<section article="ghg" article_name="Health - General" number="17-101" title_number="17" title_name="Laboratories" subtitle_number="1" subtitle_name="Public Health and Clinical Laboratories"> <text>The Secretary shall determine the number and location of public health laboratories and maintain those laboratories as needed to provide testing, consulting, and regulatory support of infectious disease, epidemiology, environmental, and regulatory public health programs.</text> </section> <section article="ghg" article_name="Health - General" number="17-102" title_number="17" title_name="Laboratories" subtitle_number="1" subtitle_name="Public Health and Clinical Laboratories"> <text>A public health and clinical laboratory shall provide services in connection with:</text> <level label="1"> <text>Any inquiry that the Department or any health officer or physician makes about a communicable disease;</text> </level> <level label="2"> <text>Any inquiry that the Department makes about sewage;</text> </level> <level label="3"> <text>Any inquiry that the Department makes about a trade waste;</text> </level> <level label="4"> <text>Any inquiry the Department makes about a nuisance;</text> </level> <level label="5"> <text>Any examination or analysis of a water supply;</text> </level> <level label="6"> <text>Any examination or analysis of milk; and</text> </level> <level label="7"> <text>Any inquiry about any other matter that the Secretary requires.</text> </level> </section> <section article="ghg" article_name="Health - General" number="17-103" title_number="17" title_name="Laboratories" subtitle_number="1" subtitle_name="Public Health and Clinical Laboratories"> <level label="a"> <text>Except as otherwise provided, the Secretary may set a fee for any service of a public health and clinical laboratory in accordance with § 2–104 of this article.</text> </level> <level label="b"> <text>Except as provided in subsection (c) of this section, the Secretary may not impose any fee for any service of a public health and clinical laboratory in connection with:</text> <level label="1"> <text>An examination or analysis of a water supply;</text> </level> <level label="2"> <text>An examination or analysis of milk; or</text> </level> <level label="3"> <text>An inquiry that any health officer or physician makes about a communicable disease.</text> </level> </level> <level label="c"> <text>Subsection (b)(2) of this section does not apply to the production of farmstead cheese.</text> </level> </section> <section article="ghg" article_name="Health - General" number="17-103.1" title_number="17" title_name="Laboratories" subtitle_number="1" subtitle_name="Public Health and Clinical Laboratories"> <level label="a"> <text>In this section, “Fund” means the Laboratory Testing Fund.</text> </level> <level label="b"> <text>There is a Laboratory Testing Fund in the Department for the provision of laboratory services associated with the production of farmstead cheese.</text> </level> <level label="c"> <text>The Department shall administer the Fund.</text> </level> <level label="d"> <level label="1"> <text>The Fund is a special, nonlapsing fund that is not subject to § 7–302 of the State Finance and Procurement Article.</text> </level> <level label="2"> <text>Any unspent portion of the Fund and any investment earnings of the Fund may not be transferred or revert to the General Fund of the State, but shall remain in the Fund.</text> </level> </level> <level label="e"> <text>The Fund consists of any laboratory testing fees collected by the Department for laboratory services associated with the production of farmstead cheese.</text> </level> <level label="f"> <text>The Fund shall only be used to support the operations of the Laboratories Administration.</text> </level> </section> <section article="ghg" article_name="Health - General" number="17-104" title_number="17" title_name="Laboratories" subtitle_number="1" subtitle_name="Public Health and Clinical Laboratories"> <level label="a"> <level label="1"> <text>In this section the following words have the meanings indicated.</text> </level> <level label="2"> <text>“Mutual aid agreement” means a written agreement between a public health laboratory in the State and a public health laboratory operated by another state to establish and carry out a plan to assist each other in providing temporary testing services to alleviate an emergency at one of the laboratories.</text> </level> <level label="3"> <text>“Public health laboratory” means a laboratory operated by a state government to provide:</text> <level label="i"> <text>Consulting and regulatory support of infectious disease, epidemiology, environmental, and regulatory public health programs; and</text> </level> <level label="ii"> <text>Tests or examinations in connection with:</text> <level label="1"> <text>The diagnosis and control of human diseases;</text> </level> <level label="2"> <text>The assessment of human health, nutritional, or medical conditions; or</text> </level> <level label="3"> <text>The environment.</text> </level> </level> </level> </level> <level label="b"> <text>This section shall be liberally construed to promote its purpose of providing aid during an emergency at a public health laboratory.</text> </level> <level label="c"> <level label="1"> <text>A public health laboratory in the State may enter into or renew a mutual aid agreement with a public health laboratory operated by another state.</text> </level> <level label="2"> <text>A public health laboratory operated by another state that enters into a mutual aid agreement shall provide written documentation of the statutory authority required for that state to meet the responsibilities set forth in the agreement.</text> </level> <level label="3"> <level label="i"> <text>Except as provided in subparagraph (ii) of this paragraph, a mutual aid agreement shall provide that the party requesting assistance under the agreement shall indemnify and hold harmless the public health laboratory that provides assistance and its authorized personnel from any claim by a third party for property damage, personal injury, or wrongful death that arises out of activities, including travel, that are authorized by the agreement.</text> </level> <level label="ii"> <text>The party that requests assistance need not indemnify the party that provides assistance if:</text> <level label="1"> <text>The party that provides assistance does not cooperate in defending against a claim made by a third party;</text> </level> <level label="2"> <text>The claim by a third party arises out of a malicious or grossly negligent act of the party that provides assistance; or</text> </level> <level label="3"> <text>The claim by a third party arises out of an act that is outside of the scope of the duties under the agreement of the party that provides assistance.</text> </level> </level> </level> <level label="4"> <text>A mutual aid agreement shall provide that each party to the agreement shall waive any claim against any other parties to the agreement if the claim arises out of the activities of a party that are within the scope of the agreement and that are performed without malice or gross negligence.</text> </level> </level> <level label="d"> <level label="1"> <text>Subject to paragraph (2) of this subsection, an employee of a public health laboratory who has been trained and certified by the director of the employee’s public health laboratory may travel to and provide services at the location of the emergency under a mutual aid agreement at the request of the Secretary, the Secretary’s designee, or an individual from another state with equivalent authority under the agreement.</text> </level> <level label="2"> <text>An employee may not travel to or provide services at the location of the emergency under a mutual aid agreement until the Secretary, the Secretary’s designee, or equivalent authority in another state approves the employee to travel to and provide services at the location of the emergency.</text> </level> </level> <level label="e"> <text>For purposes of workers’ compensation law or any other employment benefit that would apply to an individual who is performing a service for a public health laboratory under a mutual aid agreement:</text> <level label="1"> <text>The individual is considered to have performed that service in the course of employment as a State employee and in the line of duty; and</text> </level> <level label="2"> <text>The workers’ compensation law or employment benefit of the state that employs the individual shall be provided by that state when an individual is performing a service in another state.</text> </level> </level> <level label="f"> <text>Necessary expenditures made under a mutual aid agreement or otherwise made under this section may be charged against any State or local appropriations that are usually available to a public health laboratory.</text> </level> </section> <section article="ghg" article_name="Health - General" number="17-201" title_number="17" title_name="Laboratories" subtitle_number="2" subtitle_name="Medical Laboratories"> <level label="a"> <text>In this subtitle the following words have the meanings indicated.</text> </level> <level label="b"> <text>“License” means a permit, letter of exception, certificate, or other document issued by the Secretary granting approval or authority to:</text> <level label="1"> <text>Offer or perform medical laboratory tests or examinations in this State;</text> </level> <level label="2"> <text>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</text> </level> <level label="3"> <text>Represent or service in this State a medical laboratory regardless of the laboratory’s location.</text> </level> </level> <level label="c"> <level label="1"> <text>“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.</text> </level> <level label="2"> <text>“Medical laboratory” includes any laboratory owned or operated by the State or owned or operated by a county or municipal corporation in the State.</text> </level> </level> </section> <section article="ghg" article_name="Health - General" number="17-202" title_number="17" title_name="Laboratories" subtitle_number="2" subtitle_name="Medical Laboratories"> <level label="a"> <level label="1"> <text>The Secretary shall adopt regulations that set standards and requirements for medical laboratories.