This lecture covers chapter 15 and explores the regulations by which laboratory testing, including point-of-care testing, is conducted. Central to this discussion are the Clinical Laboratory Improvement Amendments of 1988, referred to as CLIA 88 or JA CLIA. CLIA is a federal mandate that identifies laboratory testing standards and supersedes the requirements outlined in the Clinical Laboratory Improvement Act of 1967. The regulations related to safety, such as the Occupational Safety and Health Administration requirements, are also discussed along with the protection of patient medical information by the Health Insurance Portability and Accountability Act. Following successful completion of this chapter, the learner will be able to, in the framework of CLIA, discuss the concepts of site neutrality, certification, test complexity categories, proficiency testing, quality systems for non-web testing, and professional personal hierarchy in a laboratory setting. The second objective is to compare and contrast CLIA Co la TJ c and c AP testing requirements for waived and non-waived testing. The third objective is to formulate strategies for meeting the regulations that are applicable to his or her healthcare organization. The fourth objective is to describe the Occupational Safety and Health Administration (Oh sh a) requirements in terms of laboratory testing, and finally, discuss the laboratory requirements for meeting the HIPAA legislation. The Clinical Laboratory Improvement Amendments of 1988 regulate all laboratory testing used for diagnosis, monitoring, or treatment. It establishes quality standards for all laboratory testing to ensure accuracy, reliability, and timeliness of patient test results. It is also a test site neutral, which means the same regulations apply regardless of the location of testing. The Centers for Disease Control and Prevention (CDC) were initially charged with developing and promulgating the CLIA regulations. Each certificate has a fee schedule dependent on the number of test specialties, test complexity level, and test volume. The...
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Clia Waiver Application Texas Form: What You Should Know
Google account. Click My Documents, and then click Download (or save as) a .PDF file. Do this with the PDF file you just downloaded. Print the CIA Waiver Application for Texas. Bring the print-out to one of the CTR's in-person or fax it to the P.O. Box or location listed above. Faxed copy to the CTR should be emailed as TX-PMA-0001. Do not use the fax to upload your signature. Your signature will be submitted electronically with the form. Click Submit Online and submit it online or at the TRC's location. If you have any questions about this form, please email us at . Form 3225, Letter of Waiver for a Non-Clinical Test, must be submitted to the CTR or the state health department that administered the state tests (see link below). When submitting a waiver application, you must submit the following documents 1. 2. a. Statement by the applicant indicating that the applicant has accepted the requirements for the test and that he/she does not intend to perform any clinical procedures that may involve the administration of coagulation factors or other substances that might have adverse effects on the applicant or any member of the applicant's family. b. A letter (or form letter) from the applicant's doctor or other licensed health care provider to the following effect: i. If the applicant is under 18 years of age, the applicant's parents or legal guardian shall authorize the applicant to sign this form on their behalf. ii. If the applicant is under 18 years of age, the legal guardian or the applicant's parents or legal guardian may authorize the applicant to authorize the applicant to sign this form on their behalf. iii. The applicant is unable to sign this form due to health concerns. iv. The applicant has signed a waiver that may be faxed or emailed (please click here for further instructions). c. A complete copy of the applicant's Social Security Number (SSN) when the applicant is 18 or later or his/her parent or guardian's SSN when the applicant is under 18 years of age. d. 3.
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