Case Study: Current Challenges For Clincal Diagnostic Commercialization

Now that I remain in the CLT program, it has actually opened my eyes to a complete different world of operating in the medical laboratory field. Having that chance to be more involved with the breakdown of the process of the clinical laboratory studies is astounding. I ‘am pleased to have prepared myself to travel beyond with a little in order to succeed with wealth of

If the patient cannot afford the bill, they do not have access to personalized medicine, which defeats the purpose of having this innovative technology. A proposed solution to this concern is allowing patients to freely purchase these tests so long as they are Federal Department of Agriculture (FDA) regulated. Without FDA regulations, patients are unable to know for sure that the tests they purchase are reliable and accurate. In addition, paying for these tests will save patients money in the long run because they will know which drugs or treatment will be effective for them without trial-and-error methods (Vogenburg, 2010). In terms of ethics, personalized medicine creates some problems for physicians. First, if physicians are unwilling to pay for these tests and the patient cannot

Grace’s story should serve as proof that doctors should always run the correct tests to ensure that their patients are properly diagnosed before it is too late. A newspaper article provided a story about a young woman who suffered from a cancerous growth that was misdiagnosed many times. Her illness was not taken seriously by doctors who accused her of being young and naive, even though she had had the cancerous disease since she was eight. "Doctors were just dismissing me all the time," she said. "They were really patronizing and treated me

The College of American Pathologists or CAP is the accrediting organization for laboratory and testing personnel. CAP’s “accreditation process is so thorough, the Joint Commission [and CMS] accepts …their standards” in place of conducting their own survey of the hospital’s laboratory and personnel (Gartee, 2011, p. 47). This is because of the guidelines they follow to maintain their integrity and to remain the industry standard. In recent years, the “CAP [has] developed new check list” for continued improvements. Additionally, they are continuing to vet the requirements for the new next-generation sequencing or NGC-based test that is speeding laboratory procedures. So much so that the recent adoption of the new technology for clinical testing” was done prior to the new standards being approved (Aziz, et.al. 2015, p. 481).

As a result of the funding for such testing, many believe the breakthrough for curing diseases is around the corner. The decision is whether or not America wants to take a step forward and progress their knowledge in medicine. Nobody agreed it would be easy, but as any other advancement in medicine, one must concur the future is near. Ultimately getting a specific drug tailored to your genetic sequence might be helpful to possibly eradicate and possibly cure deadly diseases and disorders. Within the past few years, many breakthroughs in medical advancements came through as some neurosurgeons complete brain surgeries while the patient is awake. Such testing poses crucial features to preventing things from going wrong. Similarly, being provided with the needed tools, one can hope the next step is toward cures for age-old monstrosities. Although not being enforced, many doctors are willing to refer their patients to get their genes tested. Next time a visit to the doctor’s office is scheduled, feel free to ask about a glimpse into what your future

Congress held hearings at which people who had been harmed by laboratory errors testified. These hearings revealed serious deficits in the quality of work from physician office laboratories and in Pap smear testing results (R. D. Feld, M. Schwabbauer, and J. D. Olson, 2001, The Clinical Laboratory Improvement Act [CLIA] and the physician's office laboratory; Virtual Hospital, University of Iowa College of Medi-cine [www.vh.org/adult/provider/pathology/CLIA/CLIAHP.html]). In 1988, Congress once again responded to public concerns about the quality of laboratory testing by passing CLIA '88. CLIA '88 expanded the laboratory standards set by CLIA '67 and extended them to include any facility performing a clinical test. Currently, under CLIA '88,

137). Medicare Administrative Contractors (MACs) established new, lower reimbursement rates in 2013. These prices were reviewed and some were changed, but prices remained low (Klein, 2015, p. 137). The Access to Medicare Act of 2014 includes Section 1834A which was written to change CLFS pricing methods and require certain labs to report prices for nonbundled tests. Once implemented, CLFS payments will come from a weighted mean of these reported data (Klein, 201, p. 137). Many hospitals have incentives for not reporting these prices, thus if hospital prices are not included in the reported data, then pricing will be lower due to lack of cooperation from hospitals who do not report (Klein, 2015, p. 137). Klein (2015) explains that there are numerous advantages to molecular testing which include targeted therapies, prevention of certain diseases such as cancer, and assistance in family planning (p.

