March Central laboratory Beaker LIS update. Billing and Compliance. Chemistry. Microbiology. Molecular diagnostics.

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1 March 2014 Central laboratory Beaker LIS update Central Lab go live reminders Billing and Compliance ICD 10 update Are you ready? Chemistry PTH recall and new reference range Microbiology Microbiology test changes coming with Beaker Molecular diagnostics HCV RT-PCR viral load testing changes Referral Testing Processing of specimens for coagulation testing referred to University of Minnesota Physicians Outreach Mycoplasma and Ureaplasma culture no longer available BRAC testing moved from Myriad to Gene DX

2 CENTRAL LABORATORY BEAKER LIS UPDATE Central lab go live reminders On the evening of April 11th, the Allina Health Laboratory Central core lab departments will go live on our new LIS, Beaker. With this go live, there will be changes occurring including new tests, discontinued tests and changes in test names, reference ranges, testing lab or methodology, as well as the look of our patient reports. We will be communicating these changes with our clients, and updating our Test Catalog, request forms and reference guides as needed. Key points Reports examples of Beaker reports can be found on our website at Test Changes will be communicated to clients and our electronic test catalog will be updated to include the new tests and reflect the changes to existing tests Requisition changes all manual requisitions will be updated with new and revised tests Departments affected - Chemistry, Coagulation, Immunology, Hematology, Microbiology and Urinalysis will be affected with the April 11 th go live Cytology, Cytogenetics, Flow Cytometry/Immunophenotyping, Histology, Molecular Diagnostics and Transfusion Services (Blood Bank) will remain on our current system until May 30 th. You may experience temporary delays at our Patient Service Centers and when calling our Client Services department as staff adjusts to the new system. Manual request form requirements as previously shared, any clients (hospital or clinic) submitting testing on manual request forms must supply the full patient name, date of birth, gender and complete address (street, city, state and zip code). Daily billing (charges posted) reports these reports will be discontinued as we transition to Beaker. After April 11th, clients receiving these reports will see only Cytology, Cytogenetics, Flow Cytometry/Immunophenotyping, Histology Molecular Diagnostics and Transfusion Services (Blood Bank) charges. BILLING AND COMPLIANCE ICD 10 update Are you ready? The current ICD 9 diagnosis codes will be transitioned over to ICD 10 on October 1st, What does this mean for you? Now is the time to prepare and to start changing your documentation strategy as ICD 10 is much more specific in detail than the codes that are currently in use for ICD 9. Please watch for additional communications regarding this national conversion. 2

3 CHEMISTRY PTH recall and new reference range On February 13, 2014, the PTH test performed at Allina Health Laboratory was recalled by the manufacturer with instructions to discontinue testing immediately. Due to the recall, the laboratory switched PTH testing to a different manufacturer s assay on February 20, The reference range has changed. Please note that PT numerical values cannot be compared between our old assay and the new assay, or with values from other laboratories. This is because the antibodies used in the test are proprietary for each vendor, each vendor s antibody has slightly different binding properties for PTH. Please note the new reference for this assay as indicated below. Additional communications are being shared with providers who have ordered PTH testing during the period affected by the recall. Test Name: PTH Intact with Calcium Test Number: 2317/PTH (LAB2317) Collect: 2 ml Frozen Serum Container: Plastic Transfer Vial Processing: Spin, Separate and Freeze Transport/Stability: Frozen; Stable 2 days Refrigerated; Stable 8 hrs at Room Temp Alternate Names: Parathyroid Hormone, Parathormone Performing Lab: AHL - CM Days Set Up: M - Sa Expected TAT: 1-2 days NEW Ref. Ranges: PTH Intact: pg/ml; Calcium: mg/dl Collection/ Processing Details: Fasting specimen preferred. Includes calcium. Serum is preferred specimen. Heparinized plasma is also acceptable. Label tube as Serum or Plasma. Method: Sandwich CLIA CPT Codes:

