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BP #6: INVENTORY CONTROL, INCLUDING KITS AND FORMS MANAGEMENT

The major emphasis in Business Process #6 (BP #6), Inventory Control, Including Kits and Forms Management, is inventory management of items that directly support the testing process rather than on general inventory management. These items include both internally manufactured items, such as reagents and media, along with purchased items, such as kit components. Because inventory control directly supports the testing process of a public health laboratory (PHL), it has a number of unique requirements. Inventory control for a PHL must be able to: · · Associate QC data sets to specific inventory lots of purchased and internally manufactured items. Stock both individual components and assembled items in inventory. For example, inventory control must include support for sample collection kit assembly from inventory components. This support is necessary because sometimes the assembled kit is customized for a given customer or customer sample based on requirements for field sample collection. Trigger in-house manufacturing of items such as reagent lots and media, and to supply any necessary raw materials for these manufacturing activities. (BP #5: Media, Reagent, Stains, Controls, etc. Manufacturing discusses the manufacturing business process in complete detail). Sell inventory items to other laboratories if the PHL is the best or only source for that inventory item, or if the PHL is the only source for an item that has undergone a reliable quality control process. In addition, economies of scale may make it feasible or necessary to manufacture more of an item than is needed for internal PHL consumption.1 Recycle inventory items such as shipping containers for sample collection kits. These containers are used by customers to deliver samples to the PHL. Recycling includes accounting for, refurbishing as necessary, and re-stocking in inventory. Track maximum and minimum inventory levels for items used in testing, such as chemicals, reagents, and stains.

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The design assumes the sale of manufactured items to external laboratories is conducted within this business process rather than BP #5, the manufacturing business process. The rationale behind this assumption is that manufactured items may be delivered directly to internal lab sections from the manufacturing area upon completion of the batch QC work. In contrast, manufactured items for external sale are stocked in inventory and delivered through the order fulfillment process in inventory control.

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The design for this inventory module focuses on the above requirements, which are unique to a PHL rather than addressing the requirements of a typical commercial inventory application. Exhibit IC-01, Relationship between the Inventory Control and Other Business Processes, shows how BP #6, Inventory Control, Including Kits and Forms Management, relates to several other business processes. EXHIBIT IC-01: Relationship between the Inventory Control and Other Business Processes

BP # 1 : Su b m itte r T e st Su b m itta l Pre p a ra tio n (sa m p le a n d re q u e st d o cu m e n ta tio n ) [A] BP # 5 : M e d ia , R e a g e n t, Sta in s, C o n tro ls, Etc. M a n u fa ctu rin g BP # 6 : In ve n to ry C o n tro l, In clu d in g Kits, Etc. BP # 9 : L a b o ra to ry Billin g BP # 1 :T e st Pre p a ra tio n (sa m p le h a n d lin g , b a tch p re p a ra tio n , e tc.) [C ]

BP # 1 :T e st Sa m p le & R e q u e st R e ce ip t a t L a b (re ce ivin g , ve rifyin g , a n d a cce ssio n in g ) [B]

BP # 3 : Pro a ctive Sa m p le C o lle ctio n

BP # 6, Inventory Control, Including Kits and Forms Management interacts with: · · · · · Submitter test submittal preparation (BP #1 [A]) for selling inventory items to external submitters and managing kits. Test sample receipt (BP #1 [B]) for receiving kits and supporting recycling of inventory items such as kit containers. Test preparation (BP #1 [C]) for ordering and delivering inventory items such as glassware, media, and forms to the laboratory sections. Pro-active sample collection (BP #3) for information on kit distribution needs to the support anticipated sample submittal schedules Laboratory billing (BP #9) by providing purchase order and shipment information that supports the billing process.

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· Manufacturing of items such as media, reagent, and stains (BP #5) for manufacturing recipes and fulfilling inventory replenishment requests.

The next two sections present the workflow and design for the associated user interface screens for Inventory Control and Kit Management.

