# COMAR Title 10 — Maryland Department of Health

## Subtitle 52 — Preventive Medicine

### Chapter 01 — Opioid-Associated Disease Prevention and Outreach Programs

**Authority:** Health-General Article, §§24-901—24-909, Annotated Code of Maryland

**Administrative History:** Effective date: April 24, 2017 (44:8 Md. R. 404)

#### Regulation .01 Purpose and Scope.

*COMAR 10.52.01.01*

This chapter:

A. Defines an opioid-associated disease prevention and outreach program; and

B. Sets forth:

  (1) The responsibilities of the Maryland Department of Health and local health departments in establishing opioid-associated disease prevention and outreach programs; and

  (2) Requirements for:

    (a) Monitoring and evaluating opioid-associated disease prevention and outreach programs; and

    (b) Research conducted in collaboration with an opioid-associated disease prevention and outreach program.

#### Regulation .02 Definitions.

*COMAR 10.52.01.02*

A. In this chapter, the following terms have the meaning indicated.

B. Terms Defined.

  (1) “Applicant” means a local health department or community-based organization seeking to establish an opioid-associated disease prevention and outreach program.

  (2) Body Fluid.

    (a) “Body fluid” means any fluid containing visible blood, semen, or vaginal secretions.

    (b) “Body fluid” does not include cerebrospinal fluid, synovial fluid, breast milk, amniotic fluid, saliva, stool, nasal secretions, sputum, tears, urine, or vomitus.

  (3) “Community-based organization (CBO)” means a public or private organization that:

    (a) Is representative of a community or significant segments of a community; and

    (b) Provides educational, health, or social services to individuals in the community.

  (4) “Department” means the Maryland Department of Health.

  (5) “Harm reduction education” means education on practical strategies:

    (a) To reduce negative consequences associated with drug use; and

    (b) That reflect specific individual and community needs.

  (6) “HIV” means the human immunodeficiency virus that causes acquired immune deficiency syndrome (AIDS).

  (7) “Infection control” means infection prevention and control measures that ensure the protection of individuals who are vulnerable to acquiring an infection both in the general community and while receiving health care services in a range of settings.

  (8) “Injection supplies” means materials used to inject drugs including, but not limited to:

    (a) Cookers;

    (b) Water; and

    (c) Cotton.

  (9) “Naloxone” means an opioid antagonist indicated for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory or central nervous system depression.

  (10) “OADPO program” means an opioid-associated disease prevention and outreach program established by a local health department or community-based organization that provides services including:

    (a) Dissemination of hypodermic needles or syringes and other preventive means for curtailing the spread of HIV and viral hepatitis;

    (b) Overdose prevention education; and

    (c) Harm reduction education.

  (11) “Participant” means an individual who has registered with an OADPO program.

  (12) “Sexually transmitted infection (STI)” means an infection passed from one person to another person through sexual contact.

  (13) “Viral hepatitis” means inflammation of the liver caused by the hepatitis A, B, C, D, and E viruses.

  (14) “Wound care” means treatment of the symptoms of infections that may result from using drugs.

#### Regulation .03 Program Establishment.

*COMAR 10.52.01.03*

A. Effective October 1, 2016, a local health department or CBO may establish an OADPO program with approval from the:

  (1) Department; and

  (2) Local health officer of the county in which OADPO program operations are proposed.

B. When proposing an OADPO program, a local health department may collaborate with:

  (1) A CBO; or

  (2) Another local health department.

C. A CBO may operate an OADPO program in multiple counties if approved by the local health officer in each county where the OADPO program proposes to operate.

#### Regulation .04 Application Process.

*COMAR 10.52.01.04*

A. An applicant:

  (1) Shall submit an application to establish an OADPO program to the Department that includes:

    (a) Responses to all applicable questions; and

    (b) Any supporting documentation indicated on the application;

  (2) May voluntarily withdraw an application at any time; and

  (3) May submit a new application at any time.

B. The Department shall:

  (1) Distribute the application to establish an OADPO program to the local health officer in each jurisdiction where the OADPO program proposes to operate;

  (2) Request additional information or changes to the application if necessary; and

  (3) Respond in writing to the applicant within 60 calendar days indicating the disposition of the application and explanation of the decision.

C. The Department and the local health officer in each jurisdiction where the OADPO program proposes to operate shall jointly:

  (1) Review the application; and

  (2) Either:

    (a) Approve the application if the:

      (i) Application is complete; and

      (ii) OADPO program meets the requirements of Regulations .05 and .06 of this chapter; or

    (b) Disapprove the application if the:

      (i) Application does not provide sufficient information or documentation on the OADPO program; or

      (ii) OADPO program does not meet the requirements of Regulations .05 and .06 of this chapter.

D. An applicant whose application is disapproved may appeal the decision to the Deputy Secretary for Public Health Services by submitting the request in writing to the Deputy Secretary for Public Health Services within 30 calendar days of the date postmarked on the notice of disapproval.

E. If an applicant submits an appeal, the Deputy Secretary for Public Health Services shall within 60 days:

  (1) Grant or deny the appeal; and

  (2) Respond in writing to the applicant:

    (a) Indicating whether the appeal has been granted or denied; and

    (b) Providing an explanation of the decision.

#### Regulation .05 Program Design and Operation.

*COMAR 10.52.01.05*

A. The CBO or local health department approved to operate an OADPO program:

  (1) Shall provide protocols for the safety and security of OADPO program locations, equipment, and staff in accordance with Regulation .06 of this chapter that:

    (a) Control the dissemination of hypodermic needles and syringes; and

    (b) Allow for a full accounting of the number of hypodermic needles and syringes managed by the program;

  (2) Shall offer participants:

    (a) Overdose prevention education;

    (b) Access to or a referral to obtain naloxone; and

    (c) Harm reduction education;

  (3) Shall ensure that all OADPO program staff have:

    (a) Appropriate levels of expertise in working with individuals who inject drugs;

    (b) Knowledge of harm reduction strategies; and

    (c) Skills in implementing harm reduction strategies;

  (4) Shall ensure that all OADPO program staff receive training approved by the Department to work with injection drug users and to provide referrals to:

    (a) Community services;

    (b) Counseling; and

    (c) Preventative education;

  (5) Shall ensure that all OADPO program staff demonstrate sensitivity to participant differences including:

    (a) Cultural;

    (b) Behavioral; and

    (c) Values;

  (6) Shall ensure that information collected to identify OADPO program participants is kept confidential according to:

    (a) Health-General Article, §24-906(b), Annotated Code of Maryland; and

    (b) 42 CFR Part 2;

  (7) Shall ensure that there is a method of identification and authorization for OADPO program staff members who have access to:

    (a) Hypodermic needles;

    (b) Syringes; and

    (c) OADPO program records;

  (8) Shall develop and provide a protocol for linking participants to:

    (a) Substance abuse treatment services;

    (b) Testing for:

      (i) HIV;

      (ii) Viral hepatitis; and

      (iii) STIs;

    (c) Reproductive health services;

    (d) Wound care; and

    (e) Naloxone;

  (9) Shall disseminate hypodermic needles or syringes and other preventive means for curtailing the spread of HIV and viral hepatitis at no cost to participants, including but not limited to:

    (a) Injection supplies; and

    (b) Safer sex supplies; and

  (10) May not discriminate against participants based on factors including but not limited to:

    (a) Culture;

    (b) Language;

    (c) Ability;

    (d) Socioeconomic status;

    (e) Sexual orientation;

    (f) Gender identity;

    (g) Age;

    (h) Religion;

    (i) Race; and

    (j) Ethnicity.

B. Identification Card. OADPO program staff shall:

  (1) Give each participant an identification card that includes the participant’s OADPO program identification number;

  (2) Advise participants to carry the identification card with them at all times; and

  (3) If the identification card is lost by a participant, re-issue an identification card to the participant.

C. The CBO or local health department approved to operate an OADPO program may offer other services to OADPO program participants, including:

  (1) Testing for:

    (a) HIV;

    (b) Viral hepatitis; and

    (c) STIs;

  (2) Wound care;

  (3) Reproductive health services; and

  (4) Substance abuse counseling, treatment, and recovery services.

#### Regulation .06 Program Security.

*COMAR 10.52.01.06*

A. An OADPO program shall implement protocols for the safety and security of program locations, equipment, and staff.

B. OADPO program staff shall:

  (1) Wear suitable clothing, including closed footwear, at all times;

  (2) Treat all body fluids as potentially infectious and follow infection control protocols at all times including:

    (a) Use of barriers including gloves;

    (b) Immediate washing of hands and other skin surfaces after contact with body fluids; and

    (c) Careful handling and disposal of sharp instruments during and after use;

  (3) When working off-site, have access to a communications system that allows staff to stay in contact with:

    (a) Other staff; and

    (b) Emergency support;

  (4) Obtain consent of the owner or occupier of private property to enter the property to dispense or collect syringes or hypodermic needles; and

  (5) Transport biohazardous waste to the disposal facility using a method that does not put any individuals at risk.

C. OADPO programs shall:

  (1) Have a critical incident procedure that outlines processes and responsibilities of program staff for managing incidents including:

    (a) Participant aggression;

    (b) Threats of violence; and

    (c) Other hazardous situations;

  (2) Have available the following safety equipment during program operations:

    (a) Puncture resistant utility gloves;

    (b) Bleach; and

    (c) Forceps or tongs;

  (3) Have facilities that:

    (a) Have adequate lighting; and

    (b) Are free from clutter; and

  (4) Have a:

    (a) Contract with a licensed biohazardous waste disposal facility to receive biohazardous waste; or

    (b) Written agreement that authorizes the OADPO program to drop off used syringes contained in a locked sharps container for safe disposal with a:

      (i) Hospital;

      (ii) Doctor’s office;

      (iii) Pharmacy;

      (iv) Medical testing facility; or

      (v) Other facility that already receives and safely disposes of hazardous waste.

D. To prevent needlestick injuries, OADPO program participants, staff, volunteers, and any other individuals present at the facility in an occupational capacity shall:

  (1) Receive education on safety protocols for:

    (a) Carrying and handling:

      (i) Syringes;

      (ii) Hypodermic needles; and

      (iii) Other sharps;

    (b) The transport and disposal of biohazardous waste; and

    (c) Infection control;

  (2) Refrain from touching, without safety equipment, used:

    (a) Hypodermic needles;

    (b) Syringes; and

    (c) Injection supplies; and

  (3) Be encouraged to wear clothing at all times that provides protection against needlestick injuries including:

    (a) Long pants; and

    (b) Long-sleeved shirts.

E. Use of Sharps Containers.

  (1) Used hypodermic needles, syringes, and injection supplies collected by the program from participants shall be placed in sharps containers.

  (2) Sharps containers:

    (a) Shall be leak proof;

    (b) Shall be rigid;

    (c) Shall be puncture resistant;

    (d) Shall be labeled as containing sharps;

    (e) Shall be placed on a level, secure surface that is a safe distance between participants and staff or volunteers during syringe exchange transactions; and

    (f) May not be more than 75 percent full.

  (3) Participants shall:

    (a) Place into the sharps container all used:

      (i) Hypodermic needles;

      (ii) Syringes; and

      (iii) Injection supplies;

    (b) When possible, retrieve supplies that fall outside of the sharps container, including:

      (i) Hypodermic needles;

      (ii) Syringes; and

      (iii) Injection supplies; and

    (c) When possible, cover supplies used by the participant including:

      (i) Hypodermic needles;

      (ii) Syringes; and

      (iii) Injection supplies.

F. Needlestick Injuries.

  (1) OADPO programs shall implement protocols for handling needlestick injuries.

  (2) OADPO programs shall designate at least one needlestick manager who shall:

    (a) Assist injured individuals present at the facility including:

      (i) Participants;

      (ii) Staff;

      (iii) Volunteers; and

      (iv) Any other individuals present in an occupational capacity;

    (b) Follow established procedures for accident or incident reporting; and

    (c) Immediately notify the ranking supervisor of any needlestick injuries.

  (3) Participants, staff, volunteers, and any other individuals present at the facility in an occupational capacity shall:

    (a) Report a needlestick injury to the on-site needlestick manager immediately; and

    (b) Visit the emergency room or a private physician within 24 hours of the occurrence.

G. Post-Exposure Management. OADPO programs shall implement protocols for post-exposure management including:

  (1) Testing; and

  (2) Post-exposure prophylaxis.

