Performance Work Statement - Regulated Medical Waste.pdf

Performance Work Statement Regulated Medical Waste Disposal Services

Veterans Integrated Service Network – 4 (VISN4)

1 General: The Department of Veterans Affairs, Veterans Integrated Service Network 4 (VISN 4) has a requirement for has a requirement for Hazardous, Regulated and Pharmaceutical waste collection, removal, and disposal services.

1.1 Scope Summary: The contractor shall provide all transportation, management, equipment, supplies, and reports to furnish Hazardous, Regulated and Pharmaceutical waste collection, removal, and disposal services for any or all VISN4 VA Medical Centers (VAMC) and associated Veteran’s Community Clinics (VCC).

1.2 Period of Performance: The government intendeds to award an Indefinite Delivery Contract for a period of 5 years. The contract will have 5, 1-year ordering periods for each VAMC as shown in the CLINs. The anticipated ordering periods for this contract are summarized as follows:

• Ordering Period 1: 01 July 2025 to 30 June 2026

• Ordering Period 2: 01 July 2026 to 30 June 2027

• Ordering Period 3: 01 July 2027 to 30 June 2028

• Ordering Period 4: 01 July 2028 to 30 June 2029

• Ordering Period 5: 01 July 2029 to 30 June 2030

*Contract guaranteed minimum of $5,000.00 and contract ceiling is $7,900,000.00.

1.3 General Requirements

1.3.1 Quality Control

The contractor shall establish and maintain a complete Quality Control Program (QCP) to assure the requirements of this contract are provided as specified, during the life of the contract.

The contractor’s QCP must include an inspection plan covering all services required by this contract.

The inspection plan must specify the type of inspections (i.e., scheduled, unscheduled), areas for inspection, frequency of inspections, and who will conduct the inspections, with his/her title specified.

The inspection records must note findings and necessary corrective action taken, the timeframe, and follow-up responsibility/issues. The VA reserves the right to request copies of any inspection.

The contractor must have established internal procedures for updating medical service protocols that have been revised, requires changes, and/or incorporation of new protocols since licensing. The changes to processes, equipment, and/or protocol that may affect performance of contract must be communicated in writing to the Contracting Office.

1.3.2 Quality Assurance: The government shall evaluate the contractor’s performance under this contract in accordance with the Quality Assurance Surveillance Plan. Refer to P01 Regulated Medical Waste QASP. This plan is primarily focused on what the Government must do to ensure that the contractor has performed in accordance with the performance standards. It defines how the performance standards will be applied, the frequency of surveillance, and the minimum acceptable defect rate(s).

1.3.3 Federally Recognized Holidays: The contractor will not perform services when the government facility closes due to local or national emergencies or similar government directed facility closings. Government shutdowns occur when the government refuses passage of key bills, resulting in the cession of some or all operations by the government.

If Veterans Affairs (VA) is affected by a government shutdown during the period of performance, the contractor shall not provide services or submit claims against the government during and after the shutdown. The following Federal Holidays are observed by the government:

Table 1: Federal Recognized Holidays Holiday When Observed New Year's Day January 1st Martin Luther King's Birthday Third Monday in January President's Day Third Monday in February Memorial Day Last Monday in May Juneteenth June 17th Independence Day July 4th Labor Day First Monday in September Columbus Day Second Monday in October Veterans Day November 11th Thanksgiving Day Fourth Thursday in November Christmas Day December 25th

1.3.4 Hours of Operation/Scheduling:

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

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.

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.

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

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.

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

Table 2: 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

Lancaster VCC 212 Willow Valley Lakes Drive Suite

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

1.3.6 Type of Contract and Task Orders:

This shall be a firm-fixed price Indefinite Delivery Indefinite Quantity contract. Period of performance will be from the date of award through five (5) years, with up to five (5) task order periods (for each medical center), with each task order not to exceed twelve (12) months.

The contractor shall not commence performance on the tasks in this PWS until the Contracting Officer has conducted a kickoff meeting.

1.3.7 Security Requirements and Background Checks.

All contractor employees shall comply with the security and background check requirements required by Federal, State, Local and the Department of Veterans Affairs to provide this service described in this PWS.

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.

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.

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

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:

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.

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.

1.3.8 Special Qualifications.

1.3.8.1 Permits. The contractor shall acquire and maintain all Federal, State and Local certifications, permits, licenses and registrations required to handle and/or transport RMW. Specifically contractor shall hold NJ A901 to conduct services for locations in the state of New Jersey. All permit, license, registration, and certification fees shall be borne by the Contractor unless otherwise authorized in writing to invoice the VA.

