DSCSA: EDI 856 Advance Ship Notice - Cardinal Health

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856 Advance Ship NoticeSupplier Implementation GuideNovember 2015Generated by GEFEG.FX

856 Ship Notice/ManifestINTRODUCTIONThis implementation guideline for the 856 Ship Notice/Manifest electronic data interchange (EDI) transaction set wasdeveloped by the Healthcare Distribution Management Association (HDMA) and customized by Cardinal Health.HDMA members provide business and technology expertise to develop voluntary healthcare industry implementationguidelines for use of EDI and other technology standards. HDMA member distributors and manufacturers advised onthis guideline.Previously published HDMA implementation guidelines for the 856 Ship Notice/Manifest (commonly referred to as theAdvance Ship Notice or ASN) provided manufacturers with a systematic way to advise their distributor with advanceinformation on shipments in order to better plan and automate the receipt of goods process.This version is intended to support compliance with the Drug Supply Chain Security Act of 2013, Title II of the DrugQuality and Security Act. [Public Law 113-54] This document provides a streamlined format for the exchange ofTransaction Information (TI), Transaction History (TH) and a possible Transaction Statement (TS).This publication outlines the voluntary industry conventions and implementation guidelines for the ASC X12 approved856 “Advance Ship Notice” (ASN) EDI standard used by manufacturers, repackagers, distributors, exclusivedistributors and any other parties to send required information to their trading partners to document the movement ofprescription drugs through the healthcare supply chain. This ASN can facilitate downstream product and shipping datacollection which may then be used to create a possible Transaction Statement trading partners agree upon.Defined Scope of UsePlease note these guidelines are based on evolving requirements and, as such, may change as the Food and DrugAdministration (FDA) issues guidance and regulation implementing the DSCSA. It is the responsibility of the users ofthe ASN to ensure the information contained in the ASN message is accurate and complete based on currentregulatory and business requirements. This ASN is a framework message and allows trading partners the flexibilityto determine which specific codes, identifiers, content, etc. are most appropriate for their business needs.Changes made to the guideline to facilitate DSCSA compliance:Shipment Level: In the N1 loop, N3 and N4 are included in the guideline because it is mandatory to indicatethe address of buyer and seller for DSCSA compliance. The YNQ segment is used to indicate DSCSA compliance.Item Level: An N1 loop, including N3 and N4, is added for Transaction History required information, suchas Original Manufacturer or Exclusive Distributor.Note: Although lot number is not required in all DSCSA scenarios, it can be included in the LIN segment as tradingpartners may find it a helpful way to exchange information.Generated by GEFEG.FX

Two Business Examples are provided at the end of this guideline:Example 1: Direct Purchase Scenario – Ship Notice for product sent by a manufacturer to a distributor where bothparties are authorized as required under the Drug Supply Chain Security Act (DSCSA). This initial transaction initiatesthe Transaction History that will be used on all subsequent transactions where the product’s ownership changes. Inthe example, the Transaction Statement housed in the YNQ segment is a simplified statement of compliance thattrading partners might agree to use.Example 2: Indirect Purchase Scenario – Ship Notice for product sent by a distributor to a subsequent distributorthat will ultimately sell to a dispenser, where both distributors are authorized as required under the DSCSA. Theproduct was purchased directly from the original manufacturer, so omission of the lot number is allowed through theDSCSA. In the example, the Transaction Statement housed in the YNQ segment is a simplified statement ofcompliance that trading partners might agree to use. An N1 loop for Original Manufacturer is included at the ItemLevel. The CardinalHealth supplier business model does not expect to have indirect purchase scenarios, as we buydirectly from manufacturers or wholesalers.Cardinal Health guidelines for exempt products Scenario 1: Mixed shipment with exempt and non-exempt products: Send a DSCSA-compliant ASN. For the exempt items only: (Effective from August 2015)oUniversal Product Code (UPC code) is accepted in lieu of an NDC forexempt items in a mixed shipment.oOmission of Lot number & expiration date is permitted for exempt items thatlack those properties.Scenario 2: Supplier sends two distinct types of shipments: exempt and non-exempt. Send a DSCSA-compliant ASN for the non-exempt items. Put a value of N in the YNQ02 for exempt shipments.Scenario 3: Supplier only deals in exempt products: No need to use DSCSA-compliant ASN.Cardinal Health required fieldsThe next section, the EDI 856 Technical Guidelines, provides the EDI standard and technical documentation forthe universal standards. To simplify the process for you, below is a list of the 11 fields that Cardinal Healthrequires in the 856 transaction. You may want to refer to both this section and the next for complete technicalguidelines, but this summary will allow you to focus on exactly what’s needed for a successful 856.Generated by GEFEG.FX

