Lesson 1, Topic 1
In Progress

Closing Comments

April 11, 2024

Patient Coaching
Microorganisms such as bacteria, viruses, fungi, and parasites are responsible for most human infectious diseases. Patient education plays an important role in helping the patient and family control the spread of infection. The teaching topics in the following list can help you educate a patient about infection control:
            • An explanation of the patient’s type of infection: bacterial, viral, fungal, or parasitic
            • How infections spread
            • Hand washing and sanitization, proper storage and cleaning of personal items, and disposal of contaminated supplies
            • Risk factors for infection, such as poor nutritional habits or poor ventilation with airborne pathogens present
            • The patient’s role in specimen collection
            • Patient preparation for laboratory tests, imaging tests, and other needed procedures
Explain to the patient that an infection can be transferred from person to person in many ways. Reinforce the importance of following directions for taking any medication. If patients do not follow the directions given to them by the provider or pharmacist, there is a real chance of the following:
            • Developing complications
            • Having a relapse of an infection
            • Allowing an infection to spread to other areas or becoming systemic
Always listen to the patient. Be sure to answer all the patient’s questions. Notify the provider of patient’s concerns so that he or she can give further details or instructions before the patient leaves the facility.

Legal and Ethical Issues
Maintaining a laboratory in the office increases the physician’s liability. By testing patients’ specimens in the office, the physician assumes responsibility for the interpretation and accuracy of the results. As the person in the office who runs the tests and notes the results in the patient’s record, you are responsible for maintaining optimum accuracy in testing results. A quality assurance (QA) program, including the running, interpreting, and recording of the internal controls supplied in each test kit, must be documented. Both microbiology and immunology tests allow the patient to benefit from the convenience of office testing. Strict confidentiality is essential. Never release information to anyone other than the patient or legal guardian.
      Also note that certain infectious diseases must be reported to the CDC or local board of health. Each state legislature determines what diseases must be reported and how the data are to be reported. Additional data for nationally notifiable diseases is published weekly by the CDC in the Morbidity and Mortality Weekly Report (MMWR). For additional information on infectious disease reporting, please review the reporting procedure presented in Chapter 4.

Patient-Centered Care
Hand hygiene should be foremost in your mind with each patient encounter. Making sure that you wash hands or use hand sanitizer as you enter and leave an exam room should be part of your routine. Sanitizing hands before and after gloving is also a must. But also, remembering to sanitize hands when the patient is not in front of you is just as important. Anytime you handle specimens, containers, enter and leave a laboratory area, or put away laboratory supplies and equipment, you should also follow up with proper hand hygiene. The CDC states that the most effective means of stopping the transmission of disease is frequent and proper handwashing.

Professional Behaviors
Medicine is an ever-changing profession, and medical assistants need to remain current in all areas of their profession. The laboratory is no exception. Microbiology and immunology are areas of the laboratory where research, technical skills, and testing methods are changing rapidly. Making an effort to stay up to date with new ideas and concepts is critical to contributing to exceptional patient care.

Summary of Scenario

Laura has had another busy day at WMFM Clinic. Once again, she has seen infectious diseases in some of her patients today. Laura knows that most microorganisms are harmless, but knowing the signs and symptoms of common infectious diseases is important.
      It is also important to diagnose and treat most infectious diseases. Laura knows that proper specimen collection is essential. She is also aware that rapid CLIA-waived tests can identify pathogens and help treat patients in a timely manner.
      Microbiology and immunology tests have become useful in the physician office laboratory. Meeting the needs of patients and quickly addressing their concerns are benefits of CLIA-waived testing. Laura feels comfortable collecting specimens, testing patient samples, and reporting the results for the provider to review. As a certified medical assistant, she knows that the work she does throughout the day is helping every one of her patients.

Summary of Learning Objectives

1. Examine how microorganisms are identified.

The naming of all living organisms uses a binomial system consisting of two names; the first “family” name is the genus, and the second is the species. Both names are either italicized or underlined when written. The genus begins with a capital letter, and the species with a lowercase letter. Often the name reveals some characteristic about the organism.

2. Examine the characteristics of bacteria.

Bacteria often are classified according to their staining characteristics, shape, and the environmental conditions in which they thrive. Their staining characteristics are gram-positive (dark blue), gram negative (pink), and acid-fast (pink).

Identification of bacteria begins with an observation of their morphology. Cocci are spherical organisms, bacilli are rod-shaped organisms, and spirilla are spiral-shaped organisms. Staphylococci are cocci in clusters, streptococci and streptobacilli are organisms arranged in chains, and diplococci and diplobacilli are organisms arranged in pairs.

Organisms are classified by oxygen requirements as aerobic (needs oxygen to survive), anaerobic (lives without oxygen), or facultative (anaerobic but able to survive in the presence of oxygen). TABLE 35.1 can help explain the characteristics of common diseases caused by bacteria.

3. Differentiate among various pathogens.

Three are several types of pathogens, including unusual pathogenic bacteria, fungi, protozoa, parasites, helminths, and viruses. Chlamydia and Rickettsia organisms are tiny bacteria; however, unlike most bacteria, they require a host cell for replication. Mycoplasmas do not contain peptidoglycan in their cell wall.

