Laboratory Management : Regulation And Compliance Exam Questions And Answers Verified 100% Correct

Laboratory Management : Regulation And Compliance Exam Questions And Answers Verified 100% Correct CLIA Certificate of Registration Issued to laboratory that enables the entity to conduct moderate to high complexity testing (or both) until entity is determined by survey to be in compliance with CLIA CLIA Certificate of Compliance Issued to laboratory after an inspection that finds the laboratory to be in compliance with all applicable CLIA requirements CLIA Certificate of Accreditation Issued to laboratory on the basis of laboratory's accreditation by organization approved by HCFA Voluntary Accreditation Agencies Three principal deemed organizations: The Joint Commission (TJC) Laboratory Accreditation Program of the College of American Pathologists (LAP-CAP) COLA Health Insurance Portability and Accountability Act (HIPAA) Legislation intended to reduce health care costs by requiring use of electronic data interchange for routine healthcare transactions. Includes rules to protect security and privacy of medical records used in these transactions Main Rules to Protect Privacy/Security of PHI Under HIPAA 1. HIPAA Privacy Rule 2. HIPAA Security Rule 3. HIPAA Enforcement Rule 4. HIPAA Breach Notification Rule HIPAA Security/Privacy Rules Apply to anyone who encounters patient information (physicians, nurses, healthcare students, patient records managers, information systems staff, dietitians etc). Security vs. Privacy Security standard protect storage and transfer of electronic PHI only; privacy standards protect all forms of PHI Protected Health Information (PHI) Information relating to an identified individual's past, present, future: physical/mental health or condition, provision of healthcare services, payment for healthcare etc. Notice of Privacy Practices Advises the individual about the covered entity's privacy practices. Exceptions: emergencies, patient incapacitation HIPAA Statutory Standard Each covered entity who maintains/transmits PHI shall maintain reasonable and appropriate: 1. administrative safeguards 2. technical safeguards 3. physical safeguards Minimum Necessary Rule Amount of PHI used/disclosed is restricted to minimum amount necessary. Exceptions: 1. Disclosure to a provider 2. Release authorized by individual for their own reivew 3. Disclosure to comply with HIPAA 4. Disclosure required by law Minimum Necessary Rule - Treatment, Payment, Healthcare Operations Patients must provide consent for use of PHI in treatment, payment and operations (TPO). Minimum necessary rule does not restrict PHI used/disclosed in treatment but does apply to payment and healthcare operations. Incidental Disclosures Include patient subject to observation in waiting areas, or overheard conversations in semi-private areas. Usually not HIPAA violations if the covered entity has safeguards in place and staff observes them. HIPAA Authorization Written permission from the patient (or representative) to disclose PHI for non-TPO purposes (e.g. marketing, fundraising, research). May also be employmentrelated or patient request. HIPAA and Research HIPAA applies to all human subject research which involves creation, use or disclosure of PHI (e.g. clinical trials, medical record/chart reviews, epidemiological studies) Administrative Requirements for HIPAA Compliance