Appendix J Product Tracing (Traceback/Traceforward) and Records Collection SOP

Transcription

1 Appendix J Product Tracing (Traceback/Traceforward) and Records Collection SOP A) Purpose 1) Describe the activities of persons responsible for product tracing during Texas RRT activations. 2) Describe the structure, responsibilities, and activities of the Field Team and Documentation Unit in charge of records collection and review during TRRT activation. B) Definitions 1) Field Team Lead -- The person responsible for a Field Team when the TRRT is activated. 2) Product Tracing The activity of verifying the records of a food/feed item from its source to final distribution based on a lot number and/or other product identification. Product tracing includes both traceback and traceforward activities. There are two types of product tracing, regulatory and informational. a) Informational Product Tracing (also known as epidemiological or investigational tracing) Food product investigations that are conducted to support epidemiological investigations by determining whether food items consumed by multiple case-patients in a cluster or outbreak have a common source or distribution pattern. The purpose is to gather preliminary information that may later be verified and documented during a regulatory product tracing. Informational product tracing is typically used when epidemiological or laboratory data is not sufficient to identify a specific food commodity. The informational product tracing step may be skipped if epidemiological or laboratory data provides sufficient evidence to move directly to a regulatory product tracing. b) Regulatory Product Tracing Food product investigations that are used to determine and officially document the complete distribution pathway of a contaminated food product, tracking it back to its origin or source and forward to the consumer. Sufficient evidence is gathered to support additional regulatory actions, if needed, to ensure adulterated food and/or feed is removed from commerce. 3) Traceback - An investigation that starts with the consumer or the point-of-service and traces the distribution of the product back to the source. This process is used in response to a foodborne illness investigation. 4) Traceforward An investigation that begins with the source/farm or manufacturer/distributor and traces forward to the consumer. This process is used for product recall and it can also be helpful in outbreak investigations. C) Background Information J-1

2 Once a specific commodity is identified through epidemiological information or informational product tracing, a resulting regulatory product tracing is performed, and record collection requirements are more specific and focused. The responding investigators will need to maintain situational awareness and be clear on assignment parameters. A product tracing investigation involves interviews, including product/process specific questions, record review and collection, and timely reporting to meet its intended purpose. When conducting a product tracing investigation, the investigator determines and records the firm s receiving, shipping, transportation, back hauling practices, and/or manufacturing processes. Investigators may conduct additional investigations to determine possible routes of contamination by inspecting common distribution sites and/or processors identified in the product tracing investigation. D) Forming the Team The Incident Commander makes the decision to trace/collect records. There are various types of records to collect during an incident (e.g. traceback, traceforward, etc.). The records collection tasks can also be combined with other investigatory tasks to form a multi-disciplinary team (i.e., sampling). 1) Team Identification a) Operations Section - deploys Field Teams to gather records from the firm. b) Planning Section - reviews the records collected by the Field Team to develop recommendations for next actions. c) Logistics Section - Provides all incident support needs. 2) Team Structure The size of the teams or units can vary depending on the scope of the incident. The unit can begin as one person performing all of the functions and increase as needed. For larger investigations, product tracing/record collection may occur at multiple locations with a team designated for the task. For smaller investigations, a team may not be necessary (i.e., only one or two investigators may be assigned to collect records). The make-up and depth of the team is partially determined by the incident. Factors include: a) Number of firms; b) Geographic location; and c) Number of available resources. D) Team Responsibilities 1) Field Team (Operations) J-2