#### Regulation .07 Monitoring and Evaluation.

*COMAR 10.52.01.07*

A. OADPO programs shall:

  (1) Submit all data for each reporting period on a quarterly basis as required by the Department, including:

    (a) The number of:

      (i) Participants served by the OADPO program;

      (ii) New participants registered by the OADPO program;

    (b) Demographic data of participants served by the OADPO program, including:

      (i) Age;

      (ii) Gender identity;

      (iii) Sexual orientation;

      (iv) Race;

      (v) Ethnicity;

      (vi) Zip code; and

      (vii) Types of drugs the participant reports using;

    (c) The number of hypodermic needles and syringes distributed and collected;

    (d) Each location where hypodermic needles and syringes were distributed; and

    (e) The number of referrals to services provided to participants listed in Health-General Article, §24-903(A)(6), Annotated Code of Maryland, and Regulation .05A(4) of this chapter; and

  (2) Collect data using methods that will not deter participants from utilizing OADPO program services.

B. The Department may conduct site visits to monitor and evaluate an OADPO program.

#### Regulation .08 Research.

*COMAR 10.52.01.08*

A. An individual researcher or institution shall apply for and receive approval from the Department before starting research in collaboration with an OADPO program.

B. The Department shall:

  (1) Review each request; and

  (2) Approve or disapprove the proposed research based on whether the proposed research:

    (a) Advances scientific knowledge or practice related to opioid-associated disease prevention and outreach;

    (b) Has approaches, aims, and methods that will allow the researcher to perform descriptive analyses or test hypotheses;

    (c) Has one or more investigators who have training and experience with the approaches and methods;

    (d) Will impede or interfere with the operations of the OADPO program;

    (e) Is approved by the Department’s Institutional Review Board to ensure that the research will be conducted according to established ethical guidelines for research in the field of opioid-associated disease prevention and outreach; and

    (f) Will keep any data used for the research confidential as required by:

      (i) Health-General Article, §24-906(B), Annotated Code of Maryland;

      (ii) 42 U.S.C. §290dd-2; and

      (iii) 42 CFR Part 2.

#### Regulation .09 Revocation of Approval and Appeals.

*COMAR 10.52.01.09*

A. The Department and the local health officer may revoke the approval of an OADPO program if the OADPO program does not:

  (1) Meet the requirements of Health-General Article, Title 24, Subtitle 9, Annotated Code of Maryland; or

  (2) Operate in accordance with the requirements of Regulations .05 and .06 of this chapter.

B. The Department shall:

  (1) Notify the OADPO program in writing of the revocation of approval; and

  (2) Provide an explanation of the decision.

C. An OADPO program may appeal the decision to revoke approval to the Deputy Secretary for Public Health Services by submitting the request in writing to the Deputy Secretary for Public Health Services within 30 calendar days of the date postmarked on the notice of revocation of approval.

D. If an applicant submits an appeal, the Deputy Secretary for Public Health Services shall within 60 days:

  (1) Grant or deny the appeal; and

  (2) Respond in writing to the applicant:

    (a) Indicating whether the appeal has been granted or denied; and

    (b) Providing an explanation of the decision.

### Chapter 02 — High Blood Pressure Control Services

**Administrative History:** Effective date: April 8, 1985 (12:7 Md. R. 707)

**Administrative History:** Regulation .01A, B amended effective November 20, 1994 (21:23 Md. R. 1934)

**Administrative History:** Regulation .01 repealed effective October 5, 2020 (47:20 Md. R. 875)

### Chapter 03 — Health Education — General Regulations

**Authority:** Health-General Article, §§2-104(b) and 2-105(b), Annotated Code of Maryland

**Administrative History:** Effective date: April 8, 1985 (12:7 Md. R. 707)

**Administrative History:** Regulation .01A, C amended effective June 25, 2012 (39:12 Md. R. 745)

#### Regulation .01 Health Education Services Regulations.

*COMAR 10.52.03.01*

A. Type of Service to Be Provided. Services to be provided are health education services of a general nature for purposes of informing the public about various health issues, promoting health enhancing behaviors, and organizing groups to promote the health enhancing activities of others or to achieve societal and environmental changes conducive to health. These services include but are not limited to the following:

  (1) Planning, conducting, and evaluating a media campaign or a component of a media campaign;

  (2) Planning, conducting, and evaluating an employee or community intervention for a specified behavior change;

  (3) Training health professionals to provide effective education to their clients;

  (4) Distributing existing or newly developed health-related educational materials and resources;

  (5) Organizing and leading a group to find goals and strategies to achieve a health end;

  (6) Implementing population-based health education programs using evidence-based methods and strategies;

  (7) Assessing and analyzing community needs and assets;

  (8) Accessing, interpreting, and disseminating qualitative and quantitative data; and

  (9) Planning, conducting, and evaluating health promotion and education interventions and initiatives.

B. Client Eligibility Standards. All permanent residents of Maryland are eligible to receive services subject to the funding available and limited by the jurisdiction or jurisdictions and target populations specified in a request for proposal.

C. Licensing or Certification Requirements of Professional Service Providers and Facilities as Applicable.

  (1) All organizations, public and private, which are permitted to engage in business in Maryland may be contractors for health education services.

  (2) If candidates seeking health educator positions in State service have similar qualifications, the Maryland Department of Health shall give a hiring preference to those candidates who have Certified Health Education Specialist (CHES) credentials issued by the National Commission for Health Education Credentialing, Inc.

  (3) Vendor requirements for specific programs, if any, will be specified in a request for proposal.

### Chapter 04 — Condom Vending Machines

**Authority:** Health-General Article, §§2-104 and 18-335; Criminal Law Article, §10-104; Annotated Code of Maryland

**Administrative History:** Effective date: November 26, 1990 (17:23 Md. R. 2733)

**Administrative History:** Chapter revised effective January 7, 2002 (28:26 Md. R. 2274)

#### Regulation .01 Scope.

*COMAR 10.52.04.01*

A. This chapter applies to a condom offered for sale or sold by means of a vending machine or other automatic device, and to a vending machine or other automatic device used for selling condoms.

B. This chapter does not apply to a condom sold person-to-person in a business establishment.

#### Regulation .02 Approved Condoms.

*COMAR 10.52.04.02*

A condom that is approved by the U.S. Food and Drug Administration (FDA) as a medical device may be sold or offered for sale by means of a vending machine or other automatic device.

#### Regulation .03 Labeling of Product.

*COMAR 10.52.04.03*

A novelty device which resembles a condom but is not intended for prevention of sexually transmitted diseases or pregnancy and is not FDA approved as a medical device shall be clearly marked: “This item is not intended for prevention of sexually transmitted diseases or pregnancy.”

#### Regulation .04 Labeling of Vending Machine.

*COMAR 10.52.04.04*

A vending machine or other automatic device used for selling condoms shall be labeled with the name, address, and telephone number of the person or firm responsible for stocking the machine with condoms.

### Chapter 05 — Pertussis and Pertussis Vaccine

**Authority:** Health-General Article, §§2-104(b)(1) and 18-332, Annotated Code of Maryland

**Administrative History:** Effective date: May 19, 1986 (13:10 Md. R. 1156)

**Administrative History:** Regulation .04 amended effective August 10, 2009 (36:16 Md. R. 1251)

#### Regulation .01 Definitions.

*COMAR 10.52.05.01*

A. “Department” means the Maryland Department of Health.

B. “Health care provider” means any licensed health care professional, organization, or institution, whether public or private, under whose authority pertussis vaccine is administered.

C. “Major adverse reaction” means any:

  (1) Serious illness, disability, or impairment of mental, emotional, behavioral, or physical functioning or development, the first manifestation of which appears within 7 days after the date of administration of pertussis vaccine and for which there is reasonable scientific or medical evidence pertussis vaccine causes, or significantly contributes to, the effect; and

  (2) Other reaction which the Department, after consultation with the Medical and Chirurgical Faculty of Maryland, determines is a basis for not continuing with pertussis vaccine administration.

D. “Patient” means the individual to whom pertussis vaccine is being administered.

E. “Pertussis vaccine” means any vaccine that contains materials intended to prevent the occurrence of pertussis, whether the materials are administered separately or in conjunction with other materials intended to prevent the occurrence of other diseases.

#### Regulation .02 Requirements for Health Care Providers.

*COMAR 10.52.05.02*

A. Before the administration of pertussis vaccine, the health care provider shall provide to the patient's parent or guardian written information addressing:

  (1) The frequency, severity, and potential long-term effects of pertussis;

  (2) Possible adverse reactions to pertussis vaccine, which, if they occur, should be brought to the immediate attention of the health care provider;

  (3) A form that lists symptoms of possible pertussis vaccine adverse reactions to be monitored and which contains places where information can be recorded to assist in reporting to the health care provider, local health officer, and the Department;

  (4) Measures parents should take to reduce the risk of, or to respond to, any major adverse reaction to pertussis vaccine;

  (5) Early warning signs or symptoms to which parents should be alert as possible precursors to a major adverse reaction to pertussis vaccine;

  (6) When and to whom parents should report any major adverse reactions to pertussis vaccine;

  (7) A summary of the immunization requirements adopted under Education Article, §7-402(a), Annotated Code of Maryland, including those related to pertussis vaccine;

  (8) The circumstances under which pertussis vaccine may not be administered;

  (9) The circumstances under which administration of pertussis vaccine shall be delayed; and

  (10) Categories of potential recipients who are significantly more vulnerable to major adverse reactions to pertussis vaccine than is the general population.

B. Before the administration of pertussis vaccine, the health care provider shall, by appropriate inquiries, attempt to elicit the information necessary to determine, based on a physician's medical judgement whether:

  (1) Pertussis vaccine should not be administered to the patient;

  (2) Administration of pertussis vaccine should be delayed; or

  (3) The risk to the potential recipient of the vaccine outweighs the benefits both to the potential recipient and to the public in administering the vaccine.

C. The circumstances under which the administration of pertussis vaccine shall be delayed or may not occur are established by the Immunization Practices Advisory Committee (ACIP) to the Public Health Service. The Department will notify all health care providers of these circumstances.

D. A physician who determines, pursuant to §B, of this regulation, that the administration of the pertussis vaccine to a patient shall be delayed or may not occur shall submit to the local health officer the name, address, date of birth, and the basis for the determination for each patient.

E. Pertussis vaccine should not be given if in the physician's medical judgment, taking into account any categories of potential recipients who are significantly more vulnerable to major adverse reactions than is the general population, as well as all other relevant information, the risk to the potential recipient outweighs the benefits both to the potential recipient and the public in administering the vaccine.

F. At the time of administration of pertussis vaccine to a patient, the health care provider shall record in a permanent record to which the patient's parent or guardian shall have access upon request:

  (1) The date each dose of pertussis vaccine is administered;

  (2) The manufacturer and lot number of the vaccine used for each;

  (3) Other identifying information on the vaccine used; and

  (4) The name and title of the health care provider who authorized the vaccine to be administered and the one who administered it.

G. A health care provider who has administered the pertussis vaccine to a patient and who has been informed by the parent or guardian of the patient, or has reason to believe that the patient has had a major adverse reaction to pertussis vaccine, shall within 24 hours of receipt of that knowledge:

  (1) Record to the extent of his knowledge all relevant information in the patient's permanent medical record; and

  (2) Report information, including the manufacturer's name, date of administration, type and lot number of the vaccine, a brief description of the reaction, and other specified information on a morbidity report card, to the local health officer. These reports can also be made by telephone.

#### Regulation .03 Requirements of Local Health Officers.

*COMAR 10.52.05.03*

A. Upon receipt of notification of a major adverse reaction to a pertussis vaccine, the local health officer shall:

  (1) Notify and forward the morbidity report card to the Department within 24 hours; and

  (2) Assure that the necessary information to fill out a “Report of Adverse Event Following Immunization” is obtained.

B. At the time of completion, the report shall be submitted to the Department.

#### Regulation .04 Requirements of the Department.

*COMAR 10.52.05.04*

A. Whenever a resident birth occurs, the Department shall promptly provide parents of the newborn child with information included in Regulation .02A(1)—(10) of this chapter.

B. The Department shall prescribe the form and content of the information about immunizations provided to parents at times of birth and of administration of pertussis vaccine, according to Regulation .02A(1)—(10) of this chapter.

C. Upon receipt of information regarding a major adverse reaction to a pertussis vaccine, the Department shall immediately notify the vaccine manufacturer of the following:

  (1) Date of immunization;

  (2) Lot number of vaccine; and

  (3) Type of reaction.

D. The Department shall establish a system to collect data from local health officers, from public and private health care providers, and from parents, on the incidence of pertussis and major adverse reactions to pertussis vaccine. This system shall be organized so that periodic revisions and updates of information and guidelines may be made. In addition, the information collected shall be sufficient for any reports required by the Department on pertussis and major adverse reactions to pertussis vaccine.

