This document provides information about the clinical laboratory and the roles of various personnel within it. It discusses: 1) Personnel in the laboratory including pathologists, medical technologists, technicians, and assistants. 2) The use of laboratory testing to obtain diagnostic data alongside a health history and exam. 3) Certifying agencies that regulate laboratory personnel. 4) The role of the clinical laboratory in providing diagnostic tools to physicians.

1. MA114
Chapter 45
Assisting in the
Clinical
Laboratory
WEEK 3

2. Personnel in the Clinical
Laboratory
 Laboratory tests are an essential part of a
medical diagnosis
 Personnel may include a pathologist, certified
medical technologists (MTs), medical
laboratory technicians (MLTs) or medical
laboratory assistants (MLAs), and
credentialed medical assistants (CMAs,
RMAs, CCMAs, NCMAs)
2

3. Clinical Laboratory Testing
 Used with a thorough health history and physical exam
to obtain essential data for diagnosis and management
of patient’s condition
 Abnormal test results can indicate more than one
pathologic condition, so more information is needed
 Screening tests examine a particular specimen for
presence of a substance that may indicate a disease,
often qualitative
 Quantitative tests measure numeric values with a unit,
such as analyte per given volume
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4. Certifying Agencies for
Laboratory Personnel
4

5. The Role of the Clinical
Laboratory in Patient Care
 The laboratory provides the physician with
powerful diagnostic tools. Laboratory staff
analyze blood, urine, and other body samples
to facilitate identification of diseases and
disorders.
 Results of laboratory testing are compared
with normal or reference values (acceptable
ranges for a healthy population) to determine
the relative health of body systems or organs.
5

6. The Role of the Clinical
Laboratory in Patient Care
 Blood levels of various medications are
determined to adjust dosages to therapeutic
levels.
 Bacteria, viruses, parasites, and other
microorganism are identified to begin the
treatment process.
6

7. Laboratory Testing
 Most commonly used for:
 Detecting and diagnosing disease
 Following the progress of a disease and its response
to treatment
 Meeting legal requirements (e.g., drug testing,
marriage license).
 Monitoring a patient’s medication and treatment.
 Determining the levels of essential substances in the
body
 Identifying the cause of an infection
 Determining a baseline value
 Preventing disease
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8. Medical assistants role
 Informing patients of the proper procedure or
preparation for obtaining laboratory specimens
(samples, such as blood or urine, used to evaluate a
patient’s condition)
 Obtaining a quality specimen
 Arranging for appropriate transport if the specimen is to
be analyzed at another site.
 Performing common laboratory tests in the physician’s
office or clinic in compliance with the Clinical
Laboratory Improvement Amendments (CLIA), which
are federal quality standards for all laboratory testing to
ensure the accuracy, reliability, and timeliness of
patient test results regardless of where the test was
performed.
8

9. 9
A reference or referral laboratory is a large facility in which thousands of
tests of various types are performed each day.
A reference laboratory’s direct patient contact is limited to its own satellite
specimen procurement stations.

10. Clinical Laboratory Improvement
Amendments (CLIA)
 Established quality standards for all lab testing to
ensure accuracy, reliability, and timeliness of
patient results.
 All facilities in the United States that perform
laboratory testing on human specimens for health
assessment or the diagnosis, prevention, or
treatment of disease are regulated under the
Clinical Laboratory Improvement Amendments of
1988 (CLIA).
 Three regulatory categories:
 Waived tests
 Moderate-complexity tests
 High-complexity tests
10

11. CLIA Waived Tests
 Waived tests include test systems cleared by the
FDA for home use and those tests approved for
waiver under the CLIA criteria. Although CLIA
requires that waived tests must be simple and
have a low risk for erroneous results, this does not
mean that waived tests are completely error-proof.
 Errors can occur anywhere in the testing process,
particularly when the manufacturer's instructions
are not followed and when testing personnel are
not familiar with all aspects of the test system.
11

12. Moderate- and High-Complexity
Tests
 Laboratories that perform these tests must meet
CLIA regulations and are subject to unannounced
inspections every 2 years
 Must establish a system to maintain integrity and
identification of patients’ specimens throughout
testing process and to ensure accurate reporting
of results
 Medical assistants may perform all CLIA-waived
tests and some moderately complex tests,
depending on the certification of the laboratory or
POL in which they are employed

13. Quality Assurance Guidelines
 Quality assurance encompasses a comprehensive
set of policies developed to ensure excellent
documentation and reliability of laboratory testing
 Also focuses on establishing a series of operating
procedures for the benefit of the patient and the
medical assistant doing the laboratory testing
 Process is divided into three stages
 Preanalytic
 Analytic
 Postanalytic
13

14. Quality Assurance (QA)
Guidelines
 QA is the pledge of healthcare professionals
to work to achieve the highest degree of
excellence in the healthcare given to every
patient
 Reduce liability for the physician, produce
reliable results for the patient

15. Quality Control (QC) Guidelines
 Specially prepared QC samples are tested
daily, along with patient samples
 Objective of QC in the laboratory is to ensure
the reliability of the test results
 On every day that patient tests are performed,
QC tests must also be performed and the
results entered on the flow sheet
15