4 MICROBIOLOGY Microbiology test changes coming with Beaker The following tables include a summary of the changes that will be occurring in our Microbiology laboratory with the Beaker LIS go live, effective the evening of April 11th. Our electronic test catalog, manual requisitions and resource guides will be updated to reflect the indicated changes. New tests available New Microbiology Tests (available 4/12/2014) Aerobic Bacterial Culture, Stain Staph aureus Culture (MSSA + MRSA) Rectal Non-OB Strep Culture Vaginal Non-OB Strep Culture Referral - Positive Urine Culture Workup Referral - Positive Non-Urine Culture Workup Actinomyces Culture Nocardia Culture, Stain Hardware Culture, Stain Comments Replaces discontinued tests: Miscellaneous Bacterial Culture, Stain Nasal Culture Wound Culture, Stain For detection of Staphyococcus aureus (methicillin susceptible) and MRSA in nasal cultures or other sources. For detection of MRSA only, continue to order MRSA Culture. Replaces discontinued test: Rectal/Vaginal Non-OB Strep Culture Replaces discontinued test: Rectal/Vaginal Non-OB Strep Culture Order when sending a primary plate from a urine specimen for workup of all pathogens. Order when sending a primary plate from a non-urine specimen for workup of all pathogens. Submit specimen in anaerobic transport at ambient temperature within 48 hours: ESwab Fluids: Port-A-Cul vial Tissue: Amies transport fluid of ESwab Submit in sterile container at ambient temperature within 24 hours. Order for culture of contact lenses, pacemaker wires, grafting material, and other patient-related hardware usually obtained during surgery. Do NOT use for environmental objects. 4

5 Name changes to existing tests Microbiology Test Name Changes New name (effective 4/12/2014) Current Name Aerobic Bacterial Culture, Stain Miscellaneous Bacterial Culture, Stain Catheter Tip (IV) Culture IV Catheter Culture Stool WBC WBC Stool Referral Isolate ID only - Anaerobe Referral ID only - Anaerobe Referral Isolate ID only - Nonurine Referral ID only - Nonurine Referral Isolate ID only - Urine Referral ID only - Urine Referral Isolate ID/Susceptibility - Anaerobe Referral ID/Susceptibility - Anaerobe Referral Isolate ID/Susceptibility - Nonurine Referral Isolate ID/Susceptibility - Urine Referral Isolate Susceptibility Referral ID/Susceptibility - Nonurine Referral ID/Susceptibility - Urine Referral Susceptibility MOLECULAR DIAGNOSTICS HCV RT-PCR viral load testing changes Due to the implementation of a new version of the Roche HCV viral load test by our Molecular Diagnostics laboratory, effective February 24, 2014, the linear (reportable) range for the HCV RT-PCR Viral Load assay (2242/QHC) was expanded. Previous linear (reportable) range: New linear (reportable) range: 43-63,000,000 IU/mL ,000,000 IU/mL The Roche assay is designed to accurately determine the amount of hepatitis C virus ribonucleic acid (RNA) in order to assess a patient s response to antiviral therapy. Patients do not need to be re-baselined if you are using HCV RT-PCR Viral Load assay to monitor treatment. There are no other changes to the assay as a result of this implementation. 5

6 REFERRAL TESTING Processing of specimens for coagulation testing referred to University of Minnesota Physicians Outreach We have received notification from the University of MN Physicians Outreach (UMP) laboratory of processing requirements for coagulation testing performed at their laboratory. Effective immediately, any specimens submitted to UMP for coagulation testing must be processed using a centrifuge calibrated to ensure platelet counts of <10,000 in the end plasma product. Due to this requirement, coagulation specimens forwarded to UMP must be processed at an Allina Health Laboratory hospital site, and should not be spun down in clinics without a properly calibrated centrifuge. Tests affected by this requirement include: Activated Protein C Resistance 2969/APC or LAB2969 Fondaparinux Level 994/MSO or LAB994 Please note that these are time sensitive specimens. The Activated Protein C Resistance specimen must reach the UMP within 24 hours of collection, or undergo the platelet poor plasma processing, and the Fondaparinux specimen must have a platelet poor plasma specimen preparation performed within 3 hours of specimen collection. In order to undergo the processing within these time constraints, APC specimens must reach Allina Health Laboratory within 23 hours of collection, and specimens for Fondaparinux level testing must reach Allina Health Laboratory within 2 hours of collection. Mycoplasma and Ureaplasma culture no longer available We have received notice from our referral laboratories that effective immediately, the test kits for Mycoplasma and Ureaplasma culture are no longer available. The recommended replacement tests are the Mycoplasma hominis, Molecular Detection, PCR (994/MSO, LAB994) and the Ureaplasma species, Molecular Detection, PCR (994/MSO, LAB994) both referred to Mayo Medical Laboratories (MML). Note: Specimens collected using Eswab s are not acceptable for PCR testing Any tests for Mycoplasma or Ureaplasma testing received on an Eswab will be cancelled If both Mycoplasma and Ureaplasma PCR testing are requested, two (2) swabs must be collected and submitted Refer to the following pages for complete ordering and specimen details for the Mycoplasma hominis, Molecular Detection, PCR (994/MSO, LAB994) and the Ureaplasma species, Molecular Detection, PCR (994/MSO, LAB994). 6

