INTRODUCTION TO THE CLINICAL LABORATORY

1
CHAPTER 15

• INTRODUCTION TO THE CLINICAL LABORATORY

2
PRETEST
True or False

1. 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.

3
PRETEST, CONT.
True or False

1. A patient who is fasting in preparation for a
   laboratory test is permitted to drink diet soda.
2. A small sample taken from the body to represent
   the nature of the whole is known as a specimen.
3. A laboratory report marked QNS means that the
   patient did not prepare properly.
4. Fecal occult blood testing is an example of a
   CLIA-waived test.
5. The purpose of quality control is to prevent
   accidents in the laboratory.

4
Content Outline
Introduction to Clinical Laboratory

• Laboratory tests
• Used along with the health history and physical
  examination to diagnose patient's condition
• Laboratory tests Provide objective and
  quantitative information regarding status of body
  conditions and functions

5
Introduction to Clinical Laboratory

• 2. Homeostasis state in which body systems are
  functioning normally
• Internal environment of the body is in
  equilibrium
• Body is in a healthy state
• Normal or reference range An established range
  within which laboratory test results of a normal
  person are expected to fall

6
Introduction to Clinical Laboratory, cont.

• 4. Body in homeostasis
• Physical and chemical characteristics of body
  substances fall within normal range
• Body substances include
• Fluids
• Secretions
• Excretions

7
Introduction to Clinical Laboratory, cont.

• 5. Pathologic condition
• 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.

• May cause alteration in body substances
• Chemical content of blood or urine
• Antibody level
• Cell counts
• Cellular morphology
• 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.

• 6. Abnormal value for a particular test may be
  seen with more than one pathologic condition
• Example Decrease in hemoglobin levels seen
  with
• Iron-deficiency anemia
• Hyperthyroidism
• Cirrhosis of the liver

10
Introduction to Clinical Laboratory, cont.

• 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

11
Laboratory Tests

• Number of tests ordered depends on physician's
  clinical findings (health history and physical
  examination)
• May only need to order one test (e.g., urine
  culture for a urinary tract infection)
• 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

12
Laboratory Tests, cont.

• Not all pathologic conditions require use of
  laboratory tests to arrive at a final diagnosis
• Diagnosis can be made from patient's symptoms and
  physical examination (e.g., otitis media)
• MA should have knowledge of laboratory tests
  performed most often
• Purpose of tests
• Normal value or range

13
Laboratory Tests, cont.

• Advance patient preparation or special
  instructions
• Any substances that might interfere with accurate
  test results
• Food
• Medication
• Make sure physician is alerted to abnormal
  results on laboratory tests as soon as possible

14
Purpose of Laboratory Testing

• Assist in diagnosis of pathologic conditions
  most frequent use of laboratory tests
• 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)

15
Purpose of Laboratory Testing, cont.

• Assist in differential diagnosis
• Two or more diseases may have similar symptoms
• Laboratory tests ordered to determine which
  disease is present

16
Purpose of Laboratory Testing, cont.

• 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

17
Purpose of Laboratory Testing, cont.

• Evaluate patient's progress and to regulate
  treatment after making the final diagnosis
• 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

18
Purpose of Laboratory Testing, cont.

• Establish patient's baseline
• Age, gender, race, geographic location cause
  individuals to have different normal levels
  within established normal range
• Laboratory tests establish each patient's
  baseline against which future results can be
  compared

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Purpose of Laboratory Testing, cont.

