AMENDMENT-36C25024Q0631 0002.docx

36C25024Q0631

PERFORMANCE WORK STATEMENT

A. Title of project: Regulated Medical Waste and Sharps (Collection, Transport, Autoclave/Incineration, and Disposal) B. Purpose of the project: VA Northeast Ohio Health Care system is looking to procure regulated medical waste services and consumable items (includes boxes, bins, sharps containers, cabinets, transporters) for our main medical facility and all offsite locations.

C. Background: Environmental Management Service (EMS), Waste Management division is tasked with the oversight and responsibility for the handling of Regulated Medical Waste within the entire VA Northeast Ohio Health Care System. Our current contract is set to expire, and with the grown of the health care system, we need to ensure that we have in place a robust contract that will be able to handle this level of need.

D. Locations where work is to be performed: CBOC = Community Based Outpatient Clinic

Louis Stokes Cleveland Department of Veterans Affairs Medical Center 10701 East Boulevard Cleveland, Ohio 44106-1702 Facility Includes the following Locations: Cares Tower (8 Levels), Main Hospital (7 Levels), Atrium Tower (5 Levels), VA Annex (2 Levels), Domiciliary (4 levels) and any new/future construction that may occur to this location. Pathological/Chemotherapy waste is picked up from Animal Research Lab, Human Pathology (Morgue), and designated Biohazard storage facility.

Akron VA Clinic (CBOC) 55 West Waterloo Road Akron, Ohio 44319-1116 Facility includes the following locations: Primary and Secondary buildings, and any new/future construction that may occur to this location including movement from the current location.

Akron Infusion Center (CBOC) 95 West Waterloo Road Akron, Ohio 44319-1116 Facility includes the following locations: Primary and Secondary buildings, and any new/future construction that may occur to this location including movement from the current location.

Canton VA Clinic (CBOC) 733 Market Avenue South Canton, Ohio 44702-1018 Facility Includes any new/future construction that may occur to this location including movement from the current location.

Carl Nunziato VA Clinic (CBOC) 1815 Belmont Avenue Youngstown, Ohio 44504-1106 Facility includes any new/future construction that may occur to this location including movement from the current location.

Cleveland VA Clinic: Euclid 7000 Euclid Avenue, Suites 102 and 202 Cleveland, Ohio 44103-4014 Facility includes outpatient Dialysis, homeless care, any new/future construction that may occur to this location including movement from the current location.

Cleveland VA Clinic: Superior 8901 Superior Avenue Cleveland, Ohio 44106 Facility includes Outpatient Surgery Center, Endoscopy, PACU, any new/future construction that may occur to this location including movement from the current location.

David F. Winder Department of Veterans Affairs Community Based Outpatient Clinic (CBOC) 1025 South Trimble Road Mansfield, Ohio 44906-3427 Facility includes any new/future construction that may occur to this location including movement from the current location.

East Liverpool VA Clinic (CBOC) 15655 State Route 170, Suite A Calcutta, Ohio 43920-9672 Facility includes any new/future construction that may occur to this location including movement from the current location.

Lake County VA Clinic (CBOC) 35000 Kaiser Court Willoughby, Ohio 44094-3382 Facility includes any new/future construction that may occur to this location including movement from the current location.

Lorain VA Clinic (CBOC) 5275 North Abbe Road Sheffield Village, Ohio 44035-1451 Facility includes any new/future construction that may occur to this location including movement from the current location.

New Philadelphia VA Clinic (CBOC) 1260 Monroe Street Northwest, Suite 1A New Philadelphia, Ohio 44663-4147 Facility includes any new/future construction that may occur to this location including movement from the current location.

Parma VA Clinic 8787 Brookpark Road Parma, Ohio 44129-6809 Facility includes a 2-level structure, any new/future construction that may occur to this location including movement from the current location.

Ravenna VA Clinic (CBOC) 6751 North Chestnut Street Ravenna, Ohio 44266-3903 Facility includes any new/future construction that may occur to this location including movement from the current location.

Sandusky VA Clinic (CBOC) 1912 Hayes Avenue Sandusky, Ohio 44870-5557 Facility includes any new/future construction that may occur to this location including movement from the current location.

Summit County VA Clinic (CBOC) 111 East Voris Street, Community Resource & Referral Center (CRRC) Akron, Ohio 44311-1513 Facility includes any new/future construction that may occur to this location including movement from the current location.