E. On the basis of the data collected and of any other information available, the Department shall periodically revise and update:

  (1) The information provided to parents at the times of birth and of administration of pertussis vaccine;

  (2) The information provided to health care providers regarding pertussis immunization deferral or exemption, and all other information otherwise regarding risks and benefits to the patient and to the public; and

  (3) Other pertinent information on pertussis and pertussis vaccine

F. The Department shall report to the Centers for Disease Control (CDC) the incidence of pertussis and major adverse reactions to pertussis vaccine.

G. The Department shall notify by mail or other means, or both, all health care providers of their responsibilities relevant to these regulations as well as other appropriate materials (for example, ACIP recommendations, parent information pamphlets, and morbidity report cards). Revisions of these and new materials shall also be distributed in the same manner.

#### Regulation .05 General.

*COMAR 10.52.05.05*

Nothing in these regulations shall be construed to affect any emergency authority of the Secretary of Health and under any other provision of law to protect the public health.

### Chapter 06 — Use of Tanning Devices by Minors

**Authority:** Health-General Article, §20-106, Annotated Code of Maryland

**Administrative History:** Effective date: June 29, 2009 (36:13 Md. R. 900)

**Administrative History:** Regulation .12B amended effective March 14, 2016 (43:5 Md. R. 385)

**Administrative History:** Chapter revised effective October 5, 2020 (47:20 Md. R. 875)

#### Regulation .01 Scope.

*COMAR 10.52.06.01*

A. This chapter establishes regulations on the use of tanning devices by minors.

B. Nothing in this chapter preempts a county or municipal government from enacting and enforcing more stringent measures to regulate the use of tanning devices by minors.

#### Regulation .02 Definitions.

*COMAR 10.52.06.02*

A. In this chapter, the following terms have the meanings indicated.

B. Terms Defined.

  (1) “Customer” means a member of the public who is provided access to a tanning device in exchange for a fee, membership dues, or other compensation.

  (2) “Department” means the Maryland Department of Health.

  (3) “Health officer” means the health officer of each of the 23 counties in Maryland and the Commissioner of Health in Baltimore City, the duly designated representative of the health officer, or both.

  (4) “Minor” means an individual younger than 18 years old.

  (5) “Owner” means an individual or entity having an ownership interest in a tanning facility.

  (6) “Person-in-charge” means an owner, operator, manager, employee, or other individual who controls, governs, or directs the activities of a tanning facility and is present on site.

  (7) “Phototherapy device” means any equipment that emits ultraviolet radiation and is used in the diagnosis or treatment of disease or injury.

  (8) “Radiation” means ultraviolet radiation.

  (9) “Secretary” means the Secretary of Health or the Secretary's designee.

  (10) “Tanning device” means any equipment that emits radiation used for tanning of the skin, including sunlamps, tanning booths, or tanning beds.

  (11) “Tanning facility” means any place where a tanning device is used for a fee, membership dues, or other compensation.

#### Regulation .03 Exclusions.

*COMAR 10.52.06.03*

This chapter does not apply to the use of any phototherapy device by a health care practitioner acting within the scope of the license of the health care practitioner or by order of a health care practitioner acting within the scope of the license of the health care practitioner.

#### Regulation .04 Verification of Age.

*COMAR 10.52.06.04*

A person-in-charge may not allow a customer to use a tanning device at a tanning facility without confirmation, with a State or federal government-issued identification card, that the individual is not a minor.

#### Regulation .05 Posting of Notices.

*COMAR 10.52.06.05*

A. A tanning facility shall display conspicuously a notice that conforms to the requirements of §B of this regulation.

B. The notice shall state:

  (1) That it is unlawful for a tanning facility owner, employee, or operator to allow a minor to use any tanning device;

  (2) That a tanning facility owner, employee, or operator that violates one or more provisions of this section may be subject to a civil penalty;

  (3) The health risks associated with tanning, including skin cancer, premature skin aging, injuries including burns, and adverse reactions when combined with certain medications, foods, and cosmetics; and

  (4) That an individual may report a violation of one or more provisions of this chapter to the local law enforcement agency or local health department.

C. The notice shall be:

  (1) Readily visible and at least 18-point type font; and

  (2) Made available to a tanning facility by the Department on the Department’s website.

D. The owner or person-in-charge shall ensure that the notice required under this regulation is conspicuously posted and in good condition.

#### Regulation .06 Complaints and Investigations.

*COMAR 10.52.06.06*

A. A person or law enforcement officer may report a violation of this chapter to the health officer in the jurisdiction where the alleged violation took place.

B. The Department shall make available a complaint form at the Department's website and at a local health department.

C. Upon receipt of a complaint, the health officer shall investigate the complaint.

#### Regulation .07 Enforcement.

*COMAR 10.52.06.07*

A. A health officer may investigate conditions relative to the enforcement of this chapter.

B. The person-in-charge of a tanning facility shall permit a health officer to enter the tanning facility during business hours for the purpose of determining compliance with this chapter.

C. If an investigation is made, the health officer shall:

  (1) Document:

    (a) The result of the investigation on a report form provided by the Department; and

    (b) A condition found that is in violation of a provision of this chapter;

  (2) Furnish one copy of the report form to the person-in-charge of the tanning facility; and

  (3) Make the completed report form available for public disclosure in accordance with the Maryland Public Information Act, State Government Article, §§10-611—10-628, Annotated Code of Maryland.

#### Regulation .08 Violations and Certification of Correction.

*COMAR 10.52.06.08*

A. The health officer shall provide the owner of a tanning facility found in violation of a provision of this chapter or Health-General Article, §20-106, Annotated Code of Maryland, with a written notice that contains:

  (1) The specific finding and, if applicable, the penalty for the violation, as set forth in Regulation .09 of this chapter;

  (2) A specific date by which the owner shall correct the violation;

  (3) A provision that, if the owner fails to correct the violation by the date specified or is in violation of another provision of Health-General Article, §20-106, Annotated Code of Maryland, at another time, the Secretary may impose a subsequent penalty, if applicable, as set forth in Regulation .09 of this chapter; and

  (4) A provision that the owner is entitled to request a hearing under Regulation .10 of this chapter on a violation with a penalty.

B. The owner of a tanning facility shall submit to the health officer a written certification of correction within a time frame provided by the local health department that states:

  (1) The violation; and

  (2) How the violation was corrected.

#### Regulation .09 Penalties.

*COMAR 10.52.06.09*

The penalties for a violation of Regulation .04 or .05 of this chapter, or of Health-General Article, §20-106, Annotated Code of Maryland, are:

A. A letter of reprimand for the first violation;

B. A civil penalty of $250 for a second violation;

C. A civil penalty of $500 for a third violation; and

D. A civil penalty of $1,000 for each subsequent violation.

#### Regulation .10 Request for Hearing.

*COMAR 10.52.06.10*

A. A person who receives a notice of violation with a penalty for a violation of Regulation .04, .05C, D, or E, or .06 of this chapter, or of Health-General Article, §20-106, Annotated Code of Maryland, may request a hearing on the notice of violation with a penalty.

B. In order to preserve a right to a hearing on a violation with a penalty under this chapter, if a hearing is desired, a person shall submit a written request to the Department’s Environmental Health Bureau under the Prevention and Health Promotion Administration for a hearing within 10 days of receipt of the notice of violation with a penalty.

C. In accordance with the Administrative Procedure Act, State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland, the Secretary shall provide for a hearing on the violation with a penalty by referring the matter to the Office of Administrative Hearings.

D. The Office of Administrative Hearings shall:

  (1) Schedule and conduct the hearing on the violation with a penalty; and

  (2) Render a decision and notify the parties of the decision within 90 days after the hearing.

### Chapter 07 — State Advisory Council on Health and Wellness

**Authority:** Health-General Article, §§13-201—13-206, Annotated Code of Maryland

**Administrative History:** Effective date: January 29, 2018 (45:2 Md. R. 69)

#### Regulation .01 Definitions.

*COMAR 10.52.07.01*

A. In this chapter, the following terms have the meanings indicated.

B. Terms Defined.

  (1) “Chronic disease” means a noncommunicable condition that is a major cause of sickness or disability, including, but not limited to:

    (a) Heart disease;

    (b) Cancer;

    (c) Arthritis; and

    (d) Diabetes.

  (2) “Council” means the State Advisory Council on Health and Wellness established by Health-General Article, §13-202, Annotated Code of Maryland.

  (3) “Evidence-based program” means a program that:

    (a) Engages the community in assessment and decision making;

    (b) Uses data and information systems to inform program activities;

    (c) Is based on peer-reviewed evidence;

    (d) Uses program-planning frame works;

    (e) Conducts evaluation; and

    (f) Disseminates the results of the evaluation.

  (4) “Healthy lifestyle” means behaviors that promote wellness and prevent disease including, but not limited to:

    (a) Maintaining a healthy weight;

    (b) Engaging in regular physical activity;

    (c) Refraining from smoking;

    (d) Limiting consumption of alcohol;

    (e) Reducing stress; and

    (f) Getting sufficient sleep.

  (5) “Quorum” means a majority of the full membership of the Council or of a committee.

  (6) “Secretary” means the Secretary of Health.

#### Regulation .02 Membership.

*COMAR 10.52.07.02*

A. The Council shall consist of 34 members appointed by the Secretary according to Health-General Article, §13-203, Annotated Code of Maryland.

B. A member shall:

  (1) Be a Maryland resident; or

  (2) If a qualified Maryland resident is not available to be appointed to a Council position, possess special knowledge or training required for the Council position to which they are appointed.

C. A member that is subject to term limits:

  (1) Shall serve a 4-year term;

  (2) May serve two consecutive full terms;

  (3) At the end of a term, shall continue to serve until a successor is appointed and qualifies;

  (4) If appointed after a term has begun, shall only serve for the rest of the term and until a successor is appointed and qualifies; and

  (5) May not be reappointed to the Council for 4 years after serving two consecutive full terms.

D. Members shall serve on at least one committee.

E. The Council Chair shall:

  (1) Be appointed by the Secretary;

  (2) Serve a 2-year term;

  (3) Be allowed to serve two consecutive terms; and

  (4) Appoint the Chairs of the committees.

#### Regulation .03 Committees.

*COMAR 10.52.07.03*

A. The Council shall have the following four committees:

  (1) Arthritis;

  (2) Diabetes;

  (3) Heart Disease and Stroke; and

  (4) Physical Fitness.

B. The Council may create:

  (1) Additional committees to organize the Council’s work; and

  (2) Temporary ad hoc committees to accomplish a specific task.

C. Except for the committees created according to §A of this regulation, the Council may dissolve a committee at any time.

#### Regulation .04 Council Duties.

*COMAR 10.52.07.04*

A. The Council shall:

  (1) Provide guidance to the Secretary on Statewide chronic disease prevention and control;

  (2) Direct the priorities and work of the committees; and

  (3) Promote evidence-based programs for:

    (a) Healthy lifestyles; and

    (b) The prevention, early detection, and treatment of chronic disease.

B. The Council shall submit a report of its activities to the Secretary on or before December 31, 2019 and every 2 years thereafter.

#### Regulation .05 Meetings and Procedures.

*COMAR 10.52.07.05*

A. Meeting Frequency.

  (1) The Council shall meet at least two times per year.

  (2) A committee created by Regulation .03A of this chapter shall meet at least four times per year.

B. Quorum.

  (1) A quorum shall be present to conduct a Council or committee vote.

  (2) If a quorum is not present:

    (a) A meeting may still be held; and

    (b) An activity requiring a vote shall be deferred to the next meeting with a quorum present.

C. Voting.

  (1) A member shall have one vote.

  (2) Voting shall be:

    (a) In person; or

    (b) By phone.

D. Attendance.

  (1) A member shall attend at least:

    (a) 50 percent of the Council meetings per year; and

    (b) 75 percent of the meetings of a committee on which the member serves per year.

  (2) The Council shall ensure that attendance is:

    (a) Recorded in the meeting minutes; and

    (b) Submitted to the Secretary at least once per year.

  (3) The Secretary may remove a member for:

    (a) Neglect of duty;

    (b) Incompetence;

    (c) Misconduct;

    (d) Malfeasance;

    (e) Misfeasance in office; or

    (f) Failing to meet the requirements of §D(1) of this regulation.

