PWS Biomedical Waste Removal.docx

PERFORMANCE WORK STATEMENT (PWS)

Biomedical Waste Disposal US Army Research Institute of Environmental Medicine

SECTION 1 PURPOSE

1.1. Introduction: The U.S. Army Research Institute of Environmental Medicine is the U.S Army’s main institution and facility for military environmental medicine and exercise physiology research.

1.2. Mission: USARIEM is engaged in essential medical research focused on optimizing servicemen and women's health and performance during training and on the battlefield.

1.3. Background: To safely package, collect and dispose of regulated Medical waste in compliance with all Federal, State and local regulations.

1.4. Scope: To safely package, collect and dispose of regulated Medical waste in compliance with all Federal, State and local regulations on a quarterly.

SECTION 2 GENERAL REQUIREMENT

2.1. Performance

2.1.1. Place of Performance: USARIEM

2.1.2. Primary On-Site Government Location USARIEM BLDG 42, 10 General Greene Ave Natick MA 01760.

2.1.1. Period of Performance. This contract is for one (1) twelve (12) months Base Period and four (4) twelve (12) months Option Periods.

2.2. Type of Services

2.2.1 Non-Personal Services

This PWS identifies services that are strictly non-personal in nature, as defined by Federal Acquisition Regulation (FAR) Part 37, Service Contracting. To ensure there is no appearance of any personal services, the Government shall neither supervise contractor personnel nor control the method by which the contractor performs the required tasks. Under no circumstances shall the Government assign tasks or prepare work schedules for individual contractor personnel. It shall be the responsibility of the contractor to manage its personnel and to guard against any actions that 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 Contractor Officer (KO) immediately.

2.2.2 Severable / Non-Severable Services

This award identifies services that are severable in nature.

2.2.3 Inherently Governmental Functions

This requirement has been reviewed and contains no services that are inherently governmental functions.

2.3. Contract Management

2.3.1. Government Management. The Contracting Officer’s Representative (COR) for this contract will be appointed by the Contracting Officer (KO). The COR will serve as the primary point of contact for all activities and issues that occur under this contract.

2.3.2. Contractor Management. The contractor shall designate a single Program Manager (PM) to be the contractor’s authorized point of contact (POC) with the COR. The PM will be responsible for formulating and enforcing performance standards, assigning contractor schedules, reviewing performance quality, communicating policies, purposes, and goals to subordinates. This will include coordination with the KO and the COR to resolve any issues that may arise, trends relating to the contract, or proposed changes or modifications to the contract.

2.3.3. The contractor shall provide a draft Quality Control Plan (QCP) with their proposal and a final QCP no later than 15 days after contract award. The contractor shall prepare and adhere to a QCP describing how the contractor intends to manage the contract to achieve the established standards set forth in the Performance Standards Summary Matrix and the contractor’s QCP.

2.4. Reports

2.4.1. Reports and documents delivered by the contractor in the performance of this contract shall be considered Technical Data as defined in the applicable FAR clause 52.227-14, Rights in Data. All documentation shall reflect the latest version of the work product or activity, unless specifically directed otherwise by the Government. All documentation shall be prepared in accordance with (IAW) standard industry practices, ensuring electronically produced documents which reflect logical flow of material, tables of contents indexes and page numbering. Where applicable, the contractor’s attention is called to the availability of commercial, industry, federal, and military guides, instructions, and standards for many of the topics addressed in this PWS and under this contract.

2.4.2. Quarterly Report. The contractor shall provide a Quarterly report detailing all work, including the subcontractor’s work, and where there is critical or significant data related to the provided support. The report shall include a detailed list of all hours worked and workload accomplished.

2.5. Training Requirements

2.5.1 AT Level 1 training required, needs to be completed within 30 calendar days after contract start date or effective date of incorporation. AT level 1 training can be found at http://jko.jten.mil;

2.5.2 Access and general protection policy and procedures;

2.5.3 Require access to the installation but not CAC access. The employees shall comply with adjudication standards and procedures using the National Crime Information Center Interstate Identification Index (NCIC-III) and Terrorist Screening Database (TSDB); and

2.5.4 For all contractors with security clearances they must receive annual TARP training by a CI agent or other trainer specified in 2-4 of AR 381-12.

