(a) In this subtitle the following words have the meanings indicated. (b) “License” means a permit, letter of exception, certificate, or other document issued by the Secretary granting approval or authority to: (1) Offer or perform medical laboratory tests or examinations in this State; (2) Offer or perform medical laboratory tests or examinations on specimens acquired from health care […]
(a) (1) The Secretary shall adopt regulations that set standards and requirements for medical laboratories. (2) The regulations shall contain the standards and requirements that the Secretary considers necessary to assure the citizens of this State that medical laboratories provide safe and reliable services. (b) To assure compliance with the standards and requirements adopted in regulations pursuant to this […]
(a) On written request of an individual to a medical laboratory for a copy of the results of a laboratory examination of that individual, the medical laboratory shall send a copy of those results that are sought to that individual. (b) (1) If the results of a laboratory examination are contained in or will be filed in a […]
(a) The Secretary may adopt regulations that set qualifications for the following personnel of medical laboratories: (1) Directors; (2) Supervisory technologists; (3) Technologists; (4) Cytotechnologists; and (5) Supervisory cytotechnologists. (b) The director of a medical laboratory is not required to be a physician licensed under the Health Occupations Article.
(a) A person shall hold a license issued by the Secretary before the person may: (1) Offer or perform medical laboratory tests or examinations in this State; (2) Offer or perform medical laboratory tests or examinations on specimens acquired from health care providers in this State at a medical laboratory located outside this State; or (3) Represent or service […]
To qualify for a license, an applicant shall provide evidence to satisfy the Secretary that the medical laboratory and its personnel meet the standards and requirements of the subtitle and in regulations adopted by the Secretary pursuant to this subtitle.
(a) An applicant for a license shall submit an application to the Secretary on the form that the Secretary requires. (b) An application for a license to operate a medical laboratory shall include: (1) The name of the owner; (2) The classes of services, complexity of testing, or the tests or examinations that the medical laboratory would provide; and […]
(a) The Secretary shall issue a license to any applicant who meets the standards and requirements of this subtitle and in regulations adopted pursuant to this subtitle. (b) A medical laboratory license shall include the name of the: (1) Medical laboratory; (2) Laboratory director; and (3) Owner of the laboratory. (c) A medical laboratory license shall designate the: (1) Complexity of testing […]
(a) The Secretary may deny a license to any applicant or suspend, revoke, or limit a license or the authority to offer or perform any class of service, complexity of testing, or tests that the license sets forth, if the medical laboratory or its director or other personnel fail to meet the standards and requirements under […]
(a) A laboratory issued a license under this subtitle shall enroll in and continue to demonstrate satisfactory performance as defined by the Secretary by regulations in a proficiency testing program or programs approved by the Secretary. (b) The Secretary shall adopt regulations that: (1) Define satisfactory proficiency testing performance; and (2) Set the standards and requirements that a proficiency […]
Unless a person holds a license issued by the Secretary the person may not: (1) Offer or perform medical laboratory tests or examinations in this State; (2) Represent or service in this State a medical laboratory regardless of the laboratory’s location; or (3) Offer or perform medical laboratory tests or examinations on specimens acquired from health care providers […]
Unless a medical laboratory has a valid license, no other person on the laboratory’s behalf may: (1) Offer or perform medical laboratory tests or examinations in this State; (2) Offer or perform medical laboratory tests or examinations on specimens acquired from health care providers in this State at the medical laboratory located outside this State; or (3) Represent […]
(a) (1) In this section the following words have the meanings indicated. (2) “Alcohol or controlled dangerous substance testing” means a procedure used to determine whether or not a specimen contains a controlled dangerous substance or alcohol. (3) “Certification” means the approval granted by the Department for a laboratory to engage in job–related alcohol or controlled dangerous substance testing. […]
(a) Except as provided in subsection (b) of this section, a person may not directly or indirectly advertise for or solicit business in this State for any medical laboratory, regardless of location, from anyone except a physician, hospital, medical laboratory, clinic, clinical installation, or other medical care facility. (b) (1) (i) This subsection applies only to: 1. A diagnostic laboratory […]
A person who violates any provision of this subtitle is guilty of a misdemeanor and on conviction is subject to a fine not exceeding $100 for the first offense and not exceeding $500 for each subsequent conviction for a violation of the same provision. Each day a violation is continued after the first conviction is […]
(a) The Secretary shall establish a Laboratory Advisory Committee to advise the Secretary on matters relating to the implementation of the provisions of this subtitle. (b) The Advisory Committee shall consist of: (1) At least the following representatives appointed biennially from a list of eligibles: (i) 1 member of the American Academy of Family Practitioners; (ii) 1 member of the […]