• Prevent or reduce the severity of disease by
  early detection of abnormal findings (e.g.,
  hyperlipidemia, anemia, diabetes)
• 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

20
Purpose of Laboratory Testing, cont.

• Common routine tests
• Urinalysis
• Complete blood count (CBC)
• Cholesterol
• Routine blood chemistries

21
Purpose of Laboratory Testing, cont.

• Requirement by state law
• Example Statutes of most states require
  gonorrhea and syphilis tests be performed on
  pregnant women
• Purpose to protect mother and fetus from harm

22
Types of Clinical Laboratories

• Medical office may use outside laboratory or have
  its own laboratory (physician's office
  laboratory)
• Most offices use a combination of both
• Physician's Office Laboratory (POL)
• For tests that are convenient to perform and
  commonly required (e.g., glucose, urinalysis)
• Time-consuming and expensive to perform complex
  tests in the office

23
Outside Laboratories

• MA works closely with outside laboratory
• Outside laboratories include
• Hospital laboratories
• Privately owned commercial laboratories
• Laboratory provides office with supplies and
  forms to collect and prepare specimens for
  transport
• MA responsible for checking and reordering
  supplies

24
Laboratory Directory

• Reference source for proper collection and
  handling of specimens
• Provided to office by outside laboratory

25
Laboratory Directory, cont.

• Information included
• Names of tests performed by laboratory
• Normal range for each test
• Instructions on completion of forms (e.g.,
  laboratory request)
• Patient preparation required for each test

26
Laboratory Directory, cont.

• Supplies required for collection of each specimen
• Amount and type of specimen required for each
  test
• Techniques for collection of specimen
• Proper handling and storage of specimen
• Instructions for transporting specimen
• If MA has any questions Call laboratory

27
Laboratory Directory
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Collection and Testing Categories

• Categories
• Specimen collected and tested at office
• Specimen collected at office and transferred to
  outside laboratory
• Patient given laboratory request to have specimen
  collected and tested at outside laboratory
• Responsibilities of MA depend on which method is
  used

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Laboratory Requests
Purpose

• 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

30
Laboratory Requests, cont.

• 2. Required when a specimen is
• Collected at office and sent to outside
  laboratory for testing
• Collected and tested at an outside laboratory
• Request given to patient at office to take to
  laboratory

31
Laboratory Requests, cont.

• Provides laboratory with information for
• Accurate testing
• Reporting of results
• Billing
• Format of laboratory requests varies depending on
  laboratory

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Laboratory Request Form
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Parts of a Laboratory Request Form

• Physician's name and address
• Facilitates reporting of results to physician
• May be preprinted on form

34
Parts of a Laboratory Request Form, cont.

• Patient's name and address
• Needed for
• Identifying report
• Billing purposes

35
Parts of a Laboratory Request Form, cont.

• Patient's age and gender
• 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.

• Date and time of collection of specimen
• 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.

• 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.

• Laboratory tests desired
• Usually indicated by marking a box adjacent to
  tests
• Mark box clearly
• 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.

• 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

40
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

41
Laboratory Profiles
42
Laboratory Profiles
43
Parts of a Laboratory Request Form, cont.

• Source of specimen (e.g., throat, wound, ear,
  eye, urine, vagina)
• Tells laboratory where specimen came from
• May not be possible to determine by looking at
  specimen
• Method laboratory uses to test specimen based on
  source of specimen

44
Parts of a Laboratory Request Form, cont.

• Physician's clinical diagnosis
• Assists the laboratory in correlating clinical
  laboratory data with the needs of physician
• Further testing may be needed if one test method
  proves inconclusive
• Alerts laboratory to possibility of presence of a
  dangerous pathogen (e.g., hepatitis)
• Required for billing

45
Parts of a Laboratory Request Form, cont.

• Medications
• Certain medications may interfere with accuracy
  and validity of test results
• Must be indicated on request to inform laboratory

46
Parts of a Laboratory Request Form, cont.

• STAT
• Performed as soon as possible
• Results telephoned or faxed to office
• Place completed request form with specimen for
  transport to laboratory
• Without request laboratory does not have info
  to carry out orders
• Results in delay in completing tests and
  reporting results

47
Laboratory Reports

• Purpose
• Relay laboratory test results to physician
• 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

