S02 Attach 01 SEPG 287241 - Statement of Need--.docx

STATEMENT OF NEED FOR

DELIVERY AND INSTALLATION STRYKER SURGICAL LIGHTS FOR OPERATING ROOMS (1 & 5) AT

VA PITTSBURGH HEALTHCARE SYSTEM, UNIVERSITY DRIVE CAMPUS

UNIVERSITY DRIVE C

PITTSBURGH, PA

15240-1003

1. Background. The VA Pittsburgh Healthcare System (VAPHS) is a tertiary referral center for the western half of VA Healthcare—VISN 4, treating Veterans from Altoona, Erie, and Butler, in Pennsylvania and Clarksburg, West Virginia. VAPHS proudly serves the Veteran population throughout the tri-state area of Pennsylvania, Ohio, and West Virginia. VAPHS consists of two clinical care facilities in Pittsburgh (HJH and University Drive locations) as well as five community-based outpatient clinics. VAPHS maintains academic affiliations with over 170 associated health educational programs, to include the University of Pittsburgh Schools of Medicine and Dental Medicine.

VA Pittsburgh’s’ current Operating Room Surgical Lights are dated and in emergent need for replacement. Our facility would require the vendor to include infection control, structural, electrical, medical gas, and finish work to complete this requirement and within the proposal. This is an urgent and compelling requirement and has the potential to delay and disrupt patient care if not awarded by the need date.

VAPHS recognizes that other VHA facilities across the country may encounter similar challenges and the need for surgical lighting replacements and associated integration needs; therefore, the solutions procured by VAPHS may be implemented as an option at other VHA facilities.

2. Applicable Documents. In performance of the tasks associated with this Performance Work Statement, the Contractor shall comply with the following:

2.1. 44 U.S.C. § 3541, “Federal Information Security Management Act (FISMA) of 2002”

2.2. FIPS Pub 201, “Personal Identity Verification of Federal Employees and Contractors,” March 2006

2.3. 5 U.S.C. § 552a, as amended, “The Privacy Act of 1974”

2.4. 42 U.S.C. § 2000d “Title VI of the Civil Rights Act of 1964”

2.5. VA Directive 0710, “Personnel Suitability and Security Program,” September 10, 2004

2.6. VA Directive 6102, “Internet/Intranet Services,” July 15, 2008

2.7. 36 C.F.R. Part 1194 “Electronic and Information Technology Accessibility Standards,” July 1, 2003

2.8. Office of Management & Budget (OMB) Circular A-130, “Management of Federal Information Resources,” November 28, 2000

2.9. 32 C.F.R. Part 199, “Civilian Health and Medical Program of the Uniformed Services (CHAMPUS)”

2.10. An Introductory Resource Guide for Implementing the Health Insurance Portability and Accountability Act (HIPAA) Security Rule, October 2008

2.11. Sections 504 and 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

2.12. Homeland Security Presidential Directive (12) (HSPD-12)

2.13. VA Directive 6500, “Information Security Program,” August 4, 2006

2.14. VA Handbook 6500.6, “Contract Security,” March 12, 2010

2.15. Program Management Accountability System (PMAS) portal (reference PWS References – Technical Library at https://www.voa.va.gov/)

3. Scope.

3.1. The contracted vendor shall provide the following:

3.1.1. Project Management

3.1.1.1. Coordination with all necessary departments, personnel, and vendor staff to complete the project

3.1.1.2. Provide a complete schedule of the plan of competition, OR 1 & OR 5

3.1.1.3. Schedule all deliveries (Required Equipment Delivered Prior and Inspected)

3.1.1.4. On-site supervision from Contractor

3.1.1.5. Remove existing equipment

3.1.1.5.1. OR 1 & 5 Surgical lights

3.1.1.5.2. OR 1 & 5 Light Booms

3.1.1.5.3. OR 1 & 5 Any additional Hardware associated with the old lights

3.1.1.6. Install New equipment (As Per Local / State & Federal applicable building codes)

3.1.1.6.1. Install Surgical Lights within OR 1 & 5

3.1.1.6.2. Install required Boom for the lighting within OR 1 & 5

3.1.1.6.3. Install / Provide any additional Hardware associated with the new light systems

3.1.1.7. Return the OR rooms back to operational function as they were prior to the start of the project

3.2. Interim Infection Control

3.2.1. Vendor to provide ICRA plan and be approved by VA Pittsburgh stakeholders representing this area of the Medical Center, with the necessary professional expertise

3.2.2. Provide and install infection control per the ICRA plan, and approved by VA stakeholders representing the Medical Center for Infection Prevention, Facilities, and any other deemed as necessary by VA Pittsburgh representation

