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Chapter 15
Chapter 15 Intro to the clinical laboratory
| Question | Answer |
|---|---|
| What does POL stand for? | physician's office laboratory |
| What does CLIA stand for? | Clinical Laboratory Improvement Amendments |
| Is a laboratory test that has been determined to be a simple procedure that is easy to perform and has low risk of erroneous test results such as urinalysis using a reagent strip | CLIA-waived test |
| When that body is healthy, its systems function normally and a state of equilibrium of the internal environment is said to exist | homeostasis |
| Is a facility in which laboratory tests are performed on biologic specimens to obtain valuable information regarding the health of a patient | clinical laboratory |
| A complex laboratory test that does not meet the criteria for waiver and is subject to the CLIA regulations | CLIA - nonwaived test |
| A body substance that is being identified or measured by a laboratory test | Analyte |
| A mechanism to check the precision and accuracy of an automated analyzer to determine if it is providing accurate test results | calibration |
| A tentative diagnosis of a patient's condition obtained through an evaluation of the health history and a physical examination without the benefit of laboratory or diagnostic test | Clinical diagnosis |
| A solution that is used to monitor a test system to ensure reliable and accurate test results | Control |
| A patient test result that is dangerously abnormal and is life-threatening requiring immediate attention | Critical value |
| Abstaining from food or liquids (except water) for a specified amount of time before the collection of a specimen | Fasting |
| A clinical analysis and study of a body substance to obtain objective data for the diagnosis, treatment, and management of a patient's condition | Laboratory test |
| A printed document developed by the manufacturer of a laboratory test that provides detailed information on the use of the test and how to perform the test | Package insert |
| A combination of laboratory test that have been determined to be the most sensitive and specific means of identifying a disease state or evaluating a particular organ or organ system | Panel |
| A test that indicates whether or not a particular analyte is present in the specimen and may also provide approximate indication of the amount of the analyte present | Qualitative test |
| The application of methods and means to ensure that test results are reliable and valid and that errors are detected and eliminated | Quality control |
| A test that indicates the exact amount of an analyte that is present in a specimen with the results being reported in measurable units | Quantitative test |
| A chemical that reacts with a specimen to allow the detection or measurement of an analyte | Reagent |
| What is the purpose of laboratory test results? | To obtain essential data needed by the provider for the diagnosis treatment and management of a patient's condition |
| What are the advantages of performing laboratory test in a POL? | Test results are available while the patient is in office, which may allow the provider to diagnose or monitor their conditions immediately. Provider is able to initiate or adjust the course of treatment for patients before they leave the office. |
| What is the purpose of CLIA? | To improve the quality of laboratory testing in the United States to ensure accurate and reliable test results |
| Where are CLIA non-waived tests usually performed? | In an outside laboratory by certified medical laboratory personnel |
| What may occur if a POL is not maintained at room temperature? | May cause deterioration of the test components such as controls and test reagents |
| What guidelines should be followed regarding the refrigerator in a POL? | Temp should be maintained between 36° F and 46° F. Temp should be checked at least once a day and documented in a refrigerator temp log, no food or beverages can be stored in the refrigerator & must have a biohazard warning label attached |
| What is an emergency eyewash station? | Is a device that is used to flush the eyes with tepid water when substances such as blood or hazardous chemicals enter the eye |
| How long should the eyes be flushed following exposure to a hazardous substance? | For a minimum of 15 minutes |
| A certain established and acceptable range within which the laboratory test results of a healthy individual are expected to be | Reference range |
| A laboratory test performed routinely on apparently healthy individuals to assist in an early detection of disease | Screening test |
| The clear, straw-colored part of the blood that remains after the solid elements and the clotting factor fibrogen have been separated out of it | Serum |
| A small sample taken from the body to represent the nature of the whole | Specimen |
