LabOratory – Point of Care Testing (POCT): What’s New?

POCT is taking a larger role as the healthcare systems continually shifts from curative to preventive medicine by focusing on early detection and management of chronic disease, along with a more patient-centered approach to health care. POCT promotes these goals with rapid test results that providers can use to immediately inform patients of their condition or progress, and modify their treatment on-site. This provides a face-to-face opportunity to ensure understanding and discussion of future goals, thus more directly involving the patient in their own care.

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Transition from EQC to IQCP: What it means to Physician Office Laboratories

On January 1, 2014, the Centers for Medicare and Medicaid Services (CMS) implemented a new alternative Quality Control (QC) option for non-waived laboratory testing. CLIA laboratories can now begin to voluntarily transition away from Equivalent Quality Control (EQC) and begin using either the default CLIA Quality Control (QC) requirement, or the new option called the Individualized Quality Control Plan (IQCP). Physician Office Laboratories (POLs) will now have to determine if IQCP is the right choice for them. Laboratory Directors will be tasked with determining whether to maintain the CLIA minimum of at least two levels of QC per day, or to transition to the IQCP approach. The cornerstone of IQCP is identifying, evaluating, and controlling potential sources of error relevant to the individual laboratory. Performing a Risk Assessment will facilitate the development of an IQCP, which is achieved by implementing targeted quality control measures. According to CMS, “There will be an IQCP Education and...

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Laboratory Testing: Training vs. Competency

As Healthcare Professionals we often hear the terms training and competency used when referring to staff performance or education. These terms are often used interchangeably and incorrectly. Their basic meanings are similar but their applications are very different. We will clearly characterize each term as they relate to laboratory testing. Competency is an ability or skill, as defined by Miriam Webster Learner's Dictionary1. CMS further clarifies it as the "ability of personnel to apply their skill, knowledge, and experience to perform their laboratory duties correctly."2 The Dictionary definition of Training is "a process by which someone is taught the skills that are needed for an art, profession, or job."3 According to CMS, "Training may include, but is not limited to, attendance at: Seminars given by experts in the field, e.g., a lecture about antibiotic resistance given by the infection control officer of a local hospital; On-site or off-site instrument trainings given by a manufacturer, e.g...

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The Cutting Edge of Diagnostic Testing: Where's Your Lab?

Many Physician's Office Laboratories (POLs) were opened to provide quick and accurate diagnostic results to clinicians by keeping testing in house. In 2012, this model was in place for 116,634 of the 232,996 laboratories in the U.S.1 Many of these labs are in the office practices of primary care physicians, and some are in specialty practices that made the decision to have an in-house laboratory based on the necessity or desire of having certain tests at their fingertips. According to an article in the Journal of General Internal Medicine, "physicians who own diagnostic testing equipment are more likely to order tests and highlight the important role that self-referral plays in the practice of outpatient medicine."2 These specialty tests, in conjunction with traditional diagnostic tests such as Complete Blood Count (CBC), Blood Chemistry Tests/Basic Metabolic Panel and Urinalysis, have created a one-stop shopping approach to medical care in many private practices. But, as patients' ne...

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LabOratory: Office Laboratory Efficiencies

Many factors should be considered when deciding whether to implement a new test or change testing methodologies in your medical practice. Streamlining operations while maintaining the highest quality of services provided will result in a more efficient practice, whether the operational task is laboratory testing or patient examination. The difficulty is trying to decide what to minimize, improve, and/or replace. However, it may be easier if the process is an ongoing one, where optimizing quality in laboratory operations is a constant process. The Clinical Laboratory Improvement Amendments (CLIA) define a laboratory as a facility where testing is performed "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."1 Thus, if patient testing of any kind is performed in your medical office, it is considered a laboratory. You have to obtain the proper CLIA certificate and abide b...

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Drug Screen Reimbursement

Welcome to the third article in the series focusing on laboratory operations in Pain Management practices.  In this article we will outline reimbursement for Urine Drug Screen Testing. As with any service submitted for reimbursement, the procedure must meet Medical Necessity requirements, be assigned a payable diagnosis code (ICD-9) and be billed out with the appropriate CPT code.  Reimbursement varies per region so please check the Clinical Laboratory Fee Schedule (CLFS) for your state or locality’s Medicare rate. The fee schedule can be found at: www.cms.gov › Medicare  › Clinical Laboratory Fee Schedule For practices with a CLIA Certificate of Waiver performing point-of-care rapid cups, it is important to ensure that the rapid cups you are using are CLIA-waived by checking the product insert that comes with the product.  Also, please note that you can assign only one billing code per patient encounter, reg...

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LabOratory | Waived vs Non-waived Testing

Note:  Recent LabOratory columns have examined the subject of waived testing in detail, including the Centers for Disease Control and Prevention’s (CDC) new “Ready? Set? Test!” waived test education program.   In this column, we provide a comparison of the requirements for waived versus non-waived tests. Waived Testing According to the Clinical Laboratory Improvement Amendments (CLIA), waived testing systems “are simple laboratory examinations and procedures which – Are cleared by FDA (Food and Drug Administration) for home use; or Employ methodologies that are so simple and accurate as to render the likelihood of erroneous results negligible; or Pose no reasonable risk of harm to the patient if the test is performed incorrectly.1 When the CLIA regulations were first published in 1988, only nine tests were classified as waived tests.  This number has grown to include more than 100 tests incorporated into thousands of test systems.  The...

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Pain Practice Laboratory Made Simple

Welcome to the second in our series of articles focusing on Pain Management Practices. In this article we will address the topic of laboratory testing, specifically Urine Drug Screening in Pain Management. Many pain practices utilize Urine Drug Screening Point of Care Rapid Cups as there only form of laboratory testing. In many practices, those samples are then forwarded to a reference for additional testing. Point of Care Rapid Drug Screen cups utilize Flow Through Technology which basically means that the target (analyte being tested for) is attached to a membrane inside the rapid cup.  The sample, in this case your patients urine, flows across the test membrane and if the target analyte is present in the sample it attaches to the membrane and a visual change occurs allowing the test results to be read visually without any form of reader or equipment. While quick and easy, there are many ways for errors to occur.   All product inserts include storage guidelines, speci...

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Toys in the Laboratory: LEGO Models Grow Bones

Proving their delightful resilience and relevance since their 1949 inception, Danish building toys LEGO, have made some headway in the medical field. Researchers at the department of Engineering at Cambridge University are utilizing LEGO inginuity to construct automated models capable of growing artificial bone samples. The monotonous process, one which requires a scaffold to be repeatedly dipped in a variety of different solutions to grow a compound, seemed perfectly suited for the toy's simple, yet effective engineering. The research team constructed cranes from a LEGO Mindstorms robotics kit, a set which includes micro-controllers, actuators and rudimentary sensors which can be programmed to perform sequential tasks. The scaffold was secured to a string and tied to the end of a LEGO crane, enabling the robotic setup all the tools necessary to perform the repeated and sequential layering needed to grow composite bone. Check out the official press release, which contains an entertaining and info...

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