North Shore LIJ Health System, Inc s2

North Shore – LIJ Health System, Inc.

SOP TITLE: SAFETY

SOP #:

Approval Date:

Site Implementation Date:

Prepared by:

Last Revised:

Effective Date:

OBJECTIVE: The .is committed to providing a safe, secure, and functional environment of care for subjects, visitors, personnel, technology, resources and data. The objective of this Standard Operating Procedure (SOP) is to describe the safety management at the clinical trial site.

RESPONSIBILITIES:

 All employees are responsible for safety and this responsibility is met by continuously working together to promote safe work practices, eliminate safety hazards/risks, observe all applicable institutional policies, regulations and maintain property and equipment.

 All employees are required to report accidents unsafe practices, and hazardous conditions to their supervisors.

 Supervisors must assure that effective corrective measures are taken, including actions to prevent recurrence. The Administration and the Department of Safety Services will assist in the resolution of hazards and continuously monitor, assess and improve the environment of care.

 It is the responsibility of each clinical trial site to develop, maintain, and periodically test their emergency mode operations plans (business continuity) to ensure continuity of clinical trial site operations and services during a significant operational/technological or disasters/events and to provide the appropriate workforce with periodic training and awareness on the disaster event procedures.

of 6 North Shore – LIJ Health System, Inc.

 Administration has the authority to take action when conditions exist that pose an immediate threat to life or health, or pose a threat of damage to equipment and buildings.

PROCEDURES:

Power Failure Management

 The research team will maintain flashlights which are checked weekly, and the staff will maintain a monitoring log that shows battery expiration.

 There are emergency lights present on the unit which all have battery back-up in case of power failure. The Engineering maintains these emergency lights by performing operational checks monthly and a two hour maintenance check on an annual basis.

 The Facility Safety Manager is the point person to direct all safety questions and concerns. This person can be contact by calling <______>.

 The medication and nutrition refrigerators are checked during hours of operation, and use a temperature monitoring such as “TellTemp” as a safety check of temperature excursions.

 The refrigerator and freezer temperatures are checked during hours of operation.

 Freezers are maintained on the Omega system, generating automatic phone call notifications when the temperatures vary out of the acceptable range. In the event that the main freezers lose power or are out of order, emergency backup freezers will be used.

Fire Safety Management

 Personnel will be trained by the Department of Safety and Facilities Services to be aware of RACE (Rescue, Alarm, Confine, and Extinguish/Evacuate) actions required to minimize the spread of fire and smoke.

 The nearest fire extinguisher is located on the . This equipment is maintained by health system engineers.

 The research team will be provided with a review of procedures in order to assure the prompt reporting of fire, the response to fire alarms, and the immediate initiation of fire safety procedures

to safeguard life, evacuate the building and contain a fire, as feasible, until the arrival of the fire department.

 Fire evacuation drills are conducted semi-annually in this facility.

 Note: For complete information on fire safety management, refer to the Fire Safety Plan in the Feinstein Administrative Policy and Procedure Manual.

Hazardous Materials/Waste Management

 Regulated medical waste are contained, maintained and disposed in accordance with all applicable rules and regulations.

 The maintains a chemical inventory of hazardous materials used in the suite and maintains Material Safety Data Sheets (MSDS) in a location accessible to all employees (i.e. Research Nurse Manager’s office). A chemical inventory is conducted annually and shared with the Safety Officer.

 Spill kits for blood and other bodily fluids are maintained on . Other spill kits are maintained by individual labs within the and can be accessed if the need arises.

 Personal Protective Equipment (PPE) and appropriate spill kits are maintained within the (i.e. the dirty utility room and outside exam room 1). The research team is provided with instructions on how to obtain assistance with spills that are beyond their ability to control.

 Note: For complete information on hazardous materials/waste management, refer to the Environment of Care/Safety/Security Hazardous Material and Waste Management policy of the Physician and Ambulatory Network Services (PAANS) Policy and Procedure Manual.

Emergency Management

 It is the responsibility of personnel to respond to an emergency situation in a safe, effective and timely manner.

 Evacuation will be implemented if necessary. This facility is designated to respond to external disasters.

 This facility is equipped with an automatic external defibrillator (AED) and a portable suction machine.

 All emergency situations are triaged through the < YOUR SITE NAME>’s on-duty security officer. The nature of a reported emergency situation determines the response.

 Note: For complete information on emergency management, refer to the Emergency and Safety Section of the Policy and Procedure Manual and the Environment of Care/Safety/Security section of the Physician and Ambulatory Network Services (PAANS) Policy and Procedure Manual.

Security Management

 The Safety and Security polices of the have been established to provide a safe and supportive environment for patients, visitors and staff.

 In accordance with System Security policy, all employees are required to wear System issued ID badges at all times when on the premises.

 Access to research data will be limited to those who need and have approval for access.

 Note: For complete information on security management, refer to the Special Security Situations policy of the Environment of Care/Safety/Security section of the Physician and Ambulatory Network Services (PAANS) Policy and Procedure Manual as well as the Safety and Security policies of the North Shore University Hospital’s Administrative Policy and Procedure Manual.

Equipment Management

 The ’s Safety/Environment of Care Manual provides for the inspection of biomedical equipment. Equipment is tagged and dated upon initial receipt and the date of the next inspection is due. Equipment found to be in need of repair is taken out of service and is either repaired in the field or removed for repair. The Biomedical Engineering service provider supports the equipment needs of the Center.

 Note: For complete information on equipment management, refer to the Medical Equipment Management Plan section in the ’s

Safety/Environment of Care Manual.

Utilities Management

 In the event that a utility incident impacts the normal operation of the building, a decision to discontinue or transfer operations will be made in conjunction with Administration, Medical Staff, Real Estate Services and Safety.

 Yearly safety inspections of the and accompanying areas of the are conducted by the Department of Safety and Facilities Services.

 Note: For complete information on utilities management, refer to the Emergency Operations Plan for guidance on dealing with specific utility incidents.

Radiation Safety

 The Radiation Safety Office at North Shore University Hospital develops policies and executes programs to provide a safe environment.

 Essential components of the program include orientation and education of employees as to regulations, hospital policy, safety practices and overall awareness; continuous internal auditing of the program with regard to quality performance and improvement; and the support of Administration.

 Note: For Complete information on radiation safety, refer to the Radiation Safety Manual.

General Safety/Best Practice  Manuals for equipment on the are collected in one binder located on the suite. Also, some equipment, such as some of the EKG machines, are located in the manual compartments of the respective machine.

 There is a portable suction machine present on the unit and a freestanding oxygen tank secured in a holder behind a locked door as per policy.

 A Safety Manual, including the emergency management plan, is available in the Research Nurse Manager’s office within the unit.

 Patient Safety/Hazard Surveillance Rounds are performed at this facility yearly. Reports of findings and opportunities for improvement are submitted to the , < YOUR SITE NAME>.

 Note: For complete information on safety management, refer to the General Safety Procedures and Laboratory & Patient Care Area Monitoring Plan in the Feinstein Administrative Policy and Procedure Manual as well as the Environment of Care/Safety/Security section of the Physician and Ambulatory Network Services (PAANS) Policy and Procedure Manual.

REFERENCES:  NSLIJHS Policy #900.24 Disaster Planning and Operations

Author: _ Date: ____/____/____

Approved By: Date: ____/____/____