All fields below are required by the Cardinal Health Standard:Data ElementBusiness DefinitionMaps to Technical Guideline HierarchicalLevel Within theASNConfirmed Ship The date on which the manufacturerhas confirmed the item(s) has beenDateshipped to the customer.DTM (Date/Time) Segment, DataShipment LevelElement 374 with a qualifier of ‘011’for Shipped Date and the date inData Element 373.EstimatedDelivery DateThe date on which the distributor isexpected to receive the item(s) frommanufacturer.DTM (Date/Time) Segment, DataElement 374 with a qualifier of„017„ for Expected Arrival andthe date in Data Element 373.Shipment LevelCarrier NameThe name of the transportationTD5 (Carrier Details) Segment,Shipment Levelcompany who will deliver the productData Element 387.from origination to destination or the(Waived for 1/1/15 DSCSAoriginating carrier's identity.compliance, but still expected aspart of CardinalHealth Vendorcompliance statistics.)ShippingThe address or ID # of the locationN101 (Name – Ship From)Location (Shipfrom where the product is beingSegment, Data Element 098 with aFrom)shipped (Shipping point).qualifier of SF for Ship From.Carrier Tracking The number automatically assigned to REF Segment, Data Element 128every shipment to identify and trace it contains the qualifier of “CN" forNumberCarrier’s Reference Numberas it travels to its destination.(PRO/Invoice) and Data ElementShipment LevelShipment Level127 should contain the carriertracking numberDEA Number /The DEA number indicates a healthHealth Industry care provider’s authority to writeNumber / D&B prescriptions for controlledD-U-N-S Numbersubstances. The Health IndustryNumber (HIN) is a unique ID foridentifying all trading partners. Go tohttp://www.hibcc.org/hinsystem.htm toGenerated by GEFEG.FXN1 (Name – Ship From) Segment, Shipment LevelData Element 098 with a qualifier of“SF" should have Data Element066 with a qualifier of “1"."9"."11" or“21" and Data element 067 shouldcontain the

obtain your HIN. A D&B D-U-N-S supplier unique identifier.Number is a unique nine-digitsequence recognized as theuniversal standard for identifyingbusinesses worldwide.Purchase Order The Cardinal Health PurchaseOrder Number; WrittenNumberauthorization for a supplier to shipPRF (Purchase OrderOrder LevelReference) Segment, DataElement 324.products at a specified price, whichbecomes a legally binding contractonce the supplier accepts it.NDC NumberThe NDC Number associated withLIN (Line Identification)each individual item that is used toSegment, Data Element 234.Item Levelplace orders. DSCSA requires NDCfor all non-exempt items.Ship QuantityLot NumberThe number of individual piecesSN1 (Item Detail (Shipment))shipped to its destination.Segment, Data Element 382.The number assigned to aLIN (Line Identification) Segment, Item LevelData Element 235 with a qualifier of„LT" for Lot Number and in DataElement 234 the Lot number.particular batch of product.Expiration Date The date after which the product isnot recommended for use.DTM (Date/Time) Segment, DataItem LevelItem LevelElement 374 with a qualifier of„036" for Expiration dateGS1 – 128 Compliant Bar CodesThe unique identifiers applied to each pallet and case should conform to the GS1- 128 standard and toHDMA bar code guidelines. These identifiers should be included within the Advance Shipping Notice(ASN) as prescribed by HDMA EDI guidelines. These were required to help us comply with existingpedigree regulations in multiple states. However, it is not necessary to label cases and pallets of narcoticsand controlled drugs with unique identifiers, and these are also not required in the ASN.Generated by GEFEG.FX

