Maryland Department of Health
Office of Health Care Quality

Hospital Laboratories

Description

A Hospital Laboratory is one that is located in an institution that has a group​ of at least 5 physicians who are organized as a medical staff and that maintains the facility to provide, under the supervision of the medical staff, diagnostic and treatment services for 2 or more unrelated individuals and admits or retains the individuals for overnight care.  OHCQ is responsible for the oversight of physician office laboratories, including licensure and investigation of complaints.

Maryland Regulations  

Regulations related to hospital laboratories are found in COMAR 10.10​.  To order copies of COMAR regulations, contact Tarshia Neal at the Maryland Division of State Documents at 410-260-3874 or [email protected].  Regulations are also available at public libraries - Find your nearest public library.

Licensure  

To apply for a license for a new Hospital Laboratory, please mail with origi​nal signatures both the ​Maryland State Compliance Application​​​​​​​​ and CLIA application​ with supporting documents outlined on the state application checklist page to the address listed on the state application.

There is no fee to apply for a Maryland laboratory license.  CMS will bill you for CLIA fees. After a completed application and all requested information is received by OHCQ, it takes 2 - 3 weeks to receive a Hospital laboratory license and CLIA certificate.

To report any changes to your license, please use the Laboratory Licensing Change Form.​​

​Contact OHCQ

​Contact the Clinical Laboratories Team

File a Clinical Laboratories Complaint​​

Phone​ (410) 402-8025 | (877) 402-8202 | TTY (800) 735-2258 

Fax (410) 402-8213​

Cheryl Sloan and Dana Roberts, Administrators

Paul Celli, Program Manager                   ​