S02-SOW - Main Pharmacy_FINAL.pdf

CONSTRUCTION SCOPE OF WORK

Project Title: Main Pharmacy USP 797-800 Project Location: Las Vegas VA Medical Center – 6900 N. Pecos Rd., North Las Vegas, NV 89086

Project Number: 593-18-104 Project Type: NRM – Construction Date: September 28, 2022

EXECUTIVE SUMMARY

Las Vegas VA Medical Center Upgrade Inpatient Pharmacy project is remodeling of the existing Main Pharmacy Compounding space. The remodel will bring the space to current VA and United States Pharmacopeia Convention (USP) Compounding Compendium standards. This will require removing some portions of existing interior partitions, wall finishings and items attached to the walls, floor finishings, ceiling tiles and grids, casework and cabinets. Portions of the air distribution and exhaust ductwork systems are to be demolished and replaced with dedicated air volume control boxes, laminar flow diffusers with HEPA filters, and low exhaust registers with dedicated exhaust air ducts for each room. Existing plumbing fixtures are to be demolished and water branches capped as needed. New plumbing installation includes a new sink with emergency eyewash attachment and emergency eyewash station to accommodate the remodeling of the space. New electrical installations include junction boxes, receptacles, voice/data outlets, door access and hand wave entry systems, and light fixtures and controls.

BACKGROUND

In February 2016, the United States Pharmacopeial Convention (USP) published authoritative standards on the handling of hazardous drugs throughout the life of the drug. USP 797/800 outlines the responsibilities of personnel handling hazardous drugs, facility and engineering controls, environmental quality control, personal protective equipment, communication, training, transport, packaging, labeling, and disposal. The Las Vegas VA Medical Center pharmacy spaces in use for compounding and storage of hazardous drugs (HD) at the time did not meet the new USP 797/800 requirements. This effort will renovate the Main Pharmacy Compounding space to be compliant with

797/USP 800.

SCOPE OF WORK

1. The contractor shall provide minimum Cat-6a cables for IT, level V gypsum board finishes, a stainless-steel backsplash that protects the wall surface above and around the sink, and an environmental data supervisory panel outside of the suite to provide environmental data for all rooms (temp, pressure, and humidity).

2. The contractor shall work with the Contracting Officer’s Representative to minimize construction impact to daily operations of VA Southern Nevada Health Care System.

3. The contractor will be required to be fully badged with VA Security (see VA SECURITY REQUIREMENTS FOR CONTRACTORS below) and be escorted in and out of the work area due to its location within an active Pharmacy. This will require most work to be completed during normal work hours. The only exceptions will be construction of the Infection Control Risk Assessment Barriers and tie-ins to electrical and plumbing that impact daily operations of VA Southern Nevada Health Care System. Please Note: This will require significant flexibility and coordination with Pharmacy Staff.

4. The contractor shall provide all services for the successful remodel of the existing Main Pharmacy Compounding Space at VASNHS facility as outlined in this Statement of Work (SOW) and according to associated Construction Documents (CD), drawings and specifications designed and produced by the Prime Consultant Firm ‘DAV Energy Solutions”.

5. Additional documents provided in support of this project are for references only and contractor shall verify for accuracy.

6. The site will require Class V ICRA protections as identified in the ASHE ICRA 2.0. Coordination with Infection Control and Pharmacy will be required to ensure patient safety. See document at end of SOW.

7. Due to the nature of this project, the VA will allow a full time Superintendent to act as both Quality Control Manager and Safety manager, if qualified. However, a qualified Safety manager will be on site at all times.

8. The contractor shall perform a thorough site investigation, survey and analysis of existing utilities, equipment, and any other applicable existing infrastructure to verify location and depth to minimize or eliminate risks of damage. This must be accomplished per industry standard and code requirements.

ADDITIONAL CONSIDERATIONS

1. Utility Shutdowns: the contractor shall account for all anticipated utility shutdowns within their schedule as milestones for early visibility and coordinate all utility shutdowns with the COR. Utility shutdowns require no less than 20 working days advance notice to coordinate with facility.

2. The contractor shall coordinate with the COR and comply with all local and VA COVID-19 safety requirements.

3. Use of facilities bathrooms will be restricted to the contractor. The contractor shall be responsible for providing and servicing their own sanitary facilities.

CONSTRUCTION ADMINISTRATION

1. Construction Period Services Consultant: The VA has retained ‘DAVEnergy Solutions’ to provide

Construction Period Services (CPS) for this project and shall be responsible for construction support, review of construction contractor’s submittals (RFIs, shop drawings, test reports, change orders, etc.), and site visits during construction.

2. Site Visits and Observations: the COR and or VA designated representatives may require access in order to monitor, observe and review all aspects of the project to ensure compliance with Construction Documents, Specifications and other regulatory requirements.

