Description
EBOLA VIRUS DISEASE (EVD) PERSONAL PROTECTIVE EQUIPMENT (PPE) PERFORMANCE WORK STATEMENT (PWS) 1. Purpose. The Veterans Health Administration (VHA), Office of Emergency Management (OEM) has initiated a project to ensure that all VA Medical Centers are capable of responding to a highly infectious disease. In order to achieve this goal, packaging of existing bulk PPE into Kits is required. Therefore, there is a requirement to assemble approximately 95,000 individual Kits. 2. Background. The VHA's experiences with preparedness and response to an outbreak of Highly Infectious Diseases, the H1N1 outbreak, and more recently the Ebola global threats, have mandated this requirement. Currently, bulk shipments of the 12 items of PPE have arrived at the VA's warehouse in Chicago as a central location for reception. VHA developed a plan for Kit assembly, and for delivery to 150 VA Medical Centers. 3. Objectives. Contract the assembly of the bulk PPE products into Kits. There will be two types of Kits: one basic EVD PPE Kit, and one containing the PAPR ensemble. The contractor will receive the bulk product, unpack, sort, assemble into the required Kit type, load into individual Kits with two individual Packing Lists per Kit for quick content identification, and return palletized Kits as per the instructions in this work statement. The raw product awaiting repackaging shall be stored in a dry environment and protected from temperature extremes. 4. Scope. VA will provide the product to be packaged. The contractor shall procure the required packaging resources, supplies, and equipment to prepare the required Kits as instructed herein. This will include receiving the bulk PPE products shipped from VA, unpacking, sorting, and assemblage of PPE items into individual Kits and placing each Kit into single-wall corrugated cardboard boxes, 12" X 9" X 6" (L X W X H), ULine S-18339 or equivalent. Each box will include two identical Packing Lists: one inside and one secured in place in a protective sleeve on the outside, for content identification. Kits shall be palletized, with 80 Ebola PPE Kits and 25 PAPR ensemble Kits per pallet. All packaging, Packing Lists, and other requirements for shipment shall be per instructions in Attachments 1 (packaging information) and 2 (packing list) to this PWS. Final Kits shall be shipped to VA locations (scheduled, arranged, and paid by VA), with the remaining stock returned to the VA's central warehouse (scheduled, arranged, and paid by VA). 5. Mandatory Tasks and Deliverables. The Contractor shall provide and perform the following: 5.1. Management Plan - The Contractor shall provide a project management plan, which presents the Contractor's plan for completing the project. The Contractor's plan shall be responsive to this PWS and describe, in further detail, the approaches to be used to successfully complete the project and ensure a high-quality product. At a minimum, the project management plan shall include the proposed packaging, proposed labelling, proposed delivery schedule, and quality management plan, all in accordance with requirements as outlined in this PWS. 5.1.1. Deliverable: Provide a detailed initial project management plan and briefing within 15 working days after award. The briefing will include a quality management plan and proposed acceptance protocol. 5.1.2. Deliverable: As indicated above, the proposed acceptance protocol will be provided by the contractor within 15 working days of award. The contracting officer representative (COR) and the contractor will negotiate the acceptance protocol within the next 15 working days, and upon concurrence the contracting officer will incorporate it into the contract. The plan shall be updated as needed by concurrence of contractor and COR, and submit updates to the contracting officer for approval and incorporation of the change into the contract. 