PWS_RMW 20250930.pdf

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Regulated Medical Waste (RMW) Disposal and Incineration Services
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HT942626RE008
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This is a Performance Work Statement (PWS) for Regulated Medical Waste (RMW) Disposal and Incineration Services for three U.S. Department of Defense research facilities: United States Medical Research Institute of Infectious Disease (USAMRIID), Walter Reed Army Institute of Research (WRAIR), and Naval Medical Research Command (NMRC)-Frederick, all located at Fort Detrick, Maryland and Silver Spring, Maryland. The requirement is an enduring service resulting from the closure of the on-post medical incinerator on April 5, 2018, due to environmental compliance deficiencies. The Contractor must provide pickup, transport, and incineration of seven classes of regulated medical waste (Groups 1-7) including cultures, pathological waste, blood products, sharps, animal waste, and isolation wastes containing BSL Level 4 agents. Waste collection is required three times weekly (Monday, Wednesday, Friday) from multiple building locations, with monthly collections typically ranging from 70 to 95 bins at approximately 200 pounds each using contractor-supplied 200-gallon red bins.

The Contractor must obtain and maintain Maryland Department of the Environment (MDE) certification as a Special Medical Waste (SMW) Hauler and facility permit for incineration, comply with MEDCOM Regulation 40-35, and hold valid hazardous materials (HAZMAT) driver credentials and U.S. citizenship for on-post access. Key deliverables include quality control plans, destruction and disposal certificates, spill response plans, weight tickets, manifests, and vehicle placarding, all subject to 100% compliance standards. Contractor support hours are 0800-1600 Monday-Friday; government office hours are 0700-1600. The Contractor shall furnish all personnel, equipment, vehicles, transportation, and supplies necessary for performance, establish a stacker at USAMRIID to handle volume increases, and return within 24 hours if unable to load all bins. All ash must be transported to approved secure landfills. The Contractor must comply with extensive security requirements, installation access control procedures, force protection conditions, and mandatory training in Anti-Terrorism Level I, OPSEC, and iWATCH awareness programs within 30 days of contract award.

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AUG 22

Performance Work Statement Includes associated Performance Requirements Summary (PRS)

PERFORMANCE WORK STATEMENT (PWS)

Regulated Medical Waste (RMW) Disposal and Incineration Services for the

United States Medical Research Institute of Infectious Disease (USAMRIID) Walter Reed Army Institute of Research (WRAIR)

Naval Medical Research Command (NMRC) - Frederick September 2025

Part 1 General Information

1. General: This is a non-personal service(s) contract under which the personnel rendering the service(s) are not subject, either by the contract’s terms or by the manner of its administration, to the supervision and control usually prevailing in relationships between the Government and its employees.

1.1 Description of Services/Introduction: This is a non-personal service(s) contract to provide RMW Disposal and Incineration services.

1.2 Background: USAMRIID: Since 1969, USAMRIID has worked closely with other Defense Health Agency Research & Development Medical Research and Development Command (DHA R&D – MRDC) organizations, DoD, the Interagency (including Interagency Laboratories), and private companies to accomplish its mission of protecting the Warfighter from biological threats and being prepared to investigate disease outbreaks or threats to public health.

WRAIR: Around the world, WRAIR works alongside civilian researchers, medical professionals, and military personnel to develop and test products that will ultimately reduce the impact of some of the most dangerous and debilitating diseases. WRAIR provides unique research capabilities and innovative medical solutions to a range of Force Health Protection and Readiness challenges currently facing U.S. Service Members, along with threats anticipated during future operations.

Fort Detrick’s Building 568, formerly identified as the U.S. Army Center for Environmental Health Research (USACEHR), develops surveillance capabilities to detect, assess, and prevent health effects from adverse environmental, physiological and psychological exposures.

USACEHR’s operations, now under the direction of WRAIR, continues to serve as an outgrowth of a robust and comprehensive toxicology program that existed as part of the US

Army Biomedical Research and Development Laboratory (USABRDL) under DHA R&D -

MRDC.

NMRC-Frederick: Since its creation in 1992, the Biological Research Defense Directorate (BDRD) of the Naval Medical Research Command (NMRC) has researched ways to protect military personnel in the event of a biological attack. BDRD was relocated to Ft. Detrick, Frederick, MD under the 2005 Base Realignment and Closure (BRAC). The relocation of BDRD and the Navy’s biological defense research effort to Ft. Detrick in 2011 established the Naval Medical Research Command - Frederick (NMRC- Frederick) located in Building 8400 on the National Interagency Biodefense Campus (NIBC) at Fort Detrick, MD. NMRC-Frederick is a subordinate laboratory of the Naval Medical Research Command (NMRC) at Forest Glen Annex, Fort Detrick, located in Silver Spring, MD.

USAMRIID, WRAIR, and NMRC-Frederick are seeking RMW pickup, disposal, and incineration services. This is an enduring requirement resulting from the Fort Detrick, Maryland (on post) medical incinerator closure on 05 April 2018 due to deficiencies noted during an Environmental Compliance Inspection (EPA) and State of Maryland Department of the Environment (MDE) inspection. The incinerator has remained closed to this day, leading to the need for a certified Contractor to pickup, transport and incinerate the following classes of RMW: Group 1 – Cultures, Stocks and Vaccines; Group 2 – Pathological Waste; Group 3 – Blood and Blood Products; Group 4 and Group 7 – All Used (Group 4) and Unused (Group 7) Sharps; Group 5 – Animal Waste; and Group 6 – Isolation Wastes (including bedding from animals with BSL Level 4 agents).

