FINAL PWS v4.pdf

Performance Work Statement

Regulated Medical Waste Disposal Services Veterans Integrated Service Network – 04

1. SCOPE

1.1. This Performance Work Statement (PWS) describes all requirements and terms pertaining to the Department of Veterans Affairs (VA) Veterans Integrated Service Network 4’s (VISN4) requirements for regulated medical waste (RMW) and sharps waste disposal.

2. VISION STATEMENT

2.1. VISN4s regulated medical waste is safely and effectively collected, transported, and treated/destroyed.

3. INTRODUCTION

3.1. VISN4 is contracting for a Commercial Firm Fixed Price, five (5) year, Indefinite Delivery Vehicle contract for complete and comprehensive Regulated Medical Waste (RMW) Services to include pick-up, transportation, sterilization, and disposal for up to nine (9) VISN4 VA Medical Centers (VAMC) and associated Veteran’s Community Clinics (VCC).

3.2. Mission. VISN4 consists of nine (9) VA Medical Centers which all generate varying levels of RMW and sharps waste. There is a high degree of risk associated with biohazardous medical waste and any medical equipment capable of piercing human skin known as “sharps.” These hazards must be effectively mitigated through an effective RMW and sharps waste disposal program. By ensuring the proper handling and disposal of these materials, the VA is better able to accomplish its mission to fulfill President Lincoln's promise to care for those who have served in our nation's military and for their families, caregivers, and survivors.

3.3. Background. VISN4 currently contracts for the collection, transportation, treatment, and disposal of RMW and sharps waste. The current operational proceedings of each VISN4 VAMC and associated VCC can be found in Exhibit 1 at the end of this PWS.

3.4. Contract Scope. The intent of this acquisition is for the safe and effective labor, material, equipment, maintenance, repair, supplies, transportation, management, expertise, and supervision necessary to perform complete and comprehensive RMW services to include but not limited to pick-up, transportation, sterilization, and disposal for any or all VISN4 Medical Centers and associated VCC’s.

3.4.1. Medical waste is primarily regulated by state environmental and health departments.

Generally, medical waste is defined as healthcare waste that that may be contaminated by blood, body fluids, or other potentially infectious materials and is often referred to as “regulated medical waste.”

3.4.1.1. In Delaware, general provisions regarding regulated medical waste are found under 7 DE Admin. Code 1301.

3.4.1.2. In New Jersey, general provisions regarding regulated medical waste are found under N.J.A.C. 7:26 et seq.

3.4.1.3. In Pennsylvania, general provisions regarding regulated medical waste are found under Pa. Chapter 284.

3.4.1.4. Additional federal regulations are found under Occupational Safety and Health

Administration Part 1910.1030.

3.4.1.5. For purposes of this acquisition, regulated medical waste is any solid waste, generated in the diagnosis, treatment, or immunization of human beings or animals, in research pertaining thereto, or in the production or testing of biologicals, that is not excluded or exempted, and that is listed or meets any waste characteristic classification criteria as described in the aforementioned state laws including:

Cultures and Stocks: Cultures and stocks of infectious agents and associated biologicals, including cultures from medical and pathological laboratories; cultures and stocks of infectious agents from research and industrial laboratories; wastes from the production of biologicals; discarded live and attenuated vaccines; and culture dishes and devices used to transfer, inoculate, and mix cultures.

Pathological Wastes: Human pathological wastes, including tissues, organs, and body party and body fluids that are removed during surgery or autopsy, or other medical procedures, and specimens of body fluids and their containers. Equipment and equipment parts that are contaminated with etiologic agents.

Human Blood and Blood Products: Liquid waste human blood; blood; items saturated and/or dripping with human blood; or items that were saturated and/or dripping with human blood that are now caked with dried human blood; including serum, plasma, and other blood components, and their containers, which were used or intended for use in either patient care, testing and laboratory analysis or the development of pharmaceuticals.

Intravenous bags (only if they have come into contact with blood or other regulated body fluid), soft plastic pipettes and plastic blood vials are also included in this category.

Sharps: Sharps that were used in animal or human patient care or treatment or in medical research, or industrial laboratories, including sharp, or potentially sharp if broken, items such as, but not limited to, hypodermic needles, all syringes to which a needle can be attached (with or without the attached needle) and their components, including those from manufacturing research, manufacturing and marketing, pipettes, scalpel blades, blood vials, syringes, needles with attached tubing, acupuncture needles, and culture dishes (regardless of presence of infectious agents).

Also included are other types of broken or unbroken glassware that were in contact with infectious agents, such as used slides and cover slips.