Fungi are eukaryotes that are larger than bacteria, have a nucleus, and include yeasts and molds. Fungi are present in the soil, air, and water, but only a few species cause disease.

Protozoa are single-celled parasitic organisms that contain a nucleus and range in size. They are present in moist environments and in bodies of water. Parasites are transmitted by ingestion, direct penetration of the skin, and injection by an arthropod also referred to as a vector. Helminths are parasites called worms that live on or in animals or humans.

Viruses are not able to metabolize or reproduce unless they are inside of a host cell. Because of the absolute need for a host cell, a virus can be considered an obligate intracellular pathogen.

4. Examine the procedures for specimen collection and transport in the physician office laboratory.

Specimens must be collected carefully so that contaminating microorganisms are not introduced into the specimen. This means not only using sterile collection and transport devices, but also taking steps to prevent contamination. Specialized transport media are often included with specimen collection swabs or devices.

Stool specimens are commonly examined for parasitic protozoa and helminths. The specimen is collected and placed into two vials, each with a preservative (see Procedure 35.1). With pinworms, specimens are best collected late at night or early in the morning for children. Paraffin swabs impregnated with petroleum jelly or cellulose tape may be used to collect the eggs deposited by the adult worm during the night.

Nasal and nasopharyngeal specimens are obtained for several respiratory tests. Three types of specimens can be collected: anterior nasal specimen, mid-turbinate nasal specimen, and nasopharyngeal (NP) specimen (see Procedure 35.2). The swab should be gently rolled and then left in place for several seconds to allow it to absorb secretions. A specimen is obtained from both nostrils unless the swab is saturated with secretions from the first nostril.

Many times, sputum specimens are collected in the morning. For some tests, three sputum samples may be collected over 3 days. When collecting a sputum specimen, patients should avoid food for 1 to 2 hours and rinse their mouth. After coughing deeply, the sputum should be deposited into the cup.

A throat swab specimen collection is used to identify the cause of throat infections, such as strep throat. Procedure 35.3 describes the collection process. Patients should not use antiseptic mouthwash prior to the collection.

5. Examine CLIA-waived microbiology testing.

Often, growing a pathogen on a culture plate is difficult, and it takes time to grow and isolate the pathogen. A rapid “direct” immunology test demonstrates the presence of the pathogen’s antigen in a specimen that is placed in a test kit containing its specific antibody. If the pathogen is present, it produces a colored reaction, indicating a positive result. The rapid strep test detects S. pyogenes and is used in the diagnosis of strep throat (see Procedure 35.4). The influenza A and B rapid test detects surface antigens of the viruses that cause influenza. The RSV rapid test detects antigens from the respiratory syncytial virus, which causes pneumonia and bronchiolitis in young children.

6. Examine CLIA-waived immunology testing.

“Indirect” immunology testing detects antibodies in whole blood, serum, or plasma that react to the specific antigen in the test kit, producing a colored reaction. A positive reaction indicates that the antibodies have been produced and attack the pathogen in question (e.g., heterophile antibodies seen in mononucleosis).

Mononucleosis testing detects the heterophile antibodies made in reaction to an infection of the Epstein-Barr virus (see Procedure 35.5). The H. pylori test detects antibodies to the bacterium that commonly causes stomach ulcers. Early detection of Lyme disease can be accomplished using a CLIA-waived test that detects the antibodies that attack the B. burgdorferi pathogen. Rapid HIV testing detects the HIV antibodies made in reaction to an HIV infection that could develop into AIDS.

7. Examine the reference laboratory process for the identification of pathogens.

After receiving the specimens collected in the POL, the microbiology laboratory promptly inoculates the appropriate culture media first and then prepares a smear of the specimen on a slide to be stained. Pathogenic microorganisms generally are colorless, and special stains are used to differentiate bacteria based on cell membrane differences. Gram-positive bacteria stain purple, and gram-negative bacteria stain pink or red. The acid-fast stain is used in the identification protocol for Mycobacterium species. Acid-fast positive microbes stain fuchsia red. Acid-fast negative microbes stain baby blue.

Next, the specimen must be spread on specific culture media based on the source of the specimen. The inoculated culture media are placed in a body temperature incubator to grow overnight. The next day, each bacterium becomes a visible colony. Colonies can then be counted and analyzed to determine the cause of an infection.

Once a bacterial infection has been identified, additional steps are required for successful treatment. To determine the appropriate antibiotic to destroy the pathogen, the provider will order a culture and sensitivity (C&S) test. Culture refers to growing the organisms, and sensitivity refers to the organism’s susceptibility to antibiotics.

8. Examine stool-based tests.

There are two main types of stool tests:

Fecal occult blood test (FOBT): Detects blood in the stool specimen. There are two main types of FOBT:

            • Guaiac fecal occult blood test (gFOBT): A stool test that looks for the presence of occult blood.

