chapter 15
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CHAPTER 15. INTRODUCTION TO THE CLINICAL LABORATORY. PRETEST. True or False. When the body is in homeostasis, an imbalance exists in the body. A routine test is performed to assist in the early detection of disease. - PowerPoint PPT PresentationTRANSCRIPT
CHAPTER 15 CHAPTER 15
INTRODUCTION TO THE CLINICAL LABORATORY
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PRETESTPRETEST
True or False1. When the body is in homeostasis, an imbalance
exists in the body.
2. A routine test is performed to assist in the early detection of disease.
3. The laboratory request form provides the outside laboratory with information needed to test the specimen.
4. The clinical diagnosis is indicated on a laboratory request to correlate laboratory data with the needs of the physician.
5. The purpose of a laboratory report is to indicate the patient's diagnosis.
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PRETEST, CONT.PRETEST, CONT.
True or False6. A patient who is fasting in preparation for a
laboratory test is permitted to drink diet soda.
7. A small sample taken from the body to represent the nature of the whole is known as a specimen.
8. A laboratory report marked QNS means that the patient did not prepare properly.
9. Fecal occult blood testing is an example of a CLIA-waived test.
10. The purpose of quality control is to prevent accidents in the laboratory.
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Content OutlineContent Outline
1. Laboratory tests:
a. Used along with the health history and physical examination to diagnose patient's condition
b. Laboratory tests: Provide objective and quantitative information regarding status of body conditions and functions
Introduction to Clinical Laboratory
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Introduction to Clinical Laboratory
Introduction to Clinical Laboratory
2. Homeostasis: state in which body systems are functioning normally
a. Internal environment of the body is in equilibrium
b. Body is in a healthy state
3. Normal or reference range: An established range within which laboratory test results of a normal person are expected to fall
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Introduction to Clinical Laboratory, cont.
Introduction to Clinical Laboratory, cont.
4. Body in homeostasis:
a. Physical and chemical characteristics of body substances fall within normal range
b. Body substances include:• Fluids
• Secretions
• Excretions
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Introduction to Clinical Laboratory, cont.
Introduction to Clinical Laboratory, cont.
5. Pathologic condition:
a. Alters the normal functioning of the body• Results in imbalance in the body
– Causes patient to experience symptoms of that particular pathologic condition (e.g., iron-deficiency anemia)
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Introduction to Clinical Laboratory, cont.
Introduction to Clinical Laboratory, cont.
b. May cause alteration in body substances• Chemical content of blood or urine
• Antibody level
• Cell counts
• Cellular morphology
c. May result in abnormal values laboratory test results • Certain pathologic conditions cause abnormal
values for specific laboratory tests
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Introduction to Clinical Laboratory, cont.
Introduction to Clinical Laboratory, cont.
6. Abnormal value for a particular test: may be seen with more than one pathologic condition
a. Example: Decrease in hemoglobin levels seen with:• Iron-deficiency anemia
• Hyperthyroidism
• Cirrhosis of the liver
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Introduction to Clinical Laboratory, cont.
Introduction to Clinical Laboratory, cont.
b. Physician cannot rely solely on laboratory tests to make a final diagnosis• Must use a combination of data from:
– Health history
– Physical examination
– Laboratory/diagnostic test results
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Laboratory TestsLaboratory Tests
1. Number of tests ordered: depends on physician's clinical findings (health history and physical examination)
a. May only need to order one test (e.g., urine culture for a urinary tract infection)
b. May need to order a series of tests to diagnose a condition• Many diseases have more than one alteration in:
– Physical and chemical characteristics of body substances
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Laboratory Tests, cont. Laboratory Tests, cont.
2. Not all pathologic conditions require use of laboratory tests to arrive at a final diagnosis
a. Diagnosis can be made from patient's symptoms and physical examination (e.g., otitis media)
3. MA should have knowledge of laboratory tests performed most often
a. Purpose of tests
b. Normal value or range
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Laboratory Tests, cont.Laboratory Tests, cont.
c. Advance patient preparation or special instructions
d. Any substances that might interfere with accurate test results• Food
• Medication
4. Make sure physician is alerted to abnormal results on laboratory tests as soon as possible
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Purpose of Laboratory TestingPurpose of Laboratory Testing
1. Assist in diagnosis of pathologic conditions: most frequent use of laboratory tests
a. Confirm clinical diagnosis• Clinical diagnosis: A tentative diagnosis of a
patient's condition obtained through evaluation of the:
– Health history
– Physical examination
• Patient's symptoms may provide strong clinical diagnosis (e.g., diabetes)
• Laboratory tests are used to confirm that diagnosis (glucose tolerance test)
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Purpose of Laboratory Testing, cont.
