Mikhail Menis, PharmD, MS Investigative The study of disease transmission Branch OBE/CBER/FDA.


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In the event that presented, the new transfusion-related unfavorable response codes will enhance: ... 999.6 ABO contrarily response because of transfusion of blood or blood items: ...
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Proposed Changes to ICD-9-CM Transfusion Associated Adverse Events September seventeenth, 2009 ICD-9-CM Coordination and Maintenance Committee Meeting Mikhail Menis, PharmD, MS Analytic Epidemiology Branch OBE/CBER/FDA

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Overview The FDA\'s Center for Biologics Evaluation and Research (CBER) mission is to guarantee security and viability of natural items including blood and blood items and therefore to ensure and improve general wellbeing. Under the Food and Drug Administration Amendments Act (FDAAA) of 2007, FDA is in charge of directing U.S. populace based dynamic observation of therapeutic item wellbeing including blood and blood item security. As of now, we are utilizing expansive therapeutic databases from the Centers for Medicare & Medicaid Services, Health Maintenance Organizations and others to: Conduct dynamic reconnaissance of unfavorable occasions Identify and portray unfriendly occasions connected with the transfusion of blood and blood items

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Overview FDA/CBER presented a proposition for thought asking for the expansion of new particular ICD-9-CM codes for transfusion-related antagonistic responses: Hemolytic Transfusion Reactions (HTRs) Transfusion-Transmitted contaminations (TTI: viral, bacterial, parasitic diseases, and so forth.) Febrile Nonhemolytic Transfusion Reaction (FNHTR) Posttransfusion Purpura (PTP) Transfusion-Associated Circulatory Overload (TACO) Hemochromatosis (Iron Overload)

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Overview If presented, the new transfusion-related unfavorable response codes will enhance: Precision with which transfusion-related antagonistic occasions are recorded CBER\'s capacity to direct dynamic observation of transfusion-related unfriendly occasions and additionally track and distinguish drifts extra minutes CBER\'s capacity to evaluate transfusion-related antagonistic responses New Codes will advise the advancement of better transfusion-related danger lessening methodologies.

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Hemolytic Transfusion Reaction (HTR) A response of expanded devastation of red platelets because of inconsistency between blood contributor and beneficiary. Clinical and research facility indications of HTR: fever, chills, rigors, hemoglobinuria, nearness of antibodies to RBC antigens, and so on. HTR can be: Acute or Delayed relying upon the planning of event Due to either ABO or non-ABO incongruently

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Hemolytic Transfusion Reaction (HTR) Acute Hemolytic Transfusion Reaction (AHTR) – Accelerated obliteration of red platelets under 24 hours after transfusion Delayed Hemolytic Transfusion Reaction (DHTR) – Accelerated decimation of red platelets which more often than not shows 24 hours to 28 days (one month) after a transfusion Common Antibodies Associated with Hemolytic Transfusion Reactions (AHTR, DHTR) Anti-An Anti-B Anti-A,B Anti-C Anti-D Anti-E Anti-c Anti-e Anti-K Anti-k Anti-Jka Anti-Jkb Anti-S Anti-Fya Anti-Fyb Anti-M Other

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Hemolytic Transfusion Reactions (HTRs) In FY 2008, HTRs were the main source of transfusion-related passings answered to CBER, speaking to: 37% of affirmed transfusion-related fatalities 22% for ABO bungle 15% for non-ABO confuse Since 2007, the expansion in reported fatalities because of HTRs was because of an expansion in casualty reports for both the ABO and non-ABO hemolytic responses. The Fatalities Report for FYs 2005 to 2008 can be found on the FDA site: http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/ReportaProblem/TransfusionDonationFatalities/ucm113649.htm

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Hemolytic Transfusion Reactions (HTRs) Current ICD-9-CM Coding: 999.6 ABO contrarily response 999.7 Rh contradictorily response 999.8 Other mixture and transfusion response

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Hemolytic Transfusion Reactions (HTRs) Proposed new Coding adds more prominent specificity to the planning of the response and the sort of incongruently : 999.6 ABO inconsistency response because of transfusion of blood or blood items: 999.62 ABO incongruently with intense hemolytic transfusion response ABO contradictorily with hemolytic transfusion response under 24 hours after transfusion 999.63 ABO contrarily with deferred hemolytic transfusion response ABO incongruently with hemolytic transfusion response 24 hours or more after transfusion

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Hemolytic Transfusion Reactions (HTRs) Proposed new Coding adds more prominent specificity to the planning of the response and the kind of incongruently : 999.7 Rh and other non-ABO contradictorily response because of transfusion of blood or blood items: 999.72 Rh contrarily with intense hemolytic transfusion reaction AHTR because of contradictorily identified with Rh antigens (C) (D) (E) (c) (e) Rh contradictorily with hemolytic transfusion response under 24 hours after transfusion 999.73 Rh incongruently with postponed hemolytic transfusion response DHTR because of incongruently identified with Rh antigens (C) (D) (E) (c) (e) Rh contrarily with hemolytic transfusion response 24 hours or more after transfusion

