CLin Med Lab WK 1

What is the purpose of the Clinical Laboratory Improvement Act (CLIA) of 1967?

To establish minimal quality requirements for clinical laboratories engaged in crossing state lines

What amendments made all labs required to have a certificate from the department of health and human services and are required to have quality control protocols

Clinical Laboratory improvement amendments of 1988 (CLIA)

What does OSHA stand for?

Occupational Safety and Health Administration.

OSHA published guidance to make labs Sade for personnel called:

OSHA laboratory safety guidance

What is the primary goal of OSHA?

To ensure safe and healthful working conditions for workers.

What are ways of dealing with hazards according to OSHA?

fume hoods, SOPs for handling chemicals, no mouth pipetting, protective gear, hygiene plans, blood born pathogen and needle stick injury

What year was HIPAA enacted?

1996.

What does HIPAA regulate?

How personally identifiable information must be handled by healthcare entities.

As of April 5 2021 the rule on interoperability information blocking and ONC Health IT certification gives patients what?

access without charge to all healthcare records

What is the significance of the 20th century in laboratory medicine?

Development of microbiology accidentally, clinical chemistry, and detection of serum tumor markers and quantitative analysis methods, and transfusion medicine through blood group classification.

What are the normal fasting glucose levels for adults?

70-99 mg/dL.

What is the normal range for sodium in adults?

136 - 145 mEq/L.

What is the normal range for potassium in adults?

3.5 - 5.0 mEq/L.

What is the normal range for chloride in adults?

95 - 105 mEq/L.

What is the normal BUN level in adults?

7-18 mg/dL.

What is the normal creatinine range for adults?

0.6 - 1.2 mg/dL.

What is the normal white blood cell (WBC) count for adults?

4.5 - 11 x 10^9/L.

What are the normal hemoglobin levels for adults?

12 - 16 g/dL (female) / 13.5 - 17.5 g/dL (male)

What is the normal hematocrit range for adult females?

36% - 46%.

What is the normal hematocrit range for adult males?

41% - 53%.

What is the normal platelet count for adults?

150 - 400 x 10^9/L.

When did Hippocrates advocate a diagnostic protocol that included testing the patients urine?

5-4 BC

What century was the microscope invented in?

17th

What century was the discovery of the cause of coagulation?

18th

What century were WBCs identified?

19th

What was the role of the American College of Surgeons in laboratory medicine?

Conducted the first inspections of hospitals in 1918.

What act established the minimal quality requirements for clinical laboratories engaged in interstate commerce to participate in medicare

clinical laboratory improvement act of 1967

What group has the responsibility for implementing the CLIA program

the division of laboratory services within the survey and certification group

lab tests are compared to a set range before a provider can interpret

reference range

range of dosage of a therapeutic agent or it'd plasma/serum concentration where it is expected to achieve

therapeutic range

the trueness of a test

accuracy

reproducibility of a rest

precision

What are the 2 important factors regarding accuracy of a test?

sensitivity and specificity

ability of a test to correctly detect individuals who have disease

the positive rate sensitivity

ability of a test to identify people without the disease/condition

true negative specificity rate

What is the purpose of varied blood collection tubes?

To ensure proper specimen collection and preservation for accurate laboratory testing.

What must employers report to OSHA as of January 1, 2015?

All work-related fatalities within 8 hours and all work-related inpatient hospitalizations, amputations, and losses of an eye within 24 hours.

Establishes national standards for the protection of health information and individuals' privacy rights.

HIPAA

What was a significant issue with labs reading PAP smears in the late 60s?

They had a high error rate due to being overworked and understaffed.

What does the term 'false-positive' refer to in laboratory testing?

A test result indicating a condition is present when it is not.

What does the term 'false-negative' refer to in laboratory testing?

A test result indicating a condition is not present when it actually is.

What is the maximum extension allowed for interpreting a test under HIPAA?

One extension of 30 days, with written reason and expected date for providing access.

Can providers disclose reports without patient authorization?

Yes, if it is for treatment purposes, including consulting with other providers.

What are reasonable safeguards in communication of patient information?

Methods like confirming fax numbers, using cover sheets, and lowering voice in proximity to others.

What does the term 'reference range' refer to?

A set of values into which 95% of the healthy population falls, used for interpreting lab tests.

Differentiate between prevalence and incidence.

Prevalence is the proportion of people who have a condition during a time period; incidence is the proportion of new cases that occur during that time.

