The information contained here may be very important to your practice. Please take a moment to review this document.

Transcription

1 August 2016 Dear Healthcare Provider, The information contained here may be very important to your practice. Please take a moment to review this document. TEST BULLETIN ZIKA VIRUS UPDATE! On pages 2 and 3 you will find information on which populations should be tested along with how to receive the authorization to test from the State of Indiana or the State of Illinois. Please review carefully if you have patients you feel should be considered for Zika testing. BRAF (V600) BY PCR MELANOMA AND COLORECTAL CARCINOMA The cobas 4800 BRAF V600 Mutation Test is a real-time PCR test on the cobas 4800 system, and is intended to be used as an aid in selecting melanoma patients whose tumors carry the BRAF V600E mutation for treatment with vemurafenib. For more information, please see page 4. REDUCING THE INCIDENCE OF UNSATISFACTORY PAP If you perform Hologic ThinPrep Pap smears in your office, have you ever encountered an incident of an unsatisfactory pap smear, indicated by these comments on your results? If so, please read the in-depth information listed on pages 5 and 6, written by Phil McGuire, M.D., Medical Director of Cytopathology, PCL Alverno. FIND US ON FACEBOOK, LINKEDIN AND GOOGLE PLUS! Page 1

2 Test Summary Utilization Guidelines FREQUENTLY ASKED QUESTIONS: ZIKA VIRAL TESTING WHO SHOULD BE TESTED? CENTERS FOR DISEASE CONTROL (CDC) guidelines state that the following populations should be tested:! Travelers with any of the FRAC (fever, rash, arthralgia, conjunctivitis) symptoms! Pregnant women who have traveled to an area with Zika, regardless of symptoms! Pregnant women who have had unprotected sex with a man who has traveled to an area with Zika and are symptomatic MY PATIENT IS PREGNANT. SHOULD I ORDER A ZIKA TEST? CDC recommends that all pregnant patients be assessed for possible exposure during every prenatal visit. Testing is limited to women who meet the above criteria. See CDC Updated Interim Pregnancy Guidance Algorithm: WHAT STEPS DO I NEED TO TAKE FOR ZIKA TESTING? Assess patient against testing criteria.! Contact your local Department of Health for pre-authorization! Visit the PCL Alverno Collection Manual for Indiana and Illinois links to authorization forms and instructions.! Search under ZIKA VIRUS MY DEPARTMENT OF HEALTH HAS AUTHORIZED TESTING. WHAT ARE THE NEXT STEPS?! INDIANA: Authorization will have proper forms and detailed instructions! ILLINOIS (except Chicago):! Submit Test Request for Human Arbovirus Panel Form *Write LHD authorization number on the top of form.*! Submit CDC form 50.34! CHICAGO:! Submit Test Request for Human Arbovirus Panel Form *Write CDPH authorization number on the top of form.*! Submit CDC form 50.34! Collect at least 1 ml of serum (full Gold Serum Separator Tube) and 2 mls of urine in sterile leak proof container. Spin gold top tube for complete separation of cells and serum. Refrigerate.! Send refrigerated samples and all paperwork to PCL Alverno via your MedSpeed courier pickup for shipment to ISDH or IDPH Page 2

3 ! OR Send patient with all authorized paperwork to a PCL Alverno patient service center (PSC) for specimen collection.! Testing performed will be based on days since onset of symptoms. A PATIENT ARRIVES AT A PSC WITHOUT PROPER AUTHORIZATION PAPERWORK. WHAT WILL HAPPEN? PCL Alverno will be unable to process specimens for shipment to ISDH or IDPH without required paperwork. HOW DO I RECEIVE THE TEST RESULTS? ISDH and IDPH will send reports to the point of contact listed on the test request forms. PCL Alverno does not receive the reports. WHEN CAN I EXPECT MY TEST RESULTS?! Indiana:! Approximately 2-3 days from receipt at ISDH for PCR Trioplex testing.! Serological results from CDC currently have a 4-6 week turnaround time.! Illinois:! Approximately 5 days for PCR and Serology testing.! Specimens may need to be sent to CDC for additional testing. Current CDC turnaround time is 4-6 weeks. WHERE CAN I FIND MORE INFORMATION?! CDC:! Indiana: Zika Virus: Information for Providers:! Zika: Resources at Your Fingertips:! Chicago Department of Public Health:! mmunicable_disease/zikaproviderfaq_final.pdf Page 3