Animal Wastes: Contaminated animal carcasses, body parts, and bedding of animals that were known to have been exposed to infectious agents during research (including research in veterinary hospitals), production of biologicals, or testing of pharmaceuticals.

Isolation Wastes: Biological waste and discarded materials contaminated with blood, excretion, exudates, or secretions from humans who are isolated to protect others from certain highly communicable diseases, or isolated animals known to be infected with highly communicable diseases.

Unused Sharps: The following unused, discarded sharps, that were intended to be used: hypodermic needles, suture needles, syringes, and scalpel blades.

Trace Chemotherapy Waste: Trace chemotherapy waste includes Personal Protective Equipment (PPE) that is not saturated with hazardous drug waste, syringes and I.V. bags that have been fully administered, and containers that meet the definition of Resource Conservation and Recovery Act (RCRA) empty, meaning that no more than 3% of the drug, by weight of the total capacity of the container, is remaining. Trace chemotherapy waste shall be transported and treated as regulated medical waste and shall be incinerated, not autoclaved.

3.4.2. Exclusions: The following are excluded from the definition of regulated medical waste:

Hazardous or radioactive waste identified or listed under the federal regulations.

Municipal waste.

Ash from incineration of regulated medical waste once the incineration process has been completed.

Residues from treatment and destruction processes once the regulated medical waste has been both treated and destroyed.

Human corpses, remains and anatomical parts that are intended for interment or cremation.

Bulk Chemotherapy Waste: Chemotherapy waste that is not classified as

RCRA empty or where there is more than a trace amount of chemotherapy drugs in or on the item being disposed.

Any biological or nonbiological material, including RMW and sharps, if the following conditions are met:

o The generator treats all materials, through incineration or autoclave, at the site of generation before shipping the materials off site as Municipal Solid Waste (MSW); and/or o The generator destroys all sharps at the site of generation before shipping the destroyed sharps off site for recycling of the devices' component raw materials.

4. GENERAL REQUIREMENTS

4.1. General Requirements. This section describes the general requirements for this effort. Sub-sections provide the details of various requirements included in this effort.

4.2. Non-Personal Services. The Government shall not supervise contractor employees or control the methods used by the contractor to perform the required tasks. Under no circumstances shall the Government assign tasks to, or prepare work schedules for, individual contractor employees. It shall be the responsibility of the contractor to manage its employees and to guard against any actions that are of the nature of personal services or give the perception of personal services. If the contractor believes that any actions constitute, or are perceived to constitute personal services, it shall be the contractor's responsibility to notify the Contracting Officer (CO) immediately.

4.3. Business Relations. The contractor shall successfully integrate and coordinate all activity needed to execute the requirements. The contractor shall manage the timeliness, completeness, and quality of problem identification. The contractor shall provide corrective action plans, proposal submittals, timely identification of issues, and effective management of subcontractors. The contractor shall seek to ensure customer satisfaction and professional and ethical behavior of all contractor personnel.

4.4. Contract Administration and Management. The following subsections specify requirements for contract, management, and personnel administration.

4.4.1. Contract Management. The contractor shall establish clear organizational lines of authority and responsibility to ensure effective management of the resources assigned to the requirements. The contractor must maintain continuity between the CO, the VISN Contracting Officers Representative (COR), and the contractor's corporate offices.

4.4.2. Contract Administration. The contractor shall establish processes and assign appropriate resources to effectively administer the requirements. The contractor shall respond to Government requests for contractual actions in a timely fashion. The contractor shall have a single point of contact between the Government and Contractor personnel assigned to support contracts or task orders. The contractor shall assign work effort and maintain proper and accurate time keeping records of personnel assigned to work on the requirements. Designated qualified personnel shall be always available when the contract work is in progress, if needed, and shall have the ability to respond to the site, when needed, to monitor work progress and for any other emergency, as required. The Contractor or designated qualified personnel shall reply to correspondence to the COR, and/or CO within 24 (24) hours of being contacted, except for emergencies in which case the contractor shall reply to emergency calls within one

(1) hour of being contracted.

4.4.3. Personnel Administration. The contractor shall provide the following management and support as required. The contractor shall provide personnel (employees of the prime vendor or subcontractor) during designated government non-workdays or other times when government offices are closed due to weather or security conditions. The contractor shall maintain the currency of their employees by providing initial and refresher training as required to meet the PWS requirements. The contractor shall make necessary travel arrangements for employees. The contractor shall provide necessary infrastructure to support contract tasks. The contractor shall provide ordinary administrative support to employees in a timely fashion to include: time keeping, leave processing, pay, emergency needs, etc.

