Code of Maryland Regulations
Title 10 - MARYLAND DEPARTMENT OF HEALTH
Part 2
Subtitle 09 - MEDICAL CARE PROGRAMS
Chapter 10.09.09 - Medical Laboratories
Section 10.09.09.01 - Definitions
Universal Citation: MD Code Reg 10.09.09.01
Current through Register Vol. 51, No. 19, September 20, 2024
A. In addition to the definitions contained in §B of this regulation, definitions set forth in COMAR 10.09.36.01D are applicable to this chapter.
B. Terms Defined.
(1) "Authorized practitioner"
means a physician, osteopath, dentist, podiatrist, nurse midwife, nurse
anesthetist, nurse practitioner, or physician assistant employed by a physician
or clinic.
(2) Freestanding Clinic.
(a) "Freestanding clinic" means a health care
facility that is not licensed as a hospital, part of a hospital, or nursing
home and is not administratively part of a physician's, dentist's, or
osteopath's office, but which has a separate staff functioning under the
direction of a clinic administrator or health officer and is organized and
operated to provide ambulatory health services.
(b) "Freestanding clinic" does not include a
clinic or clinic site located in a participant's home.
(3) "Hospital" means any institution which
falls within the jurisdiction of Health-General Article, Title 19, Subtitle 3,
Annotated Code of Maryland, and which is licensed pursuant to COMAR 10.07.01 or
other applicable standards established by the state in which the service is
provided.
(4) "Medical laboratory"
means a licensed or certified facility, place, establishment, or institution,
operated for the examination of material derived from the human body, by means
of one or more of the scientific disciplines, for the purpose of obtaining
scientific data that may be used to determine the presence, source, progress,
or identity of disease agents, and to aid in the prevention, diagnosis,
treatment, and management of human disease.
(5) "Order" means a request, or a copy of a
request, initiated by and traceable to an authorized practitioner, authorizing
the performance of specific medical laboratory services, that identifies the
participant, the authorized ordering practitioner, the medical laboratory
services requested, and the date executed.
(6) "Participant" means an individual who is
certified as eligible for, and is receiving, Medical Assistance
benefits.
(7) "Preauthorization"
means the approval required from the Department or its designee before services
can be rendered.
(8) "Reference
laboratory" means a medical laboratory, which is enrolled with the Program as
either a provider or a renderer, to which a medical laboratory provider refers
specimens from Medical Assistance participants for analysis.
(9) "Referring laboratory" means a medical
laboratory provider that refers specimens from Medical Assistance participants
for analysis.
(10) "Special
handling" means a circumstance in which specimen collection and pickup are
accomplished as independent procedures to be responsive to the medical needs of
the participant or to preserve viability or condition of the
specimen.
(11) "Standing order"
means a request, or a copy of a request, initiated by and traceable to an
authorized practitioner, authorizing the performance of specific medical
laboratory services to be supplied over a specific time period, that identifies
the participant, the authorized ordering practitioner, the medical laboratory
services requested, and the date executed.
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