</text> </level> <level label="2"> <text>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.</text> </level> </level> <level label="b"> <text>To assure compliance with the standards and requirements adopted in regulations pursuant to this subtitle, the Secretary shall:</text> <level label="1"> <text>Conduct an inspection of each medical laboratory for which a license to operate is sought; and</text> </level> <level label="2"> <text>Conduct an inspection periodically of each medical laboratory for which a license has been issued.</text> </level> </level> <level label="c"> <level label="1"> <text>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:</text> <level label="i"> <text>Limit the number of slides an individual may examine;</text> </level> <level label="ii"> <text>Require that the examination of cytology slides be performed in a medical laboratory that has a license issued by the Secretary;</text> </level> <level label="iii"> <text>Prohibit payment to cytotechnologists for the examination of cytology specimens or slides on a piecework basis;</text> </level> <level label="iv"> <text>Require cytology laboratories to review no less than 10 percent of all negative gynecological slides;</text> </level> <level label="v"> <text>Require that the cytology review be performed by an individual who qualifies as a supervisory cytotechnologist or a pathologist;</text> </level> <level label="vi"> <text>Require the individual who directs the laboratory to establish and administer an ongoing quality assurance program using standards acceptable to the Secretary;</text> </level> <level label="vii"> <text>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;</text> </level> <level label="viii"> <text>Require cytology laboratories to maintain and store for 5 years from the date of examination any slide that was examined;</text> </level> <level label="ix"> <text>Require all cytology reports to be retained for at least 10 years;</text> </level> <level label="x"> <text>Prohibit any person from sending cytology specimens to a laboratory, including out–of–state laboratories, not licensed by the Department;</text> </level> <level label="xi"> <text>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</text> </level> <level label="xii"> <text>Establish any additional standards the Secretary considers necessary to assure that medical laboratories engaged in cytology provide safe and reliable services.</text> </level> </level> <level label="2"> <text>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.</text> </level> </level> <level label="d"> <level label="1"> <text>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.</text> </level> <level label="2"> <text>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:</text> <level label="i"> <text>Hand carry all testing materials to the testing site; and</text> </level> <level label="ii"> <text>Directly supervise the on–site proficiency testing.</text> </level> </level> <level label="3"> <text>The Secretary shall adopt regulations for the cytology proficiency testing program that:</text> <level label="i"> <text>Define satisfactory cytology proficiency testing performance; and</text> </level> <level label="ii"> <text>Set standards and requirements that a cytology proficiency testing program must meet before it can be designated an approved program.</text> </level> </level> <level label="4"> <text>The Secretary may accept the testing results of an approved cytology proficiency testing program as meeting the cytology proficiency testing requirement of this subtitle.</text> </level> </level> </section> <section article="ghg" article_name="Health - General" number="17-202.1" title_number="17" title_name="Laboratories" subtitle_number="2" subtitle_name="Medical Laboratories"> <level label="a"> <text>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.</text> </level> <level label="b"> <level label="1"> <text>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.</text> </level> <level label="2"> <text>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.</text> </level> </level> <level label="c"> <text>The medical laboratory shall notify the individual’s physician before sending the results to the individual.</text> </level> </section> <section article="ghg" article_name="Health - General" number="17-203" title_number="17" title_name="Laboratories" subtitle_number="2" subtitle_name="Medical Laboratories"> <level label="a"> <text>The Secretary may adopt regulations that set qualifications for the following personnel of medical laboratories:</text> <level label="1"> <text>Directors;</text> </level> <level label="2"> <text>Supervisory technologists;</text> </level> <level label="3"> <text>Technologists;</text> </level> <level label="4"> <text>Cytotechnologists; and</text> </level> <level label="5"> <text>Supervisory cytotechnologists.</text> </level> </level> <level label="b"> <text>The director of a medical laboratory is not required to be a physician licensed under the Health Occupations Article.</text> </level> </section> <section article="ghg" article_name="Health - General" number="17-205" title_number="17" title_name="Laboratories" subtitle_number="2" subtitle_name="Medical Laboratories"> <level label="a"> <text>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:</text> <level label="1"> <text>Offer or perform medical laboratory tests or examinations in this State;</text> </level> <level label="2"> <text>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</text> </level> <level label="3"> <text>Represent or service in this State a medical laboratory regardless of the laboratory’s location.</text> </level> </level> <level label="b"> <text>The Secretary shall issue a letter of exception to a laboratory that:</text> <level label="1"> <text>Performs only limited medical laboratory tests or examinations; and</text> </level> <level label="2"> <text>Meets the exception requirements in regulations adopted by the Secretary pursuant to this subtitle.</text> </level> </level> <level label="c"> <text>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.</text> </level> <level label="d"> <text>If preliminary screening procedures are performed by an operator who is trained under § 17–214(k) of this subtitle, an employer:</text> <level label="1"> <text>Is not required to obtain a permit or to obtain a letter of exception from the Secretary under this section to perform testing; but</text> </level> <level label="2"> <text>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.</text> </level> </level> </section> <section article="ghg" article_name="Health - General" number="17-206" title_number="17" title_name="Laboratories" subtitle_number="2" subtitle_name="Medical Laboratories"> <text>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.</text> </section> <section article="ghg" article_name="Health - General" number="17-207" title_number="17" title_name="Laboratories" subtitle_number="2" subtitle_name="Medical Laboratories"> <level label="a"> <text>An applicant for a license shall submit an application to the Secretary on the form that the Secretary requires.</text> </level> <level label="b"> <text>An application for a license to operate a medical laboratory shall include:</text> <level label="1"> <text>The name of the owner;</text> </level> <level label="2"> <text>The classes of services, complexity of testing, or the tests or examinations that the medical laboratory would provide; and</text> </level> <level label="3"> <text>Any other information that the Secretary requires.</text> </level> </level> </section> <section article="ghg" article_name="Health - General" number="17-208" title_number="17" title_name="Laboratories" subtitle_number="2" subtitle_name="Medical Laboratories"> <level label="a"> <text>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.</text> </level> <level label="b"> <text>A medical laboratory license shall include the name of the:</text> <level label="1"> <text>Medical laboratory;</text> </level> <level label="2"> <text>Laboratory director; and</text> </level> <level label="3"> <text>Owner of the laboratory.</text> </level> </level> <level label="c"> <text>A medical laboratory license shall designate the:</text> <level label="1"> <text>Complexity of testing that the laboratory may offer or perform;</text> </level> <level label="2"> <text>Classes of services that may be offered;</text> </level> <level label="3"> <text>Tests or examinations that may be offered or performed by the laboratory; or</text> </level> <level label="4"> <text>Any combination of items (1), (2), and (3) of this subsection.</text> </level> </level> <level label="d"> <text>A medical laboratory may not operate in any manner beyond what is designated by its license.</text> </level> <level label="e"> <text>A medical laboratory license issued by the Secretary under this subtitle is not transferable.</text> </level> </section> <section article="ghg" article_name="Health - General" number="17-210" title_number="17" title_name="Laboratories" subtitle_number="2" subtitle_name="Medical Laboratories"> <level label="a"> <text>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.</text> </level> <level label="b"> <level label="1"> <text>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.</text> </level> <level label="2"> <level label="i"> <text>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:</text> <level label="1"> <text>Notify the physicians or other individuals who ordered the tests of the erroneous or questionable test results; and</text> </level> <level label="2"> <text>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.</text> </level> </level> <level label="ii"> <text>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.</text> </level> </level> </level> <level label="c"> <text>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.</text> </level> </section> <section article="ghg" article_name="Health - General" number="17-211" title_number="17" title_name="Laboratories" subtitle_number="2" subtitle_name="Medical Laboratories"> <level label="a"> <text>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.