| A setup that includes all of the test components required to perform a laboratory test such as testing devices, controls, and test reagents | Test system |
| Information directly associated with an individual that reliably identifies the individual as a person for whom the service or treatment is intended | Unique identifier |
| What may occur if there is a delay in treatment following exposure of the eyes to a hazardous substance? | Could result in permanent damage to the eye |
| What are two examples of outside laboratories? | Hospital and privately owned independent labs (LabCorp & Quest Diagnostics) |
| What general information is included for each test in a laboratory test directory? | Name and CPT code of the test, synonyms for the test name, type & amount of specimen required, collection containers required, patient preparation collection and processing requirements, specimen stability, causes for rejection of specimen |
| Examples of specimens collected from the body for laboratory analysis: | Blood, urine, stool, sputum, cervical and vaginal scrapings of cells, secretions and discharges from various parts of the body |
| Laboratory analysis in hematology involves the examination of blood for? | Detection of abnormalities including blood cell counts, cellular morphology, clotting ability of blood, and identification of cell types |
| Laboratory analysis and clinical chemistry determines? | The amount of chemical substances present in the blood, body fluids, excreta, and tissues |
| Laboratory analysis in immunology and blood banking involves? | Studying antigen-antibody reactions to assess the presence of a substance or to determine the presence of disease |
| The physical, chemical, and microscopic analyses of urine to detect deviations from normal | Urinalysis |
| Laboratory analysis in microbiology involves? | Identification of pathogens present in the body specimens (ex. urine, blood, throat, sputum, wound, urethra, vagina, cerebrospinal fluid) |
| Laboratory analysis in parasitology involves? | Detection of disease-producing human parasites or eggs present and body specimens |
| Deals with detection of the presence of abnormal cells? | Cytology |
| Deals with the detection of disease tissues? | Histology |
| Why must laboratory test results be compared with the reference ranges supplied by the laboratory performing test? | Because the reference range for each test varies slightly from one laboratory to another depending on the test method, equipment, and reagents used to perform the test |
| What is a specific panel? | All tests included in the panel relate to a specific organ of the body or a particular disease state |
| What tests are included in a comprehensive metabolic panel? | Albumin ALP, ALT, AST, bilirubin, BUN, calcium, carbon dioxide, chloride, creatinine, glucose, potassium, total protein, sodium |
| What tests are included in a electrolyte panel? | Carbon dioxide, chloride, potassium, sodium |
| What tests are included in a hepatic panel? | Albumin, ALP, ALT, AST, bilirubin (direct), bilirubin (total), total protein |
| What tests are included in a hepatitis panel? | Hepatitis A antibody, IgM, Hepatitis B core antibody, (total) Hepatitis B surface antigen, Hepatitis C antibody |
| What tests are included in a lipid panel? | Total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides, VLDL cholesterol total (calulation), cholesterol/HDL ratio (calculation) |
| What tests are included in a prenatal panel? | ABO grouping and Rh typing, CBC w/diff and w/plt, Hepatitis B surface antigen, RBC antigen screen, Rubella antibody, Syphilis serology(RPR) |
| What tests are included in a renal function panel? | Albumin, BUN, calcium, carbon dioxide, chloride, creatinine, glucose, phosphorus, potassium, sodium |
| What tests are included in a rheumatoid arthritis panel? | Rheumatoid factor(RF), Cyclic citrullinated peptide(CCP), Antinuclear antibody(ANA), C-reactive protein(CRP), Erythrocyte sedimentation rate(ESR) |
| What tests are included in a thyroid panel? | Thyroxine(T4), Triiodothyronine(T3), Uptake, Thyroid-stimulating hormone (TSH), Free thyroxine intake(FTI) |
| Tepid water consist of water with a temperature between? | 60° F and 100° F |
| How many seconds after exposure of the eye to a hazardous substance are critical especially if it is a corrosive chemical? | 10 to 15 seconds |
| List five uses of laboratory test results: | To assist in the diagnosis of pathologic conditions. To evaluate the patient's progress and to regulate treatment. To establish a baseline level. To prevent or reduce the severity of disease. To comply with state laws. |
| When is a laboratory test ordered to assist in a differential diagnosis? | When two or more diseases may have similar signs and symptoms |
| List three examples of laboratory screening test: | Urinalysis, CBC, and a comprehensive metabolic panel |
