DRAFT PWS RMW W81K0420R0020_3 Dec 2019.pdf

ATTACHMENT #1

W81K0420R0020

Performance Work Statement (PWS)

For

Regulated Medical Waste (RMW) Services for DoD Medical Treatment Facilities Located in the United States

3 December 2019

Table of Contents

1. GENERAL:

Background:

1.1. Scope:

1.1.1. Changes to MTFs Pick up Locations:

1.2. Period of Performance (POP):

1.3. Days and Hours of Pick up:

1.4. Recognized Holidays:

1.5. Inclement Weather Schedule:

1.6. Missed Pick-ups:

1.7. Key Personnel:

1.8. Employee Requirements:

1.9. Post Award Conferences:

1.10. Contractor Identification:

1.11. Access and General Protection/Security Policy and Procedures:

1.12. For CSPs that do not require a CAC, but require access to a DoD facility or installation:

1.13. Contractor Facility Visits:

1.14. Quality Assurance Surveillance Plan (QASP):

1.15. Organizational Conflict of Interest (OCI):

2. DEFINITIONS & ACRONYMS:

2.1. DEFINITIONS:

3. GOVERNMENT FURNISHED PROPERTY AND SERVICES:

3.1. General:

4. CONTRACTOR FURNISHED PROPERTY AND SERVICES:

4.1. General Requirements:

4.2. Contractor Provided Materials:

4.2.4. Container/Packaging for DOT Category A Infectious Substances:

4.2.5. Red bag liners:

4.3. License and Permits:

4.4. Quality Control and Corrective Action Plan:

4.5. Contingency Plan:

4.6. Spill Response Plan:

4.7 Health and Safety Plan:

4.8 Contract Employee Training:

4.9 Insurance:

5. TASKS AND REQUIREMENTS:

6. APPENDICES/EXHIBITS:

6.1. Appendix A - Publications and Regulations:

6.2. Exhibit A - Performance Requirements Summary (PRS):

6.3. Exhibit B - Pick up RMW Sites, RMW Estimated Quantities/Frequencies

6.4. Exhibit C - Summary of RMW Contractor Deliverables:

6.5. Exhibit D - Sample Utilization Report:

1. GENERAL:

Background: The intent of this consolidated requirement is to support the continued implementation of the Military Health System (MHS) organizational reform required by 10 U.S.C. § 1073c, and sections 711 and 712 of the John S. McCain National Defense Authorization Act (NDAA) for Fiscal Year (FY) 2019, effective 25 October 2019, which eliminated separate silos of military healthcare and officially integrated healthcare under the authority, direction, and control (ADC) of the Defense Health Agency (DHA), consistent with the direction provided by the Secretary of Defense. The Medical Logistics Division supports the DHA’s transitioning the ADC of the military medical treatment facilities (MTF’s) from the Military Departments medical departments to the DHA. The DHA is responsible for providing RMW disposal services for MTFs, as defined in this PWS. MTFs are the collective term that refers to the integrated medical, dental, veterinary, research, and other healthcare services facility at a specified installation. Services will be provided throughout all fifty (50) United States, Guam, and Puerto Rico.

1.1. Scope: The Contractor shall provide all required resources to perform RMW removal services in accordance with (IAW) this PWS and its exhibits. The Contractor shall pick up (i.e., already packaged and labelled) RMW packages from a centrally-located or otherwise agreed-upon location at each site identified in Exhibit B and transported for final disposal. The RMW, to include Department of Transportation (DOT) Category A infectious substances (i.e., Ebola virus, Hantaviruses causing hemorrhagic fever with renal syndrome, etc.), shall be handled in accordance with all Federal, State, local laws, policies and regulations to include the processing of chemotherapy trace waste and pathological waste. The Contractor shall furnish all labor, supervision, management from point of collection of transport-ready packages, transportation, equipment, materials, certification, and training, except as specified as Government furnished, required to perform these services.

1.1.1. Changes to MTFs Pick up Locations: The Government, due to mission changes, may elect to add additional or potentially remove RMW pick-up sites. These sites may reside on a military installation or within a civilian community near or off the Government installation. The pricing will be negotiated by the Contracting Officer for the basic contract at the time sites are added or removed.

1.2. Period of Performance (POP): The POP is approximately five years from date of contract award. Task Orders (TO) will be funded by annual appropriations and each TO will not exceed one year.

1.3. Days and Hours of Pick up: Exhibit B defines the location and hours in which the Contractor shall pick up RMW at each facility and pick up site.

1.3.1. The contractor shall alert the Contracting Officer’s Representative (COR) in writing (hard copy or electronic) of any Government requested changes to this contract (schedule/location) and receive approval from the Contracting

Officer (KO), prior to execution.

1.4. Recognized Holidays: In general, federal holidays falling on a Saturday are observed on the preceding Friday whereas holidays falling on a Sunday are observed on the following Monday. Any holidays that are declared by Presidential Executive Order shall be observed in the same manner as the holidays listed below.

Holiday Projected Date New Year’s Day January 1 Martin Luther King, Jr. Birthday 3rd Monday in January President’s Day 3rd Monday in February Memorial Day Last Monday in May Independence Day July 4 Labor Day 1st Monday in September Columbus Day 2nd Monday in October Veteran’s Day November 11 Thanksgiving Day 4th Thursday in November Christmas Day December 25

1.4.1. In the event a scheduled pick-up falls on a federal holiday, the contractor shall coordinate and reschedule the pick-up with the Task Order Contracting Officer Representative (TO COR) prior to the holiday or within two business days following the holiday.

