A08-Solicitation 20R0069.docx

W81XWH20R0069

Section SF 1449 - CONTINUATION SHEET

PWS

PERFORMANCE WORK STATEMENT (PWS)

Regulated Medical Waste (RMW) Disposal Supplies and Services

U.S. Army Aeromedical Research Laboratory (USAARL)

SECTION 1 PURPOSE

· Introduction

USAARL is a subordinate Command of the United States Army Medical Research and Materiel Command (USAMRMC). USAARL is one of USAMRMC’s six research laboratories in the continental United States, responsible for planning and executing basic and applied medical research. USAARL is located at Fort Rucker, Alabama, the home of Army Aviation and the U.S. Army Aviation Center of Excellence (USAACE).

· Mission

The Commander, USAARL, directs the management of a number of medical research, development, and acquisition programs related to aeromedical and ground ambulance evacuation and the prevention of injury. USAARL’s military applied research primarily supports USAMRMC’s Military Operational Medicine Research Program (MOMRP) and the Joint Program Committee 5 (JPC-5) research objectives. The mission of the USAARL is to preserve and enhance the health, safety, combat effectiveness, and survivability of the U.S. Army aviator and Soldier. USAARL is the U.S. Army’s lead lab for research in combat injury prevention, head injury prevention, visual performance and protection, acoustic performance and protection, and operator performance under stress.

USAARL's research includes developing injury prevention and health performance standards, determining the effectiveness of life support equipment and personnel protective equipment, and preventing and mitigating ground and aircrew biomechanical injuries. The USAARL’s facilities and scientific experience and expertise specialize in human protection through development, test, and evaluation of helmets, restraints, and medical equipment.

USAARL has maintained a reputation as an honest broker of Soldier safety, and by combining basic science, technology, medicine, and engineering, USAARL continues to enhance the safety and performance of mounted and dismounted Service Members.

· Background

The U.S. Army Medical Research Acquisition Activity (USAMRAA) on behalf of its customer activity, the U.S. Army Aeromedical Research Laboratory (USAARL) located at Fort Rucker, Alabama has a recurring requirement for biohazard disposal services. The Injury Biomechanics and Protection Group’s (IBPG) mission is to develop biomedical assessment tools and performance standards for the prevention and mitigation of Soldier injuries. The primary threat-based competency is Blunt, Blast, and Accelerative Injury and Protection with a focus to the head and spine and overall whole body response. In order to measure human tolerance to measure human injury response to develop biofidelity curves and injury criteria, post mortem human subjects (PMHS) whole body and components are required. These services are required to dispose of regulated medical waste (RMW) as related to post mortem human subject (PMHS) injury biomechanics research activities.

· Scope

· The Contractor shall provide the RMW materials and services necessary to dispose of biohazard materials related to PMHS injury biomechanics research. The contractor shall furnish boxes appropriate to transport RMW (including sharps) and pathological waste and provide collection and disposal services of RMW material and pathological waste IAW all federal, state, and local laws. The contractor shall be solely responsible for proper management of waste and responsible for any and all spills, leaks, and clean up during pick-up, while in transit or at the treatment/disposal facility. The contractor shall clean up spills or leaks due to the contractor’s own activities in the performance of these services IAW applicable federal, state, and local laws and regulations. The clean-up, transportation, and disposal of the associated wastes shall be at no additional cost to the Government.

· The Government intends on issuing a Single-Award IDIQ for certification and calibration, and repair as necessary, of DTS DAS and instrumentation. All delivery orders will be issued by U.S. Army Medical Research Acquisition Activity (USAMRAA) Contracting Officers or authorized Ordering Officers from USAARL. Delivery shall be made in accordance with paragraph 3.1.2 and 3.1.3 of this document; unless, otherwise specified in a delivery order.

· Organizational Conflict of Interest (OCI) (Deliverable 1, Exhibit 1).

This contract will be used to procure U.S. Army Medical Research and Material Command (USAMRMC) OCI Category for Services that falls within the scope of the PWS. The contractor shall provide an OCI certification with their proposal. If there is an OCI, the contractor shall provide a draft OCI Mitigation Plan with their proposal.

