Medical testing may be a lifesaving procedure for your patients. It is important to keep strict quality control and quality assurance standards while obtaining specimens, transporting them, and obtaining the test results in a physician’s office. There are mistakes that happen that can result in poor results, including mishandled specimens and paperwork mix-ups.
A test may have been administered incorrectly, or the medical office equipment may not have been calibrated properly. Lab procedures must be adhered to because, if a test is grossly inaccurate or the symptoms don’t support the results, a physician can run the test again to confirm the original findings. Many times, a test may rule out a disease or suggest that additional testing be performed.
When a physician orders a laboratory test, there are certain tests that can be done by a medical assistant with on site medical office equipment and some that must be done at an off-site medical laboratory.
There a few different types of clinical laboratories used by physicians’ offices. These include a reference laboratory, an off-site laboratory, and a physician’s office laboratory. Reference laboratories employ scientists and technicians who are educated in the procedures of advanced testing that is too complicated for physicians’ office labs to handle.
A medical assistant will need to be familiar with the types of specimens presented to be able to determine which tests to order. When sending specimens to an off-site laboratory, the medical assistant must adhere to strict quality control procedures.
The medical laboratory professional will analyze blood, urine, and other bodily fluids to measure the substances that contribute to the diagnosis and treatment of a particular condition. The results of the laboratory testing are compared to the acceptable ranges in a healthy population to determine the health of the body system or organ tested.
Laboratory testing is most commonly used to diagnose disease, monitor a patient’s medication and treatment, identify the cause of an infection, and/or to prevent disease.
What Does a Medical Assistant Do in a Physician’s Office Laboratory?
The medical assistant can test samples within the office of the physician with specific medical equipment. The medical assistant working in the physician’s office laboratory collects samples, performs tests, follows strict procedures, manages quality control, maintains laboratory equipment, keeps accurate records, prepares specimens for transport to reference or off-site laboratories, and reports results to the physician.
Can Patients Perform Their Own Testing?
Many patients will test their blood at home for blood glucose levels or use a home pregnancy kit to determine if they are pregnant. The medical assistant’s duties include educating patients about the use of point-of-care tests and machines to assure accurate results.
What Are the Most Common Tests Performed in a Physician’s Office Laboratory?
The most common tests performed by the medical assistant in a physician’s office laboratory are urinalysis, blood cell count, hemoglobin, red blood cell percentage, and blood glucose levels. Pregnancy tests and tests for strep throat are also commonly performed in a physician’s office laboratory.
Who Manages Quality Control of Laboratory Testing?
The Clinical Laboratory Improvement Amendments (CLIA) established standards for the quality of laboratories for all facilities that test human specimens. The Centers for Medicare and Medicaid Services (CMS) regulates all laboratory testing in compliance with CLIA. All laboratories, including physicians’ office laboratories, must have a CLIA certificate to meet federal requirements.
CLIA has established three levels of testing based on the complexity of a test. The levels include waived tests, moderate complexity tests, and high complexity tests. Depending on the level of testing, the health care professional performing these tests is required to have specific education and training, as regulated by CLIA.
Waived tests are simple, one-step tests approved by CLIA for use in a physician’s office laboratory. The government requires a certificate of waiver to perform waived tests. Some waived tests include glucose monitoring, urine dipstick analysis, pregnancy testing, and fecal occult blood packets.
Moderate and high complexity testing require the use of complex manual methods and instruments and are usually approved only for use by highly trained scientists and technicians.
Should We Have a Quality Assessment Plan?
All laboratories, including the physician’s office laboratory, are required by CLIA to have a quality assessment plan. The quality assessment plan should be written down and conveyed to all clinical personnel when they start working at the physician’s office.
A quality assessment plan is used to prevent problems from happening and to have a proper procedure to document errors.
The plan must also include corrective action that should be taken if an error does happen or equipment is not calibrated properly. The quality assessment plan will monitor the patient preparation procedure. This includes specimen collection, processing, preservation, and transportation. Finally, it will offer training and continuing education for laboratory personnel.
CLIA regulations require a procedure for every test performed in the physician’s office laboratory, following the manufacturer’s testing instructions. Many procedures require a device or solution used to monitor the accurate performance of each test. A reagent is a substance that produces a reaction with the patient specimen. Both a control and reagent should be used in conjunction with manufacturer’s product instructions.
What Is Quality Control at a Physician’s Office Laboratory?
Quality control testing is designed to detect problems that happen because of operator error, test kit deterioration, equipment malfunction, or improper environmental conditions. The physician’s office laboratory must have written policies and procedures for monitoring quality control for the accuracy, precision, and quality of each test.
The manufacturer’s product insert describes the minimum requirements for internal and external control testing. Maintaining a record of each control sample result is required by CLIA. The control log must include the date and time of the test, the results expected, the results obtained, action taken for corrections if needed, and the initials of the person performing the test.
Not only are quality assessment and quality control important in a physician’s office laboratory, but the medical assistant must avoid exposure to health and safety risks in the laboratory. OSHA (Occupational Safety and Health Administration) monitors and protects the health and safety of employees who work in the physician’s office laboratory.
What Common Equipment and Supplies Will Be Used in the Physician’s Office Laboratory?
There are some basic equipment and supplies that are common to most physicians’ office laboratories.
- Microscope – A microscope is used by the physician to identify and count cells and microorganisms in blood and bodily fluids. The microscope offers magnification of a specimen and light to better focus on it.
- Centrifuge – A centrifuge rotates in a circular motion to swing its contents to separate liquids and solids into their component parts.
- Incubator – Microorganisms require an environment to thrive and reproduce. The specimen is placed into a special container that contains nutrients and is then put into an incubator at a temperature that allows microbes to grow.
- Refrigerator or Freezer – These should be used only for storing reagents, kits, and specimens. The temperature of the refrigerator or freezer must be measured and recorded daily. Food should not be stored in a laboratory refrigerator to avoid contaminating reagents, kits, and specimens.
What Are the Responsibilities of the Medical Assistant in the Physician’s Office Laboratory?
Medical assistants are not only responsible for collecting and testing samples, but for educating patients on the proper procedure and preparation when obtaining laboratory specimens, as well. They must also arrange for appropriate specimen transport if needed.
Medical assistants will need to document and maintain a quality assurance program. They must maintain laboratory instruments and equipment to manufacturer’s specifications. The medical assistant must also follow all state and federal guidelines and regulations.
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