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Mod 1 Clinic Lecture notes- CMA book – Ch. 6, 44, 45
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A. Occupational Safety and Hazard Administration
1. OSHA:
a. is a governmental agency
b. is responsible for the safety of all employees of companies operating in the United Sates
c. ensures the safety and health of America’s workers by setting and enforcing standards
d. provides training, outreach, and education related to workplace safety
e. encourages continual improvement in workplace safety and health
f. has the authority to inspect a workplace without notification
g. can fine workplaces where deficiencies in health and safety of employees exist
h. is concerned with workplace hazards that might impact the safety of employees
See pg. 118 Professionalism box
Discuss fire safety in a medical office
1. Each employee should be instructed on the proper use of fire equipment. Review the PASS acronym:
Pull, Aim, Squeeze, Sweep.
2. Define the acronym “RACE.” To help employees remember what to do in case of a fire, offices have
adopted the acronym “RACE—Rescue, Alert, Confine, and Extinguish.
3. 1. Rescue employees and patients from the fire area.
4. 2. Alert by calling 911.
5. 3. Confine by closing doors and windows.
6. 4. Extinguish the fire.
Identify the chemicals in a medical office that are hazardous to the human body.
1. Biohazards such as medical waste and samples of a virus or bacterium pose a threat to human beings and
are potentially infectious.
2. Corrosive materials cause burns, and flammable materials can burst into flames.
3. Toxic materials can cause serious illness or death by exposure through skin contact, ingestion, or
inhalation.
Discuss the purpose and contents of an MSDS.
1. Any workplace where employees handle a hazardous product is required to provide the employees with
a Material Safety Data Sheet (MSDS).
2. An MSDS contains printed material concerning a hazardous chemical.
3. Each MSDS offers basic information needed to ensure the safety and health of the user at all stages of
manufacture, storage, use, and disposal of a hazardous chemical product.
4. An MSDS provides information regarding the hazards of using the product, how to protect oneself from
injury by using the appropriate personal protection equipment (PPE), and what actions to take if an
Mod 1 Clinic Lecture notes- CMA book – Ch. 6, 44, 45
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accidental splash or exposure occurs. PPE consists of protective gloves, fluid-resistant lab coats, safety
glasses, and a surgical mask, shield, or respirator.
5. Each office must have an accessible HAZCOM binder where all MSDS information is filed, and all
employees must know where the binder is kept.
6. Each office should have a designated OSHA compliance officer, an employee who is aware of and
trained in the required controls for use and storage of hazardous materials.
7. Discuss how, through the use of personal protective equipment (PPE), employees can be protected from
exposure to bloodborne pathogens. All PPE must be provided by the employer and readily available for
use.
8. Explain how safety is the responsibility of every member of the medical office staff. While it is
imperative that the medical office staff provide a safe working environment, the staff must also be
constantly aware of their surroundings and any possible hazards. Employees must be willing to
implement all safeguards to keep themselves and patients safe.
Describe the four major types of medical waste:
1. Solid
a. Generated in many areas of medicine, including patient rooms and surgery suites
b. Not always hazardous, but can cause pollution of the environment
c. Mandatory recycling can reduce the amount of solid waste produced
2. Chemical
a. Includes substances such as germicides, cleaning solvents, and pharmaceuticals
b. Can be a causative factor in a fire or an explosion
c. The safe manner with which to handle and dispose of chemicals is included in the MSDS.
3. Radioactive
a. Any waste that contains or is contaminated with liquid or solid radioactive material, such as iodine-
123, iodine-131, and thallium-201
b. Must be clearly labeled as “radioactive”
c. Must be removed by a licensed disposal agency.
4. Infectious
a. Any waste material that has the potential to carry disease
b. Includes laboratory cultures, blood, and blood products from blood banks, operating rooms,
emergency rooms, medical and dental offices, autopsy suites, and patient rooms.
c. Must be separated from other solid and chemical waste at the point of origin
d. A licensed medical waste removal agency must dispose of these materials
1. OSHA defines body fluids as:
a. Blood
b. Semen
c. Amniotic fluid
Mod 1 Clinic Lecture notes- CMA book – Ch. 6, 44, 45
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d. Cerebrospinal fluid
e. Synovial fluid
f. Vaginal secretions
g. Pleural fluid
h. Pericardial fluid
Identify the elements of a written Exposure Control Plan that must be provided to assist in minimizing
employee exposure to infectious materials. This plan must be reviewed by all office staff and updated
annually. An Exposure Control Plan must include:
1. Exposure determination—listing of job classifications within the office to determine at-risk employees
(those with potential exposure to infectious materials)
2. Method of compliance—specific measures to reduce the risk of exposure.
3. Post-exposure—evaluation and follow-up, which specify the steps to follow when an exposure incident
occurs.
1. OSHA guidelines for using PPE and clothing are listed in Guidelines 6-2 in the textbook.
a. The employer must supply the protective clothing and provide cleaning or disposal of it.
b. The clothing or other equipment must be strong enough to act as a barrier to infectious materials
that might reach the employee’s street clothing, work clothing, eyes, mouth, or skin.
c. Disposable gloves may not be reused.
d. Protective eye equipment must have solid sides to prevent infectious material from entering the
eye area from the side.
e. All equipment and clothing must be removed and placed in a designated container before leaving
the medical office.
Discuss the purpose and use of an eyewash station.
1. An eyewash station should be available to use in the event that infectious materials enter the eyes. It
should be located close to any area where chemicals that may contaminate the eyes or skin are used.
2. The eyewash station should be checked monthly to ensure that it is working properly.
3. Each station is accompanied by a set of instructions; manufacturer’s requirements for use and
maintenance should be followed. Procedure 6-2 in the textbook explains proper use of the eyewash
station attached to a sink faucet.
Review the procedure for using OSHA housekeeping guidelines.
1. Prior to performing any housekeeping procedures, the employee should ensure that the appropriate PPE
has been applied.
2. For any wet spills, use the prepared spill kit according to package directions.
3. Immediately clean and disinfect contaminated surfaces with a 1:10 bleach/water solution after exposure
to infectious materials. All surfaces must be decontaminated on a regular schedule. This schedule must
be posted, signed by the person who performs the decontamination, and kept with OSHA records.
4. Properly bag contaminated clothing and laundry in leakproof, labeled biohazard bags. Contaminated
laundry should not be handled or washed at the medical office or with other uncontaminated clothing.
Mod 1 Clinic Lecture notes- CMA book – Ch. 6, 44, 45
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5. Replace a damaged biohazard bag by placing a second bag around the first. Do not remove infectious
material from the damaged bag.
6. Biohazardous waste must be removed by a licensed waste disposal service and incinerated or autoclaved
before placing in a designated landfill area.
7. Use puncture-proof, sealable, biohazard sharps containers for all needles and sharps, such as razors and
glass pipettes.
8. Place the sharps container close to the work area and ensure that the container remains upright.
9. Replace the sharps containers when they are 2/3 full.
10. Seal and label the sharps containers before placing with the biohazard waste for removal by the disposal
service.
11. In the event of broken glass, use a dustpan or other mechanical device such as hemostats or another type
of forceps to pick it up. Never pick up broken glass with hands.
12. Properly dispose of PPE used during housekeeping. Failure to do so may result in an OSHA citation.
13. Perform hand hygiene both before and after using gloves.
Explain the purpose of incident reports.
1. Any unusual occurrence or accident is referred to as an incident in the medical setting. Examples of
incidents include:
a. A patient falls on a wet floor
b. A housekeeping employee is stuck by a needle while emptying the trash
c. A prescription pad is missing
d. A patient receives the wrong medication
e. A patient misplaces or loses personal property, such as a hearing aid or glasses, while in the office
f. Syringes or needles are found to be missing from the supply cupboard
g. A medical assistant receives a needlestick from a contaminated needle
h. An employee’s purse is missing
i. A patient is abusive and uses vulgar language
2. Whenever any accident, injury, or unusual occurrence takes place, the employee should immediately
notify the supervisor. This is especially important if a needlestick accident is involved because time is of
the essence when drawing appropriate baseline blood specimens.
3. The supervisor will require the employee to complete a written report immediately.
4. The incident report should be completed in black ink.
5. An incident report can protect both the employer and the medical assistant against possible lawsuits.
6. Some incidents should also be reported to either the police or the liability insurance carrier. For
example, stolen property should be reported to the police, and a slip and fall should be reported to the
insurance carrier.
7. The incident should be described as simply as possible, stating only facts and not opinions.
8. The incident report may be used as a legal document; thus only objective information should be
Mod 1 Clinic Lecture notes- CMA book – Ch. 6, 44, 45
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included, such as “Patient fell while getting onto exam table.” Do not include subjective comments, such
as “Patient was not paying attention to what he was doing.”
9. Medical offices should have their own customized forms. However, most incident reports include the
following information:
a. Names of all persons involved
b. Date and time of the incident
c. Exact location of the incident (including the address of the medical facility and the location of the
incident within the facility)
d. Name of the person to whom the incident is reported and the time of the report
e. Brief description of what happened
f. Names of all witnesses
g. Name and description of any equipment involved in the incident
h. Action taken at the time of the incident
i. Action taken to prevent a recurrence
j. Signature and title of the person completing the report
10. The incident report, like all other information relating to the patient, is subject to subpoena in litigation
(lawsuits).
11. A copy of the incident report should be placed in a master incident report file, the patient’s file, and the
employee’s record.
See Pg. 128. Image on pg. 129
See Professionalism box pg. 131
Explain the purpose of the Clinical Laboratory Improvement Amendment (CLIA). The federal government now
requires that all clinical laboratories that test human specimens must be controlled. The Clinical Laboratories
Improvement Amendment of 1988 (CLIA88) divides laboratories into three categories:
A. Waived--Simple Testing (Level I) – Incorrect test results pose little risk for the patient. Laboratory is
subject to random inspectors only. Some physicians’ laboratories fall in this category.
B. Moderately Complex--Intermediate-Level Testing (Level II) – Poses risk to patient if there is an
incorrect test result. Must be certified by approved accrediting agency. Must be staffed by credentialed
personnel. Must meet quality assurance standards.
C. Highly Complex--Complex Testing (Level III) – Poses high risk to patient if there is an incorrect test
result. Must be certified by approved accrediting agency. Must be staffed by credentialed personnel.
Must meet quality assurance standards.
K. Discuss the function of the Joint Commission
1. The Joint Commission is a private, nongovernmental agency that establishes guidelines for
hospitals and health care agencies regarding quality care.
2. Supported by representatives of the American Hospital Association, American College of
Physicians, American College of Surgeons, and American Dental Association
Mod 1 Clinic Lecture notes- CMA book – Ch. 6, 44, 45
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3. Forms guidelines for hospitals, ambulatory care facilities, and long-term care institutions and
conducts surveys and accreditation programs
4. Indicators for accreditation include:
a. Mortality rate
b. Frequency of medical complications
c. Nosocomial infection rate
d. Autopsy rate
5. Does not have authority to take punitive action for poor treatment, but its survey results can be
used by other agencies to impose sanctions or penalties.
Explain the three types of clinical laboratories that perform tests of varying levels of complexity.
1. Outside laboratory
a. Either a hospital-based or independent laboratory.
b. Handles specimens collected from many types of facilities.
c. Performs tests ranging from simple to very complex.
d. A patient may go to the outside laboratory to have blood drawn or a specimen taken with the test
results to be sent to the referring physician.
e. A medical assistant may be employed in one of these laboratories as a phlebotomist (one who
performs a blood draw) or as an administrative assistant.
f. Outside laboratories typically provide supplies and forms for specimen collection and transport.
g. Most offer a directory with instructions for proper handling and transport of specimens.
h. When these instructions are available, always consult them to determine how much of a specimen
to collect, which container to use, and how to prepare the specimen for transport.
i. The MA is also responsible for requesting additional supplies to replenish the inventory on hand.
3. Physician’s office laboratory (POL)
a. Some of the tests the physician orders are performed in the office.
b. In the POL, the doctor has the advantage of receiving the results more rapidly than if tests
are done outside of the office.
c. Turnaround time is how long it takes for the test to be performed and the results
generated, sent back for physician review, and added to the patient’s chart.
d. Disadvantages to the POL: In-house testing may require more employees and the
purchase of expensive equipment.
e. This is the laboratory environment that MAs are particularly suited to, although they are
limited to performing only CLIA-waived tests.
f. The POL is usually housed in a separate room or work area that is well lighted and
adequately ventilated.
Mod 1 Clinic Lecture notes- CMA book – Ch. 6, 44, 45
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 Most have a refrigerator that is clearly labeled for storage of (potentially infectious)
specimens only.
 A supply of PPE, including gloves, masks, gowns, and protective eyewear is essential.
 A sharps container and a biohazardous waste receptacle should be within easy reach.
 Hand-washing facilities and an eyewash station are also important.
Discuss the medical assistant’s role in the clinical laboratory.