| What is the purpose of a laboratory request? | Means of communication between the medical office and the outside laboratory to designate the test(s) ordered by the provider. Provides the laboratory with essential information necessary for accurate testing, reporting of results, and billing. |
| The most common methods used to transmit laboratory requests to an outside laboratory include: | Electronic transmission. Faxed. Hand delivered by a laboratory courier. Hand delivered by a patient having a specimen collected and tested at an outside laboratory. |
| What are the two most common unique identifiers used to label specimens? | Patient's full name and date of birth |
| What two methods can be used to label a specimen? | Handwritten label or barcode label |
| How is an electronic laboratory request transmitted to an outside laboratory? | Can be transmitted electronically to the lab by the medical office computer or print it out by the computer and placed with specimen for pickup by lab |
| Why is a critical value reported immediately to the provider by an outside laboratory? | They are considered life-threatening and require immediate attention |
| What should the MA do if the patient needs to collect a specimen at home? | Provide the patient with the appropriate specimen container and instruct the patient in the proper collection, handling, and storage of the specimen until it reaches the medical office. |
| List examples of factors that may affect the test results of laboratory test | Food and fluid consumption, medications, activity, alcohol consumption, and time of day |
| Why is it important for the MA to explain the reason for the advance preparation to the patient? | So that the patient will be more likely to comply with the necessary preparations |
| What is the purpose of fasting for 8 to 12 hours? | Composition of blood is altered by the consumption of food and fluid because digestive food and fluid are absorbed into the circulatory system changing the results of certain test |
| What may occur if a specimen for transport to an outside laboratory is collected or handled improperly? | The integrity of the specimen may be adversely affected. May cause inaccurate test results and interfere with the accurate diagnosis and treatment of the patient's condition. |
| What would cause a specimen to be rejected by outside laboratory due to a labeling problem? | No Label on the specimen container or incorrect information on specimen label. Specimen label and information on lab requests don't match. |
| Why is it important to properly identify a patient? | Collecting a specimen on the wrong patient by mistake may lead to an incorrect diagnosis and the wrong treatment. |
| What occurs if an insignificant amount of a specimen is submitted to an outside laboratory for testing? | A report is sent to the medical office indicating quantity not significant (QNS) |
| What is the purpose of a biohazard specimen bag? | Prevent contamination of the specimen and protect healthcare workers and laboratory couriers from the possibility of an exposure incident |
| What is a laboratory lockbox? | Large lockable container for specimens |
| List examples of CLIA waived blood chemistry and immunoglogic test? | Blood glucose test, Hemoglobin A1c test, Cholesterol test, Triglyceride test, Rapid COVID test, Rapid HIV test ,Rapid mononucleosis test |
| What is included in a laboratory test system? | Includes all of the test components such as testing devices, controls, and test reagents required to perform a laboratory test |
| What is the purpose of a test kit package insert? | Provides detailed information on the use of the test and how to perform the test |
| What is a unitized test device? | Is a self-contained device such as a cassette, to which a specimen is added directly and in which all of the steps of the testing procedure occur |
| What is a procedure reference card and what is its purpose? | Is a condensed version of the steps in the testing procedure, and can be used as a quick reference guide when performing the test |
| Describe a CLIA-waived automated analyzer | Compact or handheld devices that permit the processing of a specimen in a short time with accurate test results |
| What is the purpose of quality control? | Methods and means to ensure that test results are reliable and valid and that errors are detected and eliminated |
| What are the storage requirements for most test components? | At room temperature and a cool dry area away from sources of heat and sunlight because these conditions can alter the effectiveness |
| What should be written on the label of a control that is stable only for a certain period of time after opening it? | The date the controlled is opened and the date it should be discarded |
