FOOD ALLERGY PANEL TESTING UPDATE AND ALLERGY REFLEX TESTING

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1 October 2015 Dear Healthcare Provider, The information contained here may be very important to your practice. Please take a moment to review this document. Details are on the included pages. FOOD ALLERGY PANEL TESTING UPDATE AND ALLERGY REFLEX TESTING On pages two and three, you will find information on updates to PCL Alverno s food allergy panel and reflex testing for egg, milk and peanut allergy testing. TEST BULLETIN FECAL OCCULT BLOOD TESTING SUPPLY UPDATE The manufacturer s discontinuation of Hemoccult II SENSA elite slides may affect your office. Please see page four for details on what product is now available. ENHANCED METHODOLOGY FOR HEMOGLOBIN A1C PCL Alverno is moving to an enhanced methodology for Hemoglobin A1c testing. See page four for further information. KAPPA/LAMBDA FREE LIGHT CHAIN ASSAY NEW METHODOLOGY PCL Alverno has moved to a new methodology, which may require re-establishing baselines for your patients. Please see page five for reference range and other information. ICD-10 IS NOW IN EFFECT! PCL Alverno s website has been updated to provide you help in switching from ICD-9 to ICD-10. Visit us at for information. On page six, you will find a copy of a letter posted on the Medicare Learning Network. UTILIZATION GUIDELINE LIMITATIONS OF CBC WITH MANUAL DIFFERENTIAL Judy Lyzak, MD, Vice President of Medical Affairs at PCL Alverno, shares information on the utilization guideline for the limitation of CBC with manual differential testing on page seven. PCL ALVERNO PASSES ISO CERTIFICATION PCL Alverno is proud to announce that it has passed ISO certification. Page eight includes information on ISO as it relates to laboratories and PCL Alverno. SIGN UP FOR OUR BLOG! We encourage you and your staff to visit to sign up for our blog, so you will continue to receive our updates! FIND US ON FACEBOOK AND GOOGLE + SEARCH PCL ALVERNO Page 1

2 Test Summary FOOD ALLERGY PANEL TESTING UPDATE October 26, 2015 The Food Allergy Panel offered by PCL Alverno is a U.S. national profile designed to assist clinicians in identifying common potential IgE-mediated allergic triggers in children and adults. Periodically, it is necessary to review the composition of allergen profiles for current clinical relevance. According to national guidelines:! Common childhood food triggers include cow s milk, hen s egg, peanut, tree nuts, soybean, wheat, fish and shellfish 1,2,3! Common adult food triggers include fish, shellfish, tree nut and peanut 1,2,3 Foods that account for 90% of all food allergy reactions include: 1,2,3! Tree Nuts (Walnut, Cashew, Almond, Hazelnut)! Peanut! Soy! Fish (Cod, Tuna, Salmon)! Egg! Wheat! Shellfish (Scallop, Shrimp)! Milk Tree nut allergy has become more common, and the current tree nut (Walnut) on the food profile does not adequately detect sensitization, via cross-reactivity, to the other tree nuts. Fish allergy is one of the top food allergies; however, the current fish (cod) on the food profile does not adequately capture other non-cross-reactive fish. Thus, almond, cashew, hazelnut, salmon and tuna are added to the food allergen profile. Corn allergy, in contrast, is uncommon. The major maize allergen is a lipid transfer protein (LTP) with a high degree of cross-reactivity among the LTPs of peach, apple, walnut, hazelnut, peanut, rice, sunflower seed, French bean and apricot. Corn can also be positive due to cross-reaction with grasses rather than a clinical allergy to corn. Therefore, corn is removed from the panel. Clam is also removed as it is likely to have a high degree of cross reactivity with scallop and is therefore considered redundant. UPDATED FOOD ALLERGY PANEL! Almond! Cashew! Codfish! Egg White! Hazelnut! Milk! Peanut! Salmon! Scallop! Sesame Seed! Shrimp! Soybean! Tuna! Walnut! Wheat SPECIMEN REQUIREMENTS: Specimen: 2-mL serum (gel separator) or EDTA plasma (gel separator) Stability: 2-8 C up to 7 days; otherwise, freeze at -20 C CAUSE FOR REJECTION: Insufficient quantity METHOD: Fluorescent enzyme immunoassay (FEIA) REFERENCE RANGE: 0.35 ku A /L TURNAROUND TIME: Monday, Wednesday, Friday (day shift) CPT CODES*: (x15) *CPT codes provided are for informational purposes only. Questions regarding coding should be directed to the payor. References: 1.Sampson HA. Update on food allergy. J Allergy Clin Immunol. 113: Sicherer S H. Food Allergy. Lancet 360: National Center for Health Statistics Data Brief Accessed June 1, Quest Diagnostics Health Trends, Allergy Report 2011:1-54. Page 2

