Quality Assurance and Compliance Flashcards
Quality Assurance Definition
Correlation of appropriate tests and test results with patient care modalities to ensure the highest quality of treatment
Quality Control Definition
A systematic group of activities that recognizes errors and assures that results are correct,
Quality Assurance purpose and goals
QA is a proactive process involving all levels of the lab that identifies problems and the necessary corrective actions to resolve these problems, also must follow up to make sure these corrective actions are working.
Quality Assessment/Assurance Monitors what 3 phases of testing?
Pre-analytical, analytical and post-analytical
How do you document your QA activities?
- Date and initials of person reviewing the problem.
- Scope and analysis of the problem
- Document corrective action and effectiveness of it.
- Document that the issue has been discussed with relevant staff, directors and supervisors.
- Retain documentation for 2 years
What is a Compliance plan ?
A plan to assist laboratories in devising internal controls that foster adherence to federal and state laws and regulations, especially important to Medicare and Medicaid.
7 Elements of a Compliance plan include:
- Written Policies and Procedures
- A compliance officer and committee
- Compliance training for staff
- Hotline to anonymously report suspected violations
- A system to respond to and take disciplinary actions against violators
- Internal monitoring and audits of the system
- Investigation and correct compliance problems
The laboratories role in medical necessity. *
They should only submit claims that they believe are medically necessary. They should have requisitions containing ICD-10 forms supporting medical necessity. They should monitor test utilization over time.
Stark Law *
Prohibits a physician from making referrals to a laboratory with which the physician or a family member has a financial relationship.
Fair Labor Standards Act (FLSA) *
Requires minimum wage and overtime of one and a half rate
Learned Professionals such as Medical Technologists are *
Exempt from the Fair Labor Standards Act
HIPPA definition
Health Insurance Portability and Accountability Act of 1996
HIPPA Title I
Focus on Health Care Access, Portability, and Renewability. Regulates availability of health insurance policies, requires coverage for existing conditions,
HIPPA Title II
Preventing Health Care Fraud and Abuse. PRIVACY RULE except under certain circumstances. Transaction and code sets rule, Security rule which pertains to electronic PHI, Unique Identifiers Rule, Enforcement Rule to make violators pay penalties.
HIPPA Title III
Tax-related Health Provisions Governing Medical Savings Accounts, amounts and availability
HIPPA Title IV
Application and Enforcements of Group Health Insurance Requirements. Specifies conditions for health plans to cover existing conditions and continuation of coverage, COBRA.
HIPPA Title V
Revenue Offset Governing Tax Deductions for Employers, prohibits tax-deduction of interest life insurance loans, company endowments, or contacts.
?????HIPPA Covered Entity and Business Associates
HIPPA only applies to covered entities such as Health Care Providers, and those laboratories that do not conduct transactions electronically????
What is Protected Health Information (PHI)?
Individually identifiable health information transmitted by covered entity or its business associate in any form which is protected by the HIPPA Privacy rule.
PHI includes?
Names, geographical, dates, Phone or fax #’s, email, social security, medical record, health ins., account #’s, license #’s, photos, or any other identifiers.
When can PHI be released without prior authorization?
Child abuse, FDA, disease exposure, employer for OSHA, law enforcement, public health surveillance.
Civil and Criminal Violations of HIPPA
Fines vary depending on willful neglect and whether it is an individual or an organization.