3. Project Meetings and Inspections: The contractor shall be required to attend or provide a designated representative for coordinated field inspections for progress evaluations and reports, and other site visits as needed, including punch list or pre-final and final inspections. Such inspections may occur on a monthly basis, or more frequently as needed. The Contracting Officer’s Representative (COR) or other designated VA representatives may inspect all aspects of the project in order to complete written progress reports, including the performance of work activities in the project schedule or schedule of values, and verification of the contractor’s compliance with applicable safety, infection control, or interim life safety requirements. Contractor shall schedule and attend weekly project meeting and is responsible for providing meeting minutes and agenda for each meeting.

4. Submittals: The contractor will provide an online system for submittal tracking and approval. After award of the contract, the VA will provide a list of individuals with names and email addresses to be given permission to the project folder within the tracking system for project submittals coordination and tracking.

4.1. The contractor will be responsible to furnish submittals in accordance with the design specifications and submittals register. The contractor shall submit shop drawings, schedules, manufacturer's literature and data, and certificates in electronic format. Physical samples shall be shipped directly to the COR for approval. Further details are provided in the project specifications for shop drawings and submittals.

4.2. The government requires 21 calendar days to review and respond to submittals unless otherwise modified this SOW.

5. RFIs and Change Orders. During construction, the contractor may submit requests for additional information concerning the design or other aspects of the project; however, these must be submitted in writing and must include, at a minimum, a description of or background information for the issue in question, as well as a complete impact assessment for any recommended changes. The COR or designated AE representative will review, evaluate, and respond as required. Any proposed changes to the scope or deviations from the design documents may be submitted to the COR for review and discussion, however any changes to the contract or scope of the project must first be approved by the CO in writing before implementation.

PERIOD OF PERFORMANCE

The Period of Performance (PoP) will begin upon issuance of a Notice to Proceed from VA Contracting.

The project requires all tasks defined within the SOW, CD and Specifications be completed within 180 calendar days after Notice to Proceed (NTP).

HOURS OF OPERATRION AND HOLIDAYS

1. Normal duty hours are 8:00 AM – 4:30 PM, Monday thru Friday not including standard Federal

Holidays. Federal Holidays can be obtained on OPM’s website (www.opm.gov). All work performed shall be coordinated and scheduled through the COR. Any off-duty work must be included as milestones on the construction schedule to facilitate user coordination and must be coordinated with the COR at least 2 weeks prior to the work taking place.

VA SECURITY REQUIREMENTS FOR CONTRACTORS

1. ALL contractor’s and subcontractor’s personnel shall be subject to VA Directive 0735, Homeland

Security Presidential Directive 12 (HSPD-12) Program, Federal laws, regulations, standards, and VA Handbooks like VA personnel regarding information and information system security.

2. Non-Personal Identity Verification (PIV) Card requests shall be submitted to VA COR by the contractor must be submitted within 14 days of contract award. Request submission is the contractor’s responsibility to properly fill out the documents identified below. These documents will become a package for submission of Non-PIV Card application: The contractor shall request the below forms shortly after contract award.

2.1. VA Fingerprinting form – See attachments.

2.2. Declaration for Federal Employment (OF306), if there are any questions that were answered

“yes” on item 9-13 on this form, fill out the appropriate addendum and include in the package.

2.3. Authorization for Release of Information (VA Form 0710)

2.4. Self-Certification of Continuous Service

2.5. Contractor Background Investigation Request

3. Non-PIV Card process may take 30-45 days, depending on the contractor’s personnel background check, Special Agreement Check (SAC). SAC is an automated records check conducted by the Federal Bureau of Investigation in collaboration with the Office of Personnel Management (OPM).

4. Non-PIV Card Applicant is subject to National Agency Check with written Inquiries (NACI) conducted by OPM. This investigation covers a period of 5 years and a review of current records in the OPM Security Investigation Index (SII), DOD Defense Central Investigations Index (DCII), FBI name check, and FBI fingerprint check as well as written inquiries from previous employers and references on the application for employment. It is used for Non-sensitive or Low Risk positions in

VA.

5. Once all documents are completely and properly filled out, hand carry and submit to VA COR. Do not send completed forms through email due to Personal Identifiable Information.

6. VA COR will then provide all documents to Engineering Service’s VA PIV Sponsor/Manager to initiate the Non-PIV process.

7. PIV Sponsor/COR will notify each applicant when to proceed for fingerprinting appointment.

8. Each applicant shall be fingerprinted at VA Southern Nevada Healthcare System’s PIV Office, located first floor in Building 6 (Administration Building), 6900 N. Pecos Road, N. Las Vegas, NV 89086. Each applicant shall sign in at the Security Desk.