48
Laboratory Report
49
Laboratory Reports, cont.

• Includes
• Name, address, and telephone number of laboratory
• Physician's name and address
• Patient's name, age, and gender
• Patient's accession number
• Provides positive identification of each specimen
  and access to patient's laboratory records

50
Laboratory Reports, cont.

1. Date specimen received by laboratory
2. Date results reported by laboratory
3. Names of tests performed
4. Results of tests

51
Laboratory Reports, cont.

• 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

52
Laboratory Reports, cont.

• Reports are relayed to office
• Hand-delivered
• Sent electronically (by computer)
• Faxed
• Mailed to office

53
Laboratory Reports, cont.

• Abnormal results posing a threat to patient's
  health or STAT reports
• Telephoned as soon as possible
• Written results will follow
• MA responsible for reviewing reports as they are
  received
• Notify physician of abnormal results
• Most reports flag abnormal results
• If not MA should circle abnormal results with
  red pen

54
Laboratory Reports, cont.

• Reports reviewed by physician correlates with
  info from health history and physical examination
• Physician initials laboratory report after
  reviewing it
• MA files report in patient's chart

55
What Would You Do?What Would You Not Do?
56
What Would You Do?What Would You Not Do?
57
Patient Preparation and Instructions

• Factors may affect results of certain laboratory
  tests
• Food consumption
• Medication
• Activity
• Time of day

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Patient Preparation and Instructions, cont.

• Advance patient preparation may be required to
  obtain a quality specimen
• Inaccurate results may occur if patient does not
  prepare properly
• MA responsible for instructing patient in advance
  preparation
• Explain reason for preparation patient will be
  more likely to comply
• To ensure accurate test results
• To avoid having to collect specimen again

59
Patient Preparation and Instructions, cont.

• Check to make sure patient completely understands
  instructions
• Written instruction sheet may be provided
• Patient can refer to it at home

60
Patient Preparation and Instructions, cont.

• Some tests may require patient to remain at site
  for specified period of time (e.g., glucose
  tolerance test)
• Patient should be told in advance of time
  requirement

61
Patient Preparation and Instructions, cont.

• Patient may collect specimen at home (e.g.,
  first-voided urine specimen)
• 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.

• Type of preparation depends on test ordered and
  method used to run test
• Outside laboratory testing preparation required
  listed in laboratory directory
• POL testing preparation listed in manufacturer's
  instructions
• Advance preparation usually in form of
• Fasting
• Medication restriction
• Diet modification

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Fasting

• Required for some venous blood specimens
• Composition of blood is altered by consumption of
  food
• Example Food intake results in falsely high
  results for
• Fasting blood sugar (FBS)
• Glucose tolerance test (GTT)
• Triglycerides
• Must also fast for any profile including a test
  that requires fasting (e.g., lipid profile)

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Fasting, cont.

• Fasting abstaining from food and fluids (except
  water) for a specified amount of time (usually 12
  to 14 hours)
• Specimen collected in the morning
• Food from evening meal completely digested and
  absorbed
• Least amount of inconvenience to patient

65
Fasting, cont.

• MA responsible for relaying instructions to
  patient
• 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

66
Fasting, cont.

• When to start fasting
• Indicate the specific time to start fasting
  (e.g., 6 PM)
• What time to report for collection of specimen

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Medication Restrictions

• Many medications affect physical and chemical
  characteristics of body substances
• May lead to inaccurate test results
• Example antibiotic therapy before collection of
  throat specimen for strep testing may cause
  falsely negative results

68
Medication Restrictions, cont.

• Patient told not to take medications before
  collection (if does not cause health threat or
  serious discomfort to patient)
• Medications discontinued
• 48 to 72 hours before urine collection
• 4 to 24 hours before blood collection
• Medications more likely to interfere with urine
  results than blood test results

69
Medication Restrictions, cont.

• If patient cannot be taken off medications
• Medications being taken should be recorded on
  laboratory request
• Laboratory may be able to use alternate method of
  testing