7 Test Name: Test Number: Collect: Container: Processing: Transport/ Stability: Alternate Names: Performing Lab: Days Set Up: Expected TAT: Ref. Ranges: Collection/ Processing Details: Mycoplasma hominis, Molecular Detection, PCR 994/MSO Swab: Cervix, urethra, urogenital or vaginal, Urine (10mL) or Kidney stones Fluid (1-2 ml): pelvic, amniotic, prostatic secretion, semen, reproductive drainage, lower respiratory or synovial Tissue (5mm): placenta, products of conception or genitourinary Mayo BBL Culturette for PCR (White cap) Fluids or tissue: Sterile Screw Cap Container Submit Entire Specimen Refrigerated (preferred) Frozen 0 within 7 days Mycoplasma hominis PCR Mayo Medical Labs (MHRP/60756) M - F 3-4 Days Negative for DNA Rapid, sensitive, and specific identification of Mycoplasma hominis from synovial fluid, genitourinary, reproductive, and lower respiratory sources. A separate swab must be collected if also ordering Ureaplasma species, Molecular Detection, PCR. Also acceptable: Specimens in M4, M5, or UTM transport media. UNACCEPTBLE specimens: ESwab, cotton or calcium alginate-tipped swab, wooden shaft swab, transport swab containing gel or charcoal, Port-A-Cul tube, anaerobic fluid vials, dry swab, formalin-fixed and/or paraffin-embedded tissues. Test developed & performance characteristics determined by Mayo Clinic, Rochester, MN, consistent with CLIA requirements. Not cleared or approved by US FDA. Method: Real-Time Polymerase Chain Reaction (PCR) and Fluorescent Resonance Energy Transfer (RET) CPT Codes: Supply Connection: Mayo BBL Culturette for PCR 7

8 Test Name: Test Number: Collect: Container: Processing: Transport/ Stability: Alternate Names: Performing Lab: Days Set Up: Expected TAT: Ref. Ranges: Collection/ Processing Details: Ureaplasma species, Molecular Detection, PCR 994/MSO Swab: Cervix, urethra, urogenital or vaginal, Urine (10mL) or Kidney stones Fluid (1-2 ml): pelvic, amniotic, prostatic secretion, semen, reproductive drainage/fluid, lower respiratory or synovial Tissue (5mm): placenta, products of conception or genitourinary Mayo MML Culturette for PCR (white cap) Fluids or tissue: Sterile Screw Cap Container Submit Entire Specimen Refrigerated (preferred) Frozen within 7 days Ureaplasma urealyticum; Ureaplasma parvum Mayo Medical Labs (URRP/60758) M - F 3-4 Days Negative for DNA A separate swab must be collected if also ordering Mycoplasma hominis, Molecular Detection, PCR. Also acceptable: Specimens in M4, M5, or UTM transport media. UNACCEPTBLE specimens: ESwab, cotton or calcium alginate-tipped swab, wooden shaft swab, transport swab containing gel or charcoal, Port-A-Cul tube, anaerobic fluid vials, dry swab, formalin-fixed and/or paraffin-embedded tissues. Test developed & performance characteristics determined by Mayo Clinic, Rochester, MN, consistent with CLIA requirements. Not cleared or approved by US FDA. Method: Real-Time Polymerase Chain Reaction (PCR) and Fluorescent Resonance Energy Transfer (FRET) CPT Codes: x 2 Supply Connection: Mayo BBL Culturette for PCR (white cap) 8

9 BRAC testing moved from Myriad to Gene DX Effective immediately, Allina Health Laboratory is referring three tests to Gene DX rather than Myriad Genetics. The three tests affected by this performing lab change are: 7731/RAC (LAB7731) BRAC Analysis Comprehensive 7733/BRS, (LAB7733) Single Site BRAC Analysis 7732/BRM (LAB7732) Multi Site BRAC 3 Analysis Please note: Consultation with a Genetic Counselor is highly recommended prior to ordering of any of these tests If for any reason one of these three tests needs to go to Myriad, a Miscellaneous send out (994/MSO, LAB994) must be ordered, and the specimen accompanied by a Myriad request form. If a BRAC Analysis Comprehensive (7731/RAC, LAB7731) is ordered, but is accompanied by a Myriad request form we will cancel the orderable test, order an MSO and send to lab designated on the test request form (Myriad). The only test that will remain at Myriad is the BRAC Analysis Rearrangement (BART) (8556/BRT, LAB8556). If we receive an order for the BART, accompanied by a Gene-DX request form, this test will be canceled and an MSO will be ordered. Regardless of testing lab chosen, insurance pre-authorization is required before any of these tests is performed. The Allina Health Laboratory test catalog has been updated to reflect these changes. Thank you for choosing Allina Health Laboratory We value your business! 9