3 In the absence of a Field Team Lead, the Operations Chief is responsible for the team lead responsibilities. a) Field Team Lead: Collaborate with the Operations Chief and the Planning section SME s to define the scope of record collection (e.g.) date ranges, type of records, etc.); Ensure team members have adequate travel information; Set up initial meeting; Make assignments to team staff. Depending on the scope of the assignment, designate some personnel to collect records and other personnel to submit records to the Planning Section Document Unit; Ensure team members understand the assignment and scope of record collection; and Requests additional resources when necessary. b) Team Member: Verify that the computer and scanner are operable and that access to the internet is available at the offsite duty station; Verify access to TRRT FoodSHIELD Workgroup; Present credentials (all members); Issue Notice of Inspection (FDA members); Collect records; and Upload records to TRRT FoodSHIELD Workgroup outbreak site. 2) Planning (Documentation Unit) The Planning Section makes recommendations for assignments based on record review to the Operations Chief. Assignments for Field Teams can only be issued from Operations. The Documentation Unit can confer with Field Team members to clarify any questions regarding records collected. The types of positions needed on a Documentation Unit are: Unit Leader, Incoming Records Reviewer, Visual Diagram Developer, and Data Entry. During large events, the Planning Chief can assign a unit leader to coordinate activities. In the absence of a unit leader for the Documentation Unit, the Planning Chief is responsible for the unit leader responsibilities. a) Unit Leader: J-3

4 Reviews assignments for records Field Teams and develops plan for the Documentation Unit to review documents; Sets up initial meeting with Documentation Unit members; Makes assignments to unit members; Ensures members understand assignment; Monitors work flow and requests additional resources as necessary; and Based on findings, makes recommendations for upcoming field assignments. b) Incoming Records Reviewer: Logs in any records received through TRRT FoodSHIELD Workgroup or other sources (fax or from local health departments); Evaluates the record to ensure it is within scope and is legible; Confers with the Field Team Leader whenever there are issues with the records. The reviewer can work directly with the team member once team leader has been contacted; and Works in conjunction with the visual diagram developer to make recommendations to the unit leader/planning Chief for field assignments during the next operational period. c) Visual Diagram Developer: Utilizes flow charting software to create traceback and traceforward diagrams of implicated product; Creates timelines for tracking invoice and purchase dates and each level of the distribution chain; Notifies incoming records reviewer when documents are forwarded to Data Entry; and Based on findings and in conjunction with incoming records reviewer, the visual diagram developer makes recommendations to unit leader/planning Chief for next set of field assignments. d) Data Entry: Enters data from records as directed by unit leader or Planning Chief; and Returns documents to incoming records reviewer upon completion. J-4

5 3) Logistics: When the Operations Chief deploys a team, or when the Planning Chief forms a unit, Logistics will: b) Work with agencies management to identify the team resources from the TRRT organizational chart. Operations will designate the Team Lead and form the records collection team. Planning will designate the Team Lead and form the Documentation Unit. c) Notify all members of the proposed teams of mobilization. The notification will include: Incident name, including an adulterant type; The name of the team lead, if the team is comprised of more than one person; The duty station; and Estimated time of arrival. d) Make travel arrangements for team members. When records collection involves overnight travel, it is preferable that all members of the team stay at the same lodging facility. E) Mobilization and Deployment Activities - Field Team (Operations) 1) Mobilization Immediately upon notification of mobilization, team members must: a) Make plans to report to the duty location at the appropriate time. If the team members have not received travel information they should contact their Field Team Lead; b) Review relevant information on suspect product and verify the kind and type of records to collect; and c) Determine the amount of records to be collected based on the assignment issued by the Operations Chief. 2) Deployment a) Field Team Lead: Immediately upon notification of deployment, the Field Team Lead sets up a time and location (e.g. physical location or conference call) for all members to meet prior to starting the assignment. During the meeting the team lead: Assigns roles to team members; J-5

6 Ensures team members understand the assignment and that all team members have a copy of the record collection request; and Seeks clarification on any questions concerning the assignment before departure. Provides the written product tracing assignments to the investigators. The assignment should specify whether the investigator will be conducting traceback and/or traceforward and include the following information: o Firm name and address; o Time frame for record collection; o Implicated product(s) information, including lot numbers, and product codes; o Background information regarding the incident; o Specific questions included in the assignment (if applicable). b) Team Members: Contact the Field Team Lead if further information or clarification is needed. Visit the facility and explain the purpose of the visit to firm management. Conduct interviews with more than one employee at multiple levels of the firm. Collect the following records and product information based upon the team instructions: o Invoices; o Purchase orders; o Shipping and receiving records; o Bills of lading; o Inventory records; o Identifying information for implicated products; o Label information; o Container type, size; o Color; o Grade; J-6