2.6. Contractor Personnel, Disciplines, and Specialties

2.6.1 The contractor shall accomplish the assigned tasks by employing and utilizing qualified personnel with appropriate combinations of education, training, and experience. The contractor shall match personnel skills to the task with a minimum of under or over employment of resources.

2.6.2. Duty Hours.

2.6.2.1. Contractor personnel shall perform services during regular duty hours. Normal work hours are ) 0900 to 1530 . Flextime workers start not earlier than 0700 and not later than 0830. Flextime must be approved by the contractor who will coordinate with the COR to ensure appropriate contractor coverage so that flextime is not detrimental to completion of the mission. Core hours of work are from 0900 to 1500 daily. All employees are expected to be available during core hours.

2.6.2.2. The contractor shall not perform services on days designated as a Federal Holiday by Federal Status, Executive Order, Presidential Proclamation or Installation Commander.

2.6.3.3. Federal holidays are an exception to the regular duty hours. Any of the holidays listed below falling on a Saturday will be observed on the preceding Friday; holidays falling on a Sunday will be observed on the following Monday. The following is a list of legal federal holidays that services shall not be performed:

2.6.3.3.1. New Year’s Day, 1 January

2.6.3.3.2. Martin Luther King’s Birthday, 3rd Monday in January

2.6.3.3.3. President’s Day, 3rd Monday in February

2.6.3.3.4. Memorial Day, last Monday in May

2.6.3.3.5 Juneteenth, 19 June

2.6.3.3.6. Independence Day, 4 July

2.6.3.3.7. Labor Day, 1st Monday in September

2.6.3.3.8. Columbus Day, 2nd Monday in October

2.6.3.3.9. Veteran’s Day, 11 November

2.6.3.3.10. Thanksgiving Day, 4th Thursday in November

2.6.3.3.11. Christmas Day, 25 December

2.6.3.4. The contractor shall not perform services or report to work on days the Government or installation is closed due to local determinations relating to safety conditions, inclement weather conditions, national emergencies, energy conservation. During these periods of closure, the contractor personnel who are not designated as essential personnel IAW USAMMA M3D’s contract shall not report for work nor shall they be compensated for those days.

2.6.3.5. Telecommuting - Telecommuting is not feasible for the services provided under this contract.

SECTION 3. PERFORMANCE REQUIREMENTS

3.1 Tasking

3.1.1 Provide Regulated Medical Waste (RMW) removal on a quarterly basis or as needed;

3.1.2 Receive shipping boxes, 3 mil red bags and packing tape for shipment of RMW;

3.1.3 Boxes should be able to fit up to 55 pounds of RMW;

3.1.4 Distinguish between pathological waste, pharmaceutical and sharps;

3.1.5 Find a facility that complies with the strict regulatory guidelines and quality controls;

3.1.6 Understands all federal, state, and local guidelines covering medical waste, hazardous waste, universal waste and other regulatory wastes; and

3.1.6 Comply with legislation to ensure that all documents are kept secure and confidential at all times.

3.2 Key Responsibilities

3.2.1 Provide the removal of an estimated 3000 lbs of regulated medical waste annually. Each shipment of RMW consists of around 10-20 cardboard boxes or 500- 800 lbs.

3.2.2 A shipping manifest needs to be created for each shipment of RMW and the record is kept for 3 years. The documents should be kept secure at all times.

3.2.3 Provide approximately 20 cardboard boxes capable of holding up to 55 lbs of waste each. Shipping bags and packaging tape is also provided for shipments. The supplies will be provided by the company at the scheduled pick-up.

3.2.4 A designated truck should be used to transport the regulated medical waste and the driver needs to be qualified to pick up and transport regulated medical waste. The use of a POV for transporting RMW is prohibited.

3.3 Additional Requirements

3.3.1 Vendor shall comply with all Defense, Army, Institute and other governmental regulatory requirements with emphasis on safety and security. Comply with OSHA, DOT and EPA regulations. Massachusetts regulations can be found at 105 CMR 480.000 minimum requirements for the management of medical or biological waste (state sanitary code VIII).

