BFA - Exam 1 (Ch. 1-4)

Quality Assessment (QA)

A programs of checks and balances to ensure the quality of a laboratory’s services

Must involve a mechanism for error detection and provide an opportunity to improve services

Encompasses all aspects of the urinalysis laboratory: Preanalytical, analytical, postanalytical

Preanalytical components

all procedures occurring before testing:

• ensuring appropriate test ordering processes

• specimen collection, transport, storage, and handling

• patient education, preparation, and instructions

• Procedures for handling inappropriate or unacceptable specimens

• documentation of any problems or unusual situations

• accurate, up-to-date, available procedure manuals

• adequate personnel training and supervision

Analytical components

Components directly involved in lab testing

• Equipment/instrumentation

• Reagents and supplies

• Procedure manuals w/ standardized procedures

• Analytical methods

• Monitoring of analytical methods/ quality control

• Lab personnel technical skills, training, monitoring, technical competence, and continuing education

Analytical components - Equipment/instrumentation

requires calibration, preventive maintenance, and monitoring and documentation of these actions

Analytical components - reagents

use of reagent-grade or analytical-grade reagents

distilled or deionized water and quality monitoring

verification of newly prepared reagents b4 use

Analytical components - procedure manuals

should be current, complete, readily available, comprehensive, and comply w/ Clinical Laboratory Standards Institute (CLSI) standards

Analytical components - Quality Control (QC)

QC materials used to monitor and assess analytical error

internal QC materials mimic patient samples in physical and chemical characteristics

Commercially obtained or laboratory prepared

Results recorded, and tolerance limits as well as troubleshooting and corrective action procedures established

Monitor personnel’s analysis of same specimen

Analytical components - Proficiency testing

Measures to monitor and evaluate a laboratory’s performance compared w/ that of other facilities

• testing surveys or programs in which many labs use the same lot of QC materials

• Reports useful for detecting quantitative small changes in systematic error in quantitative methods

Accredited laboratories must participate in proficiency testing

what can cause proficiency testing to fail?

all examples of analytical components, such as improper training, expired reagents, ill-maintained instrumentation, etc.

Postanalytical components

results reporting and interpretation

• efficient and effective communication of results

• standardized reporting format w/ reference ranges and informative comments listed

• immediate reporting critical values to health care provider, according to laboratory policy

• Appropriate documentation and evidence of review

• Critical values

What’s the goal of effective quality assessment program

to obtain consistently accurate and reproducible results

• test results should reflect patient’s condition, rather than being modified due to procedural or personnel variations

in the spirit of QA, an action has not been performed if it has not been documented

UA Quality Assurance Examples (not inclusive)

Procedural Factors

1. Volume of urine examined (10, 12, 15 mL)

2. Speed of centrifugation

3. Length of centrifugation

4. Conc. of sediment

5. Volume of sediment dispensed

Reporting Factors

1. Each lab should publish its own normal values (based on system used and patient population)

2. All personnel must use the same terminology

3. All personnel must report results in standard format

4. All abnormal results should be flagged for easy reference

True/False: Procedure manuals are part of the pre-analytical, analytical, and post-analytical components of a QA program

True

Safety in the Urinalysis Lab

practices to prevent spread of infection and ensure patient/employee safety

lab employees exposed to numerous biological, chemical, electrical hazards

Occupational Health and Safety Act of 1970

• Established formal regulation of health and safety for all employees

• Administered by Occupational Safety and Health Administration (OSHA)

Occupational Health and Safety Act of 1970

Established formal regulation of health and safety for all employees

Administered by Occupational Safety and Health Administration (OSHA)

Biological Hazards - Universal precautions

all body fluids, secretions, and excretions except sweat considered potentially infectious and capable of disease transmission

Biological Hazards - Transmission-based precautions

apply to specific patients with known or suspected infections

Three categories of transmission based precautions

• contact precautions

• droplet precautions

• airborne precautions

Three routes of infection or disease transmission:

• inhalation

• ingested

• direct inoculation or skin contact

What are the three categories of transmission based precautions

• contact

• droplet

• airborne

what are the three routes of infection or disease transmission

• inhalation

• ingested

• direct inoculation or skin contact

Biological hazards - What is required/ common procedures when dealing w/ specimens in the lab?