</text> </level> <level label="b"> <text>The Secretary shall adopt regulations that:</text> <level label="1"> <text>Define satisfactory proficiency testing performance; and</text> </level> <level label="2"> <text>Set the standards and requirements that a proficiency testing program must meet before it can be designated as an approved program.</text> </level> </level> </section> <section article="ghg" article_name="Health - General" number="17-212" title_number="17" title_name="Laboratories" subtitle_number="2" subtitle_name="Medical Laboratories"> <text>Unless a person holds a license issued by the Secretary the person may not:</text> <level label="1"> <text>Offer or perform medical laboratory tests or examinations in this State;</text> </level> <level label="2"> <text>Represent or service in this State a medical laboratory regardless of the laboratory’s location; or</text> </level> <level label="3"> <text>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.</text> </level> </section> <section article="ghg" article_name="Health - General" number="17-213" title_number="17" title_name="Laboratories" subtitle_number="2" subtitle_name="Medical Laboratories"> <text>Unless a medical laboratory has a valid license, no other person on the laboratory’s behalf may:</text> <level label="1"> <text>Offer or perform medical laboratory tests or examinations in this State;</text> </level> <level label="2"> <text>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</text> </level> <level label="3"> <text>Represent or service in this State the medical laboratory regardless of the laboratory’s location.</text> </level> </section> <section article="ghg" article_name="Health - General" number="17-214" title_number="17" title_name="Laboratories" subtitle_number="2" subtitle_name="Medical Laboratories"> <level label="a"> <level label="1"> <text>In this section the following words have the meanings indicated.</text> </level> <level label="2"> <text>“Alcohol or controlled dangerous substance testing” means a procedure used to determine whether or not a specimen contains a controlled dangerous substance or alcohol.</text> </level> <level label="3"> <text>“Certification” means the approval granted by the Department for a laboratory to engage in job–related alcohol or controlled dangerous substance testing.</text> </level> <level label="4"> <text>“Controlled dangerous substance” has the meaning stated in § 5–101 of the Criminal Law Article.</text> </level> <level label="5"> <text>“Job applicant” means an individual who:</text> <level label="i"> <text>Has applied for a position with an employer; and</text> </level> <level label="ii"> <text>Is not currently employed by the employer.</text> </level> </level> <level label="6"> <text>“Job–related” means any alcohol or controlled dangerous substance testing used by an employer for a legitimate business purpose.</text> </level> <level label="7"> <text>“Laboratory” means a facility or other entity that conducts job–related alcohol or controlled dangerous substance testing.</text> </level> <level label="8"> <text>“Medical review officer” means a licensed physician with knowledge of drug abuse disorders and drug and alcohol testing.</text> </level> <level label="9"> <text>“Preliminary screening procedure” means a controlled dangerous substance test that uses a single–use test device that:</text> <level label="i"> <text>Is easily portable and can be administered at a work site or other appropriate collection site;</text> </level> <level label="ii"> <text>Meets the requirements of the federal Food and Drug Administration for commercial distribution; and</text> </level> <level label="iii"> <text>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.</text> </level> </level> <level label="10"> <text>“Single–use test device” means the reagent–containing unit of a test system that:</text> <level label="i"> <text>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;</text> </level> <level label="ii"> <text>Is self–contained and individually packaged;</text> </level> <level label="iii"> <text>Is discarded after each test; and</text> </level> <level label="iv"> <text>Does not allow any test component or constituent of a test system to interact between tests.</text> </level> </level> <level label="11"> <text>“Specimen” means:</text> <level label="i"> <text>Blood derived from the human body;</text> </level> <level label="ii"> <text>Urine derived from the human body;</text> </level> <level label="iii"> <text>Hair derived from the human body as provided in subsection (b)(3) of this section; or</text> </level> <level label="iv"> <text>Saliva derived from the human body.</text> </level> </level> </level> <level label="b"> <level label="1"> <text>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:</text> <level label="i"> <text>Have the specimen tested by a laboratory that:</text> <level label="1"> <text>Holds a permit under this subtitle; or</text> </level> <level label="2"> <text>Is located outside of the State and is certified or otherwise approved under subsection (f) of this section; and</text> </level> </level> <level label="ii"> <text>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.</text> </level> </level> <level label="2"> <level label="i"> <level label="1"> <text>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.</text> </level> <level label="2"> <text>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.</text> </level> </level> <level label="ii"> <text>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.</text> </level> <level label="iii"> <text>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.</text> </level> <level label="iv"> <text>An employer may not use a preliminary screening procedure to test an individual who is not applying for a job with that employer.</text> </level> <level label="v"> <text>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.</text> </level> </level> <level label="3"> <level label="i"> <text>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.</text> </level> <level label="ii"> <text>An employer may use hair derived from the human body only for pre–employment purposes.</text> </level> <level label="iii"> <text>If an employer uses hair derived from the human body as a specimen, the employer may not:</text> <level label="1"> <text>Use a specimen that is longer than one and one–half inches measured from the human body; or</text> </level> <level label="2"> <text>Use the specimen for any purpose other than testing for controlled dangerous substances.</text> </level> </level> </level> </level> <level label="c"> <level label="1"> <text>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:</text> <level label="i"> <text>A copy of the laboratory test indicating the test results;</text> </level> <level label="ii"> <text>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;</text> </level> <level label="iii"> <text>If applicable, written notice of the employer’s intent to take disciplinary action, terminate employment, or change the conditions of continued employment; and</text> </level> <level label="iv"> <text>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.</text> </level> </level> <level label="2"> <text>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:</text> <level label="i"> <text>Either in person or by certified mail; and</text> </level> <level label="ii"> <text>Within 30 days from the date the test was performed.</text> </level> </level> </level> <level label="d"> <text>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:</text> <level label="1"> <text>In using a single–use test device, collect, handle, store, and ship each specimen in a manner that:</text> <level label="i"> <text>Maintains the specimen donor’s identity and confidentiality and the physical integrity of the specimen; and</text> </level> <level label="ii"> <text>Precludes contamination of the specimen; and</text> </level> </level> <level label="2"> <text>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.</text> </level> </level> <level label="e"> <level label="1"> <text>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:</text> <level label="i"> <text>Holds a permit under this subtitle; or</text> </level> <level label="ii"> <text>If located outside of the State, is certified or otherwise approved under subsection (f) of this section.</text> </level> </level> <level label="2"> <text>The person shall pay the cost of an independent test conducted under this subsection.</text> </level> </level> <level label="f"> <level label="1"> <text>The Maryland Department of Health:</text> <level label="i"> <text>Shall adopt regulations governing the certification of laboratories that conduct job–related alcohol or controlled dangerous substance testing; and</text> </level> <level label="ii"> <text>May adopt regulations governing the oversight of preliminary screening procedures administered by employers.</text> </level> </level> <level label="2"> <text>In addition to any other laboratory standards, the regulations shall:</text> <level label="i"> <text>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;</text> </level> <level label="ii"> <text>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;</text> </level> <level label="iii"> <text>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;</text> </level> <level label="iv"> <text>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</text> </level> <level label="v"> <text>Include procedures for inspection.</text> </level> </level> </level> <level label="g"> <text>This section does not apply to:</text> <level label="1"> <text>Alcohol or controlled dangerous substance testing of a person under arrest or held by a law enforcement or correctional agency;</text> </level> <level label="2"> <text>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</text> </level> <level label="3"> <text>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.</text> </level> </level> <level label="h"> <text>This section applies to job–related alcohol and controlled dangerous substance testing of any person, including preemployment applicants, employees, and contractors.