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Compliance & Safety

Chemistry, Compliance & Safety, General Information

Reference Range Update: Anti-Thyroid Peroxidase Antibody

As of October 1, 2018, the reference interval for Anti-Thyroid Peroxidase Antibody levels has been updated to 0.0 to 34.9 IU/mL from 0.0 to 8.9 IU/mL. This change is due in part to client feedback resulting in an audit of the existing range and leading to discovery that it had not  been updated when the instrument had been changed.

We appreciate and welcome any and all client feedback; if you identify what may appear to be an incorrect reference interval, please notify us immediately using the “Contact Us” link above.

Compliance & Safety, Education & Training, Immunochemistry

Collection Update to QuantiFERON Gold

Effective immediately, QuantiFERON®-TB Gold test (QFT), the industry-leading Interferon-gamma Release Assay (IGRA) for TB detection used at Spectrum Health Regional Laboratory is being replaced by the QuantiFERON-TB Gold Plus (QFT-Plus).

The QFT-Plus is now optimized with innovative tuberculosis-specific antigens that elicit both CD8 and CD4 T cell responses, enabling a more comprehensive assessment of cell-mediated immune response to TB infection. The test principle, procedures, and specimen handling will remain the same with the one exception being that the collection kit will now consist of four tubes instead of three. Three-tube collections can no longer be accepted and will thus be canceled.

If you have three-tube collection kits, please order new four-tube collection kits in Lawson (#54909) or via the Lab Supply Order Form.

Please direct urgent questions to the Laboratory Call Center at 616-774-7721 or for non-urgent inquiries use the “contact us” link above.

Compliance & Safety, Education & Training, General Information, Referral/Sendouts

Chlamydia and Gonococcus Testing on Pediatric Patients

Spectrum Health Regional Laboratory is not validated to perform Chlamydia and Gonococcus testing on pediatric patients under the age of 14 years old. Testing for these patients must be sent to a reference laboratory. Please order a Reference Miscellaneous Test (#LAB848) and indicate complete test name when ordering. Continue Reading

Compliance & Safety

Biotin Alert

Biotin is widely used in immunoassay type laboratory methods over a wide range of instruments at numerous clinical laboratories throughout the world (including Spectrum Health).

With the expansion of biotin – also known as vitamin B7 – supplementation and treatments (“over the counter” and prescription, respectively); an associated interference with many clinical laboratory tests has been identified, confirmed and documented. Unfortunately, magnitude and type (falsely increased/decreased) of interference varies with dose and assay; however, it has been confirmed that as dose increases so does the magnitude of the response. In late November 2017, the Food and Drug Administration (FDA) published a safety alert warning that biotin can interfere with certain lab tests and cause incorrect test results. Continue Reading

Blood Bank, Compliance & Safety

Blood Bank Specimens Require Two Signatures

Effective October 15th, 2017, all specimens collected for Blood Bank must have two signatures on the specimen written in ink that is resistant to smearing after a patient has been identified according to the Patient Identification Policy.

One of the two collectors/witnesses must be a lab staff member, unless specimen is collected in Spectrum Health Surgery, Infusion Center, Special Care Hospital, Cardiac Cath Lab Procedure Room, or a cord blood in Labor and Delivery. For Outpatients, the patient may serve as the witness and initial the tube label. Continue Reading

Compliance & Safety, Toxicology

Urgent Notice: Lead Testing

On May 17, 2017, the US Food and Drug Administration (FDA) issued a safety communication warning against using venous samples on Point of Care Magellan Diagnostics LeadCare Testing System devices (LeadCare, LeadCare II, LeadCare Plus, and LeadCare Ultra). Venous specimens appear to be at risk for having falsely low results.  Only Capillary (“finger stick” or “heel stick”) specimen types should be used.

IF YOUR OFFICE IS USING ANY OF THE MAGELLAN LEADCARE TESTING SYSTEM DEVICES: please DISCONTINUE the use of VENOUS specimens for testing. Continue Reading

Compliance & Safety, Education & Training, General Information

Maintaining Specimen Integrity – Purple Priority Bags

purple priority bagSpectrum Health Regional Laboratory supplies purple priority bags for specimens that must be handled and processed immediately upon receipt in the laboratory. The purple color priority transport bag will be a visual cue to the receiving laboratory that the specimens inside the bag need to be handled or processed immediately at the time of arrival in the laboratory or the integrity of the specimen will be compromised.

Use these bags for transporting specimens to the laboratory when: Continue Reading

Compliance & Safety, Cytology, Education & Training

Appropriate Labeling of Specimens

Safety of our patient and quality of care are of utmost importance. For this reason we require specimens sent to the Spectrum Health Cytology Laboratory be labeled with at least two patient identifiers, (i.e., patient name, birth date and MRN.) We will no longer return to the collection site, unlabeled, mislabeled specimens lacking two patient identifiers or specimen containers with multiple different patient labels. These specimens will be discarded and repeat collection will be necessary.

Procedures to verify correct labeling of patient specimens at the time of collection are recommended.   Specimen containers should not be pre-labeled. Variation of the “time-out” procedure used in the hospital and surgical center setting is an excellent way of confirming that the specimen is correctly labeled. This can easily be achieved by having the patient verify his or her name and birth date, by reading the label placed on the specimen container at the time the specimen is collected. This “time out” should occur before the specimen leaves the examination or treatment room.

It is our mission to provide the best and safest care we can to our patients. We know that physicians and other practitioners are required to see patients more efficiently and at times with less than adequate time allowed. Following a “time out” procedure and not pre-labeling specimen containers will prevent errors that may lead to diagnoses being assigned to wrong patients, hence, unnecessary procedures and lack of follow-up for the appropriate patient.