Warren VA Clinic (CBOC) 1460 Tod Avenue, Northwest Warren, Ohio 44485-2407 Facility includes any new/future construction that may occur to this location including movement from the current location.

Future Locations currently in the Planning stages, and unknown address of where they will be built.

· Akron/Canton Super CBOC to include Outpatient Surgery Center and Dialysis Centers

· Kent Imaging and Infusion Center

· Lisbon CBOC

· Medina CBOC

E. Current Statistics: Current Vendor is providing pick up Regulated Medical Waste Sharp containers from Main Hospital Facility (including all sub areas listed), VA Clinic Euclid, VA Clinic Superior, and Parma CBOC. Here is a current list for FY 23 for each of these areas.

Number of Sharps Containers Picked up and recycled. Note that as volumes pick up post-COVID and adding on additional sites, the frequency and size of containers used will increase each Fiscal Year.

Sharps picked up by total weight. Note that as volumes pick up post-COVID and adding on additional sites, the frequency and size of containers used will increase each Fiscal Year.

Current vendor subcontracts out CBOC and Pathological/Chemotherapy waste. Here are the statistics of what is picked up from these locations. Note that as volumes pick up post-COVID and adding on additional sites, the frequency and size of containers used will increase each Fiscal Year.

a. Vendor will ensure any employee handling Regulated Medical Waste has received proper training and education including yearly training on using proper Personal Protection Equipment, infection control, Occupational Health, and Safety Administration (OSHA) Bloodborne Pathogens, and Resource Conservation and Recovery Act (RCRA) Hazardous Waste management.

b. Vendor will ensure any employee handling Regulated Medical Waste has received proper Department of Transportation Hazmat Ground Shipper Certification per 49 CFR 172.704.

c. Certificates will be kept on file by the Vendor and will be provided to the COR when required.

d. Any subcontractors that are used must also meet the requirements stated above and keep on file by the primary vendor to be provided to the COR when required.

e. Vendors will need appropriate security training and meet all requirements to retrieve a facility contractor ID card, keys, and other credentials needed to access all areas within the hospital that have regulated medical waste.

3. Sharps Container Requirements

a. Sharps containers will be a Food and Drug Administration (FDA) cleared sharps container and will meet or exceed the following guidelines.

i. Have FDA 510(K) Market Clearance for Product

ii. Company is registered and products are listed with FDA.

iii. Compliant with CFR 21 Part 820 Quality System Regulation and Good Manufacturing Practices

iv. Labeled with adequate directions for safe use including biohazard labeling and symbols.

v. OSHA Compliant to include.

1. Securely closable to prevent leaks or punctures per 49 CFR 173.134

2. Must be puncture resistant per 49 CFR 173.197

3. Must be marked with a Biohazard marking conforming to 29 CFR 1910.1030(g)(1)(i) per 49 CFR 178/134

4. Labeled with proper UN Shipping Name and Number per 49 CFR 171. & 172.101.

5. Permanently marked for reuse and approved & Certified by US FDA as a medical device for reuse per 49 CFR 173.197

6. Must be leak and puncture resistant on sides and bottom of the container.

vi. Allows for repeated filling and emptying container of sharps, equal to stated lifespan-uses using normal processing.

vii. Compliant with DOT Vibration Test

viii. Meets FDA cleaning-before-reuse requirements in 21 CFR 820.20, 820.30, 820.70, and 820.100.

b. Sharps containers that are utilized will not contain a vertical drop lid. All containers must have an appropriate sliding locking lid (8 Gallon and 17 gallon) or a locking counter balanced lid (2-gallon, 3-gallon, 4-gallon).

c. Sharps container sizes will include a variety of 2-gallon, 3-gallon, 4- gallon, 8-gallon, and 17-gallon or equivalent.

d. Reusable or non-Reusable Sharp containers provided by the vendor can be utilized. For environmentally sound purchasing, reusable is preferred. If Reusable sharps containers are used, they must follow the below stated guidelines.

i. The Indication for Use (IFU) for reusable sharps containers will be on file by the vendor and will be provided to COR.

ii. All Reusable sharps containers will be cleaned per the Manufacturer’s Indication for use.

iii. Reusable Sharp Containers will be cleaned using mechanical washing to ensure complete cleaning of the lid and container and to prevent any potential cross-contamination.

iv. Decontamination must be Quality Controlled tested to be at 6 LOG. VA Quality Control measure will utilize ATP Devices, and the container must be between 0-10 on the ATP Scale.

v. Reusable sharp containers will be tracked to ensure that the manufacturer Indications for use are being followed as it relates to the total amount of times the container can be properly used. This can be performed via barcode scanning, or another appropriate method.

vi. If reusable sharp containers become cracked or unusable, containers will be taken out of service immediately, and will be recycled by the company.

e. All Sharps containers will be housed in appropriate wall mounted or mobile cabinets or carts provided by the vendor for each area in which a sharp container is required.

f. All Sharps containers will be provided by the vendor.