Appropriate PPE when handling body fluids

All specimens must be handled as if they are infectious and disposed of properly

Contaminated sharps must be disposed of in puncture-resistant containers and incinerated or autoclaved

Lab surfaces and equipment must be decontaminated daily w/ 10% bleach or a phenolic disinfectant

Chemical Hazards - OSHA rule (of Jan. 1990)

Requires each facility to have a Chemical Hygiene Plan defining safety policies and procedures for all hazardous chemicals

requires educating personnel annually about chemical safety policies and procedures

Components include:

• Proper labeling of chemicals

• Lab safety manuals

• Use of PPE

• Safety equipment such as an eyewash and shower

Safety Data Sheets (SDS)

ensures all employees are aware of potential chemical hazards in the workplace

Employee “Right to Know”

Requires chemical manufacturers and supplier to provide SDS for each chemical, and employers to make them available to employees

What general procedures should take place in the case of a chemical spill

consult SDS to determine appropriate action

make chemical spill kits accessible in lab

post-emergency treatment procedures for splashes and spill injuries

dispose of all chemical properly, according to the lab’s safety policies and applicable local, state, and federal laws

Procedure for flammable substances and fire

store in appropriately vented flammable storage cabinets

procedure for compressed gas tanks

tanks must be secured at all times, in use and in transit

valve caps must be in place at all times, except when in use

procedure for electrical hazards

monitor maintenance of equipment

report frayed cords or other needed maintenance

In case of emergency, generally, all personnel should be aware of:

location and operation of all safety equipment (fire extinguishers, alarm stations, emergency showers, eyewash stations)

exits and evacuations routes and procedures to follow during emergencies

What are multiple reasons to study urine?

• fluid biopsy of the kidney

• non-invasive → evaluate kidney

• urine is the ultrafiltrate of plasma

• Can be used to evaluate and monitor body homeostasis and many metabolic diseases

• can monitor therapy effectiveness

• specimen usually readily available

urine is the _______ of plasma

ultrafiltrate

Urinalysis is a ____ _____ of the kidney

fluid biopsy

• non-invasive means to evaluate the kidney, body homeostasis, metabolic diseases, and therapy effectiveness

what collection container is used for pediatrics?

adhesive bags

what containers are used for 24hr specimens

large plastic containers

what kind of container is required for cultures?

sterile containers

Specimen collection containers

disposable, wide-mouthed, flat bottomed containers w/ caps are recommended

clear containers

at least 50 mL capacity

adhesive bags for pediatrics

large plastic containers for 24 hr specimens

sterile containers required for cultures

Specimen labeling - information on label

Patient’s name and unique identification number

Date and time of specimen collection

Additional info: DOB and ordering physician

• LABEL ON CONTAINER, not lid

Specimen labeling - Requisition form

must accompany specimen

information must match label

time of receipt is stamped on requisition

type of specimen

interfering medications if applicable

what must accompany labeled specimen when its sent out for testing?

requisition form

Specimen types

First morning

• empty bladder at night before going to bed

• collect specimen first thing in the morning

• most concentrated; often preferred specimen

Random

• for routine screening

• can be affected by excess fluid intake or exercise

Timed

• collections for a predetermined length of time

• collections at a specified time of day

timed specimen

• collections for a predetermined length of time

• collections at a specified time of day

Random specimen

• for routine screening

• can be affected by excess fluid intake or exercise

first morning specimen

• empty bladder at night before going to bed

• collect specimen first thing in the morning

• most concentrated; often preferred specimen

What are some collection techniques for urinalysis?

routine void

Mid-stream “clean catch”

Catheterized specimen

suprapubic aspiration

pediatric collection

timed collections

drug specimen collection

collection technique - routine void

requires no patient preparation

collected by having patient void into appropriate container

patient normally needs no assistance other than clear directions

can be random or first morning specimen

collection technique - Mid-stream “clean catch”

For bacterial cultures or to prevent vaginal contamination and/or routine urinalysis

requires cleaning supplies, addition instructions to patient, and sterile container

requires thorough cleaning and rinsing of genital areas before collection

begin urination into toilet, collect midstream portion in container, finish voiding in toilet

collection technique - catheterized specimen

requires collection by medical personnel

sterile catheter inserted thru urethra into bladder

urine flows directly into collection bag

specimen obtained anytime from collection bag

good for culture and sensitivity

collection technique - suprapubic aspiration

requires collection by medical personnel

involves puncturing of abdominal wall and distended bladder by using needle and syringe

sample aspirated directly from bladder

bladder urine is normally sterile

used principally for cultures or in infants and usually when catheterization isn’t possible

pediatric collection techniques

often commercially available plastic urine collection bags that attach w/ a hypoallergenic skin adhesive are used

patient’s perineal area cleaned prior to bag attachment

specimen removed as soon as possible after collection

specimen appropriate for routine testing

Procedure for timed collections - 12 or 24 hr

may require addition of a chemical preservative to maintain integrity of analyte to be tested

begin and end w/ empty bladder, first void is discarded

keep on ice or refrigerate during collection period

check collection manual to identify necessary preservative

deliver specimen to lab immediately after completion of collection period

more accurate than random urine for urine chemistry tests

Drug specimen collection general procedure

proper collection, labeling and handling must be documented

if legal:

• chain of custody → documentation from the time of specimen collection until the time of receipt of lab results → standardized form always accompanies specimen

• specimen must withstand legal scrutiny → no tampering

points to consider for drug specimen collection

photo ID of urine donor or ID by employer

No unauthorized access to specimen

No adulteration, substitution or dilution of specimen

drug specimen collection: witnessed vs. unwitnessed collection

determined by individual ordering the test

both collection methods require that the specimen is handed immediately to the collector

drug specimen collection - adulteration tests

temp taken w/i 4 min - must be 32.5-37.7ºC

report temps outside of range immediately

collect another specimen asap

inspect urine color for anything unusual

-follow lab instruction for labeling, packaging and transport

What can determine whether a substance is urine or not

often need confirmation in drug screen collection or specimens collected by needle aspiration

urine creatinine conc. 50x higher than plasma

urea, sodium, and chloride higher in urine than in other body fluids

physiologic range is 1.002 to 1.035 for urine specific gravity and 4.0-8.0 for pH

urine from healthy people contains no protein or glucose , whereas many other body fluids do

urine from healthy people contains no ______ or ______, whereas many other body fluids do

protein, glucose

what is the physiologic range for urine sp. grav and pH

1.002-1.035 sp. grav

4-8 for pH

_____, _____, and _____ higher in urine than in other body fluids

urea, sodium, chloride

urine ______ conc. 50x higher than plasma

creatinine

what might cause specimen rejection

unlabeled containers

non-matching labels and requisitions

contaminated specimens (ex. stool, toilet paper)

Contamination on exterior of container

insufficient quantity

delayed or improper transport

lack of refrigeration

Note: labs have written policies for rejection

Changes in unpreserved urine: analyte color change to modified/darkened caused by

oxidation or reduction of metabolites

Changes in unpreserved urine: analyte clarity decrease caused by

bacterial growth and precipitation of amorphous material

Changes in unpreserved urine: analyte odor increase caused by

multiplication of bacteria or bacterial breakdown of urea to ammonia

Changes in unpreserved urine: analyte pH increase caused by

breakdown of urea to ammonia by urease producing bacteria/ loss of CO2

Changes in unpreserved urine: analyte glucose decrease caused by

glycolysis and bacterial utlization

Changes in unpreserved urine: analyte ketones decrease caused by

volatilization and bacterial metabolism

Changes in unpreserved urine: analyte bilirubin decrease caused by

exposure to light/photo oxidation to biliverdin

Changes in unpreserved urine: analyte urobilinogen decrease caused by

oxidation to urobilin

Changes in unpreserved urine: analyte nitrite increase caused by

multiplication of nitrate-reducing bacteria

Changes in unpreserved urine: analyte blood cells and casts decrease caused by

disintegration in dilute alkaline urine

Changes in unpreserved urine: analyte bacteria increase caused by

multiplication

How does color, clarity, odor, pH, glucose, ketones, bilirubin, urobilinogen, nitrite, blood cells and casts, and bacteria change in unpreserved urine?

Color: modified/darkened

clarity: decrease

odor: increase

ph: increase

glucose: decrease

ketones: decrease

bilirubin: decrease

urobilinogen: decrease

nitrite: increase

blood cells and cats: decreased

bacteria: increased

how to preserve specimen integrity?

tests w/i 2 hrs

for delayed testing: refrigerate, chemical preservatives

most problems are caused by bacterial growth

• increase/ change in color, turbidity, pH, nitrite, bacteria, and odor

• decrease in glucose, ketones, bilirubin, urobilinogen, RBCs, WBCs, and casts

Specimen preservation - refrigeration

required for culture specimens

causes increase in sp. grav. and precipitation of amorphous crystals

must return to room temp for chemical testing

specimen preservation - chemical preservatives

commercial transport tubes

must be compatible w/ chemical testing

ideal preservative is bactericidal, inhibit urease and preserve formed elements

Renal system/ urinary system main four responsibilities

production, transport, storage, excretion

primary purpose of the urinary system

to maintain the internal chemical balance of the body by

• removing metabolic waste products

• regulating fluid and electrolyte levels

• contributing to blood pressure control

what are the four main structures of the urinary/renal system?