Medical testing at or near the site of patient care, providing results usually within 1-3 days.

point of care testing

What is lab collection used for?

confirm disease, rule out, monitor, prognostic, screen

Out patient clinics with results in 1-3 days

routine tests

urgent care facility with results within 60-120 minutes

priority tests

emergency department with results in 30-60 minutes

STAT tests

What is the average blood volume in an adult?

Approximately 10 pints (units) of blood.

The liquid portion of anticoagulated whole blood, containing clotting factors.

plasma

The liquid portion of clotted blood samples, lacking most clotting factors.

serum

The volume percentage of red blood cells (RBC) in blood.

hematocrit

An iron-containing oxygen-transport protein in red blood cells.

hemoglobin

They create a vacuum seal to facilitate drawing of blood and contain additives to stabilize or preserve samples.

vacutainers

no additives is what color tube?

Red (serum)

serum separating gel useful for chemistry, serology, and endocrine

Gold/marble top

What does a light blue vacutainer contain?

Sodium citrate, used for coagulation studies (PT, PTT, TT).

What does a green vacutainer contain?

heparin (anticoagulation)

What does the grey vacutainer contain?

sodium fluoride inhibit glycolysis, potassium oxalate, used for glucose, lactate, blood alcohol

Acid citrate dextrose A for tissue typing, DNA studies, HIV cultures

Yellow vacutainer

whole studies like CBC, ESR using EDTA as anticoagulant

lavender vacutainer

blood typing and cross matching

pink vacutainer

heavy metal, drug toxicology

royal blue vacutainer

lead testing

tan vacutainer

What is the blood draw order?

1. blood culture 2. citrated tube 3. serum tubes 4. heparin tube 5. EDTA tube 6. glycolytic inhibitor

What is the blood draw order to avoid additive contamination?

Sterile specimens first, followed by coagulation studies, then no anticoagulant tubes, and finally tubes with anticoagulants.

What physiologic factors can affect venous blood samples?

Strenuous exercise, hemolysis, emotional stress, extended contact b/w serum and cells, clot formation and incorrect specimen collection.

What is the significance of a clean catch urine sample?

It is important for accurate test interpretation, reducing contamination from external sources.

A midstream urine sample collected to minimize contamination from skin bacteria

clean catch specimen

What should be done to the area around the urethral meatus before collecting a urine sample?

It should be cleaned to reduce contamination.

Why is it important to minimize contamination in urine samples?

Contaminated samples cannot reliably diagnose urinary tract infections (UTIs).

Where should urine samples be obtained from in patients with an indwelling catheter?

From the tubing rather than the collection bag.

What are the three main components of urinalysis?

Gross assessment, dipstick test (chemical analysis), and microscopic exam.

What does the gross assessment of urine include?

Color, clarity, and odor.

A semiquantitative assessment of various chemical components in urine.

dipstick test

What does a microscopic exam of urine involve?

Examination of urine sediment after centrifugation.

What is the range of color in a urinalysis

ranges from pale yellow to deep amber

Normal urine should be:

clear

Sweet acetone smelling urine could mean:

glycosuria

Foul smelling urine could mean:

bacteria

fecal smelling urine could mean:

fistula

What is the reference range for urine pH?

4.5 - 8.0, with an average of 7.0.

What are some causes for abnormal urine pH

medications, bacteria, diet

What is the reference range for specific gravity of urine?

1.005 - 1.030

What does a higher specific gravity in urine indicate?

More concentrated urine.

What can cause a lower specific gravity in urine?

Overhydration, diabetes insipidus, nephropathy, or acute tubular necrosis.

what is the relationship between ADH and specific gravity?

increases water reabsorption so if >ADH = >water excretion = > specific gravity

What is the reference value for protein in urine?

negative

What is elevated proteinuria a potential indicator of?

renal disease

If protein is > 3.5g/day it is consistant with?

nephrotic syndrome

What does the presence of leukocyte esterase in urine indicate?

Increased white blood cells, supporting a diagnosis of UTI and a contaminated specimen can give false positive

What does a positive nitrite test suggest?

The presence of nitrate-reducing bacteria, often gram-negative rods.

When should you send a urine culture?

if pt has UTI to see bacteria type and what antibiotics will kill it

generally more affective but does not strictly determine antibiotic selection

mean inhibitory concentration

What is the significance of glucose in urine?

Glycosuria may indicate diabetes or renal tubular disorders indicating > 150 - 180 mg/dl plasma glucose

What do elevated ketones in urine indicate?

Utilization of fats instead of carbohydrates, often seen in uncontrolled diabetes or starvation.

A medical emergency in type 1 diabetes caused by excessive ketone production due to insulin deficit.

diabetic ketoacidosis