SAMDaily.us | SNOTE | 65 | Vendor Managed Inventory (VMI)

SAMDAILY.US - ISSUE OF JULY 13, 2022 SAM #7530
SPECIAL NOTICE

65 -- Vendor Managed Inventory (VMI)

Notice Date: 7/11/2022 7:28:17 AM
Notice Type: Special Notice
NAICS: 339112 — Surgical and Medical Instrument Manufacturing
Contracting Office: OFFICE OF ASSISTANT SECRETARY FOR PREPAREDNESS AND RESPONSE
ZIP Code: 00000
Solicitation Number: 75A50122R000014
Response Due: 7/25/2022 2:00:00 PM
Point of Contact: Annette Wright, Phone: 4044980949, Akela Long, Phone: 4044985635
E-Mail Address: owf8@cdc.gov, oga1@cdc.gov
(owf8@cdc.gov, oga1@cdc.gov)
Description: Request for Information Notice � � � � � � � � � � � � � � � � � � Subject:� �� Vendor Managed Inventory (VMI), Storage and Distribution, Services Date Posted:�� 11 �July 2022�� Response Date: �� 25 �July 2022 Product Classification Code (PSC): �6515- Medical and Surgical Instruments, Equipment, and Supplies North American Industrial Classification Code (NAICS): 339112- Surgical and Medical Instrument Manufacturing � � � � � � � � � � �� Contracting Office Address: Associate Secretary Preparedness and Response/ Domestic Strategic National Stockpile (ASPR/DSNS) Office of Resource Management (ORM)/SNS Contracts Branch 2945 Flowers Road Atlanta, GA 30341 Point of Contact: Annette R Wright, Contracting, email: owf8@cdc.gov RFI Notice ID: 75A50122R000014 Place of Performance:� Variable Archive: 30 days after the response date Recovery Act Funds:� NA Set-Aside:� No Instructions: Each response must include: Company Name Company Address Company point of contact, phone, email address, and DUNS In the subject line of your response, please include:� RFI _VMI Services Responses are to be submitted via email to owf8@cdc.gov no later than 5:00 PM EDT July 25, 2022. Inquiries by telephone will not be accepted. Please limit responses to five (5) pages. Not Responding to this request does not preclude participation in future solicitations. General questions regarding this may be submitted via email to owf8@cdc.gov no later than July 19, 2022. Please note, during this time the government is unable to provide direct responses to any questions received. However, consideration will be given to all feedback, and any feedback received may be used to revise anticipated requirements.� Information from this Request for Information (RFI) may lead to one-on-one market research discussions and other recommended approaches to industry engagement.� Partial responses are acceptable. Disclaimer: This RFI is issued for information and planning purposes only and does not constitute a solicitation. All information received in response to the RFI that is marked as proprietary will be handled accordingly.� In accordance with FAR 15.201, responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding to this RFI. This is a Request for Information synopsis only. It is not a request for proposals and does not commit the Government to issue a solicitation, make an award, or pay any costs associated with responding to this announcement.� After review of the responses to this RFI, one or more solicitations are likely to be published.� All information submitted in response to the RFI shall remain with the Government and will not be returned. Request for Information Description: The purpose of this synopsis is to gain knowledge relative to current/future vendor managed inventory (VMI) services requirement(s) that meets the below minimum specifications. Responses to this synopsis will be used by the Government to make appropriate acquisition decisions. The Government is interested in attaining your current and projected capability to provide the described VMI services.The information that you provide will allow the government to assess current industry capability given customer demand and the probable effects on commercial supply chains and distribution networks. The government is interested in current and future capabilities, location, and an outlook on the industry. Please provide any additional information that you feel may be of interest to the Government when reviewing responses to this request. Scope of Work: The contractor shall perform all storage and distribution activities (such as but not limited to labor, materials, and space to safely and securely receive, store, rotate, audit, stage, package, maintain, dispose and ship material stored) for up to 626,000 pallet equivalents of material. The Contractor shall provide all personnel, support, and space to fulfill the requirements for the awarded site(s). The Contractor shall ensure that all Government products stored in the Contractor provided facility remains viable based on the requirements provided below. The Contractor shall ensure that surge requirements, whereby larger than normal quantities of product are received for storage or require packaging and distribution, can be met based on the requirements. There will be domestic and international shipments, some requiring special handling.