3.3.2 The transporter needs to be familiar with incident reporting requirements and emergency response procedures. 49 CFR part 177.816 details the specific training requirements for drivers. It is required for them to have shipping papers as specified in 105 CMR 480.00. The shipping papers need to have the name, address and phone number of the waste generator along with contact name and emergency number, a description of the waste to be shipped, total quantity of waste shipped, type of containers and destination of delivery. The shipping papers need to be kept for a period of 375 days after the material is delivered to the facility.

3.3.3 The company needs to have a designated off site facility where biological waste is rendered non-infectious prior to disposal as solid waste according to Mass. Department of Environmental Protection. Disinfection methods include steam disinfection/autoclaving, chemical disinfection, and incineration at an approved facility or any other method approved by the department of defense in writing. Any method requiring heat sterilization needs a temperature recording device to make sure it reaches temperature. Any autoclave will be calibrated annually to ensure proper disinfection of waste. Quarterly qualitative autoclave testing will also be performed.

3.4. Performance Requirement Summary Matrix

The Government intends to utilize a Quality Assurance Surveillance Plan (QASP) to monitor the quality of the Contractor’s performance in relation to performance objectives. The Government will finalize the QASP immediately following award, and the COR will provide a copy of the final QASP to the contractor. The QASP is a living document and may be updated by the Government as necessary.

The Government will use the following performance requirements to measure the performance of the contractor. The contractor shall meet the Performance Objective(s) and Acceptable Quality Level(s) within the “Performance Requirements Summary Matrix” (PRS Matrix).

PERFORMANCE REQUIREMENTS SUMMARY MATRIX

Ref.

SECTION 4 SPECIAL REQUIREMENT

4.1. Government Furnished Equipment shall not be provided.

4.2. Contractor Furnished Property: N/A

4.3. Security and Safety

4.3.1. Access and General Protection/Security Policy and Procedures.

Contractor and all associated sub-contractors employees shall provide all information required for background checks to meet installation access requirements to be accomplished by installation Provost Marshal Office, Director of Emergency Services or Security Office. Contractor workforce must comply with all personal identity verification requirements (FAR clause 52.204-9, Personal Identity Verification of Contractor Personnel) as directed by DOD, HQDA and/or local policy. In addition to the changes otherwise authorized by the changes clause of this contract, should the Force Protection Condition (FPCON) at any individual facility or installation change, the Government may require changes in contractor security matters or processes.

4.3.2. Contractors That Do Not Require CAC, But Require Access to a DoD Facility or Installation.

Contractor and all associated sub-contractors employees shall comply with adjudication standards and procedures using the National Crime Information Center Interstate Identification Index (NCIC-III) and Terrorist Screening Database (TSDB) (Army Directive 2014-05/AR 19013), applicable installation, facility and area commander installation/facility access and local security policies and procedures (provided by government representative), or, at OCONUS locations, in accordance with status of forces agreements and other theater regulations

4.4 Security Requirements.

4.4.1 General .

USARIEM considers the safety of its employees, neighbors, and the surrounding community its number one priority. USARIEM’s biological surety program is governed by a broad set of Federal, DoD and US Army regulations and policies, which enables WRAIR to safeguard both the biological materials used in the laboratories as well as the personnel who work here. USARIEM is frequently inspected by those regulating agencies, and successful completion of those inspections is required for WRAIR to continue its operation. It is therefore critical that all employees, including contractor employees, meet standards and maintain compliance with all regulations, policies, and procedures that have been instituted for their protection and the protection of others. Security, training, and other requirements may be subject to change based upon changes in regulations and policies, and the Contractor shall be immediately responsive to those changes.

4.4.2 Security Requirements.

The Contractor shall be required to obtain the necessary security clearances. A facility clearance through a servicing Defense Security Service is required to be maintained and updated when applicable as established on the DD Form 254. The Contractor shall initiate the necessary personnel background checks for successful processing of contract employees through the SOCOM’s Security Office. The minimum personnel background investigations will be a National Agency Check with Inquiries (NACI). It is anticipated that the highest clearance required will be Secret.

