Health - General (GHG) — Title 17. Laboratories

An examination or analysis of a water supply;

An examination or analysis of milk; or

An inquiry that any health officer or physician makes about a communicable disease.

The Fund is a special, nonlapsing fund that is not subject to § 7–302 of the State Finance and Procurement Article.

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.

In this section the following words have the meanings indicated.

“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.

“Public health laboratory” means a laboratory operated by a state government to provide:

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.

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.

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.

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.

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.

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

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.

Offer or perform medical laboratory tests or examinations in this State;

Offer or perform medical laboratory tests or examinations on specimens acquired from health care providers in this State at a medical laboratory located outside this State; or

Represent or service in this State a medical laboratory regardless of the laboratory’s location.

“Medical laboratory” means any facility, entity, or site that offers or performs tests or examinations in connection with the diagnosis and control of human diseases or the assessment of human health, nutritional, or medical conditions or in connection with job-related drug and alcohol testing.

“Medical laboratory” includes any laboratory owned or operated by the State or owned or operated by a county or municipal corporation in the State.

The Secretary shall adopt regulations that set standards and requirements for medical laboratories.

The regulations shall contain the standards and requirements that the Secretary considers necessary to assure the citizens of this State that medical laboratories provide safe and reliable services.

Conduct an inspection of each medical laboratory for which a license to operate is sought; and

Conduct an inspection periodically of each medical laboratory for which a license has been issued.

In addition to the regulations adopted under subsection (a) of this section, the Secretary shall adopt regulations establishing specific standards for medical laboratories engaged in cytology, including regulations that:

The requirements of paragraph (1) of this subsection are in addition to any other relevant provision of this subtitle or relevant regulation adopted in accordance with any other provision of this subtitle governing medical laboratories.

To assure compliance with standards adopted under subsection (c) of this section, the Secretary shall adopt regulations to establish and conduct a cytology proficiency testing program for all cytology personnel that examine gynecological cytology specimens.

All cytology proficiency tests under the State cytology proficiency testing program shall be conducted by an employee of the Maryland Department of Health who shall:

The Secretary shall adopt regulations for the cytology proficiency testing program that:

The Secretary may accept the testing results of an approved cytology proficiency testing program as meeting the cytology proficiency testing requirement of this subtitle.

If the results of a laboratory examination are contained in or will be filed in a medical record, as defined in § 4-301 of this article, the request for a copy of the results shall be made to the facility pursuant to the provisions of § 4-302 of this article.

In all other cases, the medical laboratory may require the individual requesting a copy of the results to pay the prevailing cost of copying and transmitting the copy.

Directors;

Supervisory technologists;

Technologists;

Cytotechnologists; and

Supervisory cytotechnologists.

Offer or perform medical laboratory tests or examinations in this State;

Offer or perform medical laboratory tests or examinations on specimens acquired from health care providers in this State at a medical laboratory located outside this State; or

Represent or service in this State a medical laboratory regardless of the laboratory’s location.

Performs only limited medical laboratory tests or examinations; and

Meets the exception requirements in regulations adopted by the Secretary pursuant to this subtitle.

Is not required to obtain a permit or to obtain a letter of exception from the Secretary under this section to perform testing; but

Is required before performing preliminary screening procedures, as defined under § 17–214(a) of this subtitle, to register with the Secretary in accordance with requirements adopted in regulations by the Maryland Department of Health.

The name of the owner;

The classes of services, complexity of testing, or the tests or examinations that the medical laboratory would provide; and

Any other information that the Secretary requires.

Medical laboratory;

Laboratory director; and

Owner of the laboratory.

Complexity of testing that the laboratory may offer or perform;

Classes of services that may be offered;

Tests or examinations that may be offered or performed by the laboratory; or

Any combination of items (1), (2), and (3) of this subsection.

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.

Define satisfactory proficiency testing performance; and

Set the standards and requirements that a proficiency testing program must meet before it can be designated as an approved program.

In this section the following words have the meanings indicated.

“Alcohol or controlled dangerous substance testing” means a procedure used to determine whether or not a specimen contains a controlled dangerous substance or alcohol.

“Certification” means the approval granted by the Department for a laboratory to engage in job–related alcohol or controlled dangerous substance testing.

“Controlled dangerous substance” has the meaning stated in § 5–101 of the Criminal Law Article.

