March Molecular diagnostics. Update distribution changes. Billing and compliance. Hematology. Immunology. Referral testing

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Dwayne Davis
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March 2016 Update distribution changes Billing and compliance

Screening Reference Range Change Immunology Testing schedule

Gene Rearrangement assay changes Referral testing Chlamydia

1 March 2016 Update distribution changes Billing and compliance Compliance Drug Analysis CPT change Hematology Hemoglobin A1c, Screening Reference Range Change Immunology Testing schedule changes Vitamin D assay changes Molecular diagnostics B Cell Gene Rearrangement assay changes Referral testing Chlamydia trachomatis culture transport requirement change VAP Cholesterol assay obsolete

2 UPDATE NEWSLETTER DISTRIBUTION CHANGES This edition of our Update newsletter is the last that will be sent to clients via US Postal Service. In order to control costs, future editions will be distributed and available via two methods; , and posting on our website. Allina Health Laboratory maintains an distribution list to share time sensitive communications, as well as our newsletter. If you are not currently receiving our communications, but would like to in the future, please contact your account representative with your request to be added to our distribution list. Website posting: The current edition of our newsletter is posted on the homepage of our website at under Newsletters. The More The Update link will take you to an archive of newsletters from the current and two previous calendar years. A comprehensive index is also posted on this page. To search the comprehensive index, press Ctrl + F, enter your search criteria in the box and press Enter. You will see an indication of how many items were located, and the located items will be highlighted. 2

3 BILLING AND COMPLIANCE Compliance Drug Analysis CPT change Due to a change in the number of drug classes being reported by MedTox Scientific, effective March 1, 2016, the CPT codes for the Compliance Drug Analysis changed. There was no change in price associated with the change in CPT. Previous CPT New CPT (March 1, 2016) G0479 and G0480 G0479 and G0482 HEMATOLOGY Hemoglobin A1c, Screening Reference Range Change Effective April 5 th, 2016, a slight change will be made to the reported reference range for Hemoglobin A1c Screening (8761/ LAB8761) to coincide with the updated recommendation from the American Association of Diabetes (ADA). Current Reference Range: <5.7% Normal 5.7% - 6.3% Indicates prediabetes 6.4% Confirms diabetes New Reference Range (eff 4/5/16): <5.7% Normal 5.7% - 6.4% Indicates prediabetes 6.5% Confirms diabetes Reference: 2015 ADA Diabetes Guidelines 3

4 IMMUNOLOGY Testing schedule changes In order to better serve your patients, the testing frequency for allergen assays performed by Allina Health Laboratory has been increased from 2 days per week (Mo, Th) to three days per week (Mo, We and Fr). This more frequent testing schedule will decrease the TAT to 1-3 days. At the same time the testing schedule for three additional assays changed as detailed below. Test Name: Test #: Current days set up: New days set up: ANCA Panel for Vasculitis 528/LAB528 Tu, Fr Tu, Th Test Name: Anti-Mitochondrial Antibody Test #: 652/ Current days set up: Mo, Th New days set up: Mo Reflex titers on positive results will be run the same day Test Name: Anti-Smooth Muscle Antibody Test #: 715/ Current days set up: Mo, Th New days set up: Mo The AHL Test Catalog has been updated to reflect the current testing schedule. 4

5 Vitamin D assay changes 113A/LAB113A Explanation On February 15 th, Allina Health Laboratory moved the Vitamin D testing from the Diasorin Liason method to the Abbott Architect. Both are chemiluminescent methods, which correlation studies have proven to give similar values. Specimen Requirements Specimen requirements are 1.0 ml (minimum 0.5mL) of either Lithium heparin plasma (PST tube) or a serum from a gold top SST tube. If a plain red top tube is collected, the serum must be transferred to an AHL False Bottom Serum/Plasma transfer vial prior to transport. Days tested Previously Vitamin D testing was performed Mon Fri. Moving the assay to the Architect methodology has allowed us to perform this assay 7 days a week on all shifts. Reference ranges There was a slight change in reference range, as they were updated to the values recommended by the Institute of Medicine. Previous New ng/ml Deficiency: <20 ng/ml Insufficiency: ng/ml Sufficiency: ng/ml Possibly Toxicity: >80 ng/ml Based on Institute of Medicine recommendations Excellian/Beaker sites Orders will combine per Beaker label logic, potentially reducing the amount of blood collected from each patient. 5

6 MOLECULAR DIAGNOSTICS B Cell Gene Rearrangement assay changes Due to the discontinuation of the IGH probes by the manufacturer, effective immediately, Allina Health Laboratory is no longer able to offer Southern Blot Analysis as part of the B Cell Gene Rearrangement test. Please note that this is specific to B Cell Gene Rearrangement analysis. Southern Blot Analysis will continue to be offered, until further notice, as part of the test for T Cell Gene Rearrangement. Test Name: B Cell Gene Rearrangement Test Number: 5453 Collect: Container: Processing: Transport/Stability: Alternate Names: Performing Lab: Days Set Up: Expected TAT: Ref. Ranges: Collection/ Processing Details: Specimen Types** See specimen types Submit entire specimen Dependent on specimen type** IgH Rearrangement, GR, LAB5453 AHL - Molecular Diagnostics; D N/A 8 days If T Cell Gene Rearrangement was ordered with the B Cell Gene Rearrangement, a TCR Southern Blot maybe performed, resulting in an increased TAT. N/A Description: Detection of clonal rearrangements of immunoglobulin heavy chain genes that are associated with malignant processes. Specimen Collection and Transport Information Questions call (612) Method: PCR and Gel Electrophoresis CPT Codes:

7 REFERRAL TESTING Chlamydia trachomatis culture transport requirement change Effective immediately, the transport temperature requirements for the Chlamydia trachomatis culture (8125/LAB8125) referred to Focus Diagnostics via Mayo Medical Laboratories, have changed to require a strict frozen transport. Specimens should be frozen immediately upon collection/inoculation of transport media, as they are no longer acceptable at refrigerated temperatures for any amount of time. The Allina Health Laboratory test catalog has been updated to reflect this change. Test Name: Chlamydia trachomatis Culture Test Number: 8125 Collect: Container: Processing: Transport/ Stability: Cervical or urethral swabs or scrapings (use when checking for test of cure), fallopian tube aspirate, rectal swab, conjunctival swab, nasopharyngeal (NP) aspirate or swab Note: Specimen source is required on request form for processing. M5 Viral Transport Media (preferred) frozen immediately after collection RTM4 is also acceptable, if frozen immediately Freeze immediately. Submit entire specimen, frozen. Frozen (strict) Refrigerated - NO Ambient - NO 7

8 VAP Cholesterol assay obsolete Mayo Medical Laboratories learned that Atherotech Diagnostics Lab has closed permanently. As a result, effective immediately, the VAP Cholesterol test (MML #FVAP), performed by Atherotech, is obsolete. Mayo Medical Laboratories offers the following guideline endorsed biomarkers as alternatives to the VAP test: Cardiovascular Risk Marker Panel 994/LAB994 MML test ID: CVRMP An advanced lipid test that includes non-hdl Cholesterol, High Sensitivity C-Reactive Protein, and Lp(a) Apolipoprotein B 2628/ MML test ID: APLB A biomarker that Mayo Clinic Preventive Cardiology recommends in special circumstances where there is concern of residual risk or if fine-tuning of therapy is needed Test ordering and specimen requirement information for the Cardiovascular Risk Marker Panel and the Apolipoprotein B have been included on the following pages for your reference. 8

9 Test Name: Cardiovascular Risk Marker Panel Test Number: 994 Collect: Container: Processing: Transport/ Stability: Alternate Names: Performing Lab: Days Set Up: Expected TAT: Ref. Ranges: Collection/ Processing Details: 2.5 ml Serum Serum Separator (SST) tube - Gold Spin Refrigerated (preferred) - 7 days Frozen - 30 days VAP Cholesterol MSO LAB994 Mayo Medical Labs (CVRMP); R Mo - Fr 2-7 days See report Useful for: assessment for risk of developing cardiovascular disease, major adverse cardiovascular events, or ischemic cerebrovascular events Test includes non-hdl Cholesterol, High Sensitivity C-Reactive Protein, and Lp(a) Fasting-overnight (12-14 hour). Patient must not consume any alcohol for 24 hours before the specimen is drawn Method: LIPA, HSCRP: Automated Turbidimetric Immunoassay TCCDC, TGCD1, HDCDC, NOHDL, CALDL: Selective Precipitation/Enzymatic Colorimetry/Friedewald Equation CPT Codes: Lipid panel (includes: HDL [CPT Code 83718], total cholesterol [CPT Code 82465], and triglycerides [CPT Code 84478]) Lipoprotein (a) C-reactive protein; high sensitivity (hscrp) 9

10 Test Name: Apolipoprotein B Test Number: 2628 Collect: Peds Collect: Container: Processing: Transport/ Stability: Alternate Names: 1.0 ml EDTA Plasma - Lavender Top 0.5 ml EDTA Plasma - Lavender Top Mayo Screw Cap Transfer Vial Spin and separate. Label transfer vial as EDTA plasma Refrigerated (preferred) - 8 days Frozen - 60 days Apolipoprotein B-100 APO APO-b APO Liporotein B APOB Apolipoprote Performing Lab: Mayo Medical Labs (APLB/80308); R-MM Days Set Up: Expected TAT: Ref. Ranges: Mo - Sa 2-4 days See report Collection/ Processing Details: Method: Automated Turbidometric Immunoassay CPT Codes:

11 WEBSITE CEU DVD s Available for Checkout Allina Health Laboratory sponsors quarterly continuing education presentations in the Twin Cities area. For those unable to attend, we record each presentation and make the DVD/videotapes available for viewing. Upcoming CEU event information as well as a listing of available presentations and a DVD Request Form can be found under the Continuing Education heading on our website homepage at allinahealth.org/laboratory. Thank you for choosing Allina Health Laboratory We value your business! 11

January Billing and compliance. Chemistry. Help us help you. Referral testing. Additional CPT code changes announced for 2015

January Billing and compliance. Chemistry. Help us help you. Referral testing. Additional CPT code changes announced for 2015 January 2015 Billing and compliance Additional CPT code changes announced for 2015 Chemistry CA 27.29 conversion to CA 15-3 nearing completion Vitamin B12 and LD, Total specimen change Timed Urine Protein