SerializationAs Cardinal Health prepares for the upcoming Federal milestones, managing Serialized information in the ASNis an option (should you choose not to use an EPCIS solution). We are planning to support serialized data atthe Pack and Item hierarchy levels before the end of 2016.HDMA changes made to the guideline to facilitate DSCSA complianceThe below represents HDMA’s interpretation of the EDI segments that correlate with the information required fortrading partners to pass Transaction Information (TI), Transaction History (TH) and the Transaction Statement(TS) under the Drug Supply Chain Security Act (DSCSA)Shipment Level: Four N1 loops are required to distinguish logistical movement from ownership transfer:1) Ship To2) Buyer3) Ship From4) Seller In each N1 loop, N3 and N4 are included in the guideline because it is mandatory to indicate the addressof buyer and seller for DSCSA compliance One YNQ segment is used to communicate the Transaction Statement (TS)oA compliant shipment level YNQ will show: YNQ02 ’Y’ YNQ05 must contain the Transaction Statement YNQ08 ‘99’ YNQ09 ‘TS’oHDMA recommends the following text in YNQ05 as the Transaction Statement:Seller has complied with each applicable subsection of FDCA Sec. 581(27) (A)–(G). A second YNQ segment may be used as a pointer for downstream segments to indicate that a directpurchase statement (DPS) or the receipt of a direct purchase statement applies to a product at itemlevel. A DPS at the shipment level is effectively a flag to look for the item level YNQ:oUse of the shipment level DPS YNQ will show:o YNQ02 ’Y’o YNQ05 must contain a direct purchase statemento YNQ08 ‘99’o YNQ09 ‘DPS’Top of PageHDMAGenerated by GEFEG.FXIssue date: 11/03/2015CAHPage:6

oHDMA recommends the following text in YNQ05 as the Direct Purchase Statement:o “As indicated below, product was purchased directly from the manufacturer,manufacturer’s exclusive distributor or repackager who purchased directly from amanufacturer.”Item Level: An N1 loop, including N3 and N4, is added for Transaction History (TH) required information, such asOriginal Manufacturer or Exclusive Distributor. A YNQ segment for the item level allows the sender to indicate:o For items where product was purchased directly:o YNQ02 ‘Y’o YNQ08 ‘99’o YNQ09 ‘DIR’o For transactions that require an indication that a direct purchase statement has beenreceived:YNQ02 ‘Y’YNQ08 ‘99’YNQ09 ‘RDPS’ Transaction Information (TI) includes:– Name of the product (Item-level PID segment – PID05)– Strength and dosage form (Item-level PID segment – PID05)– NDC (Item-level LIN segment – Pair qualifier with ID – multiple choices)– Container size (Item-level PID segment – PID05)– Number of containers (Item-level SN1 segment – SN102)– Lot number (Item-level LIN segment - Pair qualifier with ID – multiple choices)– Transaction date (BSN Segment – BSN03)– Shipment Date (Shipment-level DTM)*– Name and address of the seller (Shipment-level “Seller” N1 loop, segments N1, N3, N4)– Name and address of the purchaser (Shipment-level “Buyer” N1 loop, segments N1, N3, N4)*Needed if shipment date is more than 24 hours after date of the transactionHierarchical Levels: Tare and Inner pack hierarchical levels are optional. Cardinal Health does not support Tare or Inner Packlevel segments.Top of PageHDMAGenerated by GEFEG.FXIssue date: 11/03/2015CAHPage:7