Purpose of Laboratory Testing, cont.
b. Assist in differential diagnosis• Two or more diseases may have similar
symptoms
• Laboratory tests ordered to determine which disease is present
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Purpose of Laboratory Testing, cont.
Purpose of Laboratory Testing, cont.
c. Obtain information regarding patient's condition• May not be enough evidence to support a
clinical diagnosis
• Patient may be exhibiting vague symptoms
– Example: Nonspecific abdominal pain
• Series of laboratory and diagnostic tests ordered to pinpoint cause of patient's problems
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Purpose of Laboratory Testing, cont.
Purpose of Laboratory Testing, cont.
2. Evaluate patient's progress and to regulate treatment: after making the final diagnosis
a. Based on laboratory results: therapy may need to be adjusted or further treatment prescribed
• Examples:
– Complete blood count on patient with iron-deficiency anemia to assess response to iron therapy
– Adjusting Coumadin therapy based on results on physical therapy (PT) test
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Purpose of Laboratory Testing, cont.
Purpose of Laboratory Testing, cont.
3. Establish patient's baseline
a. Age, gender, race, geographic location: cause individuals to have different normal levels within established normal range
b. Laboratory tests establish each patient's baseline against which future results can be compared
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Purpose of Laboratory Testing, cont.
Purpose of Laboratory Testing, cont.
4. Prevent or reduce the severity of disease by early detection of abnormal findings (e.g., hyperlipidemia, anemia, diabetes)
a. Known as a routine test: a test performed on a routine basis on apparently healthy patients to assist in the early detection of disease• Easy to perform
• Usually part of general physical examination
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Purpose of Laboratory Testing, cont.
Purpose of Laboratory Testing, cont.
b. Common routine tests• Urinalysis
• Complete blood count (CBC)
• Cholesterol
• Routine blood chemistries
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Purpose of Laboratory Testing, cont.
Purpose of Laboratory Testing, cont.
5. Requirement by state law
a. Example: Statutes of most states require gonorrhea and syphilis tests be performed on pregnant women• Purpose: to protect mother and fetus from
harm
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Types of Clinical LaboratoriesTypes of Clinical Laboratories
1. Medical office may use outside laboratory or have its own laboratory (physician's office laboratory)a. Most offices use a combination of both
Physician's Office Laboratory (POL)
1. For tests that are convenient to perform and commonly required (e.g., glucose, urinalysis)
2. Time-consuming and expensive to perform complex tests in the office
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Outside LaboratoriesOutside Laboratories
1. MA works closely with outside laboratory2. Outside laboratories include:
a. Hospital laboratories
b. Privately owned commercial laboratories
3. Laboratory provides office with supplies and forms to collect and prepare specimens for transport
4. MA responsible for checking and reordering supplies
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Laboratory DirectoryLaboratory Directory
1. Reference source for proper collection and handling of specimens
2. Provided to office by outside laboratory
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Laboratory Directory, cont. Laboratory Directory, cont.
3. Information included:
a. Names of tests performed by laboratory
b. Normal range for each test
c. Instructions on completion of forms (e.g., laboratory request)
d. Patient preparation required for each test
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Laboratory Directory, cont. Laboratory Directory, cont.
e. Supplies required for collection of each specimen
f. Amount and type of specimen required for each test
g. Techniques for collection of specimen
h. Proper handling and storage of specimen
i. Instructions for transporting specimen
4. If MA has any questions: Call laboratory
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Laboratory DirectoryLaboratory Directory
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Collection and Testing Categories
Collection and Testing Categories
1. Categories:
a. Specimen collected and tested at office
b. Specimen collected at office and transferred to outside laboratory
c. Patient given laboratory request to have specimen collected and tested at outside laboratory
2. Responsibilities of MA depend on which method is used
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Laboratory RequestsLaboratory Requests
1. Laboratory request: Printed form containing a list of most frequently ordered laboratory tests
a. Can be completed manually• MA writes in all required information
b. Can be completed on a computer screen
• MA enters information on a keyboard
Purpose
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Laboratory Requests, cont.Laboratory Requests, cont.
