Pharma and Bioomedical Waste Disposal Services Draft SOW 08.28.25 - ALC-LE 9-4-2025.docx

CAMI BIOMEDICAL HAZARDOUS & PHARMACEUTICAL WASTE DISPOSAL

CIVIL AEROSPACE MEDICAL INSTITUTE (CAMI)

PHARMACUETICAL

AND

BIOMEDICAL HAZARDOUS WASTE DISPOSAL SERVICES

September 09, 2025

Prepared by Katharine T. McCauley (ABI-232)

1.0. Introduction and Overview

The Civil Aerospace Medical Institute (CAMI) is the medical certification, education, research, and occupational medicine wing of the Office of Aerospace Medicine (AAM) under the auspices of the Federal Aviation Administration (FAA’s) Office of Aviation Safety (AVS). The mission of the Aerospace Medical Research Division of CAMI (AAM-600), located at the Mike Monroney Aeronautical Center (MMAC), in Oklahoma City, OK, is “to develop new and innovative ways to support FAA regulatory and advisory missions to improve the safety of humans in civilian aerospace operations.” As such, its goal is to “Continuously maintain the Absorptive Capacity for applying Science, Medicine, Bioengineering, and Technology to unrelentingly enhance human safety.” As a result, the values promoted by the AAM-600 Division are: (1) Proactive - Taking the initiative and being prepared ahead of time, (2) Preeminent - Standing out among all others based on superior scientific achievement, and (3) Collaborative – Sharing knowledge and working with customers and stakeholders to arrive at results. The Aerospace Medical Research Division fully supports the Mission, Vision, and values of the FAA:

our stakeholders.

FAA Values:

· Safety is our passion. We work so all air and space travelers arrive safely at their destinations.

· Excellence is our promise. We seek results that embody professionalism, transparency and accountability.

· Integrity is our touchstone. We perform our duties honestly, with moral soundness, and with the highest level of ethics.

· People are our strength. Our success depends on the respect, diversity, collaboration, and commitment of our workforce.

· Innovation is our signature. We foster creativity and vision to provide solutions beyond today's boundaries.

1.1. Civil Aerospace Medical Institute Occupational Health Clinic (AAM-700) (Please revise appropriate scope of the current Clinic)

The Federal Aviation Administration (FAA) Civil Aerospace Medical Institute Clinic (CAMI) (AAM-700) provides occupational outpatient medical services to federal employees, students and international contractors to provide occupational medical surveillance, and encourage early medical management of illnesses and injuries-with an emphasis on returning employees to work quickly. CAMI services an average of 11,000 patient interactions annually.

Medical evaluation and treatment may also include limited urgent medical care activities and management of occupational illness and injury.

Other services may include:

1.2. Bioaeronautical Sciences Research Laboratory (AAM-610)

Bioaeronautical Sciences personnel perform activities regarding pilot certification and performance, aircrew health, and other factors important to aerospace safety. For example, the Forensic Toxicology and Quality Assurance teams serve as the primary national site for toxicology-testing for federal agencies, including the FAA and the National Transportation Safety Board (NTSB); the Safety Assurance team compiles and reviews health and accident data from pilots to proactively mitigate potential aviation mishaps; the Autopsy Program team, an operational team, collect, manage, and maintain all autopsy records proceeding from the investigation of U.S. fatal aircraft accidents and support the aeromedical review of said accidents; and the Knowledge Management research team support all research efforts involving information technology.

2. Scope/Requirement

CAMI intends to award a Five (5) year Contract Indefinite Delivery /Indefinite Quality (IDIQ) to a qualified vendor with capability and capacity to provide “Mail Back / On Call” Pharmaceutical and Biomedical Hazardous waste disposal services. The Contractor shall furnish all personnel, materials, tools and equipment necessary to provide the removal, transportation and disposal of all Pharmaceutical and Biomedical Hazardous waste in compliance with all current local, state and federal regulations. Medical waste will consist of isolation waste, cultures, and stocks of infectious agents, and associated biological human blood, body fluids and blood products, pathological waste, contaminated sharps miscellaneous laboratory waste, discarded dressings, and contaminated linen or disposable line substitutes. The annual requirement is as follows:

2.1. AAM-700 Pharmaceutical Waste Disposal:

Historically “Mail Back / On Call” by UPS or Fedex, dependent on the contractor preference. Estimated boxes per year 4-12 (3.4 gallons) per year.

