20 CAR § 172-125 – Tracking and recall of donor human breast milk

(a) A system of tracking donor breast milk from donor to recipient is maintained.
(b)
1. (1) A mock recall to test the breast milk bank's ability to track a donation from donor to recipient in six (6) hours or fewer is carried out and documented:
  1. (A) In a breast milk bank's first year of operation; and
  2. (B) Every two (2) years thereafter.
2. (2) The need to conduct a true recall in any given year:
  1. (A) Negates the need for a mock recall; and
  2. (B) Resets the calendar until a mock recall is needed.
(c) Product replacement is conducted at the discretion of the dispensing breast milk bank.
(d) Individual breast milk banks are responsible for ensuring that they are compliant with their state or federal requirements for operation.
(e)
1. (1) A person designated by each breast milk bank immediately investigates a suspected release of breast milk that does not meet this part.
2. (2) If a problem is determined, the designated person:
  1. (A) Initiates a root cause analysis; and
  2. (B) Modifies internal procedures as appropriate.
3. (3) It is the individual recalling breast milk bank's responsibility to gather all data investigating the risk level associated with the suspected error.