Transcript laboratory_CLIA

Clinical Laboratory
 Divided
into two main sections:
– Clinical Pathology
 Analysis
of body fluids and tissues
– Anatomical Pathology
 Concerned
with autopsies
 Cytological examinations from various
sources including surgical.
Patient Care
Clinical Laboratory
 Where
Located?
 Hospitals
 POL
 Clinics
 PH
departments
 HMOs
 Private Referral laboratories
Clinical Laboratory Director
 Pathologist
(physician specially
trained in the nature and cause of
disease.)
 Clinical Laboratory Scientist with a
doctorate degree.
Laboratory Staffing Trained
Professionals
 Certified
Medical Technologists (aka
CLS in state of California)
 Baccalaureate
degree
 Additional formal training
 National certification exam
 Continuing education with license renewal.
Laboratory Staffing
 Certified
Medical Laboratory
Technician (MLTs)
 Medical Laboratory Assistants (MLAs)
 Certified Medical Assistant (CMA)
 Laboratory Assistant Phlebotomist
Qualifications
MLTs; MLAs; CMAs and
phlebotomists
Qualifications
 1-2
year specialized training program
 Passed a registry examination
 CMA
 Refer
=CCBMA
to Table 51-1 Textbook
Conditions for Practice
Certified Medical Assistants
 With
the authorization of a licensed
physician or podiatrist who is
physically present in the facility: The
following activities may be
performed.
May Perform
 Perform
electrocardiograms (ECGs),
electroencephalograms (EEGs) and
plethysomography test (except fullbody).
 Collect specimens for testing, such
as urine, sputum, semen, and stool,
by noninvasive techniques.
 Assist patients in obtaining a
specimen for testing.
May Perform
 Provide
information and instructions
to the patient, as directed.
 Collect and record basic information
about present and previous tests.
 Perform simple laboratory and
screening tests, but without
interpreting testing results.
May Perform
 After
successful completion of
specified training, perform
venipuncture or skin puncture to
withdraw blood.
May Not Perform
 Perform
arterial punctures.
 Administer intravenous medications.
 Insert urinary catheters.
 Analyze test results
 Advise patients about their condition.
NOTE: Always check with your state
scope of practice regulations.
Patient Care
 MA
must know:
– Proper patient preparation
– Procedures for each test to be done
– Normal range of results of test
– Instructions for obtaining and labeling
specimens to be sent to the reference
lab.
– Maintain good communications among
patients, office staff and laboratory.
Laboratory Testing
 Essential
part of medical diagnosis
 Combined
exam.
 Physician’s
with health history; physical
use testing to determine
appropriate treatment.
 Help with medication decisions and
also to monitor medications.
Testing Process
 Only
health care practitioners can
request laboratory tests.
 MD
 PA
(Physician’s Assistant)
 CNP (Certified Nurse Practitioner)
 Laboratory
tests are ordered using a
Laboratory Requisition.
Requisition
Divisions of Clinical Laboratory
 Urinanalysis
 Hematology
 Chemistry
 Immuno-hematology
 Microbiology
/ Serology
Laboratory Testing
 Tests
can be simple:
 Screening
tests: Measures presence of a
substance that may indicate the presence of
disease state.
 Are not diagnostic for any particular disease
only that it may exist.
 Tests are usually “Qualitative”
Laboratory Testing
 Tests
can be quantitative
 Units
of measure are attached to numeric
values.
 Represents the amount of “analyte” per
given volume of “specimen”.
 Essential that the results be reported with
the units of measure.
 Example: RBC = 5.0 x 106/mm3
or HgB =15gm/dl
Patient Care Lab Testing
 Used
in conjunction with a thorough
health history.
 Physical Examination
 Healthy body is when equilibrium
exists in internal environment.
 State of equilibrium = homeostasis
Homeostasis
 Definition:
Internal adaptions and
change in response to environmental
factors, multiple functions that
attempt to keep the body’s function
in balance…….Staying the same.
 Physical and chemical characteristics
of body substances (fluids,
excretions and secretions) are within
a certain acceptable range…..Normal
Laboratory results
 Normal
or Reference
range……homeostasis
 Change in homeostasis = Abnormal
or outside reference range either
high or low.
 Panic value are results extremely too
high or too low. A level that
demands quick medical intervention
to reverse.
Laboratory Results
 Abnormal
test results may have
more than one pathological reason.
 Example:
Low HgB can be present in iron
deficiency anemia, hyperthyroidism or
cirrhosis of the liver.
 Conclusive
diagnosis cannot be
totally dependent on laboratory
testing.
Laboratory Regulations
 Clinical
Laboratory Improvement Act
 Congress
passed law in 1988
 Established quality standards for all
laboratory testing
 Purpose to ensure the accuracy, reliability
and timeliness of patient testing.
 Laboratory defined :any and all entities that
perform laboratory testing on specimens
derived from humans for the purpose of
providing information about the diagnosis,
prevention and treatment of disease or
impairment of or assessment of health.
CLIA
 User
funded: fees are levied
according to the testing done and the
number of tests performed by the
user per year.
 All facilities that perform even 1 test
even waived tests must meet certain
federal requirements and must
register as a laboratory.
CLIA
 CLIA
categorization of commercially
marketed “in-vitro” (outside of
human body) diagnostic tests is the
responsibility of the Food and Drug
Administration (FDA).
 Three CLIA categories exist based
on their potential risk to public
health.
CLIA Categories
 Waived
Tests:
 Procedures
approved by FDA for home use.
 Simple laboratory procedures that have an
insignificant risk of an erroneous result.
– Including those that are so simple and accurate
that erroneous results are virtually not possible.
– Proposes no risk or harm to patient if performed
incorrectly.
CLIA Categories
 Moderate
–High Complexity Tests
Must meet CLIA regulations and be subject
to unannounced inspections every 2 years.
 Establish a system to maintain the integrity
and identification of patient specimens
throughout the testing process. (barcoding)
 Ensure accurate reporting of test results.
 Must have written Quality Control and
Quality Assurance procedures.
 Participate in “Proficiency Testing” at least
3xs a year.

Proficiency Testing
A
form of External Quality Control.
 Laboratory tests samples provided
by an approved proficiency testing
agency using the same tests that the
laboratory would use for testing
patient samples.
Moderate-High Complexity
 CLIA
regulations specify
qualifications and responsibilities of
personnel performing moderate and
high complexity testing from director
to testing personnel.
 Regulations are most stringent
(strict) for High Complexity testing.
Testing Role of Medical
Assistants
 May
perform all CLIA waived testing
 May perform some moderate
complexity testing dependent on the
certification of the laboratory or POL.
 Cannot perform High Complexity
testing.
 Responsible
for collecting specimens for
high complexity
 Preparing patient for testing
 Recording results on medical record.
Anatomic Pathology Laboratory
 Forensic
Pathology (CSI)
 Autopsy (Coroner)
 Cytology
 Histology
 DNA Probe analysis (Chromosome
Analysis)
The END
 Questions?????