Quality Assurance and Legal Issues in Health Care

Flashcards covering key terminology related to Quality Assurance and Legal Issues in Health Care, including definitions for national organizations, quality improvement processes, and legal concepts relevant to phlebotomy.

Quality assurance (QA)

All the activities and programs in place to guarantee the excellence of patient care.

Continuous quality improvement (CQI) program

A system put in place to improve quality by continuous monitoring and analyzing all processes and identifying those in need of improvement.

The Joint Commission (TJC)

An independent, not-for-profit organization that establishes standards for the operation of hospitals and other health-related facilities and services, focusing on improving safety through evaluation.

Survey Analysis for Evaluating Risk (SAFERTM)

A visual representation of survey results implemented by TJC to help healthcare organizations prioritize and focus corrective actions.

SAFERTM MatrixTM

An illustration used by TJC that shows the likelihood of harm due to an area of noncompliance.

Office of Quality Monitoring

An office within TJC that evaluates and tracks complaints from patients, families, and employees.

Sentinel event (SE) policy

A TJC policy that helps organizations identify safety issues and prevent them by requiring root-cause analysis and action plans for significant adverse events.

Root-cause analysis

A thorough and credible analysis performed after a sentinel event to identify underlying safety issues and prevent recurrence.

National Patient Safety Goals (NPSGs)

Part of the overall CQI requirements overseen by TJC, focusing on areas like correct patient identification, improved staff communication, and infection prevention.

Clinical Laboratory Improvement Amendments of 1988 (CLIA

'88)

Federal regulations that establish quality standards for all laboratories, requiring certificates based on testing complexity.

Certificate of waiver (CoW)

A certificate obtained by laboratories performing only waived complexity testing under CLIA

'88.

Waived testing

Laboratory tests that are simple and have a low risk of erroneous results, requiring a Certificate of Waiver under CLIA

'88.

Good laboratory Practices (GLPs)

Guidelines for performing waived tests to ensure quality, as specified by CLIA

'88.

College of American Pathologists (CAP)

An organization of board-certified pathologists offering proficiency testing and continuous laboratory inspection for pathology/lab services, meeting Medicare/Medicaid standards.

Clinical and Laboratory Standards Institute (CLSI)

A global, nonprofit organization that develops voluntary guidelines and standards for all areas of the laboratory.

National Accrediting Agency for Clinical Laboratory Sciences (NAACLS)

An authority on educational quality that provides accreditation and approval of clinical laboratory science educational programs, including phlebotomy.

International Organization for Standardization (ISO)

An independent, nongovernmental organization that develops voluntary international standards across industries to ensure quality and reliability of products.

Process improvement (PI)

Techniques used in quality assurance to identify and solve problems within processes.

Failure Modes and Effects Analysis (FMEA)

A quality assurance process improvement technique.

Lean Methodology

A quality assurance process improvement technique focused on minimizing waste.

Six Sigma

A quality assurance process improvement technique focused on reducing variation and defects.

Lean Six Sigma

A hybrid quality assurance process improvement technique combining Lean Methodology and Six Sigma principles.

Quality Indicators

Measurable, well-defined, objective, and specific guides used to monitor all aspects of patient care.

Threshold value

A level of acceptable practice beyond which quality patient care cannot be assured, triggering evaluation and potential corrective action if exceeded.

Corrective action preventative action (CAPA) plan

A plan established to address issues when a threshold value is exceeded, involving data collection and implementing improvements.

Quality Control (QC)

Operational checks used to ensure that procedures are performed correctly and that equipment and reagents are functioning as expected.

Delta Checks

A quality assurance tool that compares current patient laboratory results with previous results to detect significant changes, potentially indicating an error.

The Patient

's Record

A chronological documentation of medical care given, serving as a legal document, communication aid, and performance evaluation tool.

Test Catalogs and Reference Manuals

Documents that detail how to prepare a patient for a high-quality sample, listing test specifics, handling, and rejection criteria.

Procedure Manual

A manual that states policies and procedures for each test/practice, must be available to all laboratory employees, and updated annually.

Safety Manual

A manual containing procedures related to chemical, electrical, fire, and radiation safety, exposure control, disaster plans, and handling hazardous materials.

Infection Prevention and Control Manual

A manual detailing handwashing, decontamination procedures, precautions, and actions after exposure incidents.

QA Forms

Forms such as equipment check forms and internal incident/occurrence reports used to document problems, consequences, and corrections.

Risk Management

A process focused on identifying and minimizing risks to patients and employees, involving controlling risks and addressing occurrences after they happen.

Individualized Quality Control Plan (IQCP)

A quality control approach tailored to a laboratory

's specific testing, patient population, and other unique factors, allowing flexibility in using PI tools.

Sexual Harassment

A form of sexual discrimination violating Title VII of the Civil Rights Act, defined as persistent or offensive conduct related to a person

's sex that negatively affects a reasonable person

's job.

Hostile work environment

A type of workplace harassment that differs from sexual harassment, often involving offensive conduct not limited by gender or direct sexual nature.

Tort

A wrongful act committed against a person, property, or reputation, with or without just cause, intentional or not.

Assault

A tort action involving the act of threatening to touch or harm another person without their consent.

Battery

A tort action involving the actual touching or harming of another person without their consent.

Breach of confidentiality

A tort action involving the unauthorized disclosure of a patient's personal or medical information.

Fraud

A tort action involving deceitful practices with the intent to deprive another person of their rights or property.

Invasion of privacy

A tort action involving the unauthorized intrusion into a person's private affairs.

Malpractice

A type of negligence committed by a professional, such as a healthcare worker, acting outside the accepted standards of care.

Negligence

A tort action involving the failure to exercise reasonable care, resulting in harm to another person.

Res ipsa loquitur

A legal doctrine meaning 'the thing speaks for itself,' used when negligence is so obvious that it doesn't need to be proven directly.

Respondeat superior

A legal doctrine meaning 'let the master answer,' holding an employer liable for the actions of their employees.

Standard of care

The level of medical care that is reasonably expected of a healthcare professional in a given situation.

Statute of limitations

A law that sets the maximum time after an event within which legal proceedings may be initiated.

Vicarious liability

A legal doctrine where one person is held responsible for the actions of another, often an employer for an employee.

Malpractice Insurance

Insurance that compensates the insured in the event of malpractice liability, often covering individual workers named as codefendants.

Informed Consent

Voluntary and competent permission obtained from a patient after they have been given adequate information about a procedure in nontechnical terms, prior to the procedure.

Expressed Consent

Consent that is specific and can be verbal (followed by a chart entry) or written (signed by provider and patient, witnessed by a third party).

Implied Consent

Consent that is inferred from a patient's actions, often used in emergencies, with laws varying by state.

HIV Consent

Specific consent required in most states for HIV tests, where the client must be advised on the test's purpose, use, meaning, and limitations.

Consent for Minors

Permission for medical treatment required from a parent or guardian, as minors cannot legally give consent themselves.

Refusal of Consent

A patient's constitutional right to refuse a medical procedure, which may be based on religious or personal beliefs and usually requires written verification.

Litigation Process

The sequence of phases in a lawsuit, starting with an incident, proceeding through attorney consultation, discovery, trial, and potentially appeal.

Discovery

A phase in the litigation process where depositions are taken and witnesses are interrogated to gather information.