Change Of Status Form Page 2
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1
2
3State Lab ID #
(required)
Federal CLIA # 39D __
(required)
Please use the chart below and list the tests you are adding or deleting from your current test menu as well as
the laboratories’ current test menu. List the effective date of the change for the addition or deletion. For each
test, indicate the instrument/kit and 510(k) Number. If your laboratory is adding moderate and/or high
complexity testing, include the following documents: procedure, validation studies, training documentation and
proof of proficiency testing enrollment.
Changes/Additions/Deletions to Test
Test Name
Kit/Instrument/510(k) Number
Add/Delete
Effective Date
__________________
_______________________________________
____________
____________
__________________
_______________________________________
____________
____________
__________________
_______________________________________
____________
____________
__________________
_______________________________________
____________
____________
__________________
_______________________________________
____________
____________
__________________
_______________________________________
____________
____________
__________________
_______________________________________
____________
____________
If your laboratory is adding alcohol, drug, lead or EP testing, enrollment into the Pennsylvania Toxicology Proficiency Testing Program
is a requirement for state licensure. Your lab will be contacted with details concerning this program.
Change my CLIA Certificate to:
Waiver
Compliance
Provider-Performed Microscopic Procedures (PPMP)
Accreditation-with which program?
Effective Date: ___________________
Our office has closed and/or discontinued all clinical testing.
Effective Date:
Print Laboratory Director Name
Signature of Director
Date
Print Owner/Corporation Name
Authorized Signature
Date
THIS FORM MUST BE SIGNED BY THE DIRECTOR/OWNER FOR ALL CHANGES TO BE VALID -
for director changes, the new director MUST sign this form.
Revised MAM 3/10/2014
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