1.3 Scope: The Contractor shall provide non-personal service(s). The Contractor shall provide all personnel, equipment, supplies, transportation, facilities, and other items necessary to perform services as described in the PWS and associated contract documents, except for those items specified in Part 3 Government Property and Services.

The Contractor shall be regulated by the State of Maryland Department of the Environment (MDE) and the Code of Maryland Regulations (COMAR.) The facility shall be permitted to process Special Medical Waste (SMW) using a highly controlled combustion technology to safely and efficiently thermally oxidize all types of SMW. Proof of this certification will be required at time of proposal submission.

The Contractor must comply with the disposal provisions of MEDCOM Regulation 40-35, Management of Regulated Medical Waste. Due to security requirement for on-post visitor access, the Hazardous Materials (HAZMAT) driver transporting the SMW must be a U.S.

Citizen and have in their possession valid USG identification

1.4 Objectives:

1.4.1 The Contractor shall provide RMW pickup, disposal and incineration services to USAMRIID, WRAIR, NMRC-Frederick, and other locations as necessary at Fort Detrick.

Collection services are expected to be provided three (3) times per week (Monday, Wednesday and Friday).

The Contractor must have a Certification by the State of Maryland Department of the Environment as a Special Medical Waste (SMW) Hauler and receive driver’s training as specified in applicable State requirements and the Code of Federal Regulations, Title 49, Parts 100-185. Proof of this certification will be required at time of proposal submission.

1.4.2 The Contractor must be permitted with the Maryland Department of the Environment for refuse disposal by means of incineration.

1.4.3 The Contractor shall supply personnel, vehicles, and 200-gallon red bins specifically designed for regulated medical waste disposal. Only these gallon bins will be used; no smaller containers or cardboard boxes are permitted. Monthly collections typically range from 70 to 95 bins, with each bin averaging approximately 200 pounds in weight. Regulated medical waste bins provided must be, clean/sanitized, contain no residual waste or waste materials, and in serviceable condition (i.e., leakproof, no cracks, and functional wheels).The Hazardous Material (HAZMAT) driver must be a US citizen and have in their possession valid identification which will enable access to Fort Detrick, Maryland and Forest Glenn Annex, Silver Spring, MD.

Repetitive services provided by designated personnel will be issued on-going access for the duration of the designated service(s).

1.4.4 The Contractor shall comply with all Federal, State, and local laws and standards pertaining to the Fort Detrick U.S. Army Garrison and USAMRIID, WRAIR, and NMRC- Frederick security requirements. The contractor shall comply with all Federal, State, and local Environmental, Safety, and Transportation laws. The contractor shall also comply with all U.S.

Army, Department of Defense (DoD), Defense Health Agency (DHA), U.S. Army Medical Command (MEDCOM), DHA R&D – MRDC, USAMRIID, U.S. Navy Bureau of Medicine and Surgery (BUMED) policies and procedures, along with WRAIRs College of American Pathologist (CAP) requirements for disposal of biospecimens containing Private Health Information / Personal Identifying Information.

1.4.5 There are two vehicle check points for access to locations on Fort Detrick; one at the Fort Detrick Garrison Visitor Gate and one at the USAMRIID entry control point (ECP). WRAIR has one entry control point on Brookville Road, Silver Spring, MD. Access to NMRC-Frederick requires entry through the NIBC Campus Truck Inspection Station (TIS). Therefore, the HAZMAT Vehicle is subject to search at any time.

1.4.6 The Contractor shall provide a destruction report along with the invoice for each pick up at each location as identified in paragraph 1.5.5. The destruction report shall contain Handler Name and Destination Facility Name, Reporting Period, Generator Identification (ID) Number, Government Entity Name, Building Number, Destruction and Disposal Methods, and a Certification Statement with Signature.

1.4.7 The Contractor shall ensure all incinerated ash is transported to an approved, secure landfill for disposal, thus rendering the waste unrecognizable.

1.4.8 The Contractor will be notified in advance of increases in the projected volumes of regulated medical waste generated. The contractor must have sufficient sized vehicle, or modify the number of pickups to a mutually agreed upon schedule to accommodate the amount of RMW at each pickup. Contractor shall place a stacker at USAMRIID, which will be maintained and operated only by Contractor personnel to provide the ability to transport the additional waste generated. If the contractor is unable to load all the bins, the Contractor shall return to remove the remaining portion of the bins left that day. No location fee will be authorized for the second pickup.

1.4.9 The Contractor shall place a stacker at USAMRIID, which will be maintained and operated only by Contractor personnel to provide the ability to transport the additional waste generated.

1.4.10. If the contractor is unable to load all RMW, the Contractor shall return within 24 hours to remove the remaining portion of the bins left that day. No location fee will be authorized for the second pickup.

1.4.8 The Contractor may be asked, on a Firm-Fixed-Price, Not-To-Exceed (FFP-NTE) basis, to provide Disposable Transport Boxes and/or Autoclave Bags with, at least, the following specifications:

Item Size Estimated Quantity Disposable Transport Boxes 24 x 12 x 12 100 Autoclave Bags 24 x 30 500

1.5 General Information:

1.5.1 Quality Control Plan (QCP): The Contractor shall develop and maintain a QCP to ensure services are performed in accordance with (IAW) this PWS. The Contractor shall develop and implement procedures to identify, prevent, and ensure non-recurrence of defective services. The Contractor's QCP is the means by which it assures that the work provided complies with the requirements of the contract.