7 o Lot codes; o Universal Product Codes (UPCS) or Global Trade Item Numbers (GTINDs); o Production or pull dates; o Product origin; and o Processing records. When analyzing the records the team member/investigator should also: o Verify label and product information with invoices and shipping receipts; and o Verify any hand written comments or marks on the documents and determine their meaning and significance. Determine product ordering practices: o Identify and describe how the firm orders the product; o Identify and describe when the firm orders the product; o Identify an estimate of daily average use of the product; o Identify alternative sources of product if establishment runs out before another shipment is received (e.g. purchase from grocery store, request more from supplier, etc.); o Identify and describe how the firm records deliveries and receipt dates; o Identify and compare the shipping dates to the dates received; o Identify all suppliers during the time period of interest, including cash transactions; o Estimate the transportation time from the supplier(s) to the establishment; and o Determine if the product (e.g. fresh produce) was re-packed during distribution. Determine product shipping and distribution practices: o Identify if the product is further distributed; o Identify the distribution list of customers; o Identify and describe how customers order product; J-7

8 o Identify when the customer orders product; o Identify frequency of shipment(s); o Identify and describe how the firm distributed the product; o Identify and describe all modes of transportation and conveyance vehicles; o Identify and describe back hauling practice(s); o Identify and describe the shipping and receiving practices, noting the exact receiving dates and times for each shipment; and o Identify and describe the firm s procedure for returned product(s). Determine and verify by observation that the procedures described by the employees are reflected in their work. Determine if implicated food/feed product(s) are used as an ingredient in the preparation or manufacture of another food/feed product. Determine the firm s handling procedures for reworked product or ingredients. Determine if firm diverts any food product for animal feed usage. Determine how the firm records stock inventory: o Identify how the firm accounts for partial cases/containers; and o Identify if the firm records carryover. Determine if first-in-first-out (FIFO) rotation policy is standard procedure; and how closely the firm follows this policy. 3) Reporting a) The team member/investigator analyzes the information and summarizes activities in a narrative (See Attachment J-1). b) The team lead provides the team member/investigator with instructions on how to organize the documents. c) The team member/investigator uploads the summary sheet and the records to the FoodSHIELD TRRT Workgroup website according to procedures in Appendix D FoodSHIELD SOP. F) Mobilization and Deployment Activities - Documentation Unit (Planning) 1) Mobilization J-8

9 Immediately upon notification of mobilization, team members must: a) Review relevant information on case information (buying habits, reported purchase locations, etc.), suspect product, and; b) Review field assignments to prepare for receipt of records. 2) Deployment Immediately upon notification of deployment the unit leader sets up a time and location for all members to meet prior to starting the assignment. During the meeting the unit leader: a) Designates roles to team members b) Affirms members understand the assignment c) Seeks clarification on any questions concerning the assignment before developing any data collection systems and flow chart d) Assigns staff complete flow diagrams and time lines as records are received. e) Develops recommendations for additional field assignments based on flow chart and time line review; and f) Makes recommendations to Planning Chief for next Field Team assignments 3) Resources: Use the most current version of the resources listed below: a) FDA, Guide to Traceback of Fresh Fruits and Vegetables Implicated in Epidemiological linvestigations b) RRT Best Practices Manual Investigations Chapter B Tracebacks c) FDA Investigations Operations Manual, Subchapter (IOM), Tracebacks of Foods Implicated in Foodborne Outbreaks d) Office of the Texas State Chemist (OTSC) Policies and Procedures Manual e) AAFCO Feed Inspector s Manual J-9

10 Appendix J-1 - Product Tracing Records Submission Form (insert name of Incident) Name of records: (At(space)Name of firm records were collected(space)from(space)name of supplier(space)time bracket of record collection assignment mmddyyyy(underscore)mmddyyy). Bracketed time frame: Investigator(s) Name: Date of collection: Firm Name: Firm Address: Type of records collected (invoice, bill of lading, scale tickets, air bills) Explanation of documents: Describe the identifiers that link the documents. Explain any hand written comments or marks on the documents and determine their meaning and significance. Answers to specific questions included in the assignment (if applicable). J-10

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