POSIDNAMEREQUSE/REPEAT010STTransaction Set HeaderM1020BSNBeginning Segment for Ship NoticeM1010HLShipment LevelM200000010HLHierarchical LevelM1110TD1Carrier Details (Quantity and Weight)O20120TD5Carrier Details (Routing Sequence/Transit Time)M12130TD3Carrier Details (Equipment)O12150REFReference Identification (Tracking number)M 1200DTMShipped DateM10200DTMDelivery DateM10220N1N1-N3-N4-REF – Ship ToM200220N1NameM1240N3Address InformationM2250N4Geographic LocationM1260REFReference IdentificationO12220N1N1-N3-N4-REF - BuyerM200220N1NameM1240N3Address InformationM2250N4Geographic LocationM1260REFReference IdentificationO12220N1N1-N3-N4-REF-PER – Ship FromM200220N1NameM1240N3Address InformationM2250N4Geographic LocationM1USAGETop of PageHDMAGenerated by GEFEG.FXIssue date: 11/03/2015CAHPage:8

260REFReference IdentificationO12270PERAdministrative Communications ContactO3220N1N1-N3-N4-REF - SellerM200220N1NameM1240N3Address InformationM2250N4Geographic LocationM1260REFReference IdentificationO12335YNQDSCSA Transaction StatementM10335YNQDirect Purchase StatementO10010HLOrder LevelM200000010HLHierarchical LevelM1050PRFPurchase Order ReferenceM1150REFReference IdentificationO 1010HLTare LevelO200000010HLHierarchical LevelM1150REFReference IdentificationO 1190MANMarks and NumbersO 1010HLPack LevelO200000010HLHierarchical LevelM1020LINItem IdentificationO1060PO4Item Physical DetailsO1150REFReference IdentificationO 1190MANMarks and NumbersO 1190MANMarks and NumbersO 1Top of PageHDMAGenerated by GEFEG.FXIssue date: 11/03/2015CAHPage:9

SIDNAMEREQUSE/REPEAT200DTMDate/Time ReferenceO10010HLInner Pack LevelO200000010HLHierarchical LevelM1020LINItem IdentificationO1060PO4Item Physical DetailsO1150REFReference IdentificationO 1190MANMarks and NumbersO 1190MANMarks and NumbersO 1200DTMDate/Time ReferenceO10010HLItem LevelM200000010HLHierarchical LevelM1020LINItem Identification (NDC & Lot number of the item)M1030SN1Item Detail (Shipment)M1070PIDProduct/Item DescriptionM200150REFReference IdentificationO 1150REFReference IdentificationO 1200DTMLot Expiration DateM10220N1N1-N3-N4-REF (TH)C200220N1NameC1240N3Address InformationC2250N4Geographic LocationC1260REFReference IdentificationO12335YNQDirect Purchase StatementO10010CTTTransaction TotalsM1020SETransaction Set TrailerM1USAGETop of PageHDMAGenerated by GEFEG.FXIssue date: 11/03/2015CAHPage:10

Top of PageHDMAGenerated by GEFEG.FXIssue date: 11/03/2015CAHPage:11

STSegment:Requirement:Max Use:Purpose:Transaction Set HeaderM1To indicate the start of a transaction set and to assign a control numberSemantic Notes:1. The transaction set identifier (ST01) used by the translation routines of the interchangepartners to select the appropriate transaction set definition (e.g., 810 selects the InvoiceTransaction Set).ST*856*0121 Example:ELEMENT SUMMARYUSAGEMust UseREFST 01IDELEMENT NAMEREQREPRREP143Transaction Set Identifier CodeMID 3/31MAN 4/91Code uniquely identifying a Transaction Set856Must UseST 02329Ship Notice/ManifestTransaction Set Control NumberIdentifying control number that must be unique within the transaction setfunctional group assigned by the originator for a transaction setThis is a sequential control number.REFIDREQREPRTop of PageSegment Tag and Position NumberElement IDRequirement (M Mandatory, C Conditional, R Required, O Optional, A Advised, D Dependent)Elements RepresentationHDMAGenerated by GEFEG.FXIssue date:4/18/2014Page:12