Clinical Laboratory Improvement Amendments of 1988 (CLIA) facilities in the United States that perform laboratory testing on human specimens for health assessment or the diagnosis, prevention, or treatment of disease are regulated under the Waived tests. Although CLIA have a low risk for erroneous results, but CLIA is not completely error-proof. Errors can occur anywhere in the testing process. Sometimes CLIA have errors in the manufacturer's instructions are not followed and when testing personnel.

With the passage of Clinical Laboratory Improvement Amendments (CLIA) Act the patient would know that unsafe practices and poor quality within any laboratory will not be tolerated. CLIA rules for laboratory testing are more standardized because it outlines the expectations of laboratories. This passage would allow the patient and/or their personal representative access to his or her laboratory test reports and the results of such test from the laboratory. The patient would know that this amendment requires laboratories to implement policies and procedures relating to a patient request for information. Also, the patient would know that there must be a proper verification of identification before he or she has access to PHI. Any laboratory

The earliest version of CDST allowed physicians to bypass the alert and continue with the order. The alert system proved to be useful, and it helped decrease unnecessary orders for costly molecular diagnosis tests. Still, it was unsuccessful for stopping duplicate test orders for routine assays. It was proposed by the Test Utilization Committee of the Cleveland Clinic to change the CDST so that duplicate test orders would be blocked for certain tests. The researchers monitored the intervention for 2 years and also assessed patients’ records for the first year after the

In analyzing the themes and events shaping the biotechnology sector, I enlisted the expertise of Bob Rochelle. Mr. Rochelle is a Biotechnology consultant with over thirty-two years of experience. Prior to becoming a consultant, Mr. Rochelle served as Vice President of commercial planning and corporate communication for Good Start Genetics. During our conversation, we discussed the Noninvasive Prenatal Testing (NIPT) space, specifically: potential demand drivers, consolidation in the diagnostics industry, reimbursement, as well as determining the effect NIPT demand could have on Illumina (ILMN : Nasdaq : $171.67). I believe that demand for Illumina's instruments and consumables will continue to strengthen in response to the positive trends taking

Undoubtedly, laboratory analysis and results are vital part of diagnosis of many disorders and diseases these days. According to Peter et al. (2010), an estimated 60% to 80% of patient management decisions are based on laboratory data. Therefore, accreditation of processes and competence of pathology laboratories is very significant particularly for benefit of patients. The UK was, along with Holland, the first European country to introduce a laboratory accreditation scheme for pathology (Barnes, 2014). Organisations, such as the Institute of Biomedical Science (IBMS), the Health and Care Professions Council (HCPC) and Clinical Pathology Accreditation (CPA) are crucial institutions in process of laboratory accreditation in UK. The IBMS is

First, what is a clinical laboratory? A clinical laboratory is a laboratory with several departments that perform test to help provide better information to the patient to provide them with a diagnosis, a treatment or even to prevent disease. So who oversee these labs? One of the monitoring agencies is American society of clinical laboratory science. They “assure reliable test results which contribute to the prevention, diagnosis, prognosis, and treatment of physiological and pathological conditions.” In 1988 The Clinical Laboratory Improvement Act of 1988 was inputted. (CLIA ’88) This act has divided the clinical laboratory testing in to waved, moderately complex, and highly complex categories’. Waved testing is a simple and accurate test. Some examples would be pregnancy test, blood glucose test, and also the urine dipstick test. Moderately complex testing is manual procedures with minimal steps and minimal preparation. Highly complex testing is including all laboratory testing. There are many positions in

In the United States, 1 in 20 medical diagnoses are incorrect, half of which can prove fatal (BMJ Quality and Safety, 2014). With the average patient waiting 29 days for a specialty appointment (Merritt Hawkins, 2014), an early, accurate diagnosis deserves the utmost priority. The earlier a disease is accurately diagnosed, the more likely it can be effectively treated. My family’s pain is my motivation towards a career in pathology, working by a habit of superior quality, so I may prevent another

Particularly more than 84% of laboratory errors can be attributed to pre-analytical factors that include patient condition, specimen collection, transport, processing and analysis [15].