4.5. Subcontract Management. According to Small Business Administration (SBA) Rule 88 FR 26164, dated May 30, 2023, the prime contractor shall not be overly reliant on the use of subcontractors. The prime contractor must perform the primary and vital requirements of the contract, Section 5.2, and must demonstrate that it possesses the ability to perform contract elements with a sufficient level of independence from its subcontractors. The contractor shall be responsible for any subcontract management necessary to integrate work performed on this requirement and shall be responsible and accountable for subcontractor performance on this requirement.

4.6. Contractor Personnel, Disciplines, and Specialties. The contractor shall accomplish the assigned work by employing and utilizing qualified personnel with appropriate combinations of education, training, and experience. The contractor shall match personnel skills to the work or task to avoid under- or over-utilizing resources. The contractor shall ensure the labor categories as defined in the Labor Categories document (provided at the time of award), labor rates, and man-hours utilized in the performance of each Task Order issued hereunder will be the minimum necessary to accomplish the task.

4.6.1. Physical Security. The COR is responsible for ensuring that all Contractors comply with physical security policies. A compliant ID badge must be always worn by Contractors while on VA premises. The Contractor employees shall always wear a distinctive uniform. The contractor shall ensure contractor employees look neat and wear applicable safety equipment/clothing. Contractor employees working on VA property shall be familiar with and obey established fire, safety, environmental, and security regulations.

4.7. Continuity of Operations. The Contractor shall have a Continuity of Operations plan which includes a back-up source of disposal in the event the primary source of disposal is not accessible due to an emergency, natural disaster, terrorist attack, act of war, or biological disease outbreak.

4.8. Place of Performance. Accomplishment of the results contained in this PWS requires work at the following locations:

Table 1: VAMC and Associated Clinic’s Physical Addresses Altoona VAMC 2907 Pleasant Valley Blvd. Altoona PA 16602 DuBois CBOC 5690 Shaffer Rd. DuBois PA 15801 Johnstown CBOC 600 Galleria Dr. Johnstown PA 15904 State College CBOC 2581 Clyde Ave. State College PA 16801 Abie Abraham VA Health Care Clinic

353 N Duffy Rd Butler PA 16001

Butler VAMC 325 New Castle Rd Butler PA 16001 Lawrence Co. CBOC 1750 New Butler Rd New Castle PA 16101 Mercer Co. CBOC 295 North Kerrwood Drive, Suite 110 Hermitage PA 16148 Coatesville VAMC 1400 Blackhorse Hill Road Coatesville PA 19320 Delco CBOC 4883 West Chester Pike Newtown Square PA 19073 West Norriton CBOC 2495 General Armistead Ave Ste A Norristown PA 19403 Erie VAMC 135 East 38th St. Erie PA 16504 Ashtabula County

CBOC

2044 Lambros Lane Ashtabula OH 44004

Crawford County CBOC 11200 Perry Hwy, Meadville, PA 16335 Meadville PA 16335 Venango County CBOC 125 Home Depot Dr. Franklin PA 16323 Warren County CBOC 3 Farm Colony Drive Warren PA 16365 Lebanon VAMC 1700 South Lincoln Ave. Lebanon PA 17042 Berks VCC 2762 Century Blvd. Wyomissing PA 19610 Cumberland VCC 5070 Ritter Road Mechanicsburg PA 17055

4.9. Hours of Operation. The hours of operation for work under this contract will be determined by each participating Medical Center's designated primary point of contact.

4.9.1. The Contractor may be required to interrupt their work at any time so as not to interfere with Medical Center operations, including utility services, fire protection systems, and passage of facility patients, personnel, equipment, and carts. Contractor shall not block access to areas of the facility during RMW pick-up.

4.10. Scheduling. Each participating Medical Center’s designated POC will establish, in coordination with Contractor, regularly scheduled pick-up times (minimum of one pickup per month for each VAMC) prior to the start of service. The POC shall be notified in advance of any schedule deviations and determine an alternate pick-up time. Changes to the regularly scheduled pick-up times shall be coordinated with and approved by the POC or COR.

4.10.1. The Contractor shall reschedule and complete missed pick-ups within one day of the missed pick-up.

4.10.2. Any instance of the Contractor failing to communicate a schedule deviation, otherwise known as a “no-show,” shall immediately result in a Deficiency Notice and may result in the withholding of payment until the contractor corrects the deficiency.

4.10.3. If a federal holiday has the potential to disrupt scheduled pick-ups, an alternate pick-up time may be scheduled in coordination with and approval by the designated facility

POC.

