May Billing and Compliance. Hematology. Immunohistochemistry. Immunology. Microbiology. Referral Testing. Supplies

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1 May 2018 Billing and Compliance Glomerular basement membrane, IgG assay CPT code Hematology Differential reporting changes Immunohistochemistry Anaplastic lymphoma kinas (ALK) therapeutic update Multiple stains discontinued Immunology Celiac cascade methodology and reference range changes QuantiFERON-TB gold assay replaced by QuantiFERON-TB gold plus Microbiology 2017 Antimicrobial susceptibility data Influenza and RSV testing update Referral Testing QuantiFERON gold QT4 obsolete Y chromosome microdeletion testing referred to Mayo Medical Labs Supplies Vacutainer product alert 2.7mL citrate tube

2 BILLING AND COMPLIANCE Glomerular basement membrane, IgG assay CPT code Mayo Medical Laboratories (MML) has shared notice that, effective immediately, the CPT code for the Glomerular basement membrane, IgG assay (1016/ ) has changed from to There is no price change associated with this CPT change. HEMATOLOGY Differential reporting changes Effective May 15th, our differential reports were changed in that reference ranges and flagging no longer appear with differential percent parameters. This change was made to comply with guidelines from our laboratory accreditation agency to improve cost-effective care. High/low flags on the relative percent (%) are often discordant with the absolute WBC counts as shown in the screenshot below. Misleading abnormal flags can lead to unnecessary follow up testing. The absolute and relative values for each white blood cell (WBC) type (i.e., neutrophils, lymphocytes, monocytes, eosinophils, and basophils) are still reported, but normal ranges and high/low flagging are only present for the absolute count of these cell types (thou/cu mm). Certain cell types which are not expected to be seen in the peripheral blood (blasts, lymphoma cells, metamyelocytes, etc.), continue to be flagged and quantified by percentage to optimize patient care. This change also applies to the differentials reported as a part of the Complete blood count (CBC) & differential (400) and Complete blood count (CBC) & differential, no platelet (800) assays. The report example above demonstrates a result report as it appears; the report does not include reference ranges on the first 5 components (highlighted). 2

3 IMMUNOHISTOCHEMISTRY Anaplastic lymphoma kinas (ALK) therapeutic update Effective May 21, 2018, Allina Health Laboratory will institute a change in the methodology for ALK Therapeutic testing, used for the evaluation of therapeutic options in non-small lung cancer patients, from immunohistochemistry (IHC) to Fluorescent In-Situ Hybridization (FISH). Due to reports of increased non-specific background staining, Roche Tissue Diagnostics has initiated a worldwide stock out of the VENTANA ALK (D5F3) CDx Assay. The assay has not been recalled, but production was voluntarily ceased for further investigation by Roche. At this time, Roche has linked the cause of the background staining to raw materials sourced from a third party vendor. Roche is currently working to resolve the issue and has a projection date of June 28, 2018 for assay availability. In response to this, on May 21, 2018, Allina Health Laboratory will temporarily change methodology for ALK testing from immunohistochemistry (IHC) to Fluorescent In-Situ Hybridization (FISH). Although there will be no change in the quality of care by converting to the FISH test methodology, there may be an increased turnaround time for results due to FISH testing taking 4 to 7 days longer to complete as compared to IHC. Multiple stains discontinued Due to low utilization, the Allina Health Laboratory Immunohistochemistry laboratory has discontinued performance of the following IHC stains: Alpha fetoprotein (AFP) Hepatitis B surface Ag (HBsAg) Pancreatic polypeptide Ubiquitin Vasoactive intestine polypeptide (VIP) ZAP 70 The IHC request forms have been updated to reflect this change in stain offerings. 3

4 IMMUNOLOGY Celiac cascade methodology and reference range changes On May 15th, 2018, the celiac cascade (12442/LAB12442) testing moved from a chemiluminescent to an ELISA immunoassay platform. As result of the change in testing platform, reference ranges and units of measure also underwent change. Note that the numerical values of results are not comparable between the previous and new assay formulations. Test New ref range Previous ref range Tissue transglutaminase IgA 2993/ Neg: <4.0 U/mL Weak pos: U/mL Pos: >10 U/mL Neg: <20 CU Weak pos: CU Pos: >30 CU Neg: <6.0 U/mL Neg: <20 CU Tissue transglutaminase IgG Weak pos: U/mL Weak Pos: CU 4888/ Pos: >9 U/mL Pos: >30 CU Neg: <20 U/mL Neg: <20 CU Gliadin antibody IgA Weak pos: U/mL Weak pos: CU 2992/LAB2992 Pos: >30 U/mL Pos: >30 CU QuantiFERON-TB gold assay replaced by QuantiFERON-TB gold plus On May 15th, 2018, Allina Health Laboratory transitioned from the QuantiFERON- TB Gold assay to the QuantiFERON -TB Gold Plus assay. The QuantiFERON -TB Gold Plus (QFT- Plus) test is the fourth generation in QuantiFERON -TB testing technology assessing cellmediated response through a quantitative measurement of IFN-γ in a whole blood sample. The QFT-Plus assay has a four-tube format with an additional antigen tube (TB2) containing both CD4 and CD8 stimulating antigens. The Nil and Mitogen tubes remain the same, while the TB Antigen Tube 1 (TB1) contains CD4 T cell stimulating ESAT-6 and CFP-10 antigens as before, without TB7.7. The second TB Antigen Tube 2 (TB2) contains the same CD4 antigens of TB1 and proprietary CD8 antigens. Having the two separate TB Antigen tubes in QFT-Plus has the potential to provide additional clinical information that was not available in QFT. Test name: Test #: Collect: Container: Processing: Transport/stability: Reference range: QuantiFERON -TB gold plus 12805/LAB ml whole blood; one ml in each of the 4 collection kit tubes QuantiFERON -TB gold plus collection kit Shake tubes 10 times, just firmly enough to ensure that the inner surface of the tube is coated in blood Ambient 12 hours Specimens must reach the Central Laboratory within 12 hours of collection. Negative 4

