Quality Assurance and Legal Issues in Healthcare

Chapter 2: Quality Assurance and Legal Issues in Healthcare

Objectives

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

• Define quality and performance improvement measurements related to phlebotomy.

• Describe components of a quality assurance (QA) program for phlebotomy.

• Identify areas in phlebotomy subject to quality control (QC).

• Outline legal aspects associated with phlebotomy procedures and situations with legal ramifications.

Quality Assurance in Healthcare

• Quality: Degree of excellence of care.

• Quality Assurance (QA): Activities ensuring excellence in patient care.

• Continuous Quality Improvement (CQI): Ongoing system for monitoring and improving healthcare quality.

National Standard and Regulatory Agencies

The Joint Commission (TJC)

• Independent organization setting healthcare standards.

• Focus on improving patient safety and quality of care.

• Implements Survey Analysis for Evaluating Risk (SAFERTM) since 2017 to visualize survey results and prioritize corrective actions.

• Sentinel Event (SE) Policy: Identifies safety issues and mandates action plans following sentinel events.

• National Patient Safety Goals (NPSGs) for 2018 include:

  • Identifying patients correctly.

  • Improving staff communication.

  • Preventing infections.

Clinical Laboratory Improvement Amendments (CLIA)

• Federal regulations ensuring quality standards across laboratories.

• Address QA, QC, proficiency testing, laboratory records, and personnel qualifications.

• Specimen collection is part of CLIA oversight.

College of American Pathologists (CAP)

• Focuses solely on pathology/lab services with ongoing inspections and proficiency testing.

• Ensures documentation confirms employee qualifications.

Clinical and Laboratory Standards Institute (CLSI)

• Develops voluntary guidelines and standards for laboratory practices.

National Accrediting Agency for Clinical Laboratory Sciences (NAACLS)

• Provides accreditation for clinical laboratory sciences educational programs.

International Organization for Standardization (ISO)

• Develops voluntary international standards for various industries.

Quality Assurance in Phlebotomy

QA Processes

• Failure Modes & Effects Analysis (FMEA): Identifying potential failures.

• Six Sigma: Methodology for process improvement.

• Lean Methodology: Efficiency improvements in workflows.

• Root-Cause Analysis (RCA): Identifying underlying causes of issues.

Quality Indicators

• Must be measurable, well-defined, objective, specific, and related to important aspects of care.

Thresholds & Data

• Threshold value: Acceptable practice level; exceeding triggers evaluation and corrective actions.

Process & Outcomes

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

• Quality Control (QC): Ensures procedures are performed correctly through operational checks.

Areas of Phlebotomy Subject to QA

• Patient preparation procedures and specimen collection techniques.

• Includes patient identification, labeling, techniques, and collection priorities.

Documentation

Patient’s Record

• Chronological documentation required by law, aims to improve medical practice and communication, and serves legal purposes.

Test Catalogs and Reference Manuals

• Outline preparation requirements and specimen handling protocols.

Procedure Manual

• Includes policies and procedures for laboratory tests, updated annually.

Safety Manual

• Contains safety procedures for various hazards and emergency protocols.

QA Forms

• Include equipment checks and internal reports detailing incidents and corrections.

Risk Management

• Definition: Identifying and minimizing risks to patients and employees.

• Steps involve identification, treatment, education, and evaluation of risks.

Individualized Quality Control Plan (IQCP)

• Tailors quality control approaches specific to laboratory needs and populations.

Sexual Harassment

• Defined as persistent or offensive conduct affecting a person's job; governed by Title VII of the Civil Rights Act.

Legal Issues in Healthcare

Tort

• Wrongful acts against a person, property, or reputation, intentional or not.

• Types include assault, battery, fraud, invasion of privacy, malpractice, and negligence.

Malpractice Insurance

• Provides coverage for malpractice liabilities; typically doesn't target individual employees directly but may involve them as co-defendants.

Avoiding Lawsuits

• Obtain informed consent, identity patients and specimens meticulously, monitor patients, and maintain confidentiality.

Types of Consent

• Informed Consent: Requires competent permission with adequate information.

• Expressed Consent: Specific agreement detailing procedures, preferably in writing.

• Implied Consent: Inferred from patient actions, often used in emergencies.

• Consent for Minors: Requires parental or guardian consent.

• Refusal of Consent: Patients retain the right to refuse treatment.

Litigation Process

• Phases include recognizing incidents, consulting attorneys, possibly negotiating settlements, and if needed, trial procedures.

NAACLS Entry-Level Competencies Met in This Chapter

• Discuss legal and ethical importance in patient/sample identification, QA in blood collection, applicable policies, and medicolegal terms.