1.5. Inclement Weather Schedule: Waste shall be collected as scheduled during periods of inclement weather unless specific approval to delay collections is requested by the Contractor and received from the TO COR. Such approval will normally be granted only in cases of particularly severe weather, such a heavy snow, tropical storm, or hurricane, etc. In the event an MTF is closed, paragraph 1.6 shall be followed.

1.5.1. In the event that the base is closed the contractor shall contact the TO

COR or TO KO/KS to confirm that the MTF is also closed.

1.6. Missed Pick-ups: The rescheduling of missed pick-ups shall be agreed upon with consideration given to the holding time limitations for RMW at a given location. Contractor shall also notify TO COR or TO KO/KS, by the next work day, of missed pick-ups caused by Government delay.

1.7. Key Personnel: The contractor shall identify a primary and alternate point of contact (POC) for each site that shall be responsible for the day-to-day performance of work. The name, email, and phone number shall be provided to the TO COR and TO KO/KS within 7 calendar days prior to the start of the performance. The government shall notify the contractor regarding a TO COR for each site. The contractor shall notify the TO COR and TO KO/KS within five business days when there is a change to the contractor’s POC.

1.8. Employee Requirements: Contractor shall be trained IAW all Federal, State, local laws, policies and regulations. Training shall include elements as required by the federal Department of Transportation (DOT) under 49 Code of Federal Regulation (CFR) 173, and as required by the Occupational Safety and Health Administration (OSHA) under 29 CFR 1910.1030.

1.9. Post Award Conferences: If the KO determines a post award conference is necessary, the contractor shall attend the post award conference convened by the contracting activity or contract administration office IAW FAR Subpart 42.5.

1.10. Contractor Identification: The Contractor shall provide all Contract Service Providers (CSP’s) working under this contract with a distinctive nameplate, emblem, or patch attached in a prominent place on an outer garment as employee identification. The Contractor shall ensure that all employees present a professional appearance that is appropriate for their position. Clothing shall be neat, clean, and in good condition. Contractor employees shall identify themselves as Contractor personnel by introducing themselves or being introduced as Contractor personnel and displaying distinguishing badges or other visible identification for meetings with Government personnel.

1.10.1. All Contractor employees shall appropriately identify themselves as Contractor employees in telephone conversations and in formal and informal written correspondence.

1.11. Access and General Protection/Security Policy and Procedures: All CSP performing tasks on this PWS shall comply with applicable installation, facility and area commander installation/facility access and local security policies. The CSP shall provide all information required for background checks to meet installation access requirements as performed by installation law enforcement, Director of Emergency Services or Security Office. CSPs shall comply with all personal identity verification requirements as directed by the Department of Defense (DoD), and/or local policy. In addition to the changes otherwise authorized by the changes clause of this contract, should the Force Protection Condition at any individual facility or installation change, the Government may require changes in Contractor security matters or processes. Failure to receive access for any reason does not mitigate contract requirements.

1.12. For CSPs that do not require a CAC, but require access to a DoD facility or installation: Contractor and all associated subcontractor CSPs shall comply with adjudication standards and procedures using the National Crime Information Center Interstate Identification Index (NCIC-III) and Terrorist

Screening Database; applicable installation, facility and area commander installation and facility access and local security policies and procedures (provided by Government representative).

1.13. Contractor Facility Visits: The TO COR and/or TO KO/KS at any time during the performance of this contract may visit any treatment, storage, or disposal facility used in the performance of this contract. The TO COR will provide a minimum of five business days advanced notification and coordination, with the Contractor, prior to visiting a Contractor’s facility. The TO COR at his or her discretion may be accompanied by other Government representative(s).

1.14. Quality Assurance Surveillance Plan (QASP): The Government will use a QASP to monitor compliance with the contract terms and conditions and identify nonconforming services. The QASP sets forth the method and manner by which the Government intends to conduct surveillance of work under the contract and is subject to unilateral change by the Government without modification to the contract. All work required by the contract is subject to surveillance whether or not specifically included in the QASP.

1.15. Organizational Conflict of Interest (OCI): The Contractor shall notify the KO immediately whenever it becomes aware that a potential or actual OCI exists, as defined in FAR 9.5 – Organizational and Consultant Conflicts of Interest. The Contractor shall then submit a plan to the Contracting Officer detailing how to avoid or mitigate the OCI within 10 business days. The Contractor's mitigation plan will be determined to be acceptable solely at the discretion of the KO and in the event the KO unilaterally determines that any such OCI cannot be satisfactorily avoided or mitigated, the KO may affect other remedies as he or she deems necessary, including prohibiting the Contractor from participating in subsequent contracted requirements which may be effected by the OCI.

2. DEFINITIONS & ACRONYMS:

2.1. DEFINITIONS: The following terms used throughout this PWS shall have the following meanings:

Acceptable Quality Level (AQL) - The maximum allowable percentage of deviation from perfect performance for an individual service output.

Bloodborne Pathogens Regulation - All currently applicable and effective Occupational Safety and Health Administration (OSHA) regulations to eliminate or minimize occupational exposure to Hepatitis B Virus, Human Immunodeficiency Virus, and other bloodborne pathogens.

Cleaning - The removal of visible soil and organic contamination from a device or surface using the physical action of scrubbing with a surfactant or detergent and water.