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

1.3.8.3 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.

1.3.9 Post Award Conference/Periodic Progress Meetings. The contractor agrees to attend any post award conference convened by the contracting activity or contract administration office in accordance with Federal Acquisition Regulation Subpart 42.5.

The contracting officer, Contracting Officers Representative (COR), and other Government personnel, as appropriate, may meet periodically with the contractor to review the contractor's performance. At these meetings the contracting officer will apprise the contractor of how the government views the contractor's performance and the contractor will apprise the Government of problems, if any, being experienced.

Appropriate action shall be taken to resolve outstanding issues. These meetings shall be at no additional cost to the government. The contractor shall not commence performance on the tasks in this PWS until the Contracting Officer has conducted a kickoff meeting.

1.3.10 Contracting Officer’s Representative (COR). The (COR) if designated will be identified by separate letter issued by the cognizant government Contracting Officer.

The COR monitors all technical aspects of the contract and assists in contract administration The COR is authorized to perform the following functions: assure that the contractor performs the technical requirements of the contract: perform inspections necessary in connection with contract performance: maintain written and oral communications with the Contractor concerning technical aspects of the contract: issue written interpretations of technical requirements, including Government drawings, designs, specifications: monitor Contractor's performance and notifies both the Contracting Officer and contractor of any deficiencies; coordinate availability of government furnished property, and provide site entry of contractor personnel. A letter of designation issued to the COR, a copy of which is sent to the contractor, states the responsibilities and limitations of the COR, especially with regard to changes in cost or price, estimates or changes in delivery dates. The COR is not authorized to change any of the terms and conditions of the resulting order.

1.3.11 Personnel:

The contractor shall be responsible for the performance and conduct of its employees.

Personnel employed by the contractor in the performance of this SOW or any representative of the Contractor entering the VA premises shall be subject to inspections by the Government as deemed necessary. The Contractor shall not reemploy for performance under this contract, any person whose employment would result in a conflict of interest with the Government’s standards of conduct.

The contractor is completely responsible for all actions of their employees. All contractor personnel employed in the performance of this contract shall comply with all VA building regulations, policies, and guidelines while on the premises. Contractor personnel shall be free of body odor and wear clean clothing (uniforms as appropriate) while performing duties under this contract. The contractor shall consider the clinical environment and instruct/train their personnel in applicable safety precautions and unique requirements.

These requirements may include but are not limited to such conditions as human secretions, blood, barium, etc. Contractor personnel shall take appropriate precautions while performing duties applicable to this contract.

Personal Appearance - contractor employees shall be well-groomed, clean, and neat in appearance; clothes properly fitted, uniform appearance with nametags, and appropriately dressed for the work to be done. Contractor employees shall not wear clothing with slogans, drawings, or language which could be construed as being lewd, obscene, profane, racially offensive, sexually suggestive, and anti-American or which advocates the use of illegal drugs or other unlawful conduct.

Personnel Courtesy - contractor employees shall not exhibit rude behavior. Loudness, vulgarity, rudeness, or other similar offensive conduct by an employee of the Contractor will be ground for denying the employee further access to the VA premises.

1.3.12 Identification of Contractor Employees:

1.3.1.12.1 Identification Badges: The COR will coordinate the issuance of required access badges to contractor personnel. Contracted personnel visiting any of the locations listed above must be issued a temporary badge or have an escort with him/her always. Badges will be issued from the location’s visitor’s desk or from the Facilities Management desk. All badges will be returned daily. Contract personnel shall wear laminated identification badges provided by the VA always when present and performing work. Badges shall be worn on the outer garment, attached to the outer shirt or jacket pocket by a button or clip or worn around the neck secured by an appropriate identification card lanyard.

Government issued identification badge remains the property of the Government and shall be returned to the issuing office upon completion of work or at the end of the workday, which ever applies.

1.3.1.12.2 Contractor Badges: In addition to the government furnished badge, contractor personnel shall also wear a laminated contractor identification badge always when performing services under this Contract, including when on Government directed travel. The badge will contain a personal picture, name of employee, and Contractor's name. Badges shall be worn on the outer garment attached to the outer shirt or jacket pocket by a button or clip or worn around the neck secured by an appropriate identification card lanyard.