Lancaster VCC 212 Willow Valley Lakes Drive Suite 208 Willow Street PA 17584 York VCC 2251 Eastern Blvd. York PA 17042 Corporal Michael J.

Crescenz VAMC

3900 Woodland Ave Philadelphia PA 19104

Victor J. Saracini Outpatient Clinic

433 Caredean Drive Horsham PA 19044

West Philadelphia VA Clinic

801 Arch Street, Suite 102 Philadelphia PA 19139

Outpatient Dialysis 4219 Chestnut Street Philadelphia PA 19104 Community Living Center

3461 Civic Center Blvd. Philadelphia PA 19104

VA Pittsburgh Healthcare System - University Drive

University Drive C Pittsburgh PA 15240

VA Pittsburgh Healthcare System - HJ Heinz

1010 Delafield Road Pittsburgh PA 15240

Wilkes-Barre VAMC 1111 East End Blvd. Wilkes-Barre PA 18711 Allentown OPC 3110 Hamilton Blvd Allentown PA 18103 Sayre OPC 1537 Elmira Street Sayre PA 18840 Williamsport OPC 1705 Warren Ave. Suite 304 Williamsport PA 17701 Wilmington VAMC 1601 Kirkwood Highway Wilmington DE 19805 Sussex CBOC 21748 Roth Avenue Georgetown DE 19947 Cape May CBOC 3801 Route 9 South, Suite 2 Rio Grande NJ 08242 Kent CBOC 655 South Bay Road, Suite 3C Dover DE 19901 Atlantic CBOC 1909 New Road Northfield NJ 08225 Cumberland CBOC 79 West Landis Avenue Vineland NJ 08360

4.11. Travel. Transportation of RMW is not included in the definition of travel. Travel to government facilities or other contractor facilities for the purposes of contract management may be required to satisfy the requirements of this contract. All travel for contract administration, to include site-visits, shall be pre-approved by the COR or Medical Center Primary Point of Contact. Costs for administrative travel are not included in this contract.

4.12. Quality Assurance. The contractor shall develop a comprehensive program of inspections and performance monitoring and submit a quality assurance plan to the Contracting Officer and COR for acceptance.

4.12.1. The Contractor shall inform the Contracting Officer and COR of any issue(s) affecting the quality of service to include proposed resolution.

4.12.2. Refer to P01 Regulated Medical Waste QASP.

4.13. Material Sources. The Government, in accordance with the Buy American Act, encourages the use of American-made products and services. This clause implements a preference for American-made sharps containers, medical waste containers, and brackets used in the performance of this contract. Offers that propose the use of American-made Products will receive additional points in the technical approach evaluation category (up to 5 out of 35 total points allocated for technical approach found in section 10 of this contract).

4.13.1. For the purposes of this clause, "American-Made Products" means Products manufactured or substantially assembled in the United States. A Product is considered "substantially assembled in the United States" if at least 50% of the cost of its component parts (excluding the cost of transportation) is of U.S. origin.

5. PERFORMANCE REQUIREMENTS

5.1. Performance Requirements. The following section specifies the primary and vital Performance Elements of the contract.

5.2. Regulated Medical Waste Disposal.

5.2.1. The Contractor shall provide all labor, material, equipment, maintenance, repair, supplies, and transportation necessary for complete and comprehensive RMW services to include but not limited to pick-up, transportation, sterilization, disposal, and reporting for any or all VISN4 Medical Centers and associated CBOCs and VCCs.

5.2.2. The Contractor shall provide three (3) primary service options and one (1) optional service options for each VAMC to choose from on a yearly basis. The service preferences for each facility can be found in Exhibit 1 and service selections for each VAMC will be reflected in individual Task Orders (TOs) The options provided by the Contractor shall include:

5.2.2.1. Service 1: Sharps waste is not separated; it is included in the non-sharps

RMW. Reusable sharps containers are not included in this service. The RMW is consolidated to a central location at each facility for Contractor pick-up.

Pricing is based on a flat rate per pound for all RMW removal to include trace chemo and disposable sharps containers.

5.2.2.2. Service 2: Sharps waste is separated from non-sharps RMW. Contractor provides reusable sharps containers and mounting brackets. VA employees collect and distribute reusable sharps containers throughout the Medical Center and applicable VCC’s and consolidate the collected full containers to a central location at each facility for pick-up by Contractor. The non-sharps RMW is also consolidated to a central location at each facility for Contractor pick-up. This service includes the hardware and installation required to mount sharps containers to walls, floors, or carts by the contractor. Pricing is based on a flat rate per pound for RMW removal including trace chemo and a separate flat rate for reusable sharps containers removal.

