S--Pharmaceutical Waste Removal Services for the period of April 1, 2017 through March 31,2018

Solicitation documents and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2005-95. The NAICS code is 562112, with a size standard of $32.5 million. This is being conducted as a Total Service Disabled Veteran Owned Small Business Set aside. This requirement is being solicited in accordance with FAR Parts 12 and 13. Statement of Work This solicitation is for a hazardous waste disposal firm to characterize, collect, accumulate and haul off site for proper disposal, waste and unusable pharmaceuticals generated at the Veterans Administration Illiana Health Care System (VAIHCS) that may be classified as hazardous under the regulations of the Resource Conservation and Recovery Act (RCRA). Specific activities to be undertaken are listed below. Contractor shall also provide weekly collection of wastes from individual locations, transport them to central storage room, and transfer materials to 55 Gallon storage Drum. Scope of Service Components for Pharmaceutical Waste Management and Disposal 1.0 Facility Assessment o Contractor shall review current process for determination of RCRA hazardous pharmaceutical waste. o Contractor shall review current pharmaceutical waste accumulation, management and disposal practices. o Contractor shall ensure hospital s written plan for managing hazardous materials and waste is being followed during examination of waste stream for disposal. o Contractor shall inspect current pharmaceutical waste accumulation locations including satellite accumulation and hazardous waste storage areas. o Contractor shall ensure current pharmaceutical waste training programs including training materials and employee training documentation are accurate and up to date. 2.0 Initial and On-going Pharmaceutical Waste Characterization References: EPA (40 CFR §262.11), (40 CFR§261.3), (40 CFR§265.177), (40 CFR§ 265.17) o Initial and on-going waste characterization of the hospital s RX formulary by determining RCRA hazardous and non-RCRA hazardous pharmaceuticals at NDC level including, determination of DOT hazardous materials class for RCRA hazardous pharmaceuticals. o RCRA hazardous determinations shall be based on both active and inactive/preservative ingredients. o Waste characterization shall be determined upon service implementation and, for all pharmaceuticals added to the hospital s RX formulary thereafter. o Waste characterization shall include identification of incompatible pharmaceutical wastes. 3.0 EPA ID Number Reference: EPA (40 CFR§262.12(a)) o Contractor shall confirm that each hazardous waste generating facility (both hospitals and off-site facilities) has an EPA ID number and/or state required identification (if applicable) - except for facilities with a Conditionally Exempt Small Quantity Generator status. o Contractor shall confirm that the State recognizes Conditionally Exempt Small Quantity Generator as a waste generator status. 4.0 Waste Generator Status Reference: EPA (40 CFR §261.5), (40 CFR Part 262) o Contractor shall confirm EPA waste generator status for each facility to be serviced. o If EPA waste generator status is unknown, contractor shall assist in determining waste generator status. 5.0 Internal Logistics References: EPA (40 CFR §262.34 (c)(1)), (40 CFR 265.177), (40 CFR §265.171, 265.172, 265.173) o Internal logistics process shall employ colored-containers. * o Internal logistics process shall be designed to prevent incompatible pharmaceutical waste from being placed in the same container or commingled with any other pharmaceutical waste. o Internal logistics process shall include an easily implemented method or means to assist clinicians in identifying RCRA hazardous and incompatible pharmaceutical waste. * o Internal logistics process shall include vendor provided point-of-use instructional posters. o Internal logistics process shall be designed to assure that colored-containers are in good condition, compatible with their waste stream contents, marked and labeled appropriately and, marked with instructions specific to container management requirements. 6.0 Training References: EPA (40 CFR §265.16), DOT (49 CFR §172.702 & 172.704), OSHA (29 CFR §1910.1200) o On-site training shall be provided for all employees who are involved with or occupationally exposed to hazardous pharmaceutical waste including but not limited to: clinicians (pharmacists, pharmacy techs, nurses), personnel involved in moving partially-full or full pharmaceutical waste containers from points of accumulation to storage areas, personnel responsible for managing hazardous waste storage areas and, personnel responsible for performing or managing the packing and shipping of pharmaceutical waste. o Training shall meet EPA, DOT and OSHA training requirements. o Training material content shall be specific to job performance requirements in relation to RCRA hazardous pharmaceutical waste. o Training materials shall be provided in an electronic format adaptable to the hospital s internal employee training system. o Training shall include on-site review training at regulatory defined frequencies. o Training materials shall include a list of all hazardous pharmaceuticals in the hospital s RX formulary. 7.0 Hazardous Waste Storage References: EPA (40 CFR §265 Subpart I), (40 CFR §265.32), (40 CFR §265.174) o Service shall include assessment of existing hazardous waste storage area and assistance (as needed) to assure that the hospital has and maintains a regulatory compliant hazardous waste storage area. 8.0 Hazardous Waste Segregation References: EPA (40 CFR §262.30), (40 CFR §265.177), (40 CFR§265.17) o Procedure used for segregation, storage, packing and disposal of RCRA hazardous pharmaceutical waste shall comply with applicable EPA and DOT regulations and, the DOT Hazardous Materials table. o Procedure for packing hazardous pharmaceutical waste for transport and disposal shall assure that incompatible wastes and materials are not placed in the same container. o If commingling of incompatible hazardous waste exists, contractor shall define the procedure used to assure that commingled incompatible hazardous waste is packaged and stored in a manner that assures that storage and disposal container contents will not: a) generate extreme heat or pressure, fire or explosion, or violent reaction; b) produce uncontrolled toxic mists, fumes, dusts, or gases in sufficient quantities to threaten human health; c) produce uncontrolled flammable fumes or gases in sufficient quantities to pose a risk of fire or explosions; d) damage the structural integrity of the device or facility containing the waste or threaten human health or the environment. 