“Job applicant” means an individual who:

“Job–related” means any alcohol or controlled dangerous substance testing used by an employer for a legitimate business purpose.

“Laboratory” means a facility or other entity that conducts job–related alcohol or controlled dangerous substance testing.

“Medical review officer” means a licensed physician with knowledge of drug abuse disorders and drug and alcohol testing.

“Preliminary screening procedure” means a controlled dangerous substance test that uses a single–use test device that:

“Single–use test device” means the reagent–containing unit of a test system that:

“Specimen” means:

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:

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:

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:

In using a single–use test device, collect, handle, store, and ship each specimen in a manner that:

Maintain a written record of the chain of custody of each specimen from the time that the specimen is collected until the time that the specimen is no longer needed for retesting.

A person who is required to submit to job–related testing, under subsection (b) or (c) of this section, may request independent testing of the same specimen for verification of the test results by a laboratory that:

The person shall pay the cost of an independent test conducted under this subsection.

The Maryland Department of Health:

In addition to any other laboratory standards, the regulations shall:

Alcohol or controlled dangerous substance testing of a person under arrest or held by a law enforcement or correctional agency;

Alcohol testing procedures conducted by a law enforcement or correctional agency on breath testing equipment certified by the toxicologist in the Department of State Police Forensic Sciences Division; or

Controlled dangerous substance testing by a laboratory facility of a law enforcement or correctional agency that maintains laboratory testing standards comparable to the standards in this section.

Except as provided in paragraphs (2) and (3) of this subsection, in the course of obtaining information for, or as a result of, conducting job–related alcohol or controlled dangerous substance testing for an employer under this section, a laboratory, a physician, including a physician retained by the employer, or any other person may not reveal to the employer information regarding:

The prohibitions against disclosure of information under paragraph (1) of this subsection do not apply to the extent that they prevent a person from complying with the applicable provisions of the federal Commercial Motor Vehicle Safety Act of 1986 and the federal Motor Carrier Safety Regulations.

The prohibitions against disclosure of information under paragraph (1) of this subsection do not apply if, prior to the administration of a preliminary screening for controlled dangerous substances, the test operator notifies the applicant that if the preliminary test is positive, the applicant may voluntarily disclose and provide documentation to the operator that the applicant is taking a legally prescribed medication.

An employer using preliminary screening procedures to test job applicants under this section shall have a medical review officer review a positive test result after laboratory confirmation of the positive test result.

The employer may contract for the services of an outside medical review officer if the employer does not have a medical review officer on staff.

An employer using preliminary screening procedures shall establish a program to train individuals to collect specimens and perform controlled dangerous substance tests in the workplace.

The employer may designate an employee or any other individual to be trained, including any individual employed by a medical laboratory designated under subsection (b)(2)(v) of this section who will perform preliminary screening procedures for the employer.

A trainee shall receive appropriate and practical instruction, which includes:

Subject to paragraph (3) of this subsection, a person may directly or indirectly advertise for or solicit business in the State for a diagnostic laboratory test or procedure ordered by a physician and performed by a medical laboratory certified under 42 U.S.C. § 263a.

A person that directly or indirectly advertises for or solicits business in the State for a diagnostic laboratory test or procedure under this subsection:

The Secretary may take legal action to restrict the marketing of a diagnostic laboratory test or procedure if the Secretary determines that:

At least the following representatives appointed biennially from a list of eligibles:

1 representative of the Advanced Medical Technology Association.

“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.

“Forensic analysis” includes an examination or test required by a law enforcement agency, prosecutor, criminal suspect or defendant, or court.

“Forensic analysis” does not include:

“Forensic laboratory” means a facility, entity, or site that offers or performs forensic analysis.

“Forensic laboratory” includes a laboratory owned or operated by the State, a county or municipal corporation in the State, or another governmental entity.

“Forensic laboratory” does not include:

The Secretary shall adopt regulations that set standards and requirements for forensic laboratories.

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.

The regulations shall:

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.

The Secretary shall adopt regulations for the forensic proficiency testing program that:

The Department shall review a forensic laboratory’s proficiency testing program.

An inspection of each forensic laboratory for which a license to operate is sought; and

An inspection of each forensic laboratory for which a license has been issued.

