Homepage Fill Out Your Maryland Laboratory Licensing Template

Dos and Don'ts

When filling out the Maryland Laboratory Licensing form, it is essential to follow specific guidelines to ensure that your application is processed smoothly. Here is a list of things you should and shouldn't do:

  • Do provide accurate and complete information in all fields.
  • Do ensure that the form is signed by the Director, as this is crucial for validity.
  • Do submit copies of required documents, such as medical licenses and diplomas, when applicable.
  • Do indicate the effective date of any changes clearly.
  • Don't leave any fields blank; incomplete forms may delay processing.
  • Don't forget to include your current contact information for follow-up.
  • Don't send the form without double-checking for any errors or omissions.

Misconceptions

Understanding the Maryland Laboratory Licensing form is crucial for those involved in laboratory operations. However, several misconceptions can lead to confusion. Here are six common misunderstandings:

  • This form is only for new applications. The Maryland Laboratory Licensing Change Form is specifically designed for updates and changes to existing licenses, not for new applications.
  • Only the laboratory owner can sign the form. While the owner may be involved, the form must be signed by the laboratory director for all changes to be valid.
  • All changes require a complete reapplication. Only specific updates, such as changes in the laboratory director or test menu, require submission of this form. A full reapplication is not necessary for minor updates.
  • The form can be submitted by anyone. Only the laboratory director is authorized to sign and submit the form, ensuring that all changes are officially recognized.
  • Faxing the form is the only submission method. The form can be submitted either by fax or by mail, providing flexibility in how it is sent to the Office of Health Care Quality.
  • Changes to the test menu do not need to be documented. Any additions or deletions to the test menu must be clearly indicated on the form, along with the effective dates, to ensure compliance.

Clarifying these misconceptions can help streamline the process of updating laboratory information in Maryland.

Key takeaways

Key Takeaways for Filling Out the Maryland Laboratory Licensing Form:

  • Ensure that all changes are clearly noted on the form. Only provide updates in the designated fields along with the effective dates.
  • For a change of Director, include necessary documentation such as the Director's medical license, diploma, and board certification. A CV is also required for PhD Directors.
  • The form must be signed by the Director for any changes to be considered valid. Without this signature, the updates will not be processed.
  • Submit the completed form either by fax or by mail to the specified address. Make sure to include all relevant information to avoid delays.

Guidelines on Utilizing Maryland Laboratory Licensing

Filling out the Maryland Laboratory Licensing form requires careful attention to detail. After completing the form, you will need to submit it via fax or mail to ensure your changes are processed. Make sure that the laboratory director signs the form, as this is crucial for the validity of the changes.

  1. Begin by entering the Current Name of Lab and the State Lab ID #.
  2. Provide the Federal CLIA # and indicate if this CLIA is a multisite by marking 'Y' for yes or 'N' for no.
  3. Fill in the Laboratory Name and the Date of Change.
  4. List the Owner and the corresponding Date of Change.
  5. Enter the Tax ID # and the Date of Change.
  6. Provide the Director's Name and the Date of Change.
  7. Fill in the Physical Address and the Date of Change.
  8. Enter the Mailing/Billing Address and the Date of Change.
  9. Provide the Telephone # and the Date of Change.
  10. Fill in the Fax # and the Date of Change.
  11. List any tests you are adding or deleting in the provided chart. For each test, specify the Test Name, Kit/Instrument Used, and mark whether you are adding or deleting it along with the Date of Change.
  12. If applicable, change the State License Status to either 'Letter of Exception' or 'General Permit' and provide the Date of Change.
  13. Change your CLIA Certification Status as needed, indicating the appropriate status and providing the Date of Change.
  14. If your office has closed or discontinued all clinical testing, note this and provide the Date of Change.
  15. Print the Laboratory Director’s Name and ensure the Laboratory Director’s Signature is included along with the Date.

