Attachment A- Statement of Work.pdf

Statement of Work Charlie Norwood VA Medical Center (Uptown & Downtown Campuses)

Augusta Georgia Reusable Sharps Container

1. General

1.1. Services:

Contractor to furnish all supplies & labor to operate and manage a sharps waste container exchange system. This is a total turnkey service where contractor staff will order, deliver, handle, change out, transport, treat and dispose of all sharp related waste streams in strict accordance with all Federal, State and local regulations. Service is to be provided at the Augusta

VAMC on a regularly scheduled basis. Includes distribution, collection and disposal system at the Augusta VAMC (Downtown Facility), 800 Bailie Street, Augusta Ga, 30904; VAMC

Augusta (Uptown Facility), 1 Freedom Way, Augusta Ga, 30904; VAMC Augusta (Athens

CBOC), 9249 HWY. 29S - Suite A, Athens, Ga, 30601, Statesboro VA Clinic 658Northside Dr

E, Statesboro, GA 30458 and the VAMC Augusta (Aiken CBOC), 951 Millbrook Ave, Aiken

SC.

This service agreement is for approximately 1290 sharps container locations which shall be provided and serviced by Contractor. Containers must be approved by Infection Control prior to contract award.

This program shall not include chemotherapy waste sharps containers, as this waste stream should be managed as hazardous waste versus medical waste.

1.2. Period of Performance:

1. The term of this agreement shall be (1) base year with (4) option years.

Base Year May 1, 2023, through April 30, 2024

Option Year 1 May 1, 2024, through April 30, 2025

Option Year 2 May 1, 2025, through April 30, 2026

Option Year 3 May 1, 2026, through April 30, 2027

Option Year 4 May 1, 2027, through April 30, 2028

1.3 Place of Performance:

Augusta VAMC (Dwntwn), 800 Bailie Street, Augusta Ga, 30904; Tuesdays 8am – 4:30 pm Augusta VAMC (Uptwn), 1 Freedom Way, Augusta Ga, 30904; Wednesdays 8am – 4:30 pm Athens CBOC, 9249 HWY. 29S - Suite A, Athens, Ga, 30601 (on-call basis only) Aiken CBOC, 951 Millbrook Ave, Aiken SC, 29803 (on-call basis only)

Statesboro CBOC, 658Northside Dr E, Statesboro, GA 30458 (on Call basis only)

Contractor shall schedule services Monday through Friday, 8am – 4:30pm, excluding Federal Holidays, unless other arrangements are made in advance with the COR. Contractor shall report to the EMS Office (or information booth at the CBOC locations) upon arrival and departure at the respective VAMC facility. They will be issued a contractor name badge that must be properly worn for identification while performing the work under this contract.

1.4 Background:

The CNVAMC currently has a requirement for reusable sharps container services. Determination was made in 2008 that the use of a reusable sharps service would reduce supply costs, divert plastic waste from depositories, and would result in a reduction of labor. Contractor shall provide service to collect each individual sharps container at the Medical

Center/Clinic and replace with reusable sterilized container. This service will be accomplished each week. This will require the collectors to gown up, check in, discreetly enter and move about the various locations, and service every room and crash cart equipped with a sharps container.

Contaminated sharps containers shall be cleaned, sterilized and reused. All sharps shall be properly disposed of in accordance with all local state and federal regulations.

1.5 Acronyms and Definition:

1.5.1.1. CBOC – Community Based Outpatient Clinic

1.5.1.2. CDL – Commercial Driver’s License

1.5.1.2. CNVAMC – Charlie Norwood Veterans Affairs Medical Center

1.5.1.3. COR – Contracting Officer’s Representative

1.5.1.4. EMS – Environmental Management Service

1.5.1.5. ISO – Information Security Officer

1.5.1.6. PII – Personally Identifiable Information

1.5.1.7. PIV – Personal Identification Verification

1.5.1.8. QASP – Quality Assurance Surveillance Plan

1.5.1.9. TSD – Treatment, Storage and Disposal

1.5.1.10. UN – United Nations

1.5.1.11. USDOT – United States Department of Transportation

1.5.1.12. VA – Veterans Affairs or Department of Veterans Affairs

1.5.1.13. VAMC – Veterans Affairs Medical Center

1.5.1.14. VHA – Veterans Health Administration

1.5.2. Publications:

1.5.2.1. VA Handbook 6500.1 - https://www.va.gov/vapubs/

1.5.2.2. VA Handbook 6500.2 - https://www.va.gov/vapubs/

2. Personnel

2.1. Key Personnel:

Name Position License / Certification /Experience

Percentage of Work Under Contract

3. Hours of Operation:

3.1. Business Hours

8:00am – 4:30pm, Monday – Friday, excluding Federal Holidays.

