“Q & A with QA”Welcome to our first posting of “Q & A with QA” created by the Quality Assurance team. We believe all questions are important and if one individual has a question about something, then it’s likely others may have as well, or will at some point. We hope these blog posts will provide insight into common questions asked by study teams so that everyone can be included in the conversations. Of note, the questions we post are paraphrased and not taken directly from any one individual.
What is the best way to document that the treating investigator has reviewed and assessed safety labs (as clinically significant (CS) or not clinically significant (NCS))? We currently print the lab results for signing/dating by the treating investigator to document their assessment, but we would like to move away from paper. What are our options?
Printing the lab results and having the investigator document their assessment if CS or not is certainly one reliable method.
- An alternative method to document the review of safety labs by the treating provider is via the electronic medical record. The lab results can be pulled into the progress note for the applicable study visit, in which the treating investigator can document that the labs were reviewed. If any out of range labs are present, the provider should indicate whether they are CS or NCS. This allows real-time documentation as the e-signature verifies when the documentation occurred (meets ALCOA*).
For example, some teams have created a specific smart-phrase and utilized this in documentation encounters to indicate how they are documenting lab result assessment. The labs that need to be assessed are incorporated in the progress note, and the investigator bolds/highlights the specific labs that are assessed as clinically significant. The smart-phrase will indicate “Clinically significant labs are bolded in red/highlighted”.
Please discuss among your team to find a feasible work flow.
* Elements of Good Documentation Practice (GDP)= ALCOA
Attributable, Legible, Contemporaneous, Original, and Accurate.
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