Inventory Control Workflow

The workflow diagram for inventory control is shown in Exhibit IC-02, and consists of the tasks required to receive, process and ship inventory item orders received from external customers and internal laboratory sections. The workflow encompasses the interface to manufacturing for inventory items produced within the PHL, and also includes triggering replenishment orders from outside vendors. Tasks IC-01 through IC-11 are the workflow tasks associated with the inventory function. These tasks are described in the following section.

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EXHIBIT IC-02: Workflow for Inventory Control

C u sto m e r O rd e r R e ce ivin g IC -0 1 O rd e r Pe n d in g /H o ld L ist IC -0 2 No

Pre -p a y R e q u ire d ? No L a b o ra to ry Se ctio n O rd e r R e ce ivin g IC -0 3 O rd e r Pro ce ssin g IC -0 4

Ye s

Pa id ?

Ye s

Q u a n tity Ava ila b le ? Ye s C u sto m e r O rd e r Sh ip m e n t IC -0 6

No

M a n u fa ctu rin g R e q u ire d ? Ye s T rig g e r M a n u fa ctu rin g O rd e r

Ye s L a b o ra to ry Se ctio n O rd e r D istrib u tio n IC -0 5

No

IC -1 0

Au to R e p le n ish m e n t O rd e r T rig g e r IC -0 7

M a n u fa ctu rin g O rd e r R e ce ivin g IC -1 1

Needed ?

Ye s Pla ce R e p le n ish m e n t O rd e r IC -0 8 No R e p le n ish m e n t O rd e r R e ce ivin g IC -0 9

EN D

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Task IC-01: Customer Order Receiving This task includes receiving, reviewing, and creating an electronic order for inventory processing. Once the electronic order has been created, it is assigned a status code that indicates its readiness for processing. The conditions for processing the order are different for external customer orders than for orders from internal laboratory sections. For example, a pre-payment requirement may impact the readiness of a customer order for processing, while orders from internal laboratory sections are never subjected to a pre-payment requirement. Task IC-02: Order Pending/Hold List If a review of the order indicates that the order is not ready for processing, the order request is placed on hold. Task IC-02 involves obtaining from the customer any additional information required to process the order. As indicated in the workflow diagram, this task applies to external customers only. The design assumes that any missing or inaccurate information for an internal laboratory section can be resolved during order entry (Task IC-03). Task IC-03: Laboratory Section Order Receiving This task involves receiving orders for inventory items from the laboratory sections. Laboratory section orders are treated differently from processing external customer orders in that lab sections: · · Can borrow items from another lab section to meet an immediate need. Can sequester lots either internally or at the supplier. The design assumes that a PHL would not sequester lots of PHL-purchased items on behalf of an external customer, although it might sequester lots of internally manufactured items for them because the PHL is the source for any given manufactured lot. Have no pre-pay restrictions. Can clarify order content with inventory control immediately. Require no shipment information, which is critical in external customer order fulfillment.

· · ·

Task IC-04: Order Processing This task involves gathering the order contents, packing the order, and preparing the packing slip (manifest).

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Task IC-05: Laboratory Section Order Distribution Once ordered items have been retrieved from inventory, they can be distributed to the laboratory section or picked up by the lab section from the inventory area.2 Task IC-06: Customer Order Shipment The task associated with shipping external customer orders is more complex than the distribution of items to internal laboratory sections because proper packaging and labeling guidelines must be observed. This task specifically involves preparing the order for shipping, and releasing it to the shipping entity. Task IC-07: Auto Replenishment Order Trigger Within the inventory control area, the user needs to know when to replenish the stock of a particular item. This task is the decision-making process involved in making that determination and triggering the order. This task also includes determining the quantities to be ordered from the supplier. Task IC-08: Place Replenishment Order Once the quantity to order has been established, this task involves creating the purchase order and collecting any associated information. For example, inventory control may need to determine which PHL account will be used to pay for the items being purchased. If the order involves a new vendor, a vendor master file record must be established. If an item may be purchased from multiple sources, inventory control must decide which vendor to use.3

Inventory items may be stored in many areas throughout the laboratory, including within individual laboratory sections. The PHL must determine when an item is considered to be moved out of its inventory. Is an item considered to be removed from inventory when it is at the bench level, or when it is delivered to a given laboratory section? The number and types of inventory storage locations and the number of transactions required to properly track inventory levels are greatly affected by this decision. 3 In some states, public health laboratories have no control over procurement, or procurement may not be integrated into a LIMS.