Once the form is completed, double-check all entries for accuracy. Then, send it to the Office of Health Care Quality either by fax or mail as specified on the form. This will initiate the processing of your changes.

Form Preview Example

Maryland
Department
of
Health
and
Mental
Hygiene


Office
Use
Only


Office
of
Health
Care
Quality
–
Laboratory
Licensing
Programs
 Date
Received:


Spring
Grove
Center
–
Bland
Bryant
Building
 Check
#:


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:

410-402-8213

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: ___________

 

________________________________

 

Mailing/Billing Address: _____________________________

Date of Change: ___________

 

_____________________________

 

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.

 

 

Changes/Additions/Deletions to Tests

 

Test Name

 

Kit/Instrument Used

Add Delete

Date of Change

______________

 

___________________

 

_____________

______________

 

___________________

 

_____________

______________

 

___________________

 

_____________

______________

 

___________________

 

_____________

______________

 

___________________

 

_____________

______________

 

___________________

 

_____________

______________

 

___________________

 

_____________

______________

 

___________________

 

_____________

Change State License Status to:

 

 

 

Letter of Exception

General Permit

Date of Change: ____________

Change my CLIA Certification Status to: (must submit with a CMS-116)

 

Waiver

Compliance

Provider Performed Microscopic Procedures (PPMP)

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: _____________

Common mistakes

  1. Incomplete Information: Failing to fill out all required fields can delay the processing of the application. Ensure every section is completed fully.

  2. Missing Signatures: The form must be signed by the laboratory director. Without this signature, the changes will not be valid.

  3. Incorrect Dates: Providing incorrect or inconsistent dates for changes can lead to confusion. Double-check all dates entered.

  4. Omitting Required Documents: If changing the director, include necessary documents such as the medical license and CV. Missing these can result in rejection.

  5. Not Specifying Changes Clearly: Clearly indicate whether tests are being added or deleted. Ambiguity can cause misunderstandings and errors.

  6. Ignoring Submission Guidelines: Follow the specified submission methods. Forms sent to the wrong address or via the wrong method may not be processed.

  7. Failing to Review Before Submission: Always review the completed form for errors or omissions. A final check can prevent costly mistakes.

Learn More on This Form

What is the purpose of the Maryland Laboratory Licensing form?

The Maryland Laboratory Licensing form is designed to facilitate changes and updates to laboratory information. This includes modifications related to the laboratory's name, ownership, director, and other essential details. It ensures that the state has accurate and current information about laboratories operating within Maryland. By keeping this information up to date, laboratories can maintain compliance with state regulations and continue their operations smoothly.

Who needs to sign the Laboratory Licensing Change Form?

Only the laboratory director is authorized to sign the Laboratory Licensing Change Form. This signature is crucial because it validates the changes being made. Without the director's signature, the form will not be considered valid, and the requested changes may not be processed. It is essential for directors to review the changes carefully before signing to ensure that all information is accurate.

How do I submit the Laboratory Licensing Change Form?

You can submit the Laboratory Licensing Change Form either by fax or by mail. To fax the completed form, send it to 410-402-8213. If you prefer to mail it, address it to: Lab Licensing, OHCQ – Bland Bryant Building, 55 Wade Avenue, 1st Floor, Catonsville, MD 21228. Make sure to send the form promptly to avoid any delays in processing your changes.

What information must be included in the form?

The form requires several key pieces of information. You need to provide the current name of the laboratory, state lab ID, federal CLIA number, and details about any changes to the laboratory's ownership, director, or addresses. Additionally, if you are adding or deleting tests from your menu, you must list those changes along with the instruments or kits used. Each change should also include the effective date.

What happens if the laboratory has closed or discontinued testing?

If your laboratory has closed or discontinued all clinical testing, you must indicate this on the form. There is a specific section to note the date of this change. It is crucial to report this information to the state promptly to ensure that your laboratory's license status is updated accordingly. Failing to do so may lead to compliance issues or unnecessary fees.