Sec. 10.10.13.14. Screening Test Blood-Spot Specimens — Procedures, Submission, and Delivery Requirements

A. Standard Operating Procedure. The individual in charge of a birthing facility or the individual’s designated representative, or the home birth attendant shall maintain written standard operating procedures for the collection, handling, storage, and transport of newborn infant blood-spot specimen collection test requisition cards, including instructions for staff to:

(1) Ensure and maintain blood-spot specimen integrity, quality, and acceptability;

(2) Ensure proper:

(a) Site preparation and cleaning;

(b) Performance of the heel stick puncture; and

(c) Application of whole blood to the collection test requisition card;

(3) Identify precautions against:

(a) Milking or squeezing the blood-spot specimen collection site;

(b) Layering successive drops of blood on the same circle on the blood-spot specimen collection test requisition card;

(c) Filling the circles on both sides of the filter paper;

(d) Touching or smearing a blood-spot specimen before it is fully air-dried;

(e) Scratching or abrading the blood-spot specimen;

(f) Not allowing a blood-spot specimen to dry thoroughly before sending the blood-spot specimen collection test requisition card to a laboratory; and

(g) Damaging, stretching, or wrinkling the filter paper before, during or after blood-spot specimen collection;

(4) Recognize unsatisfactory blood-spot specimens; and

(5) Handle and temporarily store a blood-spot specimen collection test requisition card, including the procedures and techniques for:

(a) Drying blood-spot specimens;

(b) Stacking of blood-spot specimen collection test requisition cards; and

(c) Temporarily storing blood-spot specimen collection test requisition cards.

B. Submission and Delivery Requirements. The individual in charge of a birthing facility or the individual’s designated representative, or the home birth attendant shall transport and deliver to the Department’s public health laboratory a newborn infant blood-spot specimen collection test requisition card using:

(1) An employee or private courier;

(2) A commercial carrier providing:

(a) Overnight express delivery; or

(b) Priority delivery;

(3) A county or State operated courier system, where that service is available; or

(4) A combination of §B(1)-(3) of this regulation.