9. VA COR or PIV Sponsor/Manager will provide status of each applicant’s Non-PIV Card.

10. Non-PIV Card is critical for the construction start date, as the contractor’s personnel without Non-

PIV Card WILL result in NO access to the job site. See attached blank forms/documents that is required for submission of Non-PIV Card application for each of contractors/sub-contractors.

RECORDS MANAGEMENT LANGUAGE

1. Contractor shall comply with all applicable records management laws and regulations, as well as

National Archives and Records Administration (NARA) records policies, including but not limited to the Federal Records Act (44 U.S.C. Chapters. 21, 29, 31, 33), NARA regulations at 36 CFR Chapter XII Subchapter B, and those policies associated with the safeguarding of records covered by the Privacy Act of 1974 (5 U.S.C. 552a). These policies include the preservation of all records, regardless of form or characteristics, mode of transmission, or state of completion.

2. In accordance with 36 CFR 1222.32, all data created for Government use and delivered to, or falling under the legal control of, the Government are Federal records subject to the provisions of 44 U.S.C. chapters 21, 29, 31, and 33, the Freedom of Information Act (FOIA) (5 U.S.C. 552), as amended, and the Privacy Act of 1974 (5 U.S.C. 552a), as amended and must be managed and scheduled for disposition only as permitted by statute or regulation.

3. In accordance with 36 CFR 1222.32, the contractor shall maintain all records created for Government use or created in the course of performing the contract and/or delivered to, or under the legal control of the Government and must be managed in accordance with Federal law.

Electronic records and associated metadata must be accompanied by sufficient technical documentation to permit understanding and use of the records and data.

4. The VA Southern Nevada Healthcare System (VASNHS) and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation.

Records may not be removed from the legal custody of VASNHS or destroyed except for in accordance with the provisions of the agency records schedules and with the written concurrence of the Head of the Contracting Activity. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701.

5. In the event of any unlawful or accidental removal, defacing, alteration, or destruction of records, the contractor must report to VASNHS. The agency must report promptly to NARA in accordance with 36 CFR 1230.

6. The contractor shall immediately notify the appropriate Contracting Officer (CO) upon discovery of any inadvertent or unauthorized disclosures of information, data, documentary materials, records or equipment. Disclosure of non-public information is limited to authorized personnel with a need-to-know as described in the contract documents. The contractor shall ensure that the appropriate personnel, administrative, technical, and physical safeguards are established to ensure the security and confidentiality of this information, data, documentary material, records and/or equipment is properly protected. The contractor shall not remove material from Government facilities or systems, or facilities or systems operated or maintained on the Government’s behalf, without the express written permission of the Head of the Contracting Activity. When information, data, documentary material, records and/or equipment is no longer required, it shall be returned to VASNHS control or the contractor must hold it until otherwise directed. Items returned to the Government shall be hand carried, mailed, emailed, or securely electronically transmitted to the CO or address prescribed in the contract documents. Destruction of records is EXPRESSLY PROHIBITED unless in accordance with Paragraph (4).

7. The contractor is required to obtain the CO's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under, or relating to, contracts. The contractor (and any sub-contractor) is required to abide by Government and VASNHS guidance for protecting sensitive, proprietary information, classified, and controlled unclassified information.

8. The contractor shall only use Government IT equipment for purposes specifically tied to or authorized by the contract and in accordance with VASNHS policy.

9. The contractor shall not create or maintain any records containing any non-public VASNHS information that are not specifically tied to or authorized by the contract.

10. The contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected from public disclosure by an exemption to the FOIA.

11. VASNHS owns the rights to all data and records produced as part of this contract. All deliverables under the contract are the property of the U.S. Government for which VASNHS shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest. Any contractor rights in the data or deliverables must be identified as required by FAR 52.227-11 through FAR 52.227-20.

12. Training. All contractor employees assigned to this contract who create, work with, or otherwise handle records are required to take VHA-provided records management training. The contractor is responsible for confirming training has been completed according to agency policies, including initial training and any annual or refresher training.

13. Flowdown of requirements to Subcontractors: The contractor shall incorporate the substance of this clause, its terms and requirements including this paragraph, in all subcontracts under this contract document, and require written subcontractor acknowledgment of same. Violation by a subcontractor of any provision set forth in this clause will be attributed to the contractor.

ABBREVIATIONS AND ACRONYMS

A&E Architectural & Engineering Firm CD Construction Documents CO Contracting Officer COR Contracting Officer’s Representative CPS Construction Period Services CxA Commissioning Agent EPA Environmental Protection Agency IC Infection Control ILSM Interim Life Safety measures NTP Notice to Proceed PIV Personal Identity Verification PoP Period of Performance SOW Scope of Work TIL Technical Information Library VA Veterans Affairs

VASNHS VA Southern Nevada Healthcare System