· Non-Disclosure Statement (NDS) (Deliverable 2, Exhibit 2).

The contractor shall ensure that all contractor personnel are advised of nondisclosure policies as well as restrictions from communicating official business to media outlets. The contractor personnel may be required to sign specific non-disclosure statements as required by the contract. The contractor shall provide signed non-disclosure statements from each personnel assigned, prior to performing any services.

SECTION 2 GENERAL REQUIREMENT

· Performance

· Place of Performance

· Primary on-site Government location. Pickup will occur at Building 8825 Andrews Avenue, Fort Rucker, AL 36362.

· Contractor owned and/or leased off-post facilities. All methods of disposal should occur at one of the Contractor’s facilities IAW applicable laws and regulations.

· Period of Performance. This contract is for one (1) twelve (12) month Base Period and five (5) twelve (12) month option periods. The periods of performance for this contract are as follows:

· 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.

1. Contract Management

· Government Management. The Contracting Officer’s Representative (COR) and Alternate Contracting Officer’s Representative (ACOR) 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. In the event that the COR is not available, the ACOR will assume the COR’s responsibilities.

· 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. The PM shall demonstrate capability in the overall management of complex tasks, and strong team building skills.

· The contractor shall establish clear organizational lines of authority and responsibility to ensure effective management of the resources assigned to the requirement. The contractor shall ensure that all contractor personnel are advised of their chain of command and who they should contact if they have questions.

· The contractor shall develop and provide a Contract Management Plan (CMP) (Deliverable 3) with their proposal. The CMP shall include a key points of contact for program management and customer service.

· The contractor shall provide a Quality Control Plan (QCP) (Deliverable 4) that is based on industry best practices for the services being provided under this contract. The contractor shall 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.

· Subcontract Management. The subcontractor shallbe:

· Responsible for any subcontract management necessary to integrate services performed on this contract.

· Responsible and accountable for subcontractor performance on this contract.

· Responsible to manage task distribution to ensure there are no OCI considerations.

· Contractors may add subcontractors to their team after notification and approval from the PCO and COR. Cross teaming shall be permitted.

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. Monthly Financial Tracking Report (Deliverable 5). The contractor shall provide a spreadsheet with detail of real time expenditure levels of every contract line item number (CLIN) and delivery order. The initial report is due 45 days after contract award and monthly thereafter.

2.4.3. Contract Manpower Reporting (Deliverable 6). This is a mandatory requirement IAW Army Federal Acquisition Regulation Supplement (AFARS) 5137.91, Accounting for ContractServices.

The contractor shall report ALL contractor labor hours (including subcontractor labor hours) required for performance of services provided under this contract for the Army via a secure data collection site. The contractor is required to completely fill in all required data fields using the following web address: http://www.ecmra.mil.

Reporting inputs will be for the labor executed during the period of performance during each Government fiscal year (FY), which runs October 1 through September 30. While inputs may be reported any time during the FY, all data shall be reported no later than October 31 of each calendar year, beginning with 2013. Contractors may direct questions to the help desk at: http://www.ecmra.mil/.

2.5. Training Requirements

2.5.1. Completion of Training Requirements (Deliverable 7). The contractor shall track and complete refresher training to maintain training compliance and readiness status. The contractor shall submit certificates of completion for each 2.5.2.

affected contractor and subcontractor personnel to the COR within 5 calendar days after completion of training by all personnel and subcontractor personnel. Contractor shall track and complete refresher training to maintain training compliance and readiness status as required.

