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March 2018 Dear Healthcare Provider, The information contained here may be very important to your practice. Please take a moment to review this document. CHLAMYDIA/GONORRHEA SPECIMEN COLLECTION UPDATE SEE PAGE 2 Please inspect multi-collect devices for signs of leakage. Obvious leaking of the buffer solution or the appearance of salt crystals indicates improper seal. DO NOT USE. These will be replaced at no charge. TEST BULLETIN SUMMARY CELIAC PANEL TESTING ORDERING GUIDELINES SEE PAGE 3 The Infant Celiac Panel is only for patients under 2 years of age. PCL Alverno offers two Celiac Panels. The testing performed follows a specific algorithm based on the initial IgA result and patient age. PROTIME WITH OR WITHOUT THERAPY ORDERING REMINDER SEE PAGE 4 PCL Alverno has separate Prothrombin Time orders for patients on Coumadin therapy and for those not on therapy. Proper ordering ensures the reference range and alert values are applicable. MOLECULAR TESTING WITH BLOOD CULTURES UPDATE SEE PAGE 5 Alverno has begun PCR detection of MRSA resistance (meca gene) in Staphylococcus aureus identified in positive blood culture. This improves patient care through decreased TAT and antibiotic stewardship. SERUM OSMOLALITY REFERENCE RANGE UPDATE Serum Osmolality reference range will be standardized to 273-309 mosm/kg starting April 3, 2018. COMMON RAGWEED ALLERGEN REFERENCE RANGE CORRECTION Previously, Alverno announced that the reference range would change from <0.35 to <0.10 ku/l. This will not take effect as clinical relevance for values between 0.10-0.35 has not been determined. Find Us on Facebook, LinkedIn and Google Plus! Page 1

Chlamydia/Gonorrhea Collection Device Leaking Container Action Notification PCL Alverno has transitioned to a new method for Molecular CTNG Testing. We are now using the Abbott m2000 system. One of the benefits of the Abbott system is the single collection kit for all sample types. There have been instances of leaking unused multi-collect sample collection kits. It is important to inspect the collection kits before using. This leaking may be obvious or may simply appear as salt crystals around the rim of the collection tube. If either of these conditions exist, please do not use the collection kit. The supplier is actively working to correct the issue. Please keep track of any leaking kits, as they will be replaced at no charge. Following is an example of the appearance of a leaking tube: Please do not hesitate to call PCL Alverno directly with any questions at 1.800.937.5521 with any questions. Thank you for your support with this conversion. Page 2

Celiac Disease Panel Ordering Update March 2018 PCL Alverno offers two Celiac Disease Panels to aid in the diagnosis of Celiac Disease. Each panel follows a specific testing algorithm. Testing for children under 2 years of age requires additional testing to improve sensitivity. For this reason, proper ordering is important. All testing should be performed while patients are on a gluten-rich diet, for at least 2-12 weeks. For all patients over 2 years of age: Celiac Disease Panel (Previously Celiac Disease Panel, Adult Diagnostic) Total IgA, Tissue transglutaminase IgA & Endomysial IgA antibody Note: if the total IgA result is low, Tissue transglutaminase IgG & deamidated Gliadin IgG will be performed in place of Tissue transglutaminase IgA & Endomysial IgA antibody. Soft Code: CELAD CPT Codes: Normal or High IgA Levels: 82784; 86255; 83516 Low IgA Levels: 82784; 83516 x2 For patients under 2 years of age: Celiac Disease Panel, Infant Diagnostic Total IgA, Tissue transglutaminase IgA, Endomysial IgA antibody & deamidated Gliadin IgA Note: if the Total IgA result is low, Tissue transglutaminase IgG & deamidated Gliadin IgG will be performed in place of Tissue transglutaminase IgA, Endomysial IgA antibody & deamidated Gliadin IgA. Soft Code: CELIN CPT Codes: Normal or High IgA Levels: 82784; 86255; 83516 x2 Low IgA Levels: 82784; 83516 x2 Page 3

Coagulation Ordering Reminder When to order a Protime with or without therapy PCL Alverno Laboratories offer testing to analyze Protime with INR for patients who are receiving Coumadin therapy and for patients who are not receiving therapy. The reference intervals and critical alert values have been adjusted for these separate orders to give a clearer picture of the patient s normal status given the biological circumstance. It is necessary to order the proper test according to the patient s medication intake in order to receive the proper reference values for that patient, and to receive the proper alerts for abnormal patients. Test Name Reference Range Alert Values PT (Protime w/ INR no therapy) PTC (Protime w/ INR on therapy) 10.1 13.1 sec INR 2.0 3.0 conventional therapy INR 2.5 3.5 intensive therapy Therapeutic ranges can be found in the ACCP guidelines at www.chestnet.org 28.0 sec INR 2.4 59.0 sec INR 5.0 Page 4

Molecular Testing of Positive Blood Culture Media February 2018 On February 6, PCL Alverno began rapid MRSA resistance detection of positive blood culture media. This PCR assay is run in conjunction with MALDI-TOF rapid identification of Staphylococcus aureus. Following the identification of Staph aureus, an aliquot is sent to our molecular team to be run on the Cepheid Xpert MRSA/SA Blood Culture assay. The Cepheid assay will confirm the identification of Staph aureus and detect the meca gene for methicillin resistance. What to expect with this new algorithm. 1) First notification: MALDI-TOF sepsityper identification of Staphylococcus aureus within 2½ hours of culture positive. 2) Second notification: Cepheid result within next 1½ to 2½ hours: meca Detected (MRSA) isolate - or - meca Not Detected (Staph aureus, not MRSA) Expanded Molecular Testing coming in March. Klebsiella pneumonia, Enterococcus faecalis or faecium, and unidentified yeast will be sent to molecular for BioFire s FilmArray rapid identification confirmation and resistance gene detection. This testing will follow the same testing and alert algorithm. Page 5