The following terms are commonly used in CLIA Compliance. The inclusion of any term, however, does not constitute an endorsement or recommendation by DoctorsManagement or any of its subsidiaries or employees.
1.) CLIA means the Clinical Laboratory Improvement Amendments of 1988.
2.) Certificate of Waiver (COW) allows a facility to do only waived tests.
3.) PPMP Certificate allows qualified providers to do waived testing and certain microscopic examinations during the patients’ visit.
4.) Certificate of Registration or Registration Certificate means a certificate issued to a laboratory that enables the entity to conduct moderate or high complexity laboratory testing or both until the entity is determined to be in compliance through a survey by the Centers for Medicare and Medicaid Services (CMS) or its agent; or in accordance with Sec. 493.57 to an entity that is accredited by an approved accreditation organization.
5.) HHS means the Department of Health and Human Services, or its designee.
6.) Kit means all components of a test that are packaged together.
7.) Laboratory means a facility for the examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of, human beings. These examinations also include procedures to determine, measure, or otherwise describe the presence of various substance or organisms in the body. Facilities only collecting or preparing specimens (or both) or only serving as a mailing service and not performing testing are not considered laboratories.
8.) MedWatch is an FDA service for health care facilities to voluntarily report a serious adverse event or product problem that the user suspects is associated with a drug or medical device used, prescribed, or dispensed.
9.) A Pipet/Pipette is a narrow, usually calibrated glass or plastic tube into which small amounts of liquid are suctioned for transfer or measurement.
10.) Plasma is the usually clear, yellowish fluid portion of blood, lymph, or intramuscular fluid in which cells are suspended. It is the fluid produced when a blood specimen is collected in a vacuum tube with anticoagulant.
11.) Serum is the usually clear yellowish fluid obtained upon separating whole blood into its solid and liquid components after it has been allowed to clot. Also called blood serum.
12.) A Reagent is a substance or material or ingredient used in a lab test to detect, measure, examine, or produce other substances.
13.) Controls are materials with known values of the substance measured that help the laboratory achieve accurate and reliable testing by checking if the test system is working. Controls, also known as quality control material, are external or internal. External controls are usually a liquid and are processed or tested in the same manner is a patient specimen. Internal or procedural controls are indicators that the test procedure was performed in the proper order.
14.) Quality Control (QC) procedures help to ensure the excellence of the patient testing. If the QC results are not within the prescribed range or the expected pattern, then the laboratory cannot be sure that the patient’s test results are accurate and reliable. See Controls above.
15.) Quality Assurance (QA) is the laboratory’s self-examination of the specimen collection, testing, and test reporting processes. What does the laboratory do to assure accurate results?
Ten recommended QA questions to ask are:
- Are the patients and specimens properly identified?
- Are the patients’ charts up-to-date with the proper patient test information?
- Is the quality control performed and documented?
- Did the laboratory get the right answers for the quality control?
- Do the waived test results correlate with the patient’s history or symptoms?
- Are there any complaints about the laboratory testing?
- Are the testing personnel trained prior to performing laboratory testing?
- Are there periodic discussions about laboratory concerns?
16.) Screening Tests are initial tests to determine if a disease or medical condition exists.
17.) Diagnostic Tests are tests to identify a disease or medical condition that exists in a patient.
18.) Monitoring Tests are tests that are done once a patient is diagnosed with a disease or medical condition. These tests help the clinician keep track of the patient’s specific medical condition or response to a treatment on a periodic basis.
19.) Routine Order of Draw (when the laboratory collects more than one tube of blood at a time on a patient):
- Blood culture tube
- Non-additive serum tube
- Citrate tube
- SST (serum separator tube), plastic serum tube
- Heparin tube
- EDTA tube
- Glycolytic inhibitor tube
Please consult with the reference laboratory for specific specimen collection requirements.
20.) Package Insert is the instructions included by the manufacturer in the kit or test package. Read these carefully each time a new kit is opened to check for changes in procedures or quality control. Retain the current package insert for reference. The language used to convey the instructions is important. Words like “always”, “shall”, “must”, and “required” mean the instruction is regulatory and must be performed. “Should” or “recommend” mean the action is not regulatory, but it is good laboratory practice to perform those actions.