1. Medical assistants are particularly suited to working in POLs and clinical laboratories because of their
cross-training in administrative and clinical areas.
a. For MAs working in a laboratory, training in phlebotomy and basic knowledge of laboratory
testing are essential.
b. In addition, training in administrative duties helps medical assistants to perform the many
administrative tasks required in a laboratory.
c. MAs’ patient-oriented training helps them to be empathetic caregivers.
d. Whether you work as a medical assistant in a laboratory or in other areas of a medical practice, a
fundamental understanding of basic lab methods and techniques helps you understand the nature
and importance of specific tests. This includes an understanding of why specific tests are done,
how to prepare a patient for a test, conditions that may render a test inaccurate, and how to
evaluate the results.
2. Medical assistants may play any of several key roles in a clinical laboratory.
3. Depending on their level of involvement in the laboratory, these roles may include record management,
teaching patients, specimen management, and quality assurance.
a. Discuss record management in the clinical laboratory.
b. Methods of lab test record management vary, depending on where a sample is collected and
where it is tested.
c. The first priority is to make sure that the physician’s order is clearly recorded and the proper lab
forms are completed.
d. In-house collection and processing must be charted.
e. Results should be evaluated and carefully documented.
f. A requisition is a form that provides essential information about
 the test that is ordered
 how results will be reported
 information for billing and coding
4. The MA will need to complete a requisition if not performing the tests right away.
a. The requisition will be transported with specimens that are collected at the physician’s office and
sent out for testing.
b. Alternatively, the requisition will go with the patient, who is required to travel to a laboratory for
collection and testing.
Mod 1 Clinic Lecture notes- CMA book – Ch. 6, 44, 45
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c. If the physician wants the results immediately for a medical intervention, then the requisition
must be labeled STAT (immediately) and processed accordingly.
5. Refer to Procedure 44-1: Completing a Laboratory Requisition and Preparing a Specimen for Transport
to an Outside Laboratory in the text for detailed instructions on this process.
1. Specimen Management
a. A specimen is a small sample taken from the body, such as:
 Urine
 Feces
 Sputum
 Blood
 Other body tissues or secretions.
b. Urine and blood are the most commonly obtained specimens for laboratory testing.
 It is vital to properly collect and preserve a specimen to ensure that it truly represents the
patient’s body functions.
 Otherwise, inaccurate test results are likely, which may alter the patient’s diagnosis and
treatment.
c. In a POL:
 Specimens are generally processed for in-house testing according to office policy
 Some may be prepared for transportation to an outside lab.
 The MA should perform CLIA-waived tests precisely according to manufacturer’s instructions
after checking expiration dates.
 If specimens are sent to an outside lab:
 Determine the specific requirements of the lab being used.
 Each lab has its own policies regarding which specimen containers to use and how much to
collect.
 Some specimens will need to be refrigerated, spun, or have chemicals added to them.
 Some labs schedule routine pickups, but others may require specific contact to pick up a
specimen.
d. Refer again to Procedure 44-1 to review the steps to correctly complete a laboratory requisition and
prepare a specimen for transportation to an outside laboratory.
e. Complications of specimen collection may occur.
 If there is difficulty drawing blood, the cells may hemolyze, or burst.
 Accidental contamination or collection in the wrong container can be a problem.
 Exposure to heat or direct sunlight may cause damage.
Mod 1 Clinic Lecture notes- CMA book – Ch. 6, 44, 45
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 If less than the required amount of a specimen is collected, testing may not be possible; in this
case, a lab report will read QNS (quantity not sufficient).
 Incomplete or incorrectly handled specimens may require retesting.
f. To avoid collecting a specimen from the wrong patient, proper identification is important. Use this
three-step process:
 Check the chart to verify the order.
 During introductions, ask the patient to state his or her full name and date of birth. The patient
must state, rather than verify, this information to prevent miscommunication, especially if there
is a language barrier or the patient has difficulty hearing.
 Compare the information the patient has given with the chart to verify that this is the right
patient. Always compare both the name and the date of birth in case more than one person with
that name has a file in the same office.
g. Properly labeling specimens is essential.
 Use two identifiers (such as name and date of birth),
 Indicate the date and time collected.
h. To prevent cross contamination and mislabeling specimens:
 A label should never be placed on a removable lid
 A specimen should always be sealed and labeled before walking away from a sample.
i. If the patient was not supposed to eat before the test and forgot, label the specimen as non-fasting
and check with the physician to determine if the test should still be run.
A. Discuss the role of the medical assistant in carrying out quality assurance (QA) procedures.
1. Planned and systematic activities to ensure that requirements are met and results are accurate.
2. A QA program is a written program that includes mechanisms to evaluate laboratory procedures and
policies, identify and correct problems, and ensure reliable and prompt reporting of results and
testing by competent individuals.
3. Steps for quality assurance in the laboratory:
a. Most offices and laboratories have a policies and procedures manual with a set of routine
checklists to follow.
 A basic QA checklist generally begins with keeping the lab and patient areas clean and
providing clear patient instructions.
 It includes restocking supplies to ensure that the correct materials are available.
 Checking storage instructions and expiration dates for all reagents and test kits is
important before storage and before use.
b. QA involves routinely reviewing procedure manuals and following the most recent
manufacturer’s instructions for correct test performance.
c. Scheduling or performing routine equipment maintenance, including calibrations, should
always be properly documented.
Mod 1 Clinic Lecture notes- CMA book – Ch. 6, 44, 45
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d. Laboratory refrigerators should be properly labeled for restricted use and should have a
thermometer that is both checked and recorded daily.
e. When opening a new stock container of multiuse reagents, chemicals, or test strips, you
should date and initial the container.
f. You should also be able to identify assigned lab values and compare them to the specimen
result.
4. Maintenance
a. All laboratory equipment must be maintained on a regular basis according to manufacturers’
instructions.
b. A written record of the maintenance performed must be readily available.
c. A record of each piece of equipment with model and serial numbers, date of purchase, and
manufacturers’ inserts should be available when repair is necessary or the laboratory is being
inspected.
5. Documentation
a. Documentation is important for QA. Without a written record of a test result, control result,
maintenance performed, or temperature recorded, you have no proof of activity.
b. The end result is the same as if you did not perform the procedure.
c. If it is not written down in the appropriate place, you did not do it.
E. Discuss quality control (QC), which is focused on physical proof that results are accurate.
1. QC is accomplished by routinely performing mock tests, using one of two predetermined methods:
a. Calibration
 Some machines require evaluation by calibration devices, which are specially prepared test
strips or cartridges that are designed to produce a predetermined result.
b. Control solutions
 Other tests are evaluated by using regular testing materials but, instead of adding a patient
sample, a provided control solution is added in its place.
 Control solutions are chemicals that produce an expected result; they are usually purchased
from or provided by the manufacturer of the testing equipment.
c. In either case, the result should fall within the acceptable range listed on the calibration device or
control solution bottle.
2. Abnormal quality control results should always be investigated.
a. Things that may cause abnormal results include
 User error
 Impaired quality
 Outdated materials
 A malfunctioning machine
Mod 1 Clinic Lecture notes- CMA book – Ch. 6, 44, 45
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b. In this case, try retesting with newly opened materials or asking a coworker to perform a quality
control test.
c. If results remain abnormal, the machine is not considered accurate and should be serviced or
repaired and retested before using on patients.
3. QC tests are performed according to manufacturer’s requirements and lab policy, often daily.
a. Results are recorded in a quality control log, which is evaluated after each use.
b. The CLIA 1992 standards mandate that written policies and procedures must be in place for a
comprehensive quality control program that will “evaluate the ongoing and overall quality of the
testing process.”
c. To this end, the laboratory is required to do the following:
 Evaluate the effectiveness of its policies and procedures.
 Identify and correct problems.
 Ensure reliable and prompt test results.
 Ensure the competence and adequacy of staff.
 Take corrective action if errors are found.
 Integrate corrective procedures into future policies and procedures.
 Document employee training and assess competency yearly after the first year.
• Maintain the identity and integrity of patient samples during the entire testing process.
d. • Be subject to inspection every two years if performing moderate- or high-complexity tests.
4. Refer to Box 44-2: Using Controls to Monitor Results for more information on this topic.
a. As a professional in health care, it is important that you comprehend the importance of
patient test results and control samples. What would you do if the control sample results
were correct according to the manufacturer’s value sheet, but the patient test results were
very abnormal compared with the reference values of your facility? For example, imagine a
patient’s fasting glucose level is 47 mg/dL when tested.
b. The reference range in your facility is 70 to 100 mg/dL.
c. The control tests were 55 mg/dL and 132 mg/dL, which were in range according to the
manufacturer.
 If a result seems incongruous to you, it should not be reported without retesting.
 The test and controls should be repeated.
 The original specimen should be examined to ascertain that the specimen was not hemolyzed
(red cells burst, causing serum to be a cherry-red color) or icteric (bilious yellow-green
color). If either problem exists, a new specimen may be required and the test should be
repeated.
 The results from previous tests on this patient should be examined. Is there a pattern among
previous test results?
Mod 1 Clinic Lecture notes- CMA book – Ch. 6, 44, 45
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 The patient’s results should be flagged and brought to the attention of the supervisor or
physician if test and control results were the same as the first test results.
 A protocol should be in place in your POL that establishes the appropriate steps to follow
when a result is flagged.
 A small portion of the original specimen may be sent to an outside laboratory for testing to
compare results.
5. Refer to Procedure 44-3: Evaluating a Contour TS Glucometer Using Control Solutions for detailed
instructions for carrying out one such control solution test.
Explain the Clinical Laboratory Improvement Amendments (CLIA).
1. In 1988 Congress enacted CLIA as developed by the Centers for Medicare and Medicaid Services
(CMS) in response to widespread concern over the accuracy of laboratory tests.
2. Mandates that all laboratories that test human specimens must be regulated to help ensure accurate
patient test results.
3. Since their enactment in 1988, the CLIA have been kept current through periodic amendments and
updates. CLIA divide laboratories into three categories: waived, moderate complexity, and high
complexity.
4. Medical assistants are qualified to perform only waived testing.
5. Many CLIA-waived tests are simple enough for a patient to perform at home with basic instructions.
a. In the POL, they frequently come in a boxed test kit set, which contains several tests and the
materials needed to properly use them.
b. Many automated analyzers are now CLIA-waived, too, as a result of the advancements of
technology.
c. An automated analyzer is typically a small or handheld machine that processes a specimen with
single-use reagent test strips or cassettes.
d. Results are displayed quickly, proving an advantage for a patient who may need to be treated
right away.
6. Information regarding state laboratory regulations may be obtained from state health departments.
7. A facility is required to have a Certificate of Waiver from the Centers for Medicare and Medicaid
Services (CMS) so that its employees can legally perform simple tests used to prevent, diagnose, or
treat a disorder or disease.
a. These tests are referred to as Certificate of Waiver Tests (WTs) or CLIA-Waived Tests.
b. They are the least complex and present the least risk if performed incorrectly.
c. Some examples of these tests are indicated in Box 44-3.
d. Many of these tests have been approved by the FDA for home use.
e. These are the only laboratory tests that a medical assistant may perform without further training;
they may only be performed in a laboratory that has been granted a Certificate of Waiver.
Mod 1 Clinic Lecture notes- CMA book – Ch. 6, 44, 45
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8. Although other types of testing are discussed in the textbook, anything that is not CLIA-waived is for
demonstration purposes only and does not qualify the medical assistant to perform that test in the
laboratory.
9. To maintain CLIA-waived status, facilities must permit on-site inspections, as requested.
a. During an inspection, evaluators will determine if necessary standards are being met.
b. A significant issue of discovery is when manufacturer’s instructions are either missing, outdated,
or not followed to the letter.
c. This is a concern, because the only CLIA requirement for performing waived testing is to follow
the manufacturer’s instructions.
10. Improper testing can lead to inaccurate results, which may result in incorrect diagnosis or treatment.
Therefore, if modified even the slightest bit, tests are no longer considered waived tests and become
subject to the more stringent CLIA requirements.
11. A POL must apply to perform WTs and then may not perform the more complex tests from Level I or
Level II.
12. Approved tests are considered exempt from complying with CLIA 1988 standards and are thus termed
CLIA-waived or waived tests (WTs).
a. However, quality assurance and quality control methods should still be observed.
13. The laboratories that perform WTs may be subject to random inspections and investigation if test
results are questioned or complaints are made against the laboratory.
14. A Certificate of waiver is given to laboratories that perform only low-complexity tests.
a. A POL qualified to perform moderate-complexity and waived tests receives a Certificate of
Provider-Performed Microscopy (PPM).
b. A medical assistant employed in a facility with a PPM certificate can perform moderate-
complexity tests with further training and under the supervision of a laboratory professional or
physician.
