October Billing and compliance. Coagulation. Immunohistochemistry. Immunology. Referral testing ICD 10

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October 2015 Billing and compliance ICD 10 Coagulation Processing, transport and stability changes for multiple coagulation tests Immunohistochemistry IHC stain updates Immunology Lyme Western Blot testing schedule update Referral testing PCA3-Plus changes

BILLING AND COMPLIANCE ICD 10 On October 1, 2015, Allina Health, along with other healthcare providers nation-wide, began coding patient records with ICD 10 diagnosis and procedure codes. In preparation for this change, Allina Health Laboratory updated our three request forms that contain hard coded diagnosis codes: Andrology, Cytology Pap and Clinical. We have printed and shipped initial supplies of these request forms to any clients who use them to submit testing to us. Previous versions of these requests forms should be removed from use and the new forms (dated October 2015) placed into use. If you use any of these request forms, and have not yet received the updated documents, contact your account representative for assistance. When submitting any work to Allina Health Laboratory, and you have indicated that the work is to be billed to the patient s insurance, you must provide all appropriate ICD codes in the ICD 10 format (preferred), or a descriptive narrative. If ICD 9 or incomplete narratives are provided, you will be contacted for complete, correct codes in order that we might submit the insurance claim. If you are running low on any Allina Health Laboratory request forms, place an order for additional supplies using our Supply Catalog. To ensure that you have the most current forms, copies should be made only in emergent cases. 2

COAGULATION Processing, transport and stability changes for multiple coagulation tests In order to optimize the accuracy and reliability of coagulation testing, pre-analytic processes must be standardized according to recommended guidelines. Effective October 12, 2015, Allina Health Laboratory requirements changed to indicate that all coagulation testing, with the exception of Protime/INR and Factor10 Chromogenic, be processed for platelet poor plasma (PPP) and frozen at the collection site prior to transport. Instructions for the processing of PPP are linked to each tests in the catalog. Sites must ensure that samples are completely frozen before they are sent with the courier. If they are not, they should be held at the site until the next available courier. Protime/INR and Factor 10 Chromogenic specimens can continue to be sent as whole blood at ambient temperature as long as sending site can guarantee they will arrive at Central lab in the specified times (INR within 24 hours, and Factor 10 Chromogenic within 48 hours). Tests affected by the change include: Test Name Test #/Excellian Order code Anti Thrombin III Activity 621/85300.0 APTT 490/85730.0 D-Dimer 3433/85379.0 Argatroban 7780/85130.2 Dabigatran (Pradaxa) level 8815/LAB8815 Factor 2 Activity 7566/85210.1 Factor 5 Activity 635/85220.0 Factor 7 Activity 637/85230.0 Factor 8 Activity 638/85240.0 Factor 9 Activity 639/85250.0 Factor 11 Activity 641/85270.0 Factor 12 Activity 628/85280.0 Fibrinogen, Quant 101/85384.0 Heparin Antibodies, IgG Specific 8771/LAB8771 Heparin Antibodies, Polyspecific 8775/LAB8775 Heparin level 2283/85520.2 Low Molecular Weight Heparin 2281/85520.1 Lupus Anticoagulant 5751/LAB5751 Protein C Activity 5756/85303.0 Protein S Activity 5750/LAB5750 Thrombin Time 510/85670.2 Von Willebrand Screen 507/LAB507 The test catalog listings for each of the affected tests has been updated to reflect these changes. Again, this change does not affec the Protime/INR (487/85610.0) or the Factor 10 Chromogenic (5767/85130.0). 3

IMMUNOHISTOCHEMISTRY The following new immunohistochemistry (IHC) antibodies and in situ hybridization (ISH) probes are now available in the IHC lab. Please see below for specific information. Also, information on GATA3 staining has been updated (see below). Since this antibody has recently been found to stain other tumors (besides breast and urothelial tumors), careful attention to staining and a panel approach is recommended. New antibodies and probes in our lab: Albumin ISH HPV 16/18 ISH on head and neck cases See the following page for additional information on HPV testing in anogenital tumors. Adipophilin IHC (ADP) Albumin is abundant in liver cells and albumin ISH for mrna is highly specific to cells of hepatocyte origin. Recent studies have shown that virtually 100% of hepatocellular carcinomas and >95% of intrahepatic cholangiocarcinomas will show positive staining for albumin mrna. This marker can be useful in confirming a tumor of hepatic origin Affymetrix (HPV) 16/18 RNA probe cocktail (E6 and E7) can be used to determine if head and neck cancers are positive for HPV 16/18. HPV related squamous cell carinomcas (SCC) are associated with a better prognosis and are reportably more radiosensitive than non-hpv SCCs. HPV16/18 should be ordered with P16 IHC. This marker may be used to identify sebaceous neoplasms, including sebaceous carcinoma and sebaceoma (sensitivity is approximately 97%). Identifying the correct staining pattern is crucial; cytoplasmic membranous pattern of intracytoplasmic lipid globules is considered positive, while granular staining is considered negative for ADP. 4