70
Medication Restrictions, cont.

• If test performed in medical office
• MA should consult manufacturer's instructions for
  medications that interfere with test
• Physician determines what medications to
  discontinue
• MA ensure patient understands medication
  restrictions

71
What Would You Do?What Would You Not Do?
72
What Would You Do?What Would You Not Do?
73
Collecting, Handling, and Transporting Specimens

• Specimen small sample or part taken from the
  body to represent the nature of the whole
• Majority of laboratory tests performed on
  specimens that are easily obtained
• Blood
• Urine
• Feces
• Sputum
• Cervical and vaginal scraping of cells

74
Collecting a Blood Specimen
75
Collecting, Handling, and Transporting Specimens,
cont.

• Sample of secretion or discharge for
  microbiologic analysis
• Nose
• Throat
• Wound
• Ear and eye
• Vagina
• Urethra

76
Collecting, Handling, and Transporting Specimens,
cont.

• Other specimens not as easy to obtain
• Gastric juices
• Cerebrospinal fluid
• Pleural fluid
• Peritoneal fluid
• Synovial fluid
• Tissue specimens for biopsy

77
Collecting, Handling, and Transporting Specimens,
cont.

• Source of specimen may not be indicative of
  pathologic condition
• Example Thyroid tests are performed on blood
  serum
• MA responsible for collection of majority of
  specimens
• Most common specimens collected by MA blood and
  urine

78
Collecting, Handling, and Transporting Specimens,
cont.

• Certain specimens must be collected by the
  physician
• Examples
• Vaginal discharge
• Urethral discharge
• Tissue specimen
• MA assists with collection

79
Collecting a Tissue Specimen
80
Collecting, Handling, and Transporting Specimens,
cont.

• Handle specimen properly to maintain in vivo
  characteristics
• In vivo Occurring in the living body
• If handled improperly may cause inaccurate test
  results
• May interfere with accurate diagnosis and
  treatment

81
Guidelines for Specimen Collection

• Review and follow OSHA Bloodborne Pathogens
  Standard
• Review requirements for collection and handling
  of the specimen
• Collection materials required
• Type of specimen required (e.g., serum, plasma,
  whole blood, urine)
• Amount of specimen required
• Procedure for collecting specimen
• Proper handling and storage of specimen

82
Guidelines for Specimen Collection, cont.

• Assemble equipment and supplies
• 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

83
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

84
Guidelines for Specimen Collection, cont.

• Label each tube and container

• Patient's name
• Date
• MA initials
• Any other information required by laboratory

85
Guidelines for Specimen Collection, cont.

• Identify the patient by full name and date of
  birth
• Avoids collecting from wrong patient
• Could lead to invalid test results
• May affect patient's diagnosis and treatment
• Explaining procedure helps relax and reassure
  patient
• Gains patient's confidence and cooperation

86
Identify the Patient
87
Guidelines for Specimen Collection, cont.

• Determine if pt has prepared properly
• 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
• Alert laboratory to situation on request form
• Example Nonfasting specimen

88
Guidelines for Specimen Collection, cont.

• Explain the procedure
• a. Helps relax and reassure patient
• b. Gains patients confidence and
  cooperation

89
Guidelines for Specimen Collection, cont.

• 7. Collection of the specimen
• Involves medical and surgical asepsis
• Collect specimen using proper technique

90
Guidelines for Specimen Collection, cont.

• Collect proper type of specimen
• 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

91
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

92
Guidelines for Specimen Collection, cont.

• 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)

93
Recording Specimen Collection
94
Guidelines for Specimen Collection, cont.

• 8. Properly handle and store the specimen to
  preserve in vivo qualities

• Best to perform laboratory tests on fresh
  specimens (within 1 hour after collection)
• Yield most reliable test results

95
Guidelines for Specimen Collection, cont.

• If specimen awaiting laboratory pick-up properly
  preserve specimen to maintain in vivo physical
  and chemical characteristics