Common Access Card (CAC) - Smart card-based technology and systems used to transform and improve security in DoD processes and mission performance, thereby enhancing readiness while also improving business processes. The standard ID card for active duty Uniformed Services personnel (to include the Selected Reserve), DoD civilian employees, eligible Contractor personnel, and eligible foreign nationals. The Department's primary platform for the public key infrastructure (PKI) authentication token used to access DoD computer networks and systems in the unclassified environment and, where authorized by governing security directives, the classified environment. It is the principal card enabling physical access to installations. The CAC enables encrypting and cryptographically signing email, facilitating the use of PKI authentication tools, and establishes an authoritative process for the use of identity credentials.

Community Based Medical Home - An MTF located off the installation in leased facilities managed by the parent MTF near the communities in which Service members and their families reside.

Contract Discrepancy Report (CDR) - A report that requires the Contractor’s response when performance is unsatisfactory. The CDR requires the Contractor to explain, in writing, why performance was unsatisfactory, how performance will be returned to satisfactory levels, and how recurrence of problems will be prevented.

Contract Service Provider (CSP) - A non-Government employee under contract or working for a firm under contract with the DoD, or Uniformed Services.

Contracting Officer (KO) - The individual with the authority to enter into, administer, and/or terminate contracts. The KO is the exclusive Government official authorized to execute changes and authorize deviations or variations from the contract. This is different from a TO KO. Please see the definition for TO

KO. The KO is the only person authorized to make changes to the basic contract.

Contracting Officer's Representative (COR) - The DHA Program Manager responsible for assisting in administration of the Government's quality assurance (QA) portion of the contract. This person is designated in writing by the KO/KS to be responsible for QA, inspection, surveillance documentation and acceptance of the Contractor's services. A copy of the letter of designation will be provided to the Contractor. This is different from a TO COR. Please see the definition for TO

COR

Contracting Specialist (KS) - responsible for performing contract assignments in support of local or centralized procurement activity. This is different from a TO KS. Please see the definition for TO KS. The KO is the only person authorized to make changes to the basic contract.

DoD Certified Official - A person who has successfully completed an approved DoD hazardous materials certification course and is appointed in writing by his/her activity or unit commander, to include scope of authority.

DOT Category A Infectious Substance - For a complete definition see: 49 CFR section 173.134 Class 6, Division 6.2—Definitions and exceptions. An infectious substance transported in a form capable of causing permanent disability or life-threatening or fatal disease in otherwise healthy humans or animals when exposure occurs. Examples include, but are not limited to, Herpes B virus cultures, Human immunodeficiency virus cultures, Ebola virus, Marburg virus, Hepatitis B virus cultures, rabies virus cultures, poliovirus, West Nile virus cultures, and anthrax (Bacillus anthracis) cultures and other emerging pathogens as listed by the Center for Disease Control. Ebola Virus Disease (EVD) - EVD formerly known as Ebola hemorrhagic fever is a severe, often fatal acute viral illness in humans. Ebola virus is classified as a World Health Organization (WHO) Risk Group 4 infectious agent. The Centers for Disease Control and Prevention (CDC) classifies Ebola virus as a Biological select agent and establishes management standards in the Code of Federal Regulations,42 CFR Part 43. Based on the classifications, the Department of Transportation (DOT) categorizes Ebola and any waste generated during patient care, as a Category A infection substance, which is regulated more stringently than routine RMW.

Mandatory Documents - Directives with which the Contractor is obligated to comply.

Medical Treatment Facility (MTF) - The collective term that refers to the integrated medical, dental, veterinary, research, and other healthcare services facility at a specified installation.

Off Installation – A pick up site that is not on the military installation or where the primary medical treatment facility resides.

Out of State - A pick up site that is not in the State where the primary medical treatment facility is located.

Oversized Regulated Medical Waste - Medical waste that is too large for plastic bags or standard containers.

Quality - Meeting or exceeding contract requirements. Quality is measured by the Contractor’s compliance with Government mandated standards or service outputs.

Quality Control Program - A methodology by which the Contractor attempts to assure the MTF that expected services are provided. The methodology shall be in writing.

Regulated Medical Waste (RMW) - Waste produced by research, veterinary, dental and medical clinical treatment facilities that a legal jurisdiction has determined has the potential for causing disease in humans or may pose a risk to both individuals or community health if not managed properly, and includes the following classes:

(1) Group 1 - Cultures, Stocks, and Vaccines:

(a) Cultures and Stocks. Microbiologic waste (cultures and stocks of etiologic agents).

(b) All human and animal vaccines.

(2) Group 2 - Pathological Waste: Collect pathological waste in an RMW container lined with an RMW bag or double bag in RMW bags.

(3) Group 3 - Blood and Blood Products: Free flowing or dripping blood, plasma, serum, and other derivatives of this waste.

(4) Groups 4 and 7 - Used/Unused Sharps and Syringes: Used and unused hypodermic needles and syringes. Any object in contact with infectious agents and that can penetrate the skin such as scalpels, broken glass, and broken capillary tubes.

(5) Group 5 - Animal Waste: Infectious animal waste including blood, carcasses, and bedding.

(6) Group 6 - Isolation Waste: Consult the Infection Control Officer for specific instructions on handling isolation waste.

(7) Group 7 - Used/Unused Sharps and Syringes: See Group 4 above.

(8) Group 8 - Other: Other infectious fluids as determined by a medical authority

(9) Group 9 - Trace Chemotherapy Wastes: Items such as needles, containers, syringes, vials, gloves, and tubing that contained or were exposed to chemotherapy agents. These containers are likely to be yellow in color.

