Mon May 04 2009

recording the over-temp reading

Good morning All, We have a surveyor that is saying that our Gaymar FW600 Medi-Temp3 is non compliant because we cannot record the over-temp reading. I have discussed this with the Gaymar senior tech and he said the AABB regulations no longer require documenting this reading. The surveyor says this is an issue, TJC still requires it. Our option is replacement. Has anyone else faced this issue with this model? Gaymar says there are over 2000 of these out there with no issues with surveyors.

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Mon May 04 2009Reply from Heathers
avatar placemark
All you have to do is provide documentation that shows you and your hospitals policy are following manufactures recommendations for testing and servicing, If the manufacture is not required to test & document a certain function, end of story. On the same note if your hospital policy states you testing & documenting a function and you are not documenting it, TJC can call you on that. TJC has "recommendations" not "requirements", TJC is just as responsible to show the regulation or policy in question, as you are for documenting or not documenting that regulation. It depends on how strong your accreditation committee is and if they will back you up if you question the surveyor. Good luck!

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Mon May 04 2009Reply from Heathers
avatar placemark
The Joint Commission inspector is correct.... the JCAHO Lab regulatory compliance requirement under EC (Environment of Care) EC.6.20.14 States, " The Laboratory documents monitoring of temperature-controlled spaces and equipment." w/ foot note, " For Blood Warmers & Blood Bank Storage alarms, the activation temperature is recorded and remedial action is taken when the results are outside the acceptable range." The only advice I would have is twofold.... 1st Make a recommendation to the EOC (Safety Committee) to replace the Blood Warmers due to none compliance with "The Joint Commission" standard, or.... 2nd to put together a solution set up and slowly warm the temperature w/ heat gun and monitor the incoming fluid into the Blood Warmer and when the "Over Temp" alarms note that temperature and record it in your PM/Corrective documentation.... hope this helps.

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Mon May 04 2009Reply from Heathers
avatar placemark
Greetings, When I was responsible for a blood processing/collection center I had to document the low temp and hi temp alarm points. That is point of alarm and point of reset. ie: high alarm occurred at xtemp, alarm reset at xtemp. It paid to warm it up slowly and down slowly. The auditors wanted those four temp points if it had a high and low temp alarm. If there was a chart recorder that had to be checked for time and temp. The backup battery had to be replaced or tested. Door seals had to be checked-testing a piece of bond paper for resistance between door and seal at a min. of 4 points was acceptable. Heaters, fans, condensors & evaporators had to be cleaned and tested. You probably won't have to do this but all equipment had to be validated for temp distribution prior to use-there were no grandfathers when the process was introduced. Having said all this, these were the rules and practice for a blood center. General lab is different. I do not know the standards for hospital labs not involved with blood but I do know that most auditors I have met would like to see them get to the blood standards. Another thing to keep in mind with auditors is that they like to encourage compliance and will pick the most important issues in order to see progress. As the audits continue year to year they will check on the previous citations/recomendations and look for new ones. My advice is to never argue with an auditor. Discussion is Ok. They will punish arguing.

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