SOW Mobile - Mobile Compounding Unit.pdf

STATEMENT OF WORK

Mobile Pharmacy Cleanroom IV Preparation Trailer

A. GENERAL INFORMATION

1. Purpose: Charlie Norwood VA Medical Center (CNVAMC) downtown Pharmacy is set to undergo renovation during FY2022. The Mobile Pharmacy Cleanroom will allow

Department of Veterans Affairs (VA) Pharmacy employees to prepare pharmaceutical compounded sterile preparations (CSPs) that meet the standards of the United States

Pharmacopoeia (USP) Chapter797 (USP <797>) “Pharmaceutical Compounding-Sterile

Preparations” and Chapter (USP <800>).

2. Background: The sterile preparation of intravenous medications is a vital component of inpatient pharmacy service. The existing pharmacy is scheduled to undergo renovation. In the meantime, a mobile IV preparation trailer will be temporarily installed to fulfill the requirements of the hospital.

3. Scope of Work: The Contractor shall provide all labor, equipment, materials, supervision, test equipment, repair/replacement parts, travel and transportation, necessary to provide emergency response to service calls and perform preventive maintenance, repairs and upgrades for the Lease of a USP 797/800 compliant mobile IV preparation self-contained trailer.

4. Performance Period: The period of performance is for an initial base year (1 May

2022 – 30 April 2023. In the event construction is delayed or offset, a modification to this contract may be required.

5. Hours of Service:

a. Routine scheduled maintenance shall be conducted between the hours of 8:00a.m.

and 4:00p.m., Monday through Friday Eastern Standard Time (EST), excluding holidays.

b. Emergency Response shall be provided 24 hours a day, 7 days a week, and 365 days a year.

c. Warehouse deliveries are accepted between 8am and 3:30pm EST, Monday through Friday, excluding 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

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

6. Type of Contract: The contract will be a Firm-Fixed-Price contract.

7. Place of Performance: Charlie Norwood VA Medical Center 1 Freedom Way, Augusta GA 30904, the unit will be set up at 950 15th Street, Augusta GA 30901.

B. CONTRACT AWARD MEETING

The contractor shall not commence performance on the tasks in this SOW until the CO has conducted a kickoff meeting or has advised the contractor that a kick off meeting is waived.

A pre-proposal site inspection walk-through for all interested Contractors has been scheduled to take place on April 12, 2022, at 10:00 AM at the Charlie Norwood VA

Medical Center, 950 15th Street Augusta, GA 30901. The proposed location is the parking lot adjacent to the valet parking area behind the Emergency Room at the

Downtown Division. All interested Contractors are encouraged (not Mandatory) to attend the site inspection walk-through of the participating VA facility. Only one walk-through for this solicitation shall be conducted. You may contact Jim Carswell at 706-733-0188 ext 33088 (jim.carswell@va.gov) for further information concerning the scheduled site inspection walk-through. The intent of the site inspection is to give all interested

Contractors an opportunity to become familiar with the Mobile Unit location.

Note: Contractor shall be responsible for all costs and travel expenses associated with the site inspection visit. Failure to attend the site inspection walk-through of the participating

VA facility shall not release the Contractor from complying with the terms, conditions, specifications, and requirements of the resulting contract.

C. GENERAL REQUIREMENTS

I. Contractor Responsibilities: In addition to the other requirements contained herein or in other areas of the solicitation and/or resultant contract, the contractor shall be responsible for the following:

1. The contractor shall make an on-site visit prior to delivery to work with

CNVAMC engineering staff for any pre-delivery issues (power, plumbing, water waster, remote monitoring, etc.) at no cost to CNVAMC. The contractor will also be responsible for transporting the IV Preparation Trailer to the site location at the

CNVAMC.

2. Exterior dimensions of the IV Preparation Trailer size shall be between 8’ and 12’ wide and 50’ and 57’ long.

3. Trailer shall contain:

a. A workroom for up to 2 workstations

b. Non-hazardous anteroom

c. Non-Hazardous IV preparation/buffer room

d. Hazardous anteroom

e. Hazardous IV preparation/buffer room

f. Two laminar airflow hoods for non-hazardous compounding

g. Two biological safety cabinets for hazardous compounding

h. Two refrigerators

4. All out of warranty maintenance and service of the Trailer and Equipment to include all preventative maintenance, service calls, transportation, parts, and labor provided via a maintenance agreement with the CNVAMC.

5. All Preventative Maintenance, licensures, inspection, adjustments, calibrations, shall be current with no lapses or pending discrepancies. Note: The VA reserves the right to request copies of all documentation relating to the equipment. Evidence of performance of recommended maintenance shall be provided by the contractor upon request from the VA. All certifications required initially, and every six months will be provided by the vendor.

6. Mobile IV Preparation Trailer and Equipment shall remain in place during the duration of the contract.

7. IV Preparation Trailer shall maintain proper temperature to ensure maximum operation, calibration, and care of equipment and to ensure staff comfort and medication viability.

8. HVAC System to maintain IV Preparation Trailer environmental systems. System shall maintain ambient temperature between 15-25° C for proper medication storage.

9. 24-Hour per Day, 7 Days per Week, telephone technical support (telephone technical support shall be provided within 1 hour of phone call being made).

10. On-site emergency repair service within 4 hours of notification during normal business operations (Monday through Friday, 8am – 5pm Pacific Time). If the request is made on a weekend or holiday, the contractor shall begin repair services no later than the next work (duty) day (i.e. be onsite NLT 8am to start the repairs). The contractor’s repair personnel shall maintain constant communication with the COR concerning the status of the repairs so that the COR can notify other medical personnel of potential downtime affecting patient care. All repairs shall be conducted during normal business hours (8am to 5pm Pacific Time) unless otherwise coordinated with the COR. These services (to include all travel, labor, per diem, parts, and equipment) shall be provided via a maintenance agreement.

