Current through Register Vol. 51, No. 19, September 20, 2024
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.