### Chapter 08 — Maryland HIV Prevention Case Management Program

**Authority:** : Health-General Article, §24-1801, Annotated Code of Maryland

**Administrative History:** Effective date: May 20, 2019 (46:10 Md. R. 490)

**Administrative History:** Regulations .01—.16 under Maryland HIV Prevention Case Management Program repealed and new Regulations .01—.05 under Maryland AIDS Drug Assistance Program Fund adopted effective December 25, 2023 (50:25 Md. R. 1088)

#### Regulation .01 Scope and Purpose.

*COMAR 10.52.08.01*

This chapter:

A. Defines the Maryland AIDS Drug Assistance Program Fund;

B. Sets forth the responsibilities of the Maryland Department of Health with respect to the Maryland AIDS Drug Assistance Program Fund; and

C. Establishes eligibility criteria for receipt of HIV prevention and care services from the Fund.

#### Regulation .02 Definitions.

*COMAR 10.52.08.02*

A. In this chapter, the following terms have the meanings indicated.

B. Terms Defined.

  (1) “Acquired immunodeficiency syndrome (AIDS)” means the medical condition caused by the human immunodeficiency virus.

  (2) “Department” means the Maryland Department of Health.

  (3) “Fund” means the Maryland AIDS Assistance Program Fund.

  (4) “Human immunodeficiency virus (HIV)” means the virus that causes AIDS.

  (5) “Ryan White HIV/AIDS Program (RWHAP)” means the federal HIV/AIDS initiative administered by the U.S. Department of Health and Human Services (HHS), Health Resources and Services Administration (HRSA), HIV/AIDS Bureau (HAB).

#### Regulation .03 Maryland AIDS Drug Assistance Program Fund.

*COMAR 10.52.08.03*

A. The Maryland AIDS Drug Assistance Program Fund is a nonlapsing, special fund created by Health-General Article, §24-1801, Annotated Code of Maryland, for HIV treatment and care, which is generated from:

  (1) The 340B Drug Pricing Program and any supplemental rebate dollars; and

  (2) Interest earned on the balance of the Fund.

B. The Department may only expend funds in accordance with Title 26 of the Public Health Service Act governing the allowable uses of RWHAP funds or to meet State-identified HIV priorities.

C. The Department may make grant awards under the Fund.

D. Any unspent portions of the Fund shall remain in the Fund and may not revert to the General Fund of the State.

E. Money expended from the Fund is additive to, and is not intended to take the place of, funding that would otherwise be appropriated to the Department for HIV:

  (1) Surveillance;

  (2) Prevention;

  (3) Treatment; or

  (4) Care.

#### Regulation .04 Responsibilities of the Department.

*COMAR 10.52.08.04*

The Department:

A. Shall administer the Fund; and

B. May spend the Fund on statutorily permitted purposes under the RWHAP or State-identified HIV priorities.

#### Regulation .05 Eligibility Criteria.

*COMAR 10.52.08.05*

A. The Fund shall be the reasonable payor of last resort for receipt of HIV prevention and care services; and

B. Eligible individuals shall have exhausted all other potential payors, including but not limited to:

  (1) Third-party insurance;

  (2) Medicaid; and

  (3) Medicare.

### Chapter 09 — HIV/CD4+ Lymphocyte Count Reporting by Unique Patient Identifying Number

*Repealed*

**Administrative History:** Effective date: June 1, 1994 (21:8 Md. R. 674)

**Administrative History:** Regulation .01C amended effective April 21, 1997 (24:8 Md. R. 616)

**Administrative History:** Regulation .01-1 adopted effective April 21, 1997 (24:8 Md. R. 616)

**Administrative History:** Regulation .02B amended effective April 21, 1997 (24:8 Md. R. 616)

**Administrative History:** Regulation .03A amended as an emergency provision effective June 16, 1998 (25:14 Md. R. 1128); amended permanently effective September 21, 1998 (25:19 Md. R. 1496)

**Administrative History:** Chapter repealed effective February 18, 2002 (29:3 Md. R. 220)

### Chapter 10 — HIV and Hepatitis C Testing of Persons Accused or Convicted, or Both, of Certain Crimes

**Authority:** Criminal Procedure Article §§11-107—11-117, Annotated Code of Maryland

**Administrative History:** Effective date: December 20, 1993 (20:25 Md. R. 1948)

**Administrative History:** Regulation .01 amended effective May 7, 2018 (45:9 Md. R. 462)

**Administrative History:** Regulation .02B amended effective May 7, 2018 (45:9 Md. R. 462)

**Administrative History:** Regulation .03A, E amended effective May 7, 2018 (45:9 Md. R. 462)

**Administrative History:** Regulation .05 amended effective May 7, 2018 (45:9 Md. R. 462)

**Administrative History:** Regulation .06 amended effective May 7, 2018 (45:9 Md. R. 462)

**Administrative History:** Regulation .07 amended effective May 7, 2018 (45:9 Md. R. 462)

#### Regulation .01 Scope.

*COMAR 10.52.10.01*

This chapter establishes procedures for HIV and hepatitis C testing ordered under the provisions of Criminal Procedure Article, §§11-107—11-117, Annotated Code of Maryland.

#### Regulation .02 Definitions.

*COMAR 10.52.10.02*

A. In this chapter, the following terms have the meanings indicated.

B. Terms Defined.

  (1) “County” means Baltimore City or a Maryland county.

  (2) “Department” means the Maryland Department of Health.

  (3) Exposure.

    (a) “Exposure” means one of the following:

      (i) Percutaneous contact of a victim with blood or body fluids of an offender;

      (ii) Mucocutaneous contact of a victim with blood or body fluids of an offender;

      (iii) Open wound, including dermatitis, exudative lesions, or chapped skin, contact of a victim with blood or body fluids of an offender for a prolonged period; or

      (iv) Intact skin contact of a victim with large amounts of blood or body fluids of an offender for a prolonged period.

    (b) “Exposure” includes a prohibited exposure as defined by Criminal Procedure Article, §11-107(e), Annotated Code of Maryland.

  (4) “Health officer” means the Baltimore City Commissioner of Health or the health officer of a county.

  (5) “HIV” means a human immunodeficiency virus that causes acquired immune deficiency syndrome.

  (6) “Intact skin contact of a victim with large amounts of blood or body fluids of an offender for a prolonged period” means that a large volume of blood or bloody body fluid of an offender has been in direct contact with unbroken skin of a victim for at least 60 minutes.

  (7) “Local health department” means the official public health agency in Baltimore City or a Maryland county.

  (8) “Mucocutaneous contact of a victim with blood or body fluids of an offender” means that blood or bloody body fluid of an offender has splashed into the eye, mouth, or nose of a victim.

  (9) “Offender” means one of the following:

    (a) An individual convicted of an offense and ordered by a court to furnish a sample to be tested for the presence of HIV or hepatitis C under Criminal Procedure Article, §§11-107—11-117, Annotated Code of Maryland;

    (b) An individual being granted probation before judgment and ordered by a court to furnish a sample to be tested for the presence of HIV or hepatitis C under Criminal Procedure Article, §§11-107—11-117, Annotated Code of Maryland; or

    (c) An individual charged with an offense and ordered by a court to furnish a sample to be tested for the presence of HIV or hepatitis C under Criminal Procedure Article, §§11-107—11-117, Annotated Code of Maryland.

  (10) “Offense” means any criminal offense or delinquent act the commission of which may have caused or resulted in an exposure.

  (11) “Open wound contact of a victim with blood or body fluids of an offender for a prolonged period” means that blood or bloody body fluid of an offender has contacted an already existing open wound, sore, or chapped or non-intact skin of a victim for at least 5 minutes.

  (12) “Percutaneous contact of a victim with blood or body fluids of an offender” means that a sharp object has penetrated the skin of a victim and allowed the blood or bloody body fluid of an offender to enter the victim's body.

  (13) Residence.

    (a) “Residence” means the location where an individual normally resides.

    (b) “Residence” includes a facility where an offender is incarcerated, operated by the Department of Public Safety and Correctional Services or a Maryland county.

  (14) “Secretary” means the Secretary of Health.

  (15) Victim.

    (a) “Victim” means an individual, other than the offender, injured during the commission of an offense.

    (b) “Victim” includes the:

      (i) Parent of a victim who is a minor;

      (ii) Legal guardian of a victim;

      (iii) Individual authorized to give surrogate consent for the victim under Health-General Article, §5-605, Annotated Code of Maryland; and

      (iv) Victim as defined by Criminal Procedure Article, §11-107(f), Annotated Code of Maryland.

#### Regulation .03 Notice.

*COMAR 10.52.10.03*

A. The health officer shall require receipt of a written notice and a copy of a court order for testing from a State’s Attorney before initiating the process of HIV or hepatitis C testing and notification described in this chapter.

B. The State's Attorney shall include all of the following in the written notice:

  (1) The name of the offender to be tested;

  (2) The address of the offender's residence;

  (3) The name of the victim who has requested information; and

  (4) The address of the victim's residence.

C. If the current residence of the offender is outside of the county or counties served by the health officer who receives the notification described in §A of this regulation, the health officer shall:

  (1) Send a copy of the written notice and a copy of the court order for testing to the health officer of the county in which the offender resides; and

  (2) Request the assistance of the health officer of the county in which the offender resides in carrying out the requirements of this chapter.

D. If the current residence of the victim is in Maryland but outside of the county or counties served by the health officer who receives the notification described in §A of this regulation, the health officer shall:

  (1) Send a copy of the written notice and a copy of the court order for testing to the health officer of the county where the victim resides; and

  (2) Request assistance with carrying out the requirements of this chapter.

E. If the current residence of the victim is outside of Maryland, the health officer who receives the notification described in §A of this regulation shall send a letter to:

  (1) The state health department of the state in which the victim resides, requesting assistance with providing appropriate services to the victim; and

  (2) The victim, explaining that the victim may do one of the following to obtain information about the offender’s HIV or hepatitis C test result:

    (a) Contact the state health department in the state where the victim resides; or

    (b) Contact the local health department notified under §A of this regulation.

#### Regulation .04 Responsibility.

*COMAR 10.52.10.04*

A. The health officer of the county in which the offender currently resides shall assume responsibility for carrying out the activities described in Regulation .05 of this chapter.

B. The health officer of the county in which the victim currently resides shall assume responsibility for carrying out the activities described in Regulation .06 of this chapter.

C. If the current residence of the victim is outside of Maryland, the health officer notified under Regulation .03A of this chapter shall assume responsibility for carrying out the activities described in Regulation .06 of this chapter.

#### Regulation .05 Testing of Offender.

*COMAR 10.52.10.05*

A. HIV and Hepatitis C Testing.

  (1) Specimen Collection.

    (a) A specimen shall be collected from an offender following the methods described in the specifications for the blood or oral fluid test used.

    (b) The local health department shall provide guidance on how specimens shall be collected.

  (2) If the offender is incarcerated in a facility under the jurisdiction of the Department of Public Safety and Correctional Services, HIV and hepatitis C testing of the offender may be performed by an employee or contractor of either the:

    (a) Local health department; or

    (b) Department of Public Safety and Correctional Services.

  (3) If the offender is incarcerated in a facility under the jurisdiction of the county, HIV and hepatitis C testing may be performed by an employee or contractor of either the:

    (a) Local health department; or

    (b) County.

  (4) If the offender is not incarcerated, an employee or contractor of the local health department shall perform HIV and hepatitis C testing of the offender.

B. The health officer shall send a certified letter, accompanied by a copy of the court order for testing, to each offender who is not incarcerated, to notify the offender of all of the following:

  (1) That the health officer has been instructed by the court to perform an HIV or hepatitis C test on the offender; and

  (2) That the offender has been scheduled for a test at a specified date, time, and place.

C. The health officer or designee shall do all of the following:

  (1) Conduct a face-to-face discussion with the offender before a sample is collected for an HIV or hepatitis C test;

  (2) Include all of the topics described in COMAR 10.18.08.06 regarding the offender’s HIV test in the discussion; and

  (3) Sign a form indicating that the health officer or designee offered information to the offender on the HIV or hepatitis C test.

D. Blood Drawing and Testing.

  (1) The health officer may not use the result of a previous HIV or hepatitis C test instead of conducting an HIV or hepatitis C test required under the provisions of Criminal Procedure Article, §§11-107—11-117, Annotated Code of Maryland.

  (2) The health officer may not use a sample taken for another purpose instead of obtaining a sample in order to conduct an HIV or hepatitis C test required under Criminal Procedure Article, §§11-107—11-117, Annotated Code of Maryland.

  (3) The health officer or designee shall:

    (a) Obtain a sample from the offender;

    (b) Put the code “RP” on the blood sample and the test order; and

    (c) Send the sample to the Laboratories Administration within the Department for an HIV or hepatitis C test.

E. Upon receipt of the test result of the offender, the health officer or designee shall:

  (1) Discuss the result with the offender; or

  (2) Transmit the test result to the individual designated by the health officer to provide post-test information, including the topics listed in COMAR 10.18.08 that are applicable to the HIV test result.