| What is the purpose of calibrating an automated analyzer? | Used to check the precision and accuracy of an automated analyzer to determine if it is providing accurate test results |
| What checks are performed by an internal control? | Whether a significant amount of the specimen was added, whether a significant amount of test reagent was added, and whether the test reagent migrated through the test device properly |
| What is the purpose of an external control? | Used to determine if the test reagents are performing properly and to detect any errors and technique used to perform the test |
| What may cause an external control procedure to fail to produce expected results? | Outdated controls or test reagents, improper storage of test components, and improper environmental testing conditions, and an error and technique used to perform the procedure |
| What should be done if the external control procedure does not perform as expected? | Patient testing should not be conducted until the problem is identified and resolved |
| What is the difference between a qualitative test and a quantitative test? | Qualitative test indicates whether or not a particular analyte is present and quantitative test measures the exact amount of analyte present in specimen |
| How should a qualitative test result be documented? | Using words or abbreviations and not symbols |
| How should a quantitative test result be documented? | Using the unit of measurement of the test system. (mg/dL) |
| Consist of regulations that have been developed by the federal government to improve the quality of Laboratory Testing in the United States to ensure accurate and reliable test results | Clinical Laboratory Improvement Amendments (CLIA) |
| The temperature of the POL should be maintained at room temperature which is a temperature between? | 59° F and 86° F |
| The temperature of the refrigerator in a POL must be maintained between? | 36° F and 46° F |
| How often should the temperature of the refrigerator be checked in the POL? | At least once a day and documented in the refrigerator temperature log |
| It is important that the medical assistant inspect and activate the eyewash station each week to ensure that it is | Operating properly and to flush out the water supply lines |
| Laboratory reports can be transmitted to the medical office by one or more of the following methods: | Electronic transmission, fax, mail, or hand delivery by a laboratory courier |
| After reviewing the electronically tramsmitted laboratory report the provider signs it with his or her electric signature and the report is then? | Automatically filed in the patient's electronic health record (EHR) |
| The medical assistant is often responsible for providing instructions to a patient for a laboratory test ordered for the patient. The medical assistant should inform the patient of? | Name and purpose of the test. How to prepare for the test and how and when to expect the test results. |
| Once the specimen arrives at the outside laboratory it is assigned an accession number. The purpose of an accession number is to? | Provide positive identification of each specimen within the laboratory and to allow easy access to laboratory records should a test result need to be located again |
| Who is responsible for regulating and operating the CLIA program? | The Centers for Medicare and Medicaid services (CMS) |
| POL's that perform only waived tests must apply for a CLIA certificate of waiver (CW) from CMS which must be renewed? | Every 2 years |
| CLIA waived test that are performed most frequently in the POL include the following: | Urine and fecal tests, hematology tests, blood chemistry and immunologic tests, microbiologic tests |
| Examples of urine and fecal tests include: | Urinalysis test, CLIA-waived urine drug test, Urine pregnancy test, Fecal occult blood test |
| Examples of hematology tests include: | Hemoglobin test, Spun microhematocrit test, Prothrobin time test |
| Examples of blood chemistry and immunologic tests include: | Blood glucose test, Hemoglobin A1C test, Cholesterol test, Triglycerides test, Rapid COVID test, Rapid HIV test, rapid mononucleosis test |
| Examples of microbiologic tests include: | Group A Streptococcus test, Rapid Influenza A and B test |
| When documenting the results of a CLIA-waived test what must be included? | The brand name and lot number of the test kit used for the test |
| Some examples of brand names of CLIA-waived automated analyzers include: | Cholestech LDX STAT-Site Hemoglobin Meter CoaguChek system Accu-Chek A1C Now Clinitek urine analyzer |
| Calibration is typically performed using a device known as a? | Calibration standard |
| At a minimum a calibration check should be performed when? | Using a new lot number of test reagents |
| Qualitative test results are expressed in descriptive terms such as? | Positive or negative 1+, 2+, or 3+ reactive weakly reactive nonreactive invalid |
Created by:
Diamond87