Section 410IAC3-3-6. Maintenance of screening logs; follow-up of missing results; monthly reports as submitted by hospitals, birthing centers, midwives, and physicians providing home birth services

   (a) Each hospital or birthing center, and midwife or physician submitting screening tests on newborns or infants born outside a hospital or birthing center shall maintain a newborn screening log that shall contain the following:

(1) Name of newborn or infant.

(2) Attending physician or midwife.

(3) Medical record number.

(4) Form number of sample sent.

(5) Date sample collected.

(6) Date sample sent.

(7) Date results received.

(8) What the results were.

(9) Name of person notified of positive results and date and time of notification.

All such information and records shall be confidential but shall be open to examination by the department personnel or its designated agents for any purpose directly connected with the administration of the newborn screening program.

  (b) The log shall be reviewed daily to determine that the results of required tests have been recorded within fourteen (14) days of discharge, or that a parent's signed religious waiver has been filed in the infant or newborn's medical record.

  (c) Whenever a hospital, birthing center, physician, or midwife determines that a discharged newborn or infant has not received the mandated tests, the hospital, birthing center, physician, or midwife shall immediately contact the responsible health care provider by telephone to inform him or her that a specimen must be obtained and immediately send a written notification to the responsible health care provider and MCH/NBS. If the responsible health care provider cannot be contacted within three (3) days or will not obtain a specimen, the hospital, birthing center, physician, or midwife shall notify MCH/NBS immediately by telephone and shall send written notification within three (3) days to MCH/NBS. MCH/NBS shall then immediately notify the local health officer, who shall arrange collection of a specimen.

  (d) Whenever a hospital, birthing center, physician, or midwife determines that a specimen has been obtained but there are no results available in the infant or newborn's medical record within fourteen (14) days of discharge, the hospital, birthing center, physician, or midwife shall obtain the results from the laboratory by telephone and request that another written copy be sent. The hospital, birthing center, physician, or midwife shall also notify MCH/NBS that results have not been received. If no results are available from the laboratory, then the hospital, birthing center, physician, or midwife shall proceed as in section 7(c) of this rule.

  (e) When the responsible health care provider is notified by telephone by the hospital, birthing center, physician or midwife that a newborn or infant was discharged before a specimen was taken, or if the health care provider determines from his or her own records that no test has been performed or that no results are available, the responsible health care provider shall make every reasonable effort to have a specimen obtained within three (3) days of notification. If the responsible health care provider cannot obtain the specimen, the health care provider shall notify MCH/NBS immediately by telephone. The telephone notification shall be noted in the responsible health care provider's record, specifying the date of notification, the person notified, and the information provided.

  (f) When the responsible health care provider is notified by the laboratory by telephone that a specimen is inadequate, the health care provider so notified shall make every reasonable effort to have an adequate repeat specimen obtained within forty-eight (48) hours of notification. If the responsible health care provider so notified cannot obtain the repeat specimen, the health care provider shall notify MCH/NBS immediately by telephone. The telephone notification shall be noted in the responsible health care provider's records specifying the time and date of notification, the person notified, and the information provided.

  (g) All repeat specimens shall be forwarded to a designated laboratory within twelve (12) hours after they have been obtained.

  (h) MCH/NBS shall make every reasonable effort to follow up on all newborns and infants that have been reported as not having received a completed screening in an attempt to ensure that all newborns and infants born in the state of Indiana will have received the required screening for disorders.

  (i) Hospitals, birthing centers, midwives, and physicians providing home birth services shall provide monthly reports to the department indicating the total number of live births and the number of newborns or infants for whom specimens were submitted for initial newborn screening. (Indiana State Department of Health; 410 IAC 3-3-6; filed Nov 7, 1986, 3:30 p.m.: 10 IR 418; 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)