2.5.2.1. Anti-Terrorism (AT) Level 1. All contractor employees, including subcontractor employees, requiring access to Army installations, facilities, or controlled access areas shall complete AT Level I awareness training within 30 calendar days after contract start date or effective date of incorporation of this requirement into the contract, whichever applies. The contractor shall submit certificates of completion for each affected contractor employee and subcontractor employee to the COR (or to the contracting officer, if a COR is not assigned) with 5 calendar days after completion of training by all employees and subcontractor personnel. AT Level I awareness training is available at https://jkodirect.jten.mil/html/COI.xhtml?course_prefix=JS&course_number=-US007

2.5.2.2. iWATCH Training. The contractor and all associated subcontractors shall brief all employees on Fort Detrick iWATCH program, available on-line at http://www.detrick.army.mil/ready/iwatch.cfm. This locally developed on-line training will be used to inform contractor personnel of the types of behavior to watch for and instruct them how to report suspicious activity to the COR. This training shall be completed within 30 calendar days of contract award and within 30 calendar days of new contractor personnel commencing performance, with the results reported to the COR no later than 30 days after contractaward.

2.5.2.3. Operations Security Training (OPSEC). Per Army Regulation (AR) 530-1, Operations Security, new contractor personnel shall complete Level I OPSEC Awareness Training within 30 days of reporting for duty. This non-residential training is required every 365 days, available on-line at https://www.lms.army.mil. It takes approximately 30 minutes to complete.

2.5.2.4. Threat Awareness and Response Program (TARP). Training applies to those contract personnel who have a security clearance. Applicable contractor shall complete this required non-residential training every 365 days, available on- line at https://jkodirect.jten.mil. It takes approximately two hours to complete.

2.5.2.5. Initial Security Orientation or Annual Security Refresher Training. Per requirements in Office of the Surgeon General (OTSG)/ Medical Command (MEDCOM) Policy Memo 14-004, Standardized Security Training dated 15 January 2014. All contractors shall complete the Initial Security Orientation within 30 days then must complete the Annual Security Refresher due every 365 days. Available on-line at https://www.lms.army.mil.

2.5.2.6. Combat Trafficking in Persons General Awareness Course (CTIP). Training applies to those contractor personnel who perform contract requirements Outside Continental United States (OCONUS). Applicable contractor shall complete this required non-residential training every 365 days, available on-line at https://jkodirect.jten.mil/html/COI.xhtml?course_prefix=J3T&course_number=A-US1328 . It takes approximately 30 minutes to complete.

2.5.2.7. Emergency Preparedness Response Program. Contractor shall complete this required non-residential training every three years, available on-line at Joint Knowledge Online (JKO) Home Page accessed via https://jkodirect.jten.mil/html/COI.xhtml?course_prefix=J3O&course_number=P-US261-HB. It takes approximately one hour tocomplete.

2.5.2.8. Health Insurance Portability and Accountability Act (HIPAA) and Privacy Act Security Training. Contractor shall complete this required non-residential course annually, available on-line at https://jkodirect.jten.mil/html/COI.xhtml?course_prefix=DHA&course_number=-US001. It takes approximately two-hours to complete.

2.5.2.9. Cyber Awareness Challenge Training (Information Awareness). Contractor shall complete this required non-residential course annually, available on-line at https://cs.signal.army.mil/. It takes approximately one-hour to complete.

2.5.2.10. Sexual Harassment/Assault Reponses and Prevention (SHARP) Contractor Training. This training is IAW USAMRAA Policy 17-01, Sexual Harassment/Assault Reponses and Prevention (SHARP) Contractor Guidance.

2.5.2.11.

2.5.2.12. The contractor shall comply with OTSG/MEDCOM Policy Memo 16-033, Policy for Reporting Incidents of Sexual Assault and Sexual Harassment under the Sexual Assault Prevention and Responses Program (SHARP). The SHARP reporting requirements apply only to knowledge obtained by contractor personnel while performing services under this contract.

2.5.2.13. The contractor shall require all contractor personnel with knowledge to an incident of sexual assault or sexual harassment occurring on a Government facility, to include a Government leased facility, where the contractor is providing services under this contract, to report the incident to the contractor who shall immediately (within 24 hours) report the incident in writing to the Government’s COR or Contracting Officer. All incidents shall be reported whether they involve contractor personnel or Government personnel, or other individuals.

