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    1intro 1intro Presentation Transcript

    • Clinical Laboratory Antonio Rivas PA-C 2009
    • Clinical or Medical Laboratory
      • Laboratories that perform chemical and microscopic tests on:
      • blood
      • other body fluids
      • tissues
    • Clinical 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
      • Government Laboratories- state
          • Premarital blood testing
          • PKU testing in newborns
          • Fungi,virus, and mycobacteria culture
    • 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
    • Objectives 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
    • CMS
      • 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 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
    • Laboratory personnel
      • 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 Laboratory
      • Clinical Chemistry
      • Hematology
      • Microbiology
      • Blood Bank
      • Supports Services (Phlebotomy/Specimen Processing)
    • Clinical 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
    • Hematology
      • Studying of the cellular components of the blood
      • Quantitative or Qualitative
      • Coagulation
      • Urinalysis
      • Special hematology
    • 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
    • Blood 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
    • Support Services
      • Phlebotomists
      • Accessioning
    • POCT
      • 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
      • 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
    • safety
      • 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
    • PPE
      • Employees in the clinical lab are required to use personal protective equipment:
          • Gloves
          • Mask
          • Gowns
    • Biohazards
      • 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
    • Evolution on Biological safety
      • 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
    • Evolution on Biological safety
      • 2001-OSHA revised the BBP(blood borne pathogen) standard to prevent accidental needle-sticks in the workplace
    • Standard 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
    • 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
    • Standard Precautions,cont.
        • 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
      • 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
    • General laboratory equipment
      • 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
    • General laboratory equipment
      • Other equipments
        • Refrigerators
        • Water baths
        • PH meters
        • Incubators
        • Thermometers
        • freezer
    • The 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
    • Light microscope images A-stained cell seen with bright field microscope B-phase contrast image C-epi-fluorescence microscopy,Borrelia burgdorferi
    • Parts of the Microscope
    • Parts 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
    • Microscope 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
    • Transporting the Microscope
    • Using 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
    • Using 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
    • 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 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
    • 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
    • Blood 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
      • Safe
      • Quick
      • Small amount of blood
      • Increased use
        • Point-of-care testing (POCT)
        • Physician Office Laboratories
    • Capillary Puncture Sites
      • Fingertip
      • Great toe
      • Heel
    • Capillary Puncture Sites
    • Lancets
      • Sterile
      • Single-use
      • Different lengths
    • Collection Containers
    • Procedure
    • Routine Venipuncture
      • Phlebotomy
      • Superficial vein
      • Large sample of blood
      • Skill and experience
        • Preserve vein integrity
    • Venipuncture Supplies
      • Needles
        • Various safety designs
        • 21 ga, 1 inch
      • Needle holders
      • Phlebotomy tray
    • Venipuncture Supplies
    • Venipuncture 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
    • Safety 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
    • Select Equipment
    • Patient 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 Preparation
    • Apply Tourniquet
      • 3-4 inches above elbow
      • Use quick release tie
    • Identify Suitable Vein
      • Veins commonly used
        • Median cubital
        • Basilic
        • Cephalic
      • Palpate vein:
      • carefully inspect
      • both arms to find
      • the better site
    • Perform 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
    • Perform Venipuncture
    • Adverse 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
    • Complete Procedure
      • Activate safety feature
      • Immediate disposal
      • Label tubes before leaving the room
      • 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
    • In Case of Accident
      • Immediately clean exposed area
        • Flood with water
        • Clean with antiseptic soap
      • Report immediately to supervisor
      • Seek medical attention
    • Label 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
    • Clinician'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
    • 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.
    • 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.
    • selecting tests to use:
      • 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)
    • 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
    • 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
    • Differential diagnosis
      • Chlamydia and gonorrhea
        • In sexually active persons with multiple partners; monitor for pelvic inflammatory disease
    • 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
    • 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
      • 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
      • 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
    • The 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.
      • 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
      • 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 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.
    • test 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.
    • Reasons for deviations may include the following
      • Incorrect specimen collection, handling, storage, or labeling
      • Wrong preservative or lack of preservative
      • Delayed specimen deliver
    • Reasons for deviations may include the following
      • 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
    • Patient factors that can alter test results may include the following
      • Postprandial status (ie, time patient last ate)
      • Time of day
      • Pregnancy
      • Age and Gender
    • Patient factors that can alter test results may include the following
      • 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 mistakes
      • 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 the patient and family
      • 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.
    • Educate the patient and family
      • 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.
    • Educate the patient and family
      • 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)
    • Educate the patient and family
      • 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
    • Educate the patient and family
      • Because of factors such as anxiety, language barriers, and physical or emotional impairments, the patient may not fully understand and assimilate instructions and explanations
    • Educate the patient and family
      • 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 or reference values
      • 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.
    • normal or reference values
      • 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
    • clinical laboratory data values
      • 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).
    • 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
    • Cultural 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
    •  
    • END
    •