</text> </level> <level label="i"> <level label="1"> <text>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:</text> <level label="i"> <text>The use of a nonprescription drug, excluding alcohol, that is not prohibited under the laws of the State; or</text> </level> <level label="ii"> <text>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.</text> </level> </level> <level label="2"> <text>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.</text> </level> <level label="3"> <text>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.</text> </level> </level> <level label="j"> <level label="1"> <text>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.</text> </level> <level label="2"> <text>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.</text> </level> </level> <level label="k"> <level label="1"> <text>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.</text> </level> <level label="2"> <text>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.</text> </level> <level label="3"> <text>A trainee shall receive appropriate and practical instruction, which includes:</text> <level label="i"> <text>A reading of the test manufacturer’s package insert sheet;</text> </level> <level label="ii"> <text>Observing the test manufacturer’s training video or receiving training from the test manufacturer;</text> </level> <level label="iii"> <text>Completing the test manufacturer’s self–administered test; and</text> </level> <level label="iv"> <text>The actual performance of tests and the actual interpretation of the results.</text> </level> </level> <level label="4"> <level label="i"> <text>The employer shall:</text> <level label="1"> <text>Keep a record of the training received by each trainee; and</text> </level> <level label="2"> <text>Establish a procedure for training each trainee as having received the minimum training required to properly perform the test.</text> </level> </level> <level label="ii"> <text>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.</text> </level> </level> </level> <level label="l"> <text>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.</text> </level> </section> <section article="ghg" article_name="Health - General" number="17-215" title_number="17" title_name="Laboratories" subtitle_number="2" subtitle_name="Medical Laboratories"> <level label="a"> <text>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.</text> </level> <level label="b"> <level label="1"> <level label="i"> <text>This subsection applies only to:</text> <level label="1"> <text>A diagnostic laboratory test or procedure for the purpose of screening, diagnosing, managing, or treating a physical or mental condition or disease; and</text> </level> <level label="2"> <text>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.</text> </level> </level> <level label="ii"> <text>This subsection does not apply to germline genetic or genomic testing done in connection with the analysis, diagnosis, or prediction of human diseases.</text> </level> </level> <level label="2"> <text>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.</text> </level> <level label="3"> <text>A person that directly or indirectly advertises for or solicits business in the State for a diagnostic laboratory test or procedure under this subsection:</text> <level label="i"> <text>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;</text> </level> <level label="ii"> <text>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</text> </level> <level label="iii"> <text>Shall disclose that the diagnostic laboratory test or procedure may or may not be covered by health insurance.</text> </level> </level> <level label="4"> <text>The Secretary may take legal action to restrict the marketing of a diagnostic laboratory test or procedure if the Secretary determines that:</text> <level label="i"> <text>There is a public health threat; or</text> </level> <level label="ii"> <text>The diagnostic laboratory test or procedure is not in compliance with the requirements of this section.</text> </level> </level> </level> </section> <section article="ghg" article_name="Health - General" number="17-216" title_number="17" title_name="Laboratories" subtitle_number="2" subtitle_name="Medical Laboratories"> <text>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.</text> </section> <section article="ghg" article_name="Health - General" number="17-217" title_number="17" title_name="Laboratories" subtitle_number="2" subtitle_name="Medical Laboratories"> <level label="a"> <text>The Secretary shall establish a Laboratory Advisory Committee to advise the Secretary on matters relating to the implementation of the provisions of this subtitle.</text> </level> <level label="b"> <text>The Advisory Committee shall consist of:</text> <level label="1"> <text>At least the following representatives appointed biennially from a list of eligibles:</text> <level label="i"> <text>1 member of the American Academy of Family Practitioners;</text> </level> <level label="ii"> <text>1 member of the American Academy of Pediatricians;</text> </level> <level label="iii"> <text>1 member of the American College of Physicians;</text> </level> <level label="iv"> <text>1 member of the American Society for Clinical Pathology; and</text> </level> <level label="v"> <text>1 member of the American College of Pathology; and</text> </level> </level> <level label="2"> <text>1 representative of the Advanced Medical Technology Association.</text> </level> </level> <level label="c"> <text>The Secretary may appoint any other individuals or representatives at the Secretary’s discretion.</text> </level> <level label="d"> <text>The chairman of the Advisory Committee shall be designated by the Secretary every 2 years.</text> </level> </section> <section article="ghg" article_name="Health - General" number="17-2A-01" title_number="17" title_name="Laboratories" subtitle_number="2A" subtitle_name="Forensic Laboratories"> <level label="a"> <text>In this subtitle the following words have the meanings indicated.</text> </level> <level label="b"> <level label="1"> <text>“Forensic analysis” means a medical, chemical, toxicologic, firearms, or other expert examination or test performed on physical evidence, including DNA evidence, for the purpose of determining the connection of the evidence to a criminal act.</text> </level> <level label="2"> <text>“Forensic analysis” includes an examination or test required by a law enforcement agency, prosecutor, criminal suspect or defendant, or court.</text> </level> <level label="3"> <text>“Forensic analysis” does not include:</text> <level label="i"> <text>A test of a specimen of breath or blood to determine alcohol concentration or controlled dangerous substance content;</text> </level> <level label="ii"> <text>Forensic information technology;</text> </level> <level label="iii"> <text>A presumptive test performed at a crime scene;</text> </level> <level label="iv"> <text>A presumptive test performed for the purpose of determining compliance with a term or condition of community supervision or parole and conducted by or under contract with a county department of corrections or the State Department of Public Safety and Correctional Services; or</text> </level> <level label="v"> <text>An expert examination or test conducted principally for the purpose of scientific research, medical practice, civil or administrative litigation, or any other purpose unrelated to determining the connection of physical evidence to a criminal act.</text> </level> </level> </level> <level label="c"> <text>“Forensic information technology” means digital or electronic evidence that is stored or transmitted electronically.</text> </level> <level label="d"> <level label="1"> <text>“Forensic laboratory” means a facility, entity, or site that offers or performs forensic analysis.</text> </level> <level label="2"> <text>“Forensic laboratory” includes a laboratory owned or operated by the State, a county or municipal corporation in the State, or another governmental entity.</text> </level> <level label="3"> <text>“Forensic laboratory” does not include:</text> <level label="i"> <text>A forensic laboratory operated by the federal government; or</text> </level> <level label="ii"> <text>A laboratory licensed or certified by the Department of Agriculture.</text> </level> </level> </level> <level label="e"> <text>“License” means a permit, letter of exception, certificate, or other document issued by the Secretary granting approval or authority to offer or perform forensic laboratory tests, examinations, or analyses in the State.</text> </level> <level label="f"> <text>“Limited forensic analysis” means a forensic laboratory test or analysis defined in regulations adopted by the Secretary.</text> </level> <level label="g"> <text>“Physical evidence” means any object, thing, or substance relating to a criminal act.</text> </level> </section> <section article="ghg" article_name="Health - General" number="17-2A-02" title_number="17" title_name="Laboratories" subtitle_number="2A" subtitle_name="Forensic Laboratories"> <level label="a"> <level label="1"> <text>The Secretary shall adopt regulations that set standards and requirements for forensic laboratories.</text> </level> <level label="2"> <text>The regulations shall contain the standards and requirements that the Secretary considers necessary to assure the citizens of the State that forensic laboratories provide safe, reliable, and accurate services.</text> </level> <level label="3"> <text>The regulations shall:</text> <level label="i"> <text>Require the director of a forensic laboratory to establish and administer an ongoing quality assurance program using standards acceptable to the Secretary;</text> </level> <level label="ii"> <text>Require the director of a forensic laboratory to retain all case files for at least 10 years;</text> </level> <level label="iii"> <text>Establish qualifications for the personnel of forensic laboratories;</text> </level> <level label="iv"> <text>Establish procedures for verifying the background and education of the personnel of forensic laboratories; and</text> </level> <level label="v"> <text>Establish any additional standards that the Secretary considers necessary to assure that forensic laboratories provide accurate and reliable services.