2.5.2.14. Government Unique Training. The contractor shall ensure all services providers receive SHARP Training no later than 60 calendar days after contractor personnel begin performance under this contract and annually thereafter. Training can be self-study using the provided slides, obtained online for contractor personnel with an Enterprise Access Management Service-Army (EAMS-Army) account or in person. In-person training through USAMRAA can be scheduled by contacting (301) 619-8937 for class date/time and availability. If the employee has an AKO account, they can access training online at EAMS-Army: https://www.army.mil/core/. (Deliverable 7)

2.6. Government Work Days and Hours

2.6.1. In the event of on-equipment contractor work at Government facilities:

2.6.1.1. Contractor personnel shall perform services during regular duty hours. Duty hours range from 0600 to 1800 hours, Monday through Friday. The 8 hour regular duty day will be determined by the COR.

2.6.1.2. The contractor shall not perform services on days designated as a Federal Holiday by Federal Law, Executive Order, Presidential Proclamation or InstallationCommander.

2.6.1.3. 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:

2.6.1.3.1. New Year’s Day, 1 January

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

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

2.6.1.3.4. Memorial Day, last Monday in May

2.6.1.3.5. Independence Day, 4 July

2.6.1.3.6. Labor Day, 1st Monday in September

2.6.1.3.7. Columbus Day, 2nd Monday in October

2.6.1.3.8. Veteran’s Day, 11 November

2.6.1.3.9. Thanksgiving Day, 4th Thursday in November 2.6.1.3.10. Christmas Day, 25 December

2.6.1.4. 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, contractor personnel shall not report for work nor shall they be compensated for those days.

2.7. Travel (Reserved)

2.7.1. Travel Process.

2.7.1.1. Travel Request Procedures.

2.7.1.2. Travel Approval Process.

2.7.1.3. Travel Claim Procedures.

SECTION 3 PERFORMANCE REQUIREMENTS

3.1 RMW Materials and Services

The contractor shall provide all necessary resources required to provide RMW materials and services as related to biohazard materials produced during PMHS injury biomechanics research activities. The contractor shall provide boxes, sharps containers, and pickup services. The contractor shall be familiar with and comply with all federal and state laws applicable to the services listed above. This section specifies the Performance Objectives and Performance Elements for the contract.

3.1.1. Objective 1 – Material and Pickup Requirement. The RMW boxes (Deliverable 8) must be industry standard and shall meet all federal, state, and local laws, including 49 CFR Part 173.197, to transport such materials. These boxes shall be marked and labeled IAW federal, state, and local regulatory requirements. Collection services shall transport RMW (including sharps) and pathological waste IAW all federal, state, and local laws.

Pathological disposal services will be required on an as needed basis. Packing of pathological waste will be IAW contractor policy and federal, state, and local laws. The requirements for the materials and services are listed in Table 1.

Table 1. Estimated Material and Service Requirements

Collection Services

3.1.2. Objective 2 – Ordering Procedures. The research requiring these services is infrequent and irregular in nature. Therefore, collection services are expected to be flexible on an as needed basis, not a fixed schedule. Periods of foreseen collection pick-ups could be as often as every quarter or as sporadically as one period a year. Collection pick-ups will most often be required once a week for a two to three week period.

Once ready to order, individuals authorized to purchase using this BPA will contact the contractor with requested dates and number of supplies needed. The contractor will process orders using proposed pricing for that ordering period. Orders will be requested at least one week prior to need, but shall be flexible to be changed to meet research testing needs and timelines. All orders shall be completed by requested date.

A typical order will be eight to ten medium (18”x18”x24”) regulated medical waste boxes to be supplied for each collection date along with collection services. Collection services shall include RMW (including sharps) pick-up in provided boxes, and/or pathological waste pick-up as necessary.