15. Refer to Box 44-3: Categories of CLIA Tests for tests in the different categories:
a. Waived Tests—Simple procedures approved for home use and POL or POC testing. Common
examples include:
 Dipstick urine testing or table testing
 Fecal occult blood testing
 Ovulation testing
 Urine pregnancy testing
 Erythrocyte sedimentation rate (non-automated)
 Hemoglobin testing with CLIA-waived analyzer
 Spun hematocrit
 Blood glucose using FDA-approved glucose analyzer
 Rapid Streptococcus testing
b. Moderate-Complexity Tests/Level I Tests
Mod 1 Clinic Lecture notes- CMA book – Ch. 6, 44, 45
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 75 percent of tests performed daily using automated analyzers for chemistry and
hematology; microscopic analysis of urine sediment
c. High-Complexity Tests/Level II Tests
 All tests in the field of cytogenetics, cytology, histopathology, and histocompatibility
16. Refer to Box 44-4: Critical Steps in CLIA Testing for required procedures.
a. Follow the instructions in the most current manufacturer’s product insert EXACTLY.
b. Report results using proper documentation and recordkeeping.
c. Adhere to expiration dates.
d. Perform quality control testing regularly.
e. Use only recommended storage requirements.
f. Keep manufacturer’s instructions in an easily accessible area.
g. Replace manufacturer’s instructions every time a new product is received.
h. Be aware of federal, state, and local regulations.
Explain that the laboratory includes biohazards, chemical hazards, and physical hazards and that most accidents
are preventable.
1. Laboratory safety must be the concern of all who are employed in the laboratory field.
2. Medical assistants must be familiar with the following regulations:
a. Hazard Communication Standard
b. Universal Precautions and Bloodborne Pathogen Standards
c. Hazardous Waste Operations
d. Needlestick Safety and Prevention Act
3. Chemical hazards
a. Material Safety Data Sheets (MSDSs) provide safety information for all in the laboratory
environment including:
 Product identification
 Safety information about proper storage and disposal
 Potential health hazards
 Handling precautions
 Fire and explosion information
b. All laboratory personnel have the right to know about hazards pertaining to materials they are using
and must receive training appropriate to the materials in use.
c. Each hazardous substance must have a hazardous material label attached to the container that
provides a shortened version of the MSDS information.
4. Bloodborne pathogens
a. Biohazards are hazards that have the potential to infect others.
Mod 1 Clinic Lecture notes- CMA book – Ch. 6, 44, 45
15
b. Since 1992, OSHA’s Occupational Exposure to Bloodborne Pathogen Program must be in place at
all working laboratories.
c. The CDC specimen-handling precautions known as standard precautions (formerly universal
precautions) must be employed when dealing with any infectious materials.
d. All potentially biohazardous material must be labeled with the biohazard label.
5. Needlestick hazards
a. Since OSHA revised the bloodborne standards to include the Needlestick Safety and Prevention
Act of 2000, health care employers must follow certain safety protocols:
 Review all new safety devices to lessen the needlestick risks of their employees.
 Ask for safety input from their employees on an annual basis.
 Keep a detailed report of all contaminated needlestick incidents.
6. Fire and safety hazards
a. Staff must take care to reduce the chances of fire and electrical accidents by having an awareness of
the floor plan and exits.
b. They must be familiar with the floor plan, exits, and location of safety devices such as eye washes,
showers, and safety blankets.
7. Hazardous waste removal
a. Hazardous waste includes:
 Blood
 Blood products
 Body fluids and tissues
 Cultures
 Vaccines
 Sharps
 Gloves
 Inoculation loops
 Paper contaminated with body fluids
All must be disposed of in proper containers identified with biohazard labels. Sharps must be placed in
punctureproof, leakproof containers.
1. Microscope
a. Frequently used in the medical office to examine urine sediment, vaginal and bacteriological
smears, and differential smears, which categorize types of white cells in a sample.
 This optical instrument magnifies structures unseen by the naked eye for the purpose of
counting, naming, or differentiating.
 A compound microscope achieves maximum magnification by using two sets of lenses:
oculars (eyepiece lenses) and objectives (lenses at the bottom near the sample).
Mod 1 Clinic Lecture notes- CMA book – Ch. 6, 44, 45
16
 The resolution of a microscope refers to the ability to distinguish clearly between two
adjacent but distinct objects.
 Better microscopes have better resolution.
b. Parts of the microscope:
 One or multiple eyepieces (monocular or binocular) with magnification imprinted on them
 Body tube (directional light source)
 Arm (used in carrying the microscope)
 Revolving nosepiece (holds objectives and rotates for selection)
 Objectives (magnification imprinted on each objective: 10, low-power setting; 40, high dry
setting; and 100, oil immersion setting
 Stage
 Mechanical stage (movable device that holds slide)
 Mechanical stage adjustments (two knobs that control vertical/horizontal movement of slide)
 Coarse and fine adjustment knobs (small knob atop larger knob that adjusts stage up and
down for focusing)
 Condenser (lens system used to increase light for sharper focus)
 Condenser adjustment knob
 Light source (illuminator set in base)
 Iris diaphragm lever
 Base (holds illuminator, rheostat, and microscope upright and is used while carrying
microscope)
c. Using the microscope:
 Magnification of an object is calculated by multiplying the objective magnification by the
eyepiece magnification.
 On low power, magnification would be 10 (the objective) times 10 (the eyepiece) equaling
magnification of 100 times the size of the sample.
 It is important to use the correct lens for the type of microscopic work to be done. For
example, the low-power objective, 10×, is used to view epithelial cells, such as skin
scrapings; the high dry setting, 40×, is used for urine RBCs (red blood cells), WBCs (white
blood cells), or blood RBCs; the oil immersion setting, 100×, is for differential blood smears
(stained with Wright’s stain) or bacteria slides (stained with Gram stain).
 Microscopic work on the high dry setting is done with a cover glass on the specimen.
d. Refer to Procedure 44-4: Using and Cleaning the Microscope for instructions on these techniques.
Equipment and Supplies: Binocular compound microscope; specimen slide; lens paper; lens cleaner; dust
cover for microscope
Method
 Always carry the microscope with one hand on the arm and one hand under the base.
 Make sure the stage is in the down position before starting.
 Clean objectives with lens paper starting with 10× and ending with oil immersion.
 Turn on the light and rotate the nosepiece until the 10× objective is directly over the slide. Place
the prepared slide on the stage.
 Use the coarse adjustment knob to raise the stage until the objective is close to the slide on the
stage.
 Look through the eyepiece and adjust the coarse focus knob until the microscope field is seen (a
round circle of bright light).
Mod 1 Clinic Lecture notes- CMA book – Ch. 6, 44, 45
17
 Use the fine adjustment knob for a clearer image.
 Open the diaphragm and, if necessary, adjust the rheostat to focus. Clean the objective lens.
 Raise or lower the condenser to alter light refraction. The condenser is usually lowered when
using 10× power.
 Observe the slide.
 Change the objective to 40× and readjust as needed. Move the objective and place a drop of oil
on the slide before completing the turn to oil immersion lens.
 When focusing and examination are complete, lower the stage before removing the slide.
 Turn off the light.
 Clean the eyepieces and objectives with lens paper. Clean the oil immersion lens with lens
cleaner.
 Unplug the electrical cord and wrap it around the base.
 Cover the microscope with a dust cover.
 Clean the slide and store.
e. Care of the microscope:
 Microscopes are delicate instruments that will last for many years if maintained properly.
 Refer to Guidelines 44-1 for the rules for the proper care and maintenance of a microscope:
Care and maintenance of a microscope
 Follow cleaning requirements during mandatory daily maintenance.
 Always use two hands to carry a microscope: one hand to hold the arm of the microscope and one to
support the base.
 Clean oculars, objectives, and stage using only lens paper and lens cleaner.
 Keep extra light bulbs on hand.
 Document inspections and repairs in logbook.
 Store with electrical cord wrapped loosely around base.
 Cover the microscope with a dust cover when it is not in use.
Begin the lesson by defining microbiology and explaining microorganisms.
1. The field of microbiology is the study of living organisms too small to be seen with the naked eye
(microorganisms).
2. Antonie Van Leeuwenhoek’s invention of the microscope in 1674 allowed people to observe microbes
for the first time.
3. Louis Pasteur, the father of microbiology, developed methods for culturing and identifying microbes in
the laboratory.
4. The study of microorganisms has greatly advanced the field of medicine and currently allows
individuals to live longer, healthier lives.
a. To successfully treat a patient, it is important to first discover the exact cause of the problem.
Mod 1 Clinic Lecture notes- CMA book – Ch. 6, 44, 45
18
b. By evaluating body fluid samples, an offending microorganism may be identified so that the
most effective medication or treatment can be prescribed.
5. We are surrounded by microorganisms. Yet not all bacteria are bad.
a. Bacteria in the environment help us to decompose and recycle waste.
b. Normal flora on our bodies consist of beneficial bacteria that help us resist pathogens.
6. However, a bacterium that is harmless in one area may be pathogenic in another, especially in large
amounts or in an area that is normally sterile.
7. It is important to understand differences between microorganisms and learn which can be harmful to
effectively help patients to recover from illness.
1. Bacteria can be characterized by their reactions to certain stains.
a. A stain is a dye used in coloring microorganisms to allow for visibility under a microscope.
b. The Gram stain, named for Dr. Hans C. J. Gram, a Danish physician, is a commonly used
method of staining bacteria.
 A gram-positive bacterium retains the violet color of the stain used in the staining of the
microorganism.
 Some of the more common gram-positive bacteria are Staphylococcus aureus and
Streptococcus pneumoniae.
 A gram-negative bacterium has the pink color of the counterstain used in Gram’s method of
staining microorganisms.
 A few of the most common gram-negative bacteria are Escherichia coli, Neisseria
gonorrhoeae, and Salmonella typhimurium.
c. Some organisms do not stain well with Gram stain and require a special stain, such as the acid-
fast stain used for the organism that causes tuberculosis.
4. Bacteria can be categorized by their use of oxygen:
a. Aerobes can survive in an oxygen-rich environment.
b. Anaerobes die in the presence of oxygen.
c. Facultative anaerobes are flexible and can live with some oxygen.
d. Successful culturing requires an understanding of the oxygen requirements of bacteria.
e. If the ultimate goal is to grow and identify a sample of the organism that is causing disease in a
patient, then we must provide proper oxygen, moisture, nutrition, and temperature in the
laboratory setting.
5. Bacteria have other identifying characteristics:
a. Differences such as cell structure and the presence or absence of organelles (small structures in
the cytoplasm of a cell) are used to classify organisms.
 If they are capable of movement, their means of motility is unique to specific categories of
microorganisms.
Mod 1 Clinic Lecture notes- CMA book – Ch. 6, 44, 45
19
 They may possess flagella (long whiplike extensions of the cytoplasm) or cilia (fine hairlike
extensions).
 For example, Trichomonas vaginalis, the protozoan that is responsible for one type of
vaginitis, has four flagella at one end that produce the characteristic circular whiplike
movement seen in wet preparations and microscopic examinations of infected individuals’
urine.
b. Bacteria can also be categorized by their ability to hemolyze (burst) red blood cells in the blood
agar (a medium for growing bacterial cultures that contains whole blood).
c. Biochemical analysis, often done on semiautomated analyzers, provides the microbiologist with
information that assists in identification of certain pathogens, such as enteric organisms (those
that live in the intestines).
C. Point out how microbes can be divided into groups based on special characteristics.
1. Bacteria (singular: bacterium)
a. Small, unicellular microorganisms that are capable of rapid reproduction.
b. Although their mere presence is not necessarily harmful, the overgrowth of bacteria can cause an
imbalance and lead to disease or pathology.
c. Most bacteria thrive in a warm, dark, moist environment. Because the human body is capable of
providing this atmosphere upon entry, bacteria can easily thrive and grow.
d. Their reproductive ability explains how some infections become overwhelming in a short period of
time and can be dangerous.
 For example, one Escherichia coli organism, the most common cause of urinary tract infections
(UTIs), reproduces in about 30 minutes.
 By the end of a 24-hour period, this one Escherichia coli (E. coli) cell will have produced an
enormous number of cells capable of creating an infection if they have been introduced into the
bladder.
e. Bacteria may be named for their morphology (shape):
 Cocci (spherical)
 Bacilli (rod-shaped)
 Spirilla (spiral shape)
Discuss coccus/cocci, round bacteria that are arranged in various configurations.
1. Staphylococci are gram-positive, grape-like clusters of cocci, some of which are pathogenic.
a. Nonpathogenic staphylococci are found on our skin and in many of our body orifices, or openings.
b. Staphylococcus aureus (S. aureus), or staph, is the major pathogen of this genus and may be found
as normal flora in the nose and on the skin.
 It causes infection, especially when resistance is lowered by a break in the skin or in the
mucous membranes.
 The skin is the most common site of infection by S. aureus.
Mod 1 Clinic Lecture notes- CMA book – Ch. 6, 44, 45
20
 It produces infections such as impetigo in children and is associated with infection of wound
sites and surgical incisions.
 It causes pus-producing abscesses such as boils, carbuncles, and folliculitis.
 S. aureus is a common cause of nosocomial infections and may also cause pneumonia,
meningitis, and septicemia in individuals with reduced resistance.
 Toxic shock syndrome is also caused by this virulent organism.