96
What Would You Do?What Would You Not Do?
97
What Would You Do?What Would You Not Do?
98
Clinical Laboratory Improvement Amendments (CLIA)
Purpose of CLIA 1988

• To improve the quality of laboratory testing in
  the United States
• Consists of federal regulations governing all
  facilities that perform laboratory tests for
  means of
• Health assessment
• Diagnosis, prevention, or treatment of disease
• Health Care Financing Administration (HCF)
  (division of Department of Health and Human
  Services) responsible for monitoring compliance
  with CLIA regulations

99
Categories of Laboratory Testing
Categories of laboratory testing based on
complexity of testing methods

• Waived tests
• 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

100
Categories of Laboratory Testing, cont.

• Examples of Waived Tests
• Dipstick or tablet reagent urinalysis
• Fecal occult blood testing
• Ovulation testing
• Urine pregnancy testing
• Erythrocyte sedimentation rate (nonautomated)

101
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

102
Categories of Laboratory Testing, cont.

• Moderate-complexity tests
• Account for 75 of estimated 10,000 laboratory
  tests performed in United States
• Examples
• Hematology and blood chemistry tests performed on
  automated blood analyzer (that are not
  CLIA-waived)
• Microscopic analysis of urine sediment

103
Categories of Laboratory Testing, cont.

• High-complexity tests
• Include
• Cytogenetics
• Histopathology
• Histocompatibility
• Cytology (e.g., Pap test)

104
Requirements for Moderate- and High-Complexity
Testing

• Must meet CLIA regulations
• Subject to unannounced inspections every 2 years
  by HCFA
• Patient test management
• System to maintain optimal integrity and
  identification of specimens
• System to ensure accurate reporting of results

105
Requirements for Moderate- and High-Complexity
Testing, cont.

• Quality control to ensure accurate and reliable
  test results
• Each laboratory must establish and follow written
  procedures
• That monitor and evaluate quality of each testing
  process

106
Requirements for Moderate- and High-Complexity
Testing, cont.

• 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

107
Requirements for Moderate- and High-Complexity
Testing, cont.

• Quality assurance
• Must establish and follow written policies and
  procedures
• To monitor and evaluate the overall quality of
  the total testing process

108
Requirements for Moderate- and High-Complexity
Testing, cont.

• Proficiency testing (PT)
• Form of external quality control
• Laboratory specimens prepared by an approved PT
  agency
• Unknown specimens shipped to POL
• POL tests specimens and reports results to PT
  agency for evaluation
• Done 3 times per year

109
Requirements for Moderate- and High-Complexity
Testing, cont.

• Personnel requirements
• CLIA specifies education and training
  qualifications and responsibilities for
• Laboratory directors
• Technical consultants
• Clinical consultants
• Testing personnel

110
The Physician's Office Laboratory

• MA may be responsible for performing laboratory
  tests and recording results
• Laboratory tests can be classified into
  categories
• Hematology Examination of blood for the
  detection of abnormalities
• Includes
• Blood cell counts
• Cellular morphology
• Clotting ability of blood
• Identification of cell types

111
The Physician's Office Laboratory, cont.

• Clinical chemistry Determining the amount of
  chemical substances present in body fluids,
  excreta, and tissues
• Largest area in clinical chemistry blood
  chemistry
• Serology and blood banking Studying
  antigen-antibody reactions to assess the presence
  of a substance and/or to determine the presence
  of disease
• Urinalysis Physical, chemical, and microscopic
  analysis of urine

112
The Physician's Office Laboratory, cont.

• Microbiology Identification of pathogens present
  in specimens taken from the body
• Examples of specimens
• -Urine - Wound
• -Blood -Urethra
• -Throat -Vagina
• -Sputum -Cerebrospinal fluid

113
The Physician's Office Laboratory, cont.

• 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

114
The Physician's Office Laboratory, cont.

1. Cytology Detection of the presence of abnormal
   cells
2. Histology Detection of diseased tissue

115
Categories of Laboratory Tests
116
Categories of Laboratory Tests, cont.
117
The Physician's Office Laboratory, cont.