5.2. Assembly and Packaging of KITs. The Contractor is to provide all required assembly services, supplies, packaging and equipment to assemble and ensure that each KIT has the required Packing Lists for quick identification of all contents and sizes. The Packaging requirements are: i. Each pallet will consist of 80 EVD PPE Kits, and 25 PAPR Kits, for a total of 105 Kits. The repackaging environment shall be reasonably sterile, meaning as a minimum the repackaging area should be kept clean, the people who directly handle the product being repackaged must wear vinyl or nitrile gloves, change the gloves every thirty (30) minutes, wear face protection (mask) if the employee is coughing / sneezing, and wear hair nets to prevent hair from falling into the kits. a. PAPR Kits i. There will be five (5) PAPR Kits per pallet with the Large hoods. Each kit will be assembled as follows: 1. One (1) Large BE-10 Hood, 2. One (1) breathing tube 3. One (1) breathing tube cover and PAPR cover ii. There will be eleven (20) PAPR Kits per pallet with the regular hoods. Each kit will be assembled as follows: 1. One (1) regular BE-10 Hood, 2. One (1) breathing tube 3. One (1) breathing tube cover and PAPR cover b. EVD PPE Kits i. There will be twenty-eight (28) Small size EVD PPE Kits per pallet. Each Kit will be assembled as follows: 1. One (1) TY657S Hood 2. One (1) Waterproof Apron 3. One (1) pair of Boot Covers 4. One (1) Face Shield 5. One (1) pair of SM blue gloves 6. One (1) pair of SM purple gloves 7. One (1) SM size N95 respirator mask 8. One (1) SM size Surgical Gown 9. One (1) MED size A60 suit ii. There will be forty (40) Medium size EVD PPE Kits per pallet. Each Kit will be assembled as follows: 1. One (1) TY657S Hood 2. One (1) Waterproof Apron 3. One (1) pair of Boot Covers 4. One (1) Face Shield 5. One (1) pair of MED blue gloves 6. One (1) pair of MED purple gloves 7. One (1) LG size N95 respirator mask 8. One (1) LG size Surgical Gown 9. One (1) MED size A60 suit iii. There will be eight (8) Large size EVD PPE Kits per pallet. Each Kit will be assembled as follows: 1. One (1) TY657S Hood 2. One (1) Waterproof Apron 3. One (1) pair of Boot Covers 4. One (1) Face Shield 5. One (1) pair of LG blue gloves 6. One (1) pair of LG purple gloves 7. One (1) LG size N95 respirator mask 8. One (1) LG size Surgical Gown 9. One (1) LG size A60 suit iv. There will be four (4) X-Large size EVD PPE Kits per pallet. Each Kit will be assembled as follows: 1. One (1) TY657S Hood 2. One (1) Waterproof Apron 3. One (1) pair of Boot Covers 4. One (1) Face Shield 5. One (1) pair of XL blue gloves 6. One (1) pair of XL purple gloves 7. One (1) LG size N95 respirator mask 8. One (1) LG size Surgical Gown 9. One (1) XL size A60 suit ii. Kits will be packaged efficiently to minimize the volume of the inventory, without damaging or permanently deforming the product. iii. Kits will be packed into boxes as described above (Paragraph 4), each labeled with contents (Packing List). The label will indicate a ROTATION DATE which will be four (4) years from the date of packaging the kit. iv. Boxes will be efficiently packed onto standard 40" X 48" pallets, packed approximately 64 inches in height, and properly secured with shrink wrapping for shipment. v. Each pallet will bear a plainly visible inventory summary, including quantities, of the pallet's contents. vi. The Kits, packaged in 12"X9"X6" boxes, will be placed on each pallet so as to achieve 15 boxes per layer, and be stacked no more than 7 layers high. 5.3. Shipment of PPE. The Contractor is to provide all required shipping services to include a consolidated Packing List for quick content identification. All of the packaged and palletized product will be picked up from the contractor's dock for shipment as indicated in Paragraph 4, above. Deliverable: The contractor may prepare to ship completed pallets on a periodic basis to be determined after award. The Contractor shall provide delivery schedules within 5 working days prior to each actual delivery date. 5.4. Documentation Contractor will maintain and update a report (Paragraph 7) to provide timely reporting for required status reporting and decentralized oversight. Deliverable: The Contractor shall submit electronic versions with populated fields, as specified, from start of the project through completion. The required fields of data for this report appear in Paragraph 7 of this PWS. 5.5. Guarantee The contractor shall guarantee the packaging of the Kits. Packaging discovered to have labelling errors and/or product damaged during repackaging shall be returned, at the VA's discretion, to the contractor at the contractor's expense. When returned, the contractor shall credit the repackaging price for the Kit to the VA, or properly repackage and return the Kit at no additional cost to the VA if the product inside is not damaged. If product was damaged during initial repackaging, the contractor shall credit the repackaging price. The guarantee expiration for each Kit (box) shall be concurrent to the rotation date printed on each Kit. 5.6 Schedules for Mandatory Deliverables The Contractor shall follow project schedule below in delivering the requirements under this contract. REFERENCE DELIVERABLE DUE DATE 5.1.1 Provide an initial project management plan and briefing. 