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Task IC-09: Replenishment Order Receiving This task involves the activities associated with verifying and recording receipt of each item and item quantity, adding it to the available PHLLIMS inventory, and physically locating it in the inventory. Task IC-10: Trigger Manufacturing Order This task involves orders that include an item manufactured by the PHL. If inventory has a shortage of that item, or if fulfilling the order depletes the inventory below the re-order point, a manufacturing order for that item is triggered. Task IC-11: Manufacturing Order Receiving This task is similar to the Task IC-09, except that the quantity may be determined by manufacturing--a determination that may take into account economies of scale.

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Inventory Control Screen Design

The user interface screens that follow reflect the PHL-LIMS support of tasks IC-01 through IC-11. The screen design divides the inventory control activity into two segments: Customer Order Processing (Screens IC-01 through IC-06) and Inventory Management (Screens IC-07 through IC-12). The two segments are discussed separately in the following material. EXHIBIT IC-03: Screen Flow for Inventory Control

Ad d N e w O rd e r Scre e n IC -0 2 O rd e r D e ta il C u rre n t O rd e r L ist Scre e n IC -0 1 Scre e n IC -0 3 H e ld O rd e r D e ta il Scre e n IC -0 5 In ve n to ry M a in M enu C u sto m e r M a ste r F ile Scre e n IC -0 6 O rd e r Sh ip m e n t Scre e n IC -0 4

In ve n to ry M a ste r Ite m L istin g Scre e n IC -0 7

Au to R e -o rd e r L istin g Scre e n IC -0 8

In ve n to ry Ite m D e ta il Scre e n IC -0 9

In ve n to ry Ite m Pu rch a se O rd e rs Scre e n IC -1 0

Ve n d o r M a ste r F ile Scre e n IC -1 1

P.O . Pa ym e n t So u rce (s) Scre e n IC -1 2

Customer Order Processing The PHL-LIMS design supports processing of customer orders in receiving, processing and shipping; although if an order is from an internal laboratory section, it would likely be distributed rather than shipped. The design also supports the maintenance of external customer master records for order processing. This maintenance function of customer master records is not covered here rather than in the Phase 1 logical design document.

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SCREEN IC-01: Current Order List

Screen IC-01, the Current Order List screen shows all the customer orders that must be fulfilled by inventory control. The Customer Code field shows whether the customer is an internal or external customer. The user can click Add to open Screen IC-02, the Add New Order screen, in which they may add a new order. The user can also select an order and click Edit to open Screen IC-03, the Order Detail screen, in which they may edit the selected order. The user can click Hold to open Screen IC-04, the Held Order Detail screen, which lists those orders that are being held for various reasons. And finally, the user can click Query to search for an order or a subset of orders based on query criteria such as customer name. The user may use the querying capability to also search for historical orders.

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SCREEN IC-02: Add New Order

From Screen IC-02, the Add New Order screen, the user can create a new order or modify an existing order. To create a new order, the user selects the customer ID and completes the header fields. These fields include Order ID, Order Date, Hold Code (if the order is incomplete), and the Ship to Location Code. Once this header information is complete, the user can click Add Items to add items to the order. The user can also click Hold Detail to create a detailed hold record if a hold code has been selected in the header. And finally, the user can click Edit Customer Data Set to add a new customer record or edit an existing record.4

The design assumes that inventory items are sold to external customers based on a standard PHL pricing catalog as opposed to negotiated prices per individual customer.

