In this subtitle the following words have the meanings indicated. “License” means a permit, letter of exception, certificate, or other document issued by the Secretary granting approval or authority to: Offer or perform medical laboratory tests or examinations in this State; 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 Represent or service in this State a medical laboratory regardless of the laboratory’s location. “Medical laboratory” means any facility, entity, or site that offers or performs tests or examinations in connection with the diagnosis and control of human diseases or the assessment of human health, nutritional, or medical conditions or in connection with job-related drug and alcohol testing. “Medical laboratory” includes any laboratory owned or operated by the State or owned or operated by a county or municipal corporation in the State.

The Secretary shall adopt regulations that set standards and requirements for medical laboratories. 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. To assure compliance with the standards and requirements adopted in regulations pursuant to this subtitle, the Secretary shall: Conduct an inspection of each medical laboratory for which a license to operate is sought; and Conduct an inspection periodically of each medical laboratory for which a license has been issued. In addition to the regulations adopted under subsection (a) of this section, the Secretary shall adopt regulations establishing specific standards for medical laboratories engaged in cytology, including regulations that: Limit the number of slides an individual may examine; Require that the examination of cytology slides be performed in a medical laboratory that has a license issued by the Secretary; Prohibit payment to cytotechnologists for the examination of cytology specimens or slides on a piecework basis; Require cytology laboratories to review no less than 10 percent of all negative gynecological slides; Require that the cytology review be performed by an individual who qualifies as a supervisory cytotechnologist or a pathologist; Require the individual who directs the laboratory to establish and administer an ongoing quality assurance program using standards acceptable to the Secretary; Require cytology laboratories to reject unsatisfactorily prepared specimens, make appropriate comments regarding the quality of the specimen, and maintain records on unsatisfactorily prepared specimens for 5 years subject to review by the Department; Require cytology laboratories to maintain and store for 5 years from the date of examination any slide that was examined; Require all cytology reports to be retained for at least 10 years; Prohibit any person from sending cytology specimens to a laboratory, including out–of–state laboratories, not licensed by the Department; Require all individuals who examine gynecological slides acquired from persons in this State to demonstrate satisfactory performance in an approved cytology proficiency testing program; and Establish any additional standards the Secretary considers necessary to assure that medical laboratories engaged in cytology provide safe and reliable services. The requirements of paragraph (1) of this subsection are in addition to any other relevant provision of this subtitle or relevant regulation adopted in accordance with any other provision of this subtitle governing medical laboratories. To assure compliance with standards adopted under subsection (c) of this section, the Secretary shall adopt regulations to establish and conduct a cytology proficiency testing program for all cytology personnel that examine gynecological cytology specimens. All cytology proficiency tests under the State cytology proficiency testing program shall be conducted by an employee of the Maryland Department of Health who shall: Hand carry all testing materials to the testing site; and Directly supervise the on–site proficiency testing. The Secretary shall adopt regulations for the cytology proficiency testing program that: Define satisfactory cytology proficiency testing performance; and Set standards and requirements that a cytology proficiency testing program must meet before it can be designated an approved program. The Secretary may accept the testing results of an approved cytology proficiency testing program as meeting the cytology proficiency testing requirement of this subtitle.

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. If the results of a laboratory examination are contained in or will be filed in a medical record, as defined in § 4-301 of this article, the request for a copy of the results shall be made to the facility pursuant to the provisions of § 4-302 of this article. In all other cases, the medical laboratory may require the individual requesting a copy of the results to pay the prevailing cost of copying and transmitting the copy. The medical laboratory shall notify the individual’s physician before sending the results to the individual.

The Secretary may adopt regulations that set qualifications for the following personnel of medical laboratories: Directors; Supervisory technologists; Technologists; Cytotechnologists; and Supervisory cytotechnologists. The director of a medical laboratory is not required to be a physician licensed under the Health Occupations Article.

Except as provided in §§ 10–14A–03 and 10–14B–03 of the State Government Article, a person shall hold a license issued by the Secretary before the person may: Offer or perform medical laboratory tests or examinations in this State; 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 Represent or service in this State a medical laboratory regardless of the laboratory’s location. The Secretary shall issue a letter of exception to a laboratory that: Performs only limited medical laboratory tests or examinations; and Meets the exception requirements in regulations adopted by the Secretary pursuant to this subtitle. For the purposes of this section, “limited medical laboratory tests or examinations” means medical laboratory procedures as defined in regulations adopted by the Secretary pursuant to this subtitle. If preliminary screening procedures are performed by an operator who is trained under § 17–214(k) of this subtitle, an employer: Is not required to obtain a permit or to obtain a letter of exception from the Secretary under this section to perform testing; but Is required before performing preliminary screening procedures, as defined under § 17–214(a) of this subtitle, to register with the Secretary in accordance with requirements adopted in regulations by the Maryland Department of Health.