3.1.3. Objective 3 – Shipping. The services ordered under this contract are delivered to Bldg 8825 Andrews Avenue, Fort Rucker, Alabama. All orders will be coordinated with the COR. FAR 13.303-3(a) (5) requires that all shipments made under this agreement be accompanied by delivery tickets or sales slips (Deliverable 9) that contain the following minimum information:

3.1.4.

a. Name of supplier

b. BPA number

c. Date of purchase

d. Purchase (delivery order) number

e. Itemized list of model numbers, quantity, unit price, and extension of each item

f. Date of delivery

3.1.5. Objective 4 – Invoicing. The COR will process invoices for payment only when products and services are received, inspected, and accepted at the delivery location. Each invoice shall identify the appropriate CLIN number to be billed. If CLINs are not properly identified on an invoice, the invoice will be rejected. Additional requirements for invoicing:

a. The contractor will submit all invoices electronically to Wide Area Workflow (WAWF).

b. Invoices will be only paid upon receipt of servicesordered.

c. Payment will be made through the WAWF system upon receipt of proper documentation.

1. Proper documentation includes CLIN number, ordered description, quantity, unit of issue, unit price and total amount.

d. A summary report/invoice shall be submitted monthly for all deliveries made during a billing period (1 month), identifying the delivery tickets covered therein, stating their total dollar value, quantity ordered, product name, and supported by receipt copies of the delivery tickets. This report shall be provided to the contract specialist and the ordering official.

3.2. Performance Requirement Summary Matrix

Performance Objective

PWS

Performance Standard

Pickup

scheduled as needed.

scheduling.

100% Inspection.

b) STD: Contractor maintains flexible schedule.

Inspection.

3.3. Quality Assurance Surveillance Plan. Every DoD contract awarded for services in excess of $2,500.00 shall contain a Quality Assurance Surveillance Plan (QASP) as discussed in the FAR 46, Government Contract Quality Assurance. A QASP is a plan that specify the particular services the COR will inspect and the method(s) used to complete that surveillance. Each offeror shall digest the PWS in this RFP and offer a QASP associated therewith. The QASP shall be submitted as part of the offeror’s technical proposal. It will not be subjectively evaluated and rated. However, it may be discussed during the pre-award period for finalization prior to its inclusion in the awarded contract.

SECTION 4 SPECIAL REQUIREMENT

4.1. Government Furnished Property (Not Applicable)

4.2. Contractor Furnished Property (Not Applicable)

4.3. Security and Safety

4.3.1. Access and General Protection/Security Policy and Procedures. The contractor and all associated subcontractors’ personnel 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 also provide all information required for background checks to meet installation access requirements to be accomplished by the installation Provost Marshal Office, Director of Emergency Services, or Security Office. The contractor workforce shall 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 Requiring Common Access Card (CAC). (Not Applicable)

4.3.3. 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 190-13), applicable installation, facility and area commander installation/facility access and local security policies and procedures (provided by government representative), or, at OCONUS locations, IAW status of forces agreements and other theater regulations.

4.3.4. Contractor Personnel Who Require Access to Government Information Systems. (Not Applicable)

4.3.5. Prior to commencement of on-site services, the contractor shall provide the COR, within seven (7) calendar days in advance of the event, full names, date of birth, place of birth and Social Security numbers (or equivalent identification numbers for non-U.S. citizens) of all personnel who will be entering Army-controlled installation and facilities.

4.3.6. The contractor shall ensure that its personnel entering Army-controlled installations or facilities have obtained access badges and passes IAW facility regulations and that these badges and passes are obtained in advance so as not to delay the accomplishment of contracted services.

4.3.7. 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 personnel no longer requires access to the installation and facility. USAARL specific access badges shall be returned upon completion of on-site work and prior to departure.

4.3.8. Force Protection Condition (FPCON) impact on work levels. The contractor workforce shall comply with all personal identity verification requirements as directed by DoD, Headquarters Department of the Army (HQDA), and local 4.3.9.

policy. In addition to the changes otherwise authorized by the changes clauses of this contract, should the FPCON at any individual facility or installation change, the Government may require changes in contractor security matters or process. IAW Department of Defense Instructions (DoDI) 2000.16, DoD AT Standards, the FPCON is defined as follows:

4.3.9.1. 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 the Terrorist Threat Conditions (THREATCONS) resulting from intelligence received or as a deterrent. The measures in this THREATCON must be capable of being maintained indefinitely.

