All specimens received in the DSHS Newborn Screening (NBS) Laboratory are examined for quality and acceptability. Unsatisfactory specimens are rejected and no testing is performed. The DSHS Newborn Screening Laboratory reports unsatisfactory specimen results to the submitting facility ONLY. It is the submitting facility’s responsibility to ensure than an adequate specimen is re-collected.
See below for information on, examples of, and tips for avoiding the most common unsatisfactory qualities reported by the DSHS Newborn Screening laboratory.
- Blood Did Not Soak Through Paper - Incomplete Saturation
This is the most common reason for unsatisfactory NBS specimens.
Examples (PDF 322kb) / Tips to Avoid (PDF 143kb)
- Blood was Caked, Clotted, or Layered onto the Filter Paper
Examples (PDF 361kb) / Tips to Avoid (PDF 77kb)
- Filter Paper is Scratched from the Possible use of Capillary Tubes
The Clinical and Laboratory Standards Institute and the DSHS NBS Laboratory recommend that the preferred method for collection of NBS specimens is by direct application from a puncture on the baby’s heel. The use of capillary tubes as part of specimen collection should only occur as a last resort. It is imperative to note that EDTA, Citrate and heparin anticoagulants have been shown to interfere with NBS tests.
Examples (PDF 257kb)
- Patient Information Incomplete or Invalid (e.g. date of collection missing)
Identifies specimens that:
When possible, the Newborn Screening Laboratory will attempt to obtain the correct information from the facility that submitted the specimen. However, this can result in critical delays in testing. Every effort should be made to make sure all information on the demographic form is filled out neatly and accurately before submitting.
- Do not meet minimum patient identification requirements
- Are missing the date of specimen collection (DOC)
- Have invalid dates of birth or specimen collection
- Have no means to determine the age of the baby at the time of specimen collection
- Serial Number on Patient Information Form does not Match Number on Specimen Filter Paper
NBS collection kits are medical devices. Submitting facilities MUST not alter the kit.
- Specimen Too Old Upon Receipt
Per CLIA guidelines, newborn screening specimens must be tested within a limited timeframe from the date of specimen collection. The length of time a specimen is viable is determined by manufacturer and DSHS studies. Quick delivery of specimens is imperative as some disorders need to be identified, diagnosed and treated as soon as possible to prevent onset of clinical symptoms. It is important that submitting facilities are mindful of the time between collection and shipment.
Tips to Avoid (PDF 122kb)
- Specimen Submitted on Expired Collection Form
NBS Specimen collection kits are approved medical devices that are manufactured under guidelines developed by the Clinical and Laboratory Standards Institute. Per CLIA and CAP requirements, DSHS cannot complete testing on samples collected after the expiration date printed on each kit. ALL specimens collected on expired forms will be REJECTED and require a REDRAW. Verify each form is valid before use. ALL specimens collected on expired forms will be REJECTED and require a REDRAW. Verify each form is valid before use. Example demonstrating the locations of the expiration date on NBS kits (PDF 438kb).
- Specimen Damaged During Transport to Laboratory
If able to determine that a specimen was damaged in transport to the laboratory, it will be reported as such. The Newborn Screening laboratory recommends shipping specimens in water resistant envelopes (such as Tyvek) to help avoid water damage in transit to the laboratory.
Examples (PDF 344kb)
- Serum Separation due to Improper Drying or Specimen Collection
Examples (PDF 291kb) / Tips to Avoid (PDF 77kb)
- No Blood Samples Received with Request Form
It is not necessary to submit newborn screening kits when there has been no blood collected.
- Specimen Received in Hermetically Sealed Container
The US Postal Service and major couriers require double containment of the sample. The first level of containment is the fold-over flap that is part of the Newborn Screening kit (this flap includes a Biohazard warning label), and the second level is simply a box or envelope. No additional containment is required. Water resistant envelopes are recommended (such as Tyvek envelopes); sealed plastic bags should NOT be used.