F. Charges. The local health department shall charge the offender for the expenses incurred in carrying out the responsibilities outlined in this regulation if the court has ordered the defendant to make restitution for expenses incurred by the Department under Criminal Procedure Article, §§11-107—11-117, Annotated Code of Maryland.

G. State’s Attorney Notification. The health officer shall notify the State’s Attorney who transmitted the victim’s request for an HIV or hepatitis C test when one or more of the following actions occurs:

  (1) HIV or hepatitis C testing of an offender, including pretest and post-test information, is completed;

  (2) An offender refuses to allow a sample to be taken for testing;

  (3) An offender ordered by the court to make restitution for expenses incurred by the Department refuses to pay the required amount; or

  (4) An offender who is not incarcerated fails to appear for HIV or hepatitis C testing.

#### Regulation .06 Information for the Victim.

*COMAR 10.52.10.06*

A. The health officer or designee shall provide the victim with information addressing all of the following:

  (1) An explanation of HIV, AIDS, and hepatitis C;

  (2) An explanation of the risks of HIV and hepatitis C transmission in the course of a sexual or other offense;

  (3) The advisability of HIV and hepatitis C testing of the victim;

  (4) The advisability of the victim taking precautions to prevent the spread of HIV and hepatitis C until it is certain that the victim is not infected;

  (5) The advisability of the victim starting post-exposure prophylaxis prior to receiving test results; and

  (6) The HIV and hepatitis C test result of the offender.

B. If the HIV or hepatitis C test result of the offender is positive, the health officer or designee shall offer, provide, or arrange for appropriate HIV or hepatitis C services, including referral for appropriate health care and support services, for the victim.

C. If the HIV test result of the offender is indeterminate, the health officer or designee of the health officer shall inform the victim about the advisability of requesting the court to order a second HIV test 8 to 12 weeks after the first test to determine whether the test result has changed.

D. The health officer or designee shall inform the victim about the requirements for confidentiality of information relating to the HIV or hepatitis C test result of the offender, as specified in Regulation .07C and D of this chapter.

#### Regulation .07 Confidentiality.

*COMAR 10.52.10.07*

A. Local Health Department Records. The local health department shall maintain separate confidential records of information and test results given to an offender required under the provisions of Criminal Procedure Article, §§11-107—11-117, Annotated Code of Maryland.

B. Disclosure by Health Officer or Designee.

  (1) Except as provided in Regulations .05E and .06A(6) of this chapter and as otherwise provided by law, the health officer or designee may not disclose the HIV or hepatitis C result of the offender.

  (2) The health officer or designee may not place the HIV or hepatitis C test result of the offender in any record relating to the offender maintained within a facility in which the offender is incarcerated.

C. Disclosure by Victim. The victim may not disclose the offender's test result to any individual unless the disclosure is necessary to protect the health and safety of:

  (1) The victim;

  (2) The victim's sexual partner; or

  (3) The victim's family.

D. Redisclosure. An individual notified of the result of an HIV or hepatitis C test performed under provisions of this chapter may not disclose the information except to protect the health and safety of:

  (1) The victim;

  (2) The victim's sexual partner; or

  (3) The victim's family.

### Chapter 11 — Universal Infection Control Precautions

**Authority:** Health-General Article, §§18-102, 19-319(h), 19-3A-02(9) and (10), 19-705.3; Health Occupations Article, §§1-207, 4-313(d),4-315, 6-205, 6-312, 6-505, 7-205, 7-316, 8-205, 8-316, 8-506, 14-205, 14-404, 14-415, 14-506, 15-205, 15-314, 16-205, 16-312, and 16-404; Annotated Code of Maryland

**Administrative History:** Effective date: February 14, 1994 (21:3 Md. R. 194)

**Administrative History:** Regulation .02B amended effective October 27, 2003 (30:21 Md. R. 1529)

**Administrative History:** Regulation .03C amended effective October 27, 2003 (30:21 Md. R. 1529)

**Administrative History:** Regulation .04B amended effective October 27, 2003 (30:21 Md. R. 1529)

#### Regulation .01 Scope.

*COMAR 10.52.11.01*

A. These regulations apply to any of the following individuals when the individual is involved in patient care activities:

  (1) Acupuncturist;

  (2) Dental hygienist;

  (3) Dentist;

  (4) Electrologist;

  (5) Employee of a health care facility;

  (6) Employee of a health care professional;

  (7) Mortician;

  (8) Nurse;

  (9) Physician;

  (10) Physician assistant; and

  (11) Podiatrist.

B. These regulations apply to any health care facility or private professional office where a health care worker is involved in patient care activities.

#### Regulation .02 Definitions.

*COMAR 10.52.11.02*

A. In this chapter, the following terms have the meanings indicated.

B. Terms Defined.

  (1) “Assisted living facility” has the meaning for assisted living program stated in Health-General Article, §19-1801, Annotated Code of Maryland.

  (2) “Day care center for adults” has the meaning stated in Health-General Article, §14-301, Annotated Code of Maryland.

  (3) “Freestanding birthing center” has the meaning stated in Health-General Article, §19-3B-01, Annotated Code of Maryland.

  (4) “Freestanding medical facility” has the meaning stated in Health-General Article, §19-3A-01, Annotated Code of Maryland.

  (5) Health Care Facility.

    (a) “Health care facility” means a location where health care is provided, including:

      (i) Assisted living facility;

      (ii) Day care center for adults;

      (iii) Freestanding birthing center;

      (iv) Freestanding medical facility;

      (v) Health maintenance organization;

      (vi) Hospital;

      (vii) Managed care organization;

      (viii) Nursing home; and

      (ix) Related institution.

    (b) “Health care facility” does not include a private professional office.

  (6) “Health care professional” means an individual who is licensed or certified under one or more of the following titles of Health Occupations Article, Annotated Code of Maryland:

    (a) Title 4 Dentistry;

    (b) Title 6 Electrologists;

    (c) Title 7 Morticians;

    (d) Title 8 Nurses;

    (e) Title 14 Physicians;

    (f) Title 15 Physician Assistants; and

    (g) Title 16 Podiatrists.

  (7) “Health care worker” means an individual who is:

    (a) A health care professional;

    (b) An employee of a health care professional; or

    (c) An employee of a health care facility.

  (8) “Health maintenance organization” has the meaning stated in Health-General Article, §19-701, Annotated Code of Maryland.

  (9) “Hospital” has the meaning stated in Health-General Article, §19-301, Annotated Code of Maryland.

  (10) “Managed care organization” has the meaning stated in Health-General Article, §15-101, Annotated Code of Maryland.

  (11) “Nursing home” means either:

    (a) A comprehensive care facility, as defined in COMAR 10.07.02.01B(6); or

    (b) An extended care facility, as defined in COMAR 10.07.02.01B(12).

  (12) “Patient care activity” means an action performed by a health care worker for a patient which could result in one or more of the following:

    (a) Blood or body fluids of the patient touching non-intact skin or mucous membrane of the health care worker;

    (b) Blood or body fluids of the health care worker touching nonintact skin or mucous membrane of the patient;

    (c) Percutaneous contact of the health care worker with the blood or body fluids of the patient; or

    (d) Percutaneous contact of the patient with the blood or body fluids of the health care worker.

  (13) “Private professional office” means a location which is not a part of a health care facility where a health care professional provides services to the public on a regular basis.

  (14) “Related institution” has the meaning stated in Health-General Article, §19-301, Annotated Code of Maryland.

  (15) “Universal precautions” has the meaning stated in COMAR 10.06.01.02B(10).

#### Regulation .03 Compliance Requirements for an Individual.

*COMAR 10.52.11.03*

An individual who is performing patient care activities shall:

A. Comply with the principles of universal precautions;

B. If necessary, make an emergency exception to the use of universal precautions in a situation when failure to provide immediate care could result in serious harm to or death of a patient; and

C. Comply with current professional standards of patient care with regard to disinfection and sterilization of reusable devices used in patient care procedures, including:

  (1) Prohibiting the reuse of single use needles; and

  (2) Properly disposing of needles and other sharps devices.

#### Regulation .04 Compliance Requirements for a Health Care Facility.

*COMAR 10.52.11.04*

A. A health care facility shall:

  (1) Adopt, implement, and enforce a policy that:

    (a) Requires the use of universal precautions by medical staff and employees engaged in patient care activities,

    (b) Permits an individual to make an emergency exception to the use of universal precautions, at the individual's discretion, in a situation where failure to provide immediate care could result in serious harm to or death of a patient, and

    (c) Requires compliance with current professional standards of patient care with regard to disinfection and sterilization of reusable devices used in patient care procedures; and

  (2) Display the version of the notice “We Take Precautions for You” specified in Table A, shown in §B of this regulation, at the entrance to the health care facility.

B. Table A.

#### Regulation .05 Compliance Requirements for Health Care Professional with Private Professional Office.

*COMAR 10.52.11.05*

A. A health care professional who practices in a private professional office shall:

  (1) Ensure that an individual who performs patient care services in the professional's office:

    (a) Complies with the principles of universal precautions,

    (b) Is permitted to make an emergency exception to the use of universal precautions, at the individual's discretion, in a situation where failure to provide immediate care could result in serious harm to or death of a patient, and

    (c) Complies with current professional standards of patient care with regard to disinfection and sterilization of reusable devices used in patient care procedures; and

  (2) Except as provided in §C of this regulation, display the version of the notice “We Take Precautions for You” specified in Table B shown in §B of this regulation.

B. Table B.

C. A health care professional not listed in Table B is not required to post the notice “We Take Precautions for You”.

### Chapter 12 — Newborn Screening

**Authority:** Health-General Article, §§13-109, 13-111, and 13-601—13-605, Annotated Code of Maryland

**Administrative History:** Effective date: December 24, 1975 (2:29 Md. R. 1738)

**Administrative History:** Chapter revised and recodified from
              COMAR 10.39.01, Testing for Hereditary Metabolic Disorders in the Newborn Child, to
              COMAR 10.52.12, Screening for Treatable Disorders in the Newborn Child, effective November 20, 1994 (21:23 Md. R. 1934)

**Administrative History:** Regulations
              .01—
              .12, Screening for Treatable Disorders in the Newborn Child, repealed and new Regulations
              .01—
              .15, Newborn Screening, adopted as an emergency provision effective January 1, 2009 (36:2 Md. R. 97); adopted permanently effective March 23, 2009 (36:6 Md. R. 490)

**Administrative History:** Regulation .03B amended effective March 14, 2016 (43:5 Md. R. 385)

**Administrative History:** Regulation .07E amended effective March 14, 2016 (43:5 Md. R. 385)

**Administrative History:** Regulation .08B amended effective March 14, 2016 (43:5 Md. R. 385)

**Administrative History:** Chapter revised effective April 24, 2017 (44:8 Md. R. 404)

**Administrative History:** Regulation .05B amended effective August 23, 2021 (48:17 Md. R. 669); April 14, 2025 (52:7 Md. R. 321); May 25, 2026 (53:10 Md. R. 454)

#### Regulation .01 Purpose.

*COMAR 10.52.12.01*

This chapter and COMAR 10.10.13 establish a coordinated Statewide system for:

A. Laboratory screening of newborn infants in the State for certain hereditary and congenital disorders associated with severe problems of health or development; and

B. Follow-up services to those infants with abnormal screening results.

#### Regulation .02 Scope.

*COMAR 10.52.12.02*

This chapter identifies standards and requirements for the Department, birthing facilities, and persons participating in one or more aspects of Maryland's Newborn Screening Program for hereditary and congenital disorders.

#### Regulation .03 Definitions.

*COMAR 10.52.12.03*

A. In this chapter, the following terms have the meanings indicated.

B. Terms Defined.

  (1) Birthing Facility.

    (a) “Birthing facility” means a facility that provides the antepartum, intrapartum, and postpartum management and care of women and their newborn infants.

    (b) “Birthing facility” includes a:

      (i) Birthing service that is licensed or accredited as a unit of a hospital; and

      (ii) Freestanding birthing center as defined in COMAR 10.05.02.01B.

  (2) Blood-Spot Specimen.

    (a) “Blood-spot specimen” means a whole-blood specimen collected from a newborn infant’s heel and applied to the designated area on a blood-spot specimen collection test requisition card for the purpose of performing screening tests.

    (b) “Blood-spot specimen” includes:

      (i) The first screening blood-spot specimen collected from a newborn infant, usually in the birthing facility or other place where the newborn infant was born, within 48 hours after the newborn infant’s birth;

      (ii) The second screening blood-spot specimen collected from a newborn infant, usually collected when the newborn infant is between 10 and 14 days of age; and

      (iii) A blood-spot specimen collected subsequent to a specimen specified in §B(2)(b)(i) and (ii) of this regulation as required to meet the medical needs and condition of the newborn infant and any additional specific screening blood-spot specimen collection and screening test requirements of this chapter and COMAR 10.10.13.

