26 Aug What is the impact of this federal law on the operation of the clinical laboratory?

Hello, 

Provide 1-2 paragraphs responding to each of the following two points . 

1. What is the impact of this federal law on the operation of the clinical laboratory? The Clinical Laboratory Improvement Amendments (CLIA) Program regulates labs testing human specimens and ensures they provide accurate, reliable, and timely patient test results no matter where the test is done. the law that regulates human testing. CMS oversees all lab testing (except some research) done on humans in the U.S. through CLIA.Established in 1988 to ensure quality of diagnostic testing through laboratory regulations. The purpose of a laboratory report is to indicate the patient’s diagnosis. The clinical diagnosis is indicated on a laboratory request form to correlate laboratory data with the needs of the physician. CLIA 88 regulations require that three different procedures be performed in the quality-control protocol for automated hematology instruments. To safeguard the public by regulating all testing of specimens taken from the human body. The procedures are calibration, control sampling testing, and proficiency testing. laboratory requisitions must include doctor’s name; patient’s name, age, DOB, and ID number; tests to be performed; and date and time for specimen collection. Regulates all clinical laboratory testing regardless of where it is performed. All laboratory testing must be performed under an approved CLIA certificate. The information included on a specimen label depends on laboratory and facility policy. Specimens should contain the patient’s name and the date and time of collection. Other information that might be required includes the patient’s date of birth, provider’s name, and initials of the person collecting the specimen. CLIA was designed to. Set safety policies and procedures that protect patients. The purpose of CLIA is to prevent exposure of employees to bloodborne pathogens. If a POL is performing moderate-complexity tests, CLIA requires that two levels of controls be run daily. The study of blood-forming tissues is known as serology. Joint Commission example: A death resulting from failure to rescue. College of American Pathologists example: Brian R. Jackson, MD, associate professor of pathology, University of Utah, and medical director for support services, IT and business development at ARUP laboratories, offers this emphatic, clear-cut advice to hospital systems interested in establishing effective Laboratory Stewardship programs. According to Dr. Jackson, clinical integration and collaboration are essential: “If you get that clinical collaboration piece rightwith pathologists working closely with frontline clinicians and hospital leadership everything else can fall into place” as long as the financial measurement system is supportive.

2. The CLIA made requirements to improve the quality of laboratory testing, which includes standards for PT, QC, QA, patient test management and personnel requirements. The CLIA regulations establish quality standards for laboratory testing performed on specimens from humans, such as blood, body fluid and tissue, for diagnosis, prevention, treatment of disease, or assessment of health. The final CLIA regulations were published in 1992, phased in through 1994, and amended in 1993, 1995, and 2003

Joint Commission standards help develop strategies to address complex issues and identify vulnerabilities in the patient care experience. The standards review various aspects of caring for patients, which ensures a comprehensive review of the patient care process. It improves the quality of patient care by reducing variation in clinical processes. The Joint Commission’s standards and emphasis on clinical practice guidelines help organizations have a consistent approach to caring for patients, which reduces the risk of error. The CAP’s Laboratory Accreditation Program is an engaging, dynamic, collaborative experience that encourages continuous improvement. CAP Laboratory Accreditation helps laboratories maintain accuracy of test results and ensure accurate patient diagnosis, meet required standards from CLIA, FDA and OSHA, manage rapidly evolving changes in laboratory medicine and technology, and exchange ideas and best practices among pathology and laboratory medicine peers.

The FDA categorizes diagnostic tests by their complexity, from the least to the most complex: waived tests, moderate complexity tests, and high complexity tests. A score of 1 means the lowest level of complexity, and a score of 3 means the highest level. Examples of waived tests include dipstick urinalysis, fecal occult blood, and urine pregnancy tests. Examples of moderate complexity tests include complete blood count, urine drug screening, and automated immunoassays. Examples of high complexity tests include cytology immunohistochemistry, peripheral smears, and flow cytometry. 

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