            • Fecal immunochemical test (FIT): Also called the immunochemical fecal occult blood test (iFOBT). FIT is a screening test for colon cancer. It only detects human hemoglobin from the large intestine. InSure ONE is a FIT that detects human hemoglobin in samples of toilet bowel water collected around the feces.

Stool DNA test: Detects genetic material from polyps and cancerous tumors in the stool specimen. The multitargeted stool DNA test (MT-sDNA) detects abnormal DNA, along with the presence of occult hemoglobin in the stool. An example of a multitargeted stool DNA test (MT-sDNA) is the Cologuard, which tests stool for cancer and precancerous cells.

 

Procedure 35.1 Coach a Patient on the Collection of Fecal Specimens to Be Tested for Ova and Parasites
TASK
Coach a patient in the proper collection of stool for an ova and parasite microscopic examination.
Equipment and Supplies
            • Patient’s health record
            • Provider’s order or lab requisition
            • Clean, dry container for stool collection
            • Two parasitology collection vials∗
            • Plastic biohazard zipper-lock bag
Procedural Steps
1. Greet the patient. Identify yourself. Verify the patient’s identity with full name, then ask the patient to spell the first and last names and to state their date of birth.

2. Explain the procedure in a manner that the patient understands. Answer any general questions the patient may have about the collection procedures before you give detailed instructions.

3. Instruct the patient not to take any antacids, laxatives, or stool softeners before collecting the specimen. Instruct the patient that the liquid in the vials is extremely dangerous and to keep out of the reach of children.

PURPOSE: Laxatives increase fecal transit time and may result in a false-negative test result.

4. Instruct the patient to urinate before collecting the specimen.

PURPOSE: This eliminates the possibility of the stool becoming contaminated with urine.

5. The patient then collects the specimen.

            • Adults: Instruct the patient to defecate into the container. Stool cannot be retrieved from the toilet bowl.
            • Children: Loosely drape the toilet rim with plastic wrap and lower the seat. The child should have a bowel movement into the toilet, onto the wrap. Remove the stool using a disposable plastic spoon.
                      PURPOSE: The stool cannot be contaminated by or diluted with water.

            • Infants: Fasten a “diaper” made of plastic wrap over the child, using tape. Remove the plastic wrap immediately after a bowel movement, and remove the stool using a plastic spoon. Never leave the child unattended with the plastic wrap in place because of the risk of suffocation.
            PURPOSE: Stool cannot be collected in a diaper.

6. Instruct the patient or parent/guardian to add stool to the collection containers.

            • If the stool is formed, use the scoop on the lid of the containers to add a large, jellybean–sized piece of stool to the liquid in the containers (Figure 1).
            • If the stool is liquid, pour it into the containers.
            • In both of the previous cases, keep adding the specimen until the liquid preservative in the vial reaches the indicated level on the containers.
PURPOSE: Proper instructions will give patients confidence in what they need to do to ensure a proper specimen. (Image courtesy Meridian Bioscience.)

7. Instruct the patient or parent/guardian to tighten the caps completely and wipe the outside of the vials with rubbing alcohol or to wash carefully with soap and water.

PURPOSE: These actions ensure infection control.

8. Instruct the patient or parent/guardian that the vials should be labeled, placed in a biohazard bag with a zippered closure, and transported to the laboratory immediately, if possible. The vials should not be refrigerated.

9. Instruct patients or parents/guardians to wash their hands after the specimen collection procedure.

PURPOSE: It is important to ensure infection control.

10. Document the coaching in the patient’s health record. Include the provider’s name, what was taught, how the patient responded, and indicate the supplies and written directions sent home with the patient.

PURPOSE: It is important to document the procedure in the health record to show it was done. Documentation Example08/14/20XX 1105 Per Dr. Kahn’s order, instructed patient how to collect the ova and parasite specimen. The patient taught back the instructions accurately. Gave the patient the stool container, the O&P vials, and a biohazard bag. The patient will return the vials to the clinic later this week. ______________________________ Laura Piper, CMA (AAMA)

∗  Please note that several types of preservatives are available. Check with the referral laboratory to make sure the patient is given the proper vials for collection. Preservatives include low-viscosity polyvinyl alcohol (LV-PVA), zinc sulfite polyvinyl alcohol (ZN-PVA), sodium acetate acetic acid formalin (SAF), and 10% neutral buffered formalin.

Procedure 35.2  Collect a Nasal or Nasopharyngeal Specimen Using a Swab
TASKS
Collect an anterior nasal specimen, a mid-turbinate nasal specimen, or a nasopharyngeal specimen using a swab. Document the procedure in the patient’s health record.
Equipment and Supplies
            • Patient’s health record
            • Provider’s order or laboratory requisition
            • Fluid-impermeable lab coat, mask, face shield, and gloves (or as indicated by healthcare facility)
            • Collection kit or appropriate swab for test (e.g., sterile flocked or spun polyester tipped swab with a flexible shaft) and transport media tube
            • Biohazard waste container

Procedural Steps
1. Wash hands or use hand sanitizer. Put on the fluid-impermeable lab coat, mask, and face shield. Comply with safety practices.

