The state of Iowa requires the testing of all newborns for hypothyroidism (thyroid stimulating hormone), biotinidase deficiency (biotinidase), expanded screening disorders (amino acids and acylcarnitines), galactosemia (galactose-1-phosphate uridyl transferase), hemoglobinopathies (hemoglobin phenotype), congenital adrenal hyperplasia (17-hydroxyprogesterone) and cystic fibrosis (immunoreactive trypsinogen). Blood specimens are collected on authorized Iowa University Hygienic Laboratory filter paper collection forms and sent to the designated Central Laboratory for Newborn Screening - University Hygienic Laboratory, Ankeny, IA.
II. Clinical Significance: N.A.
1. Type: blood collected on the Iowa Neonatal Metabolic Screening Program (INMSP) collection form - S & S #903.
Note: Store specimen collection forms in a cool dry place. Do not handle the filter paper portion of the form, as skin oils will prevent saturation.
2. Quantity: all 5 circles on the form must be filled adequately.
A. Excess blood is not acceptable. If blood circles touch one another or overlap, inaccurate results may be obtained.
B. Insufficient blood is not acceptable. The examples below show circles and the dotted lines represent the minimum and maximum allowable spot sizes:
C. The blood must soak through the paper from one side and be visible on the opposite side. Do not touch each side of the card to the bleeding site as this will result in a "sandwich" of blood on the two outer sides of the card but no blood on the interior of the card.
D. It is not acceptable to spot the blood on the card after collecting it in a capillary tube.
4. Time sequence: The attending physician shall have the responsibility for assuring that infants under his/her care are screened. Should a parent refuse the test, document said refusal in writing. It will become part of the medical record.
A. The blood shall be collected at least 24 hours after birth but no later than 5 days after birth. In any event, screening should be done prior to discharge even if the patient is discharged prior to 24 hrs. The INMSP collection will be performed when requested by the nursing staff/physician.
B. The INMSP collection form must be filled out by a nurse or physician prior to collection of the specimen including the part pertaining to the status of the infant at collection. The UCL staff member who collects the specimen enters the date and time of collection and his/her initials in the designated places on the form along with the facility number.
C. Recall specimens: Upon notification from the INMSP of unsatisfactory specimen, the laboratory will notify the physician's office.
1. All materials necessary to perform a capillary puncture-heelstick. Refer to “Capillary Puncture, Heelstick” procedure.
2. INMSP collection form (S & S #903) order forms from:
University Hygienic Laboratory
P.O. Box 249
Ankeny, IA 50021
V. Reagents: N.A.
VI. Standardization: N.A.
1. Collecting the specimen is easier if the foot is warmed first.
2. Perform a capillary puncture according to the “Capillary Puncture - Heelstick" procedure.
3. When a large drop of blood has formed, soak the printed circles on the reverse side by touching the form to the blood.
4. Fill all of the circles and allow the blood to air dry at room temperature for at least three hours. (Refer to section III.3. Specimen Integrity.) Keep the specimen away from direct sunlight and heat. Never superimpose one wet filter paper upon another.
5. Provide complete information on the form, printing with pressure. Failure to comply may result in an automatic request for a repeat specimen.
6. The completed form is transported to the University Hygienic Laboratory, Ankeny, IA by Cental Delivery courier service. All specimens should be forwarded to the University Hygienic Laboratory within 24 hours after collection.
VIII. Limitations: N.A.
IX. Results Derivation: N.A.
X. Expected Result(s) and/or Critical Values:
Reports of presumptive positive results are made immediately by telephone from the University Hygienic Laboratory to the attending physician. This report is to be followed within 24 hours by confirmatory letters to the attending physician, birthing facility and birth defects institute. If the INMSP screening results are within normal limits a written report is sent by the Hygienic Laboratory to the referring laboratory. The referring laboratory then forwards the report to the requesting physician.
XI. Quality Control: N.A.
1. Iowa Neonatal Metabolic Screening Program directive, 1994/1995.
2. INMSP memorandum dated 8/10/95
3. State of Iowa, Dept. of Public Health memorandum 7/20/2006.
i. 10-17-83 J. Dall
ii. 8-22-93 K. Cox (Revised: Format; III., IX.)
iii. 8-25-95 J. Mueller (Revised: III. 4.A.)
iv. May 2005 R. Maiers (Revised: testing location, phone and FAX)
v. August 2006 M. English (Revised: I., III.2., VII.6.; addition of cystic fibrosis screening)
Interim Review: July 2011 K. Droeszler (no changes)