2. Required when a specimen is:
a. Collected at office and sent to outside laboratory for testing
b. Collected and tested at an outside laboratory• Request given to patient at office to take to
laboratory
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Laboratory Requests, cont.Laboratory Requests, cont.
3. Provides laboratory with information for:
a. Accurate testing
b. Reporting of results
c. Billing
4. Format of laboratory requests varies depending on laboratory
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Laboratory Request FormLaboratory Request Form
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Parts of a Laboratory Request Form
Parts of a Laboratory Request Form
1. Physician's name and address
a. Facilitates reporting of results to physician
b. May be preprinted on form
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Parts of a Laboratory Request Form, cont.
Parts of a Laboratory Request Form, cont.
2. Patient's name and address
a. Needed for: • Identifying report
• Billing purposes
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Parts of a Laboratory Request Form, cont.
Parts of a Laboratory Request Form, cont.
3. Patient's age and gender
a. Normal ranges for some tests vary based on age and gender• Example: Hemoglobin
– Female: 12 to 16 g/dL
– Male: 14 to 18 g/dL
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Parts of a Laboratory Request Form, cont.
Parts of a Laboratory Request Form, cont.
4. Date and time of collection of specimen
a. Date:• Indicates number of days that have passed
since specimen was collected
• Provides information regarding freshness of specimen
• Too long of a time lapse can result in inaccurate results
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Parts of a Laboratory Request Form, cont.
Parts of a Laboratory Request Form, cont.
b. Time:• Normal range for some tests vary based on
whether test is an AM or a PM specimen
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Parts of a Laboratory Request Form, cont.
Parts of a Laboratory Request Form, cont.
5. Laboratory tests desired
a. Usually indicated by marking a box adjacent to tests• Mark box clearly
b. Space designated for additional tests is provided• Use to specify a test not listed on request
form
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Parts of a Laboratory Request Form, cont.
Parts of a Laboratory Request Form, cont.
c. Profile: contains many laboratory tests• Profiles performed by laboratory and tests
included in each: listed in laboratory directory
• Specific profile: all tests relate to specific organ
– Used when physician has a good idea of what organ is involved in patient's condition
– Example: Hepatic profile tests assist in diagnosis of liver conditions
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Parts of a Laboratory Request Form, cont.
Parts of a Laboratory Request Form, cont.
• General profile: contains routine laboratory tests
– Used for routine health screens or when patient's symptoms are vague
– Example: comprehensive metabolic profile
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Laboratory ProfilesLaboratory Profiles
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Laboratory ProfilesLaboratory Profiles
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Parts of a Laboratory Request Form, cont.
Parts of a Laboratory Request Form, cont.
6. Source of specimen (e.g., throat, wound, ear, eye, urine, vagina)
a. Tells laboratory where specimen came from• May not be possible to determine by looking
at specimen
b. Method laboratory uses to test specimen: based on source of specimen
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Parts of a Laboratory Request Form, cont.
Parts of a Laboratory Request Form, cont.
7. Physician's clinical diagnosis
a. Assists the laboratory in correlating clinical laboratory data with the needs of physician• Further testing may be needed if one test
method proves inconclusive
b. Alerts laboratory to possibility of presence of a dangerous pathogen (e.g., hepatitis)
c. Required for billing
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Parts of a Laboratory Request Form, cont.
Parts of a Laboratory Request Form, cont.
8. Medications
a. Certain medications may interfere with accuracy and validity of test results
b. Must be indicated on request to inform laboratory
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Parts of a Laboratory Request Form, cont.
Parts of a Laboratory Request Form, cont.
9. STAT
a. Performed as soon as possible
b. Results telephoned or faxed to office
10.Place completed request form with specimen for transport to laboratory
a. Without request: laboratory does not have info to carry out orders• Results in delay in completing tests and
reporting results
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Laboratory ReportsLaboratory Reports
1. Purpose
a. Relay laboratory test results to physician
2. May be: a. Preprinted form:
• Results are printed on form by computer
b. Computer report• Entire report (tests and results) are printed by
the computer
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Laboratory ReportLaboratory Report
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Laboratory Reports, cont. Laboratory Reports, cont.
