Good Lab Practices for Waived Testing: Management Responsibilities

Waived tests, defined as "simple tests with an insignificant risk of an erroneous result," are so designated because they are waived from most federal oversight requirements. Thus, facilities performing only waived testing are only required to obtain a Certificate of Waiver (CW), pay biennial certificate fees, and follow manufacturers' test instructions. They have no CLIA requirements for personnel qualifications and training, quality control (QC) (unless specified as required in the test system instructions), proficiency testing (PT), and routine quality assessment) .

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Maintaining Personnel Competency: New Requirements

Knowledge of the impact of laboratory errors on patient care first reached the public arena during the 1960s and 1970s, resulting first in the passage of CLIA’67, and then CLIA ’88. Along with this, was the realization that safe and accurate laboratory testing could only be assured through a well-trained and competent staff. Competency assessment is the means to confirm that training is effective, and that personnel are competent to perform laboratory testing that produces accurate and reliable results. The Centers for Medicare and Medicaid Services (CMS) increased their emphasis on competency assessment because studies showed that laboratory errors with potential patient impact are often caused by a lack of competent personnel. Thus, an important component of CLIA '88 was a set of defined requirements for the documentation of initial personnel training and ongoing assessments of competency. While the requirements are specific in what must be assessed, they did not specify how to implement some of these specific assessments in a laboratory setting. Thus, there was considerable variation in how these were implemented. To address this uncertainty and standardize implementation guidelines, in 2012 the government updated and specified the requirements for Competency assessment. Below are the six specific requirements for assessing laboratory personnel competency as set forth by CLIA : 1. Direct observation of routine patient test performance; 2. Monitoring the recording and reporting of test results; 3. Review of intermediate test results, QC records, proficiency testing results, and preventive maintenance records; 4. Direct observation of performance of instrument maintenance and function checks; 5. Assessment of test performance by testing previously analyzed specimens, internal blind testing samples, or external proficiency testing samples; 6. Assessment of problem-solving skills.

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The Online Review - A Mostly True Account of a Millennial Patient

There’d been an ugly cyst on my elbow since high school. It was small, maybe the size of a No. 2 pencil eraser and though unsightly, totally benign. It was the kind of thing a few specialists had looked at, and barring its grotesque nature, "shouldn’t be a significant problem." And for years it honestly wasn’t. There was a moment when I turned the corner though, and if I’m being honest with myself it was probably the 5th morning I woke up with bloody sheets. OK, it sounds worse than it was but without any context, I wasn't sure how many more times I could leave my bedroom looking like that scene from Reservoir Dogs before scooting off to work. I'd knock my elbow against the wall in the middle of the night, break the cyst and bam. Terrible morning. Sounds insane right? I can't make this stuff up.

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White Coats - Function, Fashion or Neither?

Way back in antiquity, physicians wore black to denote their profession. Their garb was a visual cue for laymen and carried prominent cultural signifiers of importance and distinction. Over time, the traditional black attire shifted to white, symbolizing purity, cleanliness, and the (then) novel concept that medicine was to be treated as one of the sciences. We still use the white coat as a visual symbol for the physician, an essential ingredient of the uniform we’ve come to expect. For many medical students, a prestigious, calf-length white coat will be a confirmation of a long and arduous achievement; a wearable rite of passage.

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Ask the Expert-Barry Craig

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Here are some tips related to testing, billing, etc. Do I need a CLIA license if I perform a lab test even if I’m not billing for it? YES. Billing or not billing for a test has nothing to do with compliance. CLIA does not care if you get paid, they only care if the test is being performed correctly. You must have a CLIA license and any state required license (if applicable) to perform even one test. I must be billing the right code for my lab testing because I am getting paid for it. Just because insurance is paying you, does not mean you are billing the correct codes, it just means you haven’t got caught or audited yet. If you face an audit, they can take back the incorrect payment revenue. Double check you coding each year to make sure you are billing correctly. We have a CLIA Certificate of Waiver so we really don’t have any requirements and aren’t going to be inspected. WRONG. CLIA requires that for all waived testing performed, you must follow the manufacturer’s guidelines for running that test. The package insert that comes with the test outlines how the test is to be performed, stored, and the controls that must be run. CLIA inspects about 5% of Waived labs each year. You can have your lab testing shut down if they feel you are putting your patients in jeopardy by not following the guidelines.