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SCREEN IC-03: Order Detail

From Screen IC-03, the Order Detail screen, the user can create the appropriate shipment information when the order items are "picked" from inventory (See Exhibit IC-05). The user can click Add Item to add an item to the order. The user can also select an item and click Edit to modify details for the item. The user can select an item and click Delete to remove the item from the order. And the user can click Shipment to open Screen IC-04, Order Shipment. EXHIBIT IC-04: Customer Order Data Structure

Customer ID Order ID Location ID Order Date Location ID Location Name CUSTOM ER ORDER Item ID (PHL Item Number) Lot Number (if a current sequestered item) Quantity Ordered Sequestering Requested (0,1) Sequestering Quantity (0,1) SHIPM ENTS Ship Date Quantity (0,S)

SHIP TO LOCATION (1,L)

ITEM ORDERED S (1,I)

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Exhibit IC-04, the Customer Order Data Structure, describes the data elements required to support customer orders. The data structure supports multiple ship-to locations per order, and if no shipping location information is included in the customer master file, the order is shipped to the default customer address. The design allows external customers to sequester items when lot numbers are associated with the item, and when the item is manufactured by the PHL. The design does not allow external customers to sequester items that the PHL obtained from a vendor.5

Under the proposed design, the PHL can sequester items purchased from a vendor, but external customers cannot sequester such items from the PHL.

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SCREEN IC-04: Order Shipment

In Screen IC-04, the Order Shipment screen, the user can click Print Labels to print a shipping label. The user can click Edit Shipment to edit the information associated with an order of items that have been picked from inventory for shipment. The user can also click Add Shipment to add information associated with an order for items that have been picked from inventory. The user can click Manifest to print a packing slip to include in the shipment.

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SCREEN IC-05: Held Order Detail

Screen IC-05, the Held Order Detail screen provides information on why a particular order has been held. In this screen, the user can click Add Note to enter information explaining why the order has been held. The user can click Edit to Edit the contents of the Hold Order Detail screen. The user can also click Release to remove the hold, and enable the order to be processed.

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SCREEN IC-06: Customer Master File

Screen IC-06, the Customer Master File screen The Customer Master File is described in Section E, Chapter 1 of the Phase 1 logical design document. If the external customer is not a submitter, but is a laboratory that simply purchases items from the PHL inventory, the user can create a customer master file coded as "purchaser only."6 Inventory Management The primary purpose for supporting Inventory Management within the PHLLIMS design is to ensure that any item necessary to perform a test is available.7 Inventory management in this design enables the user to:

6 Most external customers should be covered through BP #12, Laboratory Certifications/Licensing. If the PHL is charged with overseeing the external customer, a customer record would exist showing the customer to be a submitter, a subject of oversight and licensing, or both. These records would constitute the customer data set for inventory transactions, so in a physical implementation, a single customer master record structure could be used. 7 While a PHL could assure item availability by maintaining a huge inventory, economic reasons such as cost, space, and item expiration make such large inventories infeasible. Inventory management must therefore balance economic parameters against the need to have inventory items available for testing. Experience in general industry shows that information system support for this function is highly effective in achieving that balance.

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· · · · · Monitor inventory levels. Calculate re-order points and quantities. Trigger vendor replenishment orders, or prepare an order sheet if the procurement process is in a separate system. Trigger PHL manufacturing orders. Create and maintain needed links to QC, whether from a vendor or from internal manufacturing. (BP #5: Media, Reagent, Stains, Controls, etc. Manufacturing discusses the manufacturing business process in complete detail).

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SCREEN IC-07: Inventory Master Item Listing

Screen IC-07 enables the user to see view information about any inventory item. From this screen, the user can select an inventory item and click Detail to see more information about the selected item. The user can click Query to locate a specific item. The user can click Add to add an inventory item to the list. The logical data structure for an inventory item is shown in Exhibit IC-05, Item Re-order Algorithm Logical Data Structure.

