Clinical Laboratory Improvement Amendments: A Case Study

BRLI provides laboratory services to patients jointly with physicians and other healthcare professionals. The privacy practices described in this NOPP will be followed by:

This essay is about why lab procedures and practice must be communicated in a lab.

The Clinical Laboratory Improvement Amendments (CLIA) established a program to regulate any size and all “laboratories that test patient specimens to ensure the labs produce accurate and reliable test results”, CLIA was passed in 1988 to establish quality standards and regulations on all non-research laboratory test, and they must meet applicable Federal requirements and have a CLIA certificate to operate.

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

Point of care testing (POCT) refers to laboratory testing that occurs close to the patient rather than in a central laboratory. POCT is usually performed by non-laboratory trained individuals such as nurses, physicians, respiratory therapists, percussionist’s, anesthesia assistants, midwives and paramedics [1]. In recent years, these assays have been increasingly carried out at sites of patient care, such as doctor’s offices, emergency rooms, and even at home. This trend allows for rapid estimates of the state or progress of an illness [2]. POCT is mainly characterized by proximity to the patient, quantitative or semi-quantitative single measurements, short turnaround time, no sample preparation, no pipetting, use of pre-made reagents, user-friendly dedicated analytical instruments and instant, result deduced therapeutic action [3]. In recent years, POCT has gained ground worldwide. In advanced healthcare

The SCHC addressed meaningful use by recording patient demographics, maintaining an active medication lists and incorporating clinical lab test results into the HER, as apart of their meaningful use objectives. For recording patient demographics, they maintained data for accurate billing and ensured that the practice workflow was adjusted to capture all of the necessary patient data. They addressed active medication lists by following the requirements for e-prescribing. Patients were able to review their active medication list during their visit. Changes to the medication list were reviewed with the nurse and adjusted within the EHR system by the doctor. They communicated information for the care coordination process by making test results efficient and safe to access. Physicians were able to make real time decisions when they receive the test results from LabCorp, Quest, and other health

Proper patient identification in hospitals has been an issue for many years, especially when it comes to blood specimen collection. Laboratory specimens being mislabeled are a everyday cause of harm to patients including repeat diagnostic procedures; repeat phlebotomy; delays in necessary surgical procedures; a performing unnecessary surgical procedures (Dunn and Moga, 2010). This is not only costly, but it is very stressing to patients and medical staff. The biggest concern is the possibility of making a fatal error when it comes to specimen collection. Without proper patient identification this risk increases substantially. Wallin, Sodberg, Van Guelpen, Stenlund, Grankvist, and Brulin (2009) state that critical errors in patient identification for blood testing occurs in up to one per 1000 specimens or procedures and misidentified specimens cause 160,000 adverse events every year in America.

It is important as an APRN to understand the rules and regulations of laboratory processes to better provide accurate testing for patients and because it is federal law. After reading and researching on Clinical Laboratory Improvement Amendments (CLIA), I can see how it is important for a future nurse practitioner to have this knowledge. There is a process that a clinic is required to understanding to obtain the correct certificate for performing lab testing. There are five different types of certifications: certificate of waiver (CW), Certificate for Provider- performed Microscopy Procedures (PPMP), certificate of registration (COR), certificate of compliance (COC) and certificate of accreditation (COA). I see that the certificate of waiver

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).

In conclusion, I feel that the states should have licensure for laboratory scientist if they choose to work in a clinical laboratory. The arguments for outweigh the arguments against state licensure as well as both ASCLS and ASCP are in support of such action. The laboratory field has a broad range of option for a laboratory scientist to choose with options in research, clinical or even forensic with each having a different impact on the public. The clinical laboratory has the most the most immediate impact on the health of people in the community making the people working in those laboratories responsible for accuracy and quality of the patient testing. I explained that difference between certification and licensure is that the licensure was

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,

Journal article based on Lisa Epsioteo’s article “Hospital Labs: Behind the Scenes,” posted on 30 January 2015 from U.S News, which demonstrate the importance of lab tech duties like analyzing specimen for the patient safety. It gives basic ideology of lab tech work, also informs, and provides learning experience about covert scientist and phlebotomist working at their respective work

According to the Clinical Leadership & Management Review, (2008) healthcare spending is currently taking up 16.2 percent of our nation’s economy. According to the Centers for Medicare and Medicaid Services, cost is expected to rise to twenty percent by 2015. Nearly, seventy percent of medical decisions are based on laboratory tests, yet the costs of lab tests account for only four percent of the total in health care costs. Annual sales for clinical laboratory testing in the U.S. in 2001 were thirty-five billion, and are expected to grow at four percent annually (Johnson, 2008). Upon looking at annual global growth rate, laboratory testing is projected to increase by 5.5 percent (Johnson, 2008). As a result, laboratories as a business plays a significant role, on how health care dollars are spent. Additionally, laboratories offer a tremendous service for a reasonable price by providing quality, state-of-the-art services and fair reimbursement that is essential.

In the article Medical Professionalism in the New Millennium, by Sox, the author’s focus was on the three fundamentals and ten professional responsibilities that are bestowed on medical professionals today. These are principles and guidelines that we, as medical professionals, should consider and adhere to daily while performing our duties. Although all the points made in the article are important there are a few that can be incorporated into the Medical Laboratory Scientist’s everyday performance. In my opinion, these principles are improving quality care, patient confidentiality, scientific knowledge, professional competence, and professional responsibilities. In addition, I would incorporate always having the patient’s best interest at

After discovering my passion for science and math, I pursue a career in Clinical Laboratory Science with enthusiasm. My desire to study this subject originates from the exciting and rapidly-moving subject area that is highly relevant to major issues facing society today. Clinical Laboratory Scientists play a crucial role in the healthcare field; in detection, diagnosis and treatment of disease in patients. My goal is to be involved in the latest advances in medical research and to constantly be expanding my knowledge about my field. On top of this goal, Clinical Laboratory Science remains a challenging, rewarding and inspiring topic that will motivate and shape my career for my entire life.