</text> </level> </level> </level> <level label="b"> <level label="1"> <text>A forensic laboratory that examines or analyzes physical evidence shall demonstrate satisfactory performance in an approved proficiency testing program specifically related to the particular forensic analysis being performed.</text> </level> <level label="2"> <text>The Secretary shall adopt regulations for the forensic proficiency testing program that:</text> <level label="i"> <text>Define satisfactory proficiency testing performance; and</text> </level> <level label="ii"> <text>Set standards and requirements that a forensic proficiency testing program shall meet.</text> </level> </level> <level label="3"> <text>The Department shall review a forensic laboratory’s proficiency testing program.</text> </level> </level> <level label="c"> <text>To assure compliance with the standards and requirements under this subtitle, the Secretary shall conduct:</text> <level label="1"> <text>An inspection of each forensic laboratory for which a license to operate is sought; and</text> </level> <level label="2"> <text>An inspection of each forensic laboratory for which a license has been issued.</text> </level> </level> <level label="d"> <text>To assure compliance with the standards and requirements under this subtitle, the Secretary may conduct:</text> <level label="1"> <text>A complaint investigation; and</text> </level> <level label="2"> <text>A validation survey of an accredited forensic laboratory.</text> </level> </level> </section> <section article="ghg" article_name="Health - General" number="17-2A-03" title_number="17" title_name="Laboratories" subtitle_number="2A" subtitle_name="Forensic Laboratories"> <level label="a"> <text>Forensic laboratory deficiency statements and plans of correction are public documents.</text> </level> <level label="b"> <text>A forensic laboratory shall make discrepancy logs, contamination records, and test results available to the public within 30 days of a written request.</text> </level> <level label="c"> <text>Except as provided in subsection (a) of this section, the proceedings, records, and files of an organization or State agency responsible for assuring compliance with this subtitle shall be confidential and not discoverable or admissible in evidence in a civil or criminal action.</text> </level> </section> <section article="ghg" article_name="Health - General" number="17-2A-04" title_number="17" title_name="Laboratories" subtitle_number="2A" subtitle_name="Forensic Laboratories"> <level label="a"> <text>After December 31, 2011, a forensic laboratory shall hold a license issued by the Secretary before the forensic laboratory may offer or perform forensic analysis in the State.</text> </level> <level label="b"> <text>The Secretary shall issue a letter of exception to a laboratory that:</text> <level label="1"> <text>Performs only limited forensic analysis; and</text> </level> <level label="2"> <text>Meets the exception requirements in regulations adopted by the Secretary.</text> </level> </level> <level label="c"> <text>The Secretary may grant an out–of–state forensic laboratory a waiver from the licensure requirements of this subtitle with conditions.</text> </level> </section> <section article="ghg" article_name="Health - General" number="17-2A-05" title_number="17" title_name="Laboratories" subtitle_number="2A" subtitle_name="Forensic Laboratories"> <text>To qualify for a license, an applicant shall provide evidence to satisfy the Secretary that the forensic laboratory and its personnel meet the standards and requirements of this subtitle.</text> </section> <section article="ghg" article_name="Health - General" number="17-2A-06" title_number="17" title_name="Laboratories" subtitle_number="2A" subtitle_name="Forensic Laboratories"> <level label="a"> <text>An applicant for a license shall submit an application to the Secretary on the form that the Secretary requires.</text> </level> <level label="b"> <text>An application for a license to operate a forensic laboratory shall include:</text> <level label="1"> <text>The name of the operator or owner;</text> </level> <level label="2"> <text>The tests or examinations that the forensic laboratory would provide; and</text> </level> <level label="3"> <text>Any other information that the Secretary requires.</text> </level> </level> </section> <section article="ghg" article_name="Health - General" number="17-2A-07" title_number="17" title_name="Laboratories" subtitle_number="2A" subtitle_name="Forensic Laboratories"> <level label="a"> <text>The Secretary shall issue a license to an applicant that meets the standards and requirements of this subtitle.</text> </level> <level label="b"> <text>A forensic laboratory license shall include the name of the:</text> <level label="1"> <text>Forensic laboratory;</text> </level> <level label="2"> <text>Laboratory director; and</text> </level> <level label="3"> <text>Operator or owner of the laboratory.</text> </level> </level> <level label="c"> <text>A forensic laboratory license shall designate the tests, examinations, or analyses that may be offered or performed by the laboratory.</text> </level> <level label="d"> <text>A forensic laboratory may not operate in a manner not designated by the license issued under this subtitle.</text> </level> <level label="e"> <text>A forensic laboratory license issued by the Secretary under this subtitle is not transferable.</text> </level> </section> <section article="ghg" article_name="Health - General" number="17-2A-09" title_number="17" title_name="Laboratories" subtitle_number="2A" subtitle_name="Forensic Laboratories"> <level label="a"> <text>The Secretary may deny a license to an applicant or suspend, revoke, or limit a license or the authority of a licensee to offer or perform tests that a license sets forth, if the forensic laboratory or its director or other personnel fail to meet the standards and requirements of this subtitle.</text> </level> <level label="b"> <level label="1"> <text>If the Secretary finds that a forensic laboratory licensed under this subtitle no longer meets the standards and requirements of this subtitle, the Secretary may:</text> <level label="i"> <text>Revoke the license of the forensic laboratory; or</text> </level> <level label="ii"> <text>Suspend the license of the forensic laboratory.</text> </level> </level> <level label="2"> <text>If a deficiency exists, the Secretary may:</text> <level label="i"> <text>Impose a directed plan of correction;</text> </level> <level label="ii"> <text>Regularly inspect the forensic laboratory to assure compliance with the directed plan of correction; or</text> </level> <level label="iii"> <text>Limit the testing authorized by the license.</text> </level> </level> </level> <level label="c"> <text>If the Secretary finds that a forensic laboratory provided erroneous or questionable test results, the Secretary may order the laboratory to provide written notification to:</text> <level label="1"> <text>The person or agency that ordered the tests;</text> </level> <level label="2"> <text>The Office of the Public Defender or counsel of record; and</text> </level> <level label="3"> <text>The State’s Attorney.</text> </level> </level> <level label="d"> <text>A State’s Attorney who receives notification from a laboratory under subsection (c) of this section shall notify the victim of the criminal act or the victim’s representative of the erroneous or questionable test results.</text> </level> <level label="e"> <text>A forensic laboratory that fails to comply with an order issued by the Secretary under subsection (c) of this section 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.</text> </level> <level label="f"> <text>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.</text> </level> </section> <section article="ghg" article_name="Health - General" number="17-2A-10" title_number="17" title_name="Laboratories" subtitle_number="2A" subtitle_name="Forensic Laboratories"> <level label="a"> <text>In this section, “discriminate or retaliate” includes:</text> <level label="1"> <text>Failing to promote an individual or to provide another employment–related benefit for which the individual would otherwise be eligible;</text> </level> <level label="2"> <text>Making an adverse evaluation or decision in relation to accreditation, certification, credentialing, or licensing of the individual; or</text> </level> <level label="3"> <text>Taking a personnel action that is adverse to the individual concerned.</text> </level> </level> <level label="b"> <text>An employee who works in a forensic laboratory may disclose information to the Secretary that the employee believes evidences a violation of standards and requirements for forensic laboratories in the State.</text> </level> <level label="c"> <text>A forensic laboratory may not discriminate or retaliate against an employee because the employee:</text> <level label="1"> <text>Discloses information under subsection (b) of this section; or</text> </level> <level label="2"> <text>Has agreed to cooperate with an investigation of the forensic laboratory.</text> </level> </level> <level label="d"> <level label="1"> <text>The Secretary shall develop, through regulation, a document that informs the employees of a forensic laboratory of the procedures to report instances of noncompliance or other violations of the standards and requirements for forensic laboratories in the State.</text> </level> <level label="2"> <text>The Secretary shall distribute the document developed under paragraph (1) of this subsection to forensic laboratories in the State.</text> </level> </level> <level label="e"> <text>A forensic laboratory shall post the document developed under subsection (d) of this section in a conspicuous place.</text> </level> <level label="f"> <text>An employee of a forensic laboratory who has been discriminated or retaliated against in violation of subsection (c) of this section may initiate an action and, on prevailing, shall be entitled to:</text> <level label="1"> <text>Reinstatement;</text> </level> <level label="2"> <text>Reimbursement for lost wages;</text> </level> <level label="3"> <text>Work benefits lost as a result of the unlawful acts of the employing laboratory; and</text> </level> <level label="4"> <text>Reasonable attorney’s fees and costs associated with pursuing the action.