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SCREEN IC-08: Auto Re-order Listing

Screen IC-08, the Auto Re-order Listing screen, lists all the items in inventory and details about those items that have been determined to need replenishing. From this screen, the user can select an item and click Create P.O. to create a purchase order for the item. The user can also select an item and click Detail to examine the data used to determine that a replenishment order should be triggered. Entries are automatically added to this list whenever the PHL-LIMS monitoring function determines that, under the business rules for a given item, a replenishment order needs to be issued. The re-order amount is determined using the Auto Re-order Calculator,8 which bases its calculation for a given item on the following parameters:

In general, the design does not anticipate the need to perform physical inventory counts at the laboratory section level. Instead, items are removed from the main PHLLIMS inventory when transferred to the laboratory section. This means that in "emergency" situations, a lab section in need can look at the inventory item detail to see what items are available (Exhibit IC-12).

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· · · · · · · An estimate of the average daily usage of the item if it is not tied directly to the performance of a specific test. The average daily usage of an item that is used directly in the performance of a test--for example, plates. The impact of expiration dates on usable inventory that results from general shelf life or specific lot expiration dates. The replenishment lead time. The logical quantity to be ordered. The "life expectancy" on items recycled to inventory. These items are primarily sample coolers and sample kit components. The monitoring level requirement via PHL-LIMS reports on inventory levels.

These parameters translate into data requirements for each inventory item. Exhibit IC-05, Item Re-order Algorithm Logical Data Structure, reflects the logical data structure needed to support a re-order algorithm. EXHIBIT IC-05: Item Re-order Algorithm Logical Data Structure9

Item ID Description Seasonally Adjusted Average Use per Day Vendor ID Count per Purchase Unit (box, etc.) U from Count nit U to Count nit Price per Purchase Unit Price per Item

VENDOR (1,V) ITEM

QUANTITY RANGE (1,R)

Average Lead Time (moving average over last N deliveries) Storage Location Type Code (refrigerator, etc.) Storage Space per Purchase Unit M inimum Inventory Level (usage/day times lead time with a safety factor added) M aximum Inventory Level (user defined or usage/day times average shelf life) M anagement Level Code Auto Reorder (Y/N ) Auto Reorder Quantity (if Auto Reorder = Y

The weighting of each algorithm element should be user-defined, and different PHLs will likely create different calculation formulas based on

For the Management Level Code data element, not all items deserve the same level of attention from management. For low cost items with short lead times, the only data element in the table that may be necessary to monitor is a minimum inventory level. For high cost, long lead time items, all data elements may be needed.

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their own needs. However, the objective of the PHL-LIMS is to support the user in determining when to order an item and how much to order. An additional parameter that can impact re-ordering is the distribution of expiration dates for item lots in inventory. It is possible for sufficient quantities of an item to cover the replenishment lead time, but the available inventory is due to expire prior to that time. In other words, some of the inventory will expire before the PHL is able to sell or use it. To remedy this situation, the inventory must reflect the following logical data structure for items with pre-defined expiration dates: EXHIBIT IC-06: Logical Data Structure for Items with Lot Expiration Dates

Item ID Item Description INVENTORY ITEM LOT (1,L) Lot ID Expiration Data Quantity in Inventory

Finally, the available inventory storage space may also impact the replenishment order quantity. While ordering more of an item may be more economical, limits on storage space may make it impossible to do so. This situation occurs most often with items that require refrigeration. This parameter would be entered as the "Maximum Inventory Level" in the data structure described in Exhibit IC-05.

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SCREEN IC-09: Inventory Item Detail

Screen IC-09, Inventory Item Detail provides information about a selected inventory item. The QC field in this screen provides the link to the QC data set associated with the given purchase or manufacturing run. This data element will only be relevant if it is necessary to associate a QC set with a given batch or individual test result.10 The user can click Vendors to view information about any vendors that supply the given item. Internally manufactured items will not have a vendor record but are associated with orders via the manufacturing business process. The user can click QC to see the QC data set associated with a given selected purchase or manufactured run. The user can click Order Detail to open Screen IC-03, the Order Detail screen, in which they can view any order information associated with the item. Finally, the user can click P.O. Detail to take the user to the set of purchase orders for the item. The list should present the orders and purchases/manufacturing runs in order of most recent to oldest. The logical data structure associated with

The Phase 1 logical design document establishes the need to link QC data sets to individual tests or test batches.

