Attachment A STATEMENT OF WORK - Regulated Waste.pdf

STATEMENT OF WORK

REGULATED MEDICAL WASTE REMOVAL

A. GENERAL REQUIREMENTS

1. SCOPE: The Contractor shall provide regulated medical pick-up, removal, and treatment services for the Charlie Norwood Medical Center, Department of Veterans Affairs (VA) Medical

Center, Augusta, Georgia to include Augusta VA Medical Center (Uptown Division), 1 Freedom

Way, Augusta, GA 30904: Augusta GA Medical Center (Downtown), 800 Bailie Street, Augusta, GA, 30904; and two Augusta VA Community Based Outpatient Clinics (CBOCS) located at 9249 Hwy 29, Athens, GA 30601, and 951 Millbrook Ave., Aiken, SC 29803.

2. PERIOD OF PERFORMANCE: The period of October 1,2022 through September 30, 2023, with four option periods exercised at the Governments discretion.

3. HOURS OF SERVICE: Work is to be performed during normal business hours, between

8:00a.m. and 4:00p.m., Monday through Friday, excluding holidays and weekends.

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 19th

Independence Day July 4th

Labor Day 1st Monday in September

Columbus Day 2nd Monday in October

Veteran’s Day November 11th

Thanksgiving Day Last Thursday in November

Christmas Day December 25th

B. VENDOR/CONTRACTOR RESPONSIBILITIES:

a. Provide personnel, equipment, tools, materials, management, and associated items and services to load collection carts, transport, and to treat regulated medical waste in accordance with federal, state, and local laws/regulations. Treatment shall occur at a facility licensed under local, state, and federal laws disposal, manifesting, and tracking of regulated medical waste including other types of waste including specified under the terms of this contract from the

Charlie Norwood VA Medical Center, Augusta, Georgia.

b. Package and transport waste to a treatment facility with the capability to address emergency actions and provide continuity of services in the event of emergency situations

(i.e. internal/external disasters, labor disputes, or facility shut-downs), as well as respond to VA requests for emergency response to biohazard exposure, in accordance with federal, state, and local laws and regulations. (VHA Directive 1850.06.17)

c. Contractor shall provide sanitized and clean OSHA approved “Biohazard,” rubber wheel, transport/storage carts, for bagged waste collected at the Downtown and Uptown Divisions. Full carts will be exchanged with empty cans on scheduled pick-up days. Approximately fourteen

(14) carts will be delivered, five times per week at the Downtown Division. Approximately two

(2) carts will be delivered to the Uptown Division weekly. Cart size is approximately 46” L x

44” H x 24”W. At the VAMC Outpatient clinics (Athens and Aiken locations), contractor will provide sanitized clean OSHA approved “Biohazard” containers for red bagged waste collection.

Full containers will be exchanged with empty containers on scheduled pick-up days.

Approximately one (1) container is needed at each site. Container size is approximately 20” L x

30”H x 20”W.

C. PERFORMANCE SCHEDULE:

Schedule: Pick up waste at designated location at each division:

a. Downtown Division – five (5) pickups a week on Monday-Friday at approximately

10 a.m. Bldg. 801, Location: 1B169 Southwest Loading Dock. Autoclave Holding

Area. Waste is biohazard waste. Includes waste generated from Surgical Suites, Patient Treatment rooms, and Isolation Rooms that is considered infectious or potentially infectious.

b. Downtown Division – Pick up in conjunction with the Monday, Wednesday, and

Friday pickups above, since this location is adjacent to the 1B169 area above, at approximately 10 a.m. Bldg. 801, Location 1B166 Southwest Loading Dock (Walk-in Cooler). Waste includes Yellow labeled Chemotherapy Waste including

Yellow Chemo Sharp Containers; Morgue/Autopsy Waste; Animal Waste (research);

Pharmaceutical Pills (non-narcotics).

a. Uptown Division – One (1) pick up a week on Wednesday at approximately 9 a.m.

Bldg. 110, Room 1B 149. Waste is biohazard waste. Includes waste generated from

Patient Treatment Rooms and Isolation Rooms that is considered infectious or potentially infectious; Pharmaceutical Pills (non-narcotics).

b. VAMC Outpatient Clinic, Athens, GA – VAMC Contract Officers Representative

(COR) will call contractor for pickup on an as needed basis, since very little to none may be generated in a month’s time. Waste is biohazard waste. Includes waste generated from Patient Treatment Rooms and Isolation Rooms that is considered infectious or potentially infectious.

c. VAMC Outpatient Clinic, Aiken, SC – VAMC, Contracting Officers Representative

(COR) will call contractor for pickup on an as needed basis, since very little to none may be generated in a month’s time. Waste is biohazard waste. Includes waste generated from Patient Treatment Rooms and Isolation Rooms that is considered infectious or potentially infectious.

