Rapid Specimen Testing In the Medical Office (POCT)

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1 Rapid Specimen Testing In the Medical Office (POCT) Over the past few years, the new health care system and managed care have affected patients by restricting many of their health decisions and physicians on how they treat their patients. With new regulations and new technology rapid or point-of-care (POC) diagnostic testing has more and more become the norm. Many diagnostic screening tests are now performed right in the medical office at the day of the appointment. These laboratories are regulated under the CLIA Program and maintain a high level of quality control by using highly automated and advanced laboratory equipment. Most of the reagents, kits, and instruments used for screening in a medical office are merely meant to substantiate a patient's condition. Any test results that are not within a normal range must be sent to a reference laboratory for confirmation of the results. REMEMBER: Some of the point of care type analyzations may not be as accurate as tests done by an outside reference laboratory. The last decade has seen an increased utilization of in-house (in-clinic) chemistry and hematology analyzers as well as an increase in the POC (point-of-care) type analyzers used in emergency medicine. With this increased utilization comes additional responsibility. It is up to the practitioner providing this laboratory service to assure that the service is going to benefit the patient. The practitioner has the sole responsibility of quality assurance.

2 Benefits and Disadvantages of Rapid Testing As with any relatively complex issue, there are both pro's and con's to the widespread use of rapid tests. The advantages include: Rapid tests can provide clinicians timely information to guide patient management. Rapid tests can also be more convenient for clients, thus expediting counseling to patients in a variety of clinical and public health settings. Rapid tests using finger-stick blood and oral fluids could be administered by professionals in non-clinical settings bringing testing results to hard to reach, high-risk clients, and facilitating access to other prevention services. While laboratory tests are expensive and may take up to 24 to 48 hours to generate results, rapid screening kits and instruments can provide the physician with immediate information required to take appropriate action with medication or other modalities of treatment.

3 The patient-focused care concept takes the laboratory out of a physical location and to the patient. As instrumentation for laboratory testing becomes smaller, the instrumentation is located on the nursing unit. This testing that is done at the patient s bedside is also known as point of care testing. The instrument is taken to the patient s room, the patient s blood is collected, the blood is tested in the instrument, and results are determined at the patient s bedside. This speeds the process of treatment for the patient. A physician can examine the patient, order a blood sugar, and then the patient is tested. Within a few minutes, the physician can have results and decide to continue or change treatment. Bedside testing eliminates the transportation time of the specimen to the laboratory and the wait time to get the results to the nursing unit. However, only a limited number of tests can be performed with the instrumentation available. Federal regulations also limit to some extent what tests can be performed this way. This testing of the blood work at the patient s bedside is often the duty of the multi-skilled phlebotomist or nurse.

4 Point of Care Testing Point of Care Testing encompasses all laboratory tests performed outside the formal walls of the Clinical Laboratory. Waived Testing Waived tests utilize technically simple methods and are expected to cause little or no harm to a patient if performed incorrectly. Waived tests can be further divided into instrument-based (e.g, glucose) and non-instrument based tests, which include fecal occult blood, vaginal ph, urine chemstrip and pregnancy tests. Non-waived Testing (usually moderately complex testing in POC settings) Moderately complex tests are usually instrument-based, require a higher skill level, and generally carry a higher level of risk to the patient if performed incorrectly (e.g., blood gas testing). Provider Performed Microscopy Procedures (PPMPs) Tests in this category are considered moderately complex and include a set of defined microscopic procedures, i.e., saline wet mounts, that are performed by independently licensed (MDs, DOs) and mid-level practitioners (e.g., NPs, CNMs,PAs). POCT is regulated at the federal (CLIA '88) and state levels. POCT activities - Written Hospital and Clinical Laboratory policies and procedures reflect the expectations by the regulatory and accrediting bodies, and must be followed by all staff involved in POCT.

5 A POCT Committee, with representation from the Clinical Laboratory, Hospital Administration and the Department of Nursing, usually oversees POCT.