All Contractor personnel attending meetings, answering Government telephones, and working in other situations where their contractor status is not obvious to third parties are required to identify themselves as such to avoid creating an impression in the minds of members of the public or Congress that they are Government officials. They must also ensure that all documents or reports produced by Contractor personnel are suitably marked as contractor products or that contractor participation is appropriately disclosed.

1.3.13 Contractor 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.

1.3.14 Standard of Conduct:

1.3.1.14.1 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.

1.3.1.14.2 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.

1.3.15 Phase-In /Phase-Out Period: 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.

2. DEFINITIONS AND ACRONYMS

2.1 Contracting Officer (CO): The person with the authority to enter, administer, and/or terminate contracts, and make related determinations and findings, including changes within the original contract scope, on behalf of the Department of Veterans Affairs.

2.2 Contracting Officer Representative (COR): Any person(s) designated in writing by the CO to act for the CO within the limits of the delegated authority. Under this contract, the COR shall be the VA person who is qualified to render advice and assistance to the contractor's service personnel. The COR shall also be responsible for certifying that services performed have been satisfactorily rendered in accordance with contract terms.

2.3 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.

2.5 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.

2.6 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.

2.7 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.

2.8 Biohazardous Waste: typically includes waste containing pathogens with sufficient virulence and quantity so that exposure of the waste by a susceptible host can result in an infectious disease

2.9 Hazardous Waste: waste with properties that make it dangerous or potentially harmful to human health or the environment.

2.10 Infectious Waste: any waste which, because of its infectious nature, may cause or significantly contribute to an increase in mortality or an increase in serious irreversible or incapacitating reversible illness, or pose a substantial present or potential hazard to human health or the environment when improperly treated, stored, transported, disposed, or otherwise managed.

2.11 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.

2.12 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.

2.13 Pharmaceutical Waste: waste containing pharmaceutical substances. Examples include expired, unused, and contaminated pharmaceuticals, (e.g., expired drugs, vaccines, and sera.)

2.14 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.

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

2.16 Lab Pack: typical method of waste handling. In a "lab pack" several small containers (i.e., jugs and bottles) of hazardous waste, are individually packaged in a traditional 55-gallon drum.

2.17 Regulated Medical Waste (RMW) - For this contract, RMW includes solid waste generated by the medical system, station, center, veteran community clinics (VCC), satellite support facilities, facilities and/or person in performance of medical system work such as diagnosis, treatment, research, testing for biological or pathogens, surgery, examinations or immunizations of human beings or animals.

From the point of generation, handling packaging, loading, transportation, documentation, treatment or rending RMW neutral and final disposal, RMW is strictly regulated by federal, state and local laws, directives, standards, ordinances, and regulations. This is a waste regulated and segregated from municipal waste streams because of the potential to cause injury, illness and spread of disease and is considered regulated medical waste. RMW may also be referred to as infectious waste and/or biomedical waste.

For purposes of this acquisition, RMW will consist of but not be limited to the following:

• All cultures and stocks of etiologic agents

• Waste blood and blood products

• Trace chemotherapeutic waste, sometimes referred to as Yellow Bag waste.

• Tissues, organs, body parts, blood and body fluids that are removed during surgery and autopsy of specific cases or patients with infectious diseases.

• Wastes that were in contact with pathogens in any type of lab work, including collection containers, culture dishes, slides, plates, and assemblies of diagnostic tests and devices used to transfer, inoculate, and mix cultures.

• Sharps, including hypodermic needles, suture needles, disposable razors, syringes, parteur pipettes, broken glass and scalpel blades.

• Disposable Sharps Containers

• Wastes that were in contact with the blood of patients undergoing hemodialysis at hospitals or independent treatment centers.

• Carcasses and body parts of all animals which were exposed to zoonotic pathogens.

• Animal bedding if it was in contact with animals that contained zoonotic agents.

• Pharmaceutical Waste

• Biological waste (e.g. vaccines) produced by pharmaceutical companies for human or veterinary use.

• Food and other products that are discarded because of contamination with etiologic agents.

• Discarded equipment and equipment parts that are contaminated with etiologic agents and are not to be discarded.

• High incident pathogen waste, biological agent or pathogen

• Microbiology waste, cultures, stocks of cultures, specimens, culture plates, trash cans, equipment, supplies, etc.

• Generally biosafety, the waste generated in labs is considered biosafety level 1 and 2. For this contract, the contractor is expected to be capable of RMW waste typical of level 3 and level 4 laboratory. Example would be Level 3 handling West Nile virus, encephalitis, tick borne pathogens, hanta virus, etc. Example of level 4 would be Ebola, Lassa virus, biological war pathogens or any biological or man-made pathogen with unknown with high risk of pathogenicity or transmission.