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Preparing For Your Inspection: A Laboratory Checklist

The Clinical Laboratory Improvement Amendments (CLIA), passed by Congress in 1988, mandate that all test sites performing non-waived testing must undergo an inspection every two years. These inspections are designed to evaluate compliance with the quality standards set for all testing performed, to ensure the accuracy, reliability and timeliness of patient test results. All laboratories issued a CLIA certificate and all CLIA-exempt laboratories must comply with the applicable inspection requirements. The laboratory will either be inspected by CMS/CLIA (generally by state inspectors) or by an accrediting organization (AO) that has been granted deeming authority by CMS. There are currently seven CMS-approved accreditation organizations: AABB, American Association for Laboratory Accreditation (A2LA), American Osteopathic Association (AOA), American Society of Histocompatibility and Immunogenetics (ASHI), COLA, CAP, and The Joint Commission (TJC). Regardless of the agency, all inspections focus on essentially the same areas. While being “ready” can’t guarantee a stress-free inspection, it will indicate the laboratory has already adopted the culture of quality patient care, and that it can continue to improve from there. CLIA follows a biennial inspection schedule. Some private Accrediting Organizations follow a more general 18-24 month schedule, so it would be prudent for laboratories to be additionally vigilant during these time frames. Inspections may or may not be announced in advance, depending on the Accrediting Organization. It is also important to be aware of how notification is provided: on-line, email, postal mail, telephone or fax. Make sure that the notifications go to the proper individuals. It should be noted that if there has been a complaint against a laboratory, the inspection/survey may be unannounced.

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Medical Scribes: A Great Idea on Paper

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Medical documentation isn’t as new as we might think and has been a crucial common component of the health care puzzle for at least the past century. Back then, the physicians comprising the American College of Surgeons established a clinical framework for documenting their activities and keeping data streamlined and transmittable from one physician to another. A course of criteria was established to create consistency in data from one physician to another, a handy mnemonic device (Subjective Objective Action Plan: SOAP for short) and an implicit agreement regarding clinically-guided standards for recording information across the board. While the method did establish a system for physicians, technological and medical developments in the 1970’s and 80’s created the need for more documentation necessities, like the rampant computerization of health information within the health care system, as well as ICD-9 developments in 1979 and CPT-4 developments in 1987, all re-tooled to include the financial-compensation component of cost, reimbursements and the capability for insurance companies and medical systems to agree on a system of “cost per units.”

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Hill Estate - The Ultimate Caribbean Getaway

If the grind and stress of your profession is exceeding your threshold, we have an exceptional estate that will fill the Rx for rest and relaxation. The Hill Estate at the Four Seasons Resort in Nevis provides three extraordinary properties to choose from to help create a memorable escape from your busy practice. Chris Hill, a British Real Estate Developer by trade, is married to a doctor and his son is also a physician. Because of these relationships, he is acutely aware of the pressures that are part of the medical profession. The Hill family has traveled extensively all over the world and when it came time to choosing a place to build a retreat, their shangrila, they chose to develop a magnificent residence in the rain forest, foot hills of Nevis Peak. When asked, “why Nevis?”, Mr. Hill said it was an easy decision, the people. The island is low crime, very well-educated and the islanders are very kind and friendly. It is easy to come away with a friendship with one of the maids, gardeners, or Four Seasons staff members after a stay on the amiable island. The choice to build was also made easy because of the quaint charm, the Caribbean old town feel that Nevis has, not corrupted by the trappings of commercialization. Yet the accessibility to good local restaurants and island entertainment is a bonus. In real estate, location, location, location is key. In addition to selecting the perfect location, West Indies island of Nevis, the Hill family has gone one step further. They have built a tropical compound designed with the perfect combination of class and comfort. “When we travel around the world, we stay at the top hotels, we enjoy the best of the best and The Four Seasons is a great benchmark,” says Hill. He loves that his estate is part of The Four Seasons Resort and Spa and the luxury that comes with that. The robes, towels, beds, linens, L’Occitane bath products, all the signature delights that make the hotel special, are also included in your villa retreat. The franchise is known for its incredible customer service, that along with all the wonderful amenities that the resort provides, makes this the perfect location, location, location.

