Assisting in the Clinical Laboratory Chapter 51 Copyright

Learning Objectives Define, spell, and pronounce the terms listed in the vocabulary. Apply critical thinking skills in performing patient assessment and care. Discuss the role of the clinical laboratory in patient care and the medical assistant’s role in coordinating laboratory tests and results. Describe the divisions of the clinical laboratory, and give an example of a test performed in each division. Describe the Clinical Laboratory Improvement Amendments (CLIA) and how they influence laboratory testing. Copyright © 2011, 2007, 2003, 1999 by Saunders, an imprint of Elsevier Inc. All rights reserved. 2

Learning Objectives Explain the three CLIA regulatory categories. Compare and contrast the agencies that govern or influence practice in the clinical laboratory, including the CDC, OSHA, EPA, CLSI, and CAP. Summarize techniques to minimize physical, chemical, and biological risks in the clinical laboratory. Describe the essential elements of a laboratory requisition. Display sensitivity to patient rights and feelings in collecting specimens. Copyright © 2011, 2007, 2003, 1999 by Saunders, an imprint of Elsevier Inc. All rights reserved. 3

Learning Objectives Explain the chain of custody, and illustrate why it is important. Compare and contrast quality assurance and quality control. Describe the differences between Greenwich time and military time. Identify the Fahrenheit temperature and Celsius temperature of common laboratory equipment. Name the metric units used for measuring liquid volume, distance, and mass. Copyright © 2011, 2007, 2003, 1999 by Saunders, an imprint of Elsevier Inc. All rights reserved. 4

Learning Objectives Describe the proper use of pipets. Explain how dilutions are prepared. Name the parts of a microscope, and describe their functions. Summarize selected microscopy tests that can be performed in the ambulatory care setting. Demonstrate the proper use of the microscope. Describe the safe use of a centrifuge. Copyright © 2011, 2007, 2003, 1999 by Saunders, an imprint of Elsevier Inc. All rights reserved. 5

The Role of the Clinical 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). Copyright © 2011, 2007, 2003, 1999 by Saunders, an imprint of Elsevier Inc. All rights reserved. 6

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 Copyright © 2011, 2007, 2003, 1999 by Saunders, an imprint of Elsevier Inc. All rights reserved. 7

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 pathological condition. Screening test (qualitative) – results are reported as positive or negative. Quantitative test – has units attached to numeric values; values are identified as the amount of analyte per given volume of specimen; the results must be reported with the appropriate units. Copyright © 2011, 2007, 2003, 1999 by Saunders, an imprint of Elsevier Inc. All rights reserved. 8

Critical Thinking Application The referral laboratory telephones to report the values on several tests performed on the urine of a client, Cecelia Roberts. Marsha jots down the following: Total protein, 0. 12; Occult blood, positive; Albumin, 50; Glucose, 120. What is wrong with the notations she has just made? Are these tests qualitative or quantitative? Copyright © 2011, 2007, 2003, 1999 by Saunders, an imprint of Elsevier Inc. All rights reserved. 9

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 Copyright © 2011, 2007, 2003, 1999 by Saunders, an imprint of Elsevier Inc. All rights reserved. 10

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 Ø Moderate-complexity tests Ø High-complexity tests Ø Copyright © 2011, 2007, 2003, 1999 by Saunders, an imprint of Elsevier Inc. All rights reserved. 11

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 Copyright © 2011, 2007, 2003, 1999 by Saunders, an imprint of Elsevier Inc. All rights reserved. 12

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 Ø Papanicolaou (Pap) smear analysis, blood typing and cross-matching, and cytology testing Copyright © 2011, 2007, 2003, 1999 by Saunders, an imprint of Elsevier Inc. All rights reserved. 13

Laboratory Requirements Subject to inspections every 2 years Maintain integrity and ID of patient specimens Quality-control and quality-assurance procedures Ø Proficiency tests – quality-control tests that must be performed three times/year Copyright © 2011, 2007, 2003, 1999 by Saunders, an imprint of Elsevier Inc. All rights reserved. 14

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. Copyright © 2011, 2007, 2003, 1999 by Saunders, an imprint of Elsevier Inc. All rights reserved. 15

Divisions of the Clinical Laboratory Hematology Chemistry Microbiology Specimen collection and processing Blood bank Coagulation Serology Histology Cytology Toxicology Urinalysis Special chemistry Copyright © 2011, 2007, 2003, 1999 by Saunders, an imprint of Elsevier Inc. All rights reserved. 16

