CHAP_2

Chapter Overview: Quality Assurance and Legal Issues in Health Care

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• Website: www.jblearning.com

Objectives of the Chapter

• Demonstrate basic knowledge of terminology for national organizations, agencies, and regulations that support quality assurance in healthcare.

• Define quality and performance improvement measurements as they relate to phlebotomy.

• Describe the components of a quality assurance (QA) program and identify areas in phlebotomy subject to quality control (QC).

• Demonstrate knowledge of the legal aspects associated with phlebotomy procedures.

• Understand confidentiality and regulations like HIPAA regarding personal information handling.

Quality Assurance in Healthcare

Definition of Key Terms

• Quality: The degree of excellence of something.

• Quality Assurance (QA): All activities and programs aimed at guaranteeing patient care excellence.

• Continuous Quality Improvement (CQI): Systematic method for improving quality through ongoing monitoring and analysis of processes.

National Standard and Regulatory Agencies

The Joint Commission (TJC)

• Type: Independent, not-for-profit organization;

• Function: Sets healthcare standards for hospitals and health-related services.

• Goal: Improve public health care via evaluation and safety enhancements.

• SAFER™ Program:

  • Implemented in 2017 for risk evaluation.

  • Visual representation of survey results.

  • Helps health care organizations prioritize corrective actions.

Sentinel Event Policy

• Helps organizations identify and prevent safety issues.

• Mandatory procedures following sentinel events include:

  • Conducting root-cause analysis.

  • Formulating and implementing action plans to reduce risks.

  • Monitoring effectiveness of improvements.

National Patient Safety Goals (NPSGs)

• Part of CQI requirements, managed by a safety panel.

• 2018 Goals include:

  • Correct patient identification;

  • Improving communication among healthcare staff;

  • Preventing infections.

Clinical Laboratory Improvement Amendments (CLIA ‘88)

• Federal regulations establishing quality standards for laboratories.

• Labs must be certified based on their testing complexity (high, moderate, or waived).

College of American Pathologists (CAP)

• Composed of board-certified pathologists.

• Provides proficiency testing and lab inspections.

• CAP meets Medicare/Medicaid standards and has inspection reciprocity with TJC.

Clinical and Laboratory Standards Institute (CLSI)

• A global, nonprofit organization for developing voluntary laboratory guidelines and standards.

National Accrediting Agency for Clinical Laboratory Sciences (NAACLS)

• Authority on educational quality and accreditation of clinical laboratory science educational programs.

International Organization for Standardization (ISO)

• Develops voluntary international standards across industries focusing on product quality and reliability.

Quality Assurance in Phlebotomy

QA Goals

• Ensure quality through scheduled reviews of patient care appropriateness and timeliness.

QA Processes

• Employed techniques include:

  • Failure Modes and Effects Analysis (FMEA)

  • Lean Methodology

  • Six Sigma

  • Lean Six Sigma

  • Root-Cause Analysis (RCA)

Quality Indicators

• Guide monitoring of various patient care aspects.

• Must be:

  • Measurable

  • Well-defined

  • Objective

  • Specific

  • Relevant to important care aspects.

Thresholds and Data

• Threshold Value: Level of acceptable practice for quality assurance; crossing this threshold requires evaluation using multiple data sources.

• Corrective Action Preventative Action (CAPA): Plans may be created based on the threshold evaluations.

Process and Outcomes

• Continuous review of both processes and outcomes for improvement is necessary.

• Standardization of measurement and evaluation is critical for quality control.

Documentation in Healthcare

Patient Record Documentation

• Must be chronological and legible as required by law for legally binding patient information.

• Purposes include aiding medical practice, communication, legal documentation, and performance evaluation.

Test Catalogs and Reference Manuals

• Detail preparation procedures for high-quality sample collection along with information on each test.

Procedure Manual

• States policies and procedures, available to laboratory employees, updated annually.

Safety Manual

• Contains a variety of safety procedures related to chemical, electrical, fire, and biological safety.

Risk Management in Healthcare

Definition

• Process focused on identifying and minimizing risks to patients and employees through:

  • Risk control prior to incidents.

  • Financial handling after occurrences.

Individualized Quality Control Plan (IQCP)

• Tailored QC approach to laboratory-specific factors, allowing flexibility in risk management tools.

Legal Issues in Healthcare

Tort Definition

• A wrongful act against person, property, or reputation, committed with or without intent.

Common Tort Actions

• Assault, battery, breach of confidentiality, fraud, invasion of privacy, malpractice, and negligence.

Malpractice Insurance

• Covers individuals against malpractice liability, ensure they are prepared for potential insurance claims.

Avoiding Lawsuits

• Best practices include:

  • Acquire patient informed consent.

  • Accurate patient/specimen identification.

  • Effective patient monitoring during procedures.

  • Respect patient confidentiality.

Consent Types

• Informed Consent: Voluntarily obtained permission with adequate information.

• Expressed Consent: Verbal or written permission specific to procedures.

• Implied Consent: Naturally inferred from a patient's actions, often in emergencies.

• Consent for Minors: Requires parental or guardian approval, as minors cannot provide consent independently.

Litigation Process

• Phase 1: Incident recognition and responses.

• Phase 2: Injured party consultation with an attorney and potential for filing a complaint.

• Phase 3: Trial phase following discovery and witness interrogation.

• Phase 4: Appeal stage if trial outcome is contested.

NAACLS Entry-Level Competencies

• Emphasis on understanding legal and ethical implications in patient/sample identification and quality assurance/control in phlebotomy.

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