The Contractor’s Proposed QCP shall be submitted to the Contracting Officer (CO) through the Contracting Officer’s Representative (COR) for review within ten (10) business days after date of contract award. (Deliverable A.001).

The Government will review and either notify the Contractor in writing of acceptance of the plan or return their comments to the Contractor within ten (10) business days. If the Government has provided comments, the Contractor shall then have five (5) business days to submit a Final QCP. After receipt of the Final QCP, the Contractor may receive the Contracting Officer’s acceptance in writing. Any proposed changes to the accepted QCP are required to be resubmitted for acceptance by the Contracting Officer no later than ten (10) business days prior to the anticipated change and before implementation by the Contractor. The timeline noted above will apply for review and acceptance for proposed changes. At a minimum, the QCP must include and answer the following to be acceptable:

(a) A chart showing the organizational structure and lines of authority, the names, qualifications, duties, responsibilities, and classification of each member of the Contractor's Quality Control Team;

(b) How the Contractor will monitor work to ensure performance complies with all deliverables (etc. timelines, deadlines, and goals);

(c) How the Contractor will monitor work to ensure performance complies with all specifications and requirements of the contract, including the contract’s clauses;

(d) How the Contractor will identify, investigate, and correct any non-conforming performance and prevent similar deficiencies in the future; and

(e) How the Contractor will file and save all Quality Control related documents for the life of the contract plus five 5 years.

1.5.1.1 The Contractor shall inform the COR of issues or potential issues that might affect the performance within seventy-two (72) hours of identifying those issues. Verbal reports shall be followed up by written reports withinten (10) business days.

1.5.2 Quality Assurance: The Government will evaluate the Contractor’s performance under this contract in accordance with the Quality Assurance Surveillance Plan (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 acceptable quality levels (performance thresholds).

1.5.3 Recognized Holidays: The following provides information on recognized holidays for the purpose of the PWS. If submittal of any documentation (e.g. deliverables, submittals, etc.)

deadlines fall on a holiday, the closest work day prior to the holiday will apply as the deadline for submittal.

1.5.3.1 U.S. Holidays: Work shall not be performed on U.S. federally recognized holidays occurring during the normal workweek unless otherwise directed by the Contracting Officer.

When a U.S. holiday occurs on a Saturday or a Sunday, the holiday is observed on the preceding Friday or following Monday, respectively.

New Year’s Day January 1st M. L. King Memorial Day 3rd Monday in Jan Presidents Day 3rd Monday in February Memorial Day last Monday in May Juneteenth June 19th Independence Day July 4th Labor Day 1st Monday in September

Columbus Day 2nd Monday in October Veteran’s Day November 11th Thanksgiving Day 4th Thursday in November Christmas Day December 25th

1.5.4 Operating Hours: The Government facility office hours, facility operating hours, and the Contractor support hour requirements often coincide, however, they may differ. Please refer to the following.

1.5.4.1 Government Facility Office Hours: The Government facility office hours are 0700 to 1600, and Monday through Friday except U.S. Holidays identified in paragraph 1.5.3.1 above or when the Government facility is closed due to local or national emergencies, administrative closings, or similar Government directed facility closings.

1.5.4.2 Government Facility Operating Hours: The Government facility operating hours occur between the hours of 0700 to 1600 Monday through Friday. The Government facility is open for operations during the recognized U.S. Holidays identified in paragraph 1.5.3.1 above.

The Government facility may close due to local or national emergencies, administrative closings, or similar Government directed facility closings and will be communicated by the CO to the Contractor.

1.5.4.3 Contractor Support Hours: The Contractor shall provide support between the hours of 0800 to 1600 Monday through Friday, except during local or national emergencies, administrative closings, or similar Government directed facility closings. The Contractor shall maintain an adequate workforce at all times, for the uninterrupted performance of all tasks defined within this PWS when the Government facility is not closed for the above reasons.

When hiring personnel, the Contractor shall keep in mind that the stability and continuity of the workforce is essential.

1.5.5 Place of Performance: All RMW will be picked up from several locations at Fort Detrick, and the Forest Glen Annex in Silver Spring, Maryland. USAMRIID buildings are located within Fort Detrick and are as follows: BLDG 1301, BLDG 8100, BLDG 1412 and BLDG 1425. WRAIR buildings are located both within Fort Detrick and at the Forest Glen Annex in Silver Spring, Maryland. They are as follows: BLDG 568 (Fort Detrick), BLDG 503 (Silver Spring – Forest Glen Annex), BLDG 508 (Silver Spring, MD). Lastly, BDRD/NMRC- Frederick buildings are located within Fort Detrick and are as follows: BLDG 8400.