3 REFLEX TESTING/ALLERGY TESTING UPDATE FOR EGG, MILK, PEANUT October 26, 2015 Test Summary PCL Alverno recently introduced component testing for egg, milk and peanut allergies. Now we are pleased to offer reflex component testing in conjunction with the Childhood Food and Environmental Allergy and Food Allergy Panels. If these panels are ordered with reflex, component testing will automatically be performed if results for egg, milk and/or peanut allergens are positive. Please note that additional charges will be applied for component testing. The panels will include the following: CHILDHOOD ALLERGY PANEL WITH REFLEX COMPONENT PANELS Alt Alternata Cockroach D. Pterony Milk* Shrimp Wheat C. Herbarum Codfish Dog Dander Mouse Soybean Total IgE Cat Dander D. Farinae Egg White* Peanut* Walnut FOOD ALLERGY PANEL WITH REFLEX COMPONENT PANELS Almond Egg White* Peanut* Sesame Seed Tuna Cashew Hazelnut Salmon Shrimp Walnut Codfish Milk* Scallop Soybean Wheat *If egg white is >0.35 ku A /L, then the Egg Component Panel will be reflexed at an additional charge. If milk is >0.35 ku A /L, then the Milk Component Panel will be reflexed at an additional charge. If peanut is >0.35 ku A /L, then the Peanut Component Panel will be reflexed at an additional charge. SPECIMEN REQUIREMENTS Specimen: 2-mL serum (gel separator) or EDTA plasma (gel separator) Stability: 2-8 C up to 7 days; otherwise, freeze at -20 C CAUSE FOR REJECTION: METHOD: Insufficient quantity Fluorescent enzyme immunoassay (FEIA) REFERENCE RANGE: Egg Components: 0.35 ku A /L Milk Components: 0.35 ku A /L Peanut Components: 0.1 ku A /L TURNAROUND TIME: Monday, Wednesday, Friday during day shift CPT CODES: Egg Component Panel: Additional (x2), if reflexed Milk Component Panel: Additional (x3), if reflexed Peanut Component Panel: Additional (x5), if reflexed CPT codes provided are for informational purposes only. Questions regarding coding should be directed to the payor. Page 3

4 Test Summary FECAL OCCULT BLOOD TESTING SUPPLY UPDATE Due to the recent discontinuation by the manufacturer, Hemoccult II SENSA elite slides are no longer available and have been replaced by Hemoccult II SENSA slides. The Hemoccult II SENSA is a rapid and qualitative test for detecting fecal occult blood, which may be indicative of gastrointestinal disease. In comparison to the SENSA elite test, its test formulation includes the same enhancer, which makes the test more sensitive and more readable than other guaiac-based methods. Each patient kit contains one triple slide with the performance monitor feature, three applicators, three flushable sample collection tissues, diet and test instructions and a mailing pouch (with a U.S. Postal Service-approved barrier). Kits are currently available by request, and the online supply request form has been modified to reflect product number changes. To request supplies, please refer to the product details below. PRODUCT DETAILS ITEM NUMBER: Hemoccult II SENSA Dispensapak Triple Slide Test Kit (40 Tests/Pk) METHOD: Guaiac REFERENCE RANGE: Negative TURNAROUND TIME: Daily as received CPT CODES: (Screening) (Diagnostic) ENHANCED METHODOLOGY FOR HEMOGLOBIN A1C HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY October 2015 What does HPLC provide that immunoassays cannot? Detection of Hemoglobin Variants. Hemoglobin S, C, D and E can interfere with measurement of glycosylated HA1c. In homozygous hemoglobinopathies, the hemoglobin A1 is very low or absent. When this occurs, a glycosylated A1c cannot be determined. Monitoring the diabetic patient with a hemoglobin variant requires another assay such as fructosamine. Detection of Carbamylated Hemoglogin. In renal disease, the hemoglobin molecule can be carbamylated in the presence of elevated urea. Carbamylated hemoglobin may interfere with accurate measurement of glycosylated A1c. When the chromatograph demonstrates a peak in the carbamylated region, the sample will be held and retested in 24 hours. Usually holding the sample for 24 hours will resolve the issue, and an A1c result can be reported. In a few circumstances, the carbamylated peak remains, and the specimen is unable to be analyzed. Page 4