16. Quality Control (QC) Guidelines
 To ensure the accuracy and reliability of test results
while detecting and eliminating error
 QC programs monitor all aspects of laboratory activity,
from specimen collection through the processing,
testing, and reporting steps
 QC samples are tested daily, along with patient
samples
 Standardization of laboratory instruments is mandatory
 Accurate record keeping is one of your key
responsibilities to ensure QC

17. Divisions of the Clinical
Laboratory
 Urinalysis
 Physical, chemical, and microscopic evaluation of
urine
 Hematology
 Study of blood cells and coagulation
 Chemistry
 Analyzes chemicals found in blood, cerebrospinal
fluid, urine, and joint fluid
 Microbiology
 Involves the study of bacteria, fungi, yeasts,
parasites, and viruses
17

18. Urinalysis
 Physical, chemical, and microscopic
examination of urine
 Physical includes color, clarity, specific gravity
 Chemical measures levels of glucose, protein,
ketones, blood, bilirubin, urobilinogen, nitrites,
and pH
 Microscopic looks for certain cells, mucus,
casts, crystals, yeasts, parasites, and bacteria

19. Urinalysis

20. Hematology
 Qualitative or quantitative
 Blood cell counts determine exact number of
RBCs or erythrocytes, white blood cells (WBCs,
or leukocytes), or platelets (thrombocytes)
 Qualitative tests determine characteristics of
cells, such as size, shape, and maturity

21. Hematology
21

22. Chemistry & Microbiology
 Chemistry analyzes blood, cerebrospinal fluid
(CSF), urine, and joint fluid (synovial fluid)
 Microbiology involves study of bacteria, fungi,
yeasts, parasites, and viruses
 Microorganisms are grown from specimens and
identified

23. Chemistry
 Qualitative or quantitative

24. Microbiology
 The study of bacteria, fungi, yeasts, parasites
and viruses.

25. Other departments
 Toxicology- measures both therapeutic drugs and
drugs of abuse.
 Immunohematology- commonly called blood bank,
performs blood typing and compatibility testing of
patient’s blood with blood products for transfusion
purposes.
 Immunology- Testing on the reactions of
antibodies formed against certain diseases in the
presence of proteins called antigens.
 Coagulation- Often part of the hematology
department entails evaluating how well the body's
blood clotting process performs.

26. Laboratory Safety Standards
 Safety standards for laboratories are initiated,
regulated, and reviewed by several agencies
or committees
 OSHA mandates 2 programs for safety in
labs:
 One covers occupational exposure to chemical
hazards
 One covers exposure to blood-borne pathogens

27. Laboratory Safety
 U.S. government created a system of
safeguards and regulations under the
Occupational Safety and Health Act of 1970
 CDC also has established recommendations
and resources in Standard Precautions and
Transmission Precautions
27

28. Laboratory safety

29. Physical Hazards
 Electrical
 Fire
 Mechanical

30. Chemical Hazards
 Identification of the product
 Hazard(s) identification
 Composition/information on
ingredients
 First-aid measures
 Fire-fighting measures
 Accidental release
measures
 Handling and storage
 Exposure controls/personal
protection
 Physical and chemical
properties
 Stability and reactivity
 Toxicological information
 Ecologic information
 Disposal considerations
 Transport information
 Regulatory information
 Other information

31. Chemical Safety Procedures
 Never pipet by mouth
 Work under fume hood
 Rinse exposed skin under water for 5 minutes
 Use eyewash station for at least 15 minutes
 Keep chemicals tightly sealed and know
hazard identification symbols

32. Identification System of the National
Fire Protection Association
The top diamond is red and
indicates a flammability
hazard.
The diamond on the left is
blue and indicates hazards
to health.
The bottom diamond is white
and provides special hazard
information, including
radioactivity, special
biohazards, and other
dangerous situations.
The diamond on the right is
yellow and indicates a
reactivity or stability hazard.

33. Biologic Hazards and Infection
Control
 Biohazards are materials or situations that
present risk or potential risk of infection
 Potentially infective specimens include blood,
body tissue biopsy specimens, urine,
exudates, and bacterial cultures and smears
 Label potentially biohazardous material

34. Standard Precautions
 Bloodborne Pathogen (BBP) Standard covers
all employees who could reasonably be
exposed to infectious material while doing
their job
 Laboratory employer must have a written
exposure control plan
 Urine is the only body fluid not specifically
included in the BBPS standard

35. Washing and Sanitizing the
Hands
 When entering and before leaving the area
 Before and after every patient procedure
 After contact with body fluid, even if gloves
were worn
 Before and after eating
 Before and after using the restroom

36. Safety Guidelines for Other
Potentially Infectious Materials
36

37. Laboratory Requisitions and
Reports
 Various methods are used to file laboratory
reports in a patient’s medical record
 Make sure that all reports are received for
diagnostic tests performed on the patient outside
the physician’s office
 Only file reports after the physician has reviewed
the results
 Written requisitions for outside tests must be sent
to the laboratory