PURPOSE: To ensure infection control.

2. Review the order and gather the supplies needed.

3. Greet the patient. Identify yourself. Verify the patient’s identity with full name, then ask the patient to spell the first and last names and to state their date of birth.

PURPOSE: It is important to identify the patient in two different ways to ensure that you have the correct patient.

4. Explain the procedure in a manner that the patient understands. Answer any general questions the patient may have about the collection procedures before you give detailed instructions.

PURPOSE: Explaining the procedure can make the patient feel more comfortable and reduce anxiety.

5. Obtain permission to perform the swab on the patient. Ask the patient if he or she has any nasal obstructions or a deviated septum. Have the patient blow his or her nose, if indicated.

PURPOSE: If the patient has a nasal obstruction or a deviated septum, the opposite nostril should be used for the procedure.

6. Put on gloves.

7. Remove the sterile swab from the sterile wrap with your dominant hand.

8. Collect the specimen:

      a. For an anterior nasal swab:

            • Using the appropriate swab, insert the tip of the swab into the nostril, no more than 0.75 inches (1.9 cm).
            • Slowly rotate the swab, gently pressing it against the nasal wall. Rotate four times for a total of 15 seconds. Remove the swab and insert it into the other nostril. Repeat the process.
PURPOSE: Allows for the swab to absorb the secretions.

      b. For a mid-turbinate nasal specimen:

            • Have the patient tilt her or his head back 70 degrees.
PURPOSE: Tilting the head helps the medical assistant position the swab in the correct location.

            • Using a tapered swab, rotate the swab while inserting it. Insert it less than 1 inch (2.5 cm) into the nostril along the nasal floor until resistance is met at the nasal turbinate (Figure 1). Rotate the swab for about 10 to 15 seconds. Hold in place for 5 seconds. Remove swab. Repeat the process on the other nostril.
c. For a nasopharyngeal specimen:

            • Have the patient tilt her or his head back 70 degrees.
PURPOSE: Tilting the head helps the medical assistant position the swab in the correct location.

            • Using the unobstructed nostril, insert the swab parallel to the palate until resistance is encountered (Figure 2). A swab should be inserted about 3.1 to 3.9 inches (8 to 10 cm) in an adult and 2.4 to 2.8 inches (6 to 7 cm) in a child.
PURPOSE: The swab needs to be inserted far enough back to be in the correct position.

            • Roll the swab gently, and then leave the swab in place for several sections. Rotate the swab as it is slowly removed. If the swab is not saturated with secretions, repeat the process using the other nostril if indicated by the testing procedure. The same swab can be used.
PURPOSE: Leaving the swab in place allows it to absorb the nasopharyngeal secretions.

9. Place the swab in the transport medium. Snap or cut off the applicator stick if needed. Label the tube and send it to the laboratory.

PURPOSE: A transport medium prevents the swab from drying. Labeling immediately after collection prevents specimens from getting mixed up.

10. Dispose of contaminated supplies in the biohazard waste container. Disinfect the work area.

PURPOSE: To prevent the spread of infection.

11. Remove your gloves and discard them in the biohazard waste container. Remove the face shield.

12. Wash hands or use hand sanitizer.

PURPOSE: To ensure infection control.

13. Document the procedure in the patient’s health record.

PURPOSE: Procedures are not done until they are recorded.

Documentation Example
8/14/20XX 8:55 a.m. Nasopharyngeal specimen collected via swab. Sent to University Laboratories for strep testing. __________ ______________________________ Laura Piper, CMA (AAMA)

Procedure 35.3  Collect a Specimen for a Throat Culture
TASKS:
Collect a throat culture, using sterile technique, for immediate testing or for transportation to the laboratory. Document the procedure in the patient’s health record.
Equipment and Supplies
            • Patient’s health record
            • Provider’s order or laboratory requisition
            • Fluid-impermeable lab coat, mask, face shield or protective eyewear, and gloves (or as indicated by healthcare facility)
            • Sterile swab if transporting to a reference lab for culture, or sterile swab from the rapid strep test kit if testing patient in the POL
            • Sterile tongue depressor
            • Transport medium
            • Biohazard waste container


Procedural Steps
1. Wash hands or use hand sanitizer. Put on the fluid-impermeable lab coat and face shield. Put on a mask if required by the facility. Comply with safety practices.

PURPOSE: To ensure infection control.

2. Review the order and gather the supplies needed.

3. Greet the patient. Identify yourself. Verify the patient’s identity with full name, then ask the patient to spell the first and last names and to state their date of birth.

PURPOSE: It is important to identify the patient in two different ways to ensure that you have the correct patient.

4. Explain the procedure in a manner that the patient understands. Answer any general questions the patient may have about the collection procedures before you give detailed instructions.

PURPOSE: Explaining the procedure can make the patient feel more comfortable and reduces anxiety.

5. Obtain permission to perform the throat culture on the patient.

6. Put on gloves. Position the patient so that the light shines into the mouth.

PURPOSE: To ensure infection control and to illuminate the area to be swabbed.