3. Includes:
a. Name, address, and telephone number of laboratory
b. Physician's name and address
c. Patient's name, age, and gender
d. Patient's accession number• Provides positive identification of each
specimen and access to patient's laboratory records
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Laboratory Reports, cont. Laboratory Reports, cont.
e. Date specimen received by laboratory
f. Date results reported by laboratory
g. Names of tests performed
h. Results of tests
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Laboratory Reports, cont. Laboratory Reports, cont.
i. Normal range for each test performed• A single value cannot be used because of
individual differences among general population (age, gender, race, geographic location)
• Normal range varies slightly from one laboratory to another depending on:
– Test method used
– Equipment used
– Reagents used
• Important to compare test results with normal range supplied by laboratory performing the test
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Laboratory Reports, cont. Laboratory Reports, cont.
4. Reports are relayed to office:
a. Hand-delivered
b. Sent electronically (by computer)
c. Faxed
d. Mailed to office
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Laboratory Reports, cont. Laboratory Reports, cont.
5. Abnormal results posing a threat to patient's health or STAT reports:
a. Telephoned as soon as possible
b. Written results will follow
6. MA responsible for reviewing reports as they are received
a. Notify physician of abnormal results
b. Most reports flag abnormal results– If not: MA should circle abnormal results with red
pen
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Laboratory Reports, cont. Laboratory Reports, cont.
7. Reports reviewed by physician: correlates with info from health history and physical examination
a. Physician initials laboratory report after reviewing it
8. MA files report in patient's chart
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What Would You Do?What Would You Not Do?
What Would You Do?What Would You Not Do?
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What Would You Do?What Would You Not Do?
What Would You Do?What Would You Not Do?
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Patient Preparation and Instructions
Patient Preparation and Instructions
1. Factors may affect results of certain laboratory tests:
a. Food consumption
b. Medication
c. Activity
d. Time of day
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Patient Preparation and Instructions, cont.
Patient Preparation and Instructions, cont.
2. Advance patient preparation may be required to obtain a quality specimena. Inaccurate results may occur if patient
does not prepare properly3. MA responsible for instructing patient
in advance preparationa. Explain reason for preparation: patient
will be more likely to comply• To ensure accurate test results
• To avoid having to collect specimen again
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Patient Preparation and Instructions, cont.
Patient Preparation and Instructions, cont.
b. Check to make sure patient completely understands instructions
c. Written instruction sheet may be provided• Patient can refer to it at
home
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Patient Preparation and Instructions, cont.
Patient Preparation and Instructions, cont.
4. Some tests may require patient to remain at site for specified period of time (e.g., glucose tolerance test)
a. Patient should be told in advance of time requirement
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Patient Preparation and Instructions, cont.
Patient Preparation and Instructions, cont.
5. Patient may collect specimen at home (e.g., first-voided urine specimen)
a. MA should:• Explain instructions on proper technique for
collection
• Provide appropriate specimen container
• Instruct patient on proper handling and storage of specimen
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Patient Preparation and Instructions, cont.
Patient Preparation and Instructions, cont.
6. Type of preparation: depends on test ordered and method used to run testa. Outside laboratory testing: preparation
required listed in laboratory directory
b. POL testing: preparation listed in manufacturer's instructions
c. Advance preparation usually in form of:• Fasting
• Medication restriction
• Diet modification
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FastingFasting
1. Required for some venous blood specimensa. Composition of blood is altered by
consumption of food
b. Example: Food intake results in falsely high results for:• Fasting blood sugar (FBS)
• Glucose tolerance test (GTT)
• Triglycerides
c. Must also fast for any profile including a test that requires fasting (e.g., lipid profile)
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Fasting, cont. Fasting, cont.
2. Fasting: abstaining from food and fluids (except water) for a specified amount of time (usually 12 to 14 hours)
3. Specimen collected in the morning
a. Food from evening meal completely digested and absorbed
b. Least amount of inconvenience to patient
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Fasting, cont. Fasting, cont.
4. MA responsible for relaying instructions to patient
a. Make sure patient understands to abstain from both food and fluid (except water)• Advisable to drink water:
– To prevent dehydration: can alter certain test results
– In case a urine specimen is required as part of the test
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Fasting, cont. Fasting, cont.
b. When to start fasting• Indicate the specific time to
start fasting (e.g., 6 PM)
c. What time to report for collection of specimen
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Medication RestrictionsMedication Restrictions
1. Many medications affect physical and chemical characteristics of body substances
a. May lead to inaccurate test results
b. Example: antibiotic therapy before collection of throat specimen for strep testing may cause falsely negative results
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Medication Restrictions, cont. Medication Restrictions, cont.
