SOURCES SOUGHT ANNOUNCEMENT The Department of Veteran Affairs (VA), Veterans Health Administration (VHA), Service Area Office - Central (SAOC), is seeking sources for supply for Custom Sterile Procedure Packs for VHA medical centers located within SAO East (SAOE) and SAO West (SAOW) Regions. CONTRACTING OFFICE ADDRESS: VA/VHA/SAOC 708 South 3rd Street Suite 108E Minneapolis, MN 55415 INTRODUCTION: This is a SOURCES SOUGHT TECHNICAL DESCRIPTION to determine the availability and technical capability of any qualified, capable & responsible business/source; to include small businesses (including the following subsets, Small Disadvantaged Businesses, HUBZone Firms; Certified 8(a), Service-Disabled Veteran-Owned Small Businesses and Woman Owned Small Business) to provide the required products and/or services. BACKGROUND: Medical Centers within SAOE and SAOW perform a variety of surgeries ranging from very complex cardiac surgery to less complex intermediate surgeries such as joint replacement to more standard non-complex hernia repair and/or Ear Nose Throat (ENT) surgeries. Being able to order custom surgical packs are the preferred method versus ordering non-custom surgical packs. Ordering a custom made pack for the type of surgery will; reduce errors in surgical instruments provided in the packs, reduce time for surgical set-up, create a standard practice in Operating Room (OR), and/or reduce OR turnover between surgical procedures. Custom Sterile Procedure Packs are currently being procured by sole-source bridge contracts, purchase cards, and open market purchase orders. The various contracting vehicles have resulted in lost opportunity for cost reduction, capturing standardization opportunities, increasing the number of purchase orders, quality consistency risk resulting in potential patient care issues, and the procurement lead time has been increased to ordering open market items. REQUIRED CAPABILITIES: The purpose of this sources sought is to identify possible firms that are capable of becoming a committed source of supply for production and delivery of individualized custom sterile procedure packs to be utilized by each of the estimated 127 medical centers in AK, WA, OR, ID, CA, HI, NV, AZ, NM, UT, WY, MT, CO, OK, TX, AL, GA, FL, SC, NC, VA, WV, PA, MD, DE, NJ, NY, VT, HA, MA, RI, ME, D.C., Puerto Rico, Philippines, and Guam. The custom sterile procedure pack program will include but not limited to; pack manufacturing, pack sterilization, quality assurance, and packaging, web based ordering/tracking systems, reporting, and pack delivery. Specific Contractor must be registered with the FDA and all aspects of pack assembly, packaging and sterilization must adhere to quality control standards set by the FDA. The sterilization shall be at least ISO 9001:2000 certified and must be validated at a minimum annually by the Association for Advancement of Medical Instrumentation (AAMI). The manufacturing shall be in compliance with American Society for Testing Materials (ASTM), Safe Medical Device Act, and Association of Operating Room Nurses (AORN). SOURCES SOUGHT: The anticipated North American Industry Classification System Code (NAICS) for this requirement is 339113 - Surgical Appliance and Supplies Manufacturing with a size standard of 500 employees. Review of the Small Business Administration's (SBA) non-manufacture class waiver list indicates that this NAICS description does not qualify for a non-manufacture waiver. SUBMISSION DETAILS: All responses to question below shall be submitted in writing and via email to Julie Willie at
[email protected] and/or Nicole Kutsi at
[email protected] No Later Than (NTL) March 23, 2016. Email subject line must read "Sources Sought Custom Packs SAOE and SAOW "Company Name". The attachment you submit must be named: "Company name" VA240C-16-N-0005. If for some reason a second email is needed to submit a response please note this in subject line and attachment name. Example: add to the end of subject line and attachment name: 1 of 2 or 1 of 3 etc. Your response should list each question and a response directly after each question. Please explain clearly and concisely and do not respond to a question directing us to a specific website link to search for an answer. NOTE: For security purposes our email only allows 8MB, so your attachment must be 8MB or less on each email. If interested in performing this requirement, please provide the requesting information as indicated below: 1. Company name, address, and point of contact to include phone and email address, size of business pursuant to the following questions: a. Is your business large or small? b. Is your firm registered and verified in the Vendor Information Pages (VetBiz) as a Service-Disabled Veteran Owned Small or Veteran-Owned small business? c. If your firm is a small business does your firm manufacture Custom Sterile Procedure packs? 2. Brief company profile indicating number of years in the Sterile Custom Pack Industry and describing your company's geographic scope of coverage and services offered. a. Capabilities to include at a minimum the following information: i. Do you currently or have you had past experience providing for Custom Sterile Procedure Packs for the Department of Veterans Affairs. If so how many VA Medical Centers did you support concurrently within a single contract. ii. If your firm does not have current or past experience providing services for the Department of Veterans Affairs do you have current or past experience providing services for private or public medical centers or medical clinics? If so how many do you support concurrently within a single contract? iii. What is the highest total number of Custom Sterile Procedure Packs that your firm can or has produced and distributed in one month? iv. What is the highest contract value for Custom Sterile Procedure Packs your firm has been awarded and managed? v. What is the largest number of states and/or counties within a state for which you have provided Sterile Custom Packs concurrently? vi. Do you currently have the necessary resources to provide for the estimated number of Custom Sterile Procedure Packs? If not would you be able to obtain the necessary capital, human resources, management staff, equipment and supplies within 30 days of contract award? vii. Does your firm have experience providing for Custom Sterile Procedure Packs in rural areas and within intense heat or harsh cold inclement weather conditions? Please explain your plan or policy. viii. How much of the performance under the Custom Sterile Procedure Packs requirement would your firm need to subcontract in order to provide the necessary Custom Sterile Procedure Packs requirement? b. Please indicate if your company can provide services for all the medical centers located within SAOE and SAOW, or just portions of the region (specify which portions). Any other pertinent information necessary. 3. Are components available without additional layers of packaging? For example, some drapes inside the packs are inside original supplier packaging which creates additional steps in the OR. Would those drapes be available without the additional packaging? a. What are the dimensions of each of your pack sizes, and within those pack sizes, about how many items can each of them hold? b. If you have an electronic database, what specific data fields and reports are available? Are the reports static or dynamic? c. What is your pack costs based on, aside from pack components? What is the methodology? Is it based on pack size, pack components, etc.? Is it a percentage? Please explain in detail. d. What is the most complex or largest Custom Sterile Procedure Packs you can/have provided? e. Do you manufacturer one specialty of custom packs or numerous different packs. Please explain and offer examples. i. If only a manufacturer, will you distribute, or how will you distribute (ie. MED/SURG prime vendor, third party vendor, UPS, FEDEX etc.) ? a) Please describe your supply chain processes?