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The Maryland Laboratory Licensing form serves as a crucial document for laboratories seeking to update their licensing information with the Office of Health Care Quality. This form is specifically designed for changes and updates, allowing laboratories to communicate alterations in various operational aspects. Key sections include the current name of the lab, state lab ID, and federal CLIA number, which must be accurately filled out to ensure compliance. The form requires the laboratory director's signature to validate any changes, emphasizing the importance of oversight in laboratory management. Additionally, laboratories must provide details regarding changes in ownership, director information, and physical or mailing addresses. The form also includes a section for laboratories to list tests they are adding or deleting, specifying the instruments or kits used and the effective date of each change. Furthermore, laboratories can indicate changes to their state license status and CLIA certification status, necessitating the submission of additional documentation as needed. This structured approach not only streamlines the licensing process but also helps maintain the integrity and quality of laboratory services in Maryland.
Maryland Laboratory Licensing Preview
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: |
________________________________ |
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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________________________________ |
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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: _________ |
2
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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___________________ |
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_____________ |
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______________ |
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___________________ |
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_____________ |
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______________ |
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___________________ |
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_____________ |
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______________ |
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___________________ |
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_____________ |
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______________ |
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___________________ |
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_____________ |
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______________ |
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___________________ |
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_____________ |
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______________ |
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___________________ |
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_____________ |
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______________ |
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___________________ |
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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: _____________
Form Attributes
| Fact Name | Details |
|---|---|
| Governing Authority | This form is governed by the Maryland Department of Health and Mental Hygiene. |
| Purpose | The Laboratory Licensing Change Form is specifically for reporting changes and updates to laboratory information. |
| Director's Signature Requirement | All changes submitted must be signed by the laboratory director for them to be considered valid. |
| Submission Methods | The form can be submitted via fax or by mail to the Office of Health Care Quality. |
| Contact Information | For inquiries, the laboratory can contact the office at 410-402-8025. |
| CLIA Certification | Changes to CLIA certification status require submission of a CMS-116 form. |
| Test Menu Changes | Laboratories must list any tests being added or deleted, including the instrument or kit used. |
| Address for Submission | Forms should be sent to: Lab Licensing, OHCQ – Bland Bryant Building, 55 Wade Avenue, 1st Floor, Catonsville, MD 21228. |
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