3.2.2.1. Outer plastic zipper wall with proper signage

3.2.2.2. Tacky mats

3.2.2.3. Plastic walled anteroom with zipper door (Class IV)

3.2.2.4. Tape all interior doors, windows, and cabinets

3.2.2.5. Provide HEPA filtered negative air machines to be returned within Operating Room or to return vent in the Operating Room

3.2.2.6. HEPA filters on return air ducts

3.2.2.7. Floor protection provided by the vendor being awarded the contract

3.3. General Labor

3.3.1. Remove existing ceiling mounted equipment and existing cables

3.3.2. Remove existing wall controls and finish exposed areas

3.3.3. Haul off all debris to Medical Center designated, onsite area

3.3.3.1. Equipment removal quoted with the intention to dispose

3.4. Structural

3.4.1. Install the needed mounting plates on existing structures, per Operating Room

3.4.1.1. Vendor will provide supplemental supports, if the structural analysis of existing structures is inadequate to support the required load

3.4.1.2. The vendor will perform a deflection test prior to deinstallation

3.5. Electrical

3.5.1. Disconnect existing electrical from the surgical lights, per Operating Room and Medical Center policy

3.5.2. Install Stryker-provided SK box and connect to existing wall control conduit

3.5.2.1. Flex conduit and Greenfield needed for reconnecting.

3.5.3. Install vendor provided SK box and connect to existing wall control conduit

3.5.4. Remove existing wall control back box and replace for new vendor surgical light wall control

3.5.4.1. Connect to existing conduit

3.5.4.2. Stryker supplied 14 x 14 stainless steel beauty plate

3.5.4.3. Surface-mounted wall control

3.5.5. Reconnect electrical for surgical lights to the SK box

3.6. Plumbing/Med. Gas – (If Applicable)

3.6.1. Disconnect med. Gas at removed boom locations

3.6.2. Reconfigure existing med. Gas piping and install vendor provided med. Gas risers at each boom location

3.6.3. Connect new boom med gas hoses at the boom mount

3.6.4. Pt. left boom – secure med. Gas

3.6.5. Test and certify med. Gas system

3.7. Mechanical/HVAC

3.7.1. None aside from the ICRA Plan, mentioned above

3.8. Finish Work

3.8.1. Install of vendor provided wall control trim at the wall control location

3.8.1.1. Pathing and painting not required, as the ceiling cover is designed to match existing opening

3.8.1.2. Prepare rooms for terminal clean. VA to complete final terminal clean for Infection Prevention approval et al.

3.8.1.3. Vendor to remove all debris from the projects to hospital designated on site location

3.9. Schedule

3.9.1. Complete and detailed schedule will be submitted by the vendor for Medical Center representative’s approval prior to work being completed

3.9.2. Project to be completed in 1 phase during standard working hours at non-premium wage rates with each room OR completed consecutively in approximately 1 day, per operating room, and 3 days for operating room 4

Table 1: VA Pittsburgh Healthcare System Sites

Pittsburgh, PA 15240-1003

4. Performance Period. Vendor and VAPHS staff shall develop a site schedule, to avoid any disruptions in patient care. Vendor is expected to complete installation, training, and migration of legacy data within 45-days of award of contract. It is estimated that both sites will be completed within 3 days from the start date of installation.

5. Place of Performance. Contract performance shall take place at the contractor’s location(s) and at the locations in Table 1.

6. Travel for Installation, Implementation and Training. The Government anticipates no additional charges from the Contractor related to travel, under this contract. The contractor is fully responsible for all costs associated with the need for travel to VAPHS sites, listed in Table 1, to complete the scope of work.

6.1. The Government acknowledges the use of remote access for installation, migration, interface, and implementation purposes, within the constraints of all applicable VA Information Security Requirements

7. Government Furnished Equipment/Information. The Contractor shall be allowed access to Government equipment including servers and network infrastructure. Information on Government equipment and systems shall be provided as necessary. No Government-owned property will be transferred into the Contractor’s control. Additional software products may be provided by the Government as identified to facilitate Contractor access, e.g., Microsoft Terminal Services.

8. Invoicing. Invoices shall be submitted electronically via the Financial Services Center Mandatory Electronic Invoice System, monthly. Invoices must include, at a minimum, the following information: Contractor name, purchase order number, period of service the billing covers, and a list of equipment items covered during the stated period of performance.

This requirement is in accordance with VARR Clause 852.232-72 Electronic Submission of Payment Requests: http://www.fsc.va.gov/einvoice.asp. Electronic payments are net 30 days.

9. Security Requirements. All contractor employees are subject to the same level of investigation as VA employees who have access to VA sensitive information or access to VA facilities. The background investigation includes the following requirements: 1) Completed documentation 2) Fingerprints 3) Completion of OPM’s e-QIP Questionnaire. The Contractor is required to fulfill all the security requirements. The Contractor, upon completion of fingerprinting, and an initial suitability determination, may be authorized tentative access to start the performance period of the contract, but only on condition of completion of all security requirements. This requirement is applicable to all subcontractor personnel requiring the same access.