2. Patient told not to take medications before collection (if does not cause health threat or serious discomfort to patient)
3. Medications discontinued:
a. 48 to 72 hours: before urine collection
b. 4 to 24 hours: before blood collection• Medications more likely to interfere with urine
results than blood test results
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Medication Restrictions, cont. Medication Restrictions, cont.
4. If patient cannot be taken off medications:
a. Medications being taken should be recorded on laboratory request
b. Laboratory may be able to use alternate method of testing
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Medication Restrictions, cont. Medication Restrictions, cont.
5. If test performed in medical office:
a. MA should consult manufacturer's instructions for medications that interfere with test
6. Physician determines what medications to discontinue
a. MA ensure patient understands medication restrictions
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What Would You Do?What Would You Not Do?
What Would You Do?What Would You Not Do?
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What Would You Do?What Would You Not Do?
What Would You Do?What Would You Not Do?
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Collecting, Handling, and Transporting SpecimensCollecting, Handling, and Transporting Specimens
1. Specimen: small sample or part taken from the body to represent the nature of the whole
2. Majority of laboratory tests performed on specimens that are easily obtained:a. Blood
b. Urine
c. Feces
d. Sputum
e. Cervical and vaginal scraping of cells
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Collecting a Blood SpecimenCollecting a Blood Specimen
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Collecting, Handling, and Transporting Specimens, cont.
Collecting, Handling, and Transporting Specimens, cont.
f. Sample of secretion or discharge for microbiologic analysis:• Nose
• Throat
• Wound
• Ear and eye
• Vagina
• Urethra
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Collecting, Handling, and Transporting Specimens, cont.
Collecting, Handling, and Transporting Specimens, cont.
3. Other specimens not as easy to obtain
a. Gastric juices
b. Cerebrospinal fluid
c. Pleural fluid
d. Peritoneal fluid
e. Synovial fluid
f. Tissue specimens for biopsy
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Collecting, Handling, and Transporting Specimens, cont.
Collecting, Handling, and Transporting Specimens, cont.
4. Source of specimen: may not be indicative of pathologic condition
a. Example: Thyroid tests are performed on blood serum
5. MA responsible for collection of majority of specimens
a. Most common specimens collected by MA: blood and urine
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Collecting, Handling, and Transporting Specimens, cont.
Collecting, Handling, and Transporting Specimens, cont.
6. Certain specimens must be collected by the physician
a. Examples:• Vaginal discharge
• Urethral discharge
• Tissue specimen
b. MA assists with collection
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Collecting a Tissue SpecimenCollecting a Tissue Specimen
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Collecting, Handling, and Transporting Specimens, cont.
Collecting, Handling, and Transporting Specimens, cont.
7. Handle specimen properly: to maintain in vivo characteristics
a. In vivo: Occurring in the living body
b. If handled improperly: may cause inaccurate test results• May interfere with accurate diagnosis and
treatment
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Guidelines for Specimen Collection
Guidelines for Specimen Collection
1. Review and follow OSHA Bloodborne Pathogens Standard
2. Review requirements for collection and handling of the specimen
a. Collection materials required
b. Type of specimen required (e.g., serum, plasma, whole blood, urine)
c. Amount of specimen required
d. Procedure for collecting specimen
e. Proper handling and storage of specimen
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Guidelines for Specimen Collection, cont.
Guidelines for Specimen Collection, cont.
3. Assemble equipment and supplies
a. Use only appropriate specimen containers• Substituting containers may affect test results
• Container should be sterile:
– To prevent contamination of specimen: may affect accuracy of test results
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Guidelines for Specimen Collection, cont.
Guidelines for Specimen Collection, cont.
• MA should check each container before using: to make sure it is not broken, chipped, cracked, or otherwise damaged
– Discard damaged containers
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Guidelines for Specimen Collection, cont.
Guidelines for Specimen Collection, cont.
b. Label each tube and container:• Patient's
name
• Date
• MA initials
• Any other information required by laboratory
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Guidelines for Specimen Collection, cont.
Guidelines for Specimen Collection, cont.