(10) Group 10 – State-specific Regulated Medical Waste not associated with the above Groups (1-9) will be managed according to State regulations and requirements.

Task Order Contracting Officer (TO KO) - The individual with the authority to enter into, administer, and/or terminate contracts at the task order level. The TO KO is the exclusive Government official authorized to execute changes and authorize deviations or variations from the task order.

Task Order Contracting Officer Representative (TO COR) - The medical facility representative responsible for assisting in administration of the Government's quality assurance (QA) portion of the contract at the task order level. This person is designated in writing by the TO KO/KS to be responsible for QA, inspection, surveillance documentation and acceptance of the Contractor's services. A copy of the letter of designation will be provided to the Contractor. This is different from a COR. Please see the definition for COR

Task Order Contracting Specialist (TO KS) - responsible for performing contract assignments in support of local or centralized procurement activity at the task order level.

2.2. Acronyms:

AFMES - Armed Forces Medical Examiner System AQL - Acceptable Quality Level ASTM - American Society for Testing and Materials CAC - Common Access Card CDC - Centers for Disease Control and Prevention CDR - Contract Discrepancy Report CFR - Code of Federal Regulations CMR - Contractor Manpower Reporting CONUS - Continental United States COR - Contracting Officer's Representative CPARS - Contractor Performance Assessment Reporting System CSP - Contract Service Provider DHA - Defense Health Agency DoD - Department of Defense DOT - Department of Transportation FAR - Federal Acquisition Regulation FY - Fiscal Year IAW - In Accordance With ID - Identification KO - Contracting Officer KS - Contracting Specialist MEPS - Military Entrance Processing Stations MEPS - Military Entrance Processing Stations (MEPS) MTF - Medical Treatment Facility NCIC - National Crime Information Center Interstate Identification Index NDAA - National Defense Authorization Act OCI - Organizational Conflict of Interest OSHA - Occupational Safety and Health Administration POC - Point of Contact POP - Period of Performance PRS - Performance Requirements Summary PWS - Performance Work Statement QA - Quality Assurance QASP - Quality Assurance Surveillance Plan QCP - Quality Control Plan RMW - Regulated Medical Waste SDS - Safety Data Sheets TA - Trusted Agent TO - Task Order USMEPCOM’s - Military Entrance Processing Command’s WRAIR - Walter Reed Army Institute of Research

3. GOVERNMENT FURNISHED PROPERTY AND SERVICES:

3.1. General: Government furnished property/equipment will not be provided.

4. CONTRACTOR FURNISHED PROPERTY AND SERVICES:

4.1. General Requirements: The Contractor shall provide all supplies, materials, tools, equipment, and vehicles necessary to perform the work required under this PWS. The TO COR or TO KO/KS may inspect Contractor-furnished items for adequacy and compliance with contract requirements. Inadequate items shall be removed and replaced by the Contractor at no cost to the Government.

4.2. Contractor Provided Materials: The Contractor shall provide containers, boxes, and bags that are compliant with applicable regulatory requirements for storing and transporting RMW at each location. Such items shall meet the required American Society for Testing and Materials (ASTM) standard, where applicable. The estimated quantity of boxes and containers required is based on the pick-up schedule and estimates defined in Exhibit B. The Contractor is responsible for determining minimum inventory. These estimates should be considered the minimum quantity to be on hand.

4.2.1. Contractor provided disposable fiberboard boxes: Boxes shall, at a minimum, meet the requirements of DOT regulations 49 CFR 173.197.

Boxes shall be marked and labeled to comply with Federal, State, local laws, policies and regulations and meet the following specification:

Containers Fiberboard:

Dimensions Minimum Maximum Length 14 inches 28 inches Width 14 inches 30 inches

Height 24 inches 36 inches Load Rating 50 pounds 125 pounds

Volume 24 gallons 130 gallons

4.2.2. Contractor provided reusable containers: Containers shall be polyethylene construction and appropriate for the type and quantity of waste. Containers shall meet DOT specifications and withstand handling, transfer, and transportation. All containers shall be marked and labeled IAW Federal, State, local laws, policies and regulations. The contractor shall provide the quality/quantity of containers as needed and shall exchange a clean disinfected container for each filled container picked

up. Reusable containers and Contractor provided storage units shall be free of medical waste, insects, free of odors, and cleaned & disinfected after each use. Whenever full containers are picked up at any site, enough disinfected empty containers shall be left in exchange. Reusable containers shall meet the following specifications:

Containers Reusable:

Dimensions Approximate:

Length 49 inches Width 31 inches Height 34 inches Load Rating 150 pounds Volume 130 gallons

4.2.3. Contractor provided medical waste mailback containers: These containers are to be used by those facilities (i.e. Alaska and Hawaii MEPS) with minimal RMW generation or where RMW pick up services are impractical. The mailback containers shall have the capacity to mail one 3-gallon container. Each mailback container shall be pre-paid to include disposal/treatment costs. The container shall include pre-paid postage, a tracking bar code, pre-addressed shipping labels, a 3-Gallon container, all required packaging materials, and manifest/Proof of Destruction. The mailback container shall, at a minimum, meet the requirements of DOT regulations 49 CFR 173.197 and be marked and labeled to comply with Federal, State, local laws, policies and regulations.