D. TYPES OF WASTE COVERED:

The following listing specifies the most common types of waste, regulated medical waste, which may be disposed of under the terms of this contract as identified in VHA Directive 1850.06. The

Government reserves the right to identify other types of waste to be disposed of under the terms of this contract:

a. Pathological Waste – human pathological waste including tissues, organs, body parts, extracted human teeth, body fluids that are removed during surgery, autopsy, or other medical procedures, and specimens of body fluids and their containers.

b. Cultures, Stocks, and Vaccines – culture an stocks of infectious agents and associated biological including cultures from medical and pathological laboratories, cultures and stocks of infectious agents from research and industrial laboratories, wastes from the production of biologicals, discarded live and attenuated vaccines, and culture dishes and devices used to transfer, inoculate, and mix cultures.

c. Contaminated animal carcasses, body parts, their bedding, and other wastes from such animals which are infected with or which have been exposed to infectious agents, capable of causing disease in man.

d. Blood, blood products, other potentially infectious body fluids, and contaminated items:

1. Liquid or semi-liquid blood.

2. Potentially infectious body fluids – semen, vaginal secretions, cerebrospinal fluid, synovial fluid, pleural fluid, pericardial fluid, peritoneal fluid, amniotic fluid, saliva in dental procedures, anybody fluid that is visibly contaminated with blood, and all body fluids in situations where it is difficult or impossible to differentiate between body fluids.

3. Contaminated items that would release blood or potentially infectious body fluids in a liquid or semi-liquid state if compressed.

e. Chemotherapy waste, which means any disposable material which has come in contact with cytotoxic/antineoplastic agents (agents toxic to cells) and/or antineoplastic agents

(agents that inhibit or prevent the growth and spread of tumors or malignant cells) during the preparation, handling, and administration of such agents. Such waste includes, but is not limited to, masks, gloves, gowns, empty IV tubing bags and vials, and other contaminated materials. The above waste must first be classified as empty which means such quantity that it is not subject to other federal or state waste management regulations prior to being handled as biomedical waste.

f. Excess pills and other pharmaceuticals that we cannot send back to our reverse distributor. These are not controlled substances (non-narcotics).

E. KEY PERSONNEL:

Name Position Wage Determination

Skill No.

Percentage of Work

Under Contract

F. DELIVERABLES:

Contractor shall provide:

• Copies of Insurance Certificates

• Business Licenses

• DOT Registration as an authorized hauler of biohazard waste

• Provide copy of OSHA Bloodborne Pathogen Training for employees assigned to execute the contract.

• Provide copy of Certified First Responder training for staff responding to Biohazard

Material Spills or Incidents.

• List of all personnel who will support this contract, list of administrative and field personnel, include each individuals training, refresher training, along with all relevant experience and qualifications and current valid required licenses.

All deliverables shall be provided to the Contracting Officer not later than ten (10) days prior to contract start date. Throughout the term of the contract, current copies of the above described items will be provided to the Contracting Officer to replace expired or outdated items as soon as practicable, but in no event later than thirty (30) days after the expiration of item.

At point where contractor removes waste from collection points, any spills, damage to containers, or environmental contamination, or damage caused by regulated medical waste collected under the terms of this contract shall be cleaned, repaired, or corrected by the contract and at the expense of the contractor.

Manifest:

a. Manifest shipping documents shall be provided by the contractor at the time of collection.

Manifest will include number of containers, type of waste removed (VHA Directive

1850.06.20). A signature will be required from the contractor and a responsible representative of the Charlie Norwood VAMC for weekly/ daily collection.

PERFORMANCE REQUIREMENTS SUMMARY

Performance Objective Acceptable Quality

Level

Method of

Surveillance

Remedy

Collect and dispose of Regulated Medical

Waste in accordance with the established schedule.

100% performance to be accomplished within the established schedule

Upon request, random inspection and audition

Non-payment commensurate with the services not provided.

Provide designated minimum of

Equipment: carts or containers to adequately store and transport Regulated

Medical Waste.

No more than 2 failures to provide minimum carts per month

Observation and random inspection

Non-payment commensurate with the services not provided

Accurately Invoice For services within 2 weeks of monthly completion including weight manifests and written proof verifying proper disposal in accordance with Federal and State regulations.

No more than 2 invoicing inaccuracies in a month to include weights and measures

The COR shall track and verify monthly billing statements

Non-payment commensurate with the services not provided.

Problem Resolution and Response time The expectation is that problems be resolved within 1 business day for the duration of the contract

The COR will monitor on a monthly basis

Non-payment commensurate with the services not provided.

A. INVOICES

1. Payment will be made upon receipt of a properly prepared detailed invoice, prepared by the

Contractor, validated by the Contracting Officer’s Representative (COR), and submitted electronically through OB-10 (https://portal.tungsten-network.com/).