4. Identify the patient by full name and date of birth
a. Avoids collecting from wrong patient• Could lead to invalid test results
– May affect patient's diagnosis and treatment
b. Explaining procedure helps relax and reassure patient• Gains patient's confidence and cooperation
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Identify the PatientIdentify the Patient
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Guidelines for Specimen Collection, cont.
Guidelines for Specimen Collection, cont.
5. Determine if pt has prepared properlya. Improper preparation may lead to
inaccurate test results
• Example: FBS: If patient does not fast, results will be falsely high
• Inform physician if patient failed to prepare
– Physician may want patient to prepare properly and return
– Physician may have MA collect specimen anyway
1) Alert laboratory to situation on request form
• Example: Nonfasting specimen
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Guidelines for Specimen Collection, cont.
Guidelines for Specimen Collection, cont.
6. Explain the procedure a. Helps relax and reassure patient b. Gains patient’s confidence and
cooperation
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Guidelines for Specimen Collection, cont.
Guidelines for Specimen Collection, cont.
7. Collection of the specimen
a. Involves medical and surgical asepsis
b. Collect specimen using proper technique
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Guidelines for Specimen Collection, cont.
Guidelines for Specimen Collection, cont.
c. Collect proper type of specimen
d. Collect proper amount of specimen• Refer to appropriate
reference material
– If specimen transported to outside laboratory: refer to laboratory directory
– If specimen tested in office: refer to manufacturer's instructions
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Guidelines for Specimen Collection, cont.
Guidelines for Specimen Collection, cont.
• If proper amount not collected: laboratory unable to perform test
• Laboratory request will be returned marked QNS (quantity not sufficient)
• Patient must be called back for another collection
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Guidelines for Specimen Collection, cont.
Guidelines for Specimen Collection, cont.
e. Once collected, MA records in chart:• Date and time of collection
• Laboratory tests ordered
• Type of specimen
• Source of specimen
• If transferred to outside laboratory: date specimen was collected should be recorded (if different from date of collection)
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Recording Specimen CollectionRecording Specimen Collection
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Guidelines for Specimen Collection, cont.
Guidelines for Specimen Collection, cont.
8. Properly handle and store the specimen: to preserve in vivo qualities
a. Best to perform laboratory tests on fresh specimens (within 1 hour after collection)• Yield most reliable test
results
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Guidelines for Specimen Collection, cont.
Guidelines for Specimen Collection, cont.
b. If specimen awaiting laboratory pick-up: properly preserve specimen to maintain in vivo physical and chemical characteristics
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What Would You Do?What Would You Not Do?
What Would You Do?What Would You Not Do?
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What Would You Do?What Would You Not Do?
What Would You Do?What Would You Not Do?
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Clinical Laboratory Improvement Amendments
(CLIA)
Clinical Laboratory Improvement Amendments
(CLIA)
1. To improve the quality of laboratory testing in the United States
2. Consists of federal regulations governing all facilities that perform laboratory tests for means of:
a. Health assessment
b. Diagnosis, prevention, or treatment of disease
3. Health Care Financing Administration (HCF) (division of Department of Health and Human Services): responsible for monitoring compliance with CLIA regulations
Purpose of CLIA 1988
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Categories of Laboratory Testing
Categories of Laboratory Testing
1. Waived tests
a. Simple procedures including procedures that are easy to perform
– Include procedures that patients can perform at home
b. Laboratories must apply for certificate of waiver from HCFA
• Exempts laboratory from many CLIA requirements
• Must still adhere to good laboratory practices
– Includes: following manufacturer's instructions for each product or testing kit
Categories of laboratory testing based on complexity of testing methods
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Categories of Laboratory Testing, cont.
Categories of Laboratory Testing, cont.
c. Examples of Waived Tests:• Dipstick or tablet reagent urinalysis
• Fecal occult blood testing
• Ovulation testing
• Urine pregnancy testing
• Erythrocyte sedimentation rate (nonautomated)
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Categories of Laboratory Testing, cont.
Categories of Laboratory Testing, cont.
• Hemoglobin using a CLIA-waived analyzer
• Spun microhematocrit
• Blood glucose determination (using an FDA-approved blood glucose monitor)
• Rapid strep testing
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Categories of Laboratory Testing, cont.
Categories of Laboratory Testing, cont.
2. Moderate-complexity tests
a. Account for 75% of estimated 10,000 laboratory tests performed in United States
b. Examples:• Hematology and blood chemistry tests
performed on automated blood analyzer (that are not CLIA-waived)
• Microscopic analysis of urine sediment
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Categories of Laboratory Testing, cont.