  (3) Congenital Disorder.

    (a) “Congenital disorder” means a significant structural or functional abnormality of the body that is present at birth.

    (b) “Congenital disorder” does not include a condition that results from:

      (i) An intrauterine infection; or

      (ii) A birth injury.

  (4) “Council” means the State Advisory Council on Hereditary and Congenital Disorders.

  (5) “Courier” means an entity employed by a person to convey a blood-spot specimen from the site of blood-spot specimen collection to the laboratory where the blood-spot specimen will be tested.

  (6) “Department” means the Maryland Department of Health.

  (7) “Diagnostic test” means a test that is used to establish or confirm the presence of a:

    (a) Specific disease; or

    (b) Hereditary or congenital disorder.

  (8) “First screening” means a screening performed on the first blood-spot specimen collected from a newborn infant after birth.

  (9) “First-tier test” means a blood test performed on a newborn infant's blood that:

    (a) Indicates the probable presence or absence of a hereditary or congenital disorder; or

    (b) Identifies a newborn infant who is at increased risk for a hereditary or congenital disorder.

  (10) “Follow-Up Unit” means the follow-up component and staff of the Department’s Newborn Screening Program, which carries out the duties set forth in Regulation .12 of this chapter.

  (11) Hereditary Disorder.

    (a) “Hereditary disorder” means a disorder that:

      (i) Is transmissible through the genetic material deoxyribonucleic acid (DNA); or

      (ii) Arises through the improper processing of information in the genetic material.

    (b) “Hereditary disorder” includes:

      (i) Hemoglobin disorders;

      (ii) Metabolic disorders; and

      (iii) Endocrine disorders.

  (12) “Home birth” means the birth of an infant which occurs intentionally outside of a birthing facility.

  (13) “Home birth attendant” means a physician who is licensed to practice under Health Occupations Article, Title 14, Annotated Code of Maryland, a nurse midwife who is licensed and certified to practice under Health Occupations Article, Title 8, Annotated Code of Maryland, or a direct-entry midwife who is licensed under Health Occupations Article, Title 8, Subtitle 6C, Annotated Code of Maryland, who is caring for the mother and infant at delivery during a home birth as defined in §B(12) of this regulation.

  (14) “Metabolic disorder” means a disorder caused by a genetic alteration that results in a defect in the function of a specific enzyme, hormone, or protein, which can be detected by:

    (a) Direct analysis of the enzyme, hormone, or protein; or

    (b) Testing for a substance whose metabolism is altered as a result of the defect.

  (15) “Milk feeding” means feedings received for 24 hours by:

    (a) A healthy newborn infant on a diet of milk; and

    (b) An ill or premature newborn infant on parenteral feedings providing a minimum of 1 gram of protein per kilogram of body weight per day and 75 kilocalories per kilogram of body weight per day.

  (16) “Newborn” or “newborn infant” means an infant:

    (a) Born in Maryland;

    (b) Born on federal property within Maryland;

    (c) Born outside of Maryland to parents whose residence is in Maryland;

    (d) From whom a blood-spot specimen was collected and submitted to the State’s public health laboratory for newborn screening by a birthing facility or other health care provider located in Maryland, regardless of the infant’s place of birth;

    (e) Who has a screening test requested by the Follow-Up Unit:

      (i) For first-tier screening follow-up;

      (ii) For confirmation of a previous screening test result; or

      (iii) To assist with the infant's diagnosis, therapy, or follow-up care; or

    (f) Who is in Maryland.

  (17) Newborn Screening or Screening.

    (a) “Newborn screening” or “screening” means one or more first-tier tests.

    (b) “Newborn screening” or “screening” includes:

      (i) First-tier testing on a first, second, or subsequent blood-spot specimen; and

      (ii) Supplemental first-tier testing.

  (18) Newborn Screening Program.

    (a) “Newborn Screening Program” means the Department's screening program for hereditary and congenital disorders, which performs operations and activities necessary to ensure that:

      (i) Newborn infants are given the opportunity to be tested;

      (ii) At risk newborn infants who are tested are identified and located;

      (iii) Newborn infants are given access to necessary follow-up testing;

      (iv) Diagnostic tests are available and the diagnosis is made or ruled out; and

      (v) Newborn infants diagnosed with a hereditary or congenital disorder are given access to treatment.

    (b) “Newborn Screening Program” includes:

      (i) The Department's public health laboratory as the sole screening laboratory;

      (ii) Another state's public health laboratory or a commercial laboratory that may serve the State as a screening laboratory during an emergency under a formal Departmental mutual aid agreement;

      (iii) Supplemental and second-tier testing performed by a state public health laboratory or by a licensed commercial or research laboratory;

      (iv) The Follow-Up Unit; and

      (v) The State Advisory Council on Hereditary and Congenital Disorders.

  (19) “Second screening” means a test performed on a routine second blood-spot specimen collected when the newborn infant is between 10 and 14 days old even though the test results from the newborn’s first blood-spot specimen were normal.

  (20) Second-Tier Test.

    (a) “Second-tier test” means a test performed on a newborn screening blood-spot specimen when a first-tier test provides an abnormal screening test result or a borderline abnormal screening test result.

    (b) “Second-tier test” includes a test that:

      (i) Establishes or confirms a newborn infant's risk for a hereditary or congenital disorder;

      (ii) Separates a newborn infant into a lower or higher risk category for a hereditary or congenital disorder; or

      (iii) Is diagnostic because it confirms the presence of a hereditary or congenital disorder.

  (21) “Supplemental test” means a test performed on a blood-spot specimen collected from a newborn infant that is:

    (a) Used to detect a hereditary or congenital disorder not specified in Regulation .05 of this chapter; or

    (b) Not required to be performed by the Department's public health laboratory under this chapter or COMAR 10.10.13.

  (22) “Unsatisfactory blood-spot specimen” means a blood-spot specimen that may produce an inaccurate or unreliable test result because the blood-spot specimen exhibits one of the problems of collection as specified in COMAR 10.10.13.21B and C.

#### Regulation .04 Responsibilities of the Department.

*COMAR 10.52.12.04*

A. Program Maintenance. The Department shall operate a Newborn Screening Program to identify congenital and hereditary disorders and provide follow-up services to newborn infants.

B. Laboratory Oversight. The Department shall ensure that a laboratory holding a permit to offer or perform first-tier, supplemental, or second-tier tests to identify congenital and hereditary disorders in newborn infants is subjected to regulatory oversight that includes surveys and proficiency testing as set forth in:

  (1) COMAR 10.10.02; and

  (2) COMAR 10.10.05.

C. Notification. The Department shall notify the parents and guardians of newborn infants that laboratories other than the Department’s public health laboratory may perform post screening confirmatory or diagnostic tests on newborn infants for hereditary and congenital disorders.

#### Regulation .05 Selection of Disorders for Screening.

*COMAR 10.52.12.05*

A. The Department, with the advice of the Council, shall select the disorders for which screening is required by the Newborn Screening Program.

B. The selected disorders are:

  (1) Biotinidase deficiency;

  (2) Congenital adrenal hyperplasia (CAH);

  (3) Hypothyroidism;

  (4) Galactosemia, galactose-1-phosphate uridyl transferase deficiency (GALT);

  (5) Epimerase Galactosemia, uridine diphosphate-galactose-4-epimerase deficiency (GALE);

  (6) Galactokinase Galactosemia, galactokinase deficiency (GALK1);

  (7) Sickle cell disease;

  (8) Sickle cell disease: S beta-thalessemia;

  (9) Sickle C disease: SC disease;

  (10) Other hemoglobin variants;

  (11) Phenylketonuria (PKU);

  (12) Hyperphenylalaninemia (Hyper-PHE);

  (13) Biopterin cofactor biosynthesis defects (BIOPT-BS);

  (14) Biopterin cofactor regeneration defects (BIOPT-REG);

  (15) Tyrosinemia, type I;

  (16) Tyrosinemia, type II;

  (17) Tyrosinemia, type III;

  (18) Homocystinuria;

  (19) Hypermethioninemia;

  (20) Branched chain ketoaciduria (BCK), also called maple syrup urine disease (MSUD);

  (21) Citrullinemia, type I;

  (22) Citrullinemia, type II;

  (23) Arginosuccinic aciduria;

  (24) Argininemia;

  (25) Methylmalonic acidemia, mutase deficiency (MMA);

  (26) Methylmalonic acidemia, adenosylcobalamin synthesis defects A and B (Cbl A, B);

  (27) Methylmalonic acidemia, adenosylcobalamin synthesis defects C and D (Cbl C, D);

  (28) Propionic acidemia (PA);

  (29) Isovaleric acidemia (IVA);

  (30) Glutaric aciduria type I (GA I);

  (31) 3-Hydroxy-3-methylglutaryl-CoA (HMG) lysase deficiency;

  (32) Isobutryl-CoA dehydrogenase (IBCD) deficiency;

  (33) 2-Methylbutyryl-CoA dehydrogenase deficiency (2MBG);

  (34) 3-Methlycrotonyl-CoA carboxylase deficiency (3MCC);

  (35) 3-Methlyglutaconyl-CoA hydratase deficiency (3MGA);

  (36) 2-Methyl-3-hydroxybutyrl-CoA dehydrogenase deficiency (2M3HBA);

  (37) Mitochondrial acetoacetyl-CoA thiolase (3-ketothiolase) deficiency (BKT);

  (38) Multiple carboxylase deficiency (MCD);

  (39) Malonic acidemia (MAL);

  (40) Medium chain acyl-CoA dehydrogenase deficiency (MCAD);

  (41) Medium chain ketoacyl-CoA thiolase deficiency (MCKAT);

  (42) Short chain acyl-CoA dehydrogenase deficiency (SCAD);

  (43) Short chain 3-hydroxy acyl Co-A dehydrogenase deficiency (SCHAD);

  (44) Very long chain acyl-CoA dehydrogenase deficiency (VLCAD)

  (45) 3-hydroxy long chain acyl-CoA dehydrogenase deficiency (LCHAD);

  (46) Multiple acyl-CoA dehydrogenase (MAD) or glutaric acidemia type II deficiency (GA II);

  (47) Carnitine/acylcarnitine translocase deficiency (translocase deficiency);

  (48) Carnitine palmitoyl transferase type I deficiency (CPT I);

  (49) Carnitine palmitoyl transferase type II deficiency (CPT II);

  (50) Carnitine uptake disorder;

  (51) Trifunctional protein deficiency (TFP);

  (52) 2,4-dienoyl-CoA reductase deficiency (DE RED);

  (53) Cystic fibrosis;

  (54) Severe combined immunodeficiency (SCID);

  (55) Pompe disease;

  (56) Fabry disease;

  (57) Spinal muscular atrophy (SMA);

  (58) Mucopolysaccharidosis type I (MPS I);

  (59) Mucopolysaccharidosis Type II (MPS II);

  (60) X-linked Adrenoleukodystrophy (X-ALD);

  (61) Guanidinoacetate Methyltransferase Deficiency (GAMT); and

  (62) Infantile Krabbe Disease.

C. Supplemental Tests. The State’s Newborn Screening Program may not request or perform a supplemental test until the public health laboratory has confirmed there is sufficient blood-spot specimen to test for the required panel of disorders set forth in
                §B of this regulation.

#### Regulation .06 Pre-Test Information.

*COMAR 10.52.12.06*

Before a blood-spot specimen is sent for newborn screening, a health care provider or the individual’s designated representative shall provide to the newborn infant’s parent or guardian an explanation of newborn screening that includes:

A. Reasons for newborn screening, including the;

  (1) Purpose of the testing; and

  (2) Nature and consequences of being affected by a hereditary or congenital disorder or being a carrier of a hereditary or congenital disorder; and

B. A parent or guardian's right to object to having the testing performed, including:

  (1) Stating that newborn screening is wholly voluntary;

  (2) Explaining any risk involved in having newborn screening performed; and

  (3) Providing a reasonable opportunity to object to screening.