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.

An applicant for a license shall submit an application to the Secretary on the form that the Secretary requires. An application for a license to operate a medical laboratory shall include: The name of the owner; The classes of services, complexity of testing, or the tests or examinations that the medical laboratory would provide; and Any other information that the Secretary requires.

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. A medical laboratory license shall include the name of the: Medical laboratory; Laboratory director; and Owner of the laboratory. A medical laboratory license shall designate the: Complexity of testing that the laboratory may offer or perform; Classes of services that may be offered; Tests or examinations that may be offered or performed by the laboratory; or Any combination of items (1), (2), and (3) of this subsection. A medical laboratory may not operate in any manner beyond what is designated by its license. A medical laboratory license issued by the Secretary under this subtitle is not transferable.

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 this subtitle and in regulations adopted pursuant to this subtitle. If the Secretary finds that a laboratory issued a license under this subtitle no longer meets the standards and requirements under this subtitle and in regulations adopted pursuant to this subtitle, the Secretary may impose a directed plan of correction or limit the testing authorized by the license instead of suspending or revoking a license. If the Secretary finds that a medical laboratory provided erroneous or questionable test results that pose a threat to the health and safety of patients, the Secretary may order the laboratory to: Notify the physicians or other individuals who ordered the tests of the erroneous or questionable test results; and Take any additional measures necessary to reduce or eliminate the threat to the health and safety of patients, including the notification of patients and the offering of retests. A medical laboratory that fails to comply with an order issued by the Secretary under subparagraph (i) of this paragraph is subject to a civil penalty of up to $1,000 for each day of noncompliance after the deadline for compliance stated in the Secretary’s order, not to exceed a maximum penalty of $50,000, instead of or in addition to any other sanction imposed under this section. Except as otherwise provided in the Administrative Procedure Act, before the Secretary denies, suspends or revokes a license, or imposes a civil penalty under this section, the Secretary shall give the applicant or licensee notice and an opportunity for a hearing.

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. The Secretary shall adopt regulations that: Define satisfactory proficiency testing performance; and Set the standards and requirements that a proficiency testing program must meet before it can be designated as an approved program.

Unless a person holds a license issued by the Secretary the person may not: Offer or perform medical laboratory tests or examinations in this State; Represent or service in this State a medical laboratory regardless of the laboratory’s location; or 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.

Unless a medical laboratory has a valid license, no other person on the laboratory’s behalf may: Offer or perform medical laboratory tests or examinations in this State; 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 Represent or service in this State the medical laboratory regardless of the laboratory’s location.