15 working days after award. 5.1.1 The Contractor shall provide the plan for completing the Kits. 15 working days after award. 5.3 The Contractor shall provide information in advance of shipping finished product. 5 working days prior to actual delivery date. 5.4 The Contractor shall submit electronic versions with populated fields to the contracting officer. Each business day, NLT 1200 EST, from start of the project through completion. 6. Delivery Delivery of properly palletized and assembled Kits shall begin within 14 calendar days of receipt of EVD PPE bulk products from VA. 7. Contractor Reporting. The contractor shall generate a report of the previous day's production, which will be transmitted via email to the contracting officer prior to 12PM (noon) Eastern time. It is preferred this report be generated as an Excel (or compatible) spreadsheet, or in a format which can be read using Excel. The report will be delivered each business day until all product is packaged and shipped. The report will be populated, at a minimum, with the information shown below. " Daily start and end times of repackaging process " Number of Kits packaged " Labor hours spent packaging " Total pallets prepared for shipping " Total pallets shipped " Shipping tracking information 8. The contractor shall be responsible for managing and overseeing the activities of all contractor personnel, as well as any subcontractor efforts, used in performance of this procurement. Contractor management responsibilities shall include all activities necessary to ensure the accomplishment of timely and effective support, performed in accordance with the requirements contained in the PWS. 9. Changes to the PWS. Any changes to this PWS shall be authorized and approved only by the contracting officer via formal contract modification. Costs incurred by the contractor which were not approved by the contracting officer are the responsibility of the contractor. 10. Formal Acceptance or Rejection of Deliverables. Acceptance will be in accordance with established government regulations. 11. Quality Standards for Deliverables - Performance Measures: The following Performance Requirements Summary Matrix includes performance standards based on this work statement. The Government will use these standards to determine contractor performance, and shall compare contractor performance to the Acceptable Quality Level (AQL) defined. PWS Para. Task ID Indicator Standard AQL Method of Surveillance Incentive 5.1 Management Plan 1 Meets PWS requirement Addresses in detail the approaches to be used to successfully complete the project and ensure a high-quality product. At a minimum, the project management plan shall include the proposed delivery schedule, quality management plan, and proposed acceptance protocol. 100% Review (inspection) of manufacturer's management plan Minimum requirement 5.2 Assembly of Kits 2 Proper assembly Professional quality work and performed in accordance with VA instructions 100% Inspection of every unit produced and ensure each Kit contains a packing list Minimum requirement 5.3 Shipment of Kits 3 Quality shipping and shipping methods All Kit packages assembled as required in PWS for shipment 100% Inspection of every pallet built and each pallet contains a packing list Minimum requirement 5.4 Documentation 4 Easily accessible and usable All documentation requirements are necessary and must meet delivery expectations 100% Inspection upon receipt Minimum requirement 5.5 Guarantee 5 Neatly repackaged individual Kits and pallets Contractor shall provide sound resources from the individual Kit assembly to the bulk shipments platforms and stability. This would encompass the entire scope of the project 100% Inspection upon receipt Minimum requirement 12. KICK OFF MEETING The Contractor shall coordinate and facilitate a kick-off meeting to include an agenda within in five (5) business days after award.