Mail back containers shall meet the following specifications:

Mail-back Medical Waste Container:

Dimensions Approximate:

3 Gallon Medical Waste Container

9 inches x 5-1/2 inches x 19-3/4 inches

Shipping Box, Prepaid 10 inches x 7 inches x 22 inches

4.2.3.1. The contractor shall provide an initial six month estimated quantity of prepaid mailback containers as indicated in Exhibit B. Replacement mailback containers are automatically shipped to the customer upon receipt of a used prepaid mailback container. The customer shall be in receipt of the replacement mailback container within 14 calendar days of the contractor’s receipt of the mail in.

4.2.4. Container/Packaging for DOT Category A Infectious Substances:

Upon request from the TO KO/KS the Contractor shall provide Category A Waste storage kits meeting DOT requirements consisting of 55-gallon container, liner, zip ties, Category A Waste Labels and a metal band to secure the lid. Contractor shall provide 95-gallon over pack containers with each 55-gallon container provided. The contractor shall be expected to provide at least twenty-five (25) storage kits a day within eight (8) hours of request.

4.2.5. Red bag liners: The Contractor shall provide red bag liners (also called film bags) for each Contractor provided fiberboard box and reusable container.

4.2.5.1. Red bag liners shall be marked and certified by its manufacturer as having passed the tests prescribed in ASTM Standard D1922-00a, “Standard Test Method for Propagation Tear Resistance of Plastic Film and Thin Sheeting by Pendulum Method” and ASTM Standard D1709-01, “Standard Test Methods for Impact Resistance of Plastic Film by the Free-Falling Dart Method.” IAW 49 CFR 173.197(e).

4.2.5.2. The red bag liners shall not exceed a volume of 175 L (46 gallons).

4.2.5.3. In cases where the State or local authorities require a more stringent standard or requirement, the red bag liner provided shall meet the higher standard and/or additional requirement.

4.2.5.4. Upon request by the Government, the contractor shall provide DOT-approved outer packaging to package mattresses or other large items classified as RMW.

4.2.6. Yellow Bag Liners: Upon request from the TO COR or TO KO/KS, the

Contractor shall provide approved yellow bags for trace chemotherapy waste.

4.2.6.1. Yellow bag liners shall be marked and certified by its manufacturer as having passed the tests prescribed in ASTM Standard D1922-00a, “Standard Test Method for Propagation Tear Resistance of Plastic Film and Thin Sheeting by Pendulum Method” and ASTM Standard D1709- 01, “Standard Test Methods for Impact Resistance of Plastic Film by the Free-Falling Dart Method.” IAW 49 CFR 173.197(e).

4.2.6.2. The yellow bag liners may not exceed a volume of 175 L (46 gallons).

4.2.6.3. In cases where the State or local authorities require a more stringent standard or requirement, the yellow bag liner provided shall meet the higher standard and/or additional requirement.

4.3. License and Permits: The Contractor shall obtain all required permits, licenses, and authorizations to perform RMW services under this contract and comply with all applicable Federal, State, local laws, policies and regulations to include storage and transportation of RMW.

4.3.1. A copy of the DOT special permit(s) for the transport of DOT Category A Infectious Substances shall be provided to each TO COR where the package or waste is offered for transportation within 24 hours of arranging pick up.

4.3.2. The Contractor shall possess all required Federal, State, local laws, policies and regulations permit(s) for operation of the treatment/ incineration/disposal facility. The licenses and permits shall be provided to the TO COR within 14 calendar days after award and kept current during the entire period of performance. The Contractor shall also provide all applicable renewal licenses and permits to the site COR for the State being serviced within 7 calendar days. Prior to adding an incinerator/ disposal facility, 30 calendar days’ notice must be given and all State and Federal operation permit(s) must be provided to the TO COR for the new facility. All licenses and permits shall be kept current. A full list of deliverables can be found in Exhibit C.

4.3.2.1. A copy of the DOT special permit(s) for the treatment/incineration/ disposal facilities of DOT Category A Infectious Substances shall be provided to each TO COR where the package or waste is offered for transportation within 24 hours of arranging pick up.

4.4. Quality Control and Corrective Action Plan: The contractor shall establish and maintain a quality control program that ensures the weighing, pick up, transport, and disposal of RMW are performed in accordance with commercial standards, federal, State, local laws, policies and regulations. The contractor shall provide procedures to identify, prevent, and ensure non-performance and continual repetition of defective service does not occur. As a minimum, the Quality Control Plan shall describe how work will be controlled to ensure quality, timeliness, and efficiency of the full scope of contract requirements. At a minimum, the Corrective Action Plan shall describe what measures the offeror will take to resolve non-performance and prevent recurrence of identified performance deficiencies. The Contractor’s plan shall provide an effective and efficient means of identifying and correcting problems throughout the entire scope of operations and address the following:

4.4.1. Accurate documentation of work processes, procedures, and output measures.

4.4.2. A systematic procedure for assessing compliance with performance objectives and standards.

4.4.3. Accurate documentation of quality inspections and surveillance conducted throughout the execution of work.

4.4.4. Assessment-driven corrective actions and process adjustments as appropriate in a timely manner.

4.4.5. The corrective action plan shall address procedures to address immediate correction (24 Hours) of noncompliance of (Federal, State, local laws, policies, and regulations).

4.4.6. The corrective action plan shall address procedures to address performance based issues in a timely manner (5 business days).