1.5.5.1 Generator Information: The following information applies to each pick-up location:

USAMRIID Building Locations: Bldg. 1301, 8100, 1412, and 1425:

Building Generator Name Generator Number Address 1301 USAMRIID SMW000009235 1301 Ditto Ave., Fort Detrick, MD 21702 8100 USAMRIID TBD 8100 Porter St., Fort Detrick, MD 21702 1412 USAMRIID SMW000009235 1412 Porter St., Fort Detrick, MD 21702

1425 USAMRIID SMW000009235 1425 Porter St., Fort Detrick, MD 21702

WRAIR Building Locations: Bldg. 161, 501, 503, 508, 510, 511, 568 and Bldg. 606:

Building Generator Name Generator Number Address 503 WRAIR TBD 503 Robert Grant Avenue, Silver Spring, MD 508 WRAIR TBD 508 Research Drive, Silver Spring, MD 568 WRAIR 013077-0001 568 Doughten Drive, Frederick, MD 501 WRAIR TBD Forrest Glen Annex, Silver Springs, MD 511 WRAIR TBD Forrest Glen Annex, Silver Springs, MD 161 JPC TBD Forrest Glen Annex, Silver Springs, MD 606 JPC TBD Forrest Glen Annex, Silver Springs, MD 510 JPC TBD Forrest Glen Annex, Silver Springs, MD

NMRC - FREDERICK Building Location: Bldg. 8400:

Building Generator Name Generator Number

Address

8400 NMRC –

Frederick

SMW000009665 8400 Research Plaza, Frederick, MD

1.6 Security Requirements: The following information is provided on security related matters.

1.6.1 Security Program: RESERVED

1.6.2 Personnel Security Clearance Requirements: RESERVED

1.6.3 Security

USAMRIID considers the safety of its employees, neighbors, and the surrounding community its number one priority. USAMRIID’s Biosecurity Program is governed by a broad set of Federal, DoD and US Army regulations and policies, which enables USAMRIID to safeguard both the biological materials used in the laboratories as well as the personnel who work here.

USAMRIID is frequently inspected by those regulating agencies, and successful completion of those inspections is required for USAMRIID 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.

WRAIR accredited College of American Pathologist clinical diagnostic housed within BLDG 508 Forest Glenn Annex, Silver Spring, MD must follow all Federal, DoD and US Army regulations and policies, which enables the clinical diagnostic laboratory to safeguard biological specimens tested within the laboratory as well as the personnel.

The Contractor shall not employ, or continue employment, of persons for work on this contract, if such employee is identified to the Contractor by the Contracting Officer as a potential threat to the health, safety, security, general well-being, or operational mission of the installation or its population. All Contractor employees shall be screened before hiring for active participation in any group that opposes the use of animals in research; such candidates shall not be selected for work on this PWS (all contract employees shall support the humane use of laboratory animals in research). In addition, if it becomes known that an employee is an active member of any group that opposes animal research or in any other way demonstrates a desire to compromise the security or the mission of the Institute, the Contractor employee shall be removed from this requirement immediately.

1.6.3.1. Security Requirements.

The Contractor shall protect all Controlled Unclassified Information (CUI) and unclassified information involved in the performance under this contract.

1.6.3.2. Installation Access Requirements.

1.6.3.2.1. All visitors to Ft. Detrick, MD must enter through the Nallin Gate which is open 24 hours per day, seven (7) days per week. Contractors are to provide proof of identification to the Fort Detrick security staff at the Visitor Center located at the Nallin Gate. A Criminal History Check will be conducted on all Contractor and subcontractor employees requiring base access. Acceptable forms of Government issued identification include a passport or Driver’s License that complies with the REAL ID ACT. Non-U.S. citizens visiting Fort Detrick will require a Federal employee escort onto the Base. Non-U.S. Citizens visiting or working at USAMRIID will require DHA R&D - MRDC approval. Vehicles entering the Base will be searched before being allowed to enter the Base. In addition to the vehicle, the trunk, boxes, bags, or other items located in the vehicle is subject to search. Federal law prohibits the following items on Federal property: firearms, explosives, archery equipment, dangerous weapons, knives and blades over 2 ½ inches, alcoholic beverages and open containers of alcohol. No photographs may be taken while on Fort Derick. Cell phones may be used while driving only if hands free.

1.6.3.2.2 The Contractor and all associated subcontractors’ employees shall comply with applicable installation, facility, and area commander installation and facility access and local security policies and procedures provided by the Government representative. The Contractor shall return all issued U.S. Government Common Access Cards, installation badges, access badges to the COR when the Contract is completed or when a Contractor employee no longer requires access to the installation and facility as defined in the contract.

1.6.3.2.3 Force Protection Condition (FPCON) impact on work levels. The Contractor employees must comply with all personal identity verification requirements as directed by DoD, and local policy. In addition to the changes otherwise authorized by the changes clauses of this contract, should the FPCON change, the Government may require changes in Contractor security matters or process. IAW DoDI 2000.16, the FPCON is defined as follows:

FPCON ALPHA. This condition applies when there is a general threat of possible terrorist activity against personnel and facilities, the nature and extent of which are unpredictable, and circumstances do not justify full implementation of FPCON BRAVO measures. However, it may be necessary to implement certain measures from higher THREATCONS resulting from intelligence received or as a deterrent. The measures in this THREATCON must be capable of being maintained indefinitely.

FPCON BRAVO. This condition applies when an increased and more predictable threat of terrorist activity exists. The measures in this THREATCON must be capable of being maintained for weeks without causing undue hardship, affecting operational capability, and aggravating relations with local authorities.

FPCON CHARLIE. This condition applies when an incident occurs or intelligence received indicating some form of terrorist action against personnel and facilities is imminent.

Implementation of measures in this THREATCON for more than a short period probably will create hardship and affect the peacetime activities of the unit and its personnel.

FPCON DELTA. This condition applies in the immediate area where a terrorist attack has occurred or when intelligence has been received that terrorist action against a specific location or person is likely. Normally, this THREATCON is declared as a localized condition.

