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Safety

Standard Operating Procedures

In the hierarchy of laboratory safety management, if the Chemical Hygiene Plan is the constitution, the Standard Operating Procedures (SOPs) are the specific laws governing daily conduct. The planning and creation of SOPs represent the translation of abstract risk assessments into concrete, actionable steps for the bench laboratory scientist. An SOP is a controlled document that provides detailed, written instructions to achieve uniformity of the performance of a specific function. From a safety planning perspective, the SOP is the primary administrative control used to minimize variability, as variability is a leading cause of laboratory accidents and exposure incidents. Effective SOP planning ensures that safety is not an afterthought or an addendum, but is integrated directly into the technical workflow of every assay and maintenance task

The Role of SOPs in Risk Mitigation

The development of an SOP is a proactive risk management tool. By rigorously defining the “One Best Way” to perform a task, the laboratory minimizes the decision-making burden on the operator during high-stress or routine activities. When safety protocols are codified in an SOP, they become legally binding standards of practice

  • Standardization: SOPs ensure that every laboratory scientist, regardless of shift or experience level, performs the procedure using the exact same safety measures. This eliminates “procedural drift,” where staff might gradually adopt unsafe shortcuts over time
  • Training Baseline: The SOP serves as the curriculum for safety training. A new employee cannot be deemed competent until they have read, understood, and demonstrated the safety practices outlined in the SOP
  • Legal & Regulatory Protection: In the event of an accident or external audit (OSHA, CAP, TJC), the SOP serves as proof of due diligence. It demonstrates that the laboratory administration planned for hazards and provided staff with instructions to avoid them

Anatomy of a Safety-Integrated SOP

According to CLSI guidelines (specifically QMS02, formerly GP02), technical SOPs must contain embedded safety information. It is insufficient to have a separate “Safety Manual” that is rarely opened; safety constraints must be written into the analytical procedures themselves. When planning an SOP, the following safety-specific sections are mandatory:

  • Safety Precautions / Warnings: This section should appear early in the document, before the procedural steps. It highlights specific hazards (e.g., “Reagent A is a carcinogen,” “Centrifuges must be balanced to prevent mechanical failure”). It should reference the Safety Data Sheet (SDS) for detailed chemical information
  • Specimen Handling: This section mandates the use of Standard Precautions (formerly Universal Precautions). It defines the assumption that all human blood and body fluids are potentially infectious for HIV, HBV, and HCV
  • Personal Protective Equipment (PPE): The SOP must specify the exact type of PPE required. Vague phrases like “wear appropriate protection” are unacceptable. Instead, it must specify “Nitrile gloves,” “Face shield,” “Fluid-resistant lab coat,” or “N95 Respirator” based on the specific risk of the procedure
  • Engineering Controls: The procedure must explicitly state when engineering controls are necessary. For example, “This step must be performed inside a Biosafety Cabinet (BSC) Class II” or “Open reagent containers only inside a chemical fume hood”
  • Decontamination and Spill Response: The SOP must include specific instructions for cleaning the work area after the procedure and immediate steps to take if a spill occurs (e.g., “Neutralize acid spills with sodium bicarbonate before wiping”)
  • Waste Disposal: Regulatory compliance (EPA/RCRA) dictates that the SOP must define how to dispose of waste generated by the test. It must distinguish between biohazard (red bag), sharps, chemical waste, and general trash

The SOP Development Process

The “Planning” phase of SOP management involves a structured lifecycle. Writing an SOP is not a solo endeavor; it is a collaborative process that integrates technical expertise with safety oversight. This process ensures that the document is both accurate and safe

  • Job Hazard Analysis (JHA) Integration: Before drafting the SOP, a JHA should be reviewed. If the JHA identifies a risk of splashing during a wash step, the SOP drafting phase is where the mitigation (e.g., “Install a splatter shield”) is formalized into the written procedure
  • Drafting by Subject Matter Experts: The initial draft should be written by the staff members who actually perform the work. They are most familiar with the ergonomic and physical realities of the task. Safety officers then review the draft to ensure regulatory compliance
  • Validation and Dry Runs: Before an SOP is finalized, it should be tested. A “dry run” ensures that the safety steps are practical. If an SOP requires a laboratory scientist to change gloves three times in five minutes, compliance will be low. The planning phase allows for workflow adjustments to make safety feasible
  • Approval Authority: The Laboratory Director and the Safety Officer typically must sign off on SOPs. This signature indicates that management accepts the risks associated with the procedure as written and confirms that resources (like specific PPE) are available to follow it

Document Control & Review

Planning for the maintenance of SOPs is as critical as writing them. An outdated SOP is a significant safety hazard because it may refer to discontinued reagents, old equipment, or obsolete safety standards

  • Accessibility: SOPs must be available at the point of use. Whether electronic or hard copy, the safety information must be accessible to the laboratory scientist at the bench, not locked in a manager’s office. If electronic systems go down, a paper backup plan must be in place
  • Annual Review: Accreditation agencies (like CAP) require that SOPs be reviewed annually by the laboratory director or designee. This review is a planning checkpoint to ask: “Have the hazards changed? Is there a safer chemical substitute available? Have we had any accidents with this procedure this year?”
  • Change Management: When a procedure changes, the SOP must be updated immediately. “Post-it” notes or handwritten margin notes are not acceptable in a regulated environment. Old versions must be archived to prevent accidental use, ensuring that staff are always referencing the current safety protocols