Verified Document

Clia Urinalysis Tests In Physicians' Offices Urinalysis Research Paper

CLIA URINALYSIS TESTS IN PHYSICIANS' OFFICES Urinalysis

CLIA Urinalysis Tests in Physicians' Offices

CLIA regulations cover all laboratory tests conducted medical purposes. Many of these tests no longer require intensive oversight procedures because manufacturers have designed them to be almost foolproof and safe to use. Waived urinalysis tests include those detecting illicit drug use, pregnancy, liver and kidney problems, and blood abnormalities. The ease and speed with which these tests can be performed, and the relatively relaxed CLIA regulations covering their use, are making them increasing popular for use in provider offices.

CLIA Urinalysis Tests in Physicians' Offices

All clinical laboratory services offered in the United States are regulated under the Clinical Laboratory Improvement Amendments (CLIA) of 1988 (Centers for Disease Control and Prevention [CDC], 2005, p. 2). The Centers for Medicare & Medicaid Services (CMS) administers the CLIA program and the CMS, CDC, and FDA are jointly responsible for implementing CLIA regulations.

Waived Laboratory Tests

CLIA regulations draw distinctions between high complexity, moderate complexity, and low complexity tests, due to how error-prone a given test might me and the associated safety concerns (CDC, 2005, p. 2). Low complexity tests are typically...

Waived tests are becoming more and more common, and error-free, and some can even be purchased over the counter in pharmacies for home use, e.g. pregnancy tests. For this reason, offering waived testing procedures in physician's offices is becoming more popular because of the convenience and speed with which test results can be obtained. All that's needed to begin is to obtain a Certificate of Waiver from CMS and pay the $150 biannual fee.
CLIA waived urinalysis tests are available for a large number of applications (for a complete list see: U.S. Food & Drug Administration, 2011) and include testing for illicit drug use, kidney and liver function, pregnancy, and blood problems. The most common format for these tests is test strips, which turn a specific color when exposed to the urine sample. The strips can be then graded by hand or by inserting into small automated strip readers. In terms of safety, the same biohazard precautions that a typical physician's office has in place are sufficient.

CLIA Regulations for Waived Tests

CLIA requires that the number of tests used be recorded and submitted on the CLIA application for waived testing Form CMS-116 (Centers for Medicar & Medicaid Services [CMS], 2004). Tests…

Sources used in this document:
References

Centers for Disease Control and Prevention. (2005). Good Laboratory Practices for Waived Testing Sites. Morbidity and Mortality Weekly Report, 54, 1-32.

Centers for Medicare & Medicaid Services. (2004). State Operations Manual: Appendix C -- Survey procedures and interpretive guidelines for laboratories and laboratory services. Retrieved September 2, 2011 at http://cms.gov/manuals/Downloads/som107ap_c_lab.pdf

U.S. Food & Drug Administration. (2011). CLIA -- Tests waived by FDA from January 2000 to present. Accessed September 2, 2011 from http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/testswaived.cfm
Cite this Document:
Copy Bibliography Citation

Related Documents

Exercises How Are Urinalysis, Blood
Words: 1196 Length: 4 Document Type: Essay

There is also aneed to discontinue all the nephrotoxic drugs as well as the elimination of exposure to any form of nephrotoxins. All forms of electrolyte abnormalities must be properly corrected.Uric acid and pigments can be treated using alkaline dieresis. Alcohol drip and fomepizole should be used for treating methanol or ethyl glycol poisoning. Postrenal acute renal failure is caused by the obstruction of the urinary collection system which is

Workplace Drug Screening Testing for Drugs Has
Words: 1362 Length: 4 Document Type: Essay

Workplace Drug Screening Testing for drugs has developed into a significant security concern in places of work for management. The purpose of screening is to diminish the effects that illegal substance abuse has on the places of business, comprising lateness, non-attendance, turnover, mind-set troubles, theft, reduced output, misdeeds and hostility. "The U.S. Department of Labor estimates that drug use in the workplace costs employers $75 to $100 billion dollars annually in

Diabetes Management Diabetes Mellitus Is One of
Words: 2575 Length: 10 Document Type: Essay

Diabetes Management Diabetes mellitus is one of the non-communicable diseases that have continued to be in the forefront of public health challenges. Diabetes occurs when the body system is unable to produce sufficient insulin. Typically, insulin is a hormone secreted from the beta cell within the pancreases that regulates the blood sugar as well as assisting in conversion of glucose into energy. Diabetes occurs when there is high level of glucose

Endocrine Pancreas
Words: 701 Length: 2 Document Type: Term Paper

Endocrine Pancreas Review of Symptoms and Lab Results The reported nausea, vomiting, and abdominal pain may indicate a GI disorder, but combined with the patient's diabetes, unusual thirst, constant urination, and fatigue, the symptoms are more indicative of an endocrine disorder (Lippincott Williams & Wilkins, 2006). Some of the patient's lab results fall into the normal range: BUN of 16 mg/dl (normal is 8 -- 25 mg/dl); creatinine of 1.3 (normal is 0.5

Contingency Management Alcohol & Marijuana
Words: 11354 Length: 41 Document Type: Term Paper

" (1995) The authors state: "The amphetamines occasioned dose-related increases in d- amphetamine-appropriate responding, whereas hydromorphone did not. Amphetamines also occasioned dose-related increases in reports of the drug being most like "speed," whereas hydromorphone did not. However, both amphetamines and hydromorphone occasioned dose-related increases in reports of drug liking and in three scales of the ARCI. Thus, some self-report measures were well correlated with responding on the drug-appropriate lever and some

Nursing Consider My Application to
Words: 558 Length: 2 Document Type: Term Paper

In this second phase of my 'career training in life, for over a year after I pursued a career in the medical field, I have developed administrative skills such as medical records/data management and preparation and processing of relevant medical forms and documents. Currently, I have been exposed to other responsibilities such as patient education and quality control and documentation. More importantly, as a medical assistant, I have acquired important

Sign Up for Unlimited Study Help

Our semester plans gives you unlimited, unrestricted access to our entire library of resources —writing tools, guides, example essays, tutorials, class notes, and more.

Get Started Now