SOX11 (IHC) Most (90%) mantle cell lymphomas are SOX11 positive (even when t(11;14) translocation and cyclin D1 are not detected) and most mimics are SOX11 negative. And, Sox11 identifies the 2% of mantle cell lymphomas that lack Bcl-1/cyclinD1 staining and standard t(11;14) FISH. Approximately 10% of mantle cell lymphomas are SOX11 negative, and these cases tend to present more frequently with non-nodal leukemic disease and have a more indolent course. SOX11 should be ordered with Bcl-1/cyclin D1 HPV testing: HPV testing on head and neck cancers can be performed on paraffin embedded formalin fixed tissue by in situ hybridization (ISH). These cases will be interpreted by pathologists on the ENT team, and a report will be issued for you.. For HPV testing on anogenital cases, please order by HPV-PCR, which will provide testing on many high risk strains. GATA3: GATA3 is not as specific as originally reported. And the staining can be variable, ranging from 5% to 100%. In breast cancers, the degree of staining should parallel the ER staining. Thus, if a possible breast cancer is strongly positive for GATA3 but negative or only focally/weakly positive for ER, consider additional stains to evaluate for possible ovary or endometrial cancers. Other cancers found to be positive for GATA3 include squamous cell carcinoma, pancreatic adenocarcinomas, and malignant mesotheliomas. If you have any questions regarding this information, please contact Tami Lillemoe, MD, Hospital Pathology Associates and Allina Health Laboratory at (612) 863-4670. 5

IMMUNOLOGY Lyme Western Blot testing schedule update Due to the approach of the end of tick season, and a noted decrease in the number of positive Lyme tests, Allina Health Laboratory is transitioning to our off season testing schedule for the Lyme confirmatory Western Blot (WB) testing. Lyme confirmatory testing will be performed on Tuesdays and Thursdays until the start of the 2016 tick season. REFERRAL TESTING PCA3-Plus changes Due to the acquisition of the clinical portion of Bostwick Laboratories by Laboratory Corporation of America (LabCorp), the PCA 3-Plus (LAB12479) assay previously referred to Bostwick Laboratories, is being referred to LabCorp. There are minor changes to the specimen processing and transport instructions which are all detailed below. The Allina Health Laboratory electronic test catalog has been updated with these changes. Along with the processing and transport changes, there are also CPT and pricing changes associated with the testing lab change. Previous CPT: 81479 New CPT: 81313 Previous Price: $147.40 New Price: $330.50 6

btest Name: PCA3-Plus Test Number: 12479 Collect: Container: Processing: Transport/Stability: Urine; first-catch following DRE Gen-Probe Progensa Urine Specimen Transport Tube Fill transport device to the indicated line using a disposable pipet Refrigerated - must reach LabCorp within 5 days Frozen - 3 months Alternate Names: Prostate Cancer Gene 3 PCA Progensa PCA3 LAB12479 Performing Lab: Days Set Up: Expected TAT: Ref. Ranges: Collection/ Processing Details: LabCorp (489160); R-NX N/A N/A N/A Before collection, the patient should undergo an attentive digital rectal exam (three strokes per lobe). 1. Collect a first-catch (approximately 20 to 30 ml of the initial stream) urine sample in a urine collection cup after DRE has been performed. Urine sample should be processed immediately following steps 2 and 3. 2. Invert the sample five times to resuspend the cells. Transfer 2.5 ml of urine (fill until the fluid level is between the black lines) into the urine specimen transport tube using a disposable pipette. 3. Recap the urine specimen transport tube tightly and invert five times to mix. Method: Target capture, transcription-mediated amplification (TMA) and hybrid protection assay (HPA) CPT Codes: 81313 Supply Connection: Gen-Probe Progensa Urine Specimen Transport Kit Date Created: 06/05/2009 Revised Date: 09/14/2015 7

WEBSITE CEU DVD s Available for Checkout Allina Health Laboratory has presented continuing education presentations in the Twin Cities area. For those unable to attend, we have recorded each presentation and made the DVDs available for loan. A listing of available presentations and a DVD Request Form can be found under the Continuing Education heading on our website homepage. Thank you for choosing Allina Health Laboratory We value your business! 8