5.2.2.3. Service 3: Sharps waste is separated from non-sharps RMW. Contractor provides reusable sharps containers and mounting brackets. Contractor collects and distributes reusable sharps containers throughout the Medical Center and applicable VCC’s. Reusable sharps containers, located in areas where Contractor is not permitted entry, are collected and distributed by VA employees. The sharps containers collected by VA employees and the non-sharps RMW are consolidated to a central location at each facility for pick-up by Contractor. This service includes the hardware and installation required to mount sharps containers to walls, floors, or carts by the contractor. Pricing is based on a flat rate per pound for RMW removal to include trace chemo and a separate flat rate for reusable sharps container removal.

5.2.2.4. Optional Service 1: The Contractor shall provide the installation and full-service exchange of drug sequestration units to securely manage DEA controlled substance wastage. Pricing shall be based on a flat rate per pound.

5.2.3. RMW containers shall be provided by the Contractor and shall meet all Federal, State and Local directives, standards, ordinances, laws, and regulations. The Contractor shall provide two options for sharps containers: reusable or disposable sharps containers aligning with safety standards and infection prevention protocols within each healthcare facility. Re-usable/recycled containers shall be cleaned, sanitized, and disinfected off-site prior to re-use. The Contractor shall supply a wide array of RMW containers and sharps containers of various sizes to each site. The specifications of desired containers for each facility can be found in Exhibit 1, attached.

5.2.3.1. The Contractor shall supply all packaging materials. Packaging materials consist of shipping tape and shipping labels; returnable containers and boxes;

placards as required by federal, state, or local law; and RMW approved red bags.

5.2.3.2. The Contractor shall provide both disposable and reusable sharps containers aligning with safety standards and infection prevention protocols within each healthcare facility. “Mailbox” drop-in and cabinet style sharps containers with wall mounted brackets shall be included for terms of this contract. Refer to Exhibit 1 for specific Medical Center’s sharps container requirements.

5.2.3.3. RMW containers shall meet the requirements of the standards for occupational exposure to blood borne pathogens. The general industry standard requires the packaging to be closable, constructed to prevent leakage, labeled with the biohazard symbol, and closed to prevent spillage during handling. Upon being placed in storage, red bags shall be used for the packaging of all RMW.

Packaging shall be labeled as required.

5.2.3.3.1. Prior to transporting RMW, waste will be packaged for transportation in accordance with the standards of 49 CFR Part 173 or packaged in accordance with an exemption approved by the United States Department of Transportation. All waste shall be labeled, and the label shall be securely attached to or printed on packaging. The label may be a tag securely affixed to the package. Indelible ink shall be used to complete the information on the label. The label and the information provided on the label must be clearly legible. The following information shall be included:

The name, address, and business telephone number of the generator;

"RMW" in large print; and The Biological Hazard Symbol.

5.2.3.4. RMW may be conveyed in reusable carts or containers under the following conditions:

The waste in the cart or container is packaged and labeled fully in accordance with state regulations;

Immediately following each time, a reusable cart or container is emptied and prior to being reused it is thoroughly cleaned with detergent or general-purpose disinfectant; and

When reusable carts or containers containing RMW are used for off-site transport, all aspects of the cart or container management shall comply with all applicable federal Department of Transportation Hazardous Material Regulations.

5.2.3.5. Regulated medical waste in closed bags or containers shall not be compacted or subjected to violent mechanical stress; however, after it is fully treated and it is no longer regulated medical waste, it may be compacted in a closed container.

5.2.3.6. The Government anticipates future construction and renovation projects will impact the requirements of this contract. Some facilities may require additional RMW and sharps containers and brackets to be kept on-hand. The Contractor shall provide additional containers and brackets to accommodate future construction and renovations on an as-needed basis.

5.2.4. The Contractor shall provide weights and measures data collection for all RMW services.

5.2.4.1. Upon pickup, the driver shall provide the medical center with a written/printed pickup manifest, outlined in Section 7.3. Within ten (10) business days the Contractor shall certify the manifest data provided matches the final measurement. The Contractor shall provide an updated manifest in the event the final weight is different from the measurement taken by the driver.

5.2.4.2. The Contractor shall obtain a Certification of Destruction (CD) document from the final Treatment, Storage, Disposal Facility (TSDF) and submit it along with the Medical Center’s monthly invoice.

5.2.4.3. The contractor shall submit a comprehensive weights and measures report monthly detailing various aspect of the waste stream. See Section 7.4 for additional details.

