stick with point-of-care device1 minuteWarfarin monitoring
Hemoglobin/HematocritHemoCue or i-STAT1 minuteAnemia screening
Influenza rapid testNasal/throat swab15 minutesInfluenza A/B detection
COVID-19 rapid antigenNasal swab15 minutesSARS-CoV-2 detection
Hemoglobin A1C (POCT)Finger stick5 minutesDiabetes monitoring
Fecal occult blood (FOBT/FIT)Stool sample card1-5 minutesColorectal 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

ComponentMaleFemaleClinical Significance
RBC4.5-5.5 M/mcL4.0-5.0 M/mcLLow = anemia; High = polycythemia
WBC4,500-11,000/mcL4,500-11,000/mcLHigh = infection; Low = immunosuppression
Hemoglobin13.5-17.5 g/dL12.0-16.0 g/dLLow = anemia
Hematocrit38-50%36-44%Percentage of blood volume as RBCs
Platelets150,000-400,000/mcL150,000-400,000/mcLLow = bleeding risk; High = clotting risk
MCV80-100 fL80-100 fLSize of RBCs
ESR<15 mm/hr<20 mm/hrNonspecific inflammation marker
Test Your Knowledge

When performing quality control on a lab instrument, the control sample result falls outside the acceptable range. The medical assistant should:

A
B
C
D