10. Hours of Coverage & Federal Holidays. The VA representative COR tour of duty of 6:00am to 7:00pm, Monday through Friday, excluding federal holidays. Weekends can be arranged if the need arises to keep the project date on schedule. The contractor shall contact the POC or his/her designee prior to commencing any work on the premises and provide the proposed schedule for approval by stakeholders.

11. Option to Extend Services. See Clause. No Options.

12. HIPAA Training Certificates. If the Contractor will be working onsite for installation and activation of equipment and/or software, all HIPAA training completion documentation must be provided to the Contracting Officer Representative (COR) listed in the awarded contract.

13. Tobacco Policy. All VAPHS property is tobacco free. Contractor personnel will comply all VAPHS tobacco and smoking policies. Violations of such policies will result in a warning and possible citation.

14. COVID-19 Related Policies. Upon entering VAPHS, per CDC and federal regulations, all personnel must wear the required PPE while on-site; at a minimum this includes a cloth mask. PPE will not be provided by VAPHS. All individuals are required to enter through the main entrance for temperature screening. If Contractor’s temperature exceeds the designated threshold, they will be asked to leave. In the event of an FSE being forced to vacate the premises, they shall notify the necessary Biomedical Engineering staff and provide a contact for a replacement.

15. Vendor Credentialing. Vendor access to the VAPHS is by appointment only and requires credentialing through our vendor credentialing partner, Symplr at https://vcsdatabase.com/login Symplr registration is at cost to the vendor only and VAPHS is not responsible for this.

All on-site contractor representatives agree to follow VA Pittsburgh Policy LD-073 medical center policy (MCP) Vendor Access. This includes all on-site contractor representatives shall be ‘greenlighted’ in VA Pittsburgh’s Vendor Credentialing System Symplr which includes an up-to-date flu vaccination, Tb test, Covid-19 vaccine, and HIPPA certification at a minimum. The government shall not provide any additional compensation for cost to register Zoll and any subcontractor staff in Symplr. Vendor shall follow most updated guidelines from the Occupational Safety & Health Administration (OSHA), Center for Disease Control (CDC), and Food & Drug Administration (FDA).

All vendors are required to check-in at the Symplr kiosk using their smart phone (University Drive) or desktop check-in with Symplr login (HJH) and obtain a day badge, which will include date, time, and location of approved appointment. Company badge with photo ID is also required to be worn while onsite at any of the VAPHS sites. Vendors are only permitted to visit the location identified on their Symplr generated badge and must exit the facility promptly, checking out via their smart phone once the scheduled appointment has ended.

VHA Supplemental Contract Requirements for Combatting COVID-19

1. Contractor employees who work in or travel to VHA locations must comply with the following:

a. Documentation requirements: 1) If fully vaccinated, contractors shall show proof of vaccination.

i. NOTE: Acceptable proof of vaccination includes a signed record of immunization from a health care provider or pharmacy, a copy of the COVID-19 Vaccination Record Card (CDC Form MLS- 319813_r, published on September 3, 2020), or a copy of medical records documenting the vaccination. 2) If unvaccinated, contractors shall show negative COVID-19 test results dated within three calendar days prior to desired entry date. Test must be approved by the Food and Drug Administration (FDA) for emergency use or full approval. This includes tests available by a doctor’s order or an FDA approved over-the-counter test that includes an affiliated telehealth service.

3) Documentation cited in this section shall be digitally or physically maintained on each contractor employee while in a VA facility and is subject to inspection prior to entry to VA facilities and after entry for spot inspections by Contracting Officer Representatives (CORs) or other hospital personnel.

4) Documentation will not be collected by the VA; contractors shall, at all times, adhere to and ensure compliance with federal laws designed to protect contractor employee health information and personally identifiable information.

2. Contractor employees are subject to daily screening for COVID-19 and may be denied entry to VA facilities if they fail to pass screening protocols. As part of the screening process contractors may be asked screening questions found on the COVID-19 Screening Tool. Check regularly for updates.

a. Contractor employees who work away from VA locations, but who will have direct contact with VA patients shall self-screen utilizing the COVID-19 Screening Tool, in advance, each day that they will have direct patient contact and in accordance with their person or persons who coordinate COVID-19 workplace safety efforts at covered contractor workplaces. Contractors shall, at all times, adhere to and ensure compliance with federal laws designed to protect contractor employee health information and personally identifiable information.

3. Contractor must immediately notify their COR or Contracting Officer if contract performance is jeopardized due to contractor employees being denied entry into VA Facilities.

4. For indefinite delivery contracts: Contractor agrees to comply with VHA Supplemental Contract Requirements for any task or delivery orders issued prior to this modification when performance has already commenced.