Written Procedure Requirements

16 followers
0 Likes

 I am working on revising our written procedure for all of our POCT we have. Our current written procedure has everything in from the package insert (Intended Use, Principle, QC, Storage & Stability, QC, Specimen Storage, Interpretation of Results, Limitations, Precautions, etc). Is that needed for Pennsylvania? I looked up on PA DOH and it states:  Must have written procedures for all tests performed (supplemental package inserts are acceptable).  Does that mean I can pull out parts that we use frequently, like QC timing, and then say refer to package insert for more detailed specifics and have my labs put the package insert in their lab binders with the short version written procedure with the lab directors signature?

0 Replies
Reply
Subgroup Membership is required to post Replies
Join POCT Listserv now
Stacy Boyer
about 4 hours ago
0
Replies
0
Likes
16
Followers
81
Views
Liked By:
Suggested Posts
TopicRepliesLikesViewsParticipantsLast Reply
Written Procedure Requirements
Stacy Boyer
about 4 hours ago
0082
Stacy Boyer
about 4 hours ago
GEM 5000/7000 Shipment Verification and Carryover Testing
Jo Win
about 9 hours ago
00141
Jo Win
about 9 hours ago
Capillary tubes
Erin Walters
about 12 hours ago
60175
Debra Howard
about 9 hours ago