4. Regulated Medical Waste (Biohazard)/ Pathological waste/ Chemotherapy Container requirements.

a. Vendor will provide a system that contains a large container for the collection of PPE and a small container for the collection of Sharps to all infusion areas.

b. Vendor will collect the provided trace chemotherapy system from the following infusion areas: 4A, Module J, Akron Infusion Center (Kent infusion center when it opens)

c. Any Single Use Trace Chemotherapy Containers (Yellow Boxes) that are going to be deployed outside of infusion areas will be provided by VA Northeast Ohio Health Care System, and end users/EMS will be required to appropriately box these up for shipment by the vendor.

d. The vendor will provide appropriate transport boxes for collection of Chemotherapy containers, and Single-Use Disposable Sharps containers. Appropriate bins or totes will that meet FDA requirements will be utilized for collection of Animal and Human Pathological waste. Boxes and bins will meet DOT requirements for the proper transport of chemotherapy/Pathological waste and will be UN Rated per appropriate packaging type for Regulated Medical Wastes. Reusable totes may also be utilized instead of disposable boxes. These must meet the guidelines as stated below.

e. All reusable containers and systems will be provided by the vendor.

f. Boxes and Containers will be leak resistant on the sides and the bottoms, labeled with proper UN name and code.

g. Reusable Chemotherapy Container systems and Reusable RMW Totes can be utilized. These containers must meet the following requirements.

i. The Indication for Use (IFU) for reusable trace chemo containers will be on file by the vendor and will be provided to COR.

ii. All Reusable containers will be cleaned per the Manufacturer’s Indication for use.

iii. Reusable Containers will be cleaned using mechanical washing to ensure complete cleaning of the lid and container and to prevent any potential cross-contamination.

iv. Decontamination must be Quality Controlled tested to be at LOG 6 d. VA Quality Control measure will utilize ATP Devices, and the container must be between 0-10 on the ATP Scale.

v. Reusable containers will be tracked to ensure that the manufacturer Indications for use are being followed as it relates to the total amount of times the container can be properly used. This can be performed via barcode scanning, or another appropriate method.

vi. If reusable containers become cracked or unusable, containers will be taken out of service immediately, and will be recycled by the company.

h. Reusable Containers used for the collection of all three waste streams will be free of any glue or residues and excessive labels. Reusable containers will be cleaned per manufacturer IFU and cleaning instructions. Containers will meet all requirements as stated in 49 CFR, Subtitle B, Chapter I, Subchapter C, Part 173, Subpart E, 173.197 Regulated Medical Waste. Minimum size of container will be 28-Gallon Containers, appropriately labeled for DOT Use and will have appropriate locking lids for transport.

5. Collection Requirements: SHARPS and RMW

a. Vendor will collect containers from all locations within the main medical center including those sub-listed locations, CBOCS, and offsite locations.

b. For all centers that require daily pick up of Reusable Sharps Containers, there will be a minimum of two employees and a supervisor on site. One employee without supervisor is needed to pick up single use sharps contains, trace chemotherapy and pathological waste streams.

c. Vendor will collect sharps containers from every patient room, procedure room, section/area that have sharp containers in use. Weekend/holiday work may be required to ensure that all areas have proper clean out. Weekend/holiday work will be arranged within 2 weeks of when needed by the COR & Waste Management/Recycling Coordinator.

d. It is the requirement of the vendor to ensure that there is proper staffing available to ensure that the schedule is maintained for each area and that there are no delays with services. It is recommended that the main medical center has a minimum of 2 personnel assigned to Sharps/Regulated Medical Waste Daily Monday-Friday excluding federal holidays.

e. Sharps containers will be collected when they have reached a maximum level of 2/3 full.

