Browsing Tag

Patient Safety

Compliance & Safety

Anti-TPO Assay Falsely Elevated Recovery

A reagent bulletin from Roche has informed us that the recovery of the Anti-TPO assay has been falsely elevated for a reagent lot that was in use at Corewell Health Grand Rapids from September 2024 until March, 3, 2025. Based on the product evaluation, and in conjunction with a product and safety risk assessment, the remaining risk of false positive results with the Elecsys Anti-TPO assay is in the acceptable range.

We apologize for the inconvenience. Please reach out with any concerns or questions.

Best,

Dr. Alvarez
Yasel Alvarez, Ph.D.
Clinical Chemistry and Immunology
Corewell Health Reference Laboratory, West Michigan

Test Information

Thyroid Peroxidase Antibody, Blood Level [LAB516]

Clinical Implications

The risk of false positive results with the Elecsys anti-TPO assay is generally acceptable with respect to the given discrepancy.

Resources

Roche Customer Bulletin TP-02316

Compliance & Safety, Education & Training, General Information

Appropriate Specimen Labeling

Spectrum Health Regional Laboratory is committed to the safety of our patients, and the accuracy and quality of the testing we provide.  In order to do that, we need your help to ensure that patient specimens adhere to our internal policies and quality checks.

THE DETAILS

To that end, we are asking for your help in the process of labeling specimens before they are sent to our laboratory.  It is our policy at Spectrum Health Regional Laboratory that the routine labeling of laboratory specimens MUST INCLUDE FULL LEGAL NAME and DATE OF BIRTH, and if possible, additional identifiers such as medical record number, specimen number, etc. If this information is missing, incomplete or incorrect, the specimen is considered a mislabeled specimen, and will be canceled upon receipt.  (The only exception to this is “precious specimens,” ex. cerebrospinal fluid or surgical specimens, which can sometimes be given an opportunity for relabeling after correct identification).

If a patient specimen is labeled with a NICKNAME instead of the FULL LEGAL NAME, this specimen would be considered a mislabeled specimen and have to follow the above process, which will delay patient care and/or employee eligibility to work.

EXAMPLES

“Alli” Smith Unacceptable  Allison Lynn Smith Acceptable
“Johnny” D Parker Unacceptable John David Parker Acceptable
“Dan” Stevens Unacceptable Daniel Stevens III Acceptable

WHAT WE NEED YOU TO DO

Please review this notice with your collecting/labeling staff as soon as possible to ensure proper labeling practices.  Though not new, this policy has been reviewed by our team members in central specimen processing, and will be strictly adhered to going forward.  Please feel free to forward this notice to anyone involved in the collecting or labeling of laboratory specimens that are sent to Spectrum Health.

Thank you for continuing to trust Spectrum Health Regional Laboratory for your testing needs, and thank you for partnership in attention and commitment to quality and safety!

For questions or concerns regarding this policy, please use the “Contact Us” link above.

RESOURCES

Spectrum Health Labeling Guide

The Joint Commission 2021 Patient Safety Goals

Clinical Laboratory Standards Institute

Spectrum Health Laboratory Policy #9955