• Microbiology equipment could include lab equipment, centrifuge, incubator, tubes, parts of equipment, refrigerator, mobile lab, etc.

• RWM containing legionella bacteria or bacteria

• Disposable gloves (latex, non-latex, canvas, leather, neoprene, surgical gloves, etc.)

• Textiles such as bed linens, wash cloth, towels, disposable wipes, under pads, grossly soiled materials, etc. Includes clothing, shoes, pants, tops, shirts, jackets, etc.

• Dialysis waste, suction container and waste, intravenous bags, tubing used for transfusion

• Trash bags includes general red and yellow bag with the appropriate legal biohazard symbol or globally universal symbol designating RMW waste. Trash containers may be disposed of by station as old worn out containers or otherwise.

• Surgical Room Air Filters. These filters are HEPA fabric and have metal frames and rubberized gaskets.

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

2.17 Staging location: Location designated by the COR for temporary storage prior to pick-up and disposal.

2.18 The acronyms defined and listed below are used in this contract and outlined for reference in this contract for benefit of contractor and government employees using this contract.

CBOC - Community-Based Outpatient Clinic

CLIN – Contract Line Item Number

CO – Contracting Officer

GEMS – Green Environmental Management System

IDC – Indefinite Delivery Contract

IDIQ – Indefinite Delivery/Indefinite Quantity

QASP – Quality Assurance Surveillance Plan

RCRA – Resource Conservation and Recovery Act

RMW – Regulated Medical Waste

SOO – Statement of Objectives

TSDF – Treatment, Storage, Disposal Facility

VA – Department of Veterans Affairs

VAMC – VA Medical Center

VCC – Veteran Community Clinics

VHA – Veteran’s Health Administration

VISN4 – Veterans Integrated Service Network – 04

3. GOVERNMENT FURNISHED ITEMS AND RESPONSIBILITES:

3.1 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.

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

3.3 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. CONTRACTOR FURNISHED ITEMS AND RESPONSIBILITIES:

4.1 General: 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.

4.2 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.

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.

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

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

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.

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

4.3.1 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.

4.3.2 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.

4.3.3 Personnel Administration. The contractor shall provide the following management and support as required. The contractor shall provide personnel 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.

4.3.4 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.

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

4.4.1 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.

4.4.1.1 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.

4.4.1.2 The Contractor’s services shall support VISN 4 Medical Centers and VCC’s local Green Environmental Management System (GEMS) programs.

4.4.2. 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.

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 5.3.5.

4.4 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.

4.5 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.

4.6 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.

5. PERFORMANCE REQUIREMENTS:

5.1 Regulated Medical Waste Disposal. 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 RMW containers The Contractor shall provide RMW containers that 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.

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.

5.2.1 Packaging Material: 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.

5.2.2 Sharps Containers: 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.

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.

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.

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.

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.

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

Upon pickup, the driver shall provide the medical center with a written/printed pickup manifest, outlined in Section 5.3.1. 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.

5.3 Reports:

5.3.1 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.

5.3.2 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

5.3.3 Certification 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

5.3.4 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.

5.3.5 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.

6. RELATED DOCUMENTS The following Documents are related to this project:

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

6.1.1 Exhibit 1 - Altoona Medical Center and VCC History

6.1.2 Exhibit 1 - Butler Medical Center and VCC History

6.1.3 Exhibit 1 - Coatesville Medical Center and VCC History

6.1.4 Exhibit 1 - Coatesville Sharps Container Locations

6.1.5 Exhibit 1 - Erie Medical Center and VCC History

6.1.6 Exhibit 1 - Lebanon - Floor Schedule

6.1.7 Exhibit 1 - Lebanon Medical Center and VCC History

6.1.8 Exhibit 1 - Philadelphia Medical Center and VCC History

6.1.9 Exhibit 1 - Philadelphia Sharps Locations

6.1.10 Exhibit 1 - Pittsburgh Medical Center and VCC History

6.1.11 Exhibit 1 - Wilkes-Barre Medical Center and VCC History

6.1.12 Exhibit 1 – Wilmington Medical Center and VCC History

6.1.13 Exhibit 1 - Wilmington Sharps Container Inventory

6.2 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.

6.3 Attachment 2 – CLINs for each medical center and year. Estimates where appropriate were derived from historical usage.