9.0 Pre-Transport Requirements References: EPA (40 CFR §262.30, 262.32, 262.33), DOT (49 CFR Parts 172, 173, 178 and 179) o Contractor shall assure that RCRA hazardous pharmaceutical waste and/or DOT hazardous materials are packaged in accordance with applicable EPA and DOT regulations (49 CFR Parts 173, 178 and 179) before it is offered for transportation and/or transported off-site. o Contractor shall assure that all packages of RCRA hazardous pharmaceutical waste and/or DOT hazardous materials are marked and labeled in accordance with applicable DOT regulations (49 CFR Part 172). o Contractor shall assure that the waste generator has appropriate placards (according to DOT regulations) readily available to offer hazardous waste transporter (49 CFR Part 172, subpart F). 10.0 Vendor Due Diligence References: EPA (40 CFR Parts 262 265) o Hazardous Waste Transporter(s) NOTE: The following information shall be required for any hazardous waste transporter that will be picking-up and transporting RCRA hazardous waste off-site: 1. Company name 2. Company address 3. EPA ID number 4. DOT number 5. Any State permit/license identification 6. Proof of required insurance o Waste Transfer, Storage and Disposal Facility (TSDF) NOTE: The following information shall be required for any TSDF to which hospital hazardous pharmaceutical waste is transported. 1. Company name 2. Company address 3. EPA ID number 4. Any State permit/license identification 5. Proof of required insurance o Waste Incinerator NOTE: The following information shall be required for any waste incinerator at which hospital generated waste is to be incinerated. 1. Company name 2. Company address 3. EPA ID number 4. Any State permit/license identification 5. Proof of required insurance 11.0 Disposal Reference: EPA (40 CFR Parts 262-265), Joint Commission Standard (MM.01.01.03), NIOSH, ASHP, OSHA, and Practice GreenHealth s 10 Steps to Managing Pharmaceutical Waste document. o RCRA hazardous pharmaceutical waste shall be incinerated at an EPA permitted hazardous waste incineration facility. o Mixed infectious/RCRA hazardous pharmaceutical waste (combined RCRA hazardous and infectious) shall be incinerated at an EPA permitted hazardous waste incineration facility that is permitted to incinerate both RCRA hazardous waste AND infectious waste. o NIOSH, OSHA and ASHP designated high alert non-hazardous pharmaceutical waste shall be incinerated. o All non-hazardous pharmaceutical waste shall be incinerated. 12.0 Annual Audit Reference: Joint Commission Standard (EC.04.01.01) o Contractor shall conduct an annual audit of the pharmaceutical waste management program based on applicable EPA, DOT and applicable State regulations. 13.0 Pricing The following pricing components shall be included in monthly proposed rate. o Transportation o Disposal- Estimated 2421 lbs. per year average o Labor charge for on-site waste packing (lab packing) o Pick-up fee/Stop charge o DOT RX Waste Containers (for packing, shipment, and disposal of RX Waste) 10-15 55gal drums per year 2-3 5 Gallon pails per year o Reusable colored RX waste containers (for internal collection of RX waste). Approximately 90 containers to include: (See attached listing of bins) Mounting brackets/carts Materials installation labor o Initial waste characterization fee o On-going waste characterization service fee o Waste characterization database or licensing fee o Training fees for materials and on-site training service for both initial (start-up) training and annual training o Consulting service fee o Any applicable purchase quantity discounts or GPO derived administrative rebates o Any administrative fees including: manifest fees, fuel surcharges, state waste disposal taxes (if applicable), etc. * Industry best management practices are based on recommendations and published guidelines from the Occupational Safety and Health Administration (OSHA), American Society of Health-System Pharmacists (ASHP), National Institute of Occupational Safety and Health (NIOSH) and, Practice GreenHealth s Managing Pharmaceutical Waste A 10 Step Blueprint for Healthcare Facilities In The United States . QUOTE SUBMISSION INFORMATION AND EVALUATION CRITERIA 1. Offerors are required to complete Blocks 17, and 30(a-c) of the SF1449, the price list and acknowledgement of all solicitation Amendments issued and the information identified in paragraph 4 below. 2. Quotes shall be evaluated for Technical Capability, Past Performance, and Price following the evaluation criteria of this solicitation. The quote format, which follows, has been included to assist you in preparing a complete quote. In order to provide full consideration of your qualifications and ability for Contract establishment, you are encouraged to ensure that the information furnished in support of your quote is factual, accurate and complete. You may provide additional information you believe shall enhance your quote; however, overly elaborate presentations are not desired. Failure to provide the information requested may render the offer s quote as unacceptable. The Government reserves the right to verify any information provided. The required information shall be submitted by the Offeror in order to assure complete and proper understanding of the specifications, however, Offeror may include additional information if necessary to more clearly define the Offeror s capability of performing the services or furnishing the products as defined