</text> </level> </level> <level label="g"> <text>No action may be brought under this subsection more than 2 years after the discrimination or retaliation that is the basis for the action.</text> </level> </section> <section article="ghg" article_name="Health - General" number="17-2A-11" title_number="17" title_name="Laboratories" subtitle_number="2A" subtitle_name="Forensic Laboratories"> <level label="a"> <text>A person that violates any provision of this subtitle is guilty of a misdemeanor and on conviction is subject to:</text> <level label="1"> <text>A fine not exceeding $100 for the first offense; and</text> </level> <level label="2"> <text>A fine not exceeding $500 for each subsequent conviction for a violation of the same provision.</text> </level> </level> <level label="b"> <text>Each day on which a violation occurs is a separate violation under this section.</text> </level> </section> <section article="ghg" article_name="Health - General" number="17-2A-12" title_number="17" title_name="Laboratories" subtitle_number="2A" subtitle_name="Forensic Laboratories"> <level label="a"> <text>The Governor shall establish a Forensic Laboratory Advisory Committee to advise the Secretary on matters relating to the implementation of the provisions of this subtitle.</text> </level> <level label="b"> <text>The Advisory Committee shall consist of the following 10 members:</text> <level label="1"> <text>The Director of the Laboratories Administration in the Department, or the Director’s designee;</text> </level> <level label="2"> <text>The Director of the Office of Health Care Quality in the Department, or the Director’s designee; and</text> </level> <level label="3"> <text>The following members, appointed by the Governor:</text> <level label="i"> <text>One from the American Society for Clinical Laboratory Science;</text> </level> <level label="ii"> <text>One from the University of Maryland School of Medicine, Department of Medical Research and Technology;</text> </level> <level label="iii"> <text>One from the American Association for Laboratory Accreditation;</text> </level> <level label="iv"> <text>One from the American Academy of Forensic Sciences;</text> </level> <level label="v"> <text>One from the ANSI–ASQ National Accreditation Board; and</text> </level> <level label="vi"> <text>Three directors of forensic laboratories in the State, including:</text> <level label="1"> <text>One from a forensic laboratory operated by the State;</text> </level> <level label="2"> <text>One from a forensic laboratory operated by a county; and</text> </level> <level label="3"> <text>One from a forensic laboratory operated by a municipal corporation.</text> </level> </level> </level> </level> <level label="c"> <level label="1"> <text>The term of an appointed member is 3 years.</text> </level> <level label="2"> <text>The terms of appointed members are staggered as required by the terms provided for appointed members of the Advisory Committee on October 1, 2007.</text> </level> </level> <level label="d"> <text>The Governor shall designate the chair of the Advisory Committee.</text> </level> <level label="e"> <text>A majority of the members serving on the Advisory Committee represents a quorum to conduct business.</text> </level> <level label="f"> <text>A member of the Advisory Committee may not receive compensation but is entitled to reimbursement for expenses under the Standard State Travel Regulations, as provided in the State budget.</text> </level> <level label="g"> <text>The Department shall provide staff for the Advisory Committee.</text> </level> </section> <section article="ghg" article_name="Health - General" number="17-301" title_number="17" title_name="Laboratories" subtitle_number="3" subtitle_name="Tissue Banks"> <level label="a"> <text>In this subtitle the following words have the meanings indicated.</text> </level> <level label="b"> <text>“Permit” means a permit issued by the Secretary:</text> <level label="1"> <text>To operate a tissue bank in this State; or</text> </level> <level label="2"> <text>To represent or service in this State a tissue bank that is outside this State.</text> </level> </level> <level label="c"> <level label="1"> <text>“Tissue bank” means an establishment that obtains, stores, processes, distributes, or sells human blood or other human tissue for use in the human body.</text> </level> <level label="2"> <text>“Tissue bank” includes a blood bank.</text> </level> </level> </section> <section article="ghg" article_name="Health - General" number="17-302" title_number="17" title_name="Laboratories" subtitle_number="3" subtitle_name="Tissue Banks"> <level label="a"> <level label="1"> <text>The Secretary shall adopt rules and regulations that set standards for tissue banks.</text> </level> <level label="2"> <text>The rules and regulations shall contain the standards that the Secretary considers necessary to assure the citizens of this State that tissue banks provide safe and reliable services.</text> </level> </level> <level label="b"> <text>To assure compliance with the standards adopted under this subtitle, the Secretary shall:</text> <level label="1"> <text>Have an inspection made of each tissue bank for which a permit to operate is sought; and</text> </level> <level label="2"> <text>Have an inspection made periodically or make an agreement with an organization to do, at no cost to this State, a periodic inspection of each tissue bank for which a permit has been issued.</text> </level> </level> </section> <section article="ghg" article_name="Health - General" number="17-303" title_number="17" title_name="Laboratories" subtitle_number="3" subtitle_name="Tissue Banks"> <level label="a"> <text>The Secretary shall adopt rules and regulations that set qualifications for directors of tissue banks.</text> </level> <level label="b"> <text>The rules and regulations shall require that a tissue bank in this State employ or retain under contract:</text> <level label="1"> <text>A technical director, qualified by training and experience for the scope of activities being pursued, who will oversee and be responsible for all technical aspects of the tissue bank’s operations; and</text> </level> <level label="2"> <text>A medical director who will be a physician licensed to practice medicine in this State and who will be responsible for all medical aspects of the tissue bank’s operations, unless the technical director qualifies as a medical director under this section.</text> </level> </level> </section> <section article="ghg" article_name="Health - General" number="17-305" title_number="17" title_name="Laboratories" subtitle_number="3" subtitle_name="Tissue Banks"> <text>Except as provided in §§ 10–14A–03 and 10–14B–03 of the State Government Article, a person shall hold a permit issued by the Secretary before the person may:</text> <level label="1"> <text>Operate a tissue bank in this State; or</text> </level> <level label="2"> <text>Represent or service in this State any tissue bank that is outside this State.</text> </level> </section> <section article="ghg" article_name="Health - General" number="17-306" title_number="17" title_name="Laboratories" subtitle_number="3" subtitle_name="Tissue Banks"> <text>To qualify for a permit, an applicant shall satisfy the Secretary that the tissue bank to be operated, represented, or serviced and its director meet the requirements that the Secretary adopts under this subtitle.</text> </section> <section article="ghg" article_name="Health - General" number="17-307" title_number="17" title_name="Laboratories" subtitle_number="3" subtitle_name="Tissue Banks"> <level label="a"> <text>An applicant for a permit shall submit an application to the Secretary on the form that the Secretary requires.</text> </level> <level label="b"> <level label="1"> <text>An application for a permit to operate a tissue bank shall include:</text> <level label="i"> <text>The name of the owner;</text> </level> <level label="ii"> <text>The classes of services that the tissue bank would provide; and</text> </level> <level label="iii"> <text>Any other information that the Secretary requires.</text> </level> </level> <level label="2"> <text>An application for a permit to represent or service a tissue bank shall include satisfactory evidence that the tissue bank to be represented or serviced and its director meet the requirements that the Secretary adopts under this subtitle.</text> </level> </level> </section> <section article="ghg" article_name="Health - General" number="17-308" title_number="17" title_name="Laboratories" subtitle_number="3" subtitle_name="Tissue Banks"> <level label="a"> <text>The Secretary shall issue a permit to any applicant who meets the requirements of this subtitle.</text> </level> <level label="b"> <text>The Secretary shall include on each permit that the Secretary issues:</text> <level label="1"> <text>The name of the tissue bank;</text> </level> <level label="2"> <text>The name of its director;</text> </level> <level label="3"> <text>The name of its owner; and</text> </level> <level label="4"> <text>The classes of services that the tissue bank may offer.</text> </level> </level> </section> <section article="ghg" article_name="Health - General" number="17-309" title_number="17" title_name="Laboratories" subtitle_number="3" subtitle_name="Tissue Banks"> <text>While it is effective, a permit authorizes the permit holder:</text> <level label="1"> <text>To operate or to represent or service the tissue bank named in the permit; and</text> </level> <level label="2"> <text>To offer and perform the classes of services set forth in the permit.</text> </level> </section> <section article="ghg" article_name="Health - General" number="17-311" title_number="17" title_name="Laboratories" subtitle_number="3" subtitle_name="Tissue Banks"> <level label="a"> <text>The Secretary may deny a permit to any applicant or suspend or revoke a permit or the authority to offer or perform any class of service that the permit sets forth, if the tissue bank or its director fails to meet the requirements that the Secretary adopts under this subtitle.