#### Regulation .07 Initial Screening.

*COMAR 10.52.12.07*

The individual in charge of a birthing facility or the individual’s designated representative, or the home birth attendant shall:

A. If the parent or guardian of the newborn infant does not object to newborn screening:

  (1) Collect a blood-spot specimen:

    (a) As set forth in:

      (i) Sections C and D of this regulation; and

      (ii) COMAR 10.10.13.13; and

    (b) Pursuant to the procedures established in COMAR 10.10.13.14A; and

  (2) Submit the collected blood-spot specimen to the Department’s public health laboratory;

B. When a parent or guardian objects to newborn screening:

  (1) Have the parent or guardian sign a form that states the parent or guardian objects to newborn screening; and

  (2) Inform the Follow-Up Unit by telephone, fax, or email of the objection within 12 hours after the objection;

C. For full-term healthy newborn infants:

  (1) Collect a blood-spot specimen to test for the disorders set forth in Regulation .05 of this chapter not sooner than 24 hours after the onset of milk feeding, regardless of whether the newborn is breast-fed or formula-fed; and

  (2) If the newborn infant is discharged before 24 hours after the onset of milk feeding, collect the blood-spot specimen as late as practical before the newborn infant is discharged from the birthing facility; and

D. For a newborn infant born prematurely or expected to be ill for longer than 14 days, if the newborn infant’s medical condition permits, collect:

  (1) A blood-spot specimen for the newborn screening test upon admission, before the administration of blood products or antibiotics;

  (2) A subsequent blood-spot specimen 48 to 72 hours after birth, regardless of milk feeding status;

  (3) A subsequent blood-spot specimen by 10 days of age when milk feeding is established or the infant has been receiving additional protein through intravenous fluids; and

  (4) An additional subsequent blood-spot specimen at one month of age or at discharge, whichever comes first.

#### Regulation .08 Second Screening.

*COMAR 10.52.12.08*

A health care provider shall have a blood-spot specimen collected for a second screening for the disorders set forth in Regulation .05 of this chapter when the newborn is between 10 and 14 days old.

#### Regulation .09 Transport of Blood-Spot Specimens to a Licensed Laboratory.

*COMAR 10.52.12.09*

A. A birthing facility representative, physician, or other health care provider or, in the case when a birth occurs outside a birthing facility, the individual required to prepare and file the certificate of birth, shall send newborn screening blood-spot specimens only to the Department’s public health laboratory for the performance of newborn screening, as set forth in COMAR 10.10.13.14B.

B. The individual responsible for collecting and submitting a blood-spot specimen for a newborn screening test shall ensure that blood-spot specimens are forwarded by courier to the Department’s public health laboratory within 24 hours after collection.

#### Regulation .10 Results.

*COMAR 10.52.12.10*

A. Normal Screening Results.

  (1) The Department’s public health laboratory shall report normal newborn screening test results to the submitter of the blood-spot specimen within 3 business days after receipt of the blood-spot specimen.

  (2) A birthing facility representative, health care provider, or the individual who is responsible for filing the certificate of birth if the birth occurs outside a birthing facility, or other submitter of the blood-spot specimen shall:

    (a) Enter the results in the newborn infant's medical record; and

    (b) Make the results available to the parent, guardian, or primary care providers upon request.

B. Abnormal Screening Results.

  (1) The Department’s public health laboratory shall immediately report abnormal newborn screening test results to the Follow-Up Unit.

  (2) The Department’s public health laboratory shall report to the Follow-Up Unit all known demographic and clinical data on the newborn infant in an electronic format compatible with the Department’s information system databases operated by the Department’s public health laboratory, as set forth at COMAR 10.10.13.25.

  (3) The Follow-Up Unit shall enter results in the Department’s database and initiate follow-up procedures as specified in Regulation .12 of this chapter.

  (4) The submitter of the blood-spot specimen shall:

    (a) Enter the results in the newborn infant's medical record; and

    (b) Make the abnormal results available immediately to the newborn's parent, guardian, or primary care providers.

#### Regulation .11 Referral Procedures.

*COMAR 10.52.12.11*

The individual in charge of a birthing facility or the individual’s designated representative, or the home birth attendant shall:

A. Develop collection and transport procedures to ensure against collecting and submitting unsatisfactory blood-spot specimens for each of the categories of newborn infant listed in §B of this regulation.

B. Collect or otherwise have collected:

  (1) An additional blood-spot specimen before the newborn is 7 days old for newborn infants discharged before 24 hours of milk feeding in addition to the blood-spot specimen collected before discharge, as set forth in Regulation .07C(2) of this chapter.

  (2) The blood-spot specimen before the newborn is 7 days old if a newborn infant is discharged from a birthing facility before a newborn screening blood-spot specimen is collected.

  (3) An additional blood-spot specimen within 7 days after notification if the laboratory reports to a birthing facility or a home birth attendant that the initial blood-spot specimen was unsatisfactory.

  (4) A blood-spot specimen to be tested for hemoglobins, biotinidase, and galastose -1 phosphate uridyl transferase (GALT) only, four months after the last transfusion if the initial blood-spot specimen was not collected until after the infant was transfused.

#### Regulation .12 Follow-Up Procedures.

*COMAR 10.52.12.12*

A. Department's Responsibilities.

  (1) The Follow-Up Unit shall investigate each abnormal result indicative of increased risk for a hereditary or congenital disorder by contacting the infant’s health care provider, or other appropriate individual to notify the parent or guardian, or if the health care provider cannot be contacted, by contacting the infant’s parent or guardian directly regarding:

    (a) Results of first-tier, supplemental, and second-tier tests;

    (b) The importance of identifying and locating a newborn infant with test results indicative of increased risk for an hereditary or congenital disorder;

    (c) The urgent need for follow-up; and

    (d) The need to share newborn screening information between hospitals, healthcare providers, treatment centers, and laboratory personnel.

  (2) If the parent or guardian fails to respond to the birthing facility, health care provider, or other responsible individual acting as set forth in §B(1) of this regulation, the individual in charge of the birthing facility or the individual’s designated representative, health care provider, or other responsible individual shall notify the Follow-Up Unit, which shall then try to notify the parent or guardian of the need for follow-up by using at least one of the following means, in the indicated order of priority:

    (a) Telephone;

    (b) Certified mail, if medically appropriate;

    (c) Public health nurse visit; or

    (d) Law enforcement contact.

  (3) The Follow-Up Unit shall provide recommendations to the responsible birthing facility, health care provider, and the parent or guardian, as appropriate, regarding the appropriate follow-up and diagnostic evaluation of the newborn infant.

  (4) The Follow-Up Unit shall recommend:

    (a) Sources of diagnostic evaluation, specialty care, and treatment; and

    (b) That no treatment be administered to the newborn infant until the results of the follow-up evaluation have established that the infant has a hereditary or congenital disorder.

  (5) The Follow-Up Unit shall inform health care personnel and parents or guardians of:

    (a) The nature, cost, benefits, and risks of any therapy; and

    (b) The availability of any programs to assist individuals affected by a hereditary or congenital disorder.

B. Responsibilities of the Birthing Facility or Health Care Provider. The individual in charge of the birthing facility or individual’s designated representative or health care provider shall:

  (1) Evaluate the infant for signs, symptoms, and biochemical evidence of a hereditary or congenital disorder;

  (2) Refer the newborn infant for further evaluation:

    (a) To the appropriate specialists; and

    (b) For the appropriate diagnostic tests;

  (3) Collect and submit any required blood-spot specimens for repeat screening or diagnostic testing; and

  (4) Report the results of diagnostic testing to the Follow-Up Unit.

#### Regulation .13 Records.

*COMAR 10.52.12.13*

A. The screening of newborn infants pursuant to this chapter is a population based public health surveillance program.

B. On request, a laboratory or health care provider shall make available to the Follow-Up Unit medical records, records of laboratory tests, and any other medical information the Follow-Up Unit considers necessary to:

  (1) Screen a newborn infant for hereditary and congenital disorders set forth in Regulation .05 of this chapter;

  (2) Carry out the State's Newborn Screening Program, including:

    (a) Contacting the families and primary health care providers of newborn infants with newborn screening test results indicating a high risk of having a hereditary or congenital disorder;

    (b) Providing recommendations regarding the appropriate follow-up and diagnostic evaluation of the newborn infant;

    (c) Determining what follow-up evaluations and diagnostic tests were performed and on what date the evaluations and tests were performed;

    (d) Determining if and on what date a diagnosis of a specific hereditary or congenital disorder in a newborn infant was made; and

    (e) Determining if and on what date treatment and follow-up care have been initiated; and

  (3) Ensure compliance with the pertinent regulations set forth in this chapter and in COMAR 10.10.13.

C. Information that the Department receives under this chapter is confidential and may only be used or disclosed:

  (1) To provide services to the newborn infant and the infant's family;

  (2) To study the relationships of the various factors determining the frequency and distribution of the disorders set forth in Regulation .05 of this chapter;

  (3) For State or federally mandated statistical reports; and

  (4) To ensure that the information received by the Department is accurate and reliable.

### Chapter 13 — Screening for Sickle-Cell Disease, Thalassemia, and Related Conditions

*Repealed*

**Administrative History:** Effective date: June 16, 1978 (5:12 Md. R. 968)

**Administrative History:** COMAR 10.39.02, Screening for Sickle Cell, Thalassemia, and Related Conditions, revised and recodified to COMAR 10.52.13, Screening for Sickle Cell Disease, Thalassemia, and Related Conditions, effective April 24, 1995 (22:8 Md. R. 596)

**Administrative History:** Regulations .01—.10 repealed effective December 10, 2012 (39:24 Md. R. 1578)

### Chapter 14 — Screening for Neural Tube Defects in the Fetus

*Repealed*

**Administrative History:** Effective date: December 15, 1986 (13:25 Md. R. 2660)

**Administrative History:** Chapter revised and recodified from COMAR 10.39.03 to COMAR 10.52.14 effective January 2, 1995 (21:26 Md. R. 2188)

**Administrative History:** Regulations .01—.06 repealed effective December 10, 2012 (39:24 Md. R. 1578)

### Chapter 15 — Screening for Critical Congenital Heart Disease (CCHD) in Newborns

**Authority:** Health-General Article, §§13-109, 13-111, and 18-107(a), Annotated Code of Maryland

**Administrative History:** Effective date:

**Administrative History:** Regulations .01—.08 adopted as an emergency provision effective October 5, 2012 (39:22 Md. R. 1427); emergency status extended to June 1, 2013 (40:6 Md. R. 469); adopted permanently effective April 15, 2013 (40:7 Md. R. 612)

#### Regulation .01 Purpose and Scope.

*COMAR 10.52.15.01*

A. This chapter establishes Statewide screening protocols for critical congenital heart disease in newborn infants.

B. This chapter identifies standards and requirements for the Department, birthing facilities, nurse midwives, and persons participating in newborn screening for critical congenital heart disease.

#### Regulation .02 Definitions.

*COMAR 10.52.15.02*

A. In this chapter, the following terms have the meanings indicated.

B. Terms Defined.

  (1) “Attending clinician” means an individual who is:

    (a) A health care provider as defined in Health-General Article, §5-601, Annotated Code of Maryland; and

    (b) Responsible for the care of newborn infants, and is either:

      (i) A certified nurse practitioner licensed by the Maryland Board of Nursing; or

      (ii) A certified nurse midwife licensed by the Maryland Board of Nursing.

  (2) “Attending physician” means an individual who is:

    (a) A health care provider as defined in Health-General Article, §5-601, Annotated Code of Maryland;

    (b) Responsible for the care of a newborn infant;

    (c) Licensed to practice medicine in Maryland; and

    (d) Board-certified by a member board of the American Board of Medical Specialties or an approved specialty board of the American Osteopathic Association in a specialty that includes the care of newborn infants.

  (3) “Authorized health care provider” means an individual:

    (a) Who has received training in the screening protocol; and

    (b) For whom the CCHD screening tests are within his or her professional scope of practice.

  (4) “Birth Defects Reporting and Information System” means the mandated reporting, monitoring, and follow-up of infants with birth defects as described in Health General Article, §18-206, Annotated Code of Maryland.

  (5) Birthing Facility.

    (a) “Birthing facility” means a facility that provides care for women during labor and delivery, and their newborn infants.

    (b) “Birthing facility” includes a:

      (i) Unit of a hospital that is licensed and accredited to provide birthing services; or

      (ii) Freestanding birthing center as defined in COMAR 10.05.02.01B.

  (6) “CCHD screening” means pulse oximetry testing.

  (7) “Critical congenital heart disease (CCHD)” means a congenital heart defect that places an infant at significant risk of disability or death if not diagnosed soon after birth.

  (8) “Department” means the Maryland Department of Health.

  (9) “Echocardiogram” means a test that uses ultrasound to provide an image of the heart.

  (10) “Newborn infant” means an infant in the first 28 days of life who was born:

    (a) In Maryland; or

    (b) On federal property within Maryland.

  (11) “Newborn Screening Follow-Up Unit” means the unit in the Department that carries out the duties set forth in Regulation .07 of this chapter.

  (12) “Web-based system” means the web-based database used by the Department to collect data for newborn infant screening follow-up.

