1. 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.

2. Patient Care Clinical Laboratory
Where Located?
Hospitals
POL
Clinics
PH departments
HMOs
Private Referral laboratories

3. Clinical Laboratory Director
Pathologist (physician specially trained in the nature and cause of disease.)
Clinical Laboratory Scientist with a doctorate degree.

4. 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.

5. Laboratory Staffing Certified Medical Laboratory Technician (MLTs)
Medical Laboratory Assistants (MLAs)
Certified Medical Assistant (CMA)
Laboratory Assistant Phlebotomist

6. MLTs; MLAs; CMAs and phlebotomists
Qualifications
MLTs; MLAs; CMAs and phlebotomists

7. Qualifications 1-2 year specialized training program
Passed a registry examination
CMA =CCBMA
Refer to Table 51-1 Textbook

8. 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.

9. May Perform
Perform electrocardiograms (ECGs), electroencephalograms (EEGs) and plethysomography test (except full-body).
Collect specimens for testing, such as urine, sputum, semen, and stool, by noninvasive techniques.
Assist patients in obtaining a specimen for testing.

10. 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.

11. May Perform
After successful completion of specified training, perform venipuncture or skin puncture to withdraw blood.
Plethysomography
The use of a plethysmograph to record changes in volume of an organ or extremity.

12. 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.

13. 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.

14. Laboratory Testing Essential part of medical diagnosis
Combined with health history; physical exam.
Physician’s use testing to determine appropriate treatment.
Help with medication decisions and also to monitor medications.

15. 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.

16. Requisition

17. Divisions of Clinical Laboratory
Urinanalysis
Hematology
Chemistry
Immuno-hematology / Serology
Microbiology

18. 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”
Qualitative tests have no numeric value as their results….They are either positive or negative. An example of a qualitative test. Guaic test for occult blood in a stool specimen

19. 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/mm or HgB =15gm/dl

20. 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

21. 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

22. 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.

23. 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.

24. 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.

25. 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.

26. 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.

27. 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.

28. 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.

29. 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.

30. 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.

31. 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.

32. Anatomic Pathology Laboratory
Forensic Pathology (CSI)
Autopsy (Coroner)
Cytology
Histology
DNA Probe analysis (Chromosome Analysis)

33. The END
Questions?????