CS Question: I am in the process of reviewing and revising a policy manual for the sterile processing department at my hospital. I have noticed there is neither a section nor a reference to environmental issues in the current manual. Do you think it is necessary to include these issues in the revised manual? If so, what are some of the things I should include?

CS Answer: In your revisions you should definitely include a section that addresses environmental control issues. An essential component of quality assurance in sterility maintenance and infection control is maintaining optimum environmental conditions in the sterile processing department which are in compliance with good standards of practice. The primary environmental control considerations for a sterile processing and sterile storage area are as follows:

Air Quality
· At least 10 air changes per hour (non-recirculated) is required

· Air pressure in the dirty areas, i.e. decontamination, must be negative

· Air pressure in clean processing and sterile storage area must be positive

Temperature Humidity Control
· Temperature should not exceed 72 degrees +/- 5 degrees in sterile storage areas - slightly cooler temperature should be considered for employee comfort in areas requiring precaution attire 

· Humidity control should be maintained between 35 % RH and 50 % RH

· Fans must not be utilized in any of the processing or sterile storage areas

General Housekeeping
· A program for thorough daily cleaning must be maintained

· The work environment must be maintained clean, dry and free of dust particulate

· Air vents and filters must be routinely cleaned/vacuumed and or changed to ensure that proper air circulation and quality is maintained 

· Air vents must be kept free from obstructions to allow proper air flow

· All processing and sterile storage areas must be kept free of insects and pests with documentation and monitoring by routine pest control services

· All ceiling tiles must be in place - enclosed ceilings are imperative

· There should be no exposed overhead plumbing 

Other Considerations
· Sterile product should not be stored directly under overhead sprinklers or plumbing junctures

· All areas must be secure with controlled access — appropriate dress code standards are to be enforced

· No items shall be stored closer than 18-20 inches from the ceiling

· Sterile stock must be maintained at least 8 inches from the floor

· Bottom storage shelves on transporting and storage carts and racks should be solid and or goods stored in tote boxes

· Storage carts and racks must be at least 2-3 inches from any exterior walls

· Outside shipping cartons should not enter sterile storage or “clean areas” 

· Adequate space and storage vehicles must be provided to allow for the proper holding, dispensing and management of sterile goods without compromising technique

· Appropriate monitoring and record-keeping of environmental controls, especially temperature and humidity, should be maintained and audits of other activity and conditions should be considered

CS Question: What information is essential to capture and maintain for flash sterilization record-keeping?

CS Answer: When flash sterilization is employed in healthcare institutions, healthcare workers are responsible for understanding and utilizing appropriate flash sterilization processes. They must comply with established procedures for cleaning, loading, sterilizing, removal, sterility maintenance and quality assurance.

Accurate and complete documentation of each flash sterilization cycle as well as routine and preventative maintenance activities should re-recorded and maintained. A log should be maintained for each load run in a flash sterilizer covering the following data:
· Documentation of instrument cleaning and preparation

· Sterilizer identification

· Date and time of cycle

· Type of cycle employed

· Time and temperature parameters

· Load contents

· OR number

· Patient identification (optional according to policy)

· Time in and out of sterilizer

· Sterilizer operator – responsible for loading and removal

· Documentation of processing indicators results, e.g., chemical, mechanical, biological

· Documentation of any required follow up actions

Maintenance records which chronicle the history of all scheduled and unscheduled service to flash sterilizers should be maintained and contain the following data:
· Date service was requested

· Name of person or persons who requested and authorized the service

· Identification of the sterilizer e.g., model and serial number

· Sterilizer location

· Reason for requested service routine or nature of problem

· Description of service rendered

· Identification of parts replaced

· Identification and name of service provider

· Date of work completed and document of satisfactory test run

· Signature of person acknowledging service completion

HPN

April