f. Containers housed in Outpatient areas and CBOCS that are black and labeled “RCRA /Pharmaceutical Hazardous Waste” are to be treated as both Hazardous Pharmaceutical and Medical Regulated Waste. These items will not be handled via this contract and will be handled via the appropriate VA Northeast Ohio Health Care System Hazardous Waste Contract.

g. Prior to the start of the contract, vendor will perform an in-depth walk-through of all areas within the main hospital and will create a list of all locations that contain sharps containers. A copy of this document will be used by those collecting containers and shall have the frequency of when it should be checked. This list will be provided to the COR before the first day of service.

h. Sharp Containers will be picked up within the appropriate frequencies to ensure that Regulated Medical Waste remain in a no putrescent state per Ohio Administrative Code 3745-27-35.

i. Pathological/Chemotherapy/RMW/Sharps waste will be picked up within the appropriate frequencies to ensure that Regulated Medical Waste remain in a no putrescent state per Ohio Administrative Code 3745-27-35. A minimum schedule of Every other week will be in place for those facilities that do not produce much waste to ensure compliance with Ohio Administrative Code.

j. Contracted employees will work Monday through Friday, 0700-1730. This time will allow for the vendor to enter areas that are occupied by health care providers providing care to our Veterans. Some after normal business hours work may be needed, with advance notice of the COR, in specialty areas. Below is a minimum schedule of when sharps and RMW should be exchanged or picked up. In the case of holidays, pick up times will be arranged between the COR and the Vendor.

ATRIUM

MAIN HOSPITAL

VA ANNEX

AKRON

(55 AND 95 EAST WATERLOO)

k. Collection efforts will be monitored by the COR via collection of site reviews and walk-throughs to ensure that all areas are being serviced. Other collection efforts will be made through communications received from service areas. This data will be collected and communicated to the Contracting Officer and Vendor via email and written report.

l. Vendor will provide staff with appropriate PPE needed to perform their job. Staff working for the vendor and performing the task of collections will meet or exceed existing trade worker salary requirements as presented by the VA contracting officer.

m. After hours work may need to be performed for those areas that have significantly high patient care (ie. Outpatient clinics, Operating Room).

n. Areas that are considered sterile areas, will require the vendor to don appropriate PPE for the area. This is not limited to gloves, face mask, shoe covers, beard covers, one piece Tyvek suits, and gowns.

o. On-site personnel will remove all PPE when they walk through common hallways and floors. The only exception will be a face mask when required by VA Northeast Ohio Health Care System COVID-19 Guidelines.

p. VA Northeast Ohio Health Care System, Louis Stokes Cleveland VA Health Center currently performs steam autoclavation of in-house Biohazard waste. If this sterilizer should ever go down, or the platform for sterilization is being changed over to newer technology, this contract will then cover the emergency pick up of such biohazardous waste. This waste will be required to be picked up daily Monday through Friday, with potential Saturday pick up as well upon activation by the COR. This process will continue until the COR deactivates the emergency pick up schedule.

6. Transport Requirements: Sharps and RMW

a. Vendors will transport regulated medical waste via DOT approved transportation trucks, marked with biohazard symbols and appropriate UN Code markings.

b. Contaminated Sharps Containers and other Regulated Medical Waste containers will not be transported at the same time as Clean Sharps Containers and other Regulated Medical Waste Collection bins/boxes. This process will prevent potential cross contamination.

c. Vendors will be required to submit a Regulated Medical Waste manifest to the appropriately trained VA Staff member for signature. The initial manifest and a copy of any scanned records will remain within the medical center/CBOC/Offsite for their records. A copy of every manifest from all locations once signed as received by final distribution point will be emailed to the VA Northeast Ohio Health Care System Waste Manager and COR monthly.

d. On-Site personnel must complete yearly Shipping Regulated Medical Waste course and a proper Hazmat Ground Shipper Certification course as dictated in 49 CFR 172.704.