4.3.9.2. 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.

4.3.9.3. 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.

4.3.9.4. 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. See alsoanti-terrorism

4.3.9.5. During FPCONs Charlie and Delta, non-essential services are discontinued. Designated essential service will resume when the FPCON level is reduced to level Bravo orlower.

4.3.9.6. When contractor personnel are considered mission essential, all contractor personnel are required to report for duty and remain on duty during declared emergencies or elevated FPCON levels unless otherwise directed by the contracting officer via the appropriate COR.

4.3.9.7. Generation, handling and storage of classified material. The contractor shall not generate, handle or store classified material for this contract.

4. 4. Security Requirements. The contractor shall not possess or store classified information at the contractor’s facility; therefore, level of safeguarding required is not applicable to this contract.

4.4.1. Unclassified Contract Security Requirements: The contractor shall ensure all personnel performing on-site work under this contract have a favorable National Agency Check with written inquires (NACI), including a favorable completion of Federal Bureau of Investigation (FBI) fingerprint check, which the COR will coordinate with the United States Army Garrison (USAG) Fort Rucker Security office prior to performance start date. The security requirements shall be maintained for the life of the contract, and citizenship shall be verified by presenting an original birth certificate or a U.S. passport or the original Naturalization Certificate to the USAG Fort Rucker Security office at the time of in processing for all contract personnel assigned to the contract. In order to maintain the security requirements any derogatory information, to include law enforcement issues, mental health issues, or alcohol/drug related issues shall be reported to the COR, ACOR, and USAG Fort Rucker Security Office.

4.4.2. DD Form 254, DoD Contract Security Classification Specification is not required for this contract.

4.5. Proprietary Information Assurance and Security. The contractor shall comply with Office of Management and Budget (OMB) Circular A-130, “Management of Federal Information Resources,” which requires Certification and Accreditation (C&A) of all federal information systems every three (3) years at a minimum or as changes that require re- accreditation occur. This C&A requirement ensures the effective safeguarding of sensitive but unclassified (SBU) data against unauthorized modification, disclosure, destruction, and denial of service, as directed by the DoD.

4.5.1. The contractor shall protect all data in the strictest confidence; prevent the unauthorized duplication, use and disclosure of information that is subject to the Privacy Act of 1974, HIPAA IAW applicable statutory, regulations, local policies and procedures.

4.5.2.

4.5.3. All data received, processed, evaluated, loaded, and created as a result of this contract shall remain the sole property of the Government and shall be returned to the Government at the conclusion of the contract unless the contracting officer grants specific exception.

4.5.4. The contractor is prohibited from appropriation, disclosure, or unauthorized use of proprietary information that is acquired in the execution of this contract.

4.5.5. All products including files, software, and other information, which are created, produced or developed during the period of performance is the property of the Government and shall be returned unless the Government grants the contractor permission to retain the materials and products for continued development or publication.

4.6. Visitor Group Security Agreement. The contractor shall sign a Contractor Visitor Group Security Agreement to protect Government information involved in performance under this contract. The agreement shall outline responsibilities in the following areas: contractor security supervision; standard practice procedures; access, accountability, storage, and transmission of and other responsibilities, as required.

4.7. Other Direct Costs

4.7.1. ODCs shall be billed on a cost reimbursable basis. Costs are defined as the purchase price of materials or service plus General and Administrative charges (G&A) or material and handling charges (M&H) in accordance with FAR 31.205-26, Material Cost. ODC also includes travel in accordance with FAR 31.205-46, Travel.

4.7.2. All ODCs shall be reported as stated in the Monthly Progress Report as required.

SECTION 5 DELIVERABLES

5.1. Deliverables. The contractor shall provide the following deliverable as listed.

SECTION 6 APPLICABLE DIRECTIVES, REGULATIONS, AND 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. (Reserved)

6.3. Mandatory Compliance (Reserved)

SECTION 7 DEFINITIONS AND ACRONYMS

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 theprime.