5.3. Training. The Contractor shall provide VISN-wide virtual training on a quarterly basis to comply with all requirements found in Subpart H of 49 CFR 172. This requires that waste generator employees who perform functions involving hazardous materials are trained and training is sufficiently documented. Quarterly training sessions shall be coordinated with the COR or otherwise designed POC.

6. SPECIAL REQUIREMENTS

6.1. Special Requirements. This section describes the special requirements for this effort. The following sub-sections provide details of various considerations on this effort.

6.2. Permits. The contractor shall acquire and maintain all Federal, State and Local certifications, permits, licenses and registrations required to handle and/or transport RMW. All permit, license, registration, and certification fees shall be borne by the Contractor unless otherwise authorized in writing to invoice the VA.

6.3. Insurance. The Contractor shall furnish, upon request, a copy of the insurance policies required by federal, state, and local regulation to perform this contract.

6.4. Inspection. The CO, COR, or designated facility POC may inspect the Contractor’s facility and equipment for compliance. Such inspections shall be scheduled within five (5) business days of request.

6.5. Vehicles. Vehicles shall be either owned, leased, or rented by the Contractor. The Contractor must be able to demonstrate proof of ownership, lease, or rental agreement at any time during contract performance.

6.5.1. Contractor shall ensure all vehicles are well maintained and labeled as required by law and regulations. Vehicles shall bear at a minimum the transporter’s name, state permit identification, and the words “Medical Waste”, “Regulated Medical Waste” or “Bio-hazardous Waste” on the sides of the body.

6.5.2. Vehicles shall be equipped with a fully enclosed, leak-resistant cargo body, maintained in a sanitary condition and securable when unattended.

6.5.3. Vehicles shall be used for transporting regulated medical waste; simultaneously transporting any other waste stream is not permitted.

6.5.4. All vehicles used to transport RMW or sharps waste must, at a minimum, contain a spill kit consisting of a portable decontamination unit, masks, coveralls, gloves, disinfectant, and a means of communicating during emergencies. Vehicle operators shall be knowledgeable in the use of the emergency equipment and supplies. Following spills or leaks, vehicles shall be cleaned and disinfected according to Federal, State and Local laws and standards.

6.6. Qualification. At the time of solicitation, the Contractor shall have been doing business in good standing in the RMW industry as a provider of services like those described herein.

Certifications, permits, licenses and/or registrations shall be unencumbered with no current possibility of suspension or termination.

6.7. Security and Safety. The Contractor shall ensure Contractor employees and representatives comply with VA procedures governing site and building access and security. Each designated facility POC will provide to Contractor the participating Medical Center’s escort requirements.

The Contractor shall ensure Contractor employees and representatives comply with the security regulations of VA, Veterans Health Administrative (VHA), and other Government installations where work is performed under this contract.

6.7.1. The Contractor employees and representatives shall not release, publish, or disclose sensitive information to unauthorized personnel, and shall protect such information in accordance with pertinent laws and regulations governing the confidentiality of sensitive information. All personnel assigned to this contract are required to take proper precautions to protect privacy information from disclosure in the case that such disclosures are made.

6.7.2. Contractor may not have access to the VA network or any VA sensitive information under this contract. All Contractors must receive Privacy training annually using the following method:

6.7.2.1. Complete the hard copy version of “VA Privacy Training for Personnel without

Access to VA Computer Systems or Direct Access to or Use to VA Sensitive Information” to be provided by the COR.

6.7.2.2. Signed training documents must be submitted to the COR. Training must be completed prior to the performance of the contract and annually thereafter.

Proof of training completion must be verified and tracked by the COR.

6.8. Phase-In Transition. The Contractor shall work with the COR and/or other authorized facility POCs to pick-up and remove existing, incompatible sharps containers, RMW containers, and brackets as needed. All removed brackets and containers shall be provided to the VA upon removal. Contractor shall replace incompatible sharp container brackets with new sharps container brackets and containers anywhere the facility POC designates, to include wheeled medication carts. Contractor shall provide containers that comply with all necessary requirements, and which are in accordance with Federal, State, and Local regulations. All containers shall be clearly labeled with Biohazard symbol and the word "BIOHAZARD” displayed on the container which includes a bar code. The removal of old sharps containers and installation of new containers shall be performed after the facility's normal business hours to minimize disruption to patient care, unless otherwise authorized. The Contractor shall be responsible for the repair of any damage caused during the removal of the old sharp containers and/or brackets or installation of the new sharp containers and/or brackets. This may require filling holes (patching) and painting by the Contractor. Paint colors and numbers of the paint to be used will be provided by the government to the Contractor so the existing colors will match the existing décor. Installed containers shall be at a height to meet American Act (ADA) requirements. It is anticipated that this phase-in shall be accomplished within a period of one month for all VISN Medical Centers and clinics.