 S. aureus produces one type of enteritis (food poisoning) that occurs within in a few hours of
eating improperly refrigerated food contaminated with the toxin produced by the bacteria.
This toxin causes nausea, vomiting, diarrhea, and abdominal cramping.
 S. aureus is coagulase positive, meaning it produces an enzyme that can be used to help
differentiate S. aureus from other species of this organism.
2. Today, because of increased reliance on treatment with antibiotics to treat low-level infections,
superbugs are becoming common.
a. This term refers to various microorganisms that are mutating to produce antibiotic-resistant forms.
b. Of particular interest is methicillin-resistant Staphylococcus aureus (MRSA).
 This form of S. aureus produces an enzyme the makes the organism resistant to penicillins and
cephalosporins normally used for treatment and renders these antibiotics ineffective.
 Similarly, vancomycin-resistant enterococci (VRE) and carbapenem-resistant enterobacteriaceae
(CRE) are becoming more prevalent.
 Tests are available to indicate the presence or absence of this enzyme and help determine the
most favorable treatment.
c. The problem of antibiotic resistance is a major concern for health care providers and is being
experienced worldwide.
Describe the infectious organisms known as viruses.
1. Although potent, a virus is the smallest known infectious organism and requires the use of an electron
microscope for visualization.
2. A virus, a simpler form of life than a cell, is parasitic, depending on living cells of other organisms for
growth.
3. When a virus enters a cell, it may immediately cause a disease, such as influenza, or it may remain
dormant for days or even years.
a. Herpes zoster can cause an outbreak of chickenpox within 7 to 14 days of exposure, where HIV
can lie dormant for years before symptoms are note.
4. Viruses cause many common diseases such as colds, chickenpox, mumps, infectious mononucleosis, and
warts.
5. Other illnesses caused by viruses are hepatitis, measles, encephalitis, and herpes.
6. Fortunately, vaccines are available to protect people from viral diseases such as polio, German measles,
measles, hepatitis B, mumps, and chickenpox.
Mod 1 Clinic Lecture notes- CMA book – Ch. 6, 44, 45
21
Define fungi and the classifications used for this group of microorganisms.
1. The study of fungi (singular is fungus) is known as mycology.
2. Fungi are present in soil, water, and air.
3. Fungi are unable to make their own food, so they depend on other life forms.
4. Included in this classification are yeasts and molds.
5. In our environment we encounter fungi in the form of mushrooms and penicillin molds on stale bread.
6. Penicillium mold was discovered by Alexander Fleming, and its antibiotic properties changed modern
medical treatment.
7. Penicillin is now synthetically produced.
8. Yeasts are single-celled fungi that reproduce by budding.
9. Molds are those fungi that produce spores.
10. Most fungi are not pathogenic and cause few diseases in humans. Of the ones that do, most will produce
only superficial infections, such as athlete’s foot (Tinea pedis) or ringworm.
11. A few do produce life-threatening illnesses when they invade the internal organs of the body.
12. Candida albicans is the causative agent of moniliasis or candidiasis, a yeast infection, and thrush.
13. Individuals with compromised immune systems or those who have been on long-term antibiotic therapy
may develop severe infections.
a. In these cases, the normal flora that protect the openings of the body cavities are killed by the
antibiotic therapy and allow harmful fungi a fertile environment in which to reproduce.
b. This type of infection is referred to as a superinfection.
14. It takes a long time and persistence to get rid of a fungal infection. Fungal infections are resistant to
antibiotics and must be treated with antifungal agents.
1. Collection Devices:
a. Sterile swabs are frequently used in collection of specimens.
 The shafts and the tips of swabs vary in terms of the type of material used.
 They are wrapped in a sterile wrapper or container to preserve sterility.
 Cotton swabs are used less frequently today because certain microbes are inhibited by the natural
ingredients in cotton.
 Polyester and rayon are used for the tips and wood, plastic, or wire for the shaft.
 Swabs also vary in size of tip and flexibility of the shaft to permit collection in difficult-to-reach
areas.
 After a swab is collected, it is placed in a sterile container that may or may not contain culture
media.
C. Note that pathogens can be observed in specimens of blood, feces, cerebrospinal fluids, mucus, urine,
sputum, wounds, tissue, and exudates of other body specimens. Review the types of specimens and
information for obtaining them.
1. Throat
Mod 1 Clinic Lecture notes- CMA book – Ch. 6, 44, 45
22
a. One of the most frequently requested specimens in a POL is a throat swab or culture.
b. Based on signs and symptoms the patient presents with, such as upper respiratory infection, sore
throat, or sinus infection, the physician will order a throat culture to identify the pathogen involved
and begin treatment.
c. Confirmation of Streptococcus pyogenes is important because of its virulence and possible
complications.
d. When performing a throat culture, it is important not to touch the insides of the mouth or the tongue
with the swab to avoid contaminating it.
e. If the culture is to be done in house, it is streaked.
 A bacitracin antibiotic disk will be placed on the culture plate in the area with the heaviest
inoculation.
 A zone of no growth around the disk is presumptive evidence that the pathogen is group A beta-
hemolytic strep.
 Other strep organisms are not sensitive to bacitracin.
 Bacitracin is not used to treat strep throat, only as a differentiating antibiotic.
 Broad-spectrum antibiotics such as penicillin, ampicillin, and erythromycin are used to treat
strep.
 If strep is suspected, an antigen–antibody test for strep may be ordered.
f. Nasal swabs are sometimes requested, and care should be taken to label the swabs “Right” and “Left”
to identify from which nostril the specimen was taken.
g. Smaller sterile swabs with thinner more flexible shafts are generally used for obtaining nasal
specimen.
h. Refer to Procedure 45-1: Obtaining a Throat Culture for instructions in this procedure:
2. Sputum
a.To obtain a sputum (mucous substance expelled by coughing or clearing the bronchi) specimen, the
patient must be carefully instructed to cough deeply and spit up the coughed up material into a sterile
container.
b. Explain to the patient that this should not be saliva from the mouth.
c.Often it is possible to obtain a good sputum specimen if the patient is reminded to try on rising in the
morning, using a sterile container provided by the POL.
d. The purpose for obtaining a sputum specimen is to isolate and diagnose diseases such as
streptococcal pneumonia, influenza, and tuberculosis.
e. Refer to Procedure 45-2: Obtaining a Sputum Specimen for Culture for instructions on this
procedure.
3. Urine
a. A urine specimen for culture must be either a catheterized specimen or a clean-catch midstream
sample (CCMS).
 Both methods provide sterile samples.
Mod 1 Clinic Lecture notes- CMA book – Ch. 6, 44, 45
23
 Any other type of urine specimen (one for routine analysis, for example) would be contaminated
by organisms in the container or on the hands or genitals of the patient.
b. Refer to Procedure 46-1 in Chapter 46, Urinalysis, for collection of a clean-catch midstream urine
specimen from both male and female patients.
4. Stool
a. Stool or feces (waste product from bowel) may be tested for bacterial, parasitic, or protozoal
infections; for the presence of occult blood; and for excessive amounts of fat (steatorrhea).
b. The collection of stool specimens varies with the type of test ordered.
c. Discussing stool sample collection is often embarrassing to both patient and medical assistant;
however, correct collection is critical to an accurate result.
d. Fecal specimens must be free of urine, water from the toilet, and toilet tissue.
e. Stool culture
 To detect bacteria or viruses a small amount of feces is needed.
 The collection containers must be sterile, and aseptic technique must be used in the collection
process.
 Once collected, the stool must be sent immediately to the testing facility.
 Sterile collection devices are available.
 Sheets of special paper, coverings for the toilet, and bedpans can be used to collect specimens.
 Sterile tongue depressors or applicator sticks can be used to transfer a small of amount of stool
to a sterile container for transportation to the laboratory or office.
 In the office a sterile bedpan may be used or sterile pan placed over the bowl of the toilet.
f. Occult blood
 A stool specimen is required to test for occult or hidden blood that may indicate bleeding in the
gastrointestinal tract.
 Often the patient is given the test units to take home and collect the specimen.
 Directions are provided on each test unit; however, instructions should be reviewed each time
they are given to a patient.
 Patients are instructed to write their name, date, and doctor’s name on label of the collection
unit.
 Using one of the wooden spatulas provided, they are to collect a small amount of stool and place
it in one of the circles on the back of the booklet, obtain another sample from a different area of
the stool, and placed on the other circle.
 Patients should close the unit and take it or mail it to the doctor’s office or the laboratory as
requested.
 For more accurate results patients should be instructed to refrain from consuming vitamin C and
red meat for three days prior to testing because they may cause false positives.
Mod 1 Clinic Lecture notes- CMA book – Ch. 6, 44, 45
24
 It is important to check the expiration date of any test kit before giving it to the patient.
 Refer to the procedure on testing for occult blood in Chapter 37, Assisting with Medical
Specialties.
g. Stool for ova and parasites
 The presence of microbial organisms, such as ova and parasites (O&P), may be determined by
testing feces or stool.
 The presence of ova or eggs or other forms of a parasite indicates parasitic infestation.
 Identification of the parasite aids in selecting the correct treatment.
 Commercial kits are available that provide containers for fresh stool specimen and two additional
vials for preserved specimens, one containing formalin and the other containing polyvinyl
alcohol.
 The patient should be instructed to mix portions of stool in each vial and seal.
 If O&P are suspected, three specimen collections will be requested.
 The specimen is usually obtained in the early morning.
 The patient should be instructed to defecate into a stool specimen container or by using a
bedpan, if available, placed over the toilet.
 The stool specimen samples should be taken from several different parts of the stool since
ova and parasites may be in one portion of the stool and not another.
 Refer to Procedure 45-3: Obtaining a Stool Specimen for Ova and Parasites for instructions in this
technique.
1. Explain sensitivity testing. Refer to Box 45-1: Sensitivity Testing.
a. Once the physician or laboratory specialist identifies the pathogenic organism on the culture, it is
necessary to determine which antibiotics will be effective in killing these bacteria.
b. This method of detection is called sensitivity testing.
 A petri dish with Mueller-Hinton agar and antibiotic disks are used.
 A new petri dish with Mueller-Hinton agar is prepared with the pure culture specimen, using
overlapping strokes in a technique called the lawn technique or colony count.
 Several disks, each soaked in a different antibiotic, are placed on top of the inoculated agar.
 The lid of the petri dish is replaced, inverted, and placed in the incubator for 24 hours.
 After 24 hours, the organism will have grown all over except around those disks that inhibit its
growth.
 These zones around the disks are measured to determine the susceptibility of the organism to
each particular antibiotic disk.
 The disk with the largest, clearest area around it has the most effective medication.
 After the most effective antibiotic is identified, the patient is given that medication.
Define serology and discuss serology specimen testing.
1. Serology is the study of the antigen and antibody reactions of the body’s immune system.
Mod 1 Clinic Lecture notes- CMA book – Ch. 6, 44, 45
25
2. The body’s ability to recognize a foreign substance (antigen) and produce an antibody against it is called
the immune response.
3. Antibodies are specific for a particular antigen. For instance, polio antibody is specific for polio only.
4. Antigen-antibody reaction is a frequently used testing tool for pregnancy, rheumatoid arthritis,
mononucleosis, and strep, among other conditions.
5. Test is serological because it studies or tests the serum component of the blood.
6. Test kits contain all of the equipment and supplies necessary and assist the MA in ensuring that reagents
are fresh and quality control is maintained.
7. Kits standardize testing, thus ensuring accuracy, precision, and quality control.
8. It is absolutely essential to follow exactly the manufacturer’s directions.
N. Review the why and the how of performing a strep test.
1. Group A Strep Screen is a test that is done frequently in POLs.
2. Especially efficient in the pediatric office because it is self-contained and can be done while the patient
waits.
3. Screen is an antigen detection test for group A beta-hemolytic streptococci and follows the general
procedure for antigen–antibody agglutination (clumping together) tests, which produce a clumping of
cells.
4. There are many CLIA-waived group A strep kits available that test for the extracted group A beta-
hemolytic streptococcus antigen.
a. These self-contained kits are commercially prepared diagnostic testing kits that include detailed
instructions and contain reagents, controls, and quality control suggestions.
5. A variety of other serological test kits are available for infectious mononucleosis, rheumatoid arthritis,
and HIV, to name a few.
6. The specialty of the physician will determine which tests will be used.
7. Refer to Procedure 45-8: Perform Rapid Group A Strep Testing for detailed instructions in this
technique.
2. Remember that microbiological specimens are living organisms and must have proper conditions to
survive, but not to multiply. Refer to Guidelines 45-1 in the text.
Specimen Collection
 The basic rules for specimen collection are:
 Confirm the identity of the patient by asking the patient to state his or her name and spell it, if
necessary.
 Screen the patient to determine if pretest preparation was followed.
 Collect specimen before beginning antibiotic treatment.
 Collect sufficient quantity of material for testing.
 Use only appropriate collection technique by observing proper cleaning and aseptic procedures
to control contamination.
Mod 1 Clinic Lecture notes- CMA book – Ch. 6, 44, 45
26
 Use only sterile containers.
