A05 - SOW Reg. Med. Waste.pdf

Statement of Work (SOW)

1. PROJECT TITLE: Regulated Medical Waste Disposal and Transport Services

BACKGROUND/PURPOSE: As a healthcare facility, the Crow/Northern Cheyenne Hospital and Crow Service Unit (CSU) generate Regulated Medical Waste (RMW) in the normal course of patient care and clinical operations. Regulated Medical Waste includes, but is not limited to, waste contaminated with blood or other potentially infectious materials (OPIM), microbiological laboratory waste, pathological waste, and contaminated sharps.

Pursuant to the Occupational Safety and Health Administration (OSHA) Bloodborne Pathogens Standard under 29 CFR 1910.1030 and the United States Department of Transportation (DOT) regulations governing regulated medical waste under 49 CFR 173.134, this waste must be properly segregated, packaged, labeled, transported, treated, and disposed of in accordance with all applicable federal and state laws and regulations, including those enforced by the Environmental Protection Agency and the Montana Department of Environmental Quality.

Accumulation or improper disposal of RMW constitutes an unacceptable risk to patients, staff, the public, and the environment. Such waste may not be disposed of in municipal solid waste landfills. Timely removal and proper disposal of regulated medical waste is essential to maintaining compliance and supporting the Indian Health Service mission.

2. SCOPE: The Contractor shall be responsible for biweekly removal, transport, treatment, and final disposal of all regulated medical waste, including contaminated sharps at the Crow/Northern Cheyenne Hospital (CNCH), Crow Agency, Montana. This includes supplying CSU with all containers and associated hardware for mounting or securing.

Containers must comply with DOT and American National Standards Institute (ANSI) regulations and standards. The contractor shall be a qualified vendor to remove, transport and discard or destroy used sharp instruments, including but not limited to needles, scalpels, lancets, burs, and scissors.

3. MAJOR DUTIES: The Contractor shall provide complete pick-up, transportation off-site, destruction and disposal, and manifest documentation of services for regulated medical waste generated at the CSU.

a. REQUIRED METHOD OF DISPOSAL: Regulated medical waste disposed of at the IHS facility will contain certain amounts of anatomical remains. All regulated medical waste disposed of under the terms of this contract shall be accomplished in accordance with current Joint Commission (JC) Infectious Waste Management Regulations.

b. COMPLIANCE WITH ESTABLISHED REGULATORY REQUIREMENTS: The Contractor shall be subject to quality assurance standards that must meet or exceed current recognized national standards as established by the JC. The Contractor shall perform services in accordance with principles and ethics established by JC, Occupational Safety and Health Administration (OSHA) regulations, and the policies, procedures, and regulations of the IHS or any other regulation required for off-site disposal of regulated medical waste. The Contractor shall also perform in strict accordance with State regulations governing the handling, storage, transportation, destruction, and disposal and documentation of regulated medical waste. Additionally, the successful offeror shall fully comply with all United States Environmental Protection Agency (USEPA) federal regulations.

No regulated medical waste treated or untreated, resulting from this contract may leave the United States in any form or fashion. The Contractor is liable for any and all expenses related to non-compliance issues. The Contractor shall also be responsible for full compliance with the Health Insurance Portability and Accountability Act (HIPAA) of 1996, (42 CFR Parts 160 and 164). The Contractor shall handle all regulated medical waste in such a manner that guards the privacy of the patients of the IHS and guarantees all containers are locked to prevent spillage of contents and shall not be opened until destruction. The Contractor shall confirm that all employees have been trained and certified in the protection of privacy of any information contained on/in the items submitted for destruction under the terms and conditions of the resulting contract.

c. TYPES OF WASTE COVERED: The following listing specifies the most common types of medical waste, including regulated medical waste, which may be disposed of under the terms of this contract. The Government reserves the right to identify other types of waste to be disposed of under the terms of this contract. (i) Blood and Blood Products; (ii) Human Tissues; (iii) Biologicals and Pharmaceuticals; (iv) Laboratory Specimens; (v) Needles, Syringes, and other Sharps; (vi) Pathology Samples; (vii) Isolation Waste;

