In the realm of healthcare compliance and regulation, the Maryland Laboratory Licensing form stands as a crucial document for laboratories within the state, especially those undergoing changes in their operational or management structures. Administered by the Maryland Department of Health and Mental Hygiene's Office of Health Care Quality, this form is essential for maintaining the accuracy of a laboratory's licensing records. Vital for the submission are changes including, but not limited to, adjustments in laboratory directorship, which requires the accompaniment of significant credentials such as a medical license, medical diploma, and board certification for medical directors, or a diploma and CV for directors holding a PhD. Furthermore, the form mandates the provision of changes in the laboratory's name, ownership, tax ID, physical and mailing addresses, and contact information alongside updates in the test menu that the laboratory offers. Importantly, any adjustments in the laboratory’s CLIA certification status or state license status necessitate explicit documentation through this form. Also noteworthy is the procedure for laboratories that are closing or discontinuing clinical testing, which underscores the form's broad applicative scope. Significantly, all these changes must be endorsed with the laboratory director's signature to ensure their validity, thereby underscoring the director’s accountability in the accurate representation of the laboratory. This form, while operational in nature, plays a critical role in upholding the quality and reliability of laboratory services, an aspect pivotal for patient care and the broader public health landscape.
| Question | Answer |
|---|---|
| Form Name | Maryland Laboratory Licensing Form |
| Form Length | 2 pages |
| Fillable? | No |
| Fillable fields | 0 |
| Avg. time to fill out | 30 sec |
| Other names | laboratory change form pdf, maryland laboratory change form, maryland laboratory permit change form, clia waiver maryland |
Maryland Department of Health and Mental Hygiene |
Office Use Only |
55 Wade Avenue, Catonsville, MD 21228 Amount:
Phone: 410.402.8025 Fax: 410.402.8213 Date Completed:
Laboratory Licensing Change Form
This form is for changes and updates only. Please only provide us with the changes in the fields below along with the effective date of the change.
For a change of Director, a copy of the Director’s medical license, medical diploma and board certification must be submitted. Please send diploma and CV for a PhD Director. This form must be signed by the Director for these changes to be valid.
***THIS FORM MUST BE SIGNED BY THE DIRECTOR FOR ALL CHANGES TO BE VALID.***
Please return this form by fax:
Or by mail:
Attention: Lab Licensing, OHCQ – Bland Bryant Building,
55 Wade Avenue, 1st Floor, Catonsville, MD 21228
Current Name of Lab: ___________________________
State Lab ID # __________ Federal CLIA #: ___________ Is this CLIA a multisite? Y N
Laboratory Name: |
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Date of Change: ___________ |
Owner: |
________________________________ |
Date of Change: ___________ |
Tax ID #: |
________________________________ |
Date of Change: ___________ |
Director: |
________________________________ |
Date of Change: ___________ |
Physical Address: |
________________________________ |
Date of Change: ___________ |
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Mailing/Billing Address: _____________________________ |
Date of Change: ___________ |
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_____________________________ |
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Telephone #: |
________________________________ |
Date of Change: ___________ |
Fax #: |
________________________________ |
Date of Change: _________ |
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Please list the tests you are adding or deleting from your current test menu. Please use the chart below and indicate for each test the instrument/kit used as well as the effective date of change.
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Changes/Additions/Deletions to Tests |
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Test Name |
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Kit/Instrument Used |
Add Delete |
Date of Change |
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___________________ |
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Change State License Status to: |
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Letter of Exception |
General Permit |
Date of Change: ____________ |
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Change my CLIA Certification Status to: (must submit with a |
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Waiver |
Compliance |
Provider Performed Microscopic Procedures (PPMP) |
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Accreditation with which program? ____________________________________________
Date of Change: _________________________
____________________________________________________________________________
Our office has closed and/or discontinued all clinical testing. Date of Change: __________
Print Laboratory Director’s Name: ________________________________________________
Laboratory Director’s Signature: _______________________________ Date: _____________