IS THERE A REGULATION OR A GUIDE ON HOW TO DO THE QC TEST ON THE STRIPS TO TEST RENALIN (PRESENCE AND RESIDUAL). DO WE HAVE TO QC EVERY CONTAINER OF STRIPS THAT WE USE? DO WE NEED TO KEEP RECORDS?
THANKS FOR YOUR HELP...

Check with your vendor. Many are already performing QC on the strips before shipping them out. If they are checking them they will send a report to you at your request.

Most Peroxide and Peracetic Acid Strips give instuctions on the Product Instructional Insert on how to prepare a Negative and Positive Control and how to do the Control test. Several suppliers supply a Residual Peroxide Positive Control or make them available as an option.

There is no requirement that I am aware of that dictates you to do control testing. As long as you use and store the strips within the requirements stated on the strip labels and observe te expiration dates Control tests are not required. However, individual dialysis units are free to decide if and how often they wish to do control testing.

As there is a remote chance that dry reagent test strips can be damaged by extreme heat in shipping or by improper storage (exposing to heat over 32 dgrees C 90 degrees F for extended periods or by leaving the bottle cap off for extended periods exposing the strips to excess moisture). Therefore running a postive & negative control on the first strip from a newly opened kit is not a bad idea.

Some units do this , some run controls on the first strip from each bottle, some every week or every day. Whatever test frequency you pick,document your results and have written instructions for the staff who do the test as to what is acceptable and not acceptable and what to do if the result is unacceptable.

Ken Price, Serim Research

Customers that purchase RPC manufactured or RPC distributed test strips do not need to perform QC testing of the strips.

QC testing of all RPC test strips is performed for each lot number and each type of test strip, by our Quality Assurance Department.

A certificate of conformance is available for RPC test strips, as proof for surveyors/inspectors that test strip quality assurance is performed, for you, by RPC.

RPC Quality Control Sheets for each lot number and type of strips tested will soon (within weeks) be posted to the RPC website at www.rpc-rabrenco.com. These Quality Control Sheets will be available in a printable PDF format.

For further information or questions regarding our test strip QC policy please call us at 800-647-3873 and ask for Mike Lorenson.