7. Regulated Medical Waste Treatment and Disposal

a. Regulated Medical Waste collected from the VA Northeast Ohio Health Care system will be transported to an infectious waste treatment facility regulated by the Ohio Environmental Protection Agency, Ohio County Health Department, or Equivalent.

b. Medical Waste Treatment facilities may be inspected by the VA Northeast Ohio Health Care System by the COR and/or Waste Manager to ensure compliance with standards. All inspections performed by State or County officials within the Medical Waste Treatment facility must be submitted to the COR and waste manager once final report is received.

c. The preferred method of destruction for Pathological and animal waste is Incineration per Ohio Administrative Code. For sharps, the required method of destruction is by steam sterilization via autoclave. Incineration and Steam Sterilization treatment (even if performed outside the state of Ohio) must conform to the requirements of Ohio Administrative Code 3745-27-32 or exceed the requirements of the code.

d. If Incineration/Steam Sterilization/other method of destruction is used within the State of Ohio or in any other state, the vendor must comply with Local, State, and National regulations. Vendors must ensure that they pass inspections without major incident. All inspection reports must be forwarded to the COR and Waste Management/Recycling Coordinator.

e. Alternative methods of destruction being used must be approved within the state they reside and documentation of such must be presented to the COR and Waste Management/Recycling Coordinator.

f. Reusable sharps containers, totes, and tubs used for regulated medical waste will be appropriately cleaned per the IFU of the device. VA Northeast Ohio Health Care System mandates the use of a mechanical cleaning system for all reusable containers to ensure a proper water to soap ratio and to ensure complete bioburden/biofilm elimination.

g. Disposal of Regulated Medical Waste after the process of incineration or autoclave steam sterilization is regulated by Ohio Administrative Code 3745-27-32 or equivalent state regulation.

8. Final Distribution, Paperwork, Quality Assurance

a. All manifests will be sent via email to the COR and waste manager monthly.

b. A monthly report like the sample below will be delivered monthly to the COR and waste manager. This will be repeated for all sharps containers, pathological and chemotherapy boxes that are picked up. This is required for the VA to enter our Waste Tracking Data per VHA Directive 1850

c. Reports will be delivered by the third week of month following the month serviced. For example, July reporting will be delivered no later than the 3rd week of August.

d. COR and Waste Manager will perform quality assurance audits through the collection, transport, processing, and destruction process to ensure compliance with Federal and state standards.

e. Contract will start prior to the end of the Fiscal Year, and a smooth hand off will be conducted between contractors to ensure no delay in patient care.

f. If changes in the type of cabinets and sharps containers are needed, this will be conducted in a phased approach and there may be a time where both vendors are covering the hospital at the same time.

g. All equipment for the initial startup and installation will be provided by the vendor. Installation of any equipment will be provided by the Vendor or an appropriate subcontractor. Installation phases will be presented by the COR at the time of installation.

h. Vendor is required to apply for and maintain all Federal, State, and Local Permits (not limited to air permits and infectious waste permits) and provide a copy of such permits to the COR and Waste Manager.

i. Contractor must perform a minimum of 51% of the entire contract without subcontracting.

j. Many items placed in hazardous waste disposal receptacles may contain Private Health Information (PHI) due to the placement and non-removal of identifying information. This includes patient labels on IV bags, blood tubes, cultures, and other medical objects. Sharps containers may contain PHI, therefore contents containing PHI shall be destroyed so that it is not readable or re-constructible.

9. Additional Services/products

a. Any additional supplies, cabinets, or accessories for the collection of Regulated Medical Waste, may be billed to this contract with the authorization of the COR.

b. Vendor, in collaboration with the Waste Management Coordinator, will provide Regulated Medical Waste related training to end users of the VA Northeast Ohio Health Care System and make this training available for Continuing Education Unit Hours. This training when requested will be provided Annually.

c. Vendor and COR will have weekly meetings upon start of the contract. These meetings will move to monthly after efficient contract start-up.

10. Security Requirements

a. Service & Maintenance will follow the security requirements as per VA’s Medical Device Protection Program (MDPP) which protects VA’s medical devices through a comprehensive security initiative that encompasses pre-procurement assessments, medical device isolation architecture (MDIA), communication, validation, scanning, access control list remediation, patching, and secure remote connectivity.

b. On-Site representatives will be required to obtain a VA Personal Identity Verification (PIV) Card and pass a background investigation.

c. For further requirement of the contractor (PIV) Card. Process please view How To Get a VA PIV Card - Office of Operations, Security, and Preparedness

d. Many items placed in hazardous waste disposal receptacles may contain Private Health Information (PHI) due to the placement and non-removal of identifying information. This includes patient labels on IV bags, blood tubes, cultures, and other medical objects. Sharps containers may contain PHI, therefore sharps containers shall not be opened and contents containing PHI shall be destroyed so that it is not readable or re-constructible.

11. General Security

a. Contractors, contractor personnel, subcontractors, and subcontractor personnel shall be subject to the same Federal laws, regulations, standards, and VA Directives and Handbooks as VA and VA personnel regarding information and information system security.