2.2. AAM-610 Biomedical Hazardous Waste Disposal :

Historically monthly. Estimated “Red Box” supply of 30 each (Average “Red Box” Disposal Services = 15-20 bins per month)

3. Period of Performance/Place of Performance

Period of Performance is five (5) one year ordering periods from the date of award

Order Period 2

Order Period 3

Order Period 4

Order Period 5

Place of Performance for Biomedical Hazardous Waste disposal pickup on Mike Monroney Aeronautical Center (MMAC) 6500 S MacArthur, Building #13 “South Courtyard Loading Dock”, Oklahoma City , OK 73169

4. Performance Requirements

The successful contractor will be required to provide disposal for the FAA Clinic and AAM-610 Toxicology Research Laboratory located on the MMAC, Oklahoma City, OK. Types of wastes generated are identified in Section 2. Additional wastes not listed may be added to this contract at the discretion of the Government Program Manager if such wastes are identified during the process of this contract.

A Contracting Officer Representative (COR) and/or Designated Representative (AAM-600) must be assigned to this procurement, and written notification will be provided to the Contractor after award.

Schedule of work performance must be arranged through the designative COR or designated Representative of the Civil Aerospace Medical Institute Occupational Health Clinic (AAM-700) and the Bioaeronautical Sciences Research Laboratory (AAM-610) as noted in 2.1 and 2.2.

There will be no additional surcharge for gas, administrative and environmental feeds added beyond the contracted unit price per container. The Contractor is to provide evidence of liability insurance for disposal waste services outlined in the SOW.

4.1. Contractor Furnished Materials and Equipment:

The contractor will provide a Firm Fixed Price per container / or annual cost with its proposal. As the government requires service, the contractor must invoice for each container in accordance with the list submitted with its pricing proposal. The contractor must provide at the annual meeting with the COR/program manager an annual report submitted within 30 days of the end of the year, the amounts of waste recycled or disposed of the costs to the contract-by-contract line item or make available access to its business website where ongoing records will be provided.

4.2. Documentation:

4.2.1. The Contractor is required to comply with all Federal, State and local regulations, policies and procedures regarding tracking, record keeping, manifesting and documentation of all biomedical hazardous waste. The contractor will be required to comply with all changes to such Federal, State and local regulations and procedures which occur during the term of this contract. The Contractor will provide to the Government any additional certifications that may be required due to changes in such laws.

4.2.2.The Contractor will provide all manifests, land bans, certificates of destruction and recycling, and documentation that apply to the removal and disposal of the government’s pharmaceutical and biomedical hazardous wastes . The Contractor will furnish a properly executed and legible copy of the appropriate manifests required to document the safe shipment and proper disposal of biomedical hazardous waste generated by the Government under the terms of this contract.

4.2.3. Prior to the removal and transport of Pharmaceutical and Biomedical hazardous waste generated by the FAA, the Contractor will obtain approval and signature for each manifest from the FAA Facility’s COR or his/her designee verifying that the Contractor has accepted the waste from the FAA and that the waste was properly shipped for treatment or disposal. Manifests (i.e., shipping document) not signed by the COR or his/her designee will not be deemed valid.

4.2.4. Disposal Services of Pharmaceutical and Biomedical Hazardous will be normally performed during the hours of 8:00 AM and 4:00 PM, Monday through Friday, excluding National Holidays. The COR/Designated federal employee (AAM-600) is available during those hours for the approved of manifests and other required documentation, unless exigent circumstances require services during an unscheduled time period.

4.2.5. An Annual report will be provided to the Program Manager which will identify types and amounts of wastes shipped from each facility and a breakdown of the costs of services and the specific services provided. Website access is sufficient.

4.3. Capability Requirements

4.3.1.Contractor representatives who perform services under this contract must be competent, experienced and qualified to perform such services listed herein. All work performed will be first class in accordance with established good waste management practices. The Contractor will submit proof of appropriate training and experience for vendor personnel performing services under this contract.

4.3.2. It is the intent of this contract to have a 1. “Mail Back/On Call” for the CAMI Clinic and/or 2. Regular monthly disposal pickup schedule. The responsible COR or his/her designee will notify the Contractor of the necessity for the pickup for unusual circumstances outside of the normal schedule. The Contractor must coordinate all pickups with the facility COR/Designated AAM-600 employee. The Contractor will be required to pick up waste within seven (7) calendar days of telephonic notification by government representatives. .