herein. Additional Information: Only those terms and conditions identified in the RFQ shall apply. Offer s quote shall provide an all-inclusive cost to perform all requirements as outlined herein, as applicable. Any changes made to this RFQ by any party are invalid unless agreed to in writing by the Contracting Officer (CO). Any exceptions or clarification the Offeror needs to submit shall be included in the Offeror s quote and clearly identified by the exact section, paragraph, subparagraph and page number of the requirement for which the exception or clarification is being submitted. Failure to properly identify the above may result in less than full consideration for award. Any technical information which is considered to be proprietary or confidential must be marked as such. Offeror confirms that he/she has a regularly established firm in the business called for and who, in the judgment of the Contracting Officer (based upon information provided), is financially responsible. The offeror must show evidence of their firm s reliability, ability, experience, equipment, facilities, and personnel directly employed or supervised by them to render prompt and satisfactory service. Each Offeror submitting a quote shall obtain/possess any certifications, licenses and accreditations to furnish the services required for the VA Illiana Healthcare System. All costs associated with obtaining/ possessing such certifications, licenses and accreditations are included in the Contract price. 3. Quote Submission a. Offerors shall submit one (1) electronic copy of the quote. The quote shall be submitted in two sections, the pricing quote and the technical and past performance Quote. 4. Items to be evaluated are: a. Technical Capability- i. Contractor shall demonstrate relevant experience and qualifications regarding the Statement of Work Requirements. ii. Contractor and his/her personnel shall provide evidence of compliance with all Federal, State, and local regulations, laws, and licensing requirements. Contractor shall demonstrate that they have the licensing and access to appropriate to licensed disposal sites for the services that they propose to provide. iii. Contractor shall provide environmental compliance record of hauling and disposal facilities used iv Demonstrated record of timely delivery of services. b. Past Performance- Past performance evaluations shall be conducted using information provided with the offer, information obtained from references, information obtained information obtained from the Past Performance Information Retrieval System (PPIRS), the Federal Awardee Performance & Integrity Information System (FAPIIS), and information from any other sources deemed appropriate. The Past Performance evaluation shall assess the relative risks associated with an Offeror's likelihood of success in fulfilling the solicitation's requirements as indicated by that Offeror's record of past performance. When evaluating past performance the government may consider the currency and relevancy of the information, the source of the information, the context of the data provided, and the general trends in the contractor's performance. The government may take into account past performance information regarding predecessor companies and key personnel who have relevant experience that shall perform major or critical aspects of the requirement. Offerors shall provide Information on contracts executed within the past three (3) years with Federal, State, or local Government agencies, along with private sector customers which are relevant to the efforts required by this solicitation. A minimum of three (3) references shall be submitted with your offer however, in the case of an Offeror without a record of relevant past performance or for whom information on past performance is not available, the Offeror may not be evaluated favorably or unfavorably. c. Price- The Price shall include all labor, materials, project management, supplies and supervision. Price will be evaluated by the Contracting Officer for the base and all option periods to determine reasonableness and may be evaluated to determine whether the price realistically supports the requirements of the solicitation. If more than one offer is received, the prices from the offers will be entered into an abstract or documented in the Contracting Officer s Award Decision. 5. Failure to submit the necessary information may render the offer unacceptable, in which case it will not be considered for award. Proposals will be evaluated in accordance with the criteria set forth above. The Government may, at its discretion and in its best interest, make award without conducting discussions with offerors. Therefore, perspective offerors are encouraged to submit initial proposals that represent the best terms and conditions of the offeror. 6. BASIS FOR ESTABLISHMENT OF AWARD: Award will be based on Best Value in accordance with Federal Acquisition Regulation (FAR) 13.106-2., under the authority of FAR 13. The Government shall select the best overall offer, based upon an integrated assessment of evaluation factors listed in the FAR 52.212-2 Evaluation Commercial Items. Award shall be made to the offeror whose offer is determined to be the most advantageous to the Government. The Government intends to establish a single award to the offeror whose offer is determined to represent the best value to the Government. SUBMISSION OF PROPOSALS: The proposal shall be submitted via U.S.P.S regular mail, commercial overnight delivery or hand-delivered. It may also be emailed to Kevin Adkins, Contracting Officer, at contact@example.gov .The proposal shall be addressed to the office specified in the solicitation and shall show the time specified for receipt, the solicitation number and name and address of the offeror. Proposals shall be submitted as described below: If submitting via U.S.P.S. regular mail, commercial overnight delivery or hand-delivered, submit the proposal to the following address: Kevin Adkins VA Illiana Healthcare System 1900 East Main Street Building 102 Room 124C Danville, Illinois 61832