� Special handling refers to processes such as palletizing, weighing, wrapping heavy shipments, completing Hazmat materials, and working with cold-packed items. The Government anticipates that approximately 95 percent of the product received by the Contractor will be on standard pallets, and 5% small parcel. �The Contractor shall provide after-hours operations as needed for emergency shipments or shipments that arrive later than the scheduled time. For planning purposes, estimate up to two after-hour shipments per month with each shipment taking two to four hours. Technical Requirements: The Government is seeking to utilize the services of medical supply distributors to ensure the successful administration of the delivery of personal protective equipment (PPE) and testing supplies in the event of a pandemic or similar event during an infectious disease emergency or other public health event across the United States. Task 1: Vendor Managed Inventory (CLIN X001) The vendor shall provide VMI (logistical and supply chain support) for up to 600,000 pallets of GFP (MedSurge and equipment) and up to 26,000 pallets of pharmaceuticals, under various required storage conditions. Task 1A: Inbound/Outbound Services (CLIN X002) Inbound Services The contractor shall coordinate receipt of product (GFP shipped directly from USG or from manufacturers) into its designated warehouses across the United States. The products to be provided as GFP will be medical supplies such as but not limited to: �gloves, gowns, coveralls, goggles, face shields, masks, N-95, boot covers, test kits, swabs, media, ancillary vaccine kits, needles, medical equipment and pharmaceuticals.� At a minimum, contractor shall have locations that are geographically disperse and able to service all of the United States while being capable of warehousing the quantities proposed. The Government anticipates there could be many suitable locations and would like solutions presented based on contractor�s expertise considering population centers, historical distribution patterns for these types of products and other factors deemed relevant.� Contractor shall possess an inventory system capable of providing up to date information on all Government owned inventory, and capture this information at time of receipt to include: Manufacturer and Model Number / Part Number SKU Description Unit of Measure Quantity transported Quantity on hand by facility Warehouse location/multiple warehouse/storage points Lot number Expiration date Condition Code (used to account for product recall, materiel complaints, etc.) Note Codes (materiel subject to damage by freezing, hazardous material, etc.) Bill of Lading Packing Slip The vendor is required to receive a minimum of 80 pallets of Government owned Pharmaceutical and Medical supplies per week (Monday-Friday). There will be domestic shipments and shipments to U.S. Territories. The Government anticipates that the product received by Contractor will be on standard pallets with dimensions of 48� L x 40� W with a maximum height of 60�, per International Organization for Standardization (ISO), and weighing no more than 2,500 pounds per pallet. The Contractor is not required to accept any unpalletized containers.� Normal hours of operation are Monday-Friday, 7 a.m. - 5 p.m. local time, and full mission capability is required during these hours. The Contractor shall provide weekend and after-hours operations as needed for emergency shipments or shipments that arrive later than the scheduled time. All Contractor support shall be provided at Contractor-provided facilities. Contractor shall inventory and validate receiving documentation of the product by annotating the incoming documentation with the name of the person receiving the product, date and time of the receipt. �Any discrepancies between the incoming (packing list) documentation and the actual product shall be so annotated on the inbound documentation. Contractor shall ensure that quantities received are accurate and lot numbers match. Upon 100% visual inspection of the inbound shipment, any damage, shelf-life issues, or discrepancies in quantities shall be reported to the Contracting Officer�s Representative (COR) within 24 hours and material shall be sequestered and suspended by Contractor, pending resolution within 48 hours from the instruction of the COR. �Contractor shall acknowledge receipt and forward copies of all inbound documentation to the COR within 24 hours after receipt of material. Product may be received without a barcode. If such occurs, the contractor is required to barcode this property within 2 days. The barcode requirements will be provided to the vendor at time of occurrence.The contractor shall notify the government of any product moves from one vendor managed location to another vendor managed location within their network. Outbound Services The contractor shall provide transportation tracking information from their facility to the point of need and back when requested by the SNS. The Contractor shall: Maintain a readiness level to receive and respond to a notice to distribute from ASPR 24/7/365 and distribute product as directed. Have an emergency email established that will notify a designated contact 24/7/365 of a notice to distribute product as directed within specified timeframes. Within 24 hours of receipt of appropriate authorizations during normal hours of operation. Contractor must be able to coordinate with receiving location, load, and begin transporting product to ASPR designated location CONUS and OCONUS. Identify, pick, package, and process paperwork for the GFP requested for distribution. Make final delivery of product to the local site(s) within the continental United States within four (4) business days from the �date of shipment. It will be understood that any force majeure can impact timing of the delivery, but Contractor will use commercially reasonable efforts to have products delivered in a reasonable timeframe. For OCONUS services, it will be dependent on urgency, need, and transportation availability. Ship all items under appropriate conditions (i.e. temperature, weight limitations, etc). Confirmation of delivery will be provided to ASPR by email in a format mutually agreed upon on within 24 hours of delivery. Contractor shall have the ability to distribute from all combined locations up to 1520 pallets or 7,500 cases to multiple locations per day.