Revised CAP POC.07456 - Control Range Establishment or Verification
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"An acceptable control range is established or verified for each lot of control material."
Note: For assayed control materials, control ranges supplied by the manufacturer must be verified.
How are you guys verifying the assayed manufacturer's control ranges for non-waived testing on instruments such as ACT Plus, HMS Plus and TEG 5000?
Note: For assayed control materials, control ranges supplied by the manufacturer must be verified.
How are you guys verifying the assayed manufacturer's control ranges for non-waived testing on instruments such as ACT Plus, HMS Plus and TEG 5000?
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New QC lot control range is verified by lot-to-lot comparison with the in-use QC lot. This lot-to-lot comparison is performed by the same operator, on the same device, using the same cartridge lot number. Both new and in-use QC lots must fall within the range supplied by manufacturer to verify.