High sensitivity flow cytometry testing for paroxysmal nocturnal hemoglobinuria (PNH) is a test done on patient’s peripheral blood to screen for the presence or absence of PNH clones and/or to follow PNH clonal populations. The lower limit of detection of a PNH clone for the Spectrum Health laboratory has been validated as 0.01% (1:10,000) for red cells, 0.01% (1:10,000) for granulocytes and 0.1% for monocytes (1:1000).
The results from PNH flow cytometry testing can guide the clinical team in classifying a patient’s disease appropriately, analyzing the risk of disease progression, and choosing appropriate testing to monitor response to treatment. Therefore, the PNH flow cytometry test result will now include a pathologist’s interpretation based on the new recommendations given in Updated ICCS/ESCCA Consensus Guidelines for the Clinical Utility of Testing for GPI-Anchor Deficient Clones in Paroxysmal Nocturnal Hemoglobinuria (PNH) and other Bone Marrow Disorders (Accepted article by Dezern and Borowitz, doi: 10.1002/cyto.b.21608).
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 legal 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.
As of March 1, 2016, Spectrum Health Laboratory, Grand Rapids, will no longer draw or send a courier for outpatient Ammonia testing (#8074). If outpatient Ammonia testing is needed, the patient must be collected at the 35 Michigan Draw Site. If outpatient Ammonia testing is needed and the patient cannot be drawn at the 35 Michigan Draw Site, approval must be obtained from Dr. David Alter or the Clinical Pathologist on-call, prior to ordering the test.
There will be no changes to inpatient collection. Note: Inpatients are patients who have been admitted to a hospital in the Medical Center (HDVCH, Butterworth, and Meijer Heart Center) or Blodgett Hospital.
Any questions concerning these changes may be directed to the Pathology Department using the Contact Us link above.