� In addition, the Contractor shall have the ability to distribute from all combined locations up to 7,500 cases (parcel) to 7,500 locations daily.� This capability is in addition to and should be assumed the inbound capability be ongoing but is a maximum number.� Ship product in accordance with Task 2. Task 1B Surge Option: Inbound/Outbound Services (CLIN X004) The Government may have a need for additional inbound/outbound services, which will be defined at the time of need. Normal hours of operation are Monday-Friday, 7 a.m. - 5 p.m. local time, and full mission capability is required during these hours. The Contractor shall provide weekend and after-hours operations as needed for emergency shipments or shipments that arrive later than the scheduled time. All Contractor support shall be provided at Contractor-provided facilities. �The contractor shall have the capability to surge Inbound/outbound services to 7 a.m. - 9 p.m. local time and Saturday and Sunday within 21 days from execution of option. This Task may be exercised if the USG requires the vendor to receive or ship in excess of 626,000 pallets of GFP included in CLIN X002 or the Government requests shipment of more than 1520 pallets & 7,500 parcels per day during Normal or Extended Hours. Task 1C: Repalletization Services The Government anticipates that the majority of product received by Contractor will be on standard pallets with dimensions of 48� L x 40� W with a maximum height of 60�; however, on occasion, there may be pallets with a height of 80�, per International Organization for Standardization (ISO), and weighing no more than 1,750 pounds per pallet. �The contractor shall receive this product in and re-palletize it into 48� L x 40� W x 60� H pallets. Task 1D: Product Rotation The contractor shall rotate the GFP within their commercial inventory to provide the SNS with replacement product that has a better shelf-life. While we cannot provide an exhaustive list of products or the specific manufacturers/models/SKUs that may be provided as GFP, the following are anticipated: N95 (FDA and/or NIOSH approved) Elastomeric Half Mask Respirators Nitrile Gloves Face Shields Isolation Gowns Surgical Masks Syringes Needles Alcohol Prep Pads Equipment Aspirator Bed, Bariatric Compressor/Nebulizer CPAP Machine Glucose Meter Humidifier Oxygen Concentrator Patient Lift Thermometer Pulse, Oximeter, Finger Stretcher Pulse Oximeter, Handheld Oxygen Cylinders Portable Vaccine Refrigerators/Freezers Cardiac Monitor Defibrillators Fluid Warmer Negative Pressure Wound Therapy System Ultrasound Bed, Patient Infusion Pump Light, Exam Pump, Compression PAPR/CAPR System Ventilator High Flow Nasal Cannula 0.9% Sodium Chloride Cefepime Cisatracurium Dexamethasone Dexmedetomidine Dobutamine Enoxaparin Fentanyl Heparin Hydromorphone Lactated Ringer's (LR) Levofloxacin Midazolam Morphine Norepinephrine Ondansetron Propofol Rocuronium Task 1E: Product Warehousing & Management Services (CLIN X001) Contractor shall provide services for 626,000 pallet spaces for GFP medical supplies. This entails 600,000 pallets of GFP (MedSurge and Equipment) to be stored in controlled room temperature (CRT) ambient conditions defined as temperature range of 68�F to 77�F (20�C to 25�C), and 26,000 pallets of pharmaceuticals broken out as follows: 20,000 pallets under ambient storage at 20�C to 25�C, 4,400 pallets of controlled substances at 20�C to 25�C, and 1,600 pallets for cold chain products 2�C to 8�C /-20�C. Contractor shall be responsible to ensure that all products are managed including receiving, storing, packaging, and transporting in compliance with all applicable regulations as administered by the Department of Health and Human Services (HHS), Food and Drug Administration (FDA), Drug Enforcement Agency (DEA) , Department of Transportation (DOT), OSHA, and such other Federal, State, or local laws and regulations that may apply. Material shall be in accordance with current Good Manufacturing Practices (cGMPs). At the warehouse locations, Contractor shall have adequate space for storage, staging, receiving and shipping product that accommodates up to 60� high pallets.� The facility must have dock doors to adequately support receiving and shipping simultaneously. Contractor shall ensure that accurate records and accountability of both inbound and outbound shipment records are auditable and reconcilable to the Government. Contractor shall maintain an inventory record and location system for the GFP products throughout the terms of the contract. All documentation related to the inventory quantities of product shall be retained by Contractor and made available to the USG upon request. If GFP is damaged while under possession of the vendor, the vendor is responsible for all disposal and replacement costs. The Contractor shall be responsible for disposal and the cost associated with disposing of expired GFP. Contractor shall provide loss prevention and insurance on stored product in the event of loss/damage/destruction equal to the replacement cost and payable to the United States Federal Government.� The Contractor shall report damaged material within 24 hours of finding.