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Hemolytic Transfusion Reactions (HTRs) Proposed new coding (Continued): 999.77 Non-ABO incongruently with intense hemolytic transfusion reaction AHTR from incongruently identified with minor antigens (Duffy) (Kell) (Kidd) (Lewis) (M) (N) (P) (S), and so on Non-ABO contradictorily with hemolytic transfusion response under 24 hours after transfusion 999.78 Non-ABO contrarily with deferred hemolytic transfusion response DHTR from inconsistency identified with minor antigens (Duffy) (Kell) (Kidd) (Lewis) (M) (N) (P) (S) Non-ABO incongruently with hemolytic transfusion response 24 hours or more after transfusion

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Transfusion-Transmitted Infections (TTIs) TTIs incorporate any irresistible life form (microbes, infection, parasite, other) transmitted through transfusion of blood or blood items (entire blood, RBCs, plasma, platelets, and so on.) Bacterial transfusion-transmitted diseases include: gram-negative life forms (e.g. Yersinia enterocolitica, Pseudomonas spp , Serratia spp), gram-positive living beings (e.g. Staphylococcus aureus, Staphylococcus epidermidis). Viral transfusion-transmitted diseases include: HIV, Hepatitis, Parvovirus, Cytomegalovirus, Epstein-Barr infection, West Nile infection, and so forth. Parasitic transfusion-transmitted contaminations include: Malaria, Chagas, Babesiosis, and so on. Other (e.g. prion) transfusion-transmitted contaminations include: Creutzfeldt-Jakob Disease (CJD), vCJD, and so on

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Transfusion-Transmitted Infections Currently, there is no particular ICD-9-CM determination code for TTIs. Ebb and flow Coding incorporates: 999 Complications of medicinal consideration, not somewhere else grouped 999.3 Other contamination

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Transfusion-Transmitted Infections Proposed Coding to add specificity: 999.32 Transfusion-transmitted disease Use extra code to distinguish the predefined contamination, for example, bacterial contamination: bacteremia (790.7) bacterial contamination (041.00-041.9) septicemia (038.0-038.9) sepsis (995.91) serious sepsis (995.92) septic stun (785.52)

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Transfusion-Transmitted Infections viral disease: HIV (042) hepatitis infection (070) parvovirus (079.83) West Nile infection (066.4) cytomegalovirus (078.5) Epstein-Barr infection (075) Dengue (061) parasitic contamination Babesiosis (088.82) Chagas ailment (086.0-086.2) Malaria (084.0-084.9) Leishmaniasis (085) prion/other disease Creutzfeldt-Jakob Disease (CJD) (046.19) variation Creutzfeldt-Jakob Disease (vCJD) (046.11)

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Febrile Nonhemolytic Transfusion Reaction (FNHTR) FNHTR clinical signs include: fever, chills, rigors without hemolysis and happens in the patient inside 4 hours after transfusion. Two most normal response systems: inactively transfused cytokines response between beneficiary antibodies and transfused leukocytes

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Febrile Nonhemolytic Transfusion Reaction (FNHTR) Currently there is no particular ICD-9-CM finding code for FNHTR . 999.8 Other implantation and transfusion response Proposed Specific Coding: 999.83 Febrile nonhemolytic transfusion response (FNHTR)

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Posttransfusion Purpura (PTP) PTP is described by sudden serious thrombocytopenia (platelet check <10,000/µL) for the most part emerging 5-12 days taking after transfusion of blood segments (entire blood, RBCs, plasma, or platelets). Response connected with nearness of antibodies coordinated against the Human Platelet Antigen (HPA) framework.

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Posttransfusion Purpura (PTP) Currently there is no particular ICD-9-CM analysis code for PTP . Current Coding contains: 287 Purpura and other hemorrhagic conditions 287.4 Secondary thrombocytopenia Proposed Specific Coding: 287.41 Posttransfusion purpura (PTP)

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Transfusion-Associated Circulatory Overload (TACO) TACO is a circulatory over-burden taking after transfusion of blood or blood parts Characterized by intense respiratory pain, expanded pulse, pneumonic edema auxiliary to congestive heart disappointment, positive liquid equalization, and so forth amid or inside 6 hours of transfusion. Elderly and babies are at expanded danger for TACO event even with little transfusion volumes. Event of TACO is liable to be underreported because of an assortment of differential determinations that present as Acute Respiratory Distress in the transfused people including TRALI and hypersensitivity.

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Transfusion-Associated Circulatory Overload (TACO) Currently there is no particular ICD-9-CM determination code for TACO. Current Coding incorporates: 276 Disorders of liquid, electrolyte, and corrosive base equalization 276.6 Fluid over-burden Proposed Specific Coding: 276.61 Transfusion-Associated Circulatory Overload (TACO)

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Transfusion-Associated Hemochromatosis (Iron Overload) Transfusion-Associated Hemochromatosis can come about because of the rehashed red platelet transfusions Hemochromatosis (iron over-burden) may bring about organ harm, including heart, renal, and liver brokenness .:tslidese

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