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this item presentation is shown in Exhibit IC-07, Inventory Item Orders/Purchases. EXHIBIT IC-07: Inventory Item Orders/Purchases

Item ID Item Description Order ID Customer ID Order Status Order Date Order Quantity Order Quantity Received P.O. ID Supplier ID P.O. Date P.O. Quantity QC Reference

CUSTOM ORDERS ER (0,C) INVENTORY ITEM

PURCHASES/M ANU FACTURING RUNS (1,P) Current Inventory Balance

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SCREEN IC-10: Inventory Item Purchase Orders

Screen IC-10, Inventory Item Purchase Orders lists any outstanding purchase orders for a given inventory item. Although the design focuses on separate purchase orders for each replenishment order, it is possible to leave a purchase order "open" for the addition of other items. To construct a purchase order, the user first selects a vendor (or manufacturing area, if the item is supplied by the PHL) to supply the given item. If there is an "open" purchase order for that vendor, the user would add the new item to the purchase order list. When the purchase order is ready to be sent, the user closes the purchase order and prints the supporting document. The user can click Add Item to add an item to the given purchase order. The user can also select an item in the list and click Edit Item to modify information associated with the item. The user can select a purchase order line and click Change Status to change the line's status code. For example, the user may change the line's status code to "Remainder on backorder" to explain a short in delivery quantity. The user can click Payment Source to open Screen IC-12, P.O. Payment Source, in which the user can enter the account number or numbers for the PHL account(s) from which the PHL will pay the vendor bill for the purchase order.

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SCREEN IC-11: Vendor Master File

Screen IC-11, the Vendor Master File screen provides basic vendor information along with a list of any items that the PHL has approved for purchase from the vendor. From this screen, the user can click Add Vendor to add a vendor to the list, along with any approved items. The user can also select a vendor and click Edit Vendor to edit any information associated with the vendor.

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SCREEN IC-12: P.O. Payment Source

Screen IC-12, P.O. Payment Source lists the items, quantities of items, and account numbers of the PHL entity designated to pay for a given item from a vendor. In this screen, the user enters the payment source account number and quantity for each payment source associated with a given item. The sum of the payment source quantities should equal the total quantity for the item purchase order. The logical data structure for the purchase order payment source is described in Exhibit IC-08, PHL Purchase Order Payment Source Table, which follows.

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EXHIBIT IC-08: PHL Purchase Order Payment Source Table

P.O.# Vendor ID PHL P.O. ITEM (1,I) Item ID Vendor Item ID Payment Source (0,S) Source ID Quantity Charged to Source

When a shipment is received from the vendor, the user accesses the corresponding purchase order record or records, and indicates the quantity received for each item. Multiple shipments may be associated with a given purchase order before all the purchase order items have been received in full. The user must be able to edit information and record quantities received for each item in the order and update the item order status. Item orders may have a status such as, "remainder canceled," partial shipment," or "on backorder." Kit Management Workflow and Schematic Design Kits are treated separately from other inventory items because while they are an inventory item that is supplied to external customers in response to an order, they also require some assembly before they can fulfill an order. This assembly step exists unless the PHL assembles the kits ahead of time for a particular seasonal need or because of the volume ordered by a given customer. The assembly process itself requires the picking of a set of inventory items that constitute the given kit definition. These items are then assembled into the kits that are sent to the customer.11 The order fulfillment requirements for kits are therefore similar to those discussed in the previous section, except that kits require an assembly step to be substituted in place of the manufacturing task shown in Exhibit IC-02. The modified workflow for kits is contained in the following exhibit.

