Safety Fact Sheet

Applicable Accreditation Standards

The physical space used for each service location must comply with all required standards, regulations and codes for construction, fire safety and building codes applicable in the jurisdiction where the services are provided and appropriate to the service type.

Each service location must demonstrate compliance with all applicable OSHA requirements as well as appropriate state authorities. This includes but is not limited to: 

Access to safety data sheets for hazardous materials; and 

Availability of personal protective equipment. 

Each service location must dispose of all hazardous materials in compliance with the manufacturer’s recommendations and applicable laws and regulations.

Each service location must complete and document an analysis of safety risks to patients related to the services provided at that location. This analysis must be updated periodically and no less frequently than every five years. The risk analysis must be reviewed, and the review documented, on an annual basis. Each service location must implement policies and procedures to mitigate risks identified. Risks may include: Patient falls (e.g. slippery surfaces, uneven ground, after receiving hypnotics), assault (e.g. physical or verbal), theft, intruders.

Consistent with the Significant Adverse Events policy (reference Standard N-21), each service location must investigate all significant adverse events that occur, document findings in a formal report, and have the report analyzed by the Network Director. 

Entities must create a policy and procedure for performing a root cause analysis of any significant adverse events occurring to individuals while on the premises. Significant adverse event may include:

  • Patient or staff death
  • Permanent loss of function or of a body part by a patient or staff
  • An event that leads to the hospitalization of a patient or staff
  • An event that requires activization of an emergency medical response
  • Sexual or physical assault of a patient or staff or allegations thereof
  • Release of a minor or a patient lacking capacity or competency to an unauthorized individual
  • Patient leaving testing encounter without notification to, or against the device of, medical staff
  • Complications arising from the effects of hypnotics used for the purpose of sleep testing
  • Incident, injury, or infection caused by equipment used during services
  • Any event required by the applicable jurisdiction to be reported to a government agency

Recognizing the unique vulnerability of patients and staff in a sleep testing environment, labs must have explicit policies and procedures to minimize the risk for assault or allegations of inappropriate behavior during the attended sleep testing encounter. This may include the use of continuous video monitoring in high-risk areas during the attended sleep testing encounter (patient bedrooms, hookup areas) and/or specific training for the use of chaperone during interactions between patients and staff.

Purpose of Safety Plans

Sleep policies and procedures are essential to ensure the safety of patients and staff. They provide guidelines for establishing and implementing practices that reduce workplace hazards, protect lives, and promote health. 

Physical Safety

Each service location must comply with all local laws and regulations regarding construction, building codes, and fire safety. This may include obtaining a Certificate of Occupancy, Permit, or Fire Inspection. 

Safety Compliance Requirements

Occupational Safety

Each service location must maintain policies and procedures that comply with state and federal OSHA regulations for the storage, handling, and disposal of hazardous materials. These policies should include the use and availability of personal protective equipment (PPE) and ensure access to and maintenance of safety data sheets (SDS) for hazardous materials.

Safety Risk Analysis

A written policy must be in place stating that an assessment (environmental walkthrough) will be conducted in all areas of each service location annually. The tool used for assessment should be updated every 5 years. Once the assessment is completed, it should be reviewed to analyze identified risks, and policies and procedures must be implemented to correct and prevent future safety problems

Significant Adverse Event Management                

Written policies must be maintained by both the service location and the Network, describing their respective responsibilities and procedures. 

  • Responsibilities of the Service Location:
    • Develop a written policy addressing procedures for:
      • Events required to be reported (see standard N-21).
      • Who the events should be reported to.
      • Collection of facts and data to determine what occurred, documented in a formal report.
      • Route the form to the Network Director for investigative analysis.
      • Implement corrective action plans as needed.   

Responsibilities of the Network

  • Develop a written policy and procedure for performing a root cause analysis of reported significant adverse events.
    • Root Cause Analysis: A method used to identify and understand why a problem occurred and develop a solution to prevent future occurrences.
  • Develop a corrective action plan to mitigate future occurrences.

Safety Risks Unique to In-Center Sleep Testing

To minimize the risk of inappropriate behavior or allegations of assault in the lab, policies and procedures must be developed. These may include video recording all patient and staff encounters from patient entry to discharge, including sensor hook-up and removal. If multiple staff members are required to reduce risk, this must be specified in the policy. 

Key Things to Keep In Mind

  • Each service location must comply with all local construction, building, fire safety, and building codes as required by local or state law.
  • Evidence of compliance may include a Certificate of Occupancy or a current permit. If there are no local or state requirements, a Fire Marshal Inspection report or a letter signed by the Site Director attesting to the absence of such requirements may be necessary.
  • A falls risk assessment for each patient does not meet compliance with Standard S-11; an environmental walkthrough is required.
  • Examples of Safety Risks: Patient falls (e.g., from slippery surfaces, uneven grounds, or after receiving hypnotics), theft, intruders, verbal or physical assault.
  • Hospital Significant Adverse Event Reporting policies often do not cover all 10 events listed in the standard. An addendum policy may be required to address all areas.
  • Policies and procedures should state that all patient and staff encounters are video recorded, including when recording starts and ends. It is recommended to record from the time the patient enters the room, through sensor hookup and removal, until discharge. If multiple staff members are present to reduce risk, this must be defined in the written policy.