7. Remove the sterile swab from the sterile wrap with your dominant hand, and grasp the sterile tongue depressor with your nondominant hand.

PURPOSE: These actions allow better control of the swabbing process.

8. Instruct the patient to open the mouth and say, “Ah.” Depress the tongue with the depressor.

PURPOSE: Saying “Ah” helps elevate the uvula and reduces the tendency to gag. The tongue is depressed so that you can see the back of the throat and prevent contamination of the sterile swab.

9. Swab the back of the throat between the tonsillar pillars in a figure-8 pattern, especially any reddened, patchy areas of the throat, white pus pockets, purulent areas, and the tonsils; take care not to touch any other areas in the mouth (Figure 1).

PURPOSE: Pathogenic organisms are found in the back of the throat and on the tonsils.

10. Place the swab in the transport medium, label it, and follow appropriate procedures to send it to the referral laboratory (Figure 2). If rapid strep testing is requested, it may be done in the POL or sent to a reference laboratory.

PURPOSE: A transport medium prevents the swab from drying out. Labeling immediately after collection prevents specimen misidentification.

11. Dispose of contaminated supplies in the biohazard waste container. Disinfect the work area.

PURPOSE: Disposing of contaminated supplies prevents the spread of infection.

12. Remove your gloves and discard them in the biohazard waste container. Remove the face shield.

13. Wash hands or use hand sanitizer.

PURPOSE: Hand sanitization is an important step for infection control.

14. Document the procedure in the patient’s health record.

PURPOSE: Procedures are not complete until they are recorded.

Documentation Example
8/14/20 8:35 a.m. Throat specimen collected via swab from the tonsillar area. Sent to University Laboratories for strep testing. ______________________________ Laura Piper, CMA (AAMA)


Procedure 35.4  Perform a CLIA-Waived Microbiology Test: Perform a Rapid Strep Test
TASKS
Perform a rapid strep screening test to assist in the diagnosis of strep throat. Document the results in the patient’s health record.
Equipment and Supplies
            • Patient’s health record
            • Provider’s order or lab requisition
            • QuickVue In-Line Strep A test kit contents (Figure 1):
            • Extraction solution bottles
            • Individually packaged test cassettes
            • Individually wrapped sterile rayon swabs provided in the kit
            • Positive (+) control swab provided in kit
            • Visual flowchart outlining the steps of the test
            • Rapid Strep Test Log Sheet
            • Stopwatch or laboratory timer
            • Fluid-impermeable lab coat, mask, face shield or protective eyewear, and gloves (or as indicated by healthcare facility)
            • Biohazard waste container

Procedural Steps
1. Wash hands or use hand sanitizer. Put on the fluid-impermeable lab coat and face shield or protective eyewear. Put on a mask if required by the facility. Comply with safety practices.

PURPOSE: To ensure infection control.

2. Collect all necessary supplies and equipment. Bring all reagents to room temperature. Check the expiration date on the test kit package.

Note: Before running the first patient test from a new test kit, positive and negative controls must be run using the control swabs provided in the kit. Confirm that both controls reacted correctly and record the control results on the log sheet.

PURPOSE: Both control swabs must be checked before patients are tested. If the controls show the appropriate results, the test kit is reliable.

3. Greet the patient. Identify yourself. Verify the patient’s identity with full name, then ask the patient to spell the first and last names and to state their date of birth.

PURPOSE: It is important to identify the patient in two different ways to ensure that you have the correct patient.

4. Explain the procedure in a manner that the patient understands. Answer any general questions the patient may have about the collection procedures before you give detailed instructions. Obtain permission to collect a throat culture.

PURPOSE: Explaining the procedure can make the patient feel more comfortable and reduces anxiety.

5. Put on gloves. Collect a throat specimen using the rayon swab provided in the test kit.

PURPOSE: The test kit provides a rayon swab to avoid the use of cotton swabs, which can kill bacteria, possibly causing a false-negative result.

6. Remove the test cassette from the foil pouch, and place it on a clean, dry, level surface. Using the notch at the back of the chamber as a guide, insert the patient’s swab completely into the swab chamber (Figure 2).

 

7. Place the extraction bottle between your thumb and forefinger, and squeeze once to break the glass ampule inside the extraction solution bottle. Vigorously shake the bottle five times to mix the solutions. The solution should turn green.

PURPOSE: The color change is an indicator of extraction reagent integrity and that the extraction procedure was performed correctly.

8. Immediately remove the cap on the extraction solution bottle, hold the bottle vertically over the chamber, and quickly fill the chamber to the rim (approximately 8 drops).

PURPOSE: The liquid extract reacts with the swab and then flows into the test cassette, passing through the test area (T) and then through the internal control area (C).

9. Remove your face shield. Wait 5 minutes to read the results and record them in the lab log.

            • Positive result: A pink line shows in the T area, indicating the presence of Streptococcus pyogenes antigen; a blue line appears in the C area, indicating that the fluid activated the internal control.
            • Negative result: No pink line appears in the T-test area; a blue line appears in the C control area, indicating that the internal control worked.
            • Invalid result: The blue control line does not appear next to the letter C at 5 minutes. The test result cannot be reported.
10. Discard all the test materials in the appropriate biohazard waste container. Disinfect the work area.