4.3.3. The Government requires services on a recurring basis.

4.4. Identification, Check-in, Parking, and Smoking Regulations

The Contractors employees must wear visible identification at all times while on FAA premises. The Contractor employees will report to the MMAC Security Offices and coordinate Disposal Services prior to schedule with the COR or designee’s office and upon arrival on the MMAC to commencement of Disposal pickup services. When entering the MMAC, the Contractor employee must be able to provide identification compliant to the REAL ID Act. Smoking is prohibited inside any buildings at the FAA. Possession of weapons or contraband is prohibited and will subject contractor employee to arrest and termination from future performance under this contract. Enclosed containers, including tool kits, will be subject to search. Violations of FAA regulations may result in citation answerable in the United States (Federal) District Court, not a local district, state, or municipal court.

4.5. Meetings

The successful contractor will be required to coordinate activities on annual basis, and on an annual basis to address contract performance. These meetings may take place virtually (Microsoft Teams or Zoom.) Should contract deficiencies arise, meetings may be held on a more frequent basis to resolve any/all issues.

4.6. Record Keeping/Reports

The Contractor will have a centralized waste tracking system that can be used via the internet and that can export all pharmaceutical and/or biomedical hazardous waste data to the CAMI point of contract via a Microsoft Excel spreadsheet, or other manner approved by the CAMI Program Manager. The centralized tracking system will include a centralized database for all waste characterizations and determinations, a scanned or electronic copy of each hazardous waste manifests, universal bill of lading for universal wastes, methods of final (end) disposal, final (end) disposal sites, monthly, quarterly and annual waste generation reports by facility, training records, details of each invoice, anticipated and actual costs of each shipment, and a tracking system for the government’s waste.

4.7. Badges

The contractor will be responsible for obtaining an FAA issued a temporary identification badge and car decal for each employee upon initial entry to the work site. While on FAA premises, each contractor will wear their FAA identification badge at all times in accordance with FAA/MMAC current policies and directives. Further, the FAA reserves the right to direct the contractor to remove any employee who does not comply with the provisions of the contract.

5. General Definitions / Acronyms

5.1 Definitions

· Alternative Dispute Resolution (ADR) - Process for the resolution of disputes regarding work determined to be unsatisfactory.

· Aviation Safety (AVS) Quality Management System (QMS) - is committed to continuously improving the world's safest aerospace system. AVS fulfills this commitment by responding to our stakeholders, supporting the interests of the flying public, valuing the contributions of each employee, and meeting the requirements of the AVS quality management system.

· CLIN – Contract Line-Item Number. Unit of work (Service) to be performed (or delivered) by the contractor as a pay item.

· Contract Discrepancy Report – Report Issued by the Government to the contract document a supply or service found to be unacceptable during contract performance.

· Contractor- The term Contractor as used herein refers to both the prime Contractor and any subcontractor. The prime Contractor will provide a single point of contact (an employee of the prime) to coordinate all tasks, schedules and requirements. The contractor will ensure that his subcontracts (if any) comply with the provisions of this contract. The onsite supervisor must be an employee of the Prime contractor.

· Contracting Officer (CO) - One with authority to enter into, administer, and/or terminate contracts and make related determinations.

· Contracting Officer’s Representative (COR) - One who is designated and authorized in writing by the CO to be responsible for surveillance/monitoring of the Contractor's performance.

· Contractor Owned Property- All property used on this contract is owned or furnished by the Contractor.

· Contract Working Hours: The period of performance by the contractor which routine (non-emergency) services will be performed within the contract scope. The minimum coverage for which the Government will accept is defined as "8:00 AM through 4:00 PM, Monday through Friday, excluding National Holidays.”

Contractor Service Representative: Authorized service representative(s) of the Contractor who has been provided by the Contractor to the FAA in writing for the purpose of coordination and performance of service.

· Quality Assurance (QA) - Those actions taken by the Government to ensure services meet the acceptable quality level established by the contract between the Contractor and Government.

· Quality Control (QC) - Those actions taken by the Contractor to ensure Contractor performance meets the requirements of the contract.

5.2 Acronyms

(AAM) Office of Aviation Medicine (AMRD) Aerospace Medical Research Division (AMS) Acquisition Management System (AQL) Acceptable Quality Level (AVS) Office of Aviation Safety (CAMI) Civil Aerospace Medical Institute (CDR) Contract Discrepancy Report (CLIN) Contract Line-Item Number (CO) Contracting Officer (COR) Contracting Officer’s Representative (EMS) Environmental Management System (FAA) Federal Aviation Administration (FAR) Federal Aviation Regulation (FOIA) Freedom of Information Act (MMAC) Mike Monroney Aeronautical Center (NTSB) National Transportation Safety Board (OSHA) Occupational Safety and Health (QC) Quality Control (QMS) Quality Management System (SOW) Work Statement image1.png