5 Days set up: Tu Su CPT code: Please note that the collection kits for the new QuantiFERON-TB gold plus assay are not interchangeable with the collection kits for the QuantiFERON TB gold assay. MICROBIOLOGY 2017 Antimicrobial susceptibility data Summaries of the antimicrobial susceptibilities of the major pathogens isolated from inpatients at Allina Hospitals as well as Allina Health outpatients during 2017 are now available on the Allina Health Laboratory website at the following url; allinalabs.nsf/page/microsusceptcard. This data will no longer be printed on individual cards. The inpatient document also contains antimicrobial cost/dose information. For further information, contact Mary Colson-Burns, Microbiology Technical Specialist, at (612) , or Brenda Katz, M.D., Medical Director of the Microbiology Laboratory, (612) Influenza and RSV testing update Flu season is over and the prevalence of both influenza and RSV is very low. Effective June 1 st,2018, Rapid Influenza and RSV testing will be suspended until fall, as the accuracy during the off-season is very poor. If a sporadic case of influenza or RSV is suspected, the following tests may be ordered: 5

6 References: Test Name Test Code Detects Turnaround time Influenza A/B PCR 8810/LAB8810 Influenza A and B Same day Influenza Virus type A and type B, and respiratory syncytial virus (RSV), molecular detection, PCR REFERRAL TESTING QuantiFERON gold QT4 994/LAB994 MML: FLUNP RSV, Influenza A & Influenza B 1-2 days On May 15, 2018, the QuantifFERON Gold QT4 assay, referred to Hennepin County Medical Center, became obsolete. The suggested alternate test is the QuanitFERON -TB gold plus assay (12805/LAB12805). Y chromosome microdeletion testing referred to Mayo Medical Labs Effective June 1, 2018, the Y chromosome microdeletion assay (5927/LAB5927), currently referred to Integrated Genetics, will be referred to Mayo Medical Laboratories (MML) for analysis.the Y chromosome microdeletion assay is useful for evaluating men with azoospermia, severe oligospermia or otherwise unexplained male factor fertility. Changes associated with this are as detailed below. Current New Test name Y chromosome microdeletion Y chromosome microdeletions, molecular detection Test # 5927/LAB /LAB994 Collect 20mL ACD whole blood 3.0 ml ACD whole blood Transport/ stability Ambient Ambient (preferred) 96 hours It is preferred that the specimen reach MML within 96 hours of collection. Performing lab Integrated Genetics Mayo Medical Laboratories Days set up N/A Fri; 2pm There will be price increase associated with this performing laboratory change. If this is a test utilized at your site and Allina Health Laboratory bills your site for testing performed, please contact your account representative for detailed pricing information. 6

7 SUPPLIES Vacutainer product alert 2.7mL citrate tube A manufacturer s product alert notification has been received from Beckton-Dickinson (BD) concerning the blood fill volumes for BD 2.7mL citrate (blue top) tubes. Approximately 3.4% of the tubes will over fill blood draw volumes from approximately 11-14%. This will result in an incorrect blood-to-anticoagulant ratio leading to incorrect analytic results from poor product performance. Per BD, this is not a product recall at this time, but we have been advised to notify all persons collecting these samples to inspect the tubes to ensure that an acceptable fill volume has been achieved. BD recommends that if the draw volume exceeds 10% over the fill line on the tube, the specimens be recollected. When using these tubes, in order to prevent specimen rejection, please take a little extra time to inspect the filled tubes to ensure that the optimum fill volume has been achieved. Please refer to the coag tube fill guide to the right for both the 2.7 and 4.5mL draws. This guide is also available on the Reference Guides page of our website. Thank you for choosing Allina Health Laboratory We value your business! 7