Title: Section 69-1.3 - Responsibilities of the chief executive officer

Effective Date


69-1.3 Responsibilities of the chief executive officer. The chief executive officer shall ensure that a satisfactory specimen is submitted to the testing laboratory for each newborn born in the hospital, or admitted to the hospital within the first twenty-eight (28) days of life from whom no specimen has been previously collected, and that the following procedures are carried out:

(a) The infant's parent is informed of the purpose and need for newborn screening, and given newborn screening educational materials provided by the testing laboratory.

(b) Specimen collection forms are properly stored in a cool and dry environment prior to use. Such forms shall be legibly and fully completed and shall include all information required by the testing laboratory for processing specimens, and conducting tracking and follow-up activities, including, but not limited to, information identifying:

(1) the infant's name; sex; whether single birth or, if twin birth, sequence of birth; ethnicity; date of birth; birth weight; medical record number; and whether premature and/or transfused, with transfusion date;

(2) the specimen, including identification number, the date collected, infant's age in hours at time of collection; and whether initial or repeat specimen;

(3) the mother's name, address, county of residence, telephone number, social security number, age in years and test result for hepatitis B surface antigen (HBs Ag);

(4) the hospital or responsible institution's name and city; permanent facility identifier (PFI) code; and whether hospital of birth, or home birth; and

(5) the responsible physician's name, address, telepone number and license number.

(c) The above information shall also be submitted to the department in an electronic format which is consistent with the technical specifications established by the department.

(1) Providers submitting the required information in an approved and validated electronic format, and submitting the minimal necessary identifying information with the specimen, may be exempted by the department from the manual reporting requirements of this section. Additionally, upon receipt of a request from a provider, the department may exempt the provider from electronic submission of the information if the requirement imposes an undue burden on the provider due to a low number of births and limited access to electronic communications equipment, or if temporary equipment malfunctions occur.

(2) The requirement for electronic reporting shall take effect sixty (60) days from the effective date of these regulations.

(d) Specimens shall be taken utilizing correct specimen collection techniques.

(e) A specimen shall be taken upon discharge of the infant from the facility, except as noted below. If an infant is less than twenty-four (24) hours of age upon discharge, a second specimen marked "repeat" shall be collected between the seventy-second and one-hundred and twentieth hour of life.

(1) In the event of prolonged hospitalization for specialized medical care, a specimen shall be collected between the seventy-second and one-hundred and twentieth hour of life. A second specimen marked "repeat" shall be collected upon discharge or at one month of life, whichever comes first.

(2) The responsible institution shall make every effort to obtain a specimen prior to any anticipated blood transfusion.

(3) In the case of inter-hospital transfer of the infant, the transferring hospital shall provide written notification to the receiving hospital indicating whether or not a specimen has been taken prior to transfer. Following transfer, the chief executive officer of the receiving hospital shall assume responsibility for collection of the specimen in accordance with these regulations.

(f) The date and time of specimen collection shall be recorded on the infant's permanent health record.

(g) All specimens shall be allowed to air dry thoroughly on a flat nonabsorbent surface for a minimum of four (4) hours prior to forwarding to the testing laboratory. All specimens shall be forwarded to the testing laboratory within twenty-four (24) hours of collection using the testing laboratory's delivery service or an equivalent arrangement designed to ensure delivery of specimens to the testing laboratory within no later than forty-eight (48) hours after collection.

(h) Thoroughly dried specimens shall be submitted in accordance with instructions provided by the testing laboratory.

(i) All test results forwarded to the chief executive officer or his designee by the testing laboratory shall be included in the infant's permanent health record.

(j) The chief executive officer or his designee shall transmit to the responsible physician a copy of those test results which are determined by the testing laboratory to be within acceptable limits.

(k) The chief executive officer shall be responsible for ensuring that repeat specimens are submitted whenever the hospital is notified by the testing laboratory that the initial specimen was unsatisfactory or that an additional specimen is otherwise required. (1) If a repeat specimen is required and notification has been received from the responsible physician that he/she is no longer the infant's current health provider, the chief executive officer shall determine the infant's new health care provider and cause such repeat specimen to be submitted to the testing laboratory.

(2) If a repeat specimen is not obtained, the chief executive officer shall submit to the testing laboratory written documentation of all efforts made to secure such repeat specimen within ten(10) working days of cessation of specimen collection efforts.

(l) In addition to all applicable preceding requirements for HIV testing the following specific procedures shall be carried out:

(1) Obtain a history of HIV testing and treatment from the mother to enable counseling consistent with such history and knowledge of her own HIV status, and document such history in the medical record. (2) If no HIV test result obtained during the current pregnancy is available for the mother not known to be HIV infected, arrange an immediate screening test of the mother with her consent or of her newborn for HIV antibody with results available as soon as practicable, but in no event longer than 12 hours after the mother provides consent for testing or, if she does not consent, 12 hours after the time of the infant's birth.

(3) The newborn HIV test result shall be maintained securely and confidentially in the medical record of the newborn in accordance with Public Health Law Article 27-F.

(4) The chief executive officer or his designee shall transmit to the responsible physician a copy of the newborn's HIV test result, and, at the request of the responsible physician, shall transmit the result to an HIV specialized care center.

(5) Make referrals as necessary for follow-up of HIV positive newborns who cannot be located.

(6) Ensure that data required by the department for program evaluation and, in the case of HIV positive newborns, for patient follow-up, is collected and provided to authorized staff at the department.

(7) Submit to the department information on the prior HIV testing and treatment history of the mother for the purposes of medical audits; such information shall be kept confidential as required by Public Health Law section 206(1)(j).


VOLUME A-1a (Title 10)