6.9. Government Furnished Materials. No Government Furnished Property (GFP) shall be provided. The Government shall provide access to areas and an escort when required by participating Medical Center policy.

6.10. Government Responsibilities. The Government shall provide the Contractor with a list of designated Medical Center points of contact at the time of award.

6.11. Environmental Requirements. The Contractor shall comply with all listed environmental requirements except for those identified as non-mandatory.

6.11.1. The contractor shall submit a Diversion Program customized for each Medical Center and associated VCC’s designed to improve the Medical Center’s diversion rate. The Contractor, in cooperation with the COR, shall seek improvements, new techniques and methods, new recycling markets, etc. to increase recyclable waste.

6.11.1.1. The VA is bound by Executive Order 13101, Greening the Government through Waste Prevention, Recycling, and Federal Acquisition to fully comply with the Resource Conservation and Recovery Act (RCRA) federal requirement.

6.11.1.2. The Contractor’s services shall support VISN 04 Medical Centers and VCC’s local Green Environmental Management System (GEMS) programs.

6.11.2. The contractor is solely responsible for all spills or leaks resulting from work performed by Contractor personnel during the performance of the contract. The Contractor shall clean-up and disinfect spills and/or leaks to the satisfaction of the Government in a manner which satisfies the applicable federal, state, and local laws and regulations, at no cost to the Government.

6.11.2.1. Spills or leaks that occur during the transportation of the materials shall be reported to federal, state, and local authorities as mandated by law and to the COR within two (2) hours of occurrence. If spill occurs outside of normal business hours, it must be reported to the corresponding Medical Center’s police department. If spills or leaks occur, a spill report shall be provided to the COR and shall include the information outlined in Section 7.2.

6.12. Applicable Directives. The Contractor shall obey established fire, safety, environmental, and security regulations and ensure contractor employees are trained in accordance with but not limited to applicable OSHA standards and other applicable federal, state, and local directives, standards, ordinances, laws and regulations. The Contractor shall repair and/or compensate for any damage incurred to Government property, surrounding equipment, personal belongings, or property during contract execution.

7. DELIVERABLES

7.1. Deliverables. The contractor shall provide deliverables as described below.

7.2. Spill Report. All spill reports shall be provided in the event of a spill and shall incorporate the following data:

Identify item spilled (quantity, and manifest numbers) and brief description of the incident.

If amount spilled was reportable to federal/state/local authorities, and if so, include a copy.

Exact location of spill.

Containment, clean-up procedures and plans initiated and/or completed.

Disposal location of clean-up residue/supplies.

If personal injury occurred include detailed narrative of injury.

Names and telephone numbers of all contacted federal/state/local officials.

Narrative summarizing all on-scene visits made by federal/state/local officials.

Mitigation plan on how the Contractor adapt its practices to avoid a reoccurrence.

7.3. Pickup Manifest. The Contractor shall both retain a copy and provide a copy of the manifest to the designated medical center POC. The manifest shall include all Federal, State, and Local requirements and at a minimum provide:

Transport number Handling permit number U.S. Department of Transportation identification number Transport company Quantities Destination Processing facility Date Contractor personnel name (printed) and signature

7.4. Certificate of Destruction. The Contractor shall provide a Certificate of Destruction (CD) that corresponds to all materials picked up at each facility monthly. The CD shall be submitted with the invoice submitted to each medical center. The Certificate of Destruction shall at a minimum contain the following:

Pickup/Delivery Location Date of Pickup/Delivery Amount of waste (pounds) Destruction Certification Document/Manifest Number Destruction Certification Date

7.5. Monthly Waste Stream Reporting. The contractor shall submit a comprehensive weights and measures report for each facility and its corresponding clinics monthly, detailing various aspect of the waste stream. This report shall be a Microsoft Excel spreadsheet or be included in on online reporting system. The data shall include elements such as month, cart/container weight, gross weight, net weight, container sizes and weights, total containers, pounds of recycled or reused plastic, landfill diversion metrics, corresponding invoice numbers, invoice costing details, and campus-specific breakdowns for larger facilities. If medical center chooses sharps waste plan, contractor shall provide medical center with gross sharps waste, weight of re-usable sharps containers, net weight of sharps waste (no container weight included) and total weight of plastic diverted from landfill.