 Select the proper containers for collection that comply with the reference laboratory’s or outside
laboratory’s requirements.
 Ensure that the collection container is tightly closed and appropriately sealed to avoid leakage
and contamination of the specimen and any surface with which the container may come in
contact.
 Label the specimen accurately at the time of collection with the following information:
 Patient’s full name
 Date
 Time of collection
 Type of specimen
 Antibiotic treatment in use, if any
 Your initials
 Fill out the requisition form for the reference lab and double-check that the information matches
the label.
 Deliver specimen promptly to laboratory and document it. Otherwise, maintain proper storage
until specimen can be picked up or transported appropriately.
 Note: Cerebrospinal fluid always requires immediate delivery.
 Diversity
 What might be some cultural issues with collection of specimens?

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Lecture notes test 5 ch 6 44-45

  • 1. Mod 1 Clinic Lecture notes- CMA book – Ch. 6, 44, 45 1 A. Occupational Safety and Hazard Administration 1. OSHA: a. is a governmental agency b. is responsible for the safety of all employees of companies operating in the United Sates c. ensures the safety and health of America’s workers by setting and enforcing standards d. provides training, outreach, and education related to workplace safety e. encourages continual improvement in workplace safety and health f. has the authority to inspect a workplace without notification g. can fine workplaces where deficiencies in health and safety of employees exist h. is concerned with workplace hazards that might impact the safety of employees See pg. 118 Professionalism box Discuss fire safety in a medical office 1. Each employee should be instructed on the proper use of fire equipment. Review the PASS acronym: Pull, Aim, Squeeze, Sweep. 2. Define the acronym “RACE.” To help employees remember what to do in case of a fire, offices have adopted the acronym “RACE—Rescue, Alert, Confine, and Extinguish. 3. 1. Rescue employees and patients from the fire area. 4. 2. Alert by calling 911. 5. 3. Confine by closing doors and windows. 6. 4. Extinguish the fire. Identify the chemicals in a medical office that are hazardous to the human body. 1. Biohazards such as medical waste and samples of a virus or bacterium pose a threat to human beings and are potentially infectious. 2. Corrosive materials cause burns, and flammable materials can burst into flames. 3. Toxic materials can cause serious illness or death by exposure through skin contact, ingestion, or inhalation. Discuss the purpose and contents of an MSDS. 1. Any workplace where employees handle a hazardous product is required to provide the employees with a Material Safety Data Sheet (MSDS). 2. An MSDS contains printed material concerning a hazardous chemical. 3. Each MSDS offers basic information needed to ensure the safety and health of the user at all stages of manufacture, storage, use, and disposal of a hazardous chemical product. 4. An MSDS provides information regarding the hazards of using the product, how to protect oneself from injury by using the appropriate personal protection equipment (PPE), and what actions to take if an
  • 2. Mod 1 Clinic Lecture notes- CMA book – Ch. 6, 44, 45 2 accidental splash or exposure occurs. PPE consists of protective gloves, fluid-resistant lab coats, safety glasses, and a surgical mask, shield, or respirator. 5. Each office must have an accessible HAZCOM binder where all MSDS information is filed, and all employees must know where the binder is kept. 6. Each office should have a designated OSHA compliance officer, an employee who is aware of and trained in the required controls for use and storage of hazardous materials. 7. Discuss how, through the use of personal protective equipment (PPE), employees can be protected from exposure to bloodborne pathogens. All PPE must be provided by the employer and readily available for use. 8. Explain how safety is the responsibility of every member of the medical office staff. While it is imperative that the medical office staff provide a safe working environment, the staff must also be constantly aware of their surroundings and any possible hazards. Employees must be willing to implement all safeguards to keep themselves and patients safe. Describe the four major types of medical waste: 1. Solid a. Generated in many areas of medicine, including patient rooms and surgery suites b. Not always hazardous, but can cause pollution of the environment c. Mandatory recycling can reduce the amount of solid waste produced 2. Chemical a. Includes substances such as germicides, cleaning solvents, and pharmaceuticals b. Can be a causative factor in a fire or an explosion c. The safe manner with which to handle and dispose of chemicals is included in the MSDS. 3. Radioactive a. Any waste that contains or is contaminated with liquid or solid radioactive material, such as iodine- 123, iodine-131, and thallium-201 b. Must be clearly labeled as “radioactive” c. Must be removed by a licensed disposal agency. 4. Infectious a. Any waste material that has the potential to carry disease b. Includes laboratory cultures, blood, and blood products from blood banks, operating rooms, emergency rooms, medical and dental offices, autopsy suites, and patient rooms. c. Must be separated from other solid and chemical waste at the point of origin d. A licensed medical waste removal agency must dispose of these materials 1. OSHA defines body fluids as: a. Blood b. Semen c. Amniotic fluid
  • 3. Mod 1 Clinic Lecture notes- CMA book – Ch. 6, 44, 45 3 d. Cerebrospinal fluid e. Synovial fluid f. Vaginal secretions g. Pleural fluid h. Pericardial fluid Identify the elements of a written Exposure Control Plan that must be provided to assist in minimizing employee exposure to infectious materials. This plan must be reviewed by all office staff and updated annually. An Exposure Control Plan must include: 1. Exposure determination—listing of job classifications within the office to determine at-risk employees (those with potential exposure to infectious materials) 2. Method of compliance—specific measures to reduce the risk of exposure. 3. Post-exposure—evaluation and follow-up, which specify the steps to follow when an exposure incident occurs. 1. OSHA guidelines for using PPE and clothing are listed in Guidelines 6-2 in the textbook. a. The employer must supply the protective clothing and provide cleaning or disposal of it. b. The clothing or other equipment must be strong enough to act as a barrier to infectious materials that might reach the employee’s street clothing, work clothing, eyes, mouth, or skin. c. Disposable gloves may not be reused. d. Protective eye equipment must have solid sides to prevent infectious material from entering the eye area from the side. e. All equipment and clothing must be removed and placed in a designated container before leaving the medical office. Discuss the purpose and use of an eyewash station. 1. An eyewash station should be available to use in the event that infectious materials enter the eyes. It should be located close to any area where chemicals that may contaminate the eyes or skin are used. 2. The eyewash station should be checked monthly to ensure that it is working properly. 3. Each station is accompanied by a set of instructions; manufacturer’s requirements for use and maintenance should be followed. Procedure 6-2 in the textbook explains proper use of the eyewash station attached to a sink faucet. Review the procedure for using OSHA housekeeping guidelines. 1. Prior to performing any housekeeping procedures, the employee should ensure that the appropriate PPE has been applied. 2. For any wet spills, use the prepared spill kit according to package directions. 3. Immediately clean and disinfect contaminated surfaces with a 1:10 bleach/water solution after exposure to infectious materials. All surfaces must be decontaminated on a regular schedule. This schedule must be posted, signed by the person who performs the decontamination, and kept with OSHA records. 4. Properly bag contaminated clothing and laundry in leakproof, labeled biohazard bags. Contaminated laundry should not be handled or washed at the medical office or with other uncontaminated clothing.
  • 4. Mod 1 Clinic Lecture notes- CMA book – Ch. 6, 44, 45 4 5. Replace a damaged biohazard bag by placing a second bag around the first. Do not remove infectious material from the damaged bag. 6. Biohazardous waste must be removed by a licensed waste disposal service and incinerated or autoclaved before placing in a designated landfill area. 7. Use puncture-proof, sealable, biohazard sharps containers for all needles and sharps, such as razors and glass pipettes. 8. Place the sharps container close to the work area and ensure that the container remains upright. 9. Replace the sharps containers when they are 2/3 full. 10. Seal and label the sharps containers before placing with the biohazard waste for removal by the disposal service. 11. In the event of broken glass, use a dustpan or other mechanical device such as hemostats or another type of forceps to pick it up. Never pick up broken glass with hands. 12. Properly dispose of PPE used during housekeeping. Failure to do so may result in an OSHA citation. 13. Perform hand hygiene both before and after using gloves. Explain the purpose of incident reports. 1. Any unusual occurrence or accident is referred to as an incident in the medical setting. Examples of incidents include: a. A patient falls on a wet floor b. A housekeeping employee is stuck by a needle while emptying the trash c. A prescription pad is missing d. A patient receives the wrong medication e. A patient misplaces or loses personal property, such as a hearing aid or glasses, while in the office f. Syringes or needles are found to be missing from the supply cupboard g. A medical assistant receives a needlestick from a contaminated needle h. An employee’s purse is missing i. A patient is abusive and uses vulgar language 2. Whenever any accident, injury, or unusual occurrence takes place, the employee should immediately notify the supervisor. This is especially important if a needlestick accident is involved because time is of the essence when drawing appropriate baseline blood specimens. 3. The supervisor will require the employee to complete a written report immediately. 4. The incident report should be completed in black ink. 5. An incident report can protect both the employer and the medical assistant against possible lawsuits. 6. Some incidents should also be reported to either the police or the liability insurance carrier. For example, stolen property should be reported to the police, and a slip and fall should be reported to the insurance carrier. 7. The incident should be described as simply as possible, stating only facts and not opinions. 8. The incident report may be used as a legal document; thus only objective information should be
  • 5. Mod 1 Clinic Lecture notes- CMA book – Ch. 6, 44, 45 5 included, such as “Patient fell while getting onto exam table.” Do not include subjective comments, such as “Patient was not paying attention to what he was doing.” 9. Medical offices should have their own customized forms. However, most incident reports include the following information: a. Names of all persons involved b. Date and time of the incident c. Exact location of the incident (including the address of the medical facility and the location of the incident within the facility) d. Name of the person to whom the incident is reported and the time of the report e. Brief description of what happened f. Names of all witnesses g. Name and description of any equipment involved in the incident h. Action taken at the time of the incident i. Action taken to prevent a recurrence j. Signature and title of the person completing the report 10. The incident report, like all other information relating to the patient, is subject to subpoena in litigation (lawsuits). 11. A copy of the incident report should be placed in a master incident report file, the patient’s file, and the employee’s record. See Pg. 128. Image on pg. 129 See Professionalism box pg. 131 Explain the purpose of the Clinical Laboratory Improvement Amendment (CLIA). The federal government now requires that all clinical laboratories that test human specimens must be controlled. The Clinical Laboratories Improvement Amendment of 1988 (CLIA88) divides laboratories into three categories: A. Waived--Simple Testing (Level I) – Incorrect test results pose little risk for the patient. Laboratory is subject to random inspectors only. Some physicians’ laboratories fall in this category. B. Moderately Complex--Intermediate-Level Testing (Level II) – Poses risk to patient if there is an incorrect test result. Must be certified by approved accrediting agency. Must be staffed by credentialed personnel. Must meet quality assurance standards. C. Highly Complex--Complex Testing (Level III) – Poses high risk to patient if there is an incorrect test result. Must be certified by approved accrediting agency. Must be staffed by credentialed personnel. Must meet quality assurance standards. K. Discuss the function of the Joint Commission 1. The Joint Commission is a private, nongovernmental agency that establishes guidelines for hospitals and health care agencies regarding quality care. 2. Supported by representatives of the American Hospital Association, American College of Physicians, American College of Surgeons, and American Dental Association
  • 6. Mod 1 Clinic Lecture notes- CMA book – Ch. 6, 44, 45 6 3. Forms guidelines for hospitals, ambulatory care facilities, and long-term care institutions and conducts surveys and accreditation programs 4. Indicators for accreditation include: a. Mortality rate b. Frequency of medical complications c. Nosocomial infection rate d. Autopsy rate 5. Does not have authority to take punitive action for poor treatment, but its survey results can be used by other agencies to impose sanctions or penalties. Explain the three types of clinical laboratories that perform tests of varying levels of complexity. 1. Outside laboratory a. Either a hospital-based or independent laboratory. b. Handles specimens collected from many types of facilities. c. Performs tests ranging from simple to very complex. d. A patient may go to the outside laboratory to have blood drawn or a specimen taken with the test results to be sent to the referring physician. e. A medical assistant may be employed in one of these laboratories as a phlebotomist (one who performs a blood draw) or as an administrative assistant. f. Outside laboratories typically provide supplies and forms for specimen collection and transport. g. Most offer a directory with instructions for proper handling and transport of specimens. h. When these instructions are available, always consult them to determine how much of a specimen to collect, which container to use, and how to prepare the specimen for transport. i. The MA is also responsible for requesting additional supplies to replenish the inventory on hand. 3. Physician’s office laboratory (POL) a. Some of the tests the physician orders are performed in the office. b. In the POL, the doctor has the advantage of receiving the results more rapidly than if tests are done outside of the office. c. Turnaround time is how long it takes for the test to be performed and the results generated, sent back for physician review, and added to the patient’s chart. d. Disadvantages to the POL: In-house testing may require more employees and the purchase of expensive equipment. e. This is the laboratory environment that MAs are particularly suited to, although they are limited to performing only CLIA-waived tests. f. The POL is usually housed in a separate room or work area that is well lighted and adequately ventilated.