PURPOSE: Items that come in contact with samples are considered potentially infectious.

11. Remove your gloves. Wash hands or use hand sanitizer.

PURPOSE: To ensure infection control.

12. Record the test results in the patient’s health record.

PURPOSE: A procedure is not considered complete until it has been properly documented.

13. If the test results are negative, a second throat swab should be obtained and sent to the reference laboratory for a throat culture. Often two swabs are used simultaneously when the sample is initially collected from the throat to prevent the need to re-collect a specimen.

PURPOSE: Negative rapid strep test results should be confirmed with a throat culture.

 

Procedure 35.5  Perform a CLIA-Waived Immunology Test: Perform the QuickVue+ Infectious Mononucleosis Test
TASKS:
Perform a capillary puncture. Perform and interpret a rapid CLIA-waived test for infectious mononucleosis. Document the results in the patient’s health record.
Equipment and Supplies
            • Patient’s health record
            • Provider’s order or lab requisition
            • CLIA-waived QuickVue+ test kit for infectious mononucleosis and blood collecting supplies (Figure 1):
                      • Package with test kit supplies
                      • Color-coded bottles of positive and negative controls and the developer
                      • Test cassette in foil-wrapped protective pouch
                      • Pipets supplied in kit with black line indicating amount of capillary blood to collect
            • Alcohol prep pad, gauze, and bandage
            • Lancet
            • Laboratory timer, stopwatch, or wristwatch with sweep second hand
            • Fluid-impermeable lab coat, eye protection, and gloves
            • Biohazard waste container
            • Qualitative Control/Patient Log Sheet

Procedural Steps
1. Wash hands or use hand sanitizer. Put on the fluid-impermeable lab coat. Comply with safety practices.

PURPOSE: To ensure infection control.

2. Remove the test kit from the refrigerator and allow the reagents to warm to room temperature. Check the expiration date of the kit.

PURPOSE: Outdated or cold reagents do not react as expected.

3. Before running the first patient test from a new test kit, run the positive and negative liquid controls provided in the kit to see whether they react correctly. Record your control results on the log sheet.

PURPOSE: Both control swabs must be checked before patients are tested. If the controls show the appropriate results, the test kit is reliable.

4. Greet the patient. Identify yourself. Verify the patient’s identity with full name, then ask the patient to spell the first and last names and to state their date of birth.

5. Explain the procedure in a manner that the patient understands. Answer any general questions the patient may have about the collection procedures before you give detailed instructions. Obtain permission for the capillary puncture.

6. Put on gloves and protective eyewear.

PURPOSE: To ensure infection control and safety.

7. Remove the test device from its protective pouch, and label it with the patient’s identification.

PURPOSE: Label the test kit to ensure proper identity of the test being run.

8. Disinfect the patient’s finger with the alcohol wipe. Allow it to air-dry, and then perform a capillary puncture.

PURPOSE: Disinfection will ensure infection control. If the alcohol is wet, the capillary puncture will sting and be uncomfortable for the patient.

9. Wipe away the first drop of blood, and then fill the disposable pipet provided in the kit to the calibration mark with capillary blood (Figure 2).

PURPOSE: The plastic capillary tube measures the exact amount of sample, for accurate testing.

10. Dispense all the blood from the capillary tube into the “Add” well of the testing device. (Or, if you are using venous blood, transfer a large drop from the venous whole blood specimen using the longer capillary pipet provided in the kit.)

PURPOSE: Proper specimen type and volume is required for accurate testing.

11. Hold the developer bottle vertically above the “Add” well and allow 5 drops to fall freely.

PURPOSE: Holding a dropper vertically ensures delivery of the same-size drop. If the dropper touches other materials, it becomes contaminated, and the results will be inaccurate.

12. Read the results at 5 minutes. Note: The “Test Complete” box must be visibly colored by 10 minutes.

            • Positive result: A vertical line in any shade of blue forms a plus sign in the “Read Result” window, along with a blue “Test Complete” line. Even a faint blue plus sign should be reported as a positive.
            • Negative result: No vertical blue line appears, leaving a minus sign in the “Read Result” window, along with a blue “Test Complete” line.
            • Invalid result: After 10 minutes, no line is seen in the “Test Complete” window, or a blue color fills the “Read Result” window. If either of these is noted, the test must be repeated with a new testing device. If the problem continues, request technical support.
13. Dispose of biohazard waste in the biohazard waste container. Disinfect the work area.

PURPOSE: It is important to ensure infection control.

14. Remove your gloves and protective eyewear. Wash hands or use hand sanitizer.

15. Document control results in the appropriate laboratory log. Document patient results in the appropriate laboratory log and in the patient’s health record.

PURPOSE: A procedure is not considered complete until it has been properly documented.