1.6.3.3 Security Clearance Requirements. RESERVED

1.6.3.4. Requirements for BPRP Enrollment. RESERVED

1.6.4. Installation Access. Access to U.S. installations, buildings and controlled areas is limited to personnel who meet security criteria and are authorized. Failure to submit required information/data and obtain required documentation or clearances will be grounds for denying access to U.S. installations, buildings, and controlled areas. The Contractor shall ensure that any subcontractors used in performance of this contract complies with these requirements and that all employees, of both the Contractor and any subcontractor utilized by the Contractor, are made aware of and comply with these requirements.

The Contractor shall be aware of and comply with the requirements associated with Installation Access Control. The Government is not liable for any costs associated with performance delays due solely to a firm’s failure to comply with Installation Access Control System (IACS) processing requirements.

The Contractor shall return installation passes to the issuing IACS office when the contract is completed or when a Contractor employee no longer requires access.

1.6.5 Background Checks: RESERVED

1.6.6 Physical Security: The Contractor shall safeguard all Government equipment, information, and property provided for Contractor use.

1.6.7 Operations Security (OPSEC) Requirements: Contractor personnel shall adhere to facility security policies and restrictions. The Contractor shall immediately report suspicious activities to security personnel.

1.7 Key Control: RESERVED

1.8 Post Award Conference/Periodic Progress Meetings: The Contractor shall attend any post award conference convened by the contracting activity or contract administration office in accordance with FAR Subpart 42.5. The Contracting Officer, 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 shall 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.

1.8.1 The Contractor shall attend, participate in, and furnish input to scheduled and unscheduled meetings, conferences, and briefings that relate to the functions and services herein as required by the Government to provide effective communication and impart necessary information. The Contract Manager or designated representative shall attend meetings as requested by the Government. Meeting attendees shall at times include Contractor managerial, supervisory, and other personnel knowledgeable of the subject matter.

Meetings may start or end outside of regular duty hours.

1.9 Contracting Officer’s Representative (COR): Refer to Part 2 of this PWS for the definition of a COR. As determined by the Contracting Officer, a COR will be appointed and identified by letter of designation, a copy of which will be provided to the Contractor by the Contracting Officer. The designation letter 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. The COR monitors all technical aspects of the contract and assists in contract administration. The COR is not authorized to obligate the Government. If the work is not written in the contract, the COR is not authorized to request new work. 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 property, and coordinate site entry of Contractor personnel.

1.10 Key Personnel: RESERVED

1.11. Identification of Contractor Employees: All Contractor personnel attending meetings, answering Government telephones, and working in other situations where their Contractor status is not obvious to third parties must identify themselves, to include proper marking of signature blocks in correspondence, to avoid creating an impression in the minds of members of the public that they are Government officials. The Contractor shall ensure that all documents or reports, produced by Contractors are suitably marked as Contractor products or that Contractor participation is appropriately disclosed.

1.12 Contractor Travel: RESERVED

1.13 Other Direct Costs (ODCs): This category encapsulates the associated costs for the transportation of RMW and supplies used to store and prepare waste for transportation, on an as-needed basis.

1.14 Data Rights: RESERVED

1.15 Non-Disclosure Requirements: Performance under this contract may require the Contractor to access data and information proprietary to a Government agency, another Government Contractor, or of such nature that its dissemination or use other than as specified in this work statement would be adverse to the interests of the Government or others. The Contractor and Contractor personnel, shall not divulge or release data or information developed, or obtained under performance of this PWS, except to authorized Government personnel or upon written approval of the Contracting Officer. The Contractor shall not use, disclose, or reproduce proprietary data, which bears a restrictive legend, other than as specified in this PWS. All documentation showing individual names or other personal information shall be controlled and protected under the provisions of the Privacy Act of 1974, Public Law 93-579, 5 United States Code (U.S.C.) Section 552a.

1.16 Protection of Government and Contract Information: Per Public Use Notice of Limitations stated by Defense imagery Management operations Center and contained at www.dimoc.mil/resources/limitations/ , the Contractor shall not cite any information (e.g., contract information, pictures, locations, etc.) obtained through this contract on any hard copy or digital marketing tools to include its company website.

1.17 Non-Disclosure Statements: The Contractor shall provide signed non-disclosure agreements to the Government no later than five (5) business days (Deliverable A.002) prior to commencement of work under the contract. Disclosure of information by Contractor personnel may result in removal of Contractor personnel from performance under this contract.

1.18 Organizational Conflict of Interest (OCI): RESERVED

1.19 Phase In /Phase Out Period: RESERVED

1.20 Required Training: The following provides information on training requirements.

http://www.dimoc.mil/resources/limitations/

1.20.1. Anti-Terrorism (AT) Level I Training: All Contractor employees, including subcontractor employees, who are employed under the contract, shall complete AT Level I Training within 30 days after contract start date or effective date of incorporation of this requirement into the contract, whichever applies, or 30 days after employment of new personnel. Contractor personnel travelling overseas shall complete area of responsibility (AOR) specific AT awareness training for U.S. based Contractor employees and associated subcontractor employees. The Contractor shall submit certificates of completion (Deliverable A.003) for each affected Contractor employee and subcontractor employee to the COR (or to the CO if a COR is not assigned) within 30 days completion of this training by all employees and subcontractor personnel. AT Level I awareness training is available at https://jkodirect.jten.mil. Contractor personnel shall complete refresher training every twelve

(12) months except AOR specific AT Level I training which shall be completed as required by local AT policies.

If training cannot be conducted on the website, the Contractor shall coordinate with the COR who will contact the local AT Officer at their assigned location for classroom training.

