Understanding Medical Compliance
Arrowsmith & Grant specialise in Medical, Blood and Life Sciences Refrigeration.
As a result we are fully aware of the strict requirements that blood refrigerators, plasma freezers and vaccine refrigerators must comply with in Australia.
Vaccine Refrigerators and QCPP Compliance
For pharmacies that are accredited by bodies such as the Australian General Practice Accreditation Limited, a QCPP certified refrigerator is a requirement to achieve this accreditation. This QCPP certification proves that the refrigerator is fit and proper for its intended use for maintaining the cold-chain integrity of the product.
All of Arrowsmith & Grant’s purpose built vaccine fridges have been designed to maintain 2oC-8oC at all times during normal use and defrost and are QCPP certified
Blood and Plasma Storage Compliance
The Australian Standards stipulate that all blood refrigerators and plasma freezers are required to be compliant to AS3864-2012 Medical refrigeration equipment – For the storage of blood and blood products, Part 1: Manufacturing requirements.
AS3864-2012 can be found here: http://infostore.saiglobal.com/store/details.aspx?ProductID=1600490
All pathology laboratories, blood banks, hospitals and medical centres that store any blood or blood products must have a copy of, and be familiar with AS3864-2012.
This standard ensures that blood and plasma is stored correctly, in the correct type of refrigerator/freezer and lowers the risks associated with transfusing refrigerated stored blood products.
AS3864-2012 is divided up into two distinct parts:
- Part 1 describes the methodology and the procedures involved in the manufacture of blood refrigerators and freezers.
- Part 2 describes the operational component of the requirements. It specifies maintenance frequencies, weekly and monthly checks, spatial distribution checks and what is required for NATA certification.
For pathology laboratories, NATA conduct audits and accreditations based on the requirements in this standard.
As per AS3864-2012 Part 2 3.8.3, a spatial map is required upon a new cabinet being installed, an existing cabinet being repaired/air flow changed (according to a list of major repairs within Part 2 of AS3864-2012) or if an existing cabinet is moved to a new location.
A spatial mapping test is a temperature distribution test. A NATA certified temperature data logger, with up to 16 probes is used for this task. According to our in house NATA certified spatial mapping procedure, we map the temperature distribution across the blood storage space, on every shelf, for a minimum of 8 hours, as per AS3864-2012.
If the blood refrigerator or plasma freezer passes this test, this ensures that the blood and blood products are always stored within the specifications stipulated in the Australian Standard.
This spatial map must be performed to the standard of ISO/IEC17025:2005.
Only companies that are compliant to this, and have passed the requirements for this testing certification within their scope of works, are able to perform this testing.
A list of currently compliant companies can be found on the NATA website here:
Link to NATA attachment here.
Arrowsmith & Grant employ a dedicated maintenance team who are all qualified and experienced service technicians to perform all refrigeration system maintenance to your requirements.
Arrowsmith & Grant are able to incorporate all of your required maintenance into quarterly, bi-annually or annual service agreements whether it is at single or multiple sites.
For all Pathology laboratories that store blood and blood products, to comply with AS3864-2012 all blood fridges and plasma freezers must be calibrated and have maintenance performed by a NATA certified engineer.
Arrowsmith & Grant are NATA certified and are able to offer regular calibration and maintenance schedules on all makes of blood fridges and plasma freezers to meet all Australian Standard, NATA and TGA requirements.
When it's important think Arrowsmith & Grant.