11. On-site non-emergency service within 24 hours of notification during normal business operations (Monday through Friday, 8am – 5pm EST). The contractor’s repair personnel shall maintain constant communication with the COR concerning the status of the repairs so that the COR can notify other medical personnel of potential downtime affecting patient care. All repairs shall be conducted during normal business hours (8am to 5pm EST) unless otherwise coordinated with the COR. These services (to include all travel, labor, per diem, parts, and equipment) shall be provided via a maintenance agreement.

12. IV Preparation Trailer and Equipment Uptime (in-service) Rate of 95% during normal business hours of operations (which are Monday through Friday, 8am – 5pm

EST).

13. Vendor will perform a terminal clean of the compounding trailer after install and prior to release to Pharmacy staff.

III. Deliverables: Operations and Technical Support Manuals:

1. Performance Monitoring - The contractor shall comply with the following:

a. Provide Service Reports to the Contracting Officer Representative upon request.

b. The VA reserves the right to request copies of all documentation relating to the equipment.

c. Evidence of performance of recommended maintenance shall be provided by the contractor upon request from the VA.

2. Security Requirements: CCTV with DVR capability to record 30 days of video to provide perimeter/interior security. Any hard drives that may or may not contain

Patient Privacy Information (PII) remain the property of VA.

3. Risk Control

a. IV Preparation Trailer and Equipment shall meet all Federal, State, and Local

Fire and Safety requirements.

b. Safety and Warning Systems with Visual and Audible Alarms.

c. Smoke Detectors and Fire Extinguishers.

d. Emergency Lighting.

4. Delivery Schedule:

SOW

Task#

Deliverable Title Format Number Calendar Days

After CO Start

1 Monthly Status Report Contractor-

Determined Format

2 Copies to COR;

Letter Only to CO

Monthly, on 5th

Workday

2 Commissioning Report Contractor-

Determined Format

SOW Task # 2 30 days

3 Continue as needed to document all deliverables

* Standard Distribution: 1 copy of the transmittal letter without the deliverable to the Contracting

Officer shall be Emailed.

D. CHANGES TO STATEMENT OF WORK

Any changes to this SOW shall be authorized and approved only through written correspondence from the CO. A copy of each change will be kept in a project folder along with all other products of the project. Costs incurred by the contractor through the actions of parties other than the CO shall be borne by the contractor.

E. GOVERNMENT RESPONSIBILITIES

1. Government shall determine and identify the location the trailers will be set up.

2. Government shall provide power connection, water source, and CAT VI data ports adjacent to the parking space.

3. Government reserves the right to request copies of all documentation relating to the equipment. Evidence of performance of recommended maintenance shall be provided by the contractor upon request from the VA.

4. Government Pharmacy staff shall deactivate, decontaminate, and clean all areas where hazardous drugs are handled and disinfect all sterile compounding areas daily.

5. Government shall conduct required and as needed inspections.

F. MONITORING PROCEDURES

The COR shall be responsible for monitoring the Contractor's performance. Performance deficiencies or poor performance identified during the term of the contract shall be reported to the Contractor. Upon notification of deficiencies or poor performance, the

Contractor shall be given a reasonable time to take corrective action. If determined appropriate, the Contracting Officer, COR and/or other VA staff members shall meet with representatives of the Contractor to review performance and resolve issues. All deficiencies or poor performance shall be documented and MUST be corrected within the timeframe specified in the cure notice. The Contractor shall notify the Contracting

Officer and the COR when correction(s) have been made. If the appropriate correction is not made within the timeframe specified in the cure notice, the Government shall have the right to terminate the contract in it is entirety.

G. Quality Assurance Service Plan Performance Measures

Performance

Indicators PWS Ref

Performance

Measure

Acceptable

Level of

Quality

Method of

Assessment Incentive

Dis-incentive

Trailer

Configuration

Para CI and

CII,

General

Requirements

Equipped as identified 95%

Direct observation, 100%

Inspection

Positive Past

Performance

Negative

Performance

Report

Non-

Emergency

Response

Para CI 11, Service performed within

24 Hours

100%

Direct observation, Progress reports

Positive Past

Performance

Negative

Performance

Report

Emergency

Response

Para CI 10, Service performed within

4 Hours during weekdays and the next day if on weekend and holiday

100%

Direct observation, Progress reports

Positive Past

Performance

Negative

Performance

Report

Telephone

Technical

Support

Para CI 9, Requirements

Provided within

1 hour of request 100%

Direct observation

Positive Past

Performance

Negative

Performance

Report

H. 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

I. SECURITY

PER REVIEW OF VA HANDBOOK 6500.6, CONTRACT SECURITY,

APPENDIX A- INFORMATION SECURITY AND PRIVACY CHECKLIST:

Preventive

Maintenance, Licenses, Inspection, and

Calibrations

Para CI 5, Provided initially and every 6 months

100%

Direct observation, Progress reports

Positive Past

Performance

Negative

Performance

Report

Security

Requirements

Para CIII 2, 30 days of interior/perimeter video maintained and available

95% Direct observation

Positive Past

Performance

Negative

Performance

Report https://portal.tungsten-network.com/ https://portal.tungsten-network.com/

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

N/A

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.

K. 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.

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.

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

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

L. 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.

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

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.