CMS Pub. 100-04, ch. 16, § 10.1

B3-2070.1, B3-2070.1.B, RHC-406.4

“Independent Laboratory” - An independent laboratory is one that is independent both of an attending or

consulting physician’s office and of a hospital that meets at least the requirements to qualify as an emergency

hospital as defined in §1861(e) of the Social Security Act (the Act.) (See the Medicare Benefits Policy

Manual, Chapter 15, for detailed discussion.)

“Physician Office Laboratory” - A physician office laboratory is a laboratory maintained by a physician or

group of physicians for performing diagnostic tests in connection with the physician practice.

“Clinical Laboratory” - See the Medicare Benefits Policy Manual, Chapter 15.

“Qualified Hospital Laboratory” - A qualified hospital laboratory is one that provides some clinical

laboratory tests 24 hours a day, 7 days a week, to serve a hospital’s emergency room that is also available to

provide services 24 hours a day, 7 days a week. For the qualified hospital laboratory to meet this requirement,

the hospital must have physicians physically present or available within 30 minutes through a medical staff

call roster to handle emergencies 24 hours a day, 7 days a week; and hospital laboratory technologists must be

on duty or on call at all times to provide testing for the emergency room.

"Hospital Outpatient” - See the Medicare Benefit Policy Manual, Chapter 2.

“Referring laboratory” - A Medicare-approved laboratory that receives a specimen to be tested and that

refers the specimen to another laboratory for performance of the laboratory test.

“Reference laboratory” - A Medicare-enrolled laboratory that receives a specimen from another, referring

laboratory for testing and that actually performs the test.

“Billing laboratory” - The laboratory that submits a bill or claim to Medicare.

“Service” - A clinical diagnostic laboratory test. Service and test are synonymous.

“Test” - A clinical diagnostic laboratory service. Service and test are synonymous.

“CLIA” - The Clinical Laboratory Improvement Act and CMS implementing regulations and processes.

“Certification” - A laboratory that has met the standards specified in the CLIA.

“Draw Station’ - A place where a specimen is collected but no Medicare-covered clinical laboratory testing is

performed on the drawn specimen.

“Medicare-approved laboratory - A laboratory that meets all of the enrollment standards as a Medicare

provider including the certification by a CLIA certifying authority.