Section 410IAC3-3-5. Laboratory reports

   Specific reporting/follow-up requirements vary based on whether the analysis indicated whether the specimen met all requirements for a valid screening test and whether the screening results were normal, unsatisfactory, abnormal, presumptive positive, or confirmed positive. The laboratory shall report as follows:

(1) Negative test results shall be reported within seven (7) days of the date of receipt of the specimen to the following:

(A) MCH/NBS.

(B) The hospital or birthing center submitting the specimens.

(C) The responsible physician or midwife.

The report of the test results shall become part of the patient's clinical record.

(2) Presumptive positive tests shall be reported immediately by telephone to the hospital, birthing center, responsible physician, midwife, or collection source. The notification shall be recorded in the laboratory's records, specifying date and time of notification, person notified, and information provided. This shall be followed by an official report within three (3) days. The report of the test result shall become part of the patient's clinical record. If there is no known responsible physician or midwife, the appropriate state-contracted newborn screening follow-up specialist shall be notified.

(3) Confirmed positive tests shall be reported immediately by telephone to the hospital, birthing center, responsible physician, or midwife and MCH/NBS. The notification shall be recorded in the laboratory's records specifying date and time of notification, person notified, and information provided. This shall be followed by an official report within three (3) days. The report of the test result shall become part of the patient's clinical record. If there is no known responsible physician or midwife, the local health officer in the county of the mother's residence shall be notified.

(4) Unsatisfactory specimens shall be reported immediately by telephone to the hospital or birthing center and responsible physician, midwife, or other health care provider submitting the specimen with an explanation about the reason for rejection. In the event that the responsible physician, midwife, or health care provider who submitted the specimen is no longer the primary health care provider, he or she shall be responsible for notifying the current primary health care provider.

(5) In the event a specimen is rejected for any reason as unsatisfactory, the health care provider responsible for the newborn or infant's care at the time of the report shall be responsible for the submission of an acceptable specimen within forty-eight (48) business hours. If the laboratory does not receive the repeat specimen within five (5) days, it shall send the collection source and responsible health care provider notification of the requirement for a repeat screen, with a copy provided for MCH/NBS. A reminder will be sent five (5) business days after the initial notification if no repeat specimen has been received. The laboratory will notify MCH/NBS immediately by telephone if no repeat specimen has been received seven (7) to ten (10) business days after the reminder letter has been sent so that public health nurse assistance can be obtained.

(6) The designated laboratories performing the tests shall maintain records of the results of all screening and follow-up testing of newborns or infants for these conditions in accordance with Indiana requirements for records management.

(7) The laboratory shall provide newborn heel-stick and hearing screening reports to the department in the format, media, and time frame specified by the department.

(Indiana State Department of Health; 410 IAC 3-3-5; filed Nov 7, 1986, 3:30 p.m.: 10 IR 417; readopted filed Jul 11, 2001, 2:23 p.m.: 24 IR 4234; readopted filed May 22, 2007, 1:44 p.m.: 20070613-IR-410070141RFA; filed Apr 25, 2012, 3:46 p.m.: 20120523-IR-410100504FRA)