(viii) Cultures and Slides; (ix) Intravenous bags, and associated tubing; (x) Packaging Materials, Gloves and Gowns Associated with Waste Collection;

and (xi) Body Fluids and Excretions.

d. HANDLING AND LOADING OF VEHICLE: Currently, all medical waste is stored in a designated holding area at the CSU located at 1010 7350 E, Crow Agency MT, 59022. Handling and loading of vehicle shall be in strict compliance with current practices and regulations. Offerors may propose methods which shall be subject to the Government's approval. The method proposed shall address the logistics and any additional costs to the Government that may be incurred to facilitate such. From the time that waste is received from the CSU, IHS and any spills, damage to containers, or environmental contamination or damage caused by regulated medical waste collected shall be cleaned, repaired or corrected at the expense of the contractor.

e. DESTRUCTION FACILITIES: The Contractor shall destroy all waste accepted for disposal under the terms of this contract. The Contractor shall certify in writing that the destruction facilities of regulated medical waste are operated in compliance with and comply with all Federal, State, and local regulations which govern the destruction of regulated medical waste and the operation of destruction facilities or any other regulations required for pick-up and off-site disposal of regulated medical waste. All proposed facilities to be used by the contractor or any of its subcontractors to store, transport, transfer, and destroy regulated medical waste shall be identified by name and location to the Contracting Officer (CO). All proposed facilities and subcontractors are subject to review and approval by the CSU prior to use by the Contractor. These facilities shall be available for inspection by authorized representatives of CSU, IHS upon twenty-four (24) hour notice. The Contractor shall provide written documentation that all facilities and subcontractors who store, transport, transfer and destroy regulated medical waste are in compliance with Federal, State and local regulations. The documentation shall be submitted with the price proposal and shall be subject to IHS approval.

f. DOCUMENTATION: The Contractor shall observe all Federal, State, and local laws, or any other regulations and procedures relative to the collection, transport, handling, storage, destruction, disposal, tracking, recordkeeping, manifesting, and documenting of the handling of regulated medical waste when providing regulated medical waste removal services, and shall provide written certification, acceptable to the Government, of such compliance. The Contractor shall provide all required manifest documents to the Contract Officer Representative (COR), CSU, IHS, 1010 7650 E, Crow Agency, MT 59022. The Contractor shall fill out all portions of such documents, which apply to the activities of the Contractor and of any subcontractors under the contract. The Contractor shall document, with proper manifests, the safe shipment and proper destruction of any regulated medical waste collected. An authorized IHS employee at the facility shall sign any official manifest prior to removal of waste to verify that waste was shipped for disposal. A list of authorized IHS employees will be provided to the awarded Contractor. No manifest shall be accepted as valid if not signed by an authorized representative of the CSU, IHS and a copy delivered to the COR.

g. LICENSES AND PERMITS: The Contractor, without additional cost to the

Government, shall provide and maintain all Licenses, Permits, Vehicles, Operators, and Labor to remove regulated medical waste from the CSU locations in accordance with these requirements, all applicable specifications, and all applicable Federal, State, Municipal, and local regulations. The contractor shall provide validation of such licenses and permits upon request by the Contracting Officer or COR.

h. WEIGHING FACILITIES: The Contractor shall provide and maintain equipment on its trucks or at the IHS facilities to be used for the purpose of obtaining accurate measurements of the weight of each container collected.

The Government shall have the right to approve and inspect all such equipment. The Contractor shall provide documentation supporting/demonstrating equipment is tested at least annually for accuracy, properly maintained, calibrated and operated. Credit will be provided to the Government whenever it is determined that overcharges resulted from defective weighing equipment.

i. CONTINGENCY PLAN: The Contractor shall have in place and maintain a valid contingency plan to meet the requirements of the contract whenever regulated medical waste cannot be handled by or at the primary transportation or processing facilities due to interruption of service or failure of equipment.