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Ask the Expert – Barry Craig

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This month we are going to explore the most common CLIA certificate in use, the Certificate of Waiver. Certificate of Waiver This the most common federal CLIA certificate is the Certificate of Waiver. Well over 500,000 have been issued since 1988. As defined by CLIA, waived tests are categorized as • Employ methodologies that are so simple and accurate as to render the likelihood of erroneous results negligible. • **Pose no reasonable risk of harm to the patient if the test is performed incorrectly • Are cleared by the FDA for home use. • Conduct testing that is considered non-technical requiring little or no difficulty. **This description is up for debate because any test that is not performed properly can cause harm to a patient. For a list of waived tests sorted by test name, go to the FDA website at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/analyteswaived.cfm.

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Healthy Skepticism: Helping Patients Help Themselves Online

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These days, virtually any brick and mortar service has its own internet doppleganger. One can attain a college degree by attending online classes, stream movies directly from the source and of course, there’s Wikipedia, the online staple that’s put the final nail in the coffin of the door-to-door Encyclopedia industry. And while there’s seemingly no end to the wealth of information afforded to us on the internet, that information does come at a price: internet “quality control” is spotty at best. Now, that’s well and good, likely entry level information to anyone who’s ever written a term paper or sought out unbiased information in a Honda forum...but then again, internet literacy isn’t always a straightforward metric. In a recent article by Tanya Fenke MD, (Dr. Google Should Be Sued for Malpractice. Here’s Why), the author illustrates the inherent problem of taking all of our health concerns to Google, namely that internet sources quickly become outdated, are biased towards their benefactors and constituents, aren’t often written by healthcare professionals and often lack traceable references. In fact, as the title dictates, she suggests that if Google were a physician, he or she should be sued for malpractice, based on the number of problems that disseminating false information causes (no word on Dr. Pepper and Dr. Feelgood’s prospects at the time of publication).

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The Increase in Waived Testing In Physician Office Laboratories

Introduction Laboratory testing plays a critical role in health assessment, treatment, monitoring, and ultimately, the public’s health. Test results contribute to diagnosis and prognosis of disease, the monitoring of treatment and health status, and population screening for disease. An estimated 7-10 billion laboratory tests are performed each year in the United States and laboratory test results influence approximately 70% of medical decisions. Increasingly, these decisions are based on simple tests performed using devices that are “waived” from most federal oversight requirements, and are thus designated as waived tests. When these waived laboratory tests are performed at or near the site of patient care - such as in an emergency room or urgent care clinic, or at patient’s bedside - they fall under the definition of Point of Care Testing (POCT). Physician office laboratory testing also is included under the definition of POCT when these tests are performed, and the results are provided to the physician, while the patient is still present and diagnostic and treatment decisions can then be made utilizing this information. The rapid growth of POCT testing is a prime driver for the increase in waived testing at physician office laboratories, and is a direct result of the convergence of several trends that are already impacting POL operations:  Technological advances that bring higher quality waived testing closer to the patient,  The decentralization of laboratory services, so that POLs can now perform testing previously confined to core laboratories  The Increased number and variety of tests classified as CLIA-Waived, and available to POLs  Growth of Drugs of Abuse/Pain Management Clinics performing drug testing in-house

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Sticks and Stones Aside, Words Absolutely Still Matter

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Sticks and Stones Aside, Words Absolutely Still Matter Many subcultures boast their own sets of terminology and vocabulary. Whether the discussion de rigueur is politics, college sports, toy collecting or some other deep and nuggety interest one may have, you can guarantee that the deeper one goes into the culture, the more ultra-specific the buzzwords become. Cultural anthropologists recognize the importance of this terminology to the identity of the group. Wrestling fans (for example) are full of weird terms, whether they’re talking about internet fans (“smarks”), distinguishing factors among their favorite wrestlers (“gimmicks”), losing wrestlers (“jobbers”) or the unspoken code for the scripted events they know and enjoy every week (“kayfabe.”) they run the gamut of double meaning and nomenclature. This culture-specific terminology distinguishes the group’s discussions and acts as a beacon to others within the group, giving credibility to the speaker. It also serves to galvanize the group, to set it apart from “outsiders.” In other words, those within the group know how to “talk the talk.”