Contractor personnel completing training in the classroom will receive a certificate or the training attendance roster signed by the AT Officer. Verification of the training shall be provided to the COR within 15 days after completion of the training.

1.20.2. OPSEC Training: All Contractor employees, including subcontractors, shall complete Level I OPSEC training within 30 days of employment under this contract (Deliverable A.004).

Verification of the training shall be provided to the COR within 30 days after completion of the training. OPSEC Level I training is available at http://www.cdse.edu/catalog/elearning/GS130.html. Contractor personnel must complete refresher training every 12 months .Verification of the training shall be provided to the COR within 30 days after completion of the training.

If training cannot be conducted on the website, the Contractor shall coordinate with the COR, who will contact the local OPSEC Officer at their assigned location for classroom training.

Contractor personnel completing training in the classroom will receive a certificate or the training attendance roster signed by the OPSEC Officer. Verification of the training shall be provided to the COR within 30 days after completion of the training.

1.20.3. iWATCH Training: The Contractor and all associated subcontractors shall brief all employees on the local iWATCH program (training standards provided by the requiring activity ATO). This locally developed training will be used to inform employees of the types of behavior to watch for and instruct employees to report suspicious activity to the COR. This training shall be completed within 30 days after the contract is awarded and within 30 days after new employees commence contract performance, with the results reported to the COR within 30 days after the contract is awarded and within 30 days after new employees commence contract performance. Verification of the training shall be provided to the COR within 30 days after completion of the training (Deliverable A.005). Training slides can be found on the Army OneSource we site:

http://www.myarmyonesource.com/familyprogramsandservices/iwatchprogram/default.aspx https://jkodirect.jten.mil/ http://www.cdse.edu/catalog/elearning/GS130.html http://www.myarmyonesource.com/familyprogramsandservices/iwatchprogram/default.aspx

1.20.4 Information Assurance (IA) Training RESERVED

1.20.5 Personally Identifiable Information (PII): RESERVED

1.21 Government Property and Services: RESERVED

PART 2

DEFINITIONS & ACRONYMS

2. Definitions and Acronyms

2.1 Definitions: Although not inclusive of every term used within this PWS, the following provides a list of definitions used throughout this PWS and commonly used in the acquisition field.

Contracting Officer (CO) – means a person with the authority to enter into, administer, and/or terminate contracts and make related determinations and findings on behalf of the Government. Note: The only individual who can legally bind the Government.

Contracting Officer's Representative (COR) – As defined in DFARS 202.101, means an individual designated and authorized in writing by the Contracting Officer to perform specific technical or administrative functions. DoD Instruction (DoDI) 5000.72, Part II Definitions states the following when defining a COR: “Defined in subpart 202.101 of Reference (f). Any individual delegated responsibilities pursuant to subpart 1.602-2 of Reference (e), regardless of local terminology, must be certified in accordance with this instruction. For example, local terminology can be COR, Contracting Officer’s technical representative, technical point of contact, technical representative, alternate COR, administrative COR, assistant COR, line item manager, task order manager, quality assurance personnel, quality assurance evaluator, or COR management.” In addition, Army Regulation 70-13, Chapter 2, paragraph 2-2g, states, in part, the following when providing other surveillance support personnel to assist the COR when needed, “…These other surveillance support personnel may serve as on-site representatives of the COR in performance of actual contract surveillance if they meet all COR requirements and have been appointed by the Contracting Officer as alternate CORs.”

Contractor – means 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.

Contractor-acquired Property - means property acquired, fabricated, or otherwise provided by the Contractor for performing a contract and to which the Government has title.

Day – means, unless otherwise specified, a calendar day.

Defective Service – means a service output that does not meet the standard of performance associated with the Performance Work Statement.

Deliverable – means anything that can be physically delivered, but may include non-manufactured things such as meeting minutes or reports.

Government-furnished Property – As reflected in FAR 52.245-1, Government-furnished Property “means property in the possession of, or directly acquired by, the Government and subsequently furnished to the Contractor for performance of a contract. Government-furnished property includes, but is not limited to, spares and property furnished for repair, maintenance, overhaul, or modification. Government-furnished property also includes contractor-acquired property if the contractor-acquired property is a deliverable under a cost contract when accepted by the Government for continued use under the contract

Government Property - means all property owned or leased by the Government.Government property includes both Government-furnishedand Contractor-acquired property. Government property includes material, equipment, special tooling, special test equipment, and real property. Government property does not include intellectual property and software.

High Level Objective (HLO) – means a key overarching result-based objective for a project necessary to achieve the project’s vision. HLOs are similar to Level 2 in a Work Breakdown Structure. Each HLO may contain several statements to flesh out the areas necessary to meet the objective.

Physical Security – means that part of security concerned with physical measures designed to safeguard personnel; to prevent unauthorized access to equipment, installations, material, and documents; and to safeguard against espionage, sabotage, damage, and theft.

Quality Assurance – (or Government contract quality assurance) means the various functions, including, inspection, performed by the Government to determine whether a Contractor has fulfilled the contract obligations pertaining to quality and quantity.

