2023 Laws of Puerto Rico › TITLE TWENTY-FOUR - Health and Sanitation (§§ 1 — 15010) › PART VII - Hospitals, Institutions and Health Programs (§§ 3001 — 3891) › Chapter 148B - Birth Defect Monitoring System (§§ 3531 — 3538) › § 3533 - Establishment and maintenance

(a) The current Puerto Rico Birth Defect Monitoring System shall be made mandatory, as will be the reporting of birth defects to the Department of Health.
(b) The Monitoring System shall continue to be attached to the Department of Health, which shall be responsible for assigning the personnel and resources necessary to ensure the building of a valid, reliable and continuous database on the occurrence of birth defects in Puerto Rico.
(c) The Department of Health shall draft regulations to define the norms and procedures and address all related matters for the implementation of this chapter within a term of 120 calendar days following the date of approval of this act. These regulations shall be made pursuant to the provisions of §§ 2101 et seq. of Title 3, known as the “Uniform Administrative Procedures Act”. These norms and procedures may include mechanisms to determine the birth defects to be monitored, the scope of the information to be gathered, the administration of data, the appropriate mechanisms for follow-up, referral system, and mechanisms for the revision and evaluation of the activities of the Monitoring System. This procedure shall also facilitate and define collaboration among, medical services and diagnostic facilities, health professionals and the Department of Health or its agents or officials.
(d) The development of the regulations mentioned above shall contemplate the publication and distribution of forms, instructions and notifications required by law or necessary to comply with this chapter.
(e) In the exercise of its functions, the Department of Health may adopt, promulgate, amend and repeal, pursuant to the law, any norms and regulations necessary to meet the purposes of this chapter.
(f) When establishing the Monitoring System under the law, the Department of Health shall require all health care providers and all health care and diagnostic facilities, as well as other medical facilities, to make available for review the information contained in medical records of patients suspected to have or having a confirmed diagnosis of a birth defect in Puerto Rico.
(g) The Monitoring System shall cover the entire population of Puerto Rico.
(h) The System shall use a recognized medical system to specify the birth defects to be included and researched according to their impact on public health.
(i) All health services or diagnostic facilities shall be under the obligation to notify the Department, within a term of fifteen (15) calendar days, each and every occurrence of a birth defect so diagnosed or suspected in any pregnant woman, regardless of the end result, or in a child age six (6) or under.
(j) Reports on cases to the Birth Defect Monitoring System must be submitted with a minimum of information for the case to be identified afterward by the assigned personnel. The minimum of information required on the report shall be determined by the Department of Health.
(k) The Department of Health shall require all health services and diagnostic facilities to maintain for a minimum of five (5) years, a register of their patients between the ages of zero (0) and six (6) years, inclusive, diagnosed to have birth defects, and of all women yielding a result of a pregnancy affected by a birth defect. The register shall be made available to the Department of Health if so requested and used solely for the purposes stated in this chapter.
(l) The Department of Health shall also require all health services and diagnostic facilities to maintain a register of all stillbirths or miscarriages suspected to have a birth defect.
(m) For System-related purposes, the Department shall have access to the medical record in any health services and diagnostic facility and other agencies and institutions concerned, of any case with a diagnosis of or suspected to have a birth defect, including the mother’s record.
(n) The Department of Health shall establish the procedure to obtain follow-up information from the agencies or institutions required to notify the occurrence of birth defects. Any follow-up information, including family contacts, physicians, hospitals or laboratories, required by the Department of Health shall be submitted by the abovementioned agencies or institutions within the timeframe or the period that the Department determines. This procedure, as well as everything concerning the compilation and dissemination of patient information, shall be conducted pursuant to applicable Commonwealth and federal regulations.
(o) To ensure accurate and necessary data sources to research birth defect incidence, prevalence and trends, the Department of Health shall require health services and diagnostic facilities and health professionals to make available for review by authorized personnel, the medical records or other kinds of information at the health services and diagnostic facilities or under the custody or controlled by agencies or health professionals, which may be related to the occurrence of birth defects.
(p) The Department of Health shall determine and regulate the manner in which the records and other information shall be available for review by designated personnel.
(q) Likewise, on a date subsequent to the event, the Department of Health may obtain from any health services and diagnostic facility, the records, test results, or related information on cases of birth defects not diagnosed or reported by said health services and diagnostic facility.
(r) The following persons acting in compliance with this section may not be prosecuted either civilly or criminally for furnishing required information:
(1) A hospital, clinical laboratory, genetic treatment center, or other health care facility.
(2) A hospital, clinical laboratory, genetic treatment center, or other health care facility administrator, official or employee.
(3) A physician or a physician’s employee.
(s) Any person or entity who with malice aforethought and without just cause does not provide the required information to the Birth Defect Monitoring System or who fraudulently uses the information provided to the Birth Defect Monitoring System, may be subject to penalties as established in the regulations for each premeditated act or fraudulent action.
History —Sept. 16, 2004, No. 351, § 5.