In a sense, a kit is a "finished goods" inventory item that is assembled from "raw" inventory components.

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EXHIBIT IC-09: Inventory Control Workflow (Modified version of Exhibit IC-02 specifically for Kits and Other Assembled "Finished Goods" Inventory Items)

C u sto m e r O rd e r R e ce ivin g IC -0 1 Ye s No O rd e r Pe n d in g /H o ld L ist IC -0 2

Pre -p a y R e q u ire d ? No L a b o ra to ry Se ctio n O rd e r R e ce ivin g IC -0 3 O rd e r Pro ce ssin g IC -0 4 Ye s

Pa id ?

Ye s

Q u a n tity Ava ila b le ?

No

C u sto m e r O rd e r Sh ip m e n t IC -0 6

G a th e r R a w In ve n to ry Ite m s Needed IC K-0 1

EN D

Asse m b le Kits a n d Ad d to In ve n to ry IC K-0 2

This workflow diagram substitutes two tasks (ICK-01: Gather Raw Inventory Items Needed and ICK-02: Assemble Kits and Add to Inventory) for the manufacturing triggering and manufacturing run receiving tasks shown in Exhibit IC-02, Workflow for Inventory Control (the interface with BP #5: Media, Reagent, Stains, Controls, etc., Manufacturing). In addition, the internal inventory requests have been eliminated from this diagram because collection kits are only needed for external customer use. Finally, the replenishment order process is not required because the kits are assembled in-house.12

If a kit is purchased from a vendor, it is considered a regular inventory item. This discussion is limited to those kits assembled within the PHL.

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Collection Kits Screen Design

The user interface screens that follow reflect the PHL-LIMS support of tasks PS-01 through PS-09. Exhbit IC-10, Screen Flow for Collection Kits shows the navigation flow of these screens. EXHIBIT IC-10: Screen Flow for Collection Kits

Kit C o m p o n e n t M a ste r L ist Scre e n IC K-0 2

In ve n to ry M a in M enu

C u rre n t Kit O rd e r L ist Scre e n IC K-0 1

Kit C o m p o n e n t M a ste r L ist Scre e n IC K-0 3

Kit O rd e r D e ta il Scre e n IC K-0 4

Kit O rd e r In d ivid u a l Kit D a ta Scre e n IC K-0 5

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Phase 2 Logical Design for a Public Health Laboratory Information Management System

BP #6: INVENTORY CONTROL, INCLUDING KITS AND FORMS MANAGEMENT

SCREEN ICK-01: Current Kit Order List

Screen ICK-01, the Current Kit Order List screen, is the master list of outstanding kit orders triggered from inventory control in response to a customer order for kits. Typically, the customer is a PHL test request submitter. This list is used to indicate when inventory contains an insufficient number of kits. It is also used when the reorder algorithm has triggered the manufacturing order. From this screen, the user can select a kit order and click Kit Detail to open Screen ICK-04, the Kit Order Detail screen, in which the user can view manufacturing details about the selected kit order. The user can select a kit order and click Kit Raw Material Order to open Screen ICK-02, the Kit Components Inventory Order screen, in which the user can view the items and quantities of each item needed to assemble the given kit order. Finally, the user can select a kit order and click Kit Components to open Screen ICK-03, the Kit Component Master List screen to view the list of items and associated quantities that define the given kit (Exhibit IC-11). In other words, the user can view the "recipe" for the kit.

Phase 2 Logical Design for a Public Health Laboratory Information Management System

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BP #6: INVENTORY CONTROL, INCLUDING KITS AND FORMS MANAGEMENT

SCREEN ICK-02: Kit Components Inventory Order

Screen ICK-02, the Kit Components Inventory Order screen lists the raw materials needed to assemble the kits for a given order. The quantities are derived by multiplying the quantity needed per kit by the number of kits in the order. From this screen, the user can click Kit Components to open Screen ICK-03, the Kit Component Master List, which shows the user the items required to assemble the given kit.