Any delays in recruitment caused by security issues will be the responsibility of the Contractor unless an exception is authorized by the Contracting Officer. The security requirements for other USAMRMC laboratories or customers will be specified on each individual PWS. The appropriate security clearance forms will be provided to the Contractor in accordance with FAR Clause 52.204-2 in Section I.

4.4.3 Foreign Nationals Requirements.

A foreign national can only be hired if they have a special skill that a US Citizen cannot be found to perform. The investigation must be completed in its entirety before unescorted access to the facility is granted. Government computer access may be approved, but the process has to be approved by the Fort Detrick Designated Approving Authority. (Reference PWS 2.11.8.5)

SECTION 5 DELIVERABLES

10-20 cardboard boxes 3 mil bio-waste bags provided Manifest document for shipment Packaging tape

3.1 and 3.2

Quarterly or as needed for a five year contract

POLICIES

6.1. Environmental Requirements

6.1.1. Mandatory Compliance. Occupational Safety and Health Act and AR 200-1 Environmental Protection and Enhancement.

6.1.2. Non Mandatory Documents. Additional DoD and Army environmental program and regulations are available on-line at http://aec.army.mil.

6.2. Applicable Directives. The contractor shall comply with all documents listed below as mandatory.

6.3. Mandatory Compliance

6.3.1 Dissemination of Information/Publishing

There shall be no dissemination or publication, except within and between the Contractor and any Sub Contractors or specified Integrated Product/Process Team (IPT) members who have a need to know, of information developed under this order or contained in the reports to be furnished pursuant to this order without prior written approval of the COR or the Contracting Officer. Business Program Management Office (PMO) approval for publication will require provisions that protect the intellectual property and patent rights of both Business PMO and the Contractor.

6.3.2 Contractor Identification

The Contractor shall ensure that Contractor personnel identify themselves as Contractors when attending meetings, answering Government telephones, providing any type of written correspondence, or working in situations where their actions could be construed as official Government acts.

6.3.3 Attendance at Meetings

Contractor personnel may be required to attend meetings or otherwise communicate with Government and/or other contract or assistance agreement representatives to meet the requirements of this order. Contractor personnel shall make their contractor status known during introductions.

6.3.4 Use of Military Rank by Contractor Personnel

Contractors may not use or allude to former or current military rank during the performance of this work.

SECTION 7 DEFINITIONS

7.1. Definitions

7.1.1. CONTRACTOR. A supplier or vendor awarded a contract to provide specific supplies or service to the government. The term used in this contract refers to the prime.

7.1.2. CONTRACTING OFFICER. A person with authority to enter into, administer, and/or terminate contracts, and make related determinations and findings on behalf of the government. The Contracting Officer is the only individual who can legally bind the government.

7.1.3. CONTRACTING OFFICER'S REPRESENTATIVE (COR). An employee of the U.S. Government appointed by the contracting officer to administer the contract. Such appointment shall be in writing and shall state the scope of authority and limitations. This individual has authority to provide technical direction to the contractor as long as that direction is within the scope of the contract, does not constitute a change, and has no funding implications. This individual does NOT have authority to change the terms and conditions of the contract.

7.1.4. DEFECTIVE SERVICE. A service output that does not meet the standard of performance associated with the Performance Work Statement.

7.1.5. DELIVERABLE. Anything that can be physically delivered, but may include nonmanufactured things such as meeting minutes or reports.

7.1.6. PHYSICAL SECURITY. Actions that prevent the loss or damage of Government property.

7.1.7. QUALITY ASSURANCE. The government procedures to verify that services being performed by the contractor are performed according to acceptable standards.

7.1.8. QUALITY ASSURANCE SURVEILLANCE PLAN (QASP). An organized written document specifying the surveillance methodology to be used for surveillance of contractor performance.

7.1.9. QUALITY CONTROL. All necessary measures taken by the contractor to assure that the quality of an end product or service shall meet contract requirements.

7.1.10. SUBCONTRACTOR. One that enters into a contract with a prime contractor. The Government does not have privity of contract with the subcontractor.

7.1.11. WORK DAY. The number of hours per day the contractor provides services IAW the contract.

7.1.12. WORK WEEK. Monday through Friday, unless specified otherwise.

ATTACHMENT 1 – ACRONYMS LIST

Acronym

Definition