Independent Reference Laboratories are labs that are not used solely as an adjunct to the care of patients of a medical practice or are operated as part of, or in association with a medical care facility such as pain clinics, physician offices laboratories, point of care, counseling and other health centers such as community health centers, drug treatment centers, and pharmacies.  Laboratories that accept specimens throughout the calendar year on referral from other physicians (100 or more specimens during a calendar year) are independent reference laboratories.

An independent laboratory is one that operates completely independent of an attending or consulting physician’s office and staff, per §1861(e) of the Social Security Act.

To apply for a license for a new Hospital Laboratory, please mail with original 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.​​