Assisting in the Clinical Laboratory

1. Assisting in the Clinical Laboratory Chapter 50

2. The Role of the Clinical Laboratory in Patient Care • Laboratory medicine or clinical pathology is the medical discipline that applies clinical laboratory science and technology to the care of patients. • The laboratory is the place in which a collected specimen is analyzed and evaluated. • Tests are performed manually (by hand) or through automation (by using specialized instruments).

3. Personnel in the Clinical Laboratory • Pathologist • Certified medical technologists (MTs) • Certified medical laboratory technicians (MLTs) or medical laboratory assistants (MLAs) • Certified medical assistants (CMAs) • Laboratory assistants • Phlebotomists

4. Clinical Laboratory Testing • Provides essential data needed for the diagnosis and management of a patient’s condition • Abnormal values for a particular test may be seen with more than one pathologic condition. • Screening test (qualitative) • Quantitative test

5. The Clinical Laboratory Improvement Amendments (CLIA) • Establish quality standards for all laboratory testing to ensure the accuracy, reliability, and timeliness of patient test results regardless of where the test was performed • Requires all laboratories to register and meet federal requirements

6. Food and Drug Administration (FDA) • Assigns commercially marketed in vitro diagnostic test systems to three different CLIA regulatory categories based on their potential risk to public health: • Waived tests • Moderate-complexity tests • High-complexity tests

7. Waived Tests • Employ methodologies that are so simple and accurate as to render the likelihood of erroneous results by the user negligible or • Are tests that the Secretary has determined pose no unreasonable risk of harm to the patient if performed incorrectly

8. Moderate- and High-Complexity Tests • Moderate-complexity: Hematology and chemistry testing, Gram staining, and microscopic analysis of urine sediment • High-complexity tests usually are not performed in a POL • Papanicolaou (Pap) smear analysis , blood typing and cross-matching, and cytology testing

9. Laboratory Requirements • Subject to inspections every 2 years • Maintain integrity and ID of patient specimens • Quality-control and quality-assurance procedures • Proficiency tests

10. Medical Assistant Role • The medical assistant may perform all CLIA-waived and some moderate- complexity tests. • The medical assistant may be involved in the collection of specimens for high-complexity testing.

11. Hematology Chemistry Microbiology Specimen collection and processing Blood bank Coagulation Serology Histology Cytology Toxicology Urinalysis Special chemistry Divisions of the Clinical Laboratory

12. Urinalysis • Physical • color, transparency, and specific gravity • Chemical • protein, ketones, blood, bilirubin, urobilinogen, nitrites, and pH • Microscopic • presence of red, white, and epithelial cells, mucus, casts, crystals, yeasts, parasites, and bacteria

13. Divisions • Hematology • qualitative or quantitative • Chemistry • blood, cerebrospinal fluid (CSF), urine, and joint fluid • Microbiology • the study of bacteria, fungi, yeasts, parasites, and viruses

14. Laboratory SafetySafety Standards and Governing Agencies • U.S. Department of Labor’s Occupational Safety and Health Administration (OSHA) • occupational exposure and blood-borne pathogens • Clinical and Laboratory Standards Institute (CLIS) • Centers for Disease Control and Prevention (CDC) • College of American Pathologists (CAP) • Environmental Protection Agency (EPA)

15. Laboratory Hazards • Physical hazards • Electrical, fire, and mechanical • Be familiar with location of fire extinguishers and fire safety blankets. • Emergency phone numbers should be posted on the wall near the telephone. Know the location of fire alarms, the fire escape routes, and procedures to follow if exits are blocked.