Quality Control Procedures
External positive and negative liquid controls are provided with each new kit. All new operators of the test should perform liquid positive and negative external controls once to confirm that their testing technique is correct. Also, external controls should be tested and charted when a new kit is used.
The internal control occurs in the “Test Complete” window built into each reaction unit. Chart the control results on the control log with the operator’s initials.

Procedure 35.6  Coach Patient on the Guaiac Fecal Occult Blood Test
Tasks
Coach a patient on the guaiac fecal occult blood test (gFOBT) while considering the patient’s developmental life stage. Document the coaching in the patient’s health record.
Background:
When coaching patients, it is important to consider their developmental life stage. When working with older adults, it is important to communicate with dignity and respect. Use simpler language. Speak clearly and allow time for the patient to respond. It is important to find out what patients know about the topic and respectfully correct any inaccuracies. Make sure to listen to their concerns and provide resources as needed.
Scenario:
You work at WMFM Clinic. You are working with Dr. David Kahn, who asked you to coach Charles Johnson (date of birth [DOB] 03/03/19XX) on the gFOBT. He is to receive three hemoccult cards for stool smears.
Directions:
Role-play the scenario with a peer, who is the patient. Your instructor is the provider.
Equipment and Supplies
            • Hemoccult test kit (hemoccult cards, applicator sticks, and, if available, flushable collection tissue)
            • Patient instructions
            • Patient’s health record
            • Pen
Procedural Steps
1. Wash hands or use hand sanitizer.

PURPOSE: Hand sanitization is an important step for infection control.

2. Greet the patient. Identify yourself. Verify the patient’s identity with full name and date of birth. Explain what you will be doing.

PURPOSE: It is important to identify the patient in two different ways to ensure that you have the correct patient. Explaining the procedure can make the patient feel more comfortable and reduces anxiety.

3. Use simple language when talking. Speak clearly. Communicate with dignity and respect. Allow time for the patient to respond. Listen to the patient’s concerns.

PURPOSE: When working with older patients, it is important to treat them with respect and dignity. Listening is important.

4. Ask the patient if he has ever taken a guaiac fecal occult blood test. If so, ask him what he remembers about it.

PURPOSE: It is important to find out what the patient already knows about the topic.

5. Discuss the purpose of the test and the supplies needed (e.g., hemoccult cards, applicator kits, and, if available, flushable collection tissue). Show the supplies to the patient.

PURPOSE: It is important that the patient knows what supplies will be used.

6. Discuss how the patient needs to prepare for the tests and refer to the written instructions.

PURPOSE: Referring to the written directions that will be sent home with the patient helps eliminate confusion.

7. Discuss how the patient should collect and return the hemoccult cards. Use the written directions when coaching the patient. Write the patient’s name, date of birth, and address on the hemoccult cards if required by the agency.

PURPOSE: The cards need to be labeled with the patient’s information. Having the medical assistant label the cards ensures that this step is completed.

8. Ask the patient to teach back the preparation and the collection procedures to you. Clarify any misconceptions or inaccuracies. Answer any questions the patient may have.

PURPOSE: Using the “teach back” method to evaluate the patient’s understanding will help identify any misunderstandings the patient may have.

9. Document the coaching in the patient’s health record. Include the provider’s name, what was taught, and how the patient responded, and indicate the supplies and written directions sent home with the patient.

PURPOSE: It is important to document the procedure in the health record to show it was done.

Documentation Example
08/14/20XX 1105 Per Dr. Kahn’s order, instructed patient on the gFOBT test including the preparation and collection. The patient taught back the instructions accurately. Gave the patient the hemoccult testing kit and the Hemoccult Patient Directions booklet. The patient will return the cards to the clinic later this week. _____________________________ Laura Piper, CMA (AAMA)


Procedure 35.7 Develop a Hemoccult Card and Perform Quality Control
Tasks
Develop a stool specimen using a hemoccult card, and perform a quality control test. Document the test results in the patient’s health record.
Scenario:
Charles Johnson (date of birth [DOB] 03/03/19XX) returns his hemoccult card(s). Dr. David Kahn is his provider. You need to develop (test) the sample.
Equipment and Supplies
            • Hemoccult card with stool smear applied
            • Hemoccult developer
            • Gloves
            • Biohazard waste container
            • Waste container
            • Patient’s health record
            • Timer
Procedural Steps
1. Wash hands or use hand sanitizer. Put on gloves.

PURPOSE: Hand sanitization is an important step for infection control.

2. Identify when the specimen was applied and if testing can be done.

PURPOSE: The company recommends a wait time of 3 days from when the sample was applied. This allows for the degradation of fruit and vegetable peroxidases from the sample. If immediate testing is required, wait 3 to 5 minutes to allow the sample to penetrate the test paper.

3. Open the back of the card and apply 2 drops of the hemoccult developer to the guaiac paper directly over each smear.

4. Within 60 seconds, read the result accurately.

PURPOSE: Any trace of blue on or near the edge of the sample is considered positive for occult blood.

5. Perform quality control on the card by applying 1 drop of the hemoccult developer between the positive and negative Performance Monitors area.

PURPOSE: This quality control test will indicate if the card and developer are functional.