� Upon the government�s approval, the contractor shall dispose of the material in compliance with applicable local, state, and federal regulatory requirements. Task 1F: Quality Control � The contractor shall adhere to all applicable cGMP requirements and Government quality assurance requirements. The contractor shall ensure the appropriate operation of a Government-contracted storage facility, including receiving, preparing, holding, and preparation for shipping finished pharmaceuticals, medical devices, Investigational New Drug (IND) products, and/or other Government assets. The contractor shall apply broad knowledge of how a quality assurance program manages the range of complex pharmaceutical product requirements under cGMP to maintain pertinent quality characteristics such as product integrity and reliability. The contractor shall verify manufacturing, packing, shipping and storage methods, techniques, and special processes to document the interrelationship of product to equipment and environmental conditions. The contractor shall be skilled in developing plans and calculating approaches to ensure effective control of product quality. The contractor shall demonstrate the ability to incorporate new and innovative conceptual approaches, technologies, and methods for enhancing the assessment of quality performance and identifying areas for improvement. Contractor Qualification- The Government will assess the contractor�s facility and Quality Systems on an annual basis and make a determination about the site�s acceptability and compliance to properly and safely store and handle the Government-owned product. The assessment agenda will include, but not be limited to, a review of the following areas covering the receiving, holding, and shipping preparation of product: SOPs Inventory management Software and equipment validations Deviation system Corrective Action and Preventative Action system Quality Assurance Change Control Training management system Facility maintenance Equipment maintenance and calibration Environmental Monitoring Facility Sanitation program Document control system Vendor management program Organization and personnel qualifications and responsibilities Regulatory inspection history (482, 483, warning letter, etc.) Upon completion of a Government quality assessment site visit, the contractor shall receive a written formal assessment report. Upon the contractor�s receipt of the Government�s written formal assessment report, the contractor shall have 30 calendar days to respond in writing to the Government�s required and/or suggested improvement recommendations with proposed corrective actions and target dates for completion. Based on the requirements of this agreement, the Government will determine if and when the contractor�s completed/proposed corrective actions are sufficient to allow Government-owned product to be stored at the facility. The Government may conduct �for cause� audits to address product quality or safety concerns within ten business days of notification to the contractor. The Government will schedule Quality Assessments 30 calendar days in advance, when possible. A Quality Assessment agenda shall be provided by the Government prior to the assessment date. Additional manufacturer audits may be conducted during each calendar year. The manufacturer shall schedule Quality Assessments with the Government 30 calendar days in advance, when possible. A Quality Assessment agenda shall be provided to the contractor prior to the assessment date. Document Control Program- The contractor shall be responsible for maintaining a formal document control program to manage the approval, distribution, archival, and change control of all cGMP-relevant documents. This program shall minimally include SOPs, manuals and protocols, software and equipment validation documents, and training records covering the receiving, holding, and shipping preparation of product, and it shall be made available to the Government. Standard Operating Procedures- The contractor�s performance responsibilities and activities shall be described and controlled in contractor SOPs applicable to receiving, holding, preparing, and shipping preparation of product. All contractor employees performing under the existing contract shall be trained on all approved SOPs applicable to assigned tasks prior to performing the tasks in areas that may affect Government-owned products or equipment. Current, approved, and controlled SOPs shall be readily available to contractor employees at the facility. At the Government�s request, the contractor shall make available contractor SOPs to the Government for review and/or update to reflect any regulatory changes that may impact operations. Training Program- The contractor shall implement a successful training plan that defines the training requirements for all employees performing under the contract including the receiving, holding, and distributing of product. The contractor-provided training shall be for the particular operations that the contractor performs and based on cGMP practices. All contractor employees performing under the contract shall be trained on all approved SOPs applicable to assigned tasks prior to performing the tasks in areas that may affect Government-owned products or equipment. Annual cGMP training shall be provided by the contractor and conducted by qualified individuals to ensure that employees remain familiar with cGMPs.
Web Link: SAM.gov Permalink
(https://sam.gov/opp/c87315a6b18e40f297984580fffe83cd/view)
Place of Performance: Address: Atlanta, GA 30341, USA; Zip Code: 30341; Country: USA
Record: SN06383959-F 20220713/220711230104 (samdaily.us)
Source: SAM.gov Link to This Notice
(may not be valid after Archive Date)

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65 -- Vendor Managed Inventory (VMI)