10-10-2017 12:51 PM
I am reviewing my pharmacies IV policies and we have one that says "Refrigerators and Incubators, including integrated reporting devices, will be serviced and certified to meet NIST standards on an annual basis". Is this a USP<797> requirement? How do pharmacies typically have refrigerators and incubators certified? Do I need an agency to come in and provide me documentation that they have been certified? In reviewing USP <797>, I see NIST used in the "Monitoring Controlled Storage Areas" section which says "Suitable temperature recording devices may include a calibrated continuous recording device or a National Institute of Standards and Technology (NIST) calibrated thermometer that has adequate accuracy and sensitivity for the intended purpose, and it shall be properly calibrated at suitable intervals". My pharmacy does not use continuous monitoring devices. Is "proper calibration" speaking to manufacturer recommendations? What is the definition of a "Suitable interval"? My policy states "annual basis" but was this arbitrarily chosen? No one in my pharmacy seems to know why the policy is worded the way it is. We used policies found on Simplifi797 as our guideline years ago. Any insight you can provide me would be very appreciated. Although we do have our refrigerators maintained every 6 months, we have never had them certified. We have done less with our incubator. We are monitoring temperatures of these units twice daily. I am hoping to ensure we get compliant if we are currently not.
Thank you for your help,
12-18-2017 03:59 PM
We have an outside vendor certify all of our temperature related equipment : incubators, refrigerators, autoclave twice per year. We also have them certify our balances as well. The company is able to calibrate the equipment to a standard they bring and provide certificatoin reports and equipment tags indicating the service. We monitor the equipment regularly ourselves, but do not have the equipment necesary to make the necesary calibrations. The vendor knows what they are doing in this instance as this is their business. Our vendor is SiteCal - not sure if they are a regional entity.