4.4.7. Objectives should include:

4.4.7.1. Quality organization chart to include a list of personnel, responsibilities and lines of authority, and training and qualifications

4.4.7.2. Approach to assuring quality of services provided and conformance with performance objectives and standards

4.4.7.3. Methods and procedures for effective planning, operation and control of processes and performance of work

4.4.7.4. Procedures for inspection and surveillance of services:

4.4.7.4.1. Scheduling and performance of inspection and surveillance, measurement, data collection and analysis, corrective action, preventive action, and continuous improvement, oversight of subcontracted work, documentation and records management, communication with government (customers)

4.4.8. Contractor shall submit a quality control and corrective action plan within 30 calendar days of award of the basic contract to the KO/KS and COR for review and approval.

4.4.9. The contractor shall submit a copy of its existing Quality Control Plan and Corrective Action Plan to the TO COR or TO KO/KS within 10 calendar days after a task order award.

4.4.10. The contractor shall submit, within 5 calendar days, any changes to the

Quality Control and Corrective Action Plan to the COR, KO/KS, TO COR, TO KO/KS, and DHA Program Manager.

4.5. Contingency Plan: The Contractor shall establish and maintain a contingency plan to support surges in RMW generation due to environmental conditions (inclement weather, natural disaster, etc.), manmade disasters (terrorism, explosions, etc.) or when primary means of contractor performance is unavailable.

4.5.1. The contingency plan shall identify:

4.5.1.1. Alternate treatment facilities, Treatment methods, Category A infectious disease response procedures, Specific procedures to be used for management and transport of waste during an event requiring implementation of the contingency plan.

4.5.2. Contractor shall submit a contingency plan within 30 calendar days of award of the basic contract to the KO/KS and COR for review and approval.

4.5.3. The contractor shall submit a copy of its existing Contingency Plan to the TO COR or TO KO/KS within 10 calendar days after a task order award.

4.5.4. The contractor shall submit, within 5 calendar days, any changes to the Contingency Plan to the COR, KO/KS, TO COR, TO KO/KS, and DHA Program Manager.

4.6. Spill Response Plan: The Contractor shall develop and submit a spill response plan that describes the procedures for cleaning up spills or leaks IAW applicable Federal, State, local laws, policies and regulations. 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, local laws, policies and regulations. 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, and transport. The cleanup, transportation, and disposal of the associated wastes shall be at no additional cost to the Government. The Contractor shall immediately report all spills and leaks, regardless of their quantity, to the TO COR. The Contractor shall provide a copy of its Spill Response Plan to the KO, COR and Program Manager.

4.6.1 Contractor shall submit a Spill Response Plan within 30 calendar days of award of the basic contract to the KO/KS and COR for review and

4.6.2 The contractor shall submit a copy of its existing Spill Response Plan to the

TO COR or TO KO/KS within 10 calendar days after a task order award.

4.6.3 The contractor shall submit, within 5 calendar days, any changes to the

Spill Response Plan to the COR, KO/KS, TO COR, TO KO/KS, and DHA Program Manager.

4.7 Health and Safety Plan: The Contractor shall develop and submit a health and safety plan that describes items such as personal protective equipment/clothing, emergency equipment, personnel training, employee medical surveillance/vaccination program, and sample transportation/handling prior to the commencement of work. All clothing and equipment should be compliant with Federal, State, local laws, policies and regulation standards to handle RMW.

4.7.1 Contractor shall submit a Health and Safety Plan within 30 calendar days of award of the basic contract to the KO/KS and COR for review and

4.7.2 The contractor shall submit a copy of its existing Health and Safety Plan to the TO COR or TO KO/KS within 10 calendar days after a task order award.

4.7.3 The contractor shall submit, within 5 calendar days, any changes to the Health and Safety Plan to the COR, KO/KS, TO COR, TO KO/KS, and DHA Program Manager.

4.8 Contract Employee Training: CSPs shall be trained IAW all Federal, State, local laws, policies and regulations. The Contractor shall maintain personnel certification, training, and licensing records for employee requirements specified herein. Certification, training, and licensing records shall be kept current and on file for the duration of the contract, plus one year past contract expiration. Records shall be made available for Government review within one

(1) business day of request. At a minimum, training shall include elements as required by the DOT under 49 Code of Federal Regulation (CFR) 172.700, and as required by the Occupational Safety and Health Administration (OSHA) under 29 CFR 1910.1030.

4.9 Insurance: The Contractor shall carry and maintain liability insurance during the performance of this PWS IAW FAR Clause 52.228-5, Federal, State, local laws, policies, and regulations.

4.9.1 Contractor shall submit Certificate of Insurance within 30 calendar days of award of the basic contract to the KO/KS for review and approval.

4.9.2 The contractor shall submit a copy of its existing Certificate of Insurance to the TO COR or TO KO/KS within 10 calendar days after a task order award.

4.9.3. The contractor shall submit, within 5 calendar days, any changes to the

Certificate of Insurance to the COR, KO/KS, TO COR, TO KO/KS, and

5. TASKS AND REQUIREMENTS:

5.1. Task: The initial Utilization Report is due within 60 calendar days after award.

Reference Exhibit D for format.

5.1.1. Standard: Utilization report shall be submitted within specified timeframes and in specified format.

5.2. Task: The Contractor shall submit utilization report on third Thursday of each month to the COR and KO/KS. This report will cover the preceding calendar month. Reference Exhibit D for format.

