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.
Compliance & Safety
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.
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.
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.
Spectrum 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.
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.
Leaky specimen containers may cause compromised test results and it is also a hazard to lab couriers and registration personnel. Please be sure to inform patients that leaky specimen containers are not acceptable and may be rejected.
In the College of American Pathologists publication CAP Today the question was asked, “Are there regulations guiding the practice of taking additional blood samples from a patient (in case additional testing is needed later) even though there are no orders for the blood samples?” The limited literature on this topic has shown that inpatients (in those studies) have had up to 700 mL of blood collected during hospital stays. Thus we have to step back and ask: Does that make sense?
Read the response offered by David N. Alter, MD, DABCC, Clinical/Chemical Pathologist, Spectrum Health Regional Laboratory.