4 BRAF (V600) BY PCR MELANOMA AND COLORECTAL CARCINOMA AVAILABLE NOW Test Summary Utilization Guidelines CLINICAL USE The cobas 4800 BRAF V600 Mutation Test is a real-time PCR test on the cobas 4800 system, and is intended to be used as an aid in selecting melanoma patients whose tumors carry the BRAF V600E mutation for treatment with vemurafenib. Studies suggest that the BRAF V600E mutation in colorectal cancer is associated with poor prognosis and may predict response to anti-egfr therapy. CLINICAL BACKGROUND BRAF mutations have been found in many cancers with a 40-60% frequency in malignant melanomas and an 8-15% frequency in colorectal cancers. The BRAF gene makes a protein called B-Raf, which is involved with sending signals inside cells directing cell proliferation and differentiation. Dysregulation of this signal pathway is a key factor in tumor progression. Whereas patients with BRAF V600 mutated melanomas show a clear survival benefit when treated with BRAF inhibitors, the response rate in metastatic colorectal carcinoma (harboring BRAF V600E mutation) is poor, which suggests different resistance mechanisms between the two cancer types. Detection of this mutation may also be used to identify Lynch syndrome patients since presence of the mutation is believed to be mutually exclusive to the diagnosis of Lynch syndrome. TEST DETAILS Specimen: FFPET formalin-fixed, paraffin-embedded tumor tissue Stability: Room temperature (15-30 C) indefinitely; 5 micron sections mounted on slides may be stored at C for up to 60 days. Cause for Rejection: Absence of tumor cells Method: Real-time Polymerase Chain Reaction performed on deparaffinized and DNA isolated formalin-fixed, paraffinembedded tumor tissue sections. Turnaround Time: Testing is batched once a week CPT CODE* SOFT CODE BRAF (please note that EMR codes for your system may be different) *CPT codes provided are for informational purposes only. Questions regarding coding should be directed to the payor. Page 4

5 HOW TO REDUCE THE INCIDENCE OF UNSATISFACTORY PAP SMEARS Test Summary Utilization Guidelines ABOUT UNSATISFACTORY PAP SMEARS An unsatisfactory Pap test result can be caused by a number of factors, including use of lubricants, excessive blood, and inadequate sample collection. These factors will cause a technical problem with the test and the laboratory staff cannot see the cells clearly enough to make a diagnosis. The percentage of Pap smear test results deemed unsatisfactory ranges from about 1-2% in many laboratories, including PCL Alverno. But it is possible to reduce the number of unsatisfactory Pap test results and recollections. POTENTIAL CAUSES LUBRICANT The recommendation for a patient without physical or physiologic reasons for needing lubricant is to use lukewarm water to warm to lubricate the speculum. If a lubricant is necessary, use a small amount of a water soluble gel lubricant on the sides of the speculum, not the tip. Lubricants containing carbomers or carbopol polymers can have a marked adverse impact on cellularity, and are not recommended for use with the Hologic ThinPrep Pap Test. Vaginal moisturizers, especially those of the bioadhesive type such as Replens, can also interfere with the Hologic ThinPrep Pap. Use should be suspended a week prior to the test. Two approved non-carbomer lubricants are: Pap Test Lubricating Jelly, available from: Aseptic Control Products, Inc. P: info@acpmedicalinc.com Surgilube Lubricant available for purchase though numerous medical distributors and GPOs, listed on their website EXCESSIVE BLOOD Menstrual blood can obscure the relevant cells, potentially masking a neoplasm. Therefore, it is preferable to avoid sample collection during menses. The patient should be advised to schedule her examination when she is not menstruating. SPECIMEN COLLECTION Specimen collection is a key factor in obtaining adequate cellular samples. Specimen collection for a Hologic ThinPrep Pap smear requires either a spatula, brush, or broom device. When collecting specimens using these devices, it is important to use appropriate techniques. SPATUAL COLLECTION TECHNIQUE! Rotate the spatula 360 degrees around the entire exocervix while maintaining tight contact with the exocervical surface.! Rinse the spatula in the PreservCyt by swirling vigorously in the vial 10 times.! Discard the spatula. Page 5

6 BRUSH COLLECTION TECHNIQUE! Insert the brush into the cervix until only the bottommost fibers are exposed.! Slowly rotate ¼ or ½ turn in one direction. Do not over-rotate.! Rinse the brush in the PreservCyt by rotating the brush in the vial 10 times while pushing against the vial wall.! Swirl the brush vigorously to further release material.! Discard the brush. Do not leave the brush head in the vial (the cells may adhere to the brush head). BROOM COLLECTION TECHNIQUE! Insert the central bristles of the broom into the endocervical canal deep enough to allow the shorter bristles to fully contact the ectocervix.! Push gently, and rotate the broom in a clockwise direction five times.! Rinse the broom in the PreservCyt by pushing the broom into the bottom of the vial 10 times.! Swirl the broom vigorously to further release material.! Discard the broom. Do not leave the broom head in the vial (the cells may adhere to the broom head) ADVICE TO THE PATIENT To ensure a satisfactory Pap smear test result, the patient can be advised to follow these tips PRIOR to their appointment: 1. Schedule their visit for two weeks after her period ends. 2. Refrain from sexual intercourse for 48 hours before visit. 3. Refrain from douching for 48 hours before visit. 4. Avoid using tampons or intravaginal medication for at least 48 hours before the examination to decrease the possibility that the number of exfoliated cells will be diminished or obscured by personal lubricants or spermicides. 5. Suspend use of vaginal moisturizers the week prior to visit. ADDITIONAL INFORMATION For more information about the Hologic ThinPrep Pap Test for your office and for your patients, you may also directly contact the technical support department of Hologic, the manufacturing company of ThinPrep, at: , Option Dr. Philip McGuire, Medical Director of Cytopathology at PCL Alverno, is available to assist you as well and can be reached by phone: or Philip.McGuire@franciscanalliance.org Page 6