  • 7. Mod 1 Clinic Lecture notes- CMA book – Ch. 6, 44, 45 7  Most have a refrigerator that is clearly labeled for storage of (potentially infectious) specimens only.  A supply of PPE, including gloves, masks, gowns, and protective eyewear is essential.  A sharps container and a biohazardous waste receptacle should be within easy reach.  Hand-washing facilities and an eyewash station are also important. Discuss the medical assistant’s role in the clinical laboratory. 1. Medical assistants are particularly suited to working in POLs and clinical laboratories because of their cross-training in administrative and clinical areas. a. For MAs working in a laboratory, training in phlebotomy and basic knowledge of laboratory testing are essential. b. In addition, training in administrative duties helps medical assistants to perform the many administrative tasks required in a laboratory. c. MAs’ patient-oriented training helps them to be empathetic caregivers. d. Whether you work as a medical assistant in a laboratory or in other areas of a medical practice, a fundamental understanding of basic lab methods and techniques helps you understand the nature and importance of specific tests. This includes an understanding of why specific tests are done, how to prepare a patient for a test, conditions that may render a test inaccurate, and how to evaluate the results. 2. Medical assistants may play any of several key roles in a clinical laboratory. 3. Depending on their level of involvement in the laboratory, these roles may include record management, teaching patients, specimen management, and quality assurance. a. Discuss record management in the clinical laboratory. b. Methods of lab test record management vary, depending on where a sample is collected and where it is tested. c. The first priority is to make sure that the physician’s order is clearly recorded and the proper lab forms are completed. d. In-house collection and processing must be charted. e. Results should be evaluated and carefully documented. f. A requisition is a form that provides essential information about  the test that is ordered  how results will be reported  information for billing and coding 4. The MA will need to complete a requisition if not performing the tests right away. a. The requisition will be transported with specimens that are collected at the physician’s office and sent out for testing. b. Alternatively, the requisition will go with the patient, who is required to travel to a laboratory for collection and testing.
  • 8. Mod 1 Clinic Lecture notes- CMA book – Ch. 6, 44, 45 8 c. If the physician wants the results immediately for a medical intervention, then the requisition must be labeled STAT (immediately) and processed accordingly. 5. Refer to Procedure 44-1: Completing a Laboratory Requisition and Preparing a Specimen for Transport to an Outside Laboratory in the text for detailed instructions on this process. 1. Specimen Management a. A specimen is a small sample taken from the body, such as:  Urine  Feces  Sputum  Blood  Other body tissues or secretions. b. Urine and blood are the most commonly obtained specimens for laboratory testing.  It is vital to properly collect and preserve a specimen to ensure that it truly represents the patient’s body functions.  Otherwise, inaccurate test results are likely, which may alter the patient’s diagnosis and treatment. c. In a POL:  Specimens are generally processed for in-house testing according to office policy  Some may be prepared for transportation to an outside lab.  The MA should perform CLIA-waived tests precisely according to manufacturer’s instructions after checking expiration dates.  If specimens are sent to an outside lab:  Determine the specific requirements of the lab being used.  Each lab has its own policies regarding which specimen containers to use and how much to collect.  Some specimens will need to be refrigerated, spun, or have chemicals added to them.  Some labs schedule routine pickups, but others may require specific contact to pick up a specimen. d. Refer again to Procedure 44-1 to review the steps to correctly complete a laboratory requisition and prepare a specimen for transportation to an outside laboratory. e. Complications of specimen collection may occur.  If there is difficulty drawing blood, the cells may hemolyze, or burst.  Accidental contamination or collection in the wrong container can be a problem.  Exposure to heat or direct sunlight may cause damage.
  • 9. Mod 1 Clinic Lecture notes- CMA book – Ch. 6, 44, 45 9  If less than the required amount of a specimen is collected, testing may not be possible; in this case, a lab report will read QNS (quantity not sufficient).  Incomplete or incorrectly handled specimens may require retesting. f. To avoid collecting a specimen from the wrong patient, proper identification is important. Use this three-step process:  Check the chart to verify the order.  During introductions, ask the patient to state his or her full name and date of birth. The patient must state, rather than verify, this information to prevent miscommunication, especially if there is a language barrier or the patient has difficulty hearing.  Compare the information the patient has given with the chart to verify that this is the right patient. Always compare both the name and the date of birth in case more than one person with that name has a file in the same office. g. Properly labeling specimens is essential.  Use two identifiers (such as name and date of birth),  Indicate the date and time collected. h. To prevent cross contamination and mislabeling specimens:  A label should never be placed on a removable lid  A specimen should always be sealed and labeled before walking away from a sample. i. If the patient was not supposed to eat before the test and forgot, label the specimen as non-fasting and check with the physician to determine if the test should still be run. A. Discuss the role of the medical assistant in carrying out quality assurance (QA) procedures. 1. Planned and systematic activities to ensure that requirements are met and results are accurate. 2. A QA program is a written program that includes mechanisms to evaluate laboratory procedures and policies, identify and correct problems, and ensure reliable and prompt reporting of results and testing by competent individuals. 3. Steps for quality assurance in the laboratory: a. Most offices and laboratories have a policies and procedures manual with a set of routine checklists to follow.  A basic QA checklist generally begins with keeping the lab and patient areas clean and providing clear patient instructions.  It includes restocking supplies to ensure that the correct materials are available.  Checking storage instructions and expiration dates for all reagents and test kits is important before storage and before use. b. QA involves routinely reviewing procedure manuals and following the most recent manufacturer’s instructions for correct test performance. c. Scheduling or performing routine equipment maintenance, including calibrations, should always be properly documented.
  • 10. Mod 1 Clinic Lecture notes- CMA book – Ch. 6, 44, 45 10 d. Laboratory refrigerators should be properly labeled for restricted use and should have a thermometer that is both checked and recorded daily. e. When opening a new stock container of multiuse reagents, chemicals, or test strips, you should date and initial the container. f. You should also be able to identify assigned lab values and compare them to the specimen result. 4. Maintenance a. All laboratory equipment must be maintained on a regular basis according to manufacturers’ instructions. b. A written record of the maintenance performed must be readily available. c. A record of each piece of equipment with model and serial numbers, date of purchase, and manufacturers’ inserts should be available when repair is necessary or the laboratory is being inspected. 5. Documentation a. Documentation is important for QA. Without a written record of a test result, control result, maintenance performed, or temperature recorded, you have no proof of activity. b. The end result is the same as if you did not perform the procedure. c. If it is not written down in the appropriate place, you did not do it. E. Discuss quality control (QC), which is focused on physical proof that results are accurate. 1. QC is accomplished by routinely performing mock tests, using one of two predetermined methods: a. Calibration  Some machines require evaluation by calibration devices, which are specially prepared test strips or cartridges that are designed to produce a predetermined result. b. Control solutions  Other tests are evaluated by using regular testing materials but, instead of adding a patient sample, a provided control solution is added in its place.  Control solutions are chemicals that produce an expected result; they are usually purchased from or provided by the manufacturer of the testing equipment. c. In either case, the result should fall within the acceptable range listed on the calibration device or control solution bottle. 2. Abnormal quality control results should always be investigated. a. Things that may cause abnormal results include  User error  Impaired quality  Outdated materials  A malfunctioning machine
  • 11. Mod 1 Clinic Lecture notes- CMA book – Ch. 6, 44, 45 11 b. In this case, try retesting with newly opened materials or asking a coworker to perform a quality control test. c. If results remain abnormal, the machine is not considered accurate and should be serviced or repaired and retested before using on patients. 3. QC tests are performed according to manufacturer’s requirements and lab policy, often daily. a. Results are recorded in a quality control log, which is evaluated after each use. b. The CLIA 1992 standards mandate that written policies and procedures must be in place for a comprehensive quality control program that will “evaluate the ongoing and overall quality of the testing process.” c. To this end, the laboratory is required to do the following:  Evaluate the effectiveness of its policies and procedures.  Identify and correct problems.  Ensure reliable and prompt test results.  Ensure the competence and adequacy of staff.  Take corrective action if errors are found.  Integrate corrective procedures into future policies and procedures.  Document employee training and assess competency yearly after the first year. • Maintain the identity and integrity of patient samples during the entire testing process. d. • Be subject to inspection every two years if performing moderate- or high-complexity tests. 4. Refer to Box 44-2: Using Controls to Monitor Results for more information on this topic. a. As a professional in health care, it is important that you comprehend the importance of patient test results and control samples. What would you do if the control sample results were correct according to the manufacturer’s value sheet, but the patient test results were very abnormal compared with the reference values of your facility? For example, imagine a patient’s fasting glucose level is 47 mg/dL when tested. b. The reference range in your facility is 70 to 100 mg/dL. c. The control tests were 55 mg/dL and 132 mg/dL, which were in range according to the manufacturer.  If a result seems incongruous to you, it should not be reported without retesting.  The test and controls should be repeated.  The original specimen should be examined to ascertain that the specimen was not hemolyzed (red cells burst, causing serum to be a cherry-red color) or icteric (bilious yellow-green color). If either problem exists, a new specimen may be required and the test should be repeated.  The results from previous tests on this patient should be examined. Is there a pattern among previous test results?
  • 12. Mod 1 Clinic Lecture notes- CMA book – Ch. 6, 44, 45 12  The patient’s results should be flagged and brought to the attention of the supervisor or physician if test and control results were the same as the first test results.  A protocol should be in place in your POL that establishes the appropriate steps to follow when a result is flagged.  A small portion of the original specimen may be sent to an outside laboratory for testing to compare results. 5. Refer to Procedure 44-3: Evaluating a Contour TS Glucometer Using Control Solutions for detailed instructions for carrying out one such control solution test. Explain the Clinical Laboratory Improvement Amendments (CLIA). 1. In 1988 Congress enacted CLIA as developed by the Centers for Medicare and Medicaid Services (CMS) in response to widespread concern over the accuracy of laboratory tests. 2. Mandates that all laboratories that test human specimens must be regulated to help ensure accurate patient test results. 3. Since their enactment in 1988, the CLIA have been kept current through periodic amendments and updates. CLIA divide laboratories into three categories: waived, moderate complexity, and high complexity. 4. Medical assistants are qualified to perform only waived testing. 5. Many CLIA-waived tests are simple enough for a patient to perform at home with basic instructions. a. In the POL, they frequently come in a boxed test kit set, which contains several tests and the materials needed to properly use them. b. Many automated analyzers are now CLIA-waived, too, as a result of the advancements of technology. c. An automated analyzer is typically a small or handheld machine that processes a specimen with single-use reagent test strips or cassettes. d. Results are displayed quickly, proving an advantage for a patient who may need to be treated right away. 6. Information regarding state laboratory regulations may be obtained from state health departments. 7. A facility is required to have a Certificate of Waiver from the Centers for Medicare and Medicaid Services (CMS) so that its employees can legally perform simple tests used to prevent, diagnose, or treat a disorder or disease. a. These tests are referred to as Certificate of Waiver Tests (WTs) or CLIA-Waived Tests. b. They are the least complex and present the least risk if performed incorrectly. c. Some examples of these tests are indicated in Box 44-3. d. Many of these tests have been approved by the FDA for home use. e. These are the only laboratory tests that a medical assistant may perform without further training; they may only be performed in a laboratory that has been granted a Certificate of Waiver.