The Contractor shall incur all costs associated with fulfilling this contingency plan as well as alternate contingency plans at no additional expense to the Government. Written documentation shall be made available to the Government that the contingency plan is in accordance with all Federal, State, Municipal and local specifications and regulations for the transportation, storage and disposal of regulated medical waste.

j. SERVICE REQUESTS: Contractor shall only respond to requests for service from the Contracting Officer or COR. If service is requested from any other source, the Contractor is to advise the caller of the requirement and refuse to Respond. Any billing resulting from unauthorized service will not be paid by the government.

4. REQUIREMENTS: Compliance with EPA, Montana DEQ, US DOT regulations in the transportation and disposal of regulated medical waste.

5. APPLICABLE DOCUMENTS:

29 CFR 1910.1030(g)(1)(i) 49 CFR 173.134 (B)(I)(C)(d)

6. TASKS: The Contractor shall provide:

a. Removal and disposal of all regulated medical waste generated by the Crow Service Unit during the contract period of performance.

b. Removal shall occur biweekly (every fourteen (14) calendar days/26 pickups each contracted year), unless otherwise coordinated with the Contracting Officer’s Representative (COR).

c. The Contractor shall provide an adequate supply of all necessary storage and transportation containers and packaging materials (tubs/bins/totes, red bags), required to fulfill the requirements of the resultant contract, for use in collecting the regulated medical waste by the CSU staff (estimated 255 pounds per month).

d. Shall provide a sufficient number of sharp’s containers estimated at 60 containers per month. Quantity will vary of containers collected at location.

Historically, the contractor has provided 48-gallon tote containers with lids and liners at each location at the Crow Service Unit.

e. Replacement of all used sharps containers and medical waste containers at each scheduled biweekly pickup. The Housekeeping Supervisor or his/her designee will visually verify all quantities collected and sign the pick-up manifest. Contractor shall use methods that meet all state and federal regulations, including, but not limited to Montana Infectious Waste

f. Management Rules and Laws and OSHA, and any authority having jurisdiction for states where the waste may be transported to, treated in, or disposed in. The contractor shall also be responsible for manifests and reports necessary to remove and dispose of infectious waste in accordance with all local, state, and federal regulations.

g. Shall perform all services during normal Government business hours, Monday through Friday, 8:00 a.m. to 4:30 p.m. (MST), excluding Federal holidays.

h. If a scheduled biweekly pickup date falls on a Federal holiday observed by the

Government, the contractor shall perform the required services on the next Government business day. No additional cost shall be incurred by the Government for schedule adjustments due to Federal holidays.

7. DELIVERABLES AND DELIVERY SCHEDULE:

a. Vendor shall perform first pick-up within 14 days of award.

b. Containers and hardware shall be supplied within 14 days of award

c. Any necessary hardware for mounting or securing containers shall be supplied within 30 days of award.

d. Manifest shall be completed at time of service

8. GOVERNMENT-FURNISHED EQUIPMENT AND INFORMATION: The Government will provide a designated storage area for regulated medical waste pending pickup. All contractor personnel shall check in at designated entry point prior to performing services.

9. PLACE OF PERFORMANCE: 1010 7650 E, Crow Agency MT. 59022

10. PERIOD OF PERFORMANCE: The period of performance is for a one-year base period plus four one-year option periods if exercised.

If the Government exercises the options pursuant to Federal Acquisition Regulation (FAR) 52.217-9, Option to Extend the Term of the Contract (MAR 2000) the period of performance shall be extended in accordance with the following schedule:

Base Year: 10/01/2026 – 09/30/2027 Option Year 1: 10/01/2027 – 09/30/2028 Option Year 2: 10/01/2028 – 09/30/2029 Option Year 3: 10/01/2029 – 09/30/2030 Option Year 4: 10/01/2030 – 09/30/2031

11. SECURITY: No IT or facility clearances are needed.

Statement of Work (SOW)