12. Check - In Requirements

a. The Contractor must report to the assigned POC to sign in with staff before work begins. Additionally, one must submit any mobile media devices that would be used on the system for a virus scan. Upon completion of work, the Contractor must report to Assigned POC to brief or Covering Staff if Supervisor is unavailable concerning completion of service, and then to sign out. At the end of each briefing, Contractor will and must sign out.

13. VA Information Custodial Language

a. Information made available to the contractor or subcontractor by VA for the performance or administration of this contract or information developed by the contractor/subcontractor in performance or administration of the contract shall be used only for those purposes and shall not be used in any other way without the prior written agreement of the VA. This clause expressly limits the contractor/subcontractor's rights to use data as described in Rights in Data - General, FAR 52.227-14(d) (1).

b. The contractor/subcontractor must store, transport, or transmit VA sensitive information in an encrypted form, using VA-approved encryption tools that are, at a minimum, FIPS 140-2 validated.

PRICE/COST SCHEDULE

Contractor shall provide all necessary labor, management, equipment, deliverables, and vehicles to establish general waste and recycling program in accordance with the Statement of Work Statement.

Estimated Quantities: The Government has provided its best estimate as to the number of items/units along with pounds (lbs.) that will be required over the base period. The need for services may change due to the needs of the medical center. There is no guarantee that the exact number of items/units listed in the price schedule will be always needed.

Minimum Guarantee: The minimum guarantee for this contract is $400,000.00 over the life of the contract.

Maximum Contract Value: The maximum value of this contract shall be no more than $5,000,000.00 over the life of the contract.

The government does not guarantee that it will place any orders under this contract in excess of the guaranteed minimum amount stated above.

Billing: While the contract is estimated, the contractor shall bill in arrears monthly. The Contractor shall bill by Line-Item numbers equaling the total number for the month. Invoices submitted through Tungsten shall include all requirements of the Billing and Invoicing section of this solicitation and FAR 52.212-4(g) to have payments certified.

14.

Regulated Medical Waste, Sharps (In-house Sharps Pick-up, hauling, and autoclaving) Contract Period: Ordering Period One POP Begin: 10-01-2024 POP End: 09-30-2025 PRINCIPAL NAICS CODE: 562112 - Hazardous Waste Collection PRODUCT/SERVICE CODE: S222 - Housekeeping - Waste Treatment/Storage

Regulated Medical Waste, Sharps (In-house Sharps Pick-up, hauling, and autoclaving) Contract Period: Ordering Period Two POP Begin: 10-01-2025 POP End: 09-30-2026

Regulated Medical Waste, Sharps (In-house Sharps Pick-up, hauling, and autoclaving) Contract Period: Ordering Period Three POP Begin: 10-01-2026 POP End: 09-30-2027

Regulated Medical Waste, Sharps (In-house Sharps Pick-up, hauling, and autoclaving) Contract Period: Ordering Period Four POP Begin: 10-01-2027 POP End: 09-30-2028

Regulated Medical Waste, Sharps (In-house Sharps Pick-up, hauling, and autoclaving Contract Period: Ordering Period Five POP Begin: 10-01-2028 POP End: 09-30-2029

Regulated Medical Waste, Biohazard/Trace Chemo/Pathological (In-house Pick-up, hauling, and autoclaving vs. Incineration)

POP Begin: 10-01-2024 POP End: 09-30-2025

Regulated Medical Waste, Biohazard/Trace Chemo/Pathological (In-house Pick-up, hauling, and autoclaving vs. Incineration)

POP Begin: 10-01-2025 POP End: 09-30-2026

Regulated Medical Waste, Biohazard/Trace Chemo/Pathological (In-house Pick-up, hauling, and autoclaving vs. Incineration)

POP Begin: 10-01-2026 POP End: 09-30-2027

Regulated Medical Waste, Biohazard/Trace Chemo/Pathological (In-house Pick-up, hauling, and autoclaving vs. Incineration)

POP Begin: 10-01-2027 POP End: 09-30-2028

Regulated Medical Waste, Biohazard/Trace Chemo/Pathological (In-house Pick-up, hauling, and autoclaving vs. Incineration) Contract Period: Ordering Period Five POP Begin: 10-01-2028 POP End: 09-30-2029

15.