39. Specimen Collection
 Most common specimens: blood, urine, and
swab samples collected from wounds or
mucous membranes
 Less often: feces, gastric contents, CSF,
tissue samples, semen, and aspirates, such
as synovial fluid

40. 40

41. Ensuring Accuracy
 Initial identification of the patient is essential
 Collection of the specimen in an appropriate
collection container
 Color-coded tubes or sterile specimen
containers may be used
 Labeling specimen: Patient’s name, ID#,
Date, time and source of specimen

42. Labeling Specimens
 Physician’s name, account number, address, and
phone number
 Patient’s full name, age, date of birth, gender, address,
and insurance information
 Source of specimen; date and time of collection
 Specific test (or tests) requested; medications patient is
taking
 Whether patient fasted or followed dietary restrictions if
required; time of last intake
 Possible diagnosis
 Indication of whether test is to be performed stat

43. Delivering Specimens Safely

45. Preventing Contamination
 Expiration dates on swabs, tubes, transport
media, and other collection containers should
be checked before these items are used
 Sufficient samples should be collected for
tests requested by physician
 The specimen collected must be a true
representative sample

46. Proper Handling, Processing, and
Storage
 Specimen must be handled, processed, and
stored according to individual guidelines
 Determine whether the specimen needs to be
kept warm or cool
 Laboratory specimen requirements should be
consulted to ensure that each specimen is
handled and processed properly

47. Chain of Custody
 When a specimen is evidence, certain procedures
must be followed in collecting handling
 Specimen processing must be documented
meticulously
 Chain of custody refers to the stepwise method
used to collect, process, and test a specimen
 Documentation must be signed by every person
who has contact with the specimen, from
collection to the final reporting of results

48. Steps in Collecting Specimens and
Informing the Patient of the Results
1. The healthcare practitioner orders laboratory tests
2. Complete all the fields on the lab requisition form or
EHR transmission
3. Collect the specimen after receiving the provider’s
order, or instruct the patient on how to collect
specimen at home
4. Label the appropriate container
5. Process the specimen as you have been trained, or
prepare specimen for transport
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49. Steps in Collecting Specimens and
Informing the Patient of the Results (Cont.)
6. Properly dispose of specimens collected and tested
in the office in biohazard waste containers after tests
are completed
7. Reference laboratory test results are sent to the
patient’s EHR or provided in an electronic form
8. Confidentially notify the patient of test results
according to office policy
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50. Measuring Time
 Time of day often is a critical factor in patient
care
 Many facilities use military time, based on four
digits in terms of "hundred hours"
 Noon is 1200, midnight is 0000 or 2400
 Based on 60-minute hours

51. Greenwich and Military Time
51

52. Measuring Temperature
52

53. Units of Measurement
 Metric system and Système Internationale
(SI) are used in the laboratory
 Basic units for metric system are gram (g) for
weight, meter (m) for length, liter (L) for
volume
 Some common units for reporting analytes
are mg, µ, g, dL, and L
 SI system is an adaptation of metric system

54. Measuring Liquid Volume
 Test tubes come in many sizes and are typically
disposable
 Micropipettors are used to deliver very small amounts
of liquid
 Tips may be sterile
54

55. Pipette and Micropipettes
(Modified from Linne JJ, Ringsrud KM:
Clinical laboratory science: the basics and routine techniques, ed 5, St Louis, 2007, Mosby.)

56. Preparing Dilutions
 May be necessary to dilute a body fluid
sample with a diluent, such as water, saline
solution, or a buffer
 A statement of relative concentration and
represents expressions of concentration, not
expressions of volume
 Any volume of a dilution can be made as long
as relative amounts of components remain
the same

57. Microscope “Know the parts”
(Courtesy Cynmar, Carlinville, Illinois.)

58. Microscope Use and
Maintenance
 Microscopes have three components
 Magnification system
 Illumination system
 Framework
 Must be kept scrupulously clean at all times
 Should be placed in a permanent location in the
laboratory on a sturdy table in an area where it
cannot be bumped
58

59. Microscopy Tests
 Direct wet mount
 KOH preparation
 Fecal leukocyte examination
 Pinworm examinations

60. Microscopy Tests (Cont.)
60

61. Centrifuge
 Used when solids must be separated from
liquids
 Involves the application of increased
gravitational force achieved by rapid spinning
 Directions for using the centrifuge are usually
given in terms of revolutions per minute (rpm)
 Dangerous if used incorrectly

62. Centrifuge

63. Incubator
(Courtesy NuAire, Inc., Plymouth, Minnesota.)

64. CLINITEK

65. Autoclave
 Instrument that uses steam under pressure to
sterilize materials that can withstand high
temperatures
 QA methods be followed when an autoclave is
used

66. Patient Education
 For many testing procedures, patients must be
given a specific set of instructions to follow
 You may be responsible for explaining to the
patient measures to be taken before laboratory
testing
 Make sure you have interpreted the physician’s
orders correctly
 Patient should be given written instructions

67. Legal and Ethical Issues
 Use common sense and document everything
 Make sure the physician has reviewed and
signed the test results and has given
permission for the patient to be told the
results
 Maintain confidentiality when disclosing test
results