#### Regulation .03 Pre-Test Information and the Right to Refuse Screening.

*COMAR 10.52.15.03*

A. Before a newborn infant is screened for CCHD, a health care provider shall provide to the newborn infant's parent or guardian an explanation of CCHD screening that includes:

  (1) Reasons for screening, including:

    (a) The purpose and benefits of the screening; and

    (b) The nature, risks, and consequences of not screening for CCHD.

  (2) A parent or guardian's right to refuse having the screening performed, including:

    (a) Explaining any risk involved with the screening; and

    (b) Providing a reasonable opportunity to refuse the screening.

B. Refusal of Screening.

  (1) All newborn infants shall be screened for CCHD unless the parent or guardian refuses the screening.

  (2) If a parent or guardian refuses screening, a provider may not perform CCHD screening on the infant.

  (3) When a parent or guardian refuses screening, the birthing facility or nurse midwife shall:

    (a) Document parent refusal in the medical record; and

    (b) Enter this information into the web-based system in accordance with Regulation .05 in this chapter.

  (4) If the parent or guardian of the newborn infant does not refuse the screening, the birthing facility or nurse midwife shall:

    (a) Perform screening on the newborn infant; and

    (b) Follow-up with results in accordance with Regulation .05 of this chapter.

#### Regulation .04 Screening Procedures.

*COMAR 10.52.15.04*

A. An authorized health care provider shall perform the screening.

B. Newborn Infants Receiving Routine Care.

  (1) The birthing facility or nurse midwife shall:

    (a) Perform screening on a newborn infant between 24 hours and 48 hours of life; or

    (b) If unable to perform the screening, refer the infant to another authorized health care provider to perform the screening between 24 hours and 48 hours of life.

  (2) If the newborn infant is discharged from a facility after 12 hours of life but before 24 hours of life, the birthing facility shall perform screening as late as is practical before the newborn infant is discharged from the birthing facility.

  (3) If the newborn infant is discharged before 12 hours of life, the birthing facility shall refer the infant to another authorized health care provider to perform screening between 24 hours and 48 hours of life.

C. Newborn Infants in Special Care or Intensive Care. Birthing facilities shall develop protocols for screening infants in the special care or intensive care nurseries.

D. Circumstances Where Screening Is Not Indicated. There may be instances where screening for CCHD is not indicated, including but not limited to instances where:

  (1) The newborn infant’s clinical evaluation to date has included an echocardiogram which ruled out CCHD; or

  (2) The newborn infant has confirmed CCHD based on prenatal or postnatal testing.

#### Regulation .05 Results.

*COMAR 10.52.15.05*

A. Recordation of Results.

  (1) All screening results shall be recorded in the newborn infant’s medical record.

  (2) All screening results shall be entered into the web-based system along with the following information:

    (a) Newborn infant’s:

      (i) Name;

      (ii) Date of birth;

      (iii) Gender;

      (iv) Place of birth; and

      (v) Primary care physician after discharge; and

    (b) Mother’s:

      (i) Name; and

      (ii) Date of birth.

B. Abnormal Screening Results.

  (1) Abnormal screening results shall be reported by the authorized health care provider who conducted the screening to the attending physician or attending clinician immediately.

  (2) A newborn infant shall be evaluated immediately by an attending physician in order to complete the recommended protocol.

  (3) A newborn infant may not be discharged from care until:

    (a) A cause for the abnormal screening result has been determined; or

    (b) An echocardiogram has been performed, read, and determined not to indicate CCHD.

  (4) The birthing facility shall enter screening results into the web-based system as specified in §A(2) of this regulation.

  (5) The birthing facility shall provide notification of abnormal results to the newborn infant’s:

    (a) Parent or guardian; and

    (b) Primary care provider.

C. Newborn Infants Not Screened.

  (1) If a newborn infant is not screened secondary to discharge before 12 hours of life, the birthing facility or nurse midwife shall:

    (a) Follow-up with the family to refer to an authorized health care provider for screening between 24 hours and 48 hours of life after:

      (i) Discharge from the facility; or

      (ii) A home birth; and

    (b) Enter into the web-based system the:

      (i) Identifying information specified in §A(2) of this regulation; and

      (ii) Reason for not screening which shall be “early discharge”.

  (2) If a newborn infant is not screened secondary to screening not being indicated, the birthing facility or nurse midwife shall enter into the web-based system:

    (a) The identifying information specified in §A(2) of this regulation;

    (b) The reason for not screening which shall be “screening not indicated”; and

    (c) A notation of the reason for the override.

  (3) If a newborn infant is not screened secondary to parent or guardian refusal, the birthing facility or nurse midwife shall enter into the web-based system the:

    (a) Information specified in §A(2) of this regulation; and

    (b) Reason for not screening which shall be entered as “parent refusal”.

#### Regulation .06 Birthing Facility and Nurse Midwife Responsibilities.

*COMAR 10.52.15.06*

A. Birthing Facility Responsibilities. The birthing facility shall:

  (1) Identify a clinical staff person as a contact for CCHD screening;

  (2) Develop protocols to ensure that all newborn infants are offered screening;

  (3) Develop protocols to ensure that all screening results are reported in accordance with Regulation .05 of this chapter;

  (4) Ensure that follow-up is performed for newborn infants not screened before hospital discharge; and

  (5) Develop protocols that assure the timely evaluation and referral, if necessary, of newborn infants who have abnormal screening results including:

    (a) Evaluation by the attending physician;

    (b) Performance of an echocardiogram;

    (c) Reading of the echocardiogram; and

    (d) Referral of newborn infants for further evaluation when needed.

B. Newborn Infants Born Outside a Birthing Facility. If the birth of a newborn infant occurs outside a birthing facility, the nurse midwife shall perform screening in accordance with Regulation .05 of this chapter or refer to an authorized health care provider for screening between 24 hours and 48 hours of life.

#### Regulation .07 Department Responsibilities.

*COMAR 10.52.15.07*

The Newborn Screening Follow-Up Unit shall:

A. Investigate each instance of abnormal screening results to determine the cause for the abnormal result;

B. Enter newborn infants found to have CCHD into the Birth Defects Reporting and Information System;

C. Provide condition-specific information and resources to the family; and

D. Perform ongoing evaluation of CCHD screening in the State.

#### Regulation .08 Records.

*COMAR 10.52.15.08*

A. The screening of newborn infants pursuant to this chapter is a population-based public health surveillance program as defined under the Health Insurance Portability and Accountability Act of 1996.

B. On request, a birthing facility or health care provider shall make available to the Newborn Screening Follow-Up Unit:

  (1) Medical records;

  (2) Records of laboratory tests; and

  (3) Any other medical information the Newborn Screening Follow-Up Unit considers necessary to:

    (a) Determine final outcomes of abnormal screening results; and

    (b) Evaluate CCHD Screening activities in the State, including:

      (i) Performance of follow-up evaluations and diagnostic tests;

      (ii) Initiation of treatment when necessary; and

      (iii) Surveillance of the accuracy and efficacy of the screening.

C. Information that the Department receives under this chapter is confidential and may only be used or disclosed:

  (1) To provide services to the newborn infant and the infant's family;

  (2) To study the relationships of the various factors determining the frequency and distribution of CCHD;

  (3) For State or federally mandated statistical reports; and

  (4) To ensure that the information received by the Department is accurate and reliable.

### Chapter 16 — Insect Sting Emergency Treatment Program

*Repealed*

**Administrative History:** Effective date: January 16, 2001 (27:25 Md. R. 2282)

**Administrative History:** Chapter repealed effective December 8, 2016 (43:24 Md. R. 1350)

### Chapter 17 — Maryland Asthma Control Program

**Authority:** Health-General Article, §§13-1701—13-1706, Annotated Code of Maryland

**Administrative History:** Effective date: July 31, 2006 (33:15 Md. R. 1281)

#### Regulation .01 Scope.

*COMAR 10.52.17.01*

A. The purpose of this chapter is to facilitate the implementation of the Maryland Asthma Control Program, to the extent allowed by available funding, by providing guidelines for the administration of the Asthma Coalition in its advisory capacity to the Program.

B. This chapter also authorizes the Maryland Asthma Control Program to obtain asthma-related data through an asthma data surveillance system.

#### Regulation .02 Definitions.

*COMAR 10.52.17.02*

A. In this chapter, the following terms have the meanings indicated.

B. Terms Defined.

  (1) “Asthma data surveillance” means the ongoing and systematic collection, analysis, and interpretation of asthma-related information for the purposes of planning, implementing, and evaluating public health interventions to:

    (a) Prevent asthma;

    (b) Improve asthma health outcomes, including rates of asthma-related emergency department admissions, hospital admissions, and mortality; and

    (c) Decrease health disparities associated with asthma.

  (2) “Coalition” means the Maryland Statewide Asthma Coalition established by the Director of the Asthma Control Program under Health-General Article, §13-1704, Annotated Code of Maryland.

  (3) “Department” means the Maryland Department of Health.

  (4) “Local asthma coalition” means an alliance of individuals representing personal or organizational interests whose purpose is to reduce asthma prevalence, severity, and health disparities within a particular region or jurisdiction in Maryland.

  (5) “Maryland Asthma Plan” means a comprehensive strategy that provides cohesive direction, objectives, strategies, and action steps for the Coalition to use in addressing asthma in Maryland.

  (6) “Program” means the Maryland Asthma Control Program, which is established under Health-General Article, §13-1702, Annotated Code of Maryland.

#### Regulation .03 Establishment and Membership.

*COMAR 10.52.17.03*

A. The Maryland Statewide Asthma Coalition is established.

B. The Coalition consists of members recruited by the Director of the Maryland Asthma Control Program from each of the following organizations:

  (1) The Department;

  (2) The American Lung Association of Maryland;

  (3) The Asthma and Allergy Foundation of America, Maryland-Greater Washington, D.C. Chapter;

  (4) The Johns Hopkins Medical Institutions;

  (5) The University of Maryland, School of Medicine;

  (6) Representatives from local health departments or local asthma coalitions;

  (7) Professional health care provider organizations;

  (8) Other State agencies with expertise or an interest in asthma; and

  (9) Any other interested professional and community groups with asthma expertise.

#### Regulation .04 Quorum, Meetings, Compensation, and Staff.

*COMAR 10.52.17.04*

A. The members of the Coalition who are present at a meeting are a quorum to do business provided that at least eight members including one co-chair attend the meeting.

B. The Coalition shall meet at least twice per year, at the times and places that a co-chair determines.

C. A member of the Coalition:

  (1) May not receive State-funded compensation; and

  (2) Is not entitled to State-funded reimbursement for travel or other expenses related to serving as a Coalition member.

D. Coalition Co-Chairs.

  (1) The Program Director or the Director's designee shall serve as a co-chair of the Coalition and designate the Program staff necessary to carry out this chapter.

  (2) The other co-chair shall be selected by a majority vote of a quorum of the Coalition.

#### Regulation .05 Duties.

*COMAR 10.52.17.05*

The Coalition shall provide assistance to the Department in the development and implementation of the Program by:

A. Advising the Department on asthma-related matters, including establishing priorities within the Maryland Asthma Plan, through maintaining and sharing expertise on asthma issues;

B. Facilitating communication and networking opportunities, especially through local coalitions, groups with shared interest, and other State coalitions;

C. Increasing asthma awareness throughout the State; and

D. Monitoring progress in achieving the goals established within the Maryland Asthma Plan.

#### Regulation .06 Asthma Data Surveillance System.

*COMAR 10.52.17.06*

A. The Program shall establish a State asthma data surveillance system that has the authority to access and request the submission of data related to asthma, including the submission of a uniform data set and any confidential, patient-identifying data, or information from the following sources:

  (1) Vital Statistics Administration;

  (2) Maryland Health Care Commission;

  (3) Maryland Institute for Emergency Medical Services Systems (MIEMSS);

  (4) Maryland Health Services Cost Review Commission;

  (5) Maryland Medical Assistance Program; and

  (6) Other data sources, as necessary.

B. A health care provider or facility shall release confidential patient-identifying data or information to the Program in accordance with this chapter.

C. Any identifying data or information that the Program receives under §A or B of this regulation is confidential and may be used only for public health surveillance purposes.

D. A health care provider or facility may not be held liable for releasing data or other information to the Program in accordance with this regulation.

E. Except for confidential, patient-identifying medical information, the Program may publish and disseminate data or information that relates to the incidence, severity, or cost of asthma or related conditions if the Program considers the publication beneficial and in the public's interest. However, before the data or information relating to asthma is published or disseminated, the Program shall consult with any person or entity that is the source of the data the Program intends to use. The Program and the person or entity shall agree upon the manner in which the data is published or disseminated.