10001

Consumable Items (includes boxes, bins, sharps containers, cabinets, transporters)

POP Begin: 10-01-2024 POP End: 09-30-2025

11001

Consumable Items (includes boxes, bins, sharps containers, cabinets, transporters)

POP Begin: 10-01-2025 POP End: 09-30-2026

12001

Consumable Items (includes boxes, bs bins, sharps containers, cabinets, transporters)

POP Begin: 10-01-2026 POP End: 09-30-2027

13001

Consumable Items (includes boxes, bins, sharps containers, cabinets, transporters)

POP Begin: 10-01-2027 POP End: 09-30-2028

14001

Consumable Items (includes boxes, bins, sharps containers, cabinets, transporters)

POP Begin: 10-01-2028 POP End: 09-30-2029

15001

Trace Chemo Sharps Systems and Trollies (Large bin for PPE, Small Bin for Sharps)

POP Begin: 10-01-2024 POP End: 09-30-2025

16001

Trace Chemo Sharps Systems and Trollies (Large bin for PPE, Small Bin for Sharps)

POP Begin: 10-01-2025 POP End: 09-30-2026

17001

Trace Chemo Sharps Systems and Trollies (Large bin for PPE, Small Bin for Sharps)

POP Begin: 10-01-2026 POP End: 09-30-2027

18001

Trace Chemo Sharps Systems and Trollies (Large bin for PPE, Small Bin for Sharps)

POP Begin: 10-01-2027 POP End: 09-30-2028

19001

Trace Chemo Sharps Systems and Trollies (Large bin for PPE, Small Bin for Sharps)

POP Begin: 10-01-2028 POP End: 09-30-2029

TOTAL PRICING OF CONTACT

ORDERING PERIOD ONE:

October 1, 2024, through September 30, 2025

ORDERING PERIOD TWO:

October 1, 2025, through September 30, 2026

ORDERING PERIOD THREE:

October 1, 2026, through September 30, 2027

ORDERING PERIOD FOUR:

October 1, 2027, through September 30, 2028

ORDERING PERIOD FIVE:

October 1, 2028, through September 30, 2029

GRAND TOTAL OF CONTRACT

52.216-18 ORDERING (OCT 1995)

(a) Any supplies and services to be furnished under this contract shall be ordered by issuance of delivery orders or task orders by the individuals or activities designated in the Schedule. Such orders may be issued from 10-1-2024 through 09-30-2029.

(b) All delivery orders or task orders are subject to the terms and conditions of this contract. In the event of conflict between a delivery order or task order and this contract, the contract shall control.

(c) If mailed, a delivery order or task order is considered "issued" when the Government deposits the order in the mail. Orders may be issued orally, by facsimile, or by electronic commerce methods only if authorized in the Schedule.

C.3 52.216-19 ORDER LIMITATIONS (OCT 1995)

(a) Minimum order. When the Government requires supplies or services covered by this contract in an amount of less one pickup per week, the Government is not obligated to purchase, nor is the Contractor obligated to furnish, those supplies or services under the contract.

(b) Maximum order. The Contractor is not obligated to honor—

(1) Any order for a pickup more than five times per day;

(2) Any order for a combination of items in excess of 120% of the annual estimate

(3) A series of orders from the same ordering office within 1 day that together call for quantities exceeding the limitation in paragraph (b)(1) or (2) of this section.

(c) If this is a requirements contract (i.e., includes the Requirements clause at subsection 52.216-21 of the Federal Acquisition Regulation (FAR)), the Government is not required to order a part of any one requirement from the Contractor if that requirement exceeds the maximum-order limitations in paragraph (b) of this section.

(d) Notwithstanding paragraphs (b) and (c) of this section, the Contractor shall honor any order exceeding the maximum order limitations in paragraph (b), unless that order (or orders) is returned to the ordering office within 10 minutes after issuance, with written notice stating the Contractor's intent not to ship the item (or items) called for and the reasons. Upon receiving this notice, the Government may acquire the supplies or services from another source.

The maximum value of the contract: $5,000,000.00 The minimum value of the contract: $400,000.00 (End of Clause)

52.216-22 INDEFINITE QUANTITY (OCT 1995)

(a) This is an indefinite-quantity contract for the supplies or services specified, and effective for the period stated, in the Schedule. The quantities of supplies and services specified in the Schedule are estimates only and are not purchased by this contract.