</text> </level> <level label="b"> <text>Except as otherwise provided in the Administrative Procedure Act, before the Secretary takes any action under this section, the Secretary shall give the applicant or permit holder notice and an opportunity for a hearing.</text> </level> </section> <section article="ghg" article_name="Health - General" number="17-312" title_number="17" title_name="Laboratories" subtitle_number="3" subtitle_name="Tissue Banks"> <level label="a"> <text>A person may not operate a tissue bank in this State unless the person holds a permit issued by the Secretary.</text> </level> <level label="b"> <text>A permit holder may not offer or perform any class of service of a tissue bank that is not authorized by the permit.</text> </level> </section> <section article="ghg" article_name="Health - General" number="17-313" title_number="17" title_name="Laboratories" subtitle_number="3" subtitle_name="Tissue Banks"> <level label="a"> <text>A person may not represent or service any tissue bank, regardless of location, unless the tissue bank and its director meet the standards and qualifications that the Secretary adopts under this subtitle.</text> </level> <level label="b"> <text>A person may not represent or service in this State any tissue bank that is not in this State unless the person holds a permit to represent or service the tissue bank.</text> </level> </section> <section article="ghg" article_name="Health - General" number="17-314" title_number="17" title_name="Laboratories" subtitle_number="3" subtitle_name="Tissue Banks"> <text>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.</text> </section> <section article="ghg" article_name="Health - General" number="17-501" title_number="17" title_name="Laboratories" subtitle_number="5" subtitle_name="Cholesterol Testing"> <level label="a"> <text>In this subtitle the following words have the meanings indicated.</text> </level> <level label="b"> <text>“Cholesterol testing” includes collecting a test specimen, testing to detect the amount of cholesterol in an individual’s blood, and the reporting of test results.</text> </level> <level label="c"> <text>“Permit” means a permit issued by the Secretary to a person who:</text> <level label="1"> <text>Offers to provide, with or without charge, a test to detect the amount of cholesterol in an individual’s blood; and</text> </level> <level label="2"> <text>Conducts the test outside a permanently located medical laboratory issued a permit or excepted from a permit under Subtitle 2 of this title.</text> </level> </level> </section> <section article="ghg" article_name="Health - General" number="17-502" title_number="17" title_name="Laboratories" subtitle_number="5" subtitle_name="Cholesterol Testing"> <level label="a"> <text>Except as provided under subsection (b) of this section and § 17-503 of this subtitle, a person shall obtain a permit from the Department before:</text> <level label="1"> <text>Offering to provide a test to detect the amount of cholesterol in an individual’s blood; and</text> </level> <level label="2"> <text>Conducting the cholesterol test outside a permanently located medical laboratory issued a permit or excepted from a permit under Subtitle 2 of this title.</text> </level> </level> <level label="b"> <text>A cholesterol testing permit is not required under this subtitle for a medical laboratory that:</text> <level label="1"> <text>Is licensed under Subtitle 2 of this title; and</text> </level> <level label="2"> <text>As set forth in the license, provides tests or services in the discipline of chemistry or health awareness.</text> </level> </level> </section> <section article="ghg" article_name="Health - General" number="17-503" title_number="17" title_name="Laboratories" subtitle_number="5" subtitle_name="Cholesterol Testing"> <level label="a"> <text>Any local or county health department may submit to the Secretary its cholesterol testing plan for review.</text> </level> <level label="b"> <level label="1"> <text>The Secretary shall review all submissions under this section as soon as reasonably possible after the submission in order to determine whether it meets the standards necessary for adequate off-site cholesterol testing in accordance with this subtitle.</text> </level> <level label="2"> <text>If a plan submitted under this section meets the standards of this subtitle, the Secretary may waive the permit requirements of the subtitle and permit the submitting local or county health department to conduct cholesterol testing under this subtitle for a period of 12 months, provided that:</text> <level label="i"> <text>The submission adequately describes the cholesterol testing plan for the effective 12 months;</text> </level> <level label="ii"> <text>The local or county health department provides all information that the Secretary may reasonably require to determine compliance with this section;</text> </level> <level label="iii"> <text>The local or county health department agrees to make records available and submit reports to the Secretary as the Secretary may require;</text> </level> <level label="iv"> <text>Changes and amendments to the plan are submitted 60 days prior to proposed implementation; and</text> </level> <level label="v"> <text>All changes and amendments to the plan are approved by the Secretary.</text> </level> </level> <level label="3"> <text>If a plan submitted under this section does not meet the standards of this subtitle, or if the information supplied in the submission is considered by the Secretary to be insufficient for a determination, the submitting local or county health department shall apply for a permit in accordance with this subtitle.</text> </level> </level> <level label="c"> <text>The Secretary may cancel a waiver granted under this section at any time if the Secretary finds that the local or county health department does not continue to meet the standards of this subtitle.</text> </level> </section> <section article="ghg" article_name="Health - General" number="17-504" title_number="17" title_name="Laboratories" subtitle_number="5" subtitle_name="Cholesterol Testing"> <level label="a"> <text>The Secretary shall adopt regulations to implement the provisions of this subtitle, including regulations that assure the citizens of this State that cholesterol testing conducted outside a permanently located medical laboratory meets appropriate national standards of quality assurance.</text> </level> <level label="b"> <text>The regulations shall include:</text> <level label="1"> <text>Personnel training standards, including requirements for reasonable training, experience, and competency in:</text> <level label="i"> <text>Simple procedures used in drawing blood for cholesterol testing; and</text> </level> <level label="ii"> <text>The operation of blood chemical analyzers used for cholesterol screening;</text> </level> </level> <level label="2"> <text>Quality assurance standards;</text> </level> <level label="3"> <text>Standards for counseling and referral procedures;</text> </level> <level label="4"> <text>Standards for releasing and reporting test results; and</text> </level> <level label="5"> <text>A prohibition on the payment of any sum to any person for bringing or referring a patient.</text> </level> </level> <level label="c"> <level label="1"> <text>The Secretary may not require that cholesterol testing personnel that conduct cholesterol tests under this subtitle be certified in a medical laboratory specialty.</text> </level> <level label="2"> <text>All cholesterol testing conducted under this subtitle shall be overseen by a supervisor knowledgeable in all aspects of cholesterol testing services.</text> </level> </level> </section> <section article="ghg" article_name="Health - General" number="17-505" title_number="17" title_name="Laboratories" subtitle_number="5" subtitle_name="Cholesterol Testing"> <text>To qualify for a permit, an applicant shall meet the requirements of this subtitle and any regulation that the Secretary adopts under this subtitle.</text> </section> <section article="ghg" article_name="Health - General" number="17-506" title_number="17" title_name="Laboratories" subtitle_number="5" subtitle_name="Cholesterol Testing"> <text>An applicant for a permit shall submit an application to the Secretary on the form that the Secretary requires.</text> </section> <section article="ghg" article_name="Health - General" number="17-507" title_number="17" title_name="Laboratories" subtitle_number="5" subtitle_name="Cholesterol Testing"> <level label="a"> <text>The Secretary shall issue a permit to any applicant who meets the requirements of this subtitle.</text> </level> <level label="b"> <text>The Secretary shall include on each permit:</text> <level label="1"> <text>The name of the permittee;</text> </level> <level label="2"> <text>The address of the permittee; and</text> </level> <level label="3"> <text>The expiration date of the permit.</text> </level> </level> </section> <section article="ghg" article_name="Health - General" number="17-509" title_number="17" title_name="Laboratories" subtitle_number="5" subtitle_name="Cholesterol Testing"> <level label="a"> <text>The Secretary may deny a permit to an applicant or suspend or revoke an existing permit for failure to comply with the provisions of this subtitle and any regulation adopted under this subtitle.</text> </level> <level label="b"> <text>Except as otherwise provided in the Administrative Procedure Act, before the Secretary takes any action under this section, the Secretary shall give the applicant or permit holder notice and an opportunity for a hearing.</text> </level> </section> <section article="ghg" article_name="Health - General" number="17-510" title_number="17" title_name="Laboratories" subtitle_number="5" subtitle_name="Cholesterol Testing"> <level label="a"> <text>Except as otherwise provided in this title, a person may not offer cholesterol testing in this State unless the person holds a permit from the Secretary.</text> </level> <level label="b"> <text>The permit is not transferable.</text> </level> </section> <section article="ghg" article_name="Health - General" number="17-511" title_number="17" title_name="Laboratories" subtitle_number="5" subtitle_name="Cholesterol Testing"> <text>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.