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Safety

General Duty Clause

In the realm of Laboratory Safety Management, the vast majority of compliance efforts focus on specific, written regulations such as the Bloodborne Pathogens Standard or the Laboratory Standard. However, it is impossible for regulators to write a specific rule for every conceivable hazard that might arise in a dynamic workplace. To bridge this gap, the Occupational Safety and Health Act (OSH Act) of 1970 includes Section 5(a)(1), commonly known as the General Duty Clause. For the Laboratory Safety Officer and administration, understanding this clause is essential because it serves as OSHA’s primary enforcement tool for hazards that lack specific standards, such as ergonomics and workplace violence

Role in Risk Assessment & Management

From a management perspective, the General Duty Clause functions as a “catch-all” or “gap-filler.” Technological advancements in the clinical laboratory often outpace the regulatory process. New instruments, novel reagents, or emerging pathogens may present risks that are not yet codified in 29 CFR 1910. The General Duty Clause ensures that a laboratory cannot claim immunity simply because a specific rule has not yet been written. It mandates a proactive approach to risk assessment rather than a purely reactive checklist approach

Criteria for Citation (The Four Elements)

For an OSHA inspector to issue a citation under the General Duty Clause, four specific elements must be established. A Laboratory Safety Officer performs risk management by analyzing laboratory operations against these four criteria to identify potential liabilities:

  • The Employer Failed to Keep the Workplace Free of a Hazard: The inspector must demonstrate that a hazard exists in the laboratory (e.g., a laboratory scientist is exposed to a risk)
  • The Hazard was “Recognized”: This is the most critical component for administrative planning. Recognition can be established in two ways:
    • Employer Recognition: The laboratory administration knew about the hazard (e.g., documented in Safety Committee minutes, employee injury logs, or internal emails)
    • Industry Recognition: The hazard is generally known within the industry (e.g., guidelines published by the CDC, CAP, or CLSI). Even if a specific lab manager claims ignorance, they can be cited if a “reasonable person” in the industry would have known the risk
  • The Hazard Caused or was Likely to Cause Death or Serious Physical Harm: The clause is reserved for serious hazards. Minor violations (like a messy desk) are not cited here. In the laboratory, “serious physical harm” includes cumulative trauma disorders, serious infections, or chemical toxicity
  • There was a Feasible Method to Correct the Hazard: OSHA must demonstrate that a solution exists. This could be an engineering control (equipment) or an administrative control (SOP). If a hazard is recognized but no technology exists to mitigate it, a citation cannot be issued

Common Laboratory Applications

Because the clinical laboratory is a highly regulated environment, most chemical and biological hazards are covered by specific standards. However, the General Duty Clause is frequently applied to two specific areas where laboratory standards are silent:

Ergonomics

There is no specific federal OSHA “Ergonomics Standard.” Therefore, all citations regarding repetitive strain injuries (RSI) and musculoskeletal disorders (MSDs) are issued under the General Duty Clause

  • The Hazard: Laboratory scientists performing repetitive tasks such as manual pipetting, opening thousands of specimen tubes (decapping), prolonged microscopy, or using cryostats (microtomy)
  • Management Obligation: To avoid citation, the laboratory must implement an ergonomics program. This includes training, job rotation (administrative control), and purchasing ergonomic chairs or automated pipettes (engineering controls)

Workplace Violence

Laboratories, particularly those with outpatient phlebotomy stations or those located within Emergency Departments, face the risk of violence from patients or visitors. OSHA currently has no specific standard addressing workplace violence

  • The Hazard: Physical assault or verbal threats against staff members
  • Management Obligation: Under the General Duty Clause, employers must assess this risk. Feasible abatement methods include installing panic buttons, strictly controlling access (badge swiping), creating physical barriers at reception desks, and training staff in de-escalation techniques

Administrative Defense Strategies

To manage the risk associated with the General Duty Clause, the Safety Officer must ensure that “Recognition” leads to “Action.”

  • Closing the Loop: If a hazard is identified in a safety meeting (Recognition), a plan to address it must be documented immediately. If an inspector finds minutes discussing a hazard but sees no evidence of corrective action, a Willful Violation citation may occur
  • Reference Libraries: Because “Industry Recognition” is a standard for citation, the Safety Officer must maintain access to current consensus standards from organizations like the Clinical and Laboratory Standards Institute (CLSI). If CLSI recommends a safety protocol, it effectively becomes the industry standard, and failing to follow it can expose the lab to a General Duty Clause citation