BSN Beginning Segment for Ship NoticeSegment:Requirement:MUser Option (Usage): Must useMax Use:1Purpose:To transmit identifying numbers, dates, and other basic data relating to the transaction setComments1. BSN06 and BSN07 differentiate the functionality of use for the transaction set.Syntax Notes:1. C0706 ConditionalSemantic Notes:1. BSN03 is the date the shipment transaction set is created.2. BSN04 is the time the shipment transaction set is created.3. BSN06 is limited to shipment related codes.BSN*00*C2878510004*20091218*1117*0001*AS Example:ELEMENT SUMMARYUSAGEMust UseREFBSN 01IDELEMENT NAMEREQREPRREP353Transaction Set Purpose CodeMID 2/21MAN 2/301MDT 8/81MTM 4/81Code identifying purpose of transaction set00Must UseBSN 02396OriginalShipment IdentificationA unique control number assigned by the original shipper to identify aspecific shipmentVendor Bill of Lading number or other shipment identifierMust UseBSN 03373DateDate expressed as CCYYMMDDDocument create dateMust UseBSN 04337TimeTime expressed in 24-hour clock time as follows: HHMM, or HHMMSS, orHHMMSSD, or HHMMSSDD, where H hours (00-23), M minutes (0059), S integer seconds (00-59) and DD decimal seconds; decimalseconds are expressed as follows: D tenths (0-9) and DD hundredths(00-99)REFIDREQREPRTop of PageSegment Tag and Position NumberElement IDRequirement (M Mandatory, C Conditional, R Required, O Optional, A Advised, D Dependent)Elements RepresentationHDMAGenerated by GEFEG.FXIssue date:4/18/2014Page:13

ELEMENT SUMMARYUSAGEUsedREFBSN 05IDELEMENT NAMEREQREPRREP1005Hierarchical Structure CodeOID 4/41CID 2/21Code indicating the hierarchical application structure of a transaction setthat utilizes the HL segment to define the structure of the transaction set0001 Shipment, Order, Packaging, Item0004 Shipment, Order, ItemUsedBSN 06640Transaction Type CodeCode specifying the type of transactionASDOREFIDREQREPRShipment AdviceNotification by an inventory management organization providingcurrent shipping advice relating to theoutstanding requisition or orderDrop Shipment InvoiceUsed to indicate a drop ship notice, not a drop ship invoiceTop of PageSegment Tag and Position NumberElement IDRequirement (M Mandatory, C Conditional, R Required, O Optional, A Advised, D Dependent)Elements RepresentationHDMAGenerated by GEFEG.FXIssue date:4/18/2014Page:14

Shipment LevelLoop:Repeat:200000HLSegment:Requirement:Max Use:Purpose:Hierarchical LevelM1To identify dependencies among and the content of hierarchically related groups of datasegmentsComments1. The HL segment is used to identify levels of detail information using a hierarchicalstructure, such as relating line-item data to shipment data, and packaging data to line-itemdata.The HL segment defines a top-down/left-right ordered structure.2. HL01 shall contain a unique alphanumeric number for each occurrence of the HL segmentin the transaction set. For example, HL01 could be used to indicate the number ofoccurrences of the HL segment, in which case the value of HL01 would be "1" for the initialHL segment and would be incremented by one in each subsequent HL segment within thetransaction.3. HL02 identifies the hierarchical ID number of the HL segment to which the current HLsegment is subordinate.4. HL03 indicates the context of the series of segments following the current HL segment upto the next occurrence of an HL segment in the transaction. For example, HL03 is used toindicate that subsequent segments in the HL loop form a logical grouping of data referring toshipment, order, or item-level information.5. HL04 indicates whether or not there are subordinate (or child) HL segments related to thecurrent HL segment.HL*1**S*1 Example:ELEMENT SUMMARYUSAGEMust UseREFHL 01IDELEMENT NAMEREQREPRREP628Hierarchical ID NumberMAN 1/121A unique number assigned by the sender to identify a particular datasegment in a hierarchical structureREFIDREQREPRTop of PageSegment Tag and Position NumberElement IDRequirement (M Mandatory, C Conditional, R Required, O Optional, A Advised, D Dependent)

856 “Advance Ship Notice” (ASN) EDI standard used by manufacturers, repackagers, distributors, exclusive distributors and any other parties to send required information to their trading partners to document the movement of prescription drugs through the healthcare supply chain. This ASN can facilitate downstream product and shipping data

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