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 thegovernment.

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 non-manufactured things such as meeting minutes or reports.

7.1.6. KEY PERSONNEL. Contractor personnel that are evaluated in a source selection process and that may be required to be used in the performance of a contract by the Key Personnel listed in the PWS. When key personnel are used as an evaluation factor in best value procurement, an offer can be rejected if it does not have a firm commitment from the persons that are listed in the proposal.

7.1.7.

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

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

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

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

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

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

7.1.14. WORK WEEK. Monday through Friday, unless specifiedotherwise.

7.2. Acronyms

The acronyms listed below will assist in recognizing certain key words, phrases, or departments as defined in the contract, as well as any forthcoming dialogue with the contractor.

7.3. Related Documents (Reserved)

QASP

Quality Assurance Surveillance Plan for Regulated Medical Waste (RMW) Disposal Supplies and Services

2. PURPOSE.

This Quality Assurance Surveillance Plan (QASP) provides a systematic method to evaluate performance for the stated contract. This QASP explains the following:

· What will be monitored?

· How monitoring will take place?

· Who will conduct the monitoring?

· How monitoring efforts and results will be documented?

This QASP does not detail how the contractor accomplishes the work. Rather, the QASP is created with the premise that the contractor is responsible for management and quality control actions to meet the terms of the contract. It is the Government’s responsibility to be objective, fair, and consistent in evaluating performance. In addition, the QASP should recognize that unforeseen and uncontrollable situations may occur.

This QASP is a “living document” and the Government may review and revise it on a regular basis. However, the Government shall coordinate changes with the contractor. Updates shall ensure that the QASP remains a valid, useful, and enforceable document. Copies of the original QASP and revisions shall be provided to the contractor and Government officials implementing surveillance activities.

3. GOVERNMENT ROLES AND RESPONSIBILITIES.

The following personnel shall oversee and coordinate surveillance activities.

b. Contracting Officer (KO) - The KO shall ensure performance of all necessary actions for effective contracting, ensure compliance with the contract terms, and shall safeguard the interests of the United States in the contractual relationship. The KO shall also assure that the contractor receives impartial, fair, and equitable treatment under this contract. The KO is ultimately responsible for the final determination of the adequacy of the contractor’s performance.

Assigned KO: Philip Huff Organization or Agency: US Army Medical Research Acquisition Activity Telephone: Phone: (301) 619-XXXX Email: philip.h.huff.civ@mail.mil

c. Contracting Officer’s Representative (COR) – The COR is located at the U.S. Army Aeromedical Research Laboratory. The COR will be responsible for technical administration of this contract and shall assure proper Government surveillance of the contractor’s performance. The COR shall keep a quality assurance file. At the conclusion of the contract or when requested d.

by the KO, the COR shall provide documentation to the KO. A COR is not empowered to make any contractual commitments or to authorize any contractual changes on the Government’s behalf. The contractor shall refer any changes they deem may affect contract price, terms, or conditions to the KO for action.

Primary COR: Kimberly Vasquez Telephone: 334-255-6949 Email: kimberly.b.vasquez.civ@mail.mil

Alternate COR: Ed Claunch Telephone: 334-255-6797 Email: edward.g.claunch.civ@mail.mil

4. CONTRACTOR REPRESENTATIVES:

The following employee of the contractor will serve as the contractor’s Program Manager for this contract.

Program Manager:

Title:

Telephone:

Email:

5. PERFORMANCE STANDARDS.

Performance standards define desired services. The Government performs surveillance to determine if the contractor exceeds, meets or does not meet these standards.

Table 1. Performance Requirements Performance Objective

PWS

Performance Standard

Pickup

scheduled as needed.

scheduling.

100% Inspection.

b) STD: Contractor maintains flexible schedule.

Inspection.

6. METHODS OF QUALITY ASSURANCE SURVEILLANCE.

Various methods exist to monitor performance. The COR shall use the surveillance methods listed below in the administration of this QASP.

