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Regulation agency crosswalk
The Joint Commission laboratory electronic standards have the related CLIA citation next to them. You can click on the CLIA icon and it will bring up the D tag.
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Need CFR reference for annual review of procedures by Medical Director/Technical Supervisor
Here is the link to the standards change for The Joint Commsision, effective July 2013: http://www.jointcommission.org/standards_information/prepublication_standards.aspx
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Joint Commission standard refers to FDA requirement regarding FFP labelling
From the Joint Commission Website: [h=2]Quality System Assessment for Nonwaived Testing (CAMLAB / Laboratory Services)[/h]Thawed Plasma Expiration Updated | January 19, 2012 After thawing frozen plasma, how long can it be stored before infusion?Joint Commission standards refer to the Food and Drug Administration (FDA) regulations for blood product labeling requirements. Effective July 2, 2012, the FDA regulations will allow the infusion of thawed fresh frozen plasma for up to 24 hours after thawing. The need for a variance from the FDA to transfuse plasma beyond the original six-hour limit will no longer be required. The scheduled regulation change was published in the Federal Register, Vol. 77, No. 1, Tuesday January 3, 2012/Rules and Regulations 7. When frozen plasma is thawed, the product is still considered to be fresh frozen plasma for up to the 24 hours. After 24 hours, the product should be labeled as thawed plasma. The license number should be struck, because this is no longer a licensed product according to the FDA. For more information on product modifications, an excellent resource is found on the AABB website, www.aabb.org/development/education/material/Documents/resourceguide.pdf
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"Bedside Labeling" requirement reference
Also, The Joint Commission NPSG.01.01.01, EP2 states "Label containers used for blood and other specimens in the presence of the patient."
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Need CFR reference for annual review of procedures by Medical Director/Technical Supervisor
The Joint Commission lab standards state the the director or designee can perform the annual review of procedures (LD.04.05.09, EP 10).
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Joint Commision Blood Performance Measures 2011
The Patient Blood Management Performance Measures recently posted by The Joint Commission are voluntary implementation. We heard almost universally from our pilot sites that they found the tracking of the metrics to be beneficial so we made them available on the web site along with a guide on how to collect the data in a uniform way. It is entirely up to you if and how you implement these measurement tools.
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Immucor Echo vs. Galileo
One more question as I don't seem to be able to get a response from Immucor. Can you tell me whether the Galileo and or Echo can read bar codes of multiple lengths in the same batch, i.e. a patient number with 10 digits and one with 16 digits? Thanks for all the help!
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Immucor Echo vs. Galileo
Does anyone with a volume around 30,000 type and screens per year have experience using the Immucor Echo or Galileo? If so, how many instruments do you use to met your throughput and what is your instument downtime?