36C24424Q0658.docx

SUBJECT*

Endoscope Services at Philadelphia VA Medical Center

GENERAL INFORMATION

SET-ASIDE

Network Contracting Office 4 Services 3 1700 South Lincoln Avenue

POINT OF CONTACT*

Contract Specialist Julie Garner julie.garner@va.gov 412-860-7204

PLACE OF PERFORMANCE

Philadelphia VA Medical Center

3900 Woodland Avenue

Philadelphia PA

ADDITIONAL INFORMATION

AGENCY’S URL

URL DESCRIPTION

AGENCY CONTACT’S EMAIL ADDRESS

EMAIL DESCRIPTION

DESCRIPTION

This is a SOURCES SOUGHT NOTICE only. Responses to this notice will be used for information and planning purposes. No quotes are being requested or accepted at this time with this notice.

The Department of Veterans Affairs, Veterans Affairs Philadelphia Medical Center, 3900 Woodland Avenue, Philadelphia PA 19104, has a requirement for service of government-owned endoscopes. Potential Sources shall respond with their ability to provide these services as outlined in the draft SOW (Attachment 1).

The North American Industry Classification System (NAICS) code being considered for this procurement is 811210 Electronic and Precision Equipment Repair and Maintenance (PSC) is J065 – Maintenance, Repair and Rebuilding of Equipment – Medical, Dental, and Veterinary Equipment and Supplies. The Small Business Size Standard is $34 million. Responses to this notice should include the following:

1. Company name

1. Data Universal Numbering System (DUNS) number

1. Company’s address,

1. Point of Contact information (i.e. title, phone number and email address)

1. Company’s capability to meet this requirement and any pertinent information which demonstrates the company’s ability to meet the above requirements.

1. GSA Federal Supply Schedule contract number or other applicable contract vehicle contract number, if within scope of this effort (if applicable).

Company’s type of business (small or large) and socioeconomic status whether Service Disable Veteran Owned, Veteran Owned, Hubzone, 8(a), Women Owned, Small Disadvantaged, etc. If applicable, Service-Disabled Veteran Owned Small Businesses (SDVOSB) and Veteran Owned Small Businesses (VOSB) must be verified in www.VetBiz.gov. Response should provide enough information to determine if the vendor can comply with the limitations on subcontracting as defined in VAAR 852.219-74 and all applicable CFR references where applicable.

All responses shall be submitted in writing via email no later than 10:00am (ET) May 31st, 2024, to Julie Garner at julie.garner@va.gov.

E-mail: julie.garner@va.gov. Facsimile or telephonic responses will not be accepted. There will be no question and answer period for this sources sought.

Simply responding as an “interested party” does not constitute your company as a source. Offeror must provide the above requested information. After review of the responses to this sources sought notice, a solicitation announcement may be published on the SAM or GSA website in the near future. Responses to this sources sought announcement are not considered adequate responses to the solicitation announcement. All interested offerors will have to respond to the forthcoming solicitation announcement, in addition to responding to this sources sought notice. All interested parties must be registered with System for Award Management (SAM) at https://www.sam.gov in order to be eligible for award of Government contracts.

Sources Sought Notice Sources Sought Notice

Sources Sought Notice

Statement of Work

A. GENERAL GUIDANCE

1. Title: Service Agreement for Government-owned Endoscopes at Corporal Michael J. Crescenz VA Medical Center in Philadelphia, PA.

2. Scope of Work: The contractor shall provide standard service and support for government owned Endoscopes by the requirements stated herein. The facility is located at:

Philadelphia VA Medical Center (VAMC) 3900 Woodland Ave Philadelphia, PA 19104

3. Background: This contract is issued to ensure the continuous availability and reliability of endoscopes identified in this Statement of Work (SOW). Multiple service areas in the Philadelphia VAMC use endoscopes from multiple manufacturers. Endoscopes are used frequently and require regular maintenance. The reliable and accurate operation of these devices is considered critical to the health of patients.

4. Performance period: The period of performance is the duration of the service agreement for one base year, plus (4) four one-year option periods. The period of performance for this contract is July 10, 2024 – July 09, 2029

5. Type of Contract: Firm-fixed-price.

B. GENERAL REQUIREMENTS

All items listed herein shall be included in the price of the service contract.

1. Equipment to be serviced:

a. Endoscope devices owned by the Philadelphia VAMC, included in Appendix A, Scope Inventory, are to be serviced by the contractor at the request of the VAMC in accordance with the specifications, terms, and conditions of this contract.

2. Service and support to be provided:

a. Contractor shall furnish all necessary parts, tools, materials, labor, travel, and documentation required for the repair of endoscope equipment owned by the Philadelphia VAMC.

3. Parts to be provided:

a. All parts supplied shall be fully compatible with existing equipment, such that the repaired equipment operates per OEM standards. Replacement parts shall be OEM or otherwise FDA approved, new or factory rebuilt equal to or exceeding OEM parts specifications. The contractor is required to install VA supplied parts when said parts are determined to be fully compatible by VAMC Biomedical Engineering staff.

4. Turnaround time:

a. Turnaround time for repairs shall average no longer than 14 days from receipt of device by contractor to release of repaired device to the VAMC.

5. Equipment transport:

a. The contractor shall provide a method of shipment or pick-up and delivery for equipment needing repair.

6. Field service reports:

a. The contractor shall provide documentation per Section F of services rendered under this contract.

7. Hours of Coverage:

a. Support shall be provided during normal business hours of the VAMC, 8:00am-4:30pm Mon-Fri coverage unless one of the following conditions exists:

i. The contractor wishes to furnish services at a time that is outside of the normal hours of coverage, at no additional cost to the Government, the contractor submits a request to Biomed Engineering prior to the proposed start of the work, and the request is approved in writing before work is begun.

1. Work performed outside the normal hours of coverage at the request of the Field Service Engineer (FSE)/contractor shall be considered service performed during normal hours of coverage.

ii. The technical point of contact in Biomed Engineering directs that the services be furnished at a time that is outside the normal hours of coverage and the additional cost is recommended authorized by the CO.

1. Work performed outside the normal hours of coverage must be preapproved by the CO. The Contractor will provide a written estimate of additional charges prior to approval of the work.

b. There shall be no additional charge for time spent waiting at the site during or after the normal hours of coverage for delivery of parts.

c. Federal holidays observed by the VA Medical Center which are considered outside normal business hours:

· New Year’s Day,

· Martin Luther King, Jr. Day,

· President’s Day (Washington’s birthday),

· Memorial Day,

· Juneteenth National Independence Day,

· Independence Day,

· Labor Day,

· Columbus Day,

· Veterans Day,

· Thanksgiving Day,

· Christmas Day, and any other day specifically designated by the President of the United States.

C. ADDITIONAL VALUE

All items listed herein are features of additional value to the VAMC and shall be priced out separately for evaluation by the customer prior to contract award.

1. Loaners:

a. The contractor shall provide options for loaner equipment (if available) at the request of the VAMC.

2. Training:

a. The contractor shall provide options for in-service trainings for medical center staff at the request of Biomedical Engineering at the VAMC.

D. CUSTOMER NOTIFICATION

a. Exceeded turnaround time:

i. Contractor shall notify Biomedical Engineering if the repair of the Endoscope equipment necessitates more than 14 days of repair from receipt with a detailed reasoning of the delay and time expected to be completed. This notice shall repeat for repairs greater than one month from the contractor receipt of the endoscope and for every month after the first.

b. On-site work:

i. Contractor shall schedule and confirm any on-site work at the VAMC with Biomedical Engineering prior to arrival.

ii. Contractor shall notify Biomedical Engineering when they arrive on site and prior to performing work.

c. Service reports:

i. When services are completed, the FSE shall document the services rendered on a legible Engineering Service Report(s) per Section F.

ii. The FSE shall be required to check out with the Biomedical Engineering Department and submit the ESR(s). All ESRs shall be submitted to the equipment user for an "acceptance signature" and to Biomed for an "authorization signature." If a signature is not available, a signed accepted copy of the ESR will be sent to the point of contact in Biomed within five business days of work completion.

iii. Failure to comply, either in whole or in part, with either the notification or ESR requirements will be deemed significant non-compliance with the contract and may be justification for termination of the contract.

E. CONFORMANCE STANDARDS

Contractor shall provide services and material to ensure that the equipment functions in conformance with the latest requirements of NFPA-99, TJC, NEC, OSHA, HIPAA, Federal and VA security specifications and requirements as applicable. The equipment shall be maintained such that it meets or exceeds the performance specifications as established in the OEM’s technical specifications. Additional performance specifications that exceed the OEM specifications shall be specified in writing by the VA.

F. DOCUMENTATION/REPORTS:

The documentation will include equipment down time and detailed descriptions of the scheduled and unscheduled maintenance procedures performed, including replaced parts and prices (for outside normal working hour services) required to maintain the equipment in accordance with conformance standards. Such documentation shall meet the guidelines as set forth in the Conformance Standards. ESR’s must also be emailed to vhaphibiomedicalservicereports@va.gov, with the Vendor Name and contract Obligation Number listed in the Subject Line. In addition, each ESR must at a minimum document the following data legibly and in complete detail:

1. Name of Contractor

2. Name of FSE who performed services.

3. Contractor Service ESR Number/Log Number.

4. Date, Time (starting and ending), Hours-On-Site for service call.

5. VA Purchase Obligation (PO) number covering the call, if outside normal working hours.

6. Description of Problem Reported by COR/User.

7. Identification of Equipment to be serviced to include the following: Equipment ID # or EE# from the bar-code, Manufacturer's Name, Device Name, Model#, Serial #, and any other Manufacturer's identification numbers.

8. Itemized Description of Service(s) Performed (including Costs associated with after normal working hour services), including: Labor and Travel, Parts (with part numbers) and Materials and Circuit Location of problem/corrective action.

9. Total price to be billed.

10. Signatures from the following:

a. FSE performing services described.

b. VA Employee who witnessed service described.

11. Equipment downtime calculated in accordance with Conformance Standards.

Note: Any additional charges claimed must be approved by the CO before service is started.

G. SCHEDULE FOR DELIVERABLES

If applicable, draft copies of