5.2.1. Standard: Utilization report shall be submitted within specified timeframes and in specified format.

5.3. Task: The contractor shall report ALL contractor labor hours (including subcontractor labor hours) required for performance of services provided under this contract for the MCAA-RH 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 the year of award. Contractors may direct questions to the help desk at http://www.ecmra.mil/).

5.3.1. Standard: The contractor shall report ALL contractor labor hours

(including subcontractor labor hours) required for performance of services provided under this contract for the specified time frame on http://www.ecmra.mil/.

5.4. Task: Quarterly meetings will be conducted by the TO KO/KS or a designated representative.

5.4.1. Standard: The contractor shall submit a request for approval to the TO

KO/KS and TO COR to coordinate a date, time, and location of meetings at least one week in advance. A written agenda and slides shall be prepared for each quarterly meeting by the contractor for approval by the TO KO/KS.

The agenda and slides shall be attached to the scheduling request. The written minutes of these meetings shall be prepared by the contractor and submitted to the TO KO/KS and TO COR within 15 calendar days of the meeting for approval and final signature.

5.5. Task: Contractor shall pick up RMW at locations, days and times listed in Exhibit

B. The specific location and frequency for the pick-up of DOT Category A RMW will be determined at time of need.

5.5.1. Standard: Pick up RMW IAW Exhibit B and Federal, State, local laws, policies, and regulations.

5.6. Task: Contractor shall Pick up, Transport, and Dispose of RMW.

5.6.1. Standard: Complies with applicable Federal, State, local laws, policies and regulations.

http://www.ecmra.mil/ http://www.ecmra.mil/

5.7. Task: Contractor shall provide to the Government representative (i.e., DoD

Certified Official or COR), a properly executed and legible copy of shipping papers/manifest that includes a unique tracking number (i.e., bar code label) for each RMW container to be transported at the time of pick up. In addition, the contractor shall store digital copies for at least 3 years IAW 49 CFR.

5.7.1. Standard: Shipping papers/manifest are provided to the Government’s

DoD Certified Official or COR at time of pick up.

5.7.2. Standard: Each transported container is identified by a unique tracking number.

5.7.3. Standard: Complies with applicable Federal, State, local laws, policies and

5.8. Task: The Contractor shall provide a properly executed and signed disposal certificate for each manifest to the TO COR within 30 calendar days of removal of waste from the facility. The disposal certificate shall clearly indicate that all waste has been properly disposed of and shall specify the site and date of disposal and method of disposal (autoclave, incineration, etc.). Provide treatment/destruction certificates and invoices to the TO COR. In addition, the contractor shall store digital copies for at least 3 years IAW CFR 49.

5.8.1. Standard: Treatment/destruction certificates are provided to the TO COR within 30 calendar days of removal of waste from the facility.

5.8.2. Standard: The treatment/destruction certificates includes each shipped container’s identification/tracking number and provides the date of pick up, date of treatment, method of treatment (i.e., incineration, sterilization, etc.), the treatment facility, and the total weight.

5.8.3. Standard: Invoices with manifest/shipping document number(s), tracking number (s) and weights are provided on a monthly basis.

5.9. Task: The contractor shall separate and ensure that treatment/destruction certifications are provided to the TO COR for containers originating from one location, shipped together, but are processed between two or more treatment facilities. In addition, the contractor shall store digital copies for at least three (3) years IAW CFR 49.

5.9.1. Standard: Treatment/destruction certifications are provided for each treatment facility used in the treatment of a pick-up originating from same generation source and manifest/shipment document.

5.9.2. Standard: Complies with applicable Federal, State, local laws, policies and

5.10. Task: The contractor shall render RMW unrecognizable when required by State and local regulatory agencies prior to disposal.

5.10.1. Standard: RMW rendered unrecognizable IAW State and local regulatory agencies prior to disposal.

5.10.2. Task: Contractor shall utilize a state/territory certified commercial weighing system to enable proper billing of waste poundage that was disposed. The contractor shall provide all commercial weighing system certifications within 30 calendar days after award of the basic contract. In addition, the contractor shall provide all recertification documentation within 30 calendar days of recertification.

5.10.3. Standard: RMW is accurately weighed and recorded for each pick up identified by a shipping paper/manifest document.

5.10.4. Standard: Tare weight from reusable containers are not included in the chargeable weight listed on the billing invoice. For example, if reusable containers are used and each container weighs 14 pounds the container total weight (14 pounds) is subtracted from the gross weight to determine total waste poundage to be paid.

5.10.5. Standard: Recorded weights are accurately reflected in billing invoices.

5.11. Task: The contractor shall prepare for shipment, transport and disposal of

“Oversized RMW” items (e.g., mattresses) when requested by the Government.

Provide the weight of each oversized item on the monthly billing invoice and applicable treatment/destruction certifications.

5.11.1. Standard: Oversized RMW is prepared and removed from the MTF within 72 hours of notification.

5.11.2. Standard: Oversized RMW is identified on monthly billing invoice.

5.11.3. Standard: Complies with applicable Federal, State, local laws, policies and regulations.

5.12. Task: The contractor shall provide an initial estimated amount of (two boxes for

Alaska MEPS and three for Hawaii MEPS sites) prepaid mailback container for a 3 Gallon capacity medical waste container. Continuously provide replacement mailback containers on a one for one basis.

5.12.1. Standard: Provide an initial estimated amount of (two boxes for Alaska

MEPS and three for Hawaii MEPS sites) prepaid mailback container for a

3 Gallon capacity medical waste container. Usage quantity of mailback containers are provided to the customer prior to the start of the contract.

