Risk Management & Medical-Legal Issues

Risk Management in the clinical laboratory is the systematic identification, evaluation, and mitigation of potential hazards that could cause harm to patients, employees, or the institution. While Continuous Quality Improvement (CQI) focuses on making processes better, Risk Management focuses on preventing processes from causing harm (and the subsequent liability). In Hematology, where missed diagnoses (e.g., leukemia) or incorrect results (e.g., erroneous INR leading to stroke) can be catastrophic, the medical-legal stakes are high

The Concept of Liability

For a laboratory professional or institution to be held liable for malpractice or negligence, four specific elements must be proven in a court of law. This is known as the “Tort of Negligence”

1. Duty: It must be proven that the laboratory owed a “Duty of Care” to the patient. (This is established as soon as the lab accepts the specimen)
2. Breach of Duty: It must be proven that the laboratory failed to meet the Standard of Care. This means the lab did not do what a “reasonably prudent” laboratory would have done in the same situation
3. Causation: It must be proven that the breach of duty directly caused the patient’s injury. (e.g., The missed Critical Value caused the delay in treatment)
4. Damages: It must be proven that the patient suffered actual harm (physical injury, death, or financial loss)

High-Risk Areas in Hematology

Risk managers focus their attention on specific “failure points” in Hematology that frequently lead to litigation

Misdiagnosis of Leukemia/Malignancy

• The Scenario: A laboratory scientist performs a manual differential on a patient with pancytopenia. They classify 5% blasts as “Reactive Lymphocytes” or “Monocytes.” The diagnosis of Acute Leukemia is delayed by weeks
• The Risk: Delay in treatment allows the cancer to progress, potentially reducing survival rates
• Mitigation
  • “Review Criteria”: Strict SOPs mandating Pathology review for any first-time blast, abnormal lymph, or unexplained cytopenia
  • Competency: Rigorous annual morphology assessments for all staff
  • Digital Imaging: Saving images of suspicious cells for peer review

Coagulation Errors (Warfarin/Heparin Management)

• The Scenario: A patient on Warfarin has a PT/INR drawn. The sample is short (improper 9:1 ratio) or clotted. The lab releases a result of INR 1.5 (falsely low). The doctor increases the Warfarin dose. The patient suffers a massive intracranial hemorrhage
• The Risk: Death or permanent disability from bleeding or clotting (stroke/PE)
• Mitigation
  • Automated Checks: Instruments programmed to flag/reject samples with fill errors or clot signatures
  • Delta Checks: Flagging drastic changes in INR to prompt investigation
  • Rejection Policy: Strict enforcement of “Zero Tolerance” for clotted/short blue tops

Transfusion Errors (Blood Bank/Heme Interface)

• The Scenario: A patient is misidentified at collection (Wrong Blood in Tube). The Hematology lab runs the CBC and releases a result belonging to another patient. If that sample is also used for a Crossmatch, a fatal Hemolytic Transfusion Reaction can occur
• The Risk: Patient death (Sentinel Event)
• Mitigation
  • Two-Identifier Rule: Strict adherence to checking Name and DOB
  • Barcoding: Bedside positive patient identification (PPID) systems
  • Rejection of Unlabeled Tubes: Never allowing a nurse to “come down and label it.”

Legal Documentation

In a lawsuit, the medical record is the primary evidence. Risk management dictates that documentation must be unimpeachable

• “If it isn’t documented, it didn’t happen”: If a laboratory scientist calls a critical value but doesn’t log it in the LIS, the court assumes the call was never made
• Correction of Errors
  • Never Delete: Original results are never deleted. They are “Corrected.” The LIS keeps a permanent audit trail showing the old result, the new result, the time of change, and the reason
  • Transparency: The comment should state “Original result of X reported in error due to [reason]. Corrected result is Y.” Hiding errors looks like a cover-up (Mens Rea/Guilty Mind)

Incident Reporting (Occurrence Reporting)

When an error occurs (even if it didn’t reach the patient), staff must file an Incident Report. This is an internal Risk Management document, not part of the patient’s medical record

• Purpose: To track trends and identify systemic failures (e.g., “Why do we keep losing samples from the ED?”)
• Legal Privilege: In many jurisdictions, Incident Reports prepared for Quality Improvement committees are protected from “Discovery” (lawyers can’t see them) to encourage open reporting. However, facts documented in the chart are discoverable
  • Rule: Never write “Incident Report filed” in the patient’s chart. It flags the error to lawyers. Just document the clinical facts

Chain of Custody

For forensic testing (e.g., Blood Alcohol for legal purposes, or Rape Kits), the laboratory must maintain a strict Chain of Custody

• Definition: The chronological documentation of the custody, control, transfer, analysis, and disposition of physical evidence
• Procedure: Every person who touches the sample must sign for it. The sample is never left unattended on a bench; it is locked in a secure storage area. A break in the chain renders the result inadmissible in court

Standard of Care & SOPs

In court, the “Standard of Care” is often defined by the laboratory’s own Standard Operating Procedures (SOPs)

• The Trap: If the lab’s SOP says “All critical values must be called within 10 minutes,” but the national standard is 30 minutes, the lab will be held to its own stricter 10-minute rule. If they called in 15 minutes, they violated their own standard
• Risk Management Strategy: Review SOPs to ensure they are realistic and achievable. Don’t promise perfection in a policy (“We will have zero errors”); promise a process (“We will monitor for errors”)