Md. Code Regs. 10.06.01.04

Current through Register Vol. 51, No. 22, November 1, 2024

Section 10.06.01.04 - Reporting Procedures

A. Sources of Reports and to Whom to Report.

(1) An institution, as specified in Health-General Article, § 18-202, Annotated Code of Maryland, and a health care provider who knows of a case of a reportable disease, condition, outbreak, or unusual manifestation shall report it to a health officer.

(2) A teacher at any public, private, or parochial school or a child care provider at any child care facility shall report an occurrence of a reportable disease or condition, an outbreak, or an unusual manifestation as set forth in Regulation .03 of this chapter to the principal, school nurse, or superintendent or assistant superintendent or designee, who shall transmit to a health officer a report of the name and address of a child who appears to have a reportable communicable disease or who has been exposed to a reportable communicable disease.

(3) The master or person in charge of a vessel or aircraft within the territory of the State shall report to the Secretary or a health officer at the nearest port of landing or entry, all known facts relating to the illness and physical condition of an individual aboard the vessel or aircraft who may have a reportable disease or condition, an outbreak, or an unusual manifestation.

(4) Directors of Medical Laboratories or Laboratories that Possess Biological Agents as Defined in COM4R 10.10.11.03B(8).

(a) The director of a medical laboratory or a laboratory that possesses a biological agent as defined in COMAR 10.10.11.03B(8) shall report:

(i) Laboratory evidence of a reportable condition as specified in Regulation .03C of this chapter from examination of a human specimen acquired from an individual in this State; and

(ii) Evidence of any other condition as requested by the Secretary.

(b) The director of a medical laboratory or a laboratory that possesses a biological agent as defined in COMAR 10.10.11.03B(8) located in a Maryland jurisdiction shall report to the health officer of that jurisdiction.

(c) The director of a medical laboratory located outside of Maryland shall report to the Secretary.

(d) If a medical laboratory or a laboratory that possesses ay-biological agent as defined in COMAR 10.10.11.03B(8) forwards clinical materials out of State for testing, the originating medical laboratory or a laboratory that possesses a biological agent as defined in COMAR 10.10.11.03B(8) shall comply with this subsection by:

(i) Reporting the results and submitting the clinical materials; or

(ii) Ensuring that the results are reported and materials submitted.

(e) When more than one specimen is taken from a patient during one disease episode, the director of a medical laboratory or a laboratory that possesses a biological agent as defined in COMAR 10.10.11.03B(8) need not report every test result of a specimen that shows evidence of the same disease in that patient if:

(i) At least one positive test result is reported; and

(ii) A health officer has agreed that all test reports do not need to be reported.

(5) Any individual having knowledge of an animal bite shall report the bite according to the requirements of COMAR 10.06.02.

(6) The owner or operator of a food establishment as defined in Health-General Article, § 21-301, Annotated Code of Maryland, shall report to a health officer an occurrence of a reportable disease or condition, an outbreak, or an unusual manifestation.

B. Method and Content of Reports.

(1) A person, as listed in §A(1)-(4) of this regulation, shall report:

(a) In writing on a form provided by the Secretary; or

(b) In a format approved by the Secretary, when electronic submittal is available.

(2) The report shall include at a minimum the:

(a) Date of the report;

(b) Patient's name including first and last names and middle initial;

(c) Residence address of the patient including:

(i) House or apartment number;

(ii) Street;

(iii) City or town;

(iv) State; and

(v) Zip code;

(d) Telephone number including area code;

(e) Date of birth;

(f) Sex;

(g) Race;

(h) Ethnicity;

(i) Pregnancy status if applicable; and

(j) Other epidemiologic information as specified by the Secretary or the health officer.

(3) In addition to what is specified in §B(2) of this regulation, institutions and health care providers, school and child care facility personnel, and masters of vessels or aircraft as listed in §A(1)-(3) of this regulation shall report:

(a) The date of onset of symptoms;

(b) The diagnosis;

(c) For syphilis, gonococcal infection, and Chlamydia trachomatis infection, the treatment given; and

(d) Any laboratory information supporting the diagnosis of the disease or condition, as requested.

(4) A director of a medical laboratory, in addition to what is specified in §B(2) of this regulation, shall report the:

(a) Name, address, telephone number, and federal Clinical Laboratory Improvement Amendments (CLIA) certificate number of the laboratory performing the test;

(b) Date the specimen was received by the laboratory;

(c) Accession number or other unique identifier for the specimen;

(d) Type of test performed and the results, including:

(i) Reference range;

(ii) Quantitative results; and

(iii) Results of speciating, grouping, or typing of organisms;

(e) Date of specimen collection;

(f) Type of specimen, for example, blood, urine, stool, or mucus, and the site of specimen collection, for example, cervix, eye;

(g) Date of the laboratory result;

(h) Name, address including number and street, city, state, and zip code, and phone number including area code of the health care provider who ordered the test;

(i) Name, address including number and street, city, state, and zip code, and phone number including area code of the facility that ordered the test; and

(j) For hepatitis C infection:

(i) Signal-to-cut-off ratios and critical values;

(ii) Hepatitis A IgM results; and

(iii) Hepatitis B IgM test results.

C. Timing of Reports.

(1) If the Secretary requires an immediate report, the person making the report:

(a) Shall communicate directly with an individual in person or by telephone; and

(b) May not leave a message on an answering device.

(2) A health care provider and a director of a medical laboratory shall report according to the timeframe in Regulation .03C of this chapter.

(3) School and child care facility personnel, a master of a vessel or aircraft, and the owner or operator of a food establishment shall report immediately.

(4) A health officer shall transmit to the Secretary, by mail or as otherwise specified by the Secretary, all information obtained:

(a) Within 24 hours after receiving notice of a disease or condition listed in Regulation .03C of this chapter; or

(b) Within a shorter amount of time than 24 hours as specified by the Secretary.

(5) The Secretary shall transmit to the health officer of the jurisdiction where the patient resides, by mail or as otherwise specified by the Secretary, all information related to the notice of a reportable condition provided by a director of a medical laboratory located outside of Maryland:

(a) Within 24 hours after receiving notice of a disease or condition listed in Regulation .03C of this chapter; or

(b) Within a shorter amount of time than 24 hours as specified by the Secretary.

Md. Code Regs. 10.06.01.04

Regulations .04 adopted effective December 26, 1980 (7:26 Md. R. 2420)
Regulations .04 repealed effective August 7, 1989 (16:15 Md. R. 1650)
Regulations .04 adopted effective August 7, 1989 (16:15 Md. R. 1650)
Regulation .04 amended effective March 13, 2006 (33:5 Md. R. 519); amended effective 47:9 Md. R. 516, eff. 5/18/2020