Quality Assurance Surveillance Plan (QASP) – means the key Government-developed surveillance process document, and is applied to Performance-Based Service Contracting (PBSC). The QASP is used for managing Contractor performance assessment by ensuring that systematic quality assurance methods validate that Contractor quality control efforts are timely, effective, and are delivering the results specified in the contract or task order. The QASP directly corresponds to the performance objectives and standards (i.e., quality, quantity, timeliness) specified in the Performance Work Statement (PWS). It provides specific details on how the Government will survey, observe, test, sample, evaluate, and document Contractor performance results to determine if the Contractor has met the required standards for each objective in the PWS. The QASP, with very few if any exceptions, is an internal to Government document.

Quality Control – means all necessary measures taken by the Contractor to assure that the quality of an end product or service shall meet contract requirements.

Statement – means the specific results-based activities required to satisfy HLOs. A statement contains a result, the context of the statement, and the required action(s). Statements focus on “what” is to be accomplished; however they are not prescriptive in describing “how” the outcome is to be achieved. Each HLO may have several statements to flesh out the areas necessary to meet the objective. Statements are similar to Level 3 in a Work Breakdown Structure.

Subcontractor – means one that enters into a contract with a prime Contractor. The Government does not have privity of contract with the subcontractor.

Work Day - The number of hours per day the Contractor provides services in accordance with the contract.

Work Week - Monday through Friday, unless otherwise specified.

2.2 Acronyms: Although not inclusive of every term used within this PWS, or that may be included in an acquisition, the following provides a list of acronyms commonly used in the acquisition field.

AE Army in Europe AR Army Regulation AT Anti-terrorism CAC Common Access Card CAP College of American Pathology CO Contracting Officer COR Contracting Officer’s Representative DHA R&D-MRDC Defense Health Agency Research & Development Medical Research and Development Command DoD Department of Defense EPA Environmantal Protection Agency FAR Federal Acquisition Regulation HLO High Level Objective ID Identification MDE Maryland Department of the Environment NMRC Naval Medical Research Command OCI Organizational Conflict of Interest ODC Other Direct Costs OPSEC Operations Security PII Personally Identifiable Information POC Point of Contact PRS Performance Requirements Summary PWS Performance Work Statement QA Quality Assurance

QASP Quality Assurance Surveillance Plan QC Quality Control QCP Quality Control Program RA Requiring Activity TE Technical Exhibit USAMRIID United States Army Research Institute of Infectious Diseases WRAIR Walter Reed Army Institute of Research

PART 3

GOVERNMENT PROPERTY (GP) AND SERVICES

3. Government Property and Services

3.1 Services: RESERVED

3.2 Facilities: The Contractor shall use reasonable care to avoid damaging existing buildings, equipment, and vegetation on the Government installation. If the Contractor’s failure to use reasonable care causes damage to any of this property, the Contractor shall replace or repair the damage at no expense to the Government as the CO directs. If the Contractor fails or refuses to make such repair or replacement, the Contractor shall be liable for the cost, which may be deducted from the contract price.

3.3 Utilities: RESERVED

3.4 Equipment: RESERVED

3.5 Special Tooling and Test Equipment: RESERVED

3.6 Materials: RESERVED

3.7 Training: The Government will provide the following training: AT Level 1 Awareness, OPSEC, iWATCH.

3.8 Common Access Cards (CAC): RESERVED

PART 4

CONTRACTOR FURNISHED ITEMS AND SERVICES

4. Contractor Furnished Property and Services

4.1 General: The Contractor shall furnish all personnel, equipment, supplies, facilities, transportation, tools, materials, supervision, and other items necessary to perform services as described in the PWS and associated contract documents, except for those items specified in Part 3 Government Property and Services.

4.2 Secret Facility Clearance: RESERVED

4.3 Materials: RESERVED

4.4 Vehicles and Equipment: The Contractor shall provide all necessary vehicles (no GSA vehicles provided to Contractor for use on this contract) and equipment to perform the work described in this PWS. All Contractor provided vehicles and equipment shall have the company name prominently displayed on both sides of the vehicle or equipment and present a neat, professional appearance. Contractor's vehicles and equipment used in the performance of this contract shall meet all local traffic, safety, HAZMAT, and environmental requirements for the transportation of RMW. The Contractor shall not use any Government-owned tools, materials, or parts to maintain Contractor vehicles and equipment without prior written approval of the Contracting Officer.

4.5 Background Checks): RESERVED

PART 5

SPECIFIC TASKS

5.1 Basic Services: The Contractor shall provide services for the pickup, disposal and incineration of RMW for USAMRIID, WRAIR, and NMRC-Frederick.

5.2 Tasks: Tasks consist of the following:

5.2.1 Customer Information Sheet “Manifest”

5.2.1.1 The Contractor shall provide a signed copy of the manifest to the Contracting Officer’s Representative (COR) or the Technical Point of Contact (TPOC) at each location at the time of pick-up of RMW and via email within five (5) business days. (Deliverable A.006)

(a) STD: Trip manifests shall be completed in its entirety ensuring a copy is furnished to the COR/TPOC before departing the location.

AQL: 100% Compliance

5.2.2 Destruction and Disposal Certificate

5.2.2.1 The Contractor shall provide a destruction report along with the invoice for each pick up at each location as identified in paragraph 1.5.5. The destruction report shall contain Handler Name and Destination Facility Name, Reporting Period, Generator Identification (ID) Number, Government Entity Name, Building Number, Destruction and Disposal Methods, and a Certification Statement with Signature. (Deliverable A.007)

(a) STD: The Contractor shall provide a copy of the Disposal Certificate and invoice for payment to the TPOC and COR by the 10th day of the subsequent month

AQL: 100% Compliance

5.2.3 Spill Response Plan

5.2.3.1 The Contractor shall submit a copy of its Spill Response Plan to the Contracting Officer (CO), COR, and Program Manager (PM) within Fifteen (15) business days after contract award and will provide a Spill Response Plan Report upon all spills and leaks, regardless of their quantity, to the COR no later than Twenty-Four (24) hours after the incident.