  • 13. Mod 1 Clinic Lecture notes- CMA book – Ch. 6, 44, 45 13 8. Although other types of testing are discussed in the textbook, anything that is not CLIA-waived is for demonstration purposes only and does not qualify the medical assistant to perform that test in the laboratory. 9. To maintain CLIA-waived status, facilities must permit on-site inspections, as requested. a. During an inspection, evaluators will determine if necessary standards are being met. b. A significant issue of discovery is when manufacturer’s instructions are either missing, outdated, or not followed to the letter. c. This is a concern, because the only CLIA requirement for performing waived testing is to follow the manufacturer’s instructions. 10. Improper testing can lead to inaccurate results, which may result in incorrect diagnosis or treatment. Therefore, if modified even the slightest bit, tests are no longer considered waived tests and become subject to the more stringent CLIA requirements. 11. A POL must apply to perform WTs and then may not perform the more complex tests from Level I or Level II. 12. Approved tests are considered exempt from complying with CLIA 1988 standards and are thus termed CLIA-waived or waived tests (WTs). a. However, quality assurance and quality control methods should still be observed. 13. The laboratories that perform WTs may be subject to random inspections and investigation if test results are questioned or complaints are made against the laboratory. 14. A Certificate of waiver is given to laboratories that perform only low-complexity tests. a. A POL qualified to perform moderate-complexity and waived tests receives a Certificate of Provider-Performed Microscopy (PPM). b. A medical assistant employed in a facility with a PPM certificate can perform moderate- complexity tests with further training and under the supervision of a laboratory professional or physician. 15. Refer to Box 44-3: Categories of CLIA Tests for tests in the different categories: a. Waived Tests—Simple procedures approved for home use and POL or POC testing. Common examples include:  Dipstick urine testing or table testing  Fecal occult blood testing  Ovulation testing  Urine pregnancy testing  Erythrocyte sedimentation rate (non-automated)  Hemoglobin testing with CLIA-waived analyzer  Spun hematocrit  Blood glucose using FDA-approved glucose analyzer  Rapid Streptococcus testing b. Moderate-Complexity Tests/Level I Tests
  • 14. Mod 1 Clinic Lecture notes- CMA book – Ch. 6, 44, 45 14  75 percent of tests performed daily using automated analyzers for chemistry and hematology; microscopic analysis of urine sediment c. High-Complexity Tests/Level II Tests  All tests in the field of cytogenetics, cytology, histopathology, and histocompatibility 16. Refer to Box 44-4: Critical Steps in CLIA Testing for required procedures. a. Follow the instructions in the most current manufacturer’s product insert EXACTLY. b. Report results using proper documentation and recordkeeping. c. Adhere to expiration dates. d. Perform quality control testing regularly. e. Use only recommended storage requirements. f. Keep manufacturer’s instructions in an easily accessible area. g. Replace manufacturer’s instructions every time a new product is received. h. Be aware of federal, state, and local regulations. Explain that the laboratory includes biohazards, chemical hazards, and physical hazards and that most accidents are preventable. 1. Laboratory safety must be the concern of all who are employed in the laboratory field. 2. Medical assistants must be familiar with the following regulations: a. Hazard Communication Standard b. Universal Precautions and Bloodborne Pathogen Standards c. Hazardous Waste Operations d. Needlestick Safety and Prevention Act 3. Chemical hazards a. Material Safety Data Sheets (MSDSs) provide safety information for all in the laboratory environment including:  Product identification  Safety information about proper storage and disposal  Potential health hazards  Handling precautions  Fire and explosion information b. All laboratory personnel have the right to know about hazards pertaining to materials they are using and must receive training appropriate to the materials in use. c. Each hazardous substance must have a hazardous material label attached to the container that provides a shortened version of the MSDS information. 4. Bloodborne pathogens a. Biohazards are hazards that have the potential to infect others.
  • 15. Mod 1 Clinic Lecture notes- CMA book – Ch. 6, 44, 45 15 b. Since 1992, OSHA’s Occupational Exposure to Bloodborne Pathogen Program must be in place at all working laboratories. c. The CDC specimen-handling precautions known as standard precautions (formerly universal precautions) must be employed when dealing with any infectious materials. d. All potentially biohazardous material must be labeled with the biohazard label. 5. Needlestick hazards a. Since OSHA revised the bloodborne standards to include the Needlestick Safety and Prevention Act of 2000, health care employers must follow certain safety protocols:  Review all new safety devices to lessen the needlestick risks of their employees.  Ask for safety input from their employees on an annual basis.  Keep a detailed report of all contaminated needlestick incidents. 6. Fire and safety hazards a. Staff must take care to reduce the chances of fire and electrical accidents by having an awareness of the floor plan and exits. b. They must be familiar with the floor plan, exits, and location of safety devices such as eye washes, showers, and safety blankets. 7. Hazardous waste removal a. Hazardous waste includes:  Blood  Blood products  Body fluids and tissues  Cultures  Vaccines  Sharps  Gloves  Inoculation loops  Paper contaminated with body fluids All must be disposed of in proper containers identified with biohazard labels. Sharps must be placed in punctureproof, leakproof containers. 1. Microscope a. Frequently used in the medical office to examine urine sediment, vaginal and bacteriological smears, and differential smears, which categorize types of white cells in a sample.  This optical instrument magnifies structures unseen by the naked eye for the purpose of counting, naming, or differentiating.  A compound microscope achieves maximum magnification by using two sets of lenses: oculars (eyepiece lenses) and objectives (lenses at the bottom near the sample).
  • 16. Mod 1 Clinic Lecture notes- CMA book – Ch. 6, 44, 45 16  The resolution of a microscope refers to the ability to distinguish clearly between two adjacent but distinct objects.  Better microscopes have better resolution. b. Parts of the microscope:  One or multiple eyepieces (monocular or binocular) with magnification imprinted on them  Body tube (directional light source)  Arm (used in carrying the microscope)  Revolving nosepiece (holds objectives and rotates for selection)  Objectives (magnification imprinted on each objective: 10, low-power setting; 40, high dry setting; and 100, oil immersion setting  Stage  Mechanical stage (movable device that holds slide)  Mechanical stage adjustments (two knobs that control vertical/horizontal movement of slide)  Coarse and fine adjustment knobs (small knob atop larger knob that adjusts stage up and down for focusing)  Condenser (lens system used to increase light for sharper focus)  Condenser adjustment knob  Light source (illuminator set in base)  Iris diaphragm lever  Base (holds illuminator, rheostat, and microscope upright and is used while carrying microscope) c. Using the microscope:  Magnification of an object is calculated by multiplying the objective magnification by the eyepiece magnification.  On low power, magnification would be 10 (the objective) times 10 (the eyepiece) equaling magnification of 100 times the size of the sample.  It is important to use the correct lens for the type of microscopic work to be done. For example, the low-power objective, 10×, is used to view epithelial cells, such as skin scrapings; the high dry setting, 40×, is used for urine RBCs (red blood cells), WBCs (white blood cells), or blood RBCs; the oil immersion setting, 100×, is for differential blood smears (stained with Wright’s stain) or bacteria slides (stained with Gram stain).  Microscopic work on the high dry setting is done with a cover glass on the specimen. d. Refer to Procedure 44-4: Using and Cleaning the Microscope for instructions on these techniques. Equipment and Supplies: Binocular compound microscope; specimen slide; lens paper; lens cleaner; dust cover for microscope Method  Always carry the microscope with one hand on the arm and one hand under the base.  Make sure the stage is in the down position before starting.  Clean objectives with lens paper starting with 10× and ending with oil immersion.  Turn on the light and rotate the nosepiece until the 10× objective is directly over the slide. Place the prepared slide on the stage.  Use the coarse adjustment knob to raise the stage until the objective is close to the slide on the stage.  Look through the eyepiece and adjust the coarse focus knob until the microscope field is seen (a round circle of bright light).
  • 17. Mod 1 Clinic Lecture notes- CMA book – Ch. 6, 44, 45 17  Use the fine adjustment knob for a clearer image.  Open the diaphragm and, if necessary, adjust the rheostat to focus. Clean the objective lens.  Raise or lower the condenser to alter light refraction. The condenser is usually lowered when using 10× power.  Observe the slide.  Change the objective to 40× and readjust as needed. Move the objective and place a drop of oil on the slide before completing the turn to oil immersion lens.  When focusing and examination are complete, lower the stage before removing the slide.  Turn off the light.  Clean the eyepieces and objectives with lens paper. Clean the oil immersion lens with lens cleaner.  Unplug the electrical cord and wrap it around the base.  Cover the microscope with a dust cover.  Clean the slide and store. e. Care of the microscope:  Microscopes are delicate instruments that will last for many years if maintained properly.  Refer to Guidelines 44-1 for the rules for the proper care and maintenance of a microscope: Care and maintenance of a microscope  Follow cleaning requirements during mandatory daily maintenance.  Always use two hands to carry a microscope: one hand to hold the arm of the microscope and one to support the base.  Clean oculars, objectives, and stage using only lens paper and lens cleaner.  Keep extra light bulbs on hand.  Document inspections and repairs in logbook.  Store with electrical cord wrapped loosely around base.  Cover the microscope with a dust cover when it is not in use. Begin the lesson by defining microbiology and explaining microorganisms. 1. The field of microbiology is the study of living organisms too small to be seen with the naked eye (microorganisms). 2. Antonie Van Leeuwenhoek’s invention of the microscope in 1674 allowed people to observe microbes for the first time. 3. Louis Pasteur, the father of microbiology, developed methods for culturing and identifying microbes in the laboratory. 4. The study of microorganisms has greatly advanced the field of medicine and currently allows individuals to live longer, healthier lives. a. To successfully treat a patient, it is important to first discover the exact cause of the problem.
  • 18. Mod 1 Clinic Lecture notes- CMA book – Ch. 6, 44, 45 18 b. By evaluating body fluid samples, an offending microorganism may be identified so that the most effective medication or treatment can be prescribed. 5. We are surrounded by microorganisms. Yet not all bacteria are bad. a. Bacteria in the environment help us to decompose and recycle waste. b. Normal flora on our bodies consist of beneficial bacteria that help us resist pathogens. 6. However, a bacterium that is harmless in one area may be pathogenic in another, especially in large amounts or in an area that is normally sterile. 7. It is important to understand differences between microorganisms and learn which can be harmful to effectively help patients to recover from illness. 1. Bacteria can be characterized by their reactions to certain stains. a. A stain is a dye used in coloring microorganisms to allow for visibility under a microscope. b. The Gram stain, named for Dr. Hans C. J. Gram, a Danish physician, is a commonly used method of staining bacteria.  A gram-positive bacterium retains the violet color of the stain used in the staining of the microorganism.  Some of the more common gram-positive bacteria are Staphylococcus aureus and Streptococcus pneumoniae.  A gram-negative bacterium has the pink color of the counterstain used in Gram’s method of staining microorganisms.  A few of the most common gram-negative bacteria are Escherichia coli, Neisseria gonorrhoeae, and Salmonella typhimurium. c. Some organisms do not stain well with Gram stain and require a special stain, such as the acid- fast stain used for the organism that causes tuberculosis. 4. Bacteria can be categorized by their use of oxygen: a. Aerobes can survive in an oxygen-rich environment. b. Anaerobes die in the presence of oxygen. c. Facultative anaerobes are flexible and can live with some oxygen. d. Successful culturing requires an understanding of the oxygen requirements of bacteria. e. If the ultimate goal is to grow and identify a sample of the organism that is causing disease in a patient, then we must provide proper oxygen, moisture, nutrition, and temperature in the laboratory setting. 5. Bacteria have other identifying characteristics: a. Differences such as cell structure and the presence or absence of organelles (small structures in the cytoplasm of a cell) are used to classify organisms.  If they are capable of movement, their means of motility is unique to specific categories of microorganisms.
  • 19. Mod 1 Clinic Lecture notes- CMA book – Ch. 6, 44, 45 19  They may possess flagella (long whiplike extensions of the cytoplasm) or cilia (fine hairlike extensions).  For example, Trichomonas vaginalis, the protozoan that is responsible for one type of vaginitis, has four flagella at one end that produce the characteristic circular whiplike movement seen in wet preparations and microscopic examinations of infected individuals’ urine. b. Bacteria can also be categorized by their ability to hemolyze (burst) red blood cells in the blood agar (a medium for growing bacterial cultures that contains whole blood). c. Biochemical analysis, often done on semiautomated analyzers, provides the microbiologist with information that assists in identification of certain pathogens, such as enteric organisms (those that live in the intestines). C. Point out how microbes can be divided into groups based on special characteristics. 1. Bacteria (singular: bacterium) a. Small, unicellular microorganisms that are capable of rapid reproduction. b. Although their mere presence is not necessarily harmful, the overgrowth of bacteria can cause an imbalance and lead to disease or pathology. c. Most bacteria thrive in a warm, dark, moist environment. Because the human body is capable of providing this atmosphere upon entry, bacteria can easily thrive and grow. d. Their reproductive ability explains how some infections become overwhelming in a short period of time and can be dangerous.  For example, one Escherichia coli organism, the most common cause of urinary tract infections (UTIs), reproduces in about 30 minutes.  By the end of a 24-hour period, this one Escherichia coli (E. coli) cell will have produced an enormous number of cells capable of creating an infection if they have been introduced into the bladder. e. Bacteria may be named for their morphology (shape):  Cocci (spherical)  Bacilli (rod-shaped)  Spirilla (spiral shape) Discuss coccus/cocci, round bacteria that are arranged in various configurations. 1. Staphylococci are gram-positive, grape-like clusters of cocci, some of which are pathogenic. a. Nonpathogenic staphylococci are found on our skin and in many of our body orifices, or openings. b. Staphylococcus aureus (S. aureus), or staph, is the major pathogen of this genus and may be found as normal flora in the nose and on the skin.  It causes infection, especially when resistance is lowered by a break in the skin or in the mucous membranes.  The skin is the most common site of infection by S. aureus.