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How Dr. J. Murray Hockings in Helping Reverse Type 2 Diabetes – POR Q&A with Dr. J. Murray Hockings

How Dr. J. Murray Hockings in Helping Reverse Type 2 Diabetes – POR Q&A with Dr. J. Murray Hockings: When I was 19 years old, my favorite aunt died from complications of diabetes. She was only 34, leaving behind two young adopted children to be raised without their mother. Her tragic passing at such a young age was devastating to our whole family, but it was especially hard on my mother. In the U.S. and other countries, the general public seem to have a sort of apathetic attitude towards this disease. But I see diabetes for the deadly disease it really is. I know first-hand the pain and suffering this disease wreaks on its victims. And its victims aren’t just the patients, their family suffers deeply as well. I started Help Your Diabetes to help families avoid having to go through what my family went through.

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NEW ONLINE COMMUNITY EMPHASIZES CRITICAL ROLE OF LABORATORY MEDICINE

Last year, COLA, a leading private accreditor of laboratories in the U.S., brought together more than 30 thought leaders in health care - including physicians, regulators, public health experts, medical laboratory scientists, manufacturers, nurse practitioners and others – in a Leadership Summit to discuss the future of laboratory medicine in the context of the Affordable Care Act (ACA). The Summit focused on the importance of quality, what it means to laboratory professionals, and how to promote a continuous culture of excellence within the field. Inspired by the Summit, COLA conceived an online community (www.Labtestingmatters.org) to further the exchange of ideas and experiences about the importance of laboratory medicine to quality patient care. While laboratory medicine is a largely unseen profession, it remains critical to the healthcare system, as it influences over 70 percent of all diagnostic decisions. The new website is intended to foster a sense of community around laboratory medicine, including but also transcending those who work directly in laboratories. It encourages lab professionals and other allied health partners to discuss the true value of laboratory medicine in the modern healthcare system.

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Ask the Expert

Today we are going to focus on Waived Testing. These are supposed to be the simple tests that anybody can do and if done incorrectly, would not cause harm to the patient. Waived laboratories must meet only the following requirements under CLIA: • Enroll in the CLIA program; • Pay applicable certificate fees biennially • Follow manufacturers' test instructions. The types of tests waived under CLIA have increased from 8 to approximately 100 tests since the inception of the program in 1992. Because of the few requirements for testing, the number of laboratories issued a Certificate of Waiver has grown from 20% to 69% of the approximate total of the 236,000 laboratories enrolled. That means over 162,000 labs perform only Waived testing. This does not include the higher level of labs that perform Waived testing as well. There is a report everyone performing Waived testing should read. It is called Good Laboratory Practices for Waived Testing Sites. It is a government report and can be found here: http://www.cdc.gov/mmwr/PDF/rr/rr5413.pdf This report shows the findings when the government inspected just a sampling of Waived sites. Remember, all they are required to do is follow manufacturer’s instructions for performing the testing.

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The Role of Laboratories in ACOs

Most experts now agree that a value-based model (quality of health outcomes per dollar expended) measured at the patient level is the only way to achieve real savings over time and bring about true system transformation. The Accountable Care Organization is one of several models developed to achieve this. Required is a robust IT structure across the continuum of “cradle to grave” care including HIEs, EHRs, Hospital Information Systems, Labs, e-Prescribing, Medical Device, and Diagnostic Imaging systems. It also requires multi-disciplinary, multi- organizational, team -based care models to actively manage emerging care plans, care delivery, and compliance with evidence-based care practices across multiple providers and care settings . In order to accomplish this, organizations are collecting and analyzing performance and outcomes measures. Pathologists and laboratory professionals have the expertise to identify significant trends and patterns and medical outcomes from this data. In turn, these analyses can be used to adjust the decision support and clinical pathways used to care for different disease states, and effectively reduce and control the cost of care . Indeed, laboratory clinical expertise, in combination with the lab’s network of physician and patient touch points, make laboratories a central component of an integrated provider organization. By hosting the vast majority of centralized information, laboratories reaffirm the importance of highly functioning physician/laboratory relationships .

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5 Apps to Tame Physician Twitter Feeds

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In 2015, the case for social media is a strong one. Sure, it gets a bad rap every once in a while, what with teenagers, cyber harassment and all those annoying game requests, but social media can also make us better citizens. Many of us are better informed on current affairs due to social media, and no one really has any excuse to ever forget a birthday ever again. Social media can also help physicians do their jobs better, as anyone who's followed the trend can tell you. For one, it renders physicians more visible to their patients, it allows safe, controlled conduits through which to share health and treatment information and by having social media accounts in place, physicians can place a positive spin on their own Search Engine Optimization (SEO). This means that when someone Google searches a physician's name, the first few results will be those controlled by the physician, putting the control back in place of the physician.

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