Urinalysis Physical Ø Chemical Ø color, transparency, and specific gravity protein, ketones, blood, bilirubin, urobilinogen, nitrites, and p. H Microscopic Ø presence of red, white, and epithelial cells, mucus, casts, crystals, yeasts, parasites, and bacteria Copyright © 2011, 2007, 2003, 1999 by Saunders, an imprint of Elsevier Inc. All rights reserved. 17

Divisions Hematology Ø Chemistry Ø qualitative or quantitative blood, cerebrospinal fluid (CSF), urine, and joint fluid Microbiology Ø the study of bacteria, fungi, yeasts, parasites, and viruses Copyright © 2011, 2007, 2003, 1999 by Saunders, an imprint of Elsevier Inc. All rights reserved. 18

Critical Thinking Application Dr. Watkins has ordered a routine urinalysis (UA), a urine culture and sensitivity (C&S) test, a blood glucose test, and a complete blood count (CBC) for his patient. What division of the laboratory will be responsible for analyzing the specimens for each test? Copyright © 2011, 2007, 2003, 1999 by Saunders, an imprint of Elsevier Inc. All rights reserved. 19

Safety Standards and Governing Agencies U. S. Department of Labor’s Occupational Safety and Health Administration (OSHA) Ø 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) Copyright © 2011, 2007, 2003, 1999 by Saunders, an imprint of Elsevier Inc. All rights reserved. 20

Laboratory Hazards Physical hazards Ø Electrical, fire, and mechanical From Stepp CA, Woods MA: Laboratory procedures for medical office personnel, Philadelphia, 1998, Saunders. Be familiar with location of fire extinguishers and fire safety blankets. Ø 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. Ø Copyright © 2011, 2007, 2003, 1999 by Saunders, an imprint of Elsevier Inc. All rights reserved. 21

Chemical Hazards Chemicals: flammable, caustic, poisonous, carcinogenic, and/or teratogenic Ø Chemical hygiene plan mandated by OSHA Ø MSDS on ﬁle for all chemicals used in the laboratory Ø • contains the basic information about the speciﬁc chemical Exposure: Ø inhalation, direct absorption through the skin, ingestion, entry through a mucous membrane, or entry through a break in the skin Copyright © 2011, 2007, 2003, 1999 by Saunders, an imprint of Elsevier Inc. All rights reserved. 22

Material Safety Data Sheet (MSDS) From Bonewit-West K: Clinical procedures for medical assistants, ed, 6, Philadelphia, 2004, Saunders. Copyright © 2011, 2007, 2003, 1999 by Saunders, an imprint of Elsevier Inc. All rights reserved. 23

Material Safety Data Sheet (MSDS) From Bonewit-West K: Clinical procedures for medical assistants, ed, 6, Philadelphia, 2004, Saunders. Copyright © 2011, 2007, 2003, 1999 by Saunders, an imprint of Elsevier Inc. All rights reserved. 24

Material Safety Data Sheet (MSDS) From Bonewit-West K: Clinical procedures for medical assistants, ed, 6, Philadelphia, 2004, Saunders. Copyright © 2011, 2007, 2003, 1999 by Saunders, an imprint of Elsevier Inc. All rights reserved. 25

Chemical Safety Harmful exposure can be reduced by: Ø Ø Ø 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, flush the eyes with water from an eyewash station for a minimum of 15 minutes giving prompt medical attention to victims of chemical exposure Copyright © 2011, 2007, 2003, 1999 by Saunders, an imprint of Elsevier Inc. All rights reserved. 26

Biological Hazards and Infection Control May occur during specimen collection or while handling, transporting, or testing the specimen Occupational Exposure to Blood-borne Pathogens (Standard Precautions) Copyright © 2011, 2007, 2003, 1999 by Saunders, an imprint of Elsevier Inc. All rights reserved. 27

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 after exposure Copyright © 2011, 2007, 2003, 1999 by Saunders, an imprint of Elsevier Inc. All rights reserved. 28

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 Training in the proper use of protective equipment Maintenance of records to show compliance with the BBP Standard Copyright © 2011, 2007, 2003, 1999 by Saunders, an imprint of Elsevier Inc. All rights reserved. 29

Hand Washing Most effective way to prevent infection Hand washing should be performed: When you enter and before leaving the laboratory Ø Before and after every patient procedure Ø After contact with body fluid even if gloves were worn Ø Before and after eating Ø Before and after using the rest room Ø Copyright © 2011, 2007, 2003, 1999 by Saunders, an imprint of Elsevier Inc. All rights reserved. 30

Hand Washing Copyright © 2011, 2007, 2003, 1999 by Saunders, an imprint of Elsevier

Specimen Collection, Processing, and Storage: Laboratory 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. Copyright © 2011, 2007, 2003, 1999 by Saunders, an imprint of Elsevier Inc. All rights reserved. 32