  • 20. Mod 1 Clinic Lecture notes- CMA book – Ch. 6, 44, 45 20  It produces infections such as impetigo in children and is associated with infection of wound sites and surgical incisions.  It causes pus-producing abscesses such as boils, carbuncles, and folliculitis.  S. aureus is a common cause of nosocomial infections and may also cause pneumonia, meningitis, and septicemia in individuals with reduced resistance.  Toxic shock syndrome is also caused by this virulent organism.  S. aureus produces one type of enteritis (food poisoning) that occurs within in a few hours of eating improperly refrigerated food contaminated with the toxin produced by the bacteria. This toxin causes nausea, vomiting, diarrhea, and abdominal cramping.  S. aureus is coagulase positive, meaning it produces an enzyme that can be used to help differentiate S. aureus from other species of this organism. 2. Today, because of increased reliance on treatment with antibiotics to treat low-level infections, superbugs are becoming common. a. This term refers to various microorganisms that are mutating to produce antibiotic-resistant forms. b. Of particular interest is methicillin-resistant Staphylococcus aureus (MRSA).  This form of S. aureus produces an enzyme the makes the organism resistant to penicillins and cephalosporins normally used for treatment and renders these antibiotics ineffective.  Similarly, vancomycin-resistant enterococci (VRE) and carbapenem-resistant enterobacteriaceae (CRE) are becoming more prevalent.  Tests are available to indicate the presence or absence of this enzyme and help determine the most favorable treatment. c. The problem of antibiotic resistance is a major concern for health care providers and is being experienced worldwide. Describe the infectious organisms known as viruses. 1. Although potent, a virus is the smallest known infectious organism and requires the use of an electron microscope for visualization. 2. A virus, a simpler form of life than a cell, is parasitic, depending on living cells of other organisms for growth. 3. When a virus enters a cell, it may immediately cause a disease, such as influenza, or it may remain dormant for days or even years. a. Herpes zoster can cause an outbreak of chickenpox within 7 to 14 days of exposure, where HIV can lie dormant for years before symptoms are note. 4. Viruses cause many common diseases such as colds, chickenpox, mumps, infectious mononucleosis, and warts. 5. Other illnesses caused by viruses are hepatitis, measles, encephalitis, and herpes. 6. Fortunately, vaccines are available to protect people from viral diseases such as polio, German measles, measles, hepatitis B, mumps, and chickenpox.
  • 21. Mod 1 Clinic Lecture notes- CMA book – Ch. 6, 44, 45 21 Define fungi and the classifications used for this group of microorganisms. 1. The study of fungi (singular is fungus) is known as mycology. 2. Fungi are present in soil, water, and air. 3. Fungi are unable to make their own food, so they depend on other life forms. 4. Included in this classification are yeasts and molds. 5. In our environment we encounter fungi in the form of mushrooms and penicillin molds on stale bread. 6. Penicillium mold was discovered by Alexander Fleming, and its antibiotic properties changed modern medical treatment. 7. Penicillin is now synthetically produced. 8. Yeasts are single-celled fungi that reproduce by budding. 9. Molds are those fungi that produce spores. 10. Most fungi are not pathogenic and cause few diseases in humans. Of the ones that do, most will produce only superficial infections, such as athlete’s foot (Tinea pedis) or ringworm. 11. A few do produce life-threatening illnesses when they invade the internal organs of the body. 12. Candida albicans is the causative agent of moniliasis or candidiasis, a yeast infection, and thrush. 13. Individuals with compromised immune systems or those who have been on long-term antibiotic therapy may develop severe infections. a. In these cases, the normal flora that protect the openings of the body cavities are killed by the antibiotic therapy and allow harmful fungi a fertile environment in which to reproduce. b. This type of infection is referred to as a superinfection. 14. It takes a long time and persistence to get rid of a fungal infection. Fungal infections are resistant to antibiotics and must be treated with antifungal agents. 1. Collection Devices: a. Sterile swabs are frequently used in collection of specimens.  The shafts and the tips of swabs vary in terms of the type of material used.  They are wrapped in a sterile wrapper or container to preserve sterility.  Cotton swabs are used less frequently today because certain microbes are inhibited by the natural ingredients in cotton.  Polyester and rayon are used for the tips and wood, plastic, or wire for the shaft.  Swabs also vary in size of tip and flexibility of the shaft to permit collection in difficult-to-reach areas.  After a swab is collected, it is placed in a sterile container that may or may not contain culture media. C. Note that pathogens can be observed in specimens of blood, feces, cerebrospinal fluids, mucus, urine, sputum, wounds, tissue, and exudates of other body specimens. Review the types of specimens and information for obtaining them. 1. Throat
  • 22. Mod 1 Clinic Lecture notes- CMA book – Ch. 6, 44, 45 22 a. One of the most frequently requested specimens in a POL is a throat swab or culture. b. Based on signs and symptoms the patient presents with, such as upper respiratory infection, sore throat, or sinus infection, the physician will order a throat culture to identify the pathogen involved and begin treatment. c. Confirmation of Streptococcus pyogenes is important because of its virulence and possible complications. d. When performing a throat culture, it is important not to touch the insides of the mouth or the tongue with the swab to avoid contaminating it. e. If the culture is to be done in house, it is streaked.  A bacitracin antibiotic disk will be placed on the culture plate in the area with the heaviest inoculation.  A zone of no growth around the disk is presumptive evidence that the pathogen is group A beta- hemolytic strep.  Other strep organisms are not sensitive to bacitracin.  Bacitracin is not used to treat strep throat, only as a differentiating antibiotic.  Broad-spectrum antibiotics such as penicillin, ampicillin, and erythromycin are used to treat strep.  If strep is suspected, an antigen–antibody test for strep may be ordered. f. Nasal swabs are sometimes requested, and care should be taken to label the swabs “Right” and “Left” to identify from which nostril the specimen was taken. g. Smaller sterile swabs with thinner more flexible shafts are generally used for obtaining nasal specimen. h. Refer to Procedure 45-1: Obtaining a Throat Culture for instructions in this procedure: 2. Sputum a.To obtain a sputum (mucous substance expelled by coughing or clearing the bronchi) specimen, the patient must be carefully instructed to cough deeply and spit up the coughed up material into a sterile container. b. Explain to the patient that this should not be saliva from the mouth. c.Often it is possible to obtain a good sputum specimen if the patient is reminded to try on rising in the morning, using a sterile container provided by the POL. d. The purpose for obtaining a sputum specimen is to isolate and diagnose diseases such as streptococcal pneumonia, influenza, and tuberculosis. e. Refer to Procedure 45-2: Obtaining a Sputum Specimen for Culture for instructions on this procedure. 3. Urine a. A urine specimen for culture must be either a catheterized specimen or a clean-catch midstream sample (CCMS).  Both methods provide sterile samples.
  • 23. Mod 1 Clinic Lecture notes- CMA book – Ch. 6, 44, 45 23  Any other type of urine specimen (one for routine analysis, for example) would be contaminated by organisms in the container or on the hands or genitals of the patient. b. Refer to Procedure 46-1 in Chapter 46, Urinalysis, for collection of a clean-catch midstream urine specimen from both male and female patients. 4. Stool a. Stool or feces (waste product from bowel) may be tested for bacterial, parasitic, or protozoal infections; for the presence of occult blood; and for excessive amounts of fat (steatorrhea). b. The collection of stool specimens varies with the type of test ordered. c. Discussing stool sample collection is often embarrassing to both patient and medical assistant; however, correct collection is critical to an accurate result. d. Fecal specimens must be free of urine, water from the toilet, and toilet tissue. e. Stool culture  To detect bacteria or viruses a small amount of feces is needed.  The collection containers must be sterile, and aseptic technique must be used in the collection process.  Once collected, the stool must be sent immediately to the testing facility.  Sterile collection devices are available.  Sheets of special paper, coverings for the toilet, and bedpans can be used to collect specimens.  Sterile tongue depressors or applicator sticks can be used to transfer a small of amount of stool to a sterile container for transportation to the laboratory or office.  In the office a sterile bedpan may be used or sterile pan placed over the bowl of the toilet. f. Occult blood  A stool specimen is required to test for occult or hidden blood that may indicate bleeding in the gastrointestinal tract.  Often the patient is given the test units to take home and collect the specimen.  Directions are provided on each test unit; however, instructions should be reviewed each time they are given to a patient.  Patients are instructed to write their name, date, and doctor’s name on label of the collection unit.  Using one of the wooden spatulas provided, they are to collect a small amount of stool and place it in one of the circles on the back of the booklet, obtain another sample from a different area of the stool, and placed on the other circle.  Patients should close the unit and take it or mail it to the doctor’s office or the laboratory as requested.  For more accurate results patients should be instructed to refrain from consuming vitamin C and red meat for three days prior to testing because they may cause false positives.
  • 24. Mod 1 Clinic Lecture notes- CMA book – Ch. 6, 44, 45 24  It is important to check the expiration date of any test kit before giving it to the patient.  Refer to the procedure on testing for occult blood in Chapter 37, Assisting with Medical Specialties. g. Stool for ova and parasites  The presence of microbial organisms, such as ova and parasites (O&P), may be determined by testing feces or stool.  The presence of ova or eggs or other forms of a parasite indicates parasitic infestation.  Identification of the parasite aids in selecting the correct treatment.  Commercial kits are available that provide containers for fresh stool specimen and two additional vials for preserved specimens, one containing formalin and the other containing polyvinyl alcohol.  The patient should be instructed to mix portions of stool in each vial and seal.  If O&P are suspected, three specimen collections will be requested.  The specimen is usually obtained in the early morning.  The patient should be instructed to defecate into a stool specimen container or by using a bedpan, if available, placed over the toilet.  The stool specimen samples should be taken from several different parts of the stool since ova and parasites may be in one portion of the stool and not another.  Refer to Procedure 45-3: Obtaining a Stool Specimen for Ova and Parasites for instructions in this technique. 1. Explain sensitivity testing. Refer to Box 45-1: Sensitivity Testing. a. Once the physician or laboratory specialist identifies the pathogenic organism on the culture, it is necessary to determine which antibiotics will be effective in killing these bacteria. b. This method of detection is called sensitivity testing.  A petri dish with Mueller-Hinton agar and antibiotic disks are used.  A new petri dish with Mueller-Hinton agar is prepared with the pure culture specimen, using overlapping strokes in a technique called the lawn technique or colony count.  Several disks, each soaked in a different antibiotic, are placed on top of the inoculated agar.  The lid of the petri dish is replaced, inverted, and placed in the incubator for 24 hours.  After 24 hours, the organism will have grown all over except around those disks that inhibit its growth.  These zones around the disks are measured to determine the susceptibility of the organism to each particular antibiotic disk.  The disk with the largest, clearest area around it has the most effective medication.  After the most effective antibiotic is identified, the patient is given that medication. Define serology and discuss serology specimen testing. 1. Serology is the study of the antigen and antibody reactions of the body’s immune system.
  • 25. Mod 1 Clinic Lecture notes- CMA book – Ch. 6, 44, 45 25 2. The body’s ability to recognize a foreign substance (antigen) and produce an antibody against it is called the immune response. 3. Antibodies are specific for a particular antigen. For instance, polio antibody is specific for polio only. 4. Antigen-antibody reaction is a frequently used testing tool for pregnancy, rheumatoid arthritis, mononucleosis, and strep, among other conditions. 5. Test is serological because it studies or tests the serum component of the blood. 6. Test kits contain all of the equipment and supplies necessary and assist the MA in ensuring that reagents are fresh and quality control is maintained. 7. Kits standardize testing, thus ensuring accuracy, precision, and quality control. 8. It is absolutely essential to follow exactly the manufacturer’s directions. N. Review the why and the how of performing a strep test. 1. Group A Strep Screen is a test that is done frequently in POLs. 2. Especially efficient in the pediatric office because it is self-contained and can be done while the patient waits. 3. Screen is an antigen detection test for group A beta-hemolytic streptococci and follows the general procedure for antigen–antibody agglutination (clumping together) tests, which produce a clumping of cells. 4. There are many CLIA-waived group A strep kits available that test for the extracted group A beta- hemolytic streptococcus antigen. a. These self-contained kits are commercially prepared diagnostic testing kits that include detailed instructions and contain reagents, controls, and quality control suggestions. 5. A variety of other serological test kits are available for infectious mononucleosis, rheumatoid arthritis, and HIV, to name a few. 6. The specialty of the physician will determine which tests will be used. 7. Refer to Procedure 45-8: Perform Rapid Group A Strep Testing for detailed instructions in this technique. 2. Remember that microbiological specimens are living organisms and must have proper conditions to survive, but not to multiply. Refer to Guidelines 45-1 in the text. Specimen Collection  The basic rules for specimen collection are:  Confirm the identity of the patient by asking the patient to state his or her name and spell it, if necessary.  Screen the patient to determine if pretest preparation was followed.  Collect specimen before beginning antibiotic treatment.  Collect sufficient quantity of material for testing.  Use only appropriate collection technique by observing proper cleaning and aseptic procedures to control contamination.
  • 26. Mod 1 Clinic Lecture notes- CMA book – Ch. 6, 44, 45 26  Use only sterile containers.  Select the proper containers for collection that comply with the reference laboratory’s or outside laboratory’s requirements.  Ensure that the collection container is tightly closed and appropriately sealed to avoid leakage and contamination of the specimen and any surface with which the container may come in contact.  Label the specimen accurately at the time of collection with the following information:  Patient’s full name  Date  Time of collection  Type of specimen  Antibiotic treatment in use, if any  Your initials  Fill out the requisition form for the reference lab and double-check that the information matches the label.  Deliver specimen promptly to laboratory and document it. Otherwise, maintain proper storage until specimen can be picked up or transported appropriately.  Note: Cerebrospinal fluid always requires immediate delivery.  Diversity  What might be some cultural issues with collection of specimens?