Effective November 5, 2017, Spectrum Health Regional Laboratory will be implementing the Paris System for reporting Urine Cytology.
Anal cancer incidence, including in situ and invasive carcinoma is on the rise in North America, with a sharp increase over the past several decades. Oncogenic types of human papilloma virus (HPV) have been shown to be the principle cause of both cervical and anal cancer. HPV is the most common sexually transmitted disease in the United States and anal intercourse is a major risk factor for acquiring the infection. Anal cancer affects both men and women; women having the highest overall likelihood of developing carcinomas of the anorectal region. At risk populations for developing anal carcinoma include men who have sex with men, HIV positive individuals (including those without a history of anal intercourse), immunocompromised patients including a history of organ transplant, those with a history of genital warts, and women with abnormal vulvar, vaginal or cervical Pap results.
Spectrum Health Laboratory strives to ensure that all marketing of laboratory services is honest, straightforward, fully informative and non-deceptive. The Spectrum Health’s Code of Conduct dictates that quality laboratory practices are followed and laboratory marketing activities must meet all government laws and regulations.
Spectrum Health Hospital is pleased to offer patients access to Afirma® Gene Expression Classifier (GEC), a molecular test that helps diagnose thyroid nodules from the first fine needle aspiration (FNA) biopsy.
Patient’s with thyroid nodules often undergo unnecessary surgery, with 70-80% of indeterminate nodules being benign upon surgical histopathology.1-2 By using Afirma GEC in these cases, we can reclassify about 50% of indeterminate thyroid nodules as benign,3 which helps resolve diagnostic uncertainty and reduce unnecessary surgery. Additionally, when cytopathology is malignant or suspicious for malignancy, Afirma Malignancy Classifiers (Afirma MTC and Afirma BRAF) provide actionable insight to help inform the choice of surgery.
Afirma GEC is well validated, including a multi-center, prospective, blinded study published in the New England Journal of Medicine.3 The Afirma solution represents a new standard of care for thyroid nodule patients. Afirma GEC is consistent with molecular testing recommendations from the National Comprehensive Cancer Network, UpToDate and American Thyroid Association guidelines.
Afirma GEC integrates into our thyroid diagnosis process through the following steps:
- During the first FNA, perform two extra passes in order to collect and store a separate sample in the event Afirma GEC analysis is needed.
- Spectrum Health Regional Lab will perform standard cytopathology and provide a diagnosis.
- If the cytopathology diagnosis is indeterminate4 (Bethesda III or IV), Afirma GEC is performed to identify benign nodules. Afirma GEC is not performed when cytopathology is benign or malignant.
- If cytopathology identifies suspicious or malignant results, Afirma offers additional genomic tests-Afirma Malignancy Classifiers – to help guide surgical decisions.
All insurance plans are accepted for Afirma testing, including Medicare. A financial assistance program, Afirma Access, is available for patients who need support with out-of-pocket costs.
Please contact your local Afirma representative, Howie Niskar, (249-496-5626), Howie@veracyte.com for more details. To learn more, you can also visit www.Afirma.com/physicians.
1 Wang CC, et al. A large multicenter correlation study of thyroid nodule cytopathology and histopathology. Thyroid. 2011;21:243-251.
2 Lewis CM, et al. Thyroid fine-needle aspiration biopsy: variability in reporting. Thyroid 2009;19(7):717-723.
3 Alexander E, et al. Preoperative diagnosis of benign thyroid nodules with indeterminate cytology. N Engl J Med. 2012;367:705-715.
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).
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.