Categories of Laboratory Testing, cont.
3. High-complexity tests
a. Include:• Cytogenetics
• Histopathology
• Histocompatibility
• Cytology (e.g., Pap test)
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Requirements for Moderate- and High-Complexity TestingRequirements for Moderate- and High-Complexity Testing
1. Must meet CLIA regulations2. Subject to unannounced inspections
every 2 years by HCFA3. Patient test management
a. System to maintain optimal integrity and identification of specimens
b. System to ensure accurate reporting of results
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Requirements for Moderate- and High-Complexity Testing,
cont.
Requirements for Moderate- and High-Complexity Testing,
cont.
4. Quality control: to ensure accurate and reliable test results
a. Each laboratory must establish and follow written procedures• That monitor and evaluate quality of each
testing process
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Requirements for Moderate- and High-Complexity Testing,
cont.
Requirements for Moderate- and High-Complexity Testing,
cont.
b. Includes:• Developing laboratory procedure manual
• Following manufacturer's instructions
• Performing calibration procedure every 6 months and documenting results
• Performing two levels of controls daily and documenting results
• Performing and documenting actions taken when problems or errors occur
• Documenting all quality control activities
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Requirements for Moderate- and High-Complexity Testing,
cont.
Requirements for Moderate- and High-Complexity Testing,
cont.
5. Quality assurance
a. Must establish and follow written policies and procedures:• To monitor and evaluate the overall quality of
the total testing process
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Requirements for Moderate- and High-Complexity Testing,
cont.
Requirements for Moderate- and High-Complexity Testing,
cont.
6. Proficiency testing (PT)
a. Form of external quality control
b. Laboratory specimens prepared by an approved PT agency
c. Unknown specimens shipped to POL
d. POL tests specimens and reports results to PT agency for evaluation
e. Done 3 times per year
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Requirements for Moderate- and High-Complexity Testing,
cont.
Requirements for Moderate- and High-Complexity Testing,
cont.
7. Personnel requirements
a. CLIA specifies education and training qualifications and responsibilities for:• Laboratory directors
• Technical consultants
• Clinical consultants
• Testing personnel
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The Physician's Office Laboratory
The Physician's Office Laboratory
1. MA may be responsible for performing laboratory tests and recording results
2. Laboratory tests can be classified into categories:
a. Hematology: Examination of blood for the detection of abnormalities• Includes:
– Blood cell counts
– Cellular morphology
– Clotting ability of blood
– Identification of cell types
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The Physician's Office Laboratory, cont.
The Physician's Office Laboratory, cont.
b. Clinical chemistry: Determining the amount of chemical substances present in body fluids, excreta, and tissues• Largest area in clinical chemistry: blood
chemistry
c. Serology and blood banking: Studying antigen-antibody reactions to assess the presence of a substance and/or to determine the presence of disease
d. Urinalysis: Physical, chemical, and microscopic analysis of urine
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The Physician's Office Laboratory, cont.
The Physician's Office Laboratory, cont.
e. Microbiology: Identification of pathogens present in specimens taken from the body• Examples of specimens:
-Urine - Wound
-Blood -Urethra
-Throat -Vagina
-Sputum -Cerebrospinal fluid
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The Physician's Office Laboratory, cont.
The Physician's Office Laboratory, cont.
f. Parasitology: Detection of the presence of disease-producing human parasites or eggs present in specimens taken from the body• Examples of specimens:
– Stool
– Vaginal
– Blood
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The Physician's Office Laboratory, cont.
The Physician's Office Laboratory, cont.
g. Cytology: Detection of the presence of abnormal cells
h. Histology: Detection of diseased tissue
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Categories of Laboratory TestsCategories of Laboratory Tests
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Categories of Laboratory Tests, cont.
Categories of Laboratory Tests, cont.
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The Physician's Office Laboratory, cont.
The Physician's Office Laboratory, cont.
3. Specimens can be analyzed by either manual or automated method
4. Steps for testing specimen
a. Specific amount of specimen required: measured from specimen sample
b. Chemical reagents are combined with specimen
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The Physician's Office Laboratory, cont.