5.12.2. Standard: Replacement mailback containers are automatically shipped by the Contractor to the customer upon receipt of a used prepaid mailback container. The customer shall be in receipt of the replacement mailback container within 14 calendar days of the Contractor’s receipt of the mail in.

6. APPENDICES/EXHIBITS:

Appendix A Publications and Regulations

Exhibit A Performance Requirements Summary

Exhibit B Pick up RMW Sites, Estimated Weights/Frequencies

Exhibit C Contractor Required Deliverables

Exhibit D Example Utilization Report

6.1. Appendix A - Publications and Regulations: (Mandatory (M) or Advisory (A))

6.1. Mandatory and advisory documents applicable to this PWS are listed below. The Contractor shall abide by the mandatory documents to the extent they are applicable to the service required by this contract. Advisory documents may be used by the Contractor for information and guidance. Government publications will be furnished to the Contractor upon request.

6.2. Department of Defense References.

6.2.1. DoD 4500.9-R, Defense Transportation Regulation – Part II, Cargo Movement (M)

6.3. Other References.

6.3.1. 29 Code of Federal Regulations (CFR) 1910.1030 Blood borne Pathogens (M)

6.3.2. 29 CFR 1910.1200, Hazard Communication (M)

6.3.3. 42 CFR, Public Health, Department of Health and Human Services, Part 73 (M)

6.3.4. 49 CFR, Subtitle B, Chapter 1, Subchapter C, Hazardous Materials Regulations (M)

6.3.5. 49 CFR 100-185, Pipeline and Hazardous Materials Safety Administration Department of Transportation (M)

6.3.6. 49 CFR 173.197 Regulated Medical Waste (M)

6.2. Exhibit A - Performance Requirements Summary (PRS):

Performance Objective

Performance Standard

Acceptable Quality

Level (AQL)

Surveillance Method

Performance Incentive/Disincentive

Pick up RMW Containers

In accordance with PWS paragraph 5.5 and Exhibit B

95% 100% Inspection

Re-Performance Within 24 Hours; Performance above or below the standard will be documented in CPARS

Contractor Provided Materials

In accordance with PWS Paragraph

4.2.

95% 100% Inspection

Re-Performance Within 24 Hours. Performance above or below the standard will be documented in CPARS

Transport, Store, Pick up, and Dispose RMW with

Appropriate License/ Permits

In accordance with PWS Paragraph

5.5. and

Federal State and local laws and regulations

100% 100% Inspection

Performance above or below the standard will be documented

CPARS

Contractor Deliverables

Submitted IAW Exhibit C

No more than one late report per year

100% Inspection

Performance above or below the standard will be documented in CPARS; Withholding of payment

6.3. Exhibit B - Pick up RMW Sites, RMW Estimated Quantities/Frequencies

Reference Attachment:

PWS EXHIBIT B RMW

6.4. Exhibit C - Summary of RMW Contractor Deliverables:

The following are applicable deliverables required by the Contractor:

6.4.1. As Performed Submittals:

6.4.1.1. Shipping papers/manifest: The Contractor shall provide shipping papers/manifest upon RMW being shipped.

6.4.1.2. Treatment/destruction certificates: The Contractor shall provide treatment/destruction certificates.

6.4.1.3. Special Permits: Contractor shall provide a copy of the DOT special permit for the transportation of DOT Category A RMW to each MTF COR within 24 hours of arranging pick up.

6.4.2. Monthly Submittals:

6.4.2.1. Invoice: The Contractor shall invoice monthly.

6.4.2.2. Utilization Report: The Contractor shall submit a monthly utilization report to the Contracting Officer. Reference Exhibit D for format.

6.4.3. Annual Submittals:

6.4.3.1. Contractor Manpower Reporting (CMR): The Contractor shall enter manpower data by 31 October of each calendar year.

6.4.4. Quarterly Submittals:

6.4.4.1. Quarterly Meetings: The contractor shall submit a request for approval to the TO KO/KS and TO COR to coordinate a date, time, and location of meetings at least one week in advance. A written agenda and slides shall be prepared for each quarterly meeting by the contractor for approval by the TO KO/KS. The agenda and slides shall be attached to the scheduling request. The written minutes of these meetings shall be prepared by the contractor and submitted to the TO KO/KS and TO COR within 15 calendar days of the meeting for approval and final signature.

6.4.5. Submittals:

6.4.5.1. Licenses and permits: The licenses and permits shall be provided to the on-site TO COR within 14 calendar days after award and kept current during the entire period of performance. The Contractor shall also provide all applicable renewal licenses and permits to the site TO

COR for the State being serviced within 7 calendar days. Prior to changing an incinerator/disposal facility, 30 calendar days’ notice must be given and all State and Federal operation permit(s) must be provided to the TO COR for the new facility. All licenses and permits shall be kept current throughout the period of performance.

6.4.5.2. Quality Control and Corrective Action Plan: Contractor shall submit the Quality Control and Corrective Action Plan within 30 calendar days of award of the basic contract to KO/KS and COR for review and approval. The contractor shall submit a copy of its existing Quality Control Plan and Corrective Action Plan to the TO COR or TO KO/KS within 10 calendar days after task order award. The contractor shall submit, within 5 calendar days, any changes to the Quality Control and Corrective Action Plan to the COR, KO/KS, TO COR, TO KO/KS, and DHA Program Manager.

6.4.5.3. Spill Response Plan: The Contractor shall submit the Spill…