6. Within 10 seconds, accurately read the results.

PURPOSE: A blue color in the positive Performance Monitors area and no blue in the negative Performance Monitors area means the card and the developer are functional.

7. Discard the hemoccult card in the biohazard bag. Clean up the area. Remove gloves and discard them in the waste container.

PURPOSE: It is important to discard the hemoccult card in the biohazard bag for infection control.

8. Wash hands or use hand sanitizer.

9. Document the test result and the provider notified in the patient’s health record.

PURPOSE: It is important to document the procedure in the health record to show it was done.

Documentation Example
08/18/20XX 1105 Hemoccult card × 3 developed. All results were negative. Dr. Kahn was notified. ____________________ Laura Piper, CMA (AAMA)


Procedure 35.8  Coach Patient on Health Maintenance: Collecting a Stool Specimen for the Cologuard Test
Tasks
Coach a patient on collecting a stool specimen for a Cologuard test while considering the patient’s developmental level. Document the coaching in the health record.
Background:
When coaching patients, it is important to consider their developmental life stage. When working with older adults, it is important to communicate with dignity and respect. Use simpler language. Speak clearly and allow time for the patient to respond. It is important to find out what they know about the topic and respectfully correct any inaccuracies. Make sure to listen to their concerns and provide resources as needed.
Scenario:
You work at WMFM Clinic. You are working with Dr. David Kahn, who asked you to coach Charles Johnson (DOB 03/03/19XX) on the Cologuard test.
Patient Education:
            • Purpose of the Cologuard test: to identify altered DNA and blood in the stool
            • Do not collect a stool sample from patients who have diarrhea, bleeding hemorrhoids, rectal bleeding, menstrual period, or cuts or wounds on their hands.
            • Make sure the sample can be returned within a day of collecting it. The laboratory must have the sample within 72 hours, so consider mailing delays such as holidays and weekends.
            • Made sure patients are aware of the following instructions when collecting the sample:
                      • Use the box, zippered plastic bag, and the tray to return the sample.
                      • Remove the bracket from the box and unfold the sides. Place the bracket under the toilet seat near the back of the toilet. Lower the toilet seat.
                      • Remove the sample container from the box. Remove the lid of the container and set the lid aside. Place the sample container in the hole in the center of the bracket.
                    • Empty your bladder first. Avoid getting urine, toilet paper, or other material in the sample container.
                    • Have a bowel movement. The stool sample should be no larger than the bottle of preservative, which is found in the box. Make sure the toilet paper is not placed in the container.
            • After completing the bowel movement, patients should do the following:
                    • Remove the sample (specimen) container from the bracket and place a counter or other stable surface.
                      • Remove the bracket from the toilet and discard.
                      • Remove the tube from the box and unscrew the cap. Pull the probe from the tube. Use the probe to scrap the surface of the stool in the container until the probe has stool on it. Make sure the grooves on the probe are filled with stool but do not fill the tube with stool. Place the probe back into the tube and tighten the cap. Set the tube aside.
                      • Remove the bottle of preservative out of the box and remove the cap. Pour all of the preservatives into the sample container. The preservative bottle and cap can be discarded.
                    • Place the lid on the sample container and tighten the lid.
                    • Remove the Sample Label Card from the box and complete both labels. Write your first and last name, date of birth (MM/DD/YY), the date you collected the sample (MM/DD/YY) and the time you collected the sample. Circle AM or PM. Remove one of the labels from the paper and wrap the label around the tube. Remove the other label and place it on the sample container.
                    • Place the tube and the sample container into the tray, which sits in the plastic bag in the box. Close the bag, removing the air. Close the box, peel the paper backing off the tape on the box lid, and secure the top of the box. Return the box within a day.


Directions:
Role-play the scenario with a peer, who is the patient. Your instructor is the provider.
Equipment and Supplies
            • Cologuard test kit (box with a plastic bag, sample container, a bottle of preservative, bracket, tube, sample labels, and directions)
            • Patient instructions (optional)
            • Patient’s health record
            • Pen
Procedural Steps
1. Wash hands or use hand sanitizer.

PURPOSE: Hand sanitization is an important step for infection control.

2. Greet the patient. Identify yourself. Verify the patient’s identity with full name and date of birth. Explain what you will be doing.

3. Use simple language when talking. Speak clearly. Communicate with dignity and respect. Allow time for the patient to respond. Listen to the patient’s concerns.

4. Ask the patient if he has ever collected a specimen for a Cologuard test. If so, ask him what he remembers about it.

5. Discuss the purpose of the test, the time to take the sample, and the supplies in the box.

6. Discuss how the patient should prepare to collect the sample.

7. Discuss the activities the patient needs to do after the collection, including the use of the probe, adding the preservative to the sample, and packing the box.

8. Ask the patient to teach back the preparation and the collection procedures to you. Clarify any misconceptions or inaccuracies. Answer any questions the patient may have.

9. Document the coaching in the patient’s health record. Include the provider’s name, what was taught, how the patient responded, and indicate the supplies and written directions sent home with the patient.