(b) Delivery or performance shall be made only as authorized by orders issued in accordance with the Ordering clause. The Contractor shall furnish to the Government, when and if ordered, the supplies or services specified in the Schedule up to and including the quantity designated in the Schedule as the "maximum." The Government will order at least the quantity of supplies or services designated in the Schedule as the "minimum."

(c) Except for any limitations on quantities in the Order Limitations clause or in the Schedule, there is no limit on the number of orders that may be issued. The Government may issue orders requiring delivery to multiple destinations or performance at multiple locations.

(d) Any order issued during the effective period of this contract and not completed within that period shall be completed by the Contractor within the time specified in the order. The contract shall govern the Contractor's and Government's rights and obligations with respect to that order to the same extent as if the order were completed during the contract's effective period; provided, that the Contractor shall not be required to make any deliveries under this contract after 09-30-2025.

(End of Clause)

52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)

The Government may require continued performance of any services within the limits and at the rates specified in the contract. These rates may be adjusted only as a result of revisions to prevailing labor rates provided by the Secretary of Labor. The option provision may be exercised more than once, but the total extension of performance hereunder shall not exceed 6 months. The Contracting Officer may exercise the option by written notice to the Contractor within the last 30 days contract expiration date.

(End of Clause)

52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000)

(a) The Government may extend the term of this contract by written notice to the Contractor within the last 30 days contract expiration date; provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least 60 days before the contract expires. The preliminary notice does not commit the Government to an extension.

(b) If the Government exercises this option, the extended contract shall be considered to include this option clause.

(c) The total duration of this contract, including the exercise of any options under this clause, shall not exceed five (5) years.

(End of Clause)

52.212-2 EVALUATION—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (NOV 2021)

Authority for this solicitation is FAR Part 13 (Simplified Acquisition Procedures). The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforms to the solicitation requirements. The following factors shall be used to evaluate conforming quotes: (1) Technical Capability (2) Past Performance and (3) Price. Technical Capability and Past Performance when combined are more important than Price.

Contents of the written quotes will be evaluated to determine the degree and extent to which the requirements set forth in the Request for Quote (RFQ) and PWS are satisfied. The Government reserves the right to award without discussions.

TECHNICAL CAPABILITY EVALUATION APPROACH

The contractor shall meet the following requirements:

· The contractor shall have experience in providing Regulated Medical Waste and Sharps (Collection, Transport, Autoclave/Incineration, and Disposal.)

· The contractor must have been providing Regulated Medical Waste and Sharps (Collection, Transport, Autoclave/Incineration, and Disposal) removal to either a VA Medical Center or other Similar Healthcare Environments for a minimum of three consecutive years prior to submitting quote.

· The contractor must provide evidence that they are able to handle the amount of volume contained within the Statement of Work for a Major 1A level Medical Facility by showing workflows at other facilities they are currently performing work for.

PAST PERFORMANCE EVALUATION APPROACH

· The Past Performance Approach will be evaluated based on the narrative, Past Performance Questionnaires (PPQs), and other Government sources for quality, timeliness, and relevance (i.e., experience in providing services similar in size, scope, and complexity as described in the PWS. The Government will make determination of relevance. If no past performance information is readily available. the Offeror’s past performance will not be evaluated favorably or unfavorably.

· The Government will evaluate the offerors past performance based on recent and relevant projects that they have been completed as a Contractor. Offerors shall provide a minimum of three (3) references with their quote. Recent is defined as a project performed within the last three (3) years. Relevant is defined a project for an organization that is similar in volume of service provided. Ensure phone number and email contact information is correct for your references. In addition to the past performance references listed with the quote, contractors are encouraged to have references complete the Past Performance Questionnaires, these questionnaires are to be sent directly from the company giving references to the Contracting Officer by email.

· The contractor should have past performance in the private sector and/or Federal government, in providing services similar in size, scope, and complexity as described in the PWS.

· The government will evaluate information in CPARS, FAPIIS, and personal knowledge of offerors.

PRICE EVALUATION APPROACH

· The Government will evaluate quotes by adding the total of all line-item prices, including all years. The Government will evaluate price reasonableness and in an overall best value determination.

PAST-PERFORMANCE QUESTIONNAIRE

Offerors Name and Contract Number: ____________________________________________ Contract Type and Dollar Value: ____________________________________________ Contract Start/End Dates: __________________________________________________ Brief Description of work: __________________________________________________

Name of Evaluator:

Position Title and Telephone Number:

Date

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