5 KAPPA / LAMBDA FREE LIGHT CHAIN ASSAY NEW METHODOLOGY October 2015 Test Summary Alverno is pleased to announce our Free Light Chain Kappa and Lambda assays have been validated using a new turbidimetric methodology. Our new assay will expand our clinically reportable range and provide onboard antigen excess detection. Due to reaction kinetics, antigen excess can result in falsely low results in specimens with very high levels of analyte. Please Note: New methodology may require re-establishing baseline. Please call the laboratory for baseline re-testing if clinically indicated. New Clinically Reportable Ranges Result Categories 1) Normal samples: Kappa, Lambda and ratio results are all within the normal ranges. If accompanying serum electrophoretic tests are normal, it is unlikely that the patient has a monoclonal gammopathy. 2) Abnormal ratios: Support the diagnosis of a monoclonal gammopathy and require further investigation. Borderline elevated Kappa/Lambda ratios occur with renal impairment and may require appropriate renal function tests. 3) Low concentrations of Kappa, Lambda or both: Indicate bone marrow suppression. 4) Elevated concentrations of both Kappa and Lambda with normal ratio: May be due to the following: a. Renal impairment (common) b. Over-production of polycolonal Free Light Chain from inflammatory conditions (common) c. Biclonal gammopathies of different Free Light Chain types (rare) 5) Elevated concentrations of both Kappa and Lambda with abnormal ratio: Suggest a combination of monoclonal gammopathy and renal impairment. Page 5

6 Countdown to ICD-10 Physician Orders for Lab, Radiology Services, and Other Services after ICD-10 Implementation CMS is not requiring updated physician (or non-physician practitioner) orders for lab, radiology services, or any other services after ICD-10 implementation on October 1, 2015, including Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS). However, these claims must contain a valid ICD-10-CM diagnosis code. When providing services that were ordered before the ICD-10 implementation date of October 1, 2015, providers have the option to use the General web page to translate ICD 9-CM codes into ICD 10-CM diagnosis codes. Physician orders written after the transition to ICD-10 must use ICD-10-CM codes. Page 6

7 Test Summary UTILIZATION GUIDELINE: LIMITATIONS OF CBC WITH MANUAL DIFFERENTIAL This guideline serves to educate our physician colleagues on the algorithm followed in the laboratory for CBC with an automated versus a manual differential. The automated differential is generated by the hematology analyzer and is performed on approximately 8,000 cells. Based on size and complexity, the instrument generates a differential count and alerts the technologist to the presence of potential abnormalities. Based on these flags, a smear of the blood specimen is created, stained and scanned by the hematology technologist for confirmation. If the abnormalities/cell immaturity are confirmed, a 100-cell count manual differential is performed on the WBCs, and any red cell or platelet abnormalities are noted. In addition, if criteria are met for Pathologist review, an interpretive comment is reported following this examination. This cascade of examination has been extensively validated to confirm that no clinically significant abnormalities will be missed by the instrumentation. Of note, the instrument will alert the technologist to the possible presence of immature neutrophils, triggering a manual scan and a consequent band count if immature granulocytes are noted. In contrast, ordering a CBC with manual differential omits this important and welltested cascade of testing. The guidance provided by the instrumentation in combination with the examination by the technologist (and if needed, by the Pathologist) provides the optimal combination of technology and expertise to derive the most accurate WBC differential. Page 7

8 Dear Healthcare Provider, PCL Alverno is proud to announce that the College of American Pathologists (CAP), a Centers for Medicare and Medicaid Services (CMS)-approved accreditation authority, has awarded PCL Alverno accreditation to the ISO standard under the CAP SM Accreditation Program. The accreditation is based on the International Organization for Standardization (ISO) Standard for laboratories technical competence, management and continual improvement. It focuses on improved patient safety and risk reduction, outlining standards for quality and competence particular to medical laboratories. CAP SM is a voluntary, non-regulatory accreditation to the ISO 15189:2012 Standard as published by ISO. The program does not replace the CAP s Clinical Laboratory Improvement Amendments (CLIA)-based Laboratory Accreditation Program but complements CAP accreditation and other quality systems. The program optimizes processes to improve patient care, strengthens quality standards while reducing institutional errors and risks and controls costs. CAP SM is an educational program that offers a highly disciplined approach to implementing and sustaining change. "The ISO Standard provides a comprehensive quality management framework that allows laboratories not only to 'study for the exam' but also to 'learn for life,' says Frank Schneider, MD, FCAP and Chair of the CAP SM Committee. Laboratories working toward its implementation have chosen a path of continual improvement. They embrace their problems and seek intelligent solutions, thereby enhancing patient care as well as customer and staff satisfaction." PCL Alverno is never satisfied with status quo and seeks to continually improve service and quality, and so becoming ISO certified was a natural path to follow. Our patients and healthcare providers deserve the best service and the highest quality of laboratory testing, notes Sam Terese, PCL Alverno CEO and President. We want to thank you for your continued support! PCL Alverno Page 8