In this section the following words have the meanings indicated. “Alcohol or controlled dangerous substance testing” means a procedure used to determine whether or not a specimen contains a controlled dangerous substance or alcohol. “Certification” means the approval granted by the Department for a laboratory to engage in job–related alcohol or controlled dangerous substance testing. “Controlled dangerous substance” has the meaning stated in § 5–101 of the Criminal Law Article. “Job applicant” means an individual who: Has applied for a position with an employer; and Is not currently employed by the employer. “Job–related” means any alcohol or controlled dangerous substance testing used by an employer for a legitimate business purpose. “Laboratory” means a facility or other entity that conducts job–related alcohol or controlled dangerous substance testing. “Medical review officer” means a licensed physician with knowledge of drug abuse disorders and drug and alcohol testing. “Preliminary screening procedure” means a controlled dangerous substance test that uses a single–use test device that: Is easily portable and can be administered at a work site or other appropriate collection site; Meets the requirements of the federal Food and Drug Administration for commercial distribution; and Meets generally accepted cutoff levels such as those in the federal Substance Abuse and Mental Health Services Administration Guidelines for drug–free workplace testing programs. “Single–use test device” means the reagent–containing unit of a test system that: Is in the form of a sealed container or cartridge that has a validity check, a nonresealable closure, or an evidentiary tape that ensures detection of any tampering; Is self–contained and individually packaged; Is discarded after each test; and Does not allow any test component or constituent of a test system to interact between tests. “Specimen” means: Blood derived from the human body; Urine derived from the human body; Hair derived from the human body as provided in subsection (b)(3) of this section; or Saliva derived from the human body. Except as provided in paragraph (2) of this subsection, an employer who requires any person to be tested for job–related reasons for the use or abuse of any controlled dangerous substance or alcohol shall: Have the specimen tested by a laboratory that: Holds a permit under this subtitle; or Is located outside of the State and is certified or otherwise approved under subsection (f) of this section; and At the time of testing, at the person’s request, inform the person of the name and address of the laboratory that will test the specimen. Except as provided in subsubparagraph 2 of this subparagraph, an employer may use a preliminary screening procedure to test a job applicant for the use or abuse of any controlled dangerous substance. Subsubparagraph 1 of this subparagraph does not apply to an employer that has entered into a collective bargaining agreement that prohibits the employer from using a preliminary screening procedure to test a job applicant for the use or abuse of any controlled dangerous substances. If the result of a preliminary screening procedure is positive, the employer shall submit the specimen for testing by a laboratory as required under paragraph (1) of this subsection. Following voluntary disclosure and documentation by an applicant of the taking of a legally prescribed medication, an employer may hire the applicant pending confirmation of a positive test result by the medical laboratory and review by the employer’s medical review officer. An employer may not use a preliminary screening procedure to test an individual who is not applying for a job with that employer. An employer may designate a medical laboratory licensed to perform job–related testing for controlled dangerous substances to also perform preliminary screening procedures on job applicants for the employer. An employer who requires any person to be tested for job–related reasons for the use or abuse of any controlled dangerous substance may use hair derived from the human body as a specimen in accordance with this paragraph. An employer may use hair derived from the human body only for pre–employment purposes. If an employer uses hair derived from the human body as a specimen, the employer may not: Use a specimen that is longer than one and one–half inches measured from the human body; or Use the specimen for any purpose other than testing for controlled dangerous substances. An employer who requires any employee, contractor, or other person to be tested for job–related reasons for the use or abuse of any controlled dangerous substance or alcohol and who receives notice from the laboratory under subsection (b) of this section that an employee, contractor, or other person has tested positive for the use or abuse of any controlled dangerous substance or alcohol shall, after confirmation of the test result, provide the employee, contractor, or other person with: A copy of the laboratory test indicating the test results; A copy of the employer’s written policy on the use or abuse of controlled dangerous substances or alcohol by employees, contractors, or other persons; If applicable, written notice of the employer’s intent to take disciplinary action, terminate employment, or change the conditions of continued employment; and A statement or copy of the provisions set forth in subsection (e) of this section permitting an employee to request independent testing of the same sample for verification of the test result. The information required to be provided to the employee, contractor, or other person under paragraph (1) of this subsection shall be delivered to the employee, contractor, or other person: Either in person or by certified mail; and Within 30 days from the date the test was performed. An employer that uses a preliminary screening procedure to test specimens for the use or abuse of a controlled dangerous substance under this section shall: In using a single–use test device, collect, handle, store, and ship each specimen in a manner that: Maintains the specimen donor’s identity and confidentiality and the physical integrity of the specimen; and Precludes contamination of the specimen; and Maintain a written record of the chain of custody of each specimen from the time that the specimen is collected until the time that the specimen is no longer needed for retesting. A person who is required to submit to job–related testing, under subsection (b) or (c) of this section, may request independent testing of the same specimen for verification of the test results by a laboratory that: Holds a permit under this subtitle; or If located outside of the State, is certified or otherwise approved under subsection (f) of this section. The person shall pay the cost of an independent test conducted under this subsection. The Maryland Department of Health: Shall adopt regulations governing the certification of laboratories that conduct job–related alcohol or controlled dangerous substance testing; and May adopt regulations governing the oversight of preliminary screening procedures administered by employers. In addition to any other laboratory standards, the regulations shall: Require that the laboratory comply with the guidelines for laboratory accreditation, if any, as set forth by the College of American Pathologists, the Centers for Medicare and Medicaid Services, or any other government agency or program designated to certify or approve a laboratory that is acceptable to the Secretary; Require that a laboratory performing confirmation tests for controlled dangerous substances or alcohol be inspected and accredited in forensic drug analysis by the College of American Pathologists, the Centers for Medicare and Medicaid Services, or any other government agency or program designated to inspect and accredit a laboratory that is acceptable to the Secretary; Require that, if the laboratory performs job–related drug testing, the laboratory be a participant in a program of proficiency testing of drug screening conducted by an organization acceptable to the Secretary; Require that the laboratory comply with standards regarding cutoff levels for positive testing that are established by the United States Department of Health and Human Services or established by the Secretary as mandatory guidelines for workplace drug testing programs; and Include procedures for inspection. This section does not apply to: Alcohol or controlled dangerous substance testing of a person under arrest or held by a law enforcement or correctional agency; Alcohol testing procedures conducted by a law enforcement or correctional agency on breath testing equipment certified by the toxicologist in the Department of State Police Forensic Sciences Division; or Controlled dangerous substance testing by a laboratory facility of a law enforcement or correctional agency that maintains laboratory testing standards comparable to the standards in this section. This section applies to job–related alcohol and controlled dangerous substance testing of any person, including preemployment applicants, employees, and contractors. Except as provided in paragraphs (2) and (3) of this subsection, in the course of obtaining information for, or as a result of, conducting job–related alcohol or controlled dangerous substance testing for an employer under this section, a laboratory, a physician, including a physician retained by the employer, or any other person may not reveal to the employer information regarding: The use of a nonprescription drug, excluding alcohol, that is not prohibited under the laws of the State; or The use of a medically prescribed drug, unless the person being tested is unable to establish that the drug was medically prescribed under the laws of the State. The prohibitions against disclosure of information under paragraph (1) of this subsection do not apply to the extent that they prevent a person from complying with the applicable provisions of the federal Commercial Motor Vehicle Safety Act of 1986 and the federal Motor Carrier Safety Regulations. The prohibitions against disclosure of information under paragraph (1) of this subsection do not apply if, prior to the administration of a preliminary screening for controlled dangerous substances, the test operator notifies the applicant that if the preliminary test is positive, the applicant may voluntarily disclose and provide documentation to the operator that the applicant is taking a legally prescribed medication. An employer using preliminary screening procedures to test job applicants under this section shall have a medical review officer review a positive test result after laboratory confirmation of the positive test result. The employer may contract for the services of an outside medical review officer if the employer does not have a medical review officer on staff. An employer using preliminary screening procedures shall establish a program to train individuals to collect specimens and perform controlled dangerous substance tests in the workplace. The employer may designate an employee or any other individual to be trained, including any individual employed by a medical laboratory designated under subsection (b)(2)(v) of this section who will perform preliminary screening procedures for the employer. A trainee shall receive appropriate and practical instruction, which includes: A reading of the test manufacturer’s package insert sheet; Observing the test manufacturer’s training video or receiving training from the test manufacturer; Completing the test manufacturer’s self–administered test; and The actual performance of tests and the actual interpretation of the results. The employer shall: Keep a record of the training received by each trainee; and Establish a procedure for training each trainee as having received the minimum training required to properly perform the test. After the trainee has demonstrated competency in performing the test, the employer shall maintain documentation that indicates that the trainee has been trained under this section. The provisions of a collective bargaining agreement that concern drug testing override and preempt the provisions of this section that authorize an employer to use a preliminary screening procedure to test a job applicant.