</text> </section> <section article="ghg" article_name="Health - General" number="17-601" title_number="17" title_name="Laboratories" subtitle_number="6" subtitle_name="Biological Agents Registry Program"> <level label="a"> <text>In this subtitle the following words have the meanings indicated.</text> </level> <level label="b"> <text>“Biological agent” means any biological agent as defined in Title 42, Part 73 of the Code of Federal Regulations, or Title 9, Part 121 of the Code of Federal Regulations.</text> </level> <level label="c"> <text>“Maryland Institute for Emergency Medical Services Systems” means the unit described in § 13-503 of the Education Article.</text> </level> <level label="d"> <text>“Person” includes State and federal units of government.</text> </level> <level label="e"> <text>“Program” means the Biological Agents Registry Program.</text> </level> </section> <section article="ghg" article_name="Health - General" number="17-602" title_number="17" title_name="Laboratories" subtitle_number="6" subtitle_name="Biological Agents Registry Program"> <level label="a"> <text>There is a Biological Agents Registry Program in the Department.</text> </level> <level label="b"> <text>The Biological Agents Registry shall:</text> <level label="1"> <text>Identify the biological agents possessed and maintained by any person in this State; and</text> </level> <level label="2"> <text>Contain other information as required by regulations adopted by the Department.</text> </level> </level> <level label="c"> <text>The Department shall adopt regulations for the implementation of the Program that:</text> <level label="1"> <text>Determine and list the biological agents required to be reported under this subtitle;</text> </level> <level label="2"> <text>Designate the persons required to make reports and the specific information required to be reported;</text> </level> <level label="3"> <text>Designate time limits for reporting, the form of reports, and the persons to whom reports are to be submitted;</text> </level> <level label="4"> <text>Require local jurisdictions to be informed of the location and nature of each biological agent in the Registry that is located within the local jurisdiction;</text> </level> <level label="5"> <text>Provide for the release of information in the Biological Agents Registry to:</text> <level label="i"> <text>State and federal law enforcement agencies and the Centers for Disease Control and Prevention pursuant to a communicable disease investigation commenced or conducted by the Department or other State or federal law enforcement agency having investigatory authority, or in connection with any investigation involving release, theft, or loss of biological agents;</text> </level> <level label="ii"> <text>The Maryland Department of Emergency Management and the Maryland Department of the Environment for the purposes of planning for the protection of the public in relation to the release of a biological agent and the prevention of a release of a biological agent; and</text> </level> <level label="iii"> <text>The Maryland Institute for Emergency Medical Services Systems for the purposes of providing certain specified information to:</text> <level label="1"> <text>A police officer, as defined in § 3–201(f) of the Public Safety Article, responding to an emergency; and</text> </level> <level label="2"> <text>A fire, rescue, or emergency medical services entity, as defined in § 7–101 of the Public Safety Article, performing emergency services, responding to a fire or other emergency, or dispatched on a call for emergency services;</text> </level> </level> </level> <level label="6"> <text>Establish a system of safeguards that requires persons possessing, maintaining, and transferring biological agents subject to this subtitle to comply with the same federal standards that apply to persons registered to transfer the same agents under federal law; and</text> </level> <level label="7"> <text>Establish a process for persons that possess and maintain biological agents to alert appropriate authorities of unauthorized possession or attempted possession of biological agents.</text> </level> </level> </section> <section article="ghg" article_name="Health - General" number="17-603" title_number="17" title_name="Laboratories" subtitle_number="6" subtitle_name="Biological Agents Registry Program"> <level label="a"> <text>Except as provided in subsection (b) of this section, any person that possesses and maintains any biological agent shall report to the Department the information required by the Department for inclusion in the Biological Agents Registry.</text> </level> <level label="b"> <text>Subsection (a) of this section does not apply to a biological agent or a certified laboratory or facility that is exempt from the requirements for the interstate shipment of etiologic agents under Title 42, Part 72.6(h) or Part 72, Appendix A of the Code of Federal Regulations.</text> </level> </section> <section article="ghg" article_name="Health - General" number="17-604" title_number="17" title_name="Laboratories" subtitle_number="6" subtitle_name="Biological Agents Registry Program"> <level label="a"> <text>Except as otherwise provided in this subtitle, information prepared for or maintained in the Biological Agents Registry shall be confidential and is not subject to Title 4 of the General Provisions Article.</text> </level> <level label="b"> <text>Release of information from the Registry as authorized by regulations adopted under § 17-602(c) of this subtitle shall not render the information released a public record.</text> </level> <level label="c"> <text>A person or entity to whom specified information has been released from the Registry as authorized by regulations adopted under § 17-602(c) of this subtitle may not release the information unless the release is approved by the Biological Agents Registry Program.</text> </level> </section> <section article="ghg" article_name="Health - General" number="17-605" title_number="17" title_name="Laboratories" subtitle_number="6" subtitle_name="Biological Agents Registry Program"> <level label="a"> <text>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.</text> </level> <level label="b"> <text>Each day a violation is continued after the first conviction is a subsequent offense.</text> </level> </section> <section article="ghg" article_name="Health - General" number="17-701" title_number="17" title_name="Laboratories" subtitle_number="7" subtitle_name="Biosafety Level 3 (bsl–3) Laboratories in Frederick County"> <level label="a"> <text>In this section, “BSL–3 laboratory” means a laboratory designated as a biosafety level 3 (BSL–3) laboratory by the U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Institutes of Health, Biosafety in Microbiological and Biomedical Laboratories, as applicable, based on:</text> <level label="1"> <text>Usage of biological agents that may cause serious or potentially lethal disease after inhalation, ingestion, or absorption; and</text> </level> <level label="2"> <text>Required biocontainment precautions.</text> </level> </level> <level label="b"> <text>This section applies to each BSL–3 laboratory in Frederick County that:</text> <level label="1"> <text>Does not work with federally regulated biological select agents and toxins or their products; and</text> </level> <level label="2"> <level label="i"> <text>Is a commercial or for–profit laboratory;</text> </level> <level label="ii"> <text>Is owned by or is part of a teaching hospital or an institution of postsecondary education; or</text> </level> <level label="iii"> <text>Is a privately funded biomedical research laboratory.</text> </level> </level> </level> <level label="c"> <text>The Department shall develop and make available a standardized form for a BSL–3 laboratory subject to this section to use to provide the information required under subsection (d) of this section.</text> </level> <level label="d"> <text>On or before October 30 each year, each BSL–3 laboratory subject to this section shall report to the Department:</text> <level label="1"> <text>The address of the laboratory;</text> </level> <level label="2"> <text>The name, telephone number, and e–mail address of a contact person for the laboratory; and</text> </level> <level label="3"> <text>Any other information required by the Department to determine the location of the laboratory.</text> </level> </level> <level label="e"> <text>On or before December 31 each year, the Department shall report to:</text> <level label="1"> <text>The Maryland Department of Emergency Management and the health officer and emergency management officials of Frederick County the number and location of BSL–3 laboratories subject to this section; and</text> </level> <level label="2"> <text>The Governor and, in accordance with § 2–1257 of the State Government Article, the General Assembly the total number of BSL–3 laboratories subject to this section.</text> </level> </level> <level label="f"> <level label="1"> <text>Except as provided in paragraph (2) of this subsection and subsection (e) of this section, any information the Department collects from BSL–3 laboratories subject to this section is confidential and not subject to inspection under the Public Information Act.</text> </level> <level label="2"> <text>Any information the Department collects from BSL–3 laboratories subject to this section shall be made available if requested by the BSL–3 laboratory’s insurance carrier or in a legal proceeding.</text> </level> </level> <level label="g"> <level label="1"> <text>Activity of a BSL–3 laboratory subject to this section that fails to report the information required under subsection (d) of this section shall be considered ultrahazardous and abnormally dangerous.</text> </level> <level label="2"> <text>A BSL–3 laboratory subject to this section that fails to report the information required under subsection (d) of this section is strictly liable for damages for any injury, death, or loss to person or property that is caused by the BSL–3 laboratory.</text> </level> </level> </section>