2. A properly prepared invoice will contain:

a) Invoice Number and Date

b) Contractor’s Name and Address

b) Accurate Purchase Order Number

c) Supply or Service provided

d) Total Amount Due https://portal.tungsten-network.com/

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

INFORMATION SECURITY AND PRIVACY CHECKLIST:

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

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

3. There may exist exposure to VA sensitive information, in particular to sensitive personal information (SPI) while implementing contractual services.

Minimum Statutory Requirements

1. 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.

2. 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

3. 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 considering 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)

Information System Security

The contractor shall ensure adequate LAN/Internet, data, information, and system security in accordance with VA standard operating procedures and standard contract language, conditions laws, and regulations. The contractor’s firewall and web server shall meet or exceed the government minimum requirements for security. All government data shall be protected behind an approved firewall. Any security violations or attempted violations shall be reported to the VA project manager and the VBA Headquarters Information Security Officer as soon as possible.

The contractor shall follow all applicable VA policies and procedures governing information security, especially those that pertain to certification accreditation.

Security Training

All contractor employees and subcontractors under this contract or order are required to complete the VA's on-line Security Awareness Training Course and the Privacy Awareness

Training Course annually. Contractors must provide signed certifications of completion to the

CO during each year of the contract. This requirement is in addition to any other training that may be required of the contractor and subcontractor(s).

Contractor Personnel Security

All contractor employees who require access to the Department of Veterans Affairs' computer systems shall be the subject of a background investigation and must receive a favorable adjudication from the VA Security and Investigations Center (07C). The level of background security investigation will be in accordance with VA Directive 0710 dated September 10, 2004 and is available at: http://www.va.gov/pubs/asp/edsdirec.asp (VA Handbook 0710, Appendix A, Tables 1 - 3). Appropriate Background Investigation (BI) forms will be provided upon contract

(or task order) award and are to be completed and returned to the VA Security and Investigations

Center (07C) within 30 days for processing. Contractors will be notified by 07C when the BI has been completed and adjudicated. These requirements are applicable to all subcontractor personnel requiring the same access. If the security clearance investigation is not completed prior to the start date of the contract, the employee may work on the contract while the security clearance is being processed, but the contractor will be responsible for the actions of those individuals they provide to perform work for the VA. In the event that damage arises from work performed by contractor personnel, under the auspices of the contract, the contractor will be responsible for resources necessary to remedy the incident.

The investigative history for contractor personnel working under this contract must be maintained in the databases of either the Office of Personnel Management (OPM) or the Defense

Industrial Security Clearance Organization (DISCO). Should the contractor use a vendor other than OPM or Defense Security Service (DSS) to conduct investigations, the investigative company must be certified by OPM/DSS to conduct contractor investigations.

1. Background Investigation

The position sensitivity impact for this effort has been designated as [LIMITED, MODERATE, SUBSTANTIAL, or MAJOR] Risk and the level of background investigation is [NACI, MBI, or

BI].

2. Contractor Responsibilities

a. The contractor shall bear the expense of obtaining background investigations. If the investigation is conducted by the Office of Personnel Management (OPM) through the VA, the contractor shall reimburse the VA within 30 days.

b. Background investigations from investigating agencies other than OPM are permitted if the agencies possess an OPM and Defense Security Service certification. The Vendor Cage

Code number must be provided to the Security and Investigations Center (07C), which will verify the information and advise the contracting officer whether access to the computer systems can be authorized.

c. The contractor shall prescreen all personnel requiring access to the computer systems to ensure they maintain a U.S. citizenship and are able to read, write, speak and understand the

English language.

d. After contract award and prior to contract performance, the contractor shall provide the following information, using Attachment B, to the CO:

(1) List of names of contractor personnel.

(2) Social Security Number of contractor personnel.

(3) Home address of contractor personnel or the contractor's address.

e. The contractor, when notified of an unfavorable determination by the Government, shall withdraw the employee from consideration from working under the contract.

f. Failure to comply with the contractor personnel security requirements may result in termination of the contract for default.

g. Further, the contractor will be responsible for the actions of all individuals provided to work for the VA under this contract. In the event that damages arise from work performed by contractor provided personnel, under the auspices of this contract, the contractor will be responsible for all resources necessary to remedy the incident.”

3. Government Responsibilities

a. The VA Security and Investigations Center (07C) will provide the necessary forms to the contractor or to the contractor's employees after receiving a list of names and addresses.

b. Upon receipt, the VA Security and Investigations Center (07C) will review the completed forms for accuracy and forward the forms to OPM to conduct the background investigation.

c. The VA facility will pay for investigations conducted by the OPM in advance. In these instances, the contractor will reimburse the VA facility within 30 days.

d. The VA Security and Investigations Center (07C) will notify the contracting officer and contractor after adjudicating the results of the background investigations received from

OPM.

e. The contracting officer will ensure that the contractor provides evidence that investigations have been completed or are in the process of being requested.