Federal Holidays

New Year’s Day January 1st

Martin Luther King’s Birthday 3rd Monday in January President’s Day 3rd Monday in February Memorial Day Last Monday in May Juneteenth June 19 (Determined by Federal observance)

Independence Day July 4th Labor Day 1st Monday in September Columbus Day 2nd Monday in October Veteran’s Day November 11th https://www.va.gov/vapubs/ https://www.va.gov/vapubs/

Thanksgiving Day Last Thursday in November Christmas Day December 25th

3.1.2. Work schedule

The Contractor shall be available to perform services during the normal business hours of 8:00am – 3:30pm, Monday – Friday, excluding Federal Holidays.

4. Government Responsibilities:

4.1. A Contracting Officer Representative (COR) shall be designated and is responsible for local contract administration issues such as ordering and providing specific delivery instructions. A letter of delegation that outlines the COR’s specific responsibilities shall be provided to the contractor at the time of contract award.

5. Contractor Performance Requirements and Responsibilities:

5.1. Contractor shall provide sharp containers that are puncture resistant, leak proof, tamper proof, UN and USDOT approved, appropriately labeled and compliant with all federal, state an d local regulations. All mobile carts and bulk transport carts must have wheels and be clean and in good repair at all times. Minimum requirements for the reusable sharp’s containers are as follows:

1. Reusable

2. Puncture Proof

3. Must arrive at the medical center fully assembled

4. Leak proof in all orientations

5. One hand/one step disposal mechanism

6. Overfill protection design feature built into container (i.e., container must close off automatically once fill point has been reached)

7. Secure/Tamper-Proof to include temporary and permanent locking design features

8. Sight/View port that shows when the container is full

9. 12” Large access Horizontal Drop opening with safety tray restricting hand access for public access areas and open top unrestricted access for secure areas such as lab and OR

10. Available in various sizes dependent upon need (2, 4, 8 & 16 Gallon)

11. Must have a barcode tracking feature on each container for safety and accountability

13. Able to be sanitized using a six-stage wash process to include environmentally friendly cleaning agents to ensure a high level of microbiological efficacy

14. Must meet U.S. Department of Transportation regulations

15. Must be certified to United Nations PG2 specifications for transport of dangerous goods

16. Must be labeled in accordance with Federal, State, Local regulations

5.2. All containers and/or outer cabinets shall be clearly labeled with the biohazard symbol and the word “biohazard” as required by local, state and federal regulations.

5.3. An estimated 5,575 annual “turns” are expected to occur based upon historical workload. A “turn” represents each time a container is determined to be full and is physically changed out and replaced by a clean container. Total annual pounds are estimated at 32,131.

5.4. Contractor shall supply at no additional charge, all necessary locking mounting wall brackets and floor dollies where needed.

5.5. Where containers are fastened to the wall or cart, contractor shall provide lockable hardware for security purposes.

5.6. Collection services shall be scheduled at least once per week, unless otherwise specified.

Contractor shall check, collect and replace all containers to avoid overfilling on a regularly scheduled basis. At a minimum, services are to include:

a. Replacing containers on a set frequency avoiding overfilling and disruption to healthcare providers

b. Delivering carts and container replacements on the day of service.

c. Transporting all waste off the VA premises at the completion of that day's container exchange.

d. Any rooms or areas inaccessible to service must be reported to the COR or designee before moving to next area.

5.7. Contractor shall schedule services Monday through Friday, 8am – 4:30pm, excluding Federal Holidays, unless other arrangements are made in advance with the COR. Contractor shall report to the EMS Office upon arrival and departure at the respective VAMC facility. They will be issued a contractor name badge that must be properly worn for identification while performing the work under this contract and returned to the VA Police upon departure.

5.8. Sharps containers must be changed every week in high generation areas to such as emergency departments, blood drawing rooms, Operating Rooms, and intensive care units to avoid overfilling, Containers in all other lower generation areas are changed prior to filling up (never more than 3/4 full).

5.9. All reusable sharp containers must be delivered to the VAMC clean and disinfected after each use in accordance with local, state and federal regulations.

5.10. Contractor shall provide in-service training on the use, handling, and care of the reusable sharps containers and proper segregation of medical sharps waste from other medical waste, at no additional cost to the Government. Training shall be documented and shall be provided 24-7 during initial installation to ensure that training is available to all employees.