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 Copyright © 2011, 2007, 2003, 1999 by Saunders, an imprint of Elsevier Inc. All rights reserved. 33

Laboratory Requisition Form Copyright © 2011, 2007, 2003, 1999 by Saunders, an imprint of

Specimen Collection MA should ensure proper collection of specimens. Always check the laboratory’s specimen requirements manual for any unfamiliar tests. Blood collection tubes – tubes are color-coded; the color of the stopper denotes which, if any, additive is present; collection in an incorrect tube will result in an unacceptable specimen. Check the referral laboratory’s specimen requirements manual for any unfamiliar tests. Copyright © 2011, 2007, 2003, 1999 by Saunders, an imprint of Elsevier Inc. All rights reserved. 35

Avoiding Contamination Check expiration dates on swabs, tubes, transport media, and other collection containers. Follow standard precautions. Avoid QNS samples. Copyright © 2011, 2007, 2003, 1999 by Saunders, an imprint of Elsevier Inc. All rights reserved. 36

Blood Collection Tubes Copyright © 2011, 2007, 2003, 1999 by Saunders, an imprint of

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. All specimens must be placed in the appropriate biohazard container with a laboratory requisition before sending to the referral laboratory. Laboratory specimen requirements should be consulted to ensure that each specimen is handled and processed properly. Copyright © 2011, 2007, 2003, 1999 by Saunders, an imprint of Elsevier Inc. All rights reserved. 38

Specimen Infection Control Handle and process all specimens as if they contain infectious material. Wipe the outside of specimen containers with a germicide. Dispose of all infectious materials according to state and federal guidelines. Clean up spills using a disinfectant (see Chapter 27). Immediately dispose of any chipped or broken glassware in a special disposable container. Copyright © 2011, 2007, 2003, 1999 by Saunders, an imprint of Elsevier Inc. All rights reserved. 39

Informing the Patient about Laboratory Results Laboratory tests ordered based on PE and/or diagnosis Complete laboratory requisition and collect specimen Label appropriate container Process specimen or prepare it for transport to reference laboratory Properly dispose of specimens collected and tested in the office Reference laboratory results filed in patient’s medical record after reviewed and signed by physician; test results done in office are recorded in the patient record Confidentially notify patient of test results according to office policy; document in patient record that test results were received Copyright © 2011, 2007, 2003, 1999 by Saunders, an imprint of Elsevier Inc. All rights reserved. 40

Chain of Custody Chain of custody refers to the stepwise method used to collect, process, and test a specimen. Specimen processing must be documented meticulously, ensuring that there was no tampering of evidence. Documentation must be signed by every person who has contact with the specimen, from collection to ﬁnal reporting of results. Copyright © 2011, 2007, 2003, 1999 by Saunders, an imprint of Elsevier Inc. All rights reserved. 41

Quality-Assurance Guidelines QA encompasses a comprehensive set of policies and procedures developed to ensure the reliability of laboratory testing. Ø includes quality control, personnel orientation, laboratory documentation, knowledge of laboratory instrumentation, and enrollment in a proficiency testing program Copyright © 2011, 2007, 2003, 1999 by Saunders, an imprint of Elsevier Inc. All rights reserved. 42

Quality-Control Guidelines Facilities must have a procedure manual describing the processes for testing and reporting patients’ results. Calibrate laboratory instruments and verify the calibrations at least every 6 months. Run two levels of control material each day of testing and document the results. Perform and document remedial action when errors or problems are identiﬁed. Preventive maintenance schedules must be documented and followed. Copyright © 2011, 2007, 2003, 1999 by Saunders, an imprint of Elsevier Inc. All rights reserved. 43

Critical Thinking Application As part of her daily routine, Marsha performs quality control on the laboratory’s glucometer before patient testing. The value of the control sample should be 160 mg/dl ± 3 mg/dl, according to the package insert. She performs the test, and the glucometer reads 140 mg/dl. She repeats the test three more times, obtaining values of 141, 140, and 139 mg/dl. Is the instrument accurate? Is the instrument reliable? Can she proceed with the day’s testing? If not, what should she do? Copyright © 2011, 2007, 2003, 1999 by Saunders, an imprint of Elsevier Inc. All rights reserved. 44

Critical Thinking Application Marsha is performing a blood urea nitrogen (BUN) test on a sample using an automated BUN analyzer. First she performed QC by using a test sample and made adjustments to the equipment as needed. Then she tested the patient’s sample and recorded the value. Explain why she ran the control sample and why the patient sample was the last to be tested. Copyright © 2011, 2007, 2003, 1999 by Saunders, an imprint of Elsevier Inc. All rights reserved. 45

