Thursday, March 22, 2007

Chain of custody.

There was an interesting post in KevinMD today regarding a law suit brought against a reproductive center that does IUI. As a fertility specialist, I find this particularly interesting as the suit hits directly at a major aspect of any lab: chain of custody.

Chain of custody details who has direct control of a specimen, be it a blood sample, biospy specimen, vas deferens post-vasectomy, or semen sample from the time the specimen leaves the patient's body until the it reaches the lab, even beyond. Breakdowns in chain of custody may result in big problems down the road for patients, labs, physicians, and everyone involved. As a solo practitioner, you are the number one responsible person when it comes to chain of custody. Fortunately, as a solo practice owner, you can set up policies that control every aspect of chain of custody. Here is how I do it.

  • Patients label all their own urine samples immediately after voiding. Pen and label are kept in bathroom.
  • Unlabeled specimens are discarded unless the patient can verify that the specimen is theirs.
  • Semen samples are labeled in the same way as the urines.
  • Overnight semen samples (I have a method to preserve the quality of the semen over a 24 hour period) are labeled by the patients.
  • Blood samples and taken into the lab immediately after blood draw and labeled. The label number must match the requisition form. The requisition form is immediately marked with the patients name and identifying data.
  • In-office biopsy or vasectomy specimens are handled as the blood samples.
  • Reproductive samples, for example, a testis sperm retrieval sample, are immediately labeled with the patient's name and identifying data. The specimen is then transported by either the patient or my office staff to the cryolab. If we do the transporting, the specimen never leaves our direct possession. The cryolab then verifies the name and identifying data on the specimen, matches the name to a photo ID, and makes the patient or me (whom ever delivers it) sign a chain if custody form.
  • When the reproductive specimen is used, the specimen is again matched to the patient via photo ID and the match is attested to on a signed form.

Any breakdown in protocol can result in disaster. Perhaps that is what happened in the above case. Who knows.

The IU.