The Physician's Office Laboratory, cont.
c. Specimen/reagents may require further processing (e.g., centrifuging, incubation)
d. Substance is manually or automatically measured or identified
e. Results obtained from direct readout or by mathematic calculation
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The Physician's Office Laboratory, cont.
The Physician's Office Laboratory, cont.
f. Results are recorded on laboratory report form or in patient's chart:• Patient's name (not needed if recording in
chart)
• Date
• Time
• Name of laboratory test(s)
• Results of laboratory test(s)
• Name of individual performing test(s)
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Recording Laboratory Test Results
Recording Laboratory Test Results
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Manual MethodManual Method
1. Involves performing a series of steps by hand
2. Testing kits available to speed up process
a. Examples of testing kits: -Urinalysis -Strep testing -Mono testing -Urine pregnancy testing
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Manual Method, cont.Manual Method, cont.
1. Requires a thorough knowledge of testing procedure
a. Must be careful to avoid errors
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Automated AnalyzersAutomated Analyzers
1. Automated analyzers designed for use in medical officea. Permit processing
of specimens in a short period of time
b. Provide greater precision than manual method
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Automated Analyzers, cont. Automated Analyzers, cont.
2. Tests results by direct readout (digital or printed)
3. Must be able to recognize signs that indicate analyzer is malfunctioning
a. May lead to inaccurate test results
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Automated Analyzers, cont. Automated Analyzers, cont.
4. Numerous automated systems available
a. Operating manual with each that includes information needed to:• Collect specimen
• Handle specimen
• Perform quality control procedures
• Test specimen
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Automated Analyzers, cont. Automated Analyzers, cont.
b. Personnel available for on-site training and service
c. Examples of automated analyzers:• QBC hematology analyzer
• Reflotron blood chemistry analyzer
• Clinitek urine analyzer
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Quality ControlQuality Control
1. Must make sure laboratory test is accurately measuring what it is supposed to measure
a. Encompasses every aspect of:• Patient preparation
• Specimen collection
• Handling
• Transport
• Testing
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Quality Control, cont. Quality Control, cont.
2. Quality control: the application of methods and means to ensure that test results are reliable and valid and that errors that may interfere with obtaining accurate test results are detected and eliminated
3. Quality control methodsa. Use standards and controls:
• To check the precision and accuracy of laboratory equipment
• To detect errors in technique
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Quality Control, cont. Quality Control, cont.
b. Discard outdated reagents
c. Follow the procedure exactly to test specimen
d. Perform tests in duplicate
e. Periodically check the accuracy of test results with reference laboratory
f. Maintain equipment by having it checked periodically
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Laboratory SafetyLaboratory Safety
1. Carefully handle and store glassware:
a. Arrange in storage cabinets to prevent breakage
b. Carefully remove from storage cabinets
c. If breakage occurs: dispose in puncture-resistant container
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Laboratory Safety, cont.Laboratory Safety, cont.
2. Handle chemical reagents carefully
a. Reagent container should be clearly labeled
b. If label becomes loose, reattach
c. Recap container immediately after using
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Laboratory Safety, cont.Laboratory Safety, cont.
3. Laboratory specimens should be handled carefully:
a. Follow OSHA Bloodborne Pathogens Standard
b. Wash hands immediately if accidentally touch specimen
c. Avoid hand-to-mouth contact
d. Immediately clean up any spill
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Laboratory Safety, cont.Laboratory Safety, cont.
e. Properly dispose of all contaminated materials
f. Cover any break in the skin
g. Make sure specimen containers are tightly capped
h. Handle all laboratory equipment and supplies properly
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POSTTESTPOSTTEST
True or False1. Laboratory tests are most frequently ordered by
the physician to assist in the diagnosis of pathologic conditions.
2. A laboratory directory indicates the patient preparation required for laboratory tests.
3. Laboratory tests termed profiles contain a number of different tests.
4. A lipid profile includes a test for glucose.5. The purpose of patient preparation for a
laboratory test is to ensure the test results fall within normal range.
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POSTTEST, CONT.POSTTEST, CONT.
True or False6. A comprehensive metabolic profile requires that
the patient fast.7. Antibiotics taken by the patient prior to the
collection of a throat specimen for culture may result in a false-positive result.
8. The purpose of CLIA is to prevent exposure of employees to bloodborne pathogens.
9. If a POL is performing moderate-complexity tests, CLIA requires that two levels of controls be run daily.
10. The study of blood and blood-forming tissues is known as serology.