ELECTRONIC AND INFORMATION TECHNOLOGY STANDARDS

INTERNET/INTRANET

The contractor shall comply with Department of Veterans Affairs (VA) Directive 6102 and

VA Handbook 6102 (Internet/Intranet Services).

VA Directive 6102 sets forth policies and responsibilities for the planning, design, maintenance support, and any other functions related to the administration of a VA Internet/Intranet Service

Site or related service (hereinafter referred to as Internet). This directive applies to all organizational elements in the Department. This policy applies to all individuals designing and/or maintaining VA Internet Service Sites; including but not limited to full time and part time employees, contractors, interns, and volunteers. This policy applies to all VA Internet/Intranet domains and servers that utilize VA resources. This includes but is not limited to va.gov and other extensions such as, “.com, .edu, .mil, .net, .org,” and personal Internet service pages managed from individual workstations.

VA Handbook 6102 establishes Department-wide procedures for managing, maintaining, establishing, and presenting VA Internet/Intranet Service Sites or related services (hereafter referred to as “Internet”). The handbook implements the policies contained in VA Directive

6102, Internet/Intranet Services. This includes, but is not limited to, File Transfer Protocol

(FTP), Hypertext Markup Language (HTML), Simple Mail Transfer Protocol (SMTP), Web pages, Active Server Pages (ASP), e-mail forums, and list servers.

VA Directive 6102 and VA Handbook 6102 are available at:

Internet/Intranet Services Directive 6102 http://www.va.gov/pubs/directives/Information-Resources-Management-(IRM)/6102d.doc

Internet/Intranet Services Handbook 6102 http://www.va.gov/pubs/handbooks/Information-Resources-Management-(IRM)/6102h.doc

Internet/Intranet Services Handbook 6102 Change 1 – updates VA's cookie use policy, Section

508 guidelines, guidance on posting of Hot Topics, approved warning notices, and minor editorial errors.

http://www.va.gov/pubs/handbooks/Information-Resources-Management-(IRM)/61021h.doc

In addition, any technologies that enable a Network Delivered Application (NDA) to access or modify resources of the local machine that are outside of the browser’s ”sand box" are strictly prohibited. Specifically, this prohibition includes signed-applets, or any ActiveX controls delivered through a browser's session. ActiveX is expressly forbidden within the VA while

.NET is allowed only when granted a waiver by the VA CIO *PRIOR* to use.

http://www.va.gov/pubs/directives/Information-Resources-Management-(IRM)/6102d.doc http://www.va.gov/pubs/handbooks/Information-Resources-Management-(IRM)/6102h.doc http://www.va.gov/pubs/handbooks/Information-Resources-Management-(IRM)/61021h.doc

JavaScript is the preferred language standard for developing relatively simple interactions (i.e., forms validation, interactive menus, etc.) and Applets (J2SE APIs and Java Language) for complex network delivered applications.

SECTION 508

The contractor shall comply with Section 508 of the Rehabilitation Act (29 U.S.C. § 794d), as amended by the Workforce Investment Act of 1998 (P.L. 105-220), August 7, 1998.

In December 2000, the Architectural and Transportation Barriers Compliance Board (Access

Board), pursuant to Section 508(2)(A) of the Rehabilitation Act Amendments of 1998, established Information Technology accessibility standards for the Federal Government. Section

508(a)(1) requires that when Federal departments or agencies develop, procure, maintain, or use

Electronic and Information Technology (EIT), they shall ensure that the EIT allows Federal employees with disabilities to have access to and use of information and data that is comparable to the access to and use of information and data by other Federal employees. The Section 508 requirement also applies to members of the public seeking information or services from a Federal department or agency.

Section 508 text is available at:

http://www.opm.gov/HTML/508-textOfLaw.htm http://www.section508.gov/index.cfm?FuseAction=Content&ID=14

CONFIDENTIALITY AND NONDISCLOSURE

It is agreed that:

1. The preliminary and final deliverables and all associated working papers, application source code, and other material deemed relevant by the VA which have been generated by the contractor in the performance of this task order are the exclusive property of the U.S.

Government and shall be submitted to the CO at the conclusion of the task order.

2. The CO will be the sole authorized official to release verbally or in writing, any data, the draft deliverables, the final deliverables, or any other written or printed materials pertaining to this task order. No information shall be released by the contractor. Any request for information relating to this task order presented to the contractor shall be submitted to the CO for response.

3. Press releases, marketing material or any other printed or electronic documentation related to this project, shall not be publicized without the written approval of the CO.

http://www.opm.gov/HTML/508-textOfLaw.htm http://www.section508.gov/index.cfm?FuseAction=Content&ID=14