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. This subsection applies only to: A diagnostic laboratory test or procedure for the purpose of screening, diagnosing, managing, or treating a physical or mental condition or disease; and Ancestry testing using Y–chromosome mitochondrial DNA or autosomal DNA testing limited to the detection and reporting of genetic evidence of parental lineage and genetic ethnicity. This subsection does not apply to germline genetic or genomic testing done in connection with the analysis, diagnosis, or prediction of human diseases. Subject to paragraph (3) of this subsection, a person may directly or indirectly advertise for or solicit business in the State for a diagnostic laboratory test or procedure ordered by a physician and performed by a medical laboratory certified under 42 U.S.C. § 263a. A person that directly or indirectly advertises for or solicits business in the State for a diagnostic laboratory test or procedure under this subsection: Is a covered entity or business associate of a covered entity for purposes of the federal Health Insurance Portability and Accountability Act of 1996 and the federal Health Information Technology for Economic and Clinical Health Act; May not make a claim about the reliability and validity of the test or procedure that is inconsistent with the test or procedure’s performance as measured under 42 U.S.C. § 263a; and Shall disclose that the diagnostic laboratory test or procedure may or may not be covered by health insurance. The Secretary may take legal action to restrict the marketing of a diagnostic laboratory test or procedure if the Secretary determines that: There is a public health threat; or The diagnostic laboratory test or procedure is not in compliance with the requirements of this section.

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 subsequent offense.

The Secretary shall establish a Laboratory Advisory Committee to advise the Secretary on matters relating to the implementation of the provisions of this subtitle. The Advisory Committee shall consist of: At least the following representatives appointed biennially from a list of eligibles: 1 member of the American Academy of Family Practitioners; 1 member of the American Academy of Pediatricians; 1 member of the American College of Physicians; 1 member of the American Society for Clinical Pathology; and 1 member of the American College of Pathology; and 1 representative of the Advanced Medical Technology Association. The Secretary may appoint any other individuals or representatives at the Secretary’s discretion. The chairman of the Advisory Committee shall be designated by the Secretary every 2 years.