7.6. Invoices. The Contractor shall provide monthly fee invoices to each designated facility POC for their Medical Center and associated clinics RMW fees. The invoice shall include:

Contractor name, address, and vendor code Contractor invoicing point of contact telephone number and email address Invoice number and invoice date Purchase order number covering the invoiced dates of service.

Dates of service Monthly weights excluding weight contributed by any plastic returnable container used during the weighing process by pick-up location.

8. RELATED DOCUMENTS

8.1. Related Documents. The following Documents are related to this project:

8.1.1. Exhibit 1 – A comprehensive data call, with 13 subparts, containing the current and historical RMW requirements at each facility and its corresponding clinics.

8.1.1.1. Exhibit 1 - Altoona Medical Center and VCC History

8.1.1.2. Exhibit 1 - Butler Medical Center and VCC History

8.1.1.3. Exhibit 1 - Coatesville Medical Center and VCC History

8.1.1.4. Exhibit 1 - Coatesville Sharps Container Locations

8.1.1.5. Exhibit 1 - Erie Medical Center and VCC History

8.1.1.6. Exhibit 1 - Lebanon - Floor Schedule

8.1.1.7. Exhibit 1 - Lebanon Medical Center and VCC History

8.1.1.8. Exhibit 1 - Philadelphia Medical Center and VCC History

8.1.1.9. Exhibit 1 - Philadelphia Sharps Locations

8.1.1.10. Exhibit 1 - Pittsburgh Medical Center and VCC History

8.1.1.11. Exhibit 1 - Wilkes-Barre Medical Center and VCC History

8.1.1.12. Exhibit 1 – Wilmington Medical Center and VCC History

8.1.1.13. Exhibit 1 - Wilmington Sharps Container Inventory

8.1.2. Attachment 1 - Regulated Medical Waste QASP is a contractor performance assessment document that identifies each performance requirement, applicable PWS section, performance standard and acceptable quality level (AQL), method of surveillance, and any applicable incentives or remedies.

8.1.3. Attachment 2 - Cost Schedule Illustration

8.1.4. Attachment 3 - Past Performance Questionnaire

9. SUBMISSION REQUIREMENTS

9.1. Proposals. Proposals shall be presented as a monthly fee for service for each Medical Center and associated clinics as structured in Exhibit 3.

9.1.1. Services: Proposals shall provide a clear description of all services as defined in

Exhibit 3 - Contract Line Item Number Table.

9.1.2. Preferences: Participating Medical Centers will indicate the service type best suited for the facility in Exhibit 1 and will engage the Contractor through the issuance of task orders.

9.2. Limitations. Offerors must provide and demonstrate the ability to provide services using standard and accepted industry practices. The written plan must be provided as a single document (not to exceed 30 pages) with up to three (3) attachments (not to exceed 5 pages each). The written plan shall conform to the standards of 12-point font and keep branding and images to a cover page.

10. EVALUTION CRITERIA

10.1. The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate offers:

10.2.

Sub-Criteria Breakdown Rating Scale

General Qualifications

Demonstrates ability to independently perform primary and vital elements (per section

5.2) without unusual reliance on subcontractors

Independent Overly Reliant

Relevant licenses, permits, and insurance

Satisfactory Not Acceptable

Training Programs Satisfactory

Not Acceptable Demonstrates clear understanding of requirements and provides strong plan for collection of RMW

Very Good Adequate

Poor Insufficient

Technical Approach

Proposed sharps collection and transportation methods

Very Good Adequate

Poor Insufficient

Disposal plan and adherence to regulations

Very Good Adequate

Poor Insufficient

Waste tracking and manifesting procedures

Very Good Adequate

Poor Insufficient

Customer service plan and communication protocols

Very Good Adequate

Poor Insufficient

Commitment to using American-made supplies

Very Good Adequate

Poor Insufficient

Past Performance

Performance history on similar contracts (CPARS)

Very Good Adequate

Poor Insufficient

Price

Cost proposal for services, including potential breakdown of costs for different service elements

Very Good Adequate

Poor Insufficient

Total

10.3. Options. The Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. The Government may determine that an offer is unacceptable if the option prices are significantly unbalanced. Evaluation of options shall not obligate the Government to exercise the option(s).

10.4. A written notice of award or acceptance of an offer, mailed or otherwise furnished to the successful offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offer's specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award.

10.5. The Government may determine that a proposal is unacceptable if the prices proposed are materially unbalanced between line items or subline items. Unbalanced pricing exists when, despite an acceptable total evaluated price, the price of one or more line items is significantly overstated or understated as indicated by the application of cost or price analysis techniques.

A proposal may be rejected if the Contracting Officer determines that the lack of balance poses an unacceptable risk to the Government.