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Safety

Chemical Hygiene Officer & Plan

The safe management of chemicals in the clinical laboratory is not merely a collection of good habits; it is a federally mandated organizational structure. In 1990, OSHA promulgated the Occupational Exposure to Hazardous Chemicals in Laboratories standard (29 CFR 1910.1450), commonly referred to as the “Laboratory Standard.” This regulation shifted the focus from the general industry’s “Hazard Communication Standard” to a performance-based standard specifically designed for the unique environment of a laboratory, where small quantities of many different hazardous chemicals are used. The core of this standard is the requirement for a written Chemical Hygiene Plan (CHP) managed by a designated Chemical Hygiene Officer (CHO)

The Chemical Hygiene Plan (CHP)

The Chemical Hygiene Plan is the central document governing laboratory safety. It is a written program stating the policies, procedures, and equipment that the employer will use to protect employees from the health hazards presented by hazardous chemicals. It is not a static document to be shelved; it is an active, accessible manual that must be tailored to the specific hazards of the individual laboratory

Core Components of the CHP

OSHA requires that the CHP contain specific elements to be considered compliant. If an inspector arrives, this is the first document they will request. It must include:

  • Standard Operating Procedures (SOPs): The plan must include safety-focused SOPs for the use of hazardous chemicals. These can be process-specific (e.g., “Safe Handling of Acids”), chemical-specific (e.g., “Formaldehyde Safety”), or procedure-specific (e.g., “cleaning the histology tissue processor”)
  • Control Measures: The plan must outline the criteria used to determine and implement control measures to reduce employee exposure. This includes:
    • Engineering Controls: Fume hoods, local exhaust ventilation, and safety showers
    • Administrative Controls: Hygiene practices, prohibited activities, and work schedules
    • Personal Protective Equipment (PPE): Selection criteria for gloves, goggles, and respirators
  • Fume Hood Performance: The plan must define the requirement that fume hoods and other protective equipment are functioning properly. It must specify the frequency of testing (typically annual certification) and the specific measures to be taken if equipment fails
  • Information and Training: The plan must detail how employees are informed of hazards (e.g., SDS access) and the frequency and content of safety training
  • Medical Consultation: Provisions for medical attention, including when an employee is entitled to a medical exam at the employer’s expense
  • Designated Areas: The establishment of specific areas for work with “Particularly Hazardous Substances” (carcinogens, reproductive toxins, and high-acute toxicity substances)

Accessibility & Review

  • Availability: The CHP must be readily available to employees, employee representatives, and OSHA inspectors at all times. It cannot be locked in a supervisor’s office during the night shift
  • Annual Review: The Lab Standard explicitly requires that the CHP be reviewed and evaluated for effectiveness at least annually and updated as necessary. A CHP with a review signature date from three years ago is a citation violation

The Chemical Hygiene Officer (CHO)

The “Laboratory Standard” mandates that every laboratory designate a Chemical Hygiene Officer. This is a position of legal responsibility, not just a title added to a job description

Qualifications & Designation

  • Definition: The CHO is an employee who is designated by the employer and who is qualified by training or experience to provide technical guidance in the development and implementation of the provisions of the Chemical Hygiene Plan
  • Competency: While OSHA does not specify a degree requirement (e.g., PhD or MS), the CHO must possess sufficient knowledge of chemistry, chemical safety, and regulations to effectively manage the risks. In a clinical setting, this is often a Laboratory Manager, a Lead Laboratory scientist with specialized training, or a dedicated Safety Officer
  • Authority: The CHO must have the authority to shut down operations that are deemed unsafe. Responsibility without authority renders the position ineffective

Primary Responsibilities

The CHO serves as the liaison between the laboratory bench staff and the administration regarding safety. Their duties include:

  • Developing the CHP: Writing and customizing the Chemical Hygiene Plan to fit the specific needs of the lab
  • Implementation: Ensuring that the policies in the CHP are actually practiced. This involves routine inspections, audits of chemical storage, and verification of PPE usage
  • Procurement & Inventory: Monitoring the procurement of chemicals to prevent the accumulation of unnecessary hazards (e.g., preventing the ordering of 50 liters of a chemical when only 100 mL is needed). They also oversee the maintenance of the chemical inventory list
  • Training: Developing and conducting safety training for new hires and annual refresher training for current staff
  • Waste Management: Ensuring that chemical waste is segregated, labeled, and disposed of in compliance with EPA and local regulations

Medical Consultations & Examinations

A critical component of the CHP is defining the medical safety net for employees. The plan must ensure that employees have the opportunity to receive medical attention, including follow-up exams, at no cost to them, without loss of pay, and at a reasonable time and place

Triggers for Medical Consultation

An employee is entitled to a medical consultation under the following circumstances:

  • Symptoms: Whenever an employee develops signs or symptoms associated with a hazardous chemical to which they may have been exposed (e.g., a headache and nausea after working with Xylene)
  • Monitoring Levels: When environmental monitoring reveals an exposure level routinely above the “Action Level” (or PEL) for an OSHA-regulated substance (e.g., Formaldehyde monitoring)
  • Events: Whenever an event takes place in the work area, such as a spill, leak, explosion, or other occurrence resulting in the likelihood of a hazardous exposure

The Physician’s Written Opinion

When an employee is sent to a physician, the employer must provide the doctor with the SDS, a description of the victim’s duties, and details of the exposure. In return, the physician provides a Written Opinion. To protect patient privacy (HIPAA), the written opinion provided to the employer is limited to:

  • Recommendations for future medical follow-up
  • The results of the medical examination only as they relate to the occupational exposure
  • A statement that the employee has been informed by the physician of the results
  • Privacy Rule: The written opinion to the employer must not reveal specific findings or diagnoses unrelated to the occupational exposure

Particularly Hazardous Substances

The CHP must explicitly address the management of high-risk chemicals, grouped into three categories: Select Carcinogens, Reproductive Toxins, and substances with a High Degree of Acute Toxicity

  • Designated Areas: Work with these substances must be confined to a designated area. This can be an entire room, a specific fume hood, or a delineated portion of a bench
  • Containment: Usage of containment devices (fume hoods or glove boxes) is mandatory
  • Decontamination: Specific procedures for the safe removal of contaminated waste and the decontamination of the designated area must be established
  • Signage: The designated area must be clearly posted to warn other employees (e.g., “DANGER: CANCER SUSPECT AGENT. AUTHORIZED PERSONNEL ONLY”)