A complaint investigation; and

A validation survey of an accredited forensic laboratory.

Performs only limited forensic analysis; and

Meets the exception requirements in regulations adopted by the Secretary.

The name of the operator or owner;

The tests or examinations that the forensic laboratory would provide; and

Any other information that the Secretary requires.

Forensic laboratory;

Laboratory director; and

Operator or owner of the laboratory.

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:

If a deficiency exists, the Secretary may:

The person or agency that ordered the tests;

The Office of the Public Defender or counsel of record; and

The State’s Attorney.

Failing to promote an individual or to provide another employment–related benefit for which the individual would otherwise be eligible;

Making an adverse evaluation or decision in relation to accreditation, certification, credentialing, or licensing of the individual; or

Taking a personnel action that is adverse to the individual concerned.

Discloses information under subsection (b) of this section; or

Has agreed to cooperate with an investigation of the forensic laboratory.

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.

The Secretary shall distribute the document developed under paragraph (1) of this subsection to forensic laboratories in the State.

Reinstatement;

Reimbursement for lost wages;

Work benefits lost as a result of the unlawful acts of the employing laboratory; and

Reasonable attorney’s fees and costs associated with pursuing the action.

A fine not exceeding $100 for the first offense; and

A fine not exceeding $500 for each subsequent conviction for a violation of the same provision.

The Director of the Laboratories Administration in the Department, or the Director’s designee;

The Director of the Office of Health Care Quality in the Department, or the Director’s designee; and

The following members, appointed by the Governor:

The term of an appointed member is 3 years.

The terms of appointed members are staggered as required by the terms provided for appointed members of the Advisory Committee on October 1, 2007.

To operate a tissue bank in this State; or

To represent or service in this State a tissue bank that is outside this State.

“Tissue bank” means an establishment that obtains, stores, processes, distributes, or sells human blood or other human tissue for use in the human body.

“Tissue bank” includes a blood bank.

The Secretary shall adopt rules and regulations that set standards for tissue banks.

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.

Have an inspection made of each tissue bank for which a permit to operate is sought; and

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.

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

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.

An application for a permit to operate a tissue bank shall include:

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.

The name of the tissue bank;

The name of its director;

The name of its owner; and

The classes of services that the tissue bank may offer.

Offers to provide, with or without charge, a test to detect the amount of cholesterol in an individual’s blood; and

Conducts the test outside a permanently located medical laboratory issued a permit or excepted from a permit under Subtitle 2 of this title.

Offering to provide a test to detect the amount of cholesterol in an individual’s blood; and

Conducting the cholesterol test outside a permanently located medical laboratory issued a permit or excepted from a permit under Subtitle 2 of this title.

Is licensed under Subtitle 2 of this title; and

As set forth in the license, provides tests or services in the discipline of chemistry or health awareness.

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.

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:

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.

Personnel training standards, including requirements for reasonable training, experience, and competency in:

Quality assurance standards;

Standards for counseling and referral procedures;

Standards for releasing and reporting test results; and

A prohibition on the payment of any sum to any person for bringing or referring a patient.

The Secretary may not require that cholesterol testing personnel that conduct cholesterol tests under this subtitle be certified in a medical laboratory specialty.

All cholesterol testing conducted under this subtitle shall be overseen by a supervisor knowledgeable in all aspects of cholesterol testing services.

The name of the permittee;

The address of the permittee; and

The expiration date of the permit.

Identify the biological agents possessed and maintained by any person in this State; and

Contain other information as required by regulations adopted by the Department.

Determine and list the biological agents required to be reported under this subtitle;

Designate the persons required to make reports and the specific information required to be reported;

Designate time limits for reporting, the form of reports, and the persons to whom reports are to be submitted;

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;

Provide for the release of information in the Biological Agents Registry to:

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

Establish a process for persons that possess and maintain biological agents to alert appropriate authorities of unauthorized possession or attempted possession of biological agents.

Usage of biological agents that may cause serious or potentially lethal disease after inhalation, ingestion, or absorption; and

Required biocontainment precautions.

Does not work with federally regulated biological select agents and toxins or their products; and

The address of the laboratory;

The name, telephone number, and e–mail address of a contact person for the laboratory; and

Any other information required by the Department to determine the location of the laboratory.

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

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.

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.

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.

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.

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.