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Clinical LaboratoryClinical Laboratory

Antonio Rivas PA-C2009

Antonio Rivas PA-C2009

Clinical or Medical Laboratory

Clinical or Medical Laboratory

Laboratories that perform chemical and microscopic tests on:

bloodother body fluidstissues

Laboratories that perform chemical and microscopic tests on:

bloodother body fluidstissues

Clinical LaboratoriesClinical Laboratories Play a major role in patient care Variety of settings Two types of Clinical.Laboratory

Hospital lab. Non hospital lab.

POLs Reference laboratories(LABCORP/QUEST D.) Government laboratories - federal

Center for Disease control and Prevention(CDC)

Epidemiology labs Laboratory Response Network

Play a major role in patient care Variety of settings Two types of Clinical.Laboratory

Hospital lab. Non hospital lab.

POLs Reference laboratories(LABCORP/QUEST D.) Government laboratories - federal

Center for Disease control and Prevention(CDC)

Epidemiology labs Laboratory Response Network

Government Laboratories- state

Premarital blood testing PKU testing in newborns Fungi,virus, and mycobacteria culture

Government Laboratories- state

Premarital blood testing PKU testing in newborns Fungi,virus, and mycobacteria culture

Regulations of Clinical Laboratory

Regulations of Clinical Laboratory

All laboratories, but research labs.are regulated by Federal and State agencies

CLIA’88- Clinical Laboratory Improvement Amendments of 1988:

Is a revision to the original CLIA of 1967, specifies the minimum performance standards for all Clinical Laboratories

All laboratories, but research labs.are regulated by Federal and State agencies

CLIA’88- Clinical Laboratory Improvement Amendments of 1988:

Is a revision to the original CLIA of 1967, specifies the minimum performance standards for all Clinical Laboratories

Objectives of CLIA’88Objectives of CLIA’88

To ensure quality Laboratory Testing, amendments are continually revised, updated, clarified and refined

CMS:Center for Medicare and Medicaid Services,agency within the Department of Health and Human Services responsible for implementing CLIA’88

To ensure quality Laboratory Testing, amendments are continually revised, updated, clarified and refined

CMS:Center for Medicare and Medicaid Services,agency within the Department of Health and Human Services responsible for implementing CLIA’88

CMSCMS

Any Laboratory performing Lab.tests in humans ,except for research Labs. Must obtain a certificate from CMS (center for medicare-medicaid services) to be allowed to operate

Any Laboratory performing Lab.tests in humans ,except for research Labs. Must obtain a certificate from CMS (center for medicare-medicaid services) to be allowed to operate

Laboratory PersonnelLaboratory Personnel

Director of the Lab.- Pathologist, MD, DO, or hold a doctorate in a related clinical field. Hold certification and have supervisory and clinical laboratory experience

Technical supervisor/Lab.Manager-someone educated in the clinical laboratory sciences who has additional business experience

Director of the Lab.- Pathologist, MD, DO, or hold a doctorate in a related clinical field. Hold certification and have supervisory and clinical laboratory experience

Technical supervisor/Lab.Manager-someone educated in the clinical laboratory sciences who has additional business experience

Laboratory personnelLaboratory personnel

General supervisor for each area

Testing personnel: Medical Technologists(MT/CLS) Medical Lab.Technicians(MLT/CLT) Medical assistants/nursing staff(POLs)

General supervisor for each area

Testing personnel: Medical Technologists(MT/CLS) Medical Lab.Technicians(MLT/CLT) Medical assistants/nursing staff(POLs)

Departments of the Clinical LaboratoryDepartments of the Clinical Laboratory

Clinical Chemistry Hematology Microbiology Blood Bank Supports Services (Phlebotomy/Specimen Processing)

Clinical Chemistry Hematology Microbiology Blood Bank Supports Services (Phlebotomy/Specimen Processing)

Clinical ChemistryClinical Chemistry

Tests perform in serum, plasma, urine and other body fluids such as spinal fluid, or joint fluid

Largest department in the Lab. Toxicology Special chemistry

Tests perform in serum, plasma, urine and other body fluids such as spinal fluid, or joint fluid

Largest department in the Lab. Toxicology Special chemistry

HematologyHematology

Studying of the cellular components of the blood

Quantitative or Qualitative Coagulation Urinalysis Special hematology

Studying of the cellular components of the blood

Quantitative or Qualitative Coagulation Urinalysis Special hematology

Microbiology Microbiology

Culture/identification microorganisms

From sputum, wounds, blood, urine and other body fluids

Inoculated in culture media Organisms are identified and susceptibility test are performed

Bacteriology, virology, serology, parasitology

Culture/identification microorganisms

From sputum, wounds, blood, urine and other body fluids

Inoculated in culture media Organisms are identified and susceptibility test are performed

Bacteriology, virology, serology, parasitology

Blood BankBlood Bank

Also called immunohematology or transfusion services

ABO group and Rh typing Antibody testing Storage of packed cells units Processing of some components like platelets and cryoprecipitate

Also called immunohematology or transfusion services

ABO group and Rh typing Antibody testing Storage of packed cells units Processing of some components like platelets and cryoprecipitate

Support ServicesSupport Services

Phlebotomists Accessioning

Phlebotomists Accessioning

POCTPOCT

Point of care testing brings the laboratory to the patient, also called bed-side testing

Use small simple analyzers Portable instruments Hgb, glucose, electrolytes,and cholesterol

Point of care testing brings the laboratory to the patient, also called bed-side testing

Use small simple analyzers Portable instruments Hgb, glucose, electrolytes,and cholesterol

Quality Assessment System

Quality Assessment System

QA.is incorporated to each department’s procedure manuals and day to day operation

Standardized material are analyzed on each instrument to document precision, and reproducibility

Calibration, maintenance and repair of the instruments is recorded

Participate in proficiency testing programs

QA.is incorporated to each department’s procedure manuals and day to day operation

Standardized material are analyzed on each instrument to document precision, and reproducibility

Calibration, maintenance and repair of the instruments is recorded

Participate in proficiency testing programs

Health care agencies have very specific standards, rules and regulations governing the education and job responsibilities of the laboratory personnel

Lab.professionals are required to complete an authorized program and certification

Lab. Personnel need to observe/protect patient privacy

Health care agencies have very specific standards, rules and regulations governing the education and job responsibilities of the laboratory personnel

Lab.professionals are required to complete an authorized program and certification

Lab. Personnel need to observe/protect patient privacy

safetysafety

Occupational Safety and Health Administration(OSHA) began in 1970 as a legislation and subsequent rules that mandate increased attention to safety in workplaces

The Clinical laboratory has, physical, chemical and biological hazards

Occupational Safety and Health Administration(OSHA) began in 1970 as a legislation and subsequent rules that mandate increased attention to safety in workplaces

The Clinical laboratory has, physical, chemical and biological hazards

PPEPPE

Employees in the clinical lab are required to use personal protective equipment:

Gloves Mask Gowns

Employees in the clinical lab are required to use personal protective equipment:

Gloves Mask Gowns

BiohazardsBiohazards

In 1980 clinical laboratory safety training concentrated in protection from chemical, physical,and contagious diseases such as tuberculosis

The discovery of AIDS, increased in Hepatitis B virus(HBV) and Hepatitis C virus(HCV) brought an emphasis on biological safety

The term Biohazard came into use A Biohazard symbol was adopted that indicates the presence of biological hazard or biohazardous condition

In 1980 clinical laboratory safety training concentrated in protection from chemical, physical,and contagious diseases such as tuberculosis

The discovery of AIDS, increased in Hepatitis B virus(HBV) and Hepatitis C virus(HCV) brought an emphasis on biological safety

The term Biohazard came into use A Biohazard symbol was adopted that indicates the presence of biological hazard or biohazardous condition

Evolution on Biological safety


By 1960 infectious patients were placed in ISOLATION rooms

1970-CDC outlined isolation guidelines and listed isolation categories

1985-in response to the increasing AIDS/HIV epidemic CDC adopted Universal Blood and Body fluids precautions, to be applied in all patients regardless of their infectious status

1987- Body substance Isolation, included all body fluid even if not visibly contaminated with blood

By 1960 infectious patients were placed in ISOLATION rooms

1970-CDC outlined isolation guidelines and listed isolation categories

1985-in response to the increasing AIDS/HIV epidemic CDC adopted Universal Blood and Body fluids precautions, to be applied in all patients regardless of their infectious status

1987- Body substance Isolation, included all body fluid even if not visibly contaminated with blood



1991-OSHA issued “Bloodborne pathogens standard”, not included on previous regulation

1996- CDC implemented “Standard Precautions” that includes a comprehensive set of safety guidelines for Health care workers rendering care to patients, this is the current terminology

To control nosocomial(inst.acquired) infections Transmission-based precautions(additional practices for pathogens that spread by air, droplets, and contact

1991-OSHA issued “Bloodborne pathogens standard”, not included on previous regulation

1996- CDC implemented “Standard Precautions” that includes a comprehensive set of safety guidelines for Health care workers rendering care to patients, this is the current terminology

To control nosocomial(inst.acquired) infections Transmission-based precautions(additional practices for pathogens that spread by air, droplets, and contact



2001-OSHA revised the BBP(blood borne pathogen) standard to prevent accidental needle-sticks in the workplace

2001-OSHA revised the BBP(blood borne pathogen) standard to prevent accidental needle-sticks in the workplace

Standard PrecautionsStandard Precautions Requires that every patient and every body fluid, body substance, organ, or unfixed tissue be regarded as potentially infectious Hands wash(plain soap)

After touching body fluids and contaminated items, after removing gloves and between patient contact

Wear gloves When touching blood/body fluids/secretions, wear clean gloves when touching mucous membranes and nonintact skin

Wear mask/eye protection/face shield Activities that could generate splashes, spray of blood, body fluids , or secretions

Requires that every patient and every body fluid, body substance, organ, or unfixed tissue be regarded as potentially infectious Hands wash(plain soap)

After touching body fluids and contaminated items, after removing gloves and between patient contact

Wear gloves When touching blood/body fluids/secretions, wear clean gloves when touching mucous membranes and nonintact skin

Wear mask/eye protection/face shield Activities that could generate splashes, spray of blood, body fluids , or secretions

Standard Precautions,cont.

Standard Precautions,cont. Patient care equipment

should be handled to prevent transfer of microorganisms to other patients and environment

Linen Handle,transport,and process in a manner to avoid contamination of clothing and other patients or environment

Occupational health and blood-borne pathogens Prevent injuries when using, handling, cleaning and disposing sharps

NEVER RECAP A USED NEEDLE Do not removed used needle from syringe by hand Disposed used sharps on puncture resistant containers

Patient care equipment should be handled to prevent transfer of microorganisms to other patients and environment

Linen Handle,transport,and process in a manner to avoid contamination of clothing and other patients or environment

Occupational health and blood-borne pathogens Prevent injuries when using, handling, cleaning and disposing sharps

NEVER RECAP A USED NEEDLE Do not removed used needle from syringe by hand Disposed used sharps on puncture resistant containers



Use resuscitation devices as an alternative to mouth to mouth resuscitation

Patient placement Use a private room for patients who can be a source of contamination or patients who are not expected to maintain hygiene or environmental control

Environmental control Follow hospital procedures for routine care and cleaning/desinfection of any soiled device, equipment or environmental surface

Use resuscitation devices as an alternative to mouth to mouth resuscitation

Patient placement Use a private room for patients who can be a source of contamination or patients who are not expected to maintain hygiene or environmental control

Environmental control Follow hospital procedures for routine care and cleaning/desinfection of any soiled device, equipment or environmental surface

General laboratory equipment

General laboratory equipment Centrifuges- spin samples at high

speeds forcing the heavier particles to the bottom of the container,e.g..separating plasma and blood cells Safety tips

Use Standard Precautions/PPE Load must be balanced Tubes must be capped during operation Do not open the centrifuge while rotor is moving

Clean spills immediately with surface disinfectants

Centrifuges- spin samples at high speeds forcing the heavier particles to the bottom of the container,e.g..separating plasma and blood cells Safety tips

Use Standard Precautions/PPE Load must be balanced Tubes must be capped during operation Do not open the centrifuge while rotor is moving

Clean spills immediately with surface disinfectants



Autoclaves- use steam under pressure to sterilize medical/surgical instruments, or contaminated materials before disposal Never open unless the chamber pressure reads zero

Use heat-proof gloves to remove items When sterilizing liquids use loosely capped, heat resistant containers, no more than half full

Use an autoclave tray to prevent liquids from spilling

Autoclaves- use steam under pressure to sterilize medical/surgical instruments, or contaminated materials before disposal Never open unless the chamber pressure reads zero

Use heat-proof gloves to remove items When sterilizing liquids use loosely capped, heat resistant containers, no more than half full

Use an autoclave tray to prevent liquids from spilling


General laboratory equipment Laboratory balances

Used to measure chemicals Use PPE and chemical safety precautions

Be gentle, Balances are delicate equipment

Laboratory balances Used to measure chemicals Use PPE and chemical safety precautions

Be gentle, Balances are delicate equipment



Other equipments Refrigerators Water baths PH meters Incubators Thermometers freezer

Other equipments Refrigerators Water baths PH meters Incubators Thermometers freezer

The MicroscopeThe Microscope Is a delicate and expensive instrument , special care must be taken in its use

Various types of microscopes, two categories based on type of illumination Light microscopes

Bright-field- stained specimens Phase-contrast-unstained cells,urine sediment Epi-fluorescence microscope,specimens treated with fluorescent dyes, syphilis, mycobacteria

Electron microscopes:provides greater magnification in medical research

Is a delicate and expensive instrument , special care must be taken in its use

Various types of microscopes, two categories based on type of illumination Light microscopes

Bright-field- stained specimens Phase-contrast-unstained cells,urine sediment Epi-fluorescence microscope,specimens treated with fluorescent dyes, syphilis, mycobacteria

Electron microscopes:provides greater magnification in medical research

Light microscope images

Light microscope images

A-stained cell seen with bright field microscopeB-phase contrast imageC-epi-fluorescence microscopy,Borrelia burgdorferi

Parts of the Microscope

Parts of the Microscope

Parts of the MicroscopeParts of the Microscope

Oculars: monocular or binocular Objective lenses: attached to the revolving nose piece, at least 3 present: low, high dry, and oil immersion lenses

Light condenser which focuses and directs light to the objectives, iris diaphragm that regulates the amount of light that strikes the object observed

Field diaphragm:help align the light Coarse and fine adjustments:focusing knobs

Stage:support for the object been viewed

Oculars: monocular or binocular Objective lenses: attached to the revolving nose piece, at least 3 present: low, high dry, and oil immersion lenses

Light condenser which focuses and directs light to the objectives, iris diaphragm that regulates the amount of light that strikes the object observed

Field diaphragm:help align the light Coarse and fine adjustments:focusing knobs

Stage:support for the object been viewed

Microscope safetyMicroscope safety Safety

observe electrical safety rules Glass slide handle with care to avoid breaking Unfixed specimens should be treated with standard precautions,disinfect stage after use

QA Scheduled maintenance should be performed and documented

Care and cleaning of lenses Use only lens paper, clean lenses before and after each use

Do not allowed immersion oil to touch the low and high dry lenses

Transporting and storing

Safety observe electrical safety rules Glass slide handle with care to avoid breaking Unfixed specimens should be treated with standard precautions,disinfect stage after use

QA Scheduled maintenance should be performed and documented

Care and cleaning of lenses Use only lens paper, clean lenses before and after each use

Do not allowed immersion oil to touch the low and high dry lenses

Transporting and storing

Transporting the Microscope

Transporting the Microscope

Using the MicroscopeUsing the Microscope Use low power objective to locate and to view large objects

With the coarse adjustment knob bring the objective and the slide as close together as possible

While looking through the oculars, move the coarse adjustment knob to bring the objective and slide apart until the object on the slide comes into focus

Use the fine adj.knob to bring the image into sharp focus

Use low power objective to locate and to view large objects

With the coarse adjustment knob bring the objective and the slide as close together as possible

While looking through the oculars, move the coarse adjustment knob to bring the objective and slide apart until the object on the slide comes into focus

Use the fine adj.knob to bring the image into sharp focus

Using the MicroscopeUsing the Microscope If you need to use the high power(40x), to see cells and sediments, after initial focusing with the low power(20x), rotate the high power into position

Never use the coarse adjustment knob with high power, the distance between the objective and slide is very small and the slide could break.

Oil immersion lenses(100x) give the highest magnification of the bright field objectives

If you need to use the high power(40x), to see cells and sediments, after initial focusing with the low power(20x), rotate the high power into position

Never use the coarse adjustment knob with high power, the distance between the objective and slide is very small and the slide could break.

Oil immersion lenses(100x) give the highest magnification of the bright field objectives

Using oil immersion lenses

Using oil immersion lenses After initially focusing with the low

power, rotate the objective to the side and place a small drop of immersion oil on the slide

The oil immersion objective is rotated into the drop of oil been careful no other objective touch the oil

use only fine adjustment knob with oil

Condenser should be all the way up Maximum light source Open the iris diaphragm to the maximum

After initially focusing with the low power, rotate the objective to the side and place a small drop of immersion oil on the slide

The oil immersion objective is rotated into the drop of oil been careful no other objective touch the oil

use only fine adjustment knob with oil

Condenser should be all the way up Maximum light source Open the iris diaphragm to the maximum

After using the Microscope

After using the Microscope

Always switch to the low magnification objective

With lens paper clean the oil immersion objective, stage and condenser if oil has become in contact with it

Turn the light source off Unplug the microscope Store in proper location or cover as appropriate

Always switch to the low magnification objective

With lens paper clean the oil immersion objective, stage and condenser if oil has become in contact with it

Turn the light source off Unplug the microscope Store in proper location or cover as appropriate

Calculate Magnification

Calculate Magnification Degree of magnification on the ocular

multiplied by the degree of magnification on the objectives

Example:10x(ocular) x 100x(oil immersion)= 1000x

The object viewed would be magnified 1000 times its original size Resolving power: the ability of a microscope to produce separate images of closely spaced details in the object being viewed

Degree of magnification on the ocular multiplied by the degree of magnification on the objectives

Example:10x(ocular) x 100x(oil immersion)= 1000x

The object viewed would be magnified 1000 times its original size Resolving power: the ability of a microscope to produce separate images of closely spaced details in the object being viewed

Blood collectionBlood collection

Capillary puncture: small amount of blood collected for glucose, K, electrolytes, Hgb, Htc, Plt count, or when a larger sample is difficult to obtain as in newborns

Routine venipuncture: most common method of obtaining blood, a superficial vein is punctured with a hypodermic needle and blood is collected into a syringe or vacuum tube

Capillary puncture: small amount of blood collected for glucose, K, electrolytes, Hgb, Htc, Plt count, or when a larger sample is difficult to obtain as in newborns

Routine venipuncture: most common method of obtaining blood, a superficial vein is punctured with a hypodermic needle and blood is collected into a syringe or vacuum tube

Capillary PunctureCapillary Puncture Safe Quick Small amount of blood Increased use

Point-of-care testing (POCT) Physician Office Laboratories

Safe Quick Small amount of blood Increased use

Point-of-care testing (POCT) Physician Office Laboratories

Capillary Puncture Sites


Fingertip Great toe Heel

Fingertip Great toe Heel

LancetsLancets

Sterile Single-use Different lengths

Sterile Single-use Different lengths

Collection ContainersCollection Containers

ProcedureProcedure

Routine VenipunctureRoutine Venipuncture

Phlebotomy Superficial vein Large sample of blood Skill and experience

Preserve vein integrity

Phlebotomy Superficial vein Large sample of blood Skill and experience

Preserve vein integrity

Venipuncture SuppliesVenipuncture Supplies

Needles Various safety designs 21 ga, 1 inch

Needle holders Phlebotomy tray

Needles Various safety designs 21 ga, 1 inch

Needle holders Phlebotomy tray

Venipuncture SuppliesVenipuncture Supplies

Venipuncture SuppliesVenipuncture Supplies Vacuum tubes and anticoagulants

Sizes Stopper color:

Red: no anticoagulant, to collect serum for blood chemistries and serology tests

Lavender: containing EDTA for hematologycal and blood typing tests(ethylenediaminetetraacetic acid )

Green: contains heparin, for lymphocytes studies and special chemistry

Light blue: sodium citrate for coagulation studies Gray :potasium oxalate, for glucose and legal alcohol

Black: for westergren ESR Draw exact amount

Vacuum tubes and anticoagulants Sizes Stopper color:

Red: no anticoagulant, to collect serum for blood chemistries and serology tests

Lavender: containing EDTA for hematologycal and blood typing tests(ethylenediaminetetraacetic acid )

Green: contains heparin, for lymphocytes studies and special chemistry

Light blue: sodium citrate for coagulation studies Gray :potasium oxalate, for glucose and legal alcohol

Black: for westergren ESR Draw exact amount

Safety PrecautionsSafety Precautions

Observe standard precautions Wear gloves and other PPE Never recap needles Use proper technique

Avoid Hemoconcentration: do not leave tourniquet in place for more than 1-2 minutes

Hemolysis: do not shake tubes, mix by gently inverting a few times

Observe standard precautions Wear gloves and other PPE Never recap needles Use proper technique

Avoid Hemoconcentration: do not leave tourniquet in place for more than 1-2 minutes

Hemolysis: do not shake tubes, mix by gently inverting a few times

Select EquipmentSelect Equipment

Patient PreparationPatient Preparation

Patient I.D. Explain procedure Support patient and arm Be prepared! for any sudden reaction from the patient, or occasional patient who may faint

Patient I.D. Explain procedure Support patient and arm Be prepared! for any sudden reaction from the patient, or occasional patient who may faint

Patient PreparationPatient Preparation

Apply TourniquetApply Tourniquet

•3-4 inches above elbow

•Use quick release tie

Identify Suitable VeinIdentify Suitable Vein Veins commonly used

Median cubital Basilic Cephalic

Palpate vein: carefully inspect both arms to find the better site

Veins commonly used Median cubital Basilic Cephalic

Palpate vein: carefully inspect both arms to find the better site

Perform VenipuncturePerform Venipuncture Alcohol-cleanse site, let air dry, do not touch the site after cleaning

Observe bevel up Anchor vein with thumb 1inch below the puncture site

Enter vein in the same direction of it, in a15-25 degree angle, in a smooth motion

Insert vacuum tube Clot tube first Invert anticoagulant tubes softly 5-7 times

Alcohol-cleanse site, let air dry, do not touch the site after cleaning

Observe bevel up Anchor vein with thumb 1inch below the puncture site

Enter vein in the same direction of it, in a15-25 degree angle, in a smooth motion

Insert vacuum tube Clot tube first Invert anticoagulant tubes softly 5-7 times

Perform VenipuncturePerform Venipuncture

Adverse situationsAdverse situations In case of patient developing a large hematoma while venipuncture procedure is being done, withdraw the needle, apply pressure, and intent the procedure in a different site

In case of failure to obtain the blood, ask the patient permission for a second intent, if he agrees try in a different site

After the second non-productive intent,inform the patient and find another person to draw the specimen

In case of patient developing a large hematoma while venipuncture procedure is being done, withdraw the needle, apply pressure, and intent the procedure in a different site

In case of failure to obtain the blood, ask the patient permission for a second intent, if he agrees try in a different site

After the second non-productive intent,inform the patient and find another person to draw the specimen

Complete ProcedureComplete Procedure

Activate safety feature Immediate disposal Label tubes before leaving the room

Patient care

Activate safety feature Immediate disposal Label tubes before leaving the room

Patient care

Patient care Patient care

The tourniquet is always release before needle is withdraw

Gauze should be applied over the puncture site and pressure maintained for 1-3 minutes or until bleeding stops

Ask patient to keep arm extended Offer a small bandage if necessary

The tourniquet is always release before needle is withdraw

Gauze should be applied over the puncture site and pressure maintained for 1-3 minutes or until bleeding stops

Ask patient to keep arm extended Offer a small bandage if necessary

In Case of AccidentIn Case of Accident

Immediately clean exposed area Flood with water Clean with antiseptic soap

Report immediately to supervisor

Seek medical attention

Immediately clean exposed area Flood with water Clean with antiseptic soap

Report immediately to supervisor

Seek medical attention

Label the samplesLabel the samples Must contain patient information

Name Date of birth

Date and time of collection And initials of the person drawing the blood Tubes should never be prelabeled to avoid using the prelabeled tube in the wrong patient

Make sure the tubes are clean and no blood has contaminated the outer part of the tubes

Place specimen in a biohazard labeled bag and proceed as required by the institution

Must contain patient information Name Date of birth

Date and time of collection And initials of the person drawing the blood Tubes should never be prelabeled to avoid using the prelabeled tube in the wrong patient

Make sure the tubes are clean and no blood has contaminated the outer part of the tubes

Place specimen in a biohazard labeled bag and proceed as required by the institution

Clinician's RoleClinician's Role Era of high technology, clinicians must have an understanding and working knowledge of modalities other than their own area of expertise: includes diagnostic evaluation and diagnostic services

Era of high technology, clinicians must have an understanding and working knowledge of modalities other than their own area of expertise: includes diagnostic evaluation and diagnostic services

Laboratory and diagnostic tests are tools to gain additional information

about the patient

Laboratory and diagnostic tests are tools to gain additional information

about the patient By themselves, tests are not therapeutic

used in conjunction with history and physical examination,tests: may confirm a diagnosis or provide valuable information about a patient's status and

response to therapy that may not be apparent from the history and physical examination alone.

By themselves, tests are not therapeutic

used in conjunction with history and physical examination,tests: may confirm a diagnosis or provide valuable information about a patient's status and

response to therapy that may not be apparent from the history and physical examination alone.

selecting tests to use:


Test selections are based on : subjective clinical judgment, national recommendations, and evidence-based health care. Often diagnostic tests or procedures are used as predictors of surgical risk or morbidity and mortality rates because, in some cases, the risk may outweigh the benefit.

Test selections are based on : subjective clinical judgment, national recommendations, and evidence-based health care. Often diagnostic tests or procedures are used as predictors of surgical risk or morbidity and mortality rates because, in some cases, the risk may outweigh the benefit.



1.Basic screening (frequently used with wellness groups and case finding)

2. Establishing (initial) diagnoses

3. Differential diagnosis 4. Evaluating current medical case management and outcomes

5. Evaluating disease severity

1.Basic screening (frequently used with wellness groups and case finding)

2. Establishing (initial) diagnoses

3. Differential diagnosis 4. Evaluating current medical case management and outcomes

5. Evaluating disease severity

6. Monitoring course of illness and response to treatment

7. Group and panel testing 8. Regularly scheduled screening tests as part of ongoing care

9. Testing related to specific events, certain signs and symptoms, or other exceptional situations (eg, infection and inflammation , sexual assault, drug screening, postmortem tests, to name a few)

6. Monitoring course of illness and response to treatment

7. Group and panel testing 8. Regularly scheduled screening tests as part of ongoing care

9. Testing related to specific events, certain signs and symptoms, or other exceptional situations (eg, infection and inflammation , sexual assault, drug screening, postmortem tests, to name a few)

Basic screening (frequently used with wellness groups and

case finding)

Basic screening (frequently used with wellness groups and

case finding)

Cervical Papanicolaou (Pap) test Yearly for all women 18 years of age; more often with high-risk factors (eg, dysplasia, human immunodeficiency virus [HIV], herpes simplex); check for human papillomavirus (HPV), chlamydia, and gonorrhea using DNA

Cervical Papanicolaou (Pap) test Yearly for all women 18 years of age; more often with high-risk factors (eg, dysplasia, human immunodeficiency virus [HIV], herpes simplex); check for human papillomavirus (HPV), chlamydia, and gonorrhea using DNA

Establishing (initial) diagnoses

Establishing (initial) diagnoses

Serum amylase In the presence of abdominal pain, suspect pancreatitis

Thyroid-stimulating hormone (TSH) test Suspicion of hypothyroidism, hyperthyroidism, or thyroid dysfunction in patients 50 years of age

Serum amylase In the presence of abdominal pain, suspect pancreatitis

Thyroid-stimulating hormone (TSH) test Suspicion of hypothyroidism, hyperthyroidism, or thyroid dysfunction in patients 50 years of age

Differential diagnosisDifferential diagnosis

Chlamydia and gonorrhea In sexually active persons with multiple partners; monitor for pelvic inflammatory disease

Chlamydia and gonorrhea In sexually active persons with multiple partners; monitor for pelvic inflammatory disease

Evaluating current medical case management and

outcomes

Evaluating current medical case management and

outcomes Tuberculosis (TB) blood test QuantiFERON Gold TB Blood test to assess TB exposure in risk population

Syphilis serum fluorescent treponemal antibody (FTA) test Positive rapid plasma reagin (RPR) test result

Tuberculosis (TB) blood test QuantiFERON Gold TB Blood test to assess TB exposure in risk population

Syphilis serum fluorescent treponemal antibody (FTA) test Positive rapid plasma reagin (RPR) test result

Grading Guidelines for Scientific Evidence

Grading Guidelines for Scientific Evidence

A. Clear evidence from all appropriately conducted trials Measure plasma glucose through an accredited lab to diagnose or screen for diabetes

B.Supportive evidence from well-conducted studies or registries Draw fasting blood plasma specimens for glucose analysis

A. Clear evidence from all appropriately conducted trials Measure plasma glucose through an accredited lab to diagnose or screen for diabetes

B.Supportive evidence from well-conducted studies or registries Draw fasting blood plasma specimens for glucose analysis

C.No published evidence; or only case, observational, or historical evidence • Self-monitoring of blood glucose may help to achieve better control

E.Expert consensus or clinical experience or Internet polls Measure ketones in urine or blood to monitor and diagnose diabetic ketoacidosis (DKA) (in home or clinic)

C.No published evidence; or only case, observational, or historical evidence • Self-monitoring of blood glucose may help to achieve better control

E.Expert consensus or clinical experience or Internet polls Measure ketones in urine or blood to monitor and diagnose diabetic ketoacidosis (DKA) (in home or clinic)

The diagnostic testing model

The diagnostic testing model incorporates three phases:

pretest, emphasis on appropriate test selection,

obtaining proper consent, proper patient preparation, individualized patient education, emotional support, and effective communication.

These interventions are key to achieving the desired outcomes and preventing misunderstandings and errors.

incorporates three phases: pretest,

emphasis on appropriate test selection,

obtaining proper consent, proper patient preparation, individualized patient education, emotional support, and effective communication.

These interventions are key to achieving the desired outcomes and preventing misunderstandings and errors.

Intratest Phase: Elements of Safe, Effective, Informed Care

Posttest Phase: Elements of Safe, Effective, Informed Care

Intratest Phase: Elements of Safe, Effective, Informed Care

Posttest Phase: Elements of Safe, Effective, Informed Care

The clinical value of a test is related toThe clinical value of a test is related to

sensitivity, specificity, and the incidence of the disease in the population tested.

Sensitivity and specificity do not change with different populations of ill and healthy patients

The predictive value of the same test can vary significantly with age, gender, and geographic location.

sensitivity, specificity, and the incidence of the disease in the population tested.

Sensitivity and specificity do not change with different populations of ill and healthy patients

The predictive value of the same test can vary significantly with age, gender, and geographic location.

Specificity refers to the ability of a test to identify correctly those individuals who do not have the disease.

The division formula for specificity is as follows:

Specificity%=persons w/o dis.who test neg./total # of persons w/o dis. X 100

Specificity refers to the ability of a test to identify correctly those individuals who do not have the disease.

The division formula for specificity is as follows:

Specificity%=persons w/o dis.who test neg./total # of persons w/o dis. X 100

Sensitivity refers to the ability of a test to correctly identify those individuals who truly have the disease.

The division formula for sensitivity is as follows:

Sensitivity% = persons with dis.who test positive/ total # persons tested with disease x 100

Sensitivity refers to the ability of a test to correctly identify those individuals who truly have the disease.

The division formula for sensitivity is as follows:

Sensitivity% = persons with dis.who test positive/ total # persons tested with disease x 100

Incidence refers to the number of new cases of a disease, during a specified period of time, in a specified population or community.

Prevalence refers to the number of existing cases of a disease, at a specific period of time, in a given population.

Incidence refers to the number of new cases of a disease, during a specified period of time, in a specified population or community.

Prevalence refers to the number of existing cases of a disease, at a specific period of time, in a given population.

Predictive valuesPredictive values

Predictive values refer to the ability of a screening test result to correctly identify the disease state.

The predictive value of the same test can be very different when applied to people of differing ages, gender, geographic locations, and cultures.

Predictive values refer to the ability of a screening test result to correctly identify the disease state.

The predictive value of the same test can be very different when applied to people of differing ages, gender, geographic locations, and cultures.

test outcome deviationstest outcome deviations

Minimize test outcome deviations following proper test protocols. Make certain the patient and his or her significant others know what is expected of them.

Written instructions are very helpful.

Minimize test outcome deviations following proper test protocols. Make certain the patient and his or her significant others know what is expected of them.

Written instructions are very helpful.

Reasons for deviations may include the

following


following Incorrect specimen collection, handling, storage, or labeling

Wrong preservative or lack of preservative

Delayed specimen deliver

Incorrect specimen collection, handling, storage, or labeling

Wrong preservative or lack of preservative

Delayed specimen deliver


following


following Incorrect or incomplete patient preparation

Hemolyzed blood samples Incomplete sample collection, especially of timed samples

Old or deteriorating specimens

Incorrect or incomplete patient preparation

Hemolyzed blood samples Incomplete sample collection, especially of timed samples

Old or deteriorating specimens

Patient factors that can alter test results may include the following


Incorrect pretest diet Current drug therapy Type of illness. Dehydration Position or activity at time of specimen collection

Incorrect pretest diet Current drug therapy Type of illness. Dehydration Position or activity at time of specimen collection



Postprandial status (ie, time patient last ate)

Time of day Pregnancy Age and Gender

Postprandial status (ie, time patient last ate)

Time of day Pregnancy Age and Gender



Level of patient knowledge and understanding of testing process

Stress Nonadherence or noncompliance with instructions and pretest preparation

Undisclosed drug or alcohol use

Level of patient knowledge and understanding of testing process

Stress Nonadherence or noncompliance with instructions and pretest preparation

Undisclosed drug or alcohol use

avoid costly mistakesavoid costly mistakes

Communication errors account for more incorrect results than do technical errors.

Properly identify and label every specimen as soon as it is obtained.

Communication errors account for more incorrect results than do technical errors.

Properly identify and label every specimen as soon as it is obtained.

Educate the patient and family


Educate regarding the testing process and what will be expected

Record the date, time, type of teaching, information given, and person to whom the information was given.

Educate regarding the testing process and what will be expected

Record the date, time, type of teaching, information given, and person to whom the information was given.



Giving sensory and objective information that relates to what the patient will likely physically feel and the equipment that will be used is important so that patients can envision a realistic representation of what will occur.

Giving sensory and objective information that relates to what the patient will likely physically feel and the equipment that will be used is important so that patients can envision a realistic representation of what will occur.



Avoid technical and medical jargon

and adapt information to the patient's level of understanding.

Slang terms may be necessary to get a point across.

Avoid technical and medical jargon

and adapt information to the patient's level of understanding.

Slang terms may be necessary to get a point across.



Encourage questions and verbalization of feelings, fears, and concerns

Do not dismiss, minimize, or invalidate the patient's anxiety

Develop listening skills, and be aware of nonverbal signals (ie, body language)

Encourage questions and verbalization of feelings, fears, and concerns

Do not dismiss, minimize, or invalidate the patient's anxiety

Develop listening skills, and be aware of nonverbal signals (ie, body language)



Above all, be nonjudgmental. Emphasize that there is usually a waiting period (ie, turn-around time) before test results are relayed back to the clinicians and nursing unit.

Offer listening, presence, and support during this time of great concern and anxiety

Above all, be nonjudgmental. Emphasize that there is usually a waiting period (ie, turn-around time) before test results are relayed back to the clinicians and nursing unit.

Offer listening, presence, and support during this time of great concern and anxiety



Because of factors such as anxiety, language barriers, and physical or emotional impairments, the patient may not fully understand and assimilate instructions and explanations

Because of factors such as anxiety, language barriers, and physical or emotional impairments, the patient may not fully understand and assimilate instructions and explanations



To validate the patient's understanding of what is presented, ask the patient to repeat instructions given to evaluate assimilation and understanding of presented information.

To validate the patient's understanding of what is presented, ask the patient to repeat instructions given to evaluate assimilation and understanding of presented information.

normal or reference values


Normal values are those that fall within 2 standard deviations (ie, random variation) of the mean value for the normal population.

Normal ranges can vary to some degree from laboratory to laboratory. Frequently, this is because of the particular type of equipment used

Normal values are those that fall within 2 standard deviations (ie, random variation) of the mean value for the normal population.

Normal ranges can vary to some degree from laboratory to laboratory. Frequently, this is because of the particular type of equipment used



The reported reference range for a test can vary according to the laboratory used, the method employed, the population tested, and methods of specimen collection and preservation.

The reported reference range for a test can vary according to the laboratory used, the method employed, the population tested, and methods of specimen collection and preservation.



Interpretation of laboratory results must always be in the context of the patient's state of being.

Circumstances such as hydration, nutrition, fasting state, mental status, or compliance with test protocols are only a few of the situations that can influence test outcomes.

Interpretation of laboratory results must always be in the context of the patient's state of being.

Circumstances such as hydration, nutrition, fasting state, mental status, or compliance with test protocols are only a few of the situations that can influence test outcomes.

clinical laboratory data values


may be reported in conventional units, SI units(Systéme International (SI) units), or both

The SI system uses seven dimensionally independent units of measurement to provide logical and consistent measurements

may be reported in conventional units, SI units(Systéme International (SI) units), or both

The SI system uses seven dimensionally independent units of measurement to provide logical and consistent measurements



SI concentrations are written as amount per volume (moles or millimoles per liter)

rather than as mass per volume (grams, milligrams, or milliequivalents per deciliter, 100 milliliters, or liter)

SI concentrations are written as amount per volume (moles or millimoles per liter)

rather than as mass per volume (grams, milligrams, or milliequivalents per deciliter, 100 milliliters, or liter)

Numerical values may differ between systems or may be the same.

For example, chloride is the same in both systems: 95 to 105 mEq/L (conventional)

and 95 to 105 mmol/L (SI).

Numerical values may differ between systems or may be the same.

For example, chloride is the same in both systems: 95 to 105 mEq/L (conventional)

and 95 to 105 mmol/L (SI).

Recognize margins of error

Recognize margins of error

possibility exists that some tests will be abnormal owing purely to chance

because a significant margin of error arises from the arbitrary setting of limits.

Moreover, if a laboratory test is considered normal up to the 95th percentile, then 5 times out of 100, the test will show an abnormality even though a patient is not ill

possibility exists that some tests will be abnormal owing purely to chance

because a significant margin of error arises from the arbitrary setting of limits.

Moreover, if a laboratory test is considered normal up to the 95th percentile, then 5 times out of 100, the test will show an abnormality even though a patient is not ill

Cultural SensitivityCultural Sensitivity

Many cultures have diverse beliefs about diagnostic testing that requires blood sampling

Preserving the cultural well-being of any individual or group promotes compliance with testing and easier recovery from routine as well as more invasive and complex procedures

Many cultures have diverse beliefs about diagnostic testing that requires blood sampling

Preserving the cultural well-being of any individual or group promotes compliance with testing and easier recovery from routine as well as more invasive and complex procedures

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