Contractor shall provide in–service training videos or DVDs for staff not available at the time of training at no additional cost to the Government.

5.11. All contractor personnel entering into the VA to perform any part of the service must be employees of Contractor and trained in accordance with all Federal, State and local laws and regulations in the handling of Medical Waste and Sharps. All personnel must be familiar with the medical center's procedures and etiquette and adhere to Medical Center Infection Control requirements.

5.11.1. Contractor must have experience servicing similar hospitals with sharps containers for an extended period of time. Contractor shall have infrastructure to handle all applicable issues related to sharps waste disposal and service.

5.11.2. Contractor must arrive on collection days with a fully permitted vehicle for use in collecting and transporting waste.

5.11.3. All containers shall be labeled and packaged for shipping and transport by Contractor as required, in accordance with all federal, state and local laws and regulations. Contractor shall provide a copy of the following to the Contracting Officer not later than ten (10) calendar days prior to the start of this contract:

5.11.4. Copy of Hazardous Material CDL for each employee who will be driving transport trucks

5.11.5. Proof of employee training, including Bloodborne Pathogen Training and Waste Handling, annually

5.11.6. Location of the TSD Facility and any subcontractors

5.11.7. Contingency Plan for Emergency Response and Clean up.

5.11.8. Vendor shall provide a list of all TSD facilities used (final proof/documentation may be required). These facilities are subject to inspection by the VA at any time. Advanced notification will be given by the COR.

5.11.9. Contractor shall provide evidence of insurability. The minimum limits of the insurance policy shall be 1 million (1,000,000.00) dollars for the transport of Regulated Medical

Waste. Compliance with insurance provisions “General Liability”, “Workman’s Compensation” and “Evidence of Coverage” is required.

5.11.10.Contractor is responsible for providing and completing the Medical Waste Manifest shipping documents, with all required information annotated, for the medical center. No regulated medical waste is permitted to leave the VAMC until the manifest is signed by an authorized medical center person (Environmental Management Service Supervisor, or designee) and a copy of this manifest provided to this VA official. This Manifest shall contain the VAMC location name and address, designation of the treatment site and certification that untreated medical waste has been properly handled, packaged and labeled by the contractor in accordance with all applicable regulations.

5.11.11.Contractor is responsible for ensuring copy #1 (generator copy) of medical waste manifest document is received within thirty (30) days of the date was accepted by the vendor. Additionally, Contractor shall provide a monthly poundage summary report detailing the quantity of sharps disposed of during the reporting month. These documents shall be mailed to the Chief, EMS, (contact information available upon award).

5.11.12.Contractors are urged and expected to inspect the site and to satisfy themselves regarding all general and local conditions that may affect the cost of contract performance, to the extent that the information is reasonably obtainable. In no event shall failure to inspect the site constitute grounds for a claim after the contract has been awarded. All site visits must be arranged with the COR.

Quality Assurance Specifications and Requirements:

Task ID Indicator Standard Acceptable

Quality Level

Method of

Surveillanc e

Rating

Monthly

Reports

Vendor to provide monthly poundage summary of

Sharps disposed of.

(para 5.18)

Vendor to provide report of how much sharps in pounds was disposed of within monthly

Shall be provided at least 15 days after last workday of month.

Periodic

Inspection

Satisfactory = reports received on time

Unsatisfactory = not received on time or not at all

Monthly

Invoices

Vendor to provide accurate and timely monthly invoices (para

7.1.1)

Vendor to provide accurate and timely invoices clearly stating all dates, quantities, weights and rates of services received monthly

Shall be provided at least 15 days after last workday of month.

Periodic

Inspection

Satisfactory = reports received on time

Unsatisfactory = not received on time or not at all

Daily Reports

All waste containers properly serviced as indicated in contract

SOW (para

5.1, 5.2, 5.6,

5.8 and 5.9)

Waste containers shall be serviced as outlined in

SOW

schedule

100% compliance

Validated

User/Custo me r Complaint

Satisfactory = 95% or greater effectiveness level

Unsatisfactory =

>%95 effectiveness level

Professiona l

Customer

Service customer service received by

VA (para 5.11)

Professional and courteous customer service provided by contractor at all times.

customer service received by VA

100% of the time.

Customer sa tisfa ction surveys, quarterly

Per Quarter: Excellent =0 complaints.

Sa tisfa ctory=<2 complaints.