16. Chemical Hazards • Chemicals: • flammable, caustic, poisonous, carcinogenic, and/or teratogenic • Exposure: • inhalation, direct absorption through the skin, ingestion, entry through a mucous membrane, or entry through a break in the skin

17. Material Safety Data Sheet (MSDS)

18. Material Safety Data Sheet (MSDS)

19. Material Safety Data Sheet (MSDS)

20. Chemical Hazards • Harmful exposure can be reduced by: • using proper devices for pipetting • working under a fume hood that exhausts air to the outside • rinsing the affected area of skin under running water for at least 5 minutes • removing any clothing that is contaminated • if chemicals are splashed in the eyes, flushing the eyes with water from an eyewash station for a minimum of 15 minutes • giving prompt medical attention to victims of chemical exposure

21. Biologic Hazards and Infection Control • May occur during specimen collection or while handling, transporting, or testing the specimen • Occupational Exposure to Bloodborne Pathogens

22. CDC Recommendations • An infection control plan • Engineering and work practice controls • Personal protective clothing and equipment • Sufficient training and education • Hepatitis B vaccination • Medical intervention

23. Standard Precautions:Exposure Control Plan Requirements • Identification of tasks, procedures, and job classification where possible occupational exposure to blood may occur • Establishment of methods that protect employees and comply with OSHA regulations • Implementation of a vaccination program for hepatitis B virus • Provision of training in the proper use of protective equipment regarding blood-borne pathogens • Maintenance of records to show compliance with the BBP Standard

24. Hand Washing • Most effective way to prevent infection • Hand washing should be performed: • When you enter and before leaving the laboratory • 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 rest room

25. Hand Washing

26. Specimen Collection, Processing, and StorageLaboratory Requisitions and Reports • The medical assistant’s responsibility is to make sure that all reports are received for diagnostic tests performed on the patient outside the physician’s office. • Only after the physician reviews the test results should they be filed into the patient’s record.

27. Information Usually Required When Specimens Are Ordered • Physician’s name, account number, address, and phone number • Patient’s full name, surname first • Patient’s address • Insurance information • Age, date of birth, and gender • Source of specimen • Date and time of collection • Specific test (or tests) requested • Medications the patient is taking • Possible diagnosis • Indication of whether test is stat

28. Lab Requisition Form

29. Specimen Collection • MA should ensure proper collection of specimens. • Always check the laboratory’s specimen requirements manual for any unfamiliar tests.

30. Specimen Collection (cont’d)

31. Avoiding Contamination • Check expiration dates on swabs, tubes, transport media, and other collection containers. • Follow standard precautions. • Avoid QNS samples.

32. Proper Handling, Processing, and Storage • The specimen must be handled, processed, and stored according to the instructions to avoid causing any alterations that would affect test results. • Laboratory specimen requirements should be consulted to ensure that each specimen is handled and processed properly.

33. Chain of Custody • Chain of custody refers to the stepwise method used to collect, process, and test a specimen. • Documentation

34. Quality-Assurance Guidelines • QA encompasses a comprehensive set of policies and procedures developed to ensure the reliability of laboratory testing. • includes quality control, personnel orientation, laboratory documentation, knowledge of laboratory instrumentation, and enrollment in a proficiency testing program

35. Quality-Control Guidelines • Ensure accuracy and reliability • Use quality-control samples • Standardization • Accurate record keeping

36. Laboratory Mathematics and Measurement • Measuring time • Greenwich or military time • Measuring temperature • Fahrenheit or Celsius • Units of measurement • Metric system and International System of Units (SI)

37. Laboratory Glassware

38. Manual Pipets

39. Reading the Meniscus

40. Clinical Laboratory Equipment Microscope • Three components • the magnification system, the illumination system, and the framework, which includes all components responsible for positioning the slide and focusing • Refer to Procedure 50-1

41. Parts of Microscope

42. Clinical Laboratory Equipment • Centrifuge: used when separation of solids from liquids is necessary. Involves the application of increased gravitational force achieved by rapid spinning.

43. Clinical Laboratory Equipment • Incubators are cabinets that maintain constant temperatures. • The autoclave is an instrument that uses steam under pressure to sterilize materials that can withstand high temperatures. Used in the medical laboratory to sterilize specimens or objects before disposal.

44. Patient Education • Provide the patient with written and verbal instruction. • Answer all questions regarding patient preparation.