Maryland Department of Health
Office of Health Care Quality

Point-of-Care Laboratories

Description

A point-of-care laboratory (POCL) means a laboratory operated as part of, or in association with, a medical care facility, such as a hospital, nursing home, community health center, health maintenance organization, county or municipal health department, or a pharmacy.

​OHCQ is responsible for the oversight of point-of-care laboratories, including licensure and investigation of complaints.


Maryland Regulations  

Regulations related to physician office laboratories are found in COMAR 10.10.03​.  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                                                           

​