Unsa tisfa ctory=>3 complaints.

7. Invoicing:

7.1.1. Payment shall be made monthly in arrears upon receipt of a properly prepared detailed invoice and validated by the COR. Invoices must be sent electronically through OB10 Payment

System in Austin, Texas.

7.1.2. A properly prepared invoice shall contain:

• Invoice Number and Date services were provided

• Contractor’s Name and Address

• Accurate Purchase Order Number

• Description of Supply or Service provided

• Total amount due

8. Special Contract Requirements

PER REVIEW OF VA HANDBOOK 6500.6, CONTRACT SECURITY, APPENDIX A-

INFORMATION SECURITY AND PRIVACY CHECKLIST:

• “The C&A requirements do not apply, and a Security Accreditation Package is not required.”

• Acquisition of this service does not involve the storage, generating, transmitting, or exchanging of VA sensitive information to the vendor

• There may exist exposure to VA sensitive information, to sensitive personal information

(SPI) while implementing contractual services

Minimum Statutory Requirements

Prohibition on unauthorized disclosure: 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). See VA Handbook 6500.6, Appendix C, paragraph 3.a.

Requirement for data breach notification: Upon discovery of any known or suspected security/privacy incidents, or any unauthorized disclosure of sensitive information, including that contained in system(s) to which the contractor/subcontractor has access, the contractor/subcontractor shall immediately and simultaneously notify the COR, the designated

ISO, and Privacy Officer for the contract. The term ‘security incident’ means an event that has, or could have, resulted in unauthorized access to, loss or damage to VA assets, or sensitive information, or an action that breaches VA security procedures. See VA Handbook 6500.6, Appendix C, paragraph 6.a

Requirement to pay liquidated damages in the event of a data breach: Consistent with the requirements of 38 U.S.C. §5725, a contract may require access to sensitive personal information. If so, the contractor is liable to VA for liquidated damages in the event of a data breach or privacy incident involving any SPI the contractor/subcontractor processes or maintains under this contract.

The contractor/subcontractor shall provide notice to VA of a “security incident” as set forth in the Security Incident Investigation section above. Upon such notification, VA must secure from a non-Department entity or the VA Office of Inspector General an independent risk analysis of the data breach to determine the level of risk associated with the data breach for the potential misuse of any sensitive personal information involved in the data breach. The term 'data breach' means the loss, theft, or other unauthorized access, or any access other than that incidental to the scope of employment, to data containing sensitive personal information, in electronic or printed form, that results in the potential compromise of the confidentiality or integrity of the data.

Contractor shall fully cooperate with the entity performing the risk analysis. Failure to cooperate may be deemed a material breach and grounds for contract termination.

Each risk analysis shall address all relevant information concerning the data breach, including the following:

(1) Nature of the event (loss, theft, unauthorized access);

(2) Description of the event, including:

(a) date of occurrence;

(b) data elements involved, including any PII, such as full name, social security number, date of birth, home address, account number, disability code.

(3) Number of individuals affected or potentially affected;

(4) Names of individuals or groups affected or potentially affected.

(5) Ease of logical data access to the lost, stolen or improperly accessed data in light of the degree of protection for the data, e.g., unencrypted, plain text.

(6) Amount of time the data has been out of VA control.

(7) The likelihood that the sensitive personal information will or has been compromised

(made accessible to and usable by unauthorized persons).

(8) Known misuses of data containing sensitive personal information, if any.

(9) Assessment of the potential harm to the affected individuals.

(10) Data breach analysis as outlined in 6500.2 Handbook, Management of Security and

Privacy Incidents, as appropriate: and

(11) Whether credit protection services may assist record subjects in avoiding or mitigating the results of identity theft based on the sensitive personal information that may have been compromised.

Based on the determinations of the independent risk analysis, the contractor shall be responsible for paying to the VA liquidated damages in the amount of $37.50 per affected individual to cover the cost of providing credit protection services to affected individuals consisting of the following:

(1) Notification.

(2) One year of credit monitoring services consisting of automatic daily monitoring of at least 3 relevant credit bureau reports.

(3) Data breach analysis.

(4) Fraud resolution services, including writing dispute letters, initiating fraud alerts and credit freezes, to assist affected individuals to bring matters to resolution.

(5) One year of identity theft insurance with $20,000.00 coverage at $0 deductible; and

(6) Necessary legal expenses the subjects may incur to repair falsified or damaged credit records, histories, or financial affairs (see VA handbook 6500.6, appendix c, paragraph

7.a, 7.d)