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Phase 2 Logical Design for a Public Health Laboratory Information Management System

BP #6: INVENTORY CONTROL, INCLUDING KITS AND FORMS MANAGEMENT

SCREEN ICK-03: Kit Component Master List

Screen ICK-03, the Kit Component Master List screen defines the components required to assemble a kit. A kit is defined as a set of components where one or more of the components are deemed to be "base" components. A base component is a component that must be included in a specific kit. Base components may therefore be considered the bare minimum materials required for a given kit. A kit may have only one base component, or may have several. Raw materials in addition to the base components may be included. Without at least one base component, the order is deemed to be an order for a set of raw material items rather than a kit. Kits may contain components that have expiration dates. In this case, the kit expiration date is that of the component that expires first. A kit order may have kits with different expiration dates if multiple lots of a base component were used to assemble the order.

Phase 2 Logical Design for a Public Health Laboratory Information Management System

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BP #6: INVENTORY CONTROL, INCLUDING KITS AND FORMS MANAGEMENT

SCREEN ICK-04: Kit Order Detail

Screen ICK-04, the Kit Order Detail Screen provides detailed information about a given kit order. The user can click Kit Detail to open Screen ICK05, the Kit Order Individual Kit Detail screen. This screen allows the user to view details associated with a particular kit in a given kit order.

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Phase 2 Logical Design for a Public Health Laboratory Information Management System

BP #6: INVENTORY CONTROL, INCLUDING KITS AND FORMS MANAGEMENT

SCREEN ICK-05: Kit Order Individual Kit Detail

Screen ICK-05, the Kit Order Individual Kit Detail screen provides information about a given kit in a kit order. The design anticipates that each kit shipped to a customer will contain a unique kit ID, and that when that kit is returned with a sample, the system will note that it has been returned.13 Certain components used in a kit--for example coolers--may be recycled to inventory for re-use. In this screen, the user can click Query to search for the location information of a specific kit. The user can click Add Kits or Edit Kits to add or edit a kit from this screen. Kits are typically added by scanning the ID on the kit. Expiration dates could be defaulted for a series of kit entries, so that the date does not have to be entered repeatedly.

There are two separate kit IDs used in the design; one for the kit type and the other for a unique ID that is attached to each individual kit. This second ID helps in tracking the kit.

13

Phase 2 Logical Design for a Public Health Laboratory Information Management System

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BP #6: INVENTORY CONTROL, INCLUDING KITS AND FORMS MANAGEMENT

EXHIBIT IC-11: Kit Logical Data Structure14 The following exhibit describes the logical data structure for a kit.

ID Description Active/Inactive Code ID Description Quantity Required per Kit Recycle Code Lifetime Recycle Count ID Description Quantity Required per Kit Recycle Code Lifetime Recycle Count

BASE COM PONENTS (1,C) KIT

ASSOCIATED/ADDITIONAL COM PONENTS (0,A)

KIT USED FOR TEST SAM PLES (1,T)

Test ID Auto Replenish Upon Return

In addition to indicating the tests for which the kit is used for, the PHL-LIMS also should associate kits with customers. The following exhibit shows the logical data structure required to form that association. EXHIBIT IC-12: Logical Data Structure for Kit Association with Customer

ID (Submitter) KIT CUSTOM ER (1,C) Customer ID Status (Active/No longer uses kit)

14

For certain kits such as rabies test kits, only a limited number are shipped to the submitter. When such a kit is returned and recorded as returned, the Auto Replenish upon Return data element of the PHL-LIMS triggers a "re-supply" order to send a replacement kit to the original recipient. If a given submitter is faced with a rabies outbreak, that submitter may "borrow" a kit from another submitter because only a small number of such kits would be kept at any given submitter location.

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Phase 2 Logical Design for a Public Health Laboratory Information Management System

Information

Microsoft Word - BP 6 Inventory Control Including Kits and Forms Management­

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