• Specimens can be analyzed by either manual or
  automated method
• Steps for testing specimen
• Specific amount of specimen required measured
  from specimen sample
• Chemical reagents are combined with specimen

118
The Physician's Office Laboratory, cont.

• Specimen/reagents may require further processing
  (e.g., centrifuging, incubation)
• Substance is manually or automatically measured
  or identified
• Results obtained from direct readout or by
  mathematic calculation

119
The Physician's Office Laboratory, cont.

• 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)

120
Recording Laboratory Test Results
121
Manual Method

• Involves performing a series of steps by hand
• Testing kits available to speed up process
• a. Examples of testing kits
• -Urinalysis
• -Strep testing
• -Mono testing
• -Urine pregnancy testing

122
Manual Method, cont.

• Requires a thorough knowledge of testing
  procedure
• Must be careful to avoid errors

123
Automated Analyzers

• Automated analyzers designed for use in medical
  office
• Permit processing of specimens in a short period
  of time
• Provide greater precision than manual method

124
Automated Analyzers, cont.

• Tests results by direct readout (digital or
  printed)
• Must be able to recognize signs that indicate
  analyzer is malfunctioning
• May lead to inaccurate test results

125
Automated Analyzers, cont.

• Numerous automated systems available
• Operating manual with each that includes
  information needed to
• Collect specimen
• Handle specimen
• Perform quality control procedures
• Test specimen

126
Automated Analyzers, cont.

• Personnel available for on-site training and
  service
• Examples of automated analyzers
• QBC hematology analyzer
• Reflotron blood chemistry analyzer
• Clinitek urine analyzer

127
Quality Control

• Must make sure laboratory test is accurately
  measuring what it is supposed to measure
• Encompasses every aspect of
• Patient preparation
• Specimen collection
• Handling
• Transport
• Testing

128
Quality Control, cont.

• 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
• Quality control methods
• Use standards and controls
• To check the precision and accuracy of laboratory
  equipment
• To detect errors in technique

129
Quality Control, cont.

1. Discard outdated reagents
2. Follow the procedure exactly to test specimen
3. Perform tests in duplicate
4. Periodically check the accuracy of test results
   with reference laboratory
5. Maintain equipment by having it checked
   periodically

130
Laboratory Safety

• Carefully handle and store glassware
• Arrange in storage cabinets to prevent breakage
• Carefully remove from storage cabinets
• If breakage occurs dispose in puncture-resistant
  container

131
Laboratory Safety, cont.

• Handle chemical reagents carefully
• Reagent container should be clearly labeled
• If label becomes loose, reattach
• Recap container immediately after using

132
Laboratory Safety, cont.

1. Laboratory specimens should be handled carefully

• Follow OSHA Bloodborne Pathogens Standard
• Wash hands immediately if accidentally touch
  specimen
• c. Avoid hand-to-mouth contact
• d. Immediately clean up any spill

133
Laboratory Safety, cont.

1. Properly dispose of all contaminated materials
2. Cover any break in the skin
3. Make sure specimen containers are tightly capped
4. Handle all laboratory equipment and supplies
   properly

134
POSTTEST
True or False

1. 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.

135
POSTTEST, CONT.
True or False

• A comprehensive metabolic profile requires that
  the patient fast.
• Antibiotics taken by the patient prior to the
  collection of a throat specimen for culture may
  result in a false-positive result.
• The purpose of CLIA is to prevent exposure of
  employees to bloodborne pathogens.
• If a POL is performing moderate-complexity tests,
  CLIA requires that two levels of controls be run
  daily.
• The study of blood and blood-forming tissues is
  known as serology.