Preventive Maintenance Program Follow manufacturer’s instructions for calibration of instruments. Read and understand instructions for routine instrument care. Perform all preventive maintenance provided by manufacturer’s instructions. Keep all spare parts available for immediate use. Record name, address, and phone number of a contact person for maintenance or repair. Create a maintenance form or use the one provided. Copyright © 2011, 2007, 2003, 1999 by Saunders, an imprint of Elsevier Inc. All rights reserved. 46

Laboratory Mathematics and Measurement Measuring time Ø Measuring temperature Ø Greenwich or military time Fahrenheit or Celsius Units of measurement Ø Metric system and International System of Units (SI) Copyright © 2011, 2007, 2003, 1999 by Saunders, an imprint of Elsevier Inc. All rights reserved. 47

Laboratory Glassware Redrawn from Linne JJ, Ringsrud KM: Clinical laboratory science: the basics and routine techniques, ed 5, St Louis, 2007, Mosby. Copyright © 2011, 2007, 2003, 1999 by Saunders, an imprint of Elsevier Inc. All rights reserved. 48

Manual Pipets Redrawn from Linne JJ, Ringsrud KM: Clinical laboratory science: the basics and routine techniques, ed 5, St Louis, 2007, Mosby. Copyright © 2011, 2007, 2003, 1999 by Saunders, an imprint of Elsevier Inc. All rights reserved. 49

Reading the Meniscus Redrawn from Linne JJ, Ringsrud KM: Clinical laboratory science: the basics and routine techniques, ed 5, St Louis, 2007, Mosby. Copyright © 2011, 2007, 2003, 1999 by Saunders, an imprint of Elsevier Inc. All rights reserved. 50

Critical Thinking Application Marsha is preparing a solution and is required to measure a 6 -ml volume of saline solution. She has a 10 -ml TD pipet. The pipetting device provided by the laboratory uses vacuum to draw up the liquid and forced air to expel it. Marsha knows that she should allow the pipet to drain with the force of gravity, yet she is required to use a pipetting device. How will she accurately deliver 6 ml? Copyright © 2011, 2007, 2003, 1999 by Saunders, an imprint of Elsevier Inc. All rights reserved. 51

Preparing Dilutions The term dilution refers to parts in total volume; it is a statement of relative concentration and represents expressions of concentration, not expressions of volume. Example, a 1: 10 dilution can be prepared by measuring 1 ml of sample and diluting it with diluent to 10 ml by adding 9 ml of diluent. Copyright © 2011, 2007, 2003, 1999 by Saunders, an imprint of Elsevier Inc. All rights reserved. 52

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 Ø to determine the total magniﬁcation of the specimen being observed, multiply the magniﬁcation of the objective lens by 10 Ø Used to evaluate stained blood smears, urine sediment, vaginal secretions, and smears made from body fluids or microbiological cultures. Refer to Procedure 50 -1 Copyright © 2011, 2007, 2003, 1999 by Saunders, an imprint of Elsevier Inc. All rights reserved. 53

Parts of Microscope Courtesy Cynmar, Carlinville, Ill. Copyright © 2011, 2007, 2003, 1999 by

Clinical Laboratory Equipment Centrifuge: used when separation of solids from liquids is necessary. Involves the application of increased gravitational force achieved by rapid spinning. The most important rule is to ensure that the centrifuge is balanced so that tubes of equal size and containing equal volume are directly across from one another in the rotor holders. Never open while operating; do not try to slow a centrifuge with your hands. Should be checked, cleaned, and lubricated regularly to ensure properation. Copyright © 2011, 2007, 2003, 1999 by Saunders, an imprint of Elsevier Inc. All rights reserved. 55

Centrifuge Copyright © 2011, 2007, 2003, 1999 by Saunders, an imprint of Elsevier Inc.

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. Copyright © 2011, 2007, 2003, 1999 by Saunders, an imprint of Elsevier Inc. All rights reserved. 57

Patient Education Provide the patient with written and verbal instruction. Answer all questions regarding patient preparation. Copyright © 2011, 2007, 2003, 1999 by Saunders, an imprint of Elsevier Inc. All rights reserved. 58

Legal and Ethical Issues A thorough understanding of government rules and regulations, including the CLIA, and the guidelines published by the CDC, the EPA, and OSHA helped Marsha to implement laboratory testing in the clinic, including urinalysis with a chemical reagent strip, hemoglobin and hematocrit testing, pregnancy testing, and hemoglobin A 1 c monitoring. Copyright © 2011, 2007, 2003, 1999 by Saunders, an imprint of Elsevier Inc. All rights reserved. 59