· Feedback from Oversight Board

· Feedback from Government Users

· Feedback from Property Book Officers

· Direct Observation

· 100% Inspection

· Review of Quarterly Reports (various)

· Review of Monthly Reports (various)

Regardless of the surveillance method, the COR shall always contact the contractor's task manager or on-site representative when a defect is identified and inform the manager of the specifics of the problem. The COR shall be responsible for monitoring the contractor’s performance in meeting a specific performance standard/AQL.

· DIRECT OBSERVATION. (Can be performed periodically or through 100% surveillance.)

· MANAGEMENT INFORMATION SYSTEMS (MIS). (Evaluates outputs through the use of management information reports. Best used for general surveillance and may need to be supplemented by periodic inspections.)

· PERIODIC INSPECTION. Uses a comprehensive evaluation of selected outputs. Inspections may be scheduled as required.

· Analysis of contractor's progress reports. (Evaluate cost, schedule, etc.)

· Performance reporting.

Surveillance results may be used as the basis for actions (to include payment deductions) against the contractor. In such cases, the Inspection of Services clause and the Inspection of Supplies clause in the Contract becomes the basis for the KO’s actions.

7. RATINGS.

8.

Metrics and methods are designed to determine if performance exceeds, meets, or does not meet a given standard and acceptable quality level. A rating scale shall be used to determine a positive, neutral, or negative outcome. The following ratings shall be used:

Example 1:

the Government’s benefit.

9. DOCUMENTING PERFORMANCE.

b. ACCEPTABLE PERFORMANCE.

The Government shall document positive performance. A report template is attached. Any report may become a part of the supporting documentation for fixed fee payments, award fee payments, or other actions.

c. UNACCEPTABLE PERFORMANCE.

When unacceptable performance occurs, the COR shall inform the contractor. This will normally be in writing unless circumstances necessitate verbal communication. In any case the COR shall document the discussion and place it in the COR file.

When the COR determines formal written communication is required, the COR shall prepare a Contract Discrepancy Report (CDR), and present it to the contractor's task manager or on-site representative. A CDR template is attached to this QASP.

The contractor shall acknowledge receipt of the CDR in writing. The CDR will specify if the contractor is required to prepare a corrective action plan to document how the contractor shall correct the unacceptable performance and avoid a recurrence. The CDR will also state how long after receipt the contractor has to present this corrective action plan to the COR. The Government shall review the contractor's corrective action plan to determine acceptability.

Any CDRs may become a part of the supporting documentation for contract payment deductions, fixed fee deductions, award fee nonpayment, or other actions deemed necessary by the KO.

10. FREQUENCY OF MEASUREMENT.

b. Frequency of Measurement.

c.

During contract/order performance, the COR shall take periodic measurements, quarterly as specified in the AQL column of the Performance Standards Summary Matrix, and shall analyze whether the negotiated frequency of measurement is appropriate for the work being performed.

PERFORMANCE REPORT

1. Contract Number: TBD

2. Prepared by: COR Name Entered At Time of Award

3. Date and time of observation:

4. Observation:

<Examples of items to include in a report are:

· Method of surveillance.

· How frequently you conducted surveillance.

· Surveillance results.

· Number of observations.> Prepared by: COR

Signature – Contracting Officer’s Representative Date

CONTRACT DISCREPANCY REPORT (CDR)

2. Contract Number: TBD

3. To: (Contractor Task Manager or on-site representative)

4. From: TBD

5. Date and time observed discrepancy:

6. Discrepancy or Problem:

<Describe in detail. Identify any attachments.>

7. Corrective action plan:

A written corrective action plan < is / is not > required.

< If a written corrective action plan is required include the following. > The written Corrective Action Plan will be provided to the undersigned not later than < # days after receipt of this CDR. >

Prepared by: COR

Signature – Contracting Officer’s Representative Date

Received by:

Signature - Contractor Task Manager or on-site representative Date

The COR may initiate a CDR at any time, including whenever the number of monthly recorded defects for a performance standard exceeds the allowable number of defects; anytime unacceptable performance is determined critical in nature and requires formal corrective action; and…