Kidneys (primary organs)

• bean-shaped organs located retroperitoneally

• contain nephrons (functional units) that filter blood and form urine

• responsible for excretion, reabsorption, secretion, and endocrine activity

Ureters (transport)

• muscular tubes that carry urine from each kidney to the bladder

• peristaltic waves ensure one-way movement of urine

Urinary bladder (storage organ)

• hollow, muscular organ that temporarily stores urine

• capable of expanding due to its transitional epithelium

• avg. capacity ~400-600 mL in adults

Urethra (excretory passage)

• transports urine from the bladder to the outside

• contains internal (involuntary) and external (voluntary) sphincters that control urination

main structure of the urinary system: general characteristics of the urethra

excretory passage

• transports urine from the bladder to the outside

• contains internal (involuntary) and external (voluntary) sphincters that control urination

main structure of the urinary system: general characteristics of the urinary bladder

storage organ

• hollow, muscular organ that temporarily stores urine

• capable of expanding due to its transitional epithelium

• avg. capacity ~400-600 mL in adults

main structure of the urinary system: general characteristics of the ureters

transport

• muscular tubes that carry urine from each kidney to the bladder

• peristaltic waves ensure one-way movement of urine

main structure of the urinary system: general characteristics of the kidneys

primary organ

• bean-shaped organs located retroperitoneally

• contain nephrons (functional units) that filter blood and form urine

• responsible for excretion, reabsorption, secretion, and endocrine activity

what are the two main sections of the urinary tract?

upper urinary tract → kidneys and ureters

lower urinary tract → bladder and urethra

what are the parts of the lower urinary tract

bladder and urethra

what are the parts of the upper urinary tract?

kidneys and ureters

Urinary Tract Infections (UTI)

upper and lower require different treatment

• upper → may require antibiotics administered intravenously

• lower → can usually be treated with oral antibiotics

more prevalent in women

most common infection

how are upper and lower UTIs treated differently?

• upper → may require antibiotics administered intravenously

• lower → can usually be treated with oral antibiotics

what are signs/symptoms that indicate a UTI of the upper urinary tract?

Symptoms: dysuria; urgency; acute flank/back/groin pain nausea; fever; chills; extreme fatigue

Physical: same as lower

Chemical: same as lower

Microscope: same as lower (WBCs, RBCs, microorganisms, transitional epithelial cells), but also renal tubular epithelial cells & WBC incorporated casts

what are signs/symptoms that indicate a UTI of the lower urinary tract?

symptoms: dysuria, urgency, lower abdominal pain, low-grade fever

physical: possible blood tinged color (pink, red, brown), green from rare Pseudomonas infections, strong odor, cloudy-turbid

chemical: positive leukocyte esterase and nitrite from gram-negative bacteria; small amts of blood and protein are possible

microscopic: many WBCs, RBCs, microorganisms, transitional epithelial cells, no casts or few normal hyaline casts

what is the anatomical position of the kidney?

retroperitoneal, between T12 and L3 vertebrae

-right kidney lower due to the liver

what are the external kidney borders

convex lateral border

concave medial border

-hilum - vessel and ureter passage

what are the protective layers surrounding the kidneys starting from innermost to outermost?

Renal capsule (fibrous)

• thin, tough fibrous capsule

• bound to the renal surface

perirenal fat

• cushioning layer

renal fascia (Gerota’s fascia)

• encloses the kidney and the adrena gland

pararenal fat

• outermost layer, provides additional cushioning

renal capsule

innermost protective layer surrounding the kidney

• thin, tough fibrous capsule

• bound to the renal surface

perirenal fat

protective layer surrounding the kidney → between renal capsule and renal fascia

• cushioning layer

renal fascia (Gerota’s fascia)

protective layer surrounding the kidney → between perirenal fat and pararenal fat

• encloses kidney and the adrenal gland

pararenal fat

outermost protective layer surrounding the kidney

• provides additional cushioning

what are the two parts the kidney is divided into?

renal cortex and medulla

renal cortex

inside of the kidney, outermost layer beneath the renal capsule

houses renal corpuscles (glomeruli and bowman’s capsules) and convoluted tubules

main site of filtration

renal medulla

inner portion of the kidney

organized into renal pyramids

appears striated due to collecting ducts and loops of henle

Function:

• concentration of urine by reabsorption and secretion

renal pyramids

cone-shaped structures (~8-18 per kidney) inside the medulla of the kidney

apex points inward to form the renal papilla

renal columns

extensions of cortical tissue between renal pyramids inside the medulla of the kidney

contain interlobar arteries and veins

provide structural support and pathway for blood vessels

Calyces of the kidneys

urine collection chambers

Minor:

• cup-shaped structures

• one per each renal pyramid

major:

• receives urine from 2-3 minor calyces

both funnel urine toward the renal pelvis