(Deliverable A.008)

(a) STD: Spill Response Plan shall be submitted via email to the CO and COR within fifteen (15) days after award of the contract.

AQL: 100% Compliance

(b) STD: Spill Response Plan Report shall be submitted via email to the CO and COR within twenty-four (24) hours after the occurnace of any incident involving a leaks or spill immaterial to the size.

5.2.4 Disposal Weight Ticket Report

5.2.4.1 The Contractor shall provide a copy of the weight ticket for each pickup to the COR/TPOC prior to departing the location. Subsequently, a copy of the weight ticket upon disposal and incineration certification will also be furnished. (Deliverable A.010)

(a) STD: The Contractor shall submit a copy of the weight ticket via email to the TPOC and

COR on the date of RMW pick up.

AQL: 100% Compliance

(b) STD: The Contractor shall submit a copy of the burn certification and weight upon incineration of RMW on-site to the TPOC and COR within seventy-two (72) hours after disposal.

AQL: 100% Compliance

5.2.5 Vehicle Placarding

5.2.5.1 The Contractor shall provide visible confirmation that all required safety placards for the transportation of HAZMAT in accordance with all applicable EPA and MDE are securely affixed to the vehicle being utilized for transportation of the same. (Deliverable A.011)

(a) STD: The Contractor shall ensure all required placards are procured and visily affixed to the exterior of the vehicle used for the transportation of RMW.

5.3 Service Contract Reporting: RESERVED

PART 6

APPLICABLE PUBLICATIONS

6. Applicable Publications (Current Editions): The following publications, manuals, regulations, etc. are mentioned in this PWS and are listed below.

6.1 State of Maryland Department of the Environment (MDE)

6.2 Code of Maryland Regulations (COMAR)

6.3 Special Medical Waste (SMW)

6.4 U.S. Army Medical Command (MEDCOM) Reg. 40-35

6.5 Department of Defense Security Agreement (DD Form 441)

6.6 National Industrial Security Program Operating Manual (DoD 5220.22-M)

6.7 Installation Access Control (AE Reg 190-16)

6.8 The Army Physical Security Program (AR 190-13)

6.9 Contractor Identification (AE Reg 27-715)

6.10 U.S. Army Corps of Engineers Safety and Health Requirements Manual (EM 385-1-1)

6.11 Information Assurance Workforce Improvement Program (DoD 8570-M)

6.12 Information Assurance Training Certification and Workforce Management Directive (DoDD 8570.01)

6.13 Information Assurance (AR 25-2)

6.14 Electromagnetic Compatibility Directive (2004/108/EC)

6.15 Policies and Procedures for Property Accountability (AR 735-5)

PART 7

ATTACHMENT AND TECHNICAL EXHIBIT LISTING

7. Attachment and Technical Exhibit List

7.1 Technical Exhibit A – Performance Requirements Summary (PRS)

7.2 Technical Exhibit B – Deliverables Schedule

TECHNICAL EXHIBIT A

Performance Requirements Summary (PRS)

PERFORMANCE

OBJECTIVE

STANDARD PERFORMANCE

THRESHOLD

ACCEPTABLE

QUALITY

LEVELS (AQLs)

METHOD OF

SURVEILLANCE

PRS#1 PWS Para

5.2.1 Customer

Information Sheet “Manifest”

Provide a signed copy of the manifest to the COR or the TPOC at the time of pick-up of Regulated Medical Waste.

100% completed monthly

100% inspection by the COR and TPOC

PRS#2 - PWS Para

5.2.2 Destruction

and Disposal Certificate

Provide a destruction report along with the invoice for each pick up at each location as noted above. The destruction report shall contain Handler Name and Destination Facility Name, Reporting Period, Generator Identification (ID) Number, Government Entity Name, Building Number, Destruction and Disposal Methods, and a Certification Statement with Signature.

100% completed monthly

PRS#3 - PWS Para

5.2.4 Disposal

Weight Ticket Reporting

Provide a copy of the weight ticket for each pick up to the COR/TPOC prior to departing the location.

Subsequently a copy of the weight ticket upon disposal and incineration will be furnished also.

100% completed monthly

TECHNICAL EXHIBIT B

DELIVERABLES SCHEDULE

1. Delivery Address

All deliverables shall be submitted to the COR and others specified by the COR.

2. Method of Delivery

Electronic copies shall be delivered using Microsoft Office suite of tools (i.e., MS WORD, MS EXCEL, MS POWERPOINT, MS PROJECT, or MS ACCESS format) or in Adobe PDF format, unless otherwise specified by the COR. Electronic submission shall be made via email, unless otherwise agreed to by the COR.

3. Shipping

The Contractor shall use appropriate shipping methods for all materials, equipment, and hard copy documents. In the United States, the Contractor shall use the US Postal Service standard delivery for delivery of all such shipments. The COR must approve the selected shipping method and any exceptions to these requirements.

4. Government Acceptance Period

4.1. The COR will have ten (10) business days to review draft deliverables and make comments. The Contractor shall have five (5) business days to make corrections. Upon receipt of the final deliverables, the COR will have two (2) business days for final review prior to acceptance or providing documented reasons for non-acceptance.

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