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Unsatisfactory Samples

NSO endeavors to test every blood sample we receive. Sometimes, a baby may require a repeat newborn screen, as the first sample was unsatisfactory. This means that the sample could not be tested properly. A sample could be unsatisfactory for various reasons:

  • The quality of the blood sample was poor,
  • The newborn screening card was not filled out properly or the sample was mislabeled,
  • The sample was collected less than 24 hours of age,
  • The sample was received greater than 14 days after collection,
  • Instrument failure in the lab

Repeat samples are requested for all unsatisfactory specimens. It is the submitter’s responsibility to obtain a repeat sample once notified of an unsatisfactory specimen. The submitter should attempt to communicate the need for a repeat specimen directly to the infant’s family or health care provider.

NSO procedure for tracking repeat specimen requests

  1. NSO informs the submitter of the unsatisfactory specimen and a need for a repeat specimen by faxing a report on the day of sample receipt.
  2. If a repeat specimen is not received 3 weeks following notification, NSO sends a repeat request letter to the submitter.
    • Communication attempts to the family and/or health care provider by the submitter regarding the need for a repeat sample should be documented on the repeat request letter, which is faxed back to NSO.
    • The repeat request letter permits NSO to clearly identify whether or not the family and/or health care provider has been informed of the need for a repeat. 
  3. After an additional 3 weeks, a letter is sent to parents if a submitter indicates they have been unable to contact the infant’s family OR if the infant’s health care provider has been contacted but no repeat specimen has be received. A copy of this letter is cc’d to the submitting institution and the infant’s HCP (if known).

Specimen quality and acceptability

A high-quality sample must be collected from the newborn. Unsatisfactory specimens place a burden on the screening system, and cause unnecessary trauma to the infant and anxiety to the infant’s parents. Poor quality specimens can delay the detection and treatment of an affected infant, and could contribute to a missed or late diagnosed case.  

NSO only declares a specimen unsatisfactory if its analysis might yield unreliable, misleading, or clinically inaccurate values for one or more analytes. In these cases, NSO notifies the submitter immediately so that a new sample can be collected as soon as possible. The turnaround time for analytic results is critical to initiate treatment in time to prevent adverse consequences of the disease (such as irreversible mental retardation or death). NSO assumes responsibility for the reliability of the analytic values of every specimen we test.

Contact NSO

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