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).
In 2014 The Bethesda System for reporting of Pap smears was revised. These revisions were published in 2015. We have modified our diagnostic categories to reflect these changes.
Reporting of endometrial cells in women over 40 years of age was changed to reporting endometrial cells in women over 45 years of age.
Recommendations were made to discontinue the use of Low grade squamous intraepithelial lesion (LSIL) with a few cells suggestive of high grade squamous intraepithelial lesion (HSIL). Based on the recommendations in Bethesda 2014, these lesions will be diagnosed as ASC-H in a background of LSIL.
The recommendation clarifies the treatment algorithm for these patients. These patients should have colposcopy. In our experience over 50% of these patients have biopsies diagnosed as high-grade squamous intraepithelial lesion (HSIL).
Laboratory reference ranges vary depending on the sex (gender) of the patient. Spectrum Health Laboratory’s policy is to report reference ranges for a result based on the sex the ordering provider provided on the order, or given to our staff via the patient’s ID. This will require extra care when interpreting results for patients who are transgender. Some reference ranges may change as a patient transitions between genders, while others may not. Please always evaluate results based on the reported sex and reference in light of your patient’s gender role.
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.
Numerous 1,25-Dihydroxyvitamin D (1,25(OH)2D) requests are received daily (1200 in 2015). This is not the standard test for Vitamin D status. 1,25-Dihydroxyvitamin D testing should be reserved for patients with renal disease, sarcoid, tuberculosis, lymphoma and rickets, as well as, long term use of protease inhibitors, glucocorticoids, or anticonvulsants. Vitamin D 25 (25 OH D) level is sufficient in most cases. The number of requests and review of the ordering providers raises a concern that a number of these requests were ordered inappropriately.
In an effort to decrease the number of potential improperly ordered tests and consequently decrease unnecessary costs to patients, insurance companies, and the laboratory, please review your individual ordering practices.
In the near future, this test name will be changed to “Renal 1,25 Dihydroxyvitamin D” to better reflect its appropriate utilization.
Any questions concerning Vitamin D testing may be directed to Dr. David Alter in the Pathology Department.
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 Dr. David Alter in the Pathology Department.
The Spectrum Health Laboratory is now reporting all Hepatitis C Antibody results as Negative or Positive only. (Hepatitis C Antibody, Screening; Hepatitis C Antibody, Diagnostic) The separate Low Positive result category has been eliminated.
The Laboratory has changed to a new Hepatitis C Antibody reagent which no longer includes the Low Positive result category in its product labeling (the FDA approved instructions which laboratories are required to follow). The Low Positive category was defined on the basis of old guidelines which indicated that results above a defined S/CO (signal/cutoff) value were considered to have a 95% or greater probability of being true positives and did not require RIBA confirmation. The RIBA confirmatory test has not been available for several years now. Current guidelines are that all positive Hepatitis C Antibody tests should be confirmed with a HCV RNA test. The Spectrum Health laboratory reflexes all positive antibody results to this test. A positive HCV RNA following a positive antibody result should be considered indicative of active HCV infection, and may be used as a baseline for antiviral therapy.
Non-fasting results on intended fasting laboratory tests will alter their interpretation and diminish their utility. Please help remind patients to arrive fasting if fasting tests are required. Spectrum Health Regional Laboratory recommends no caloric or caffeine intake for at least 8 hours. The patient is not to drink (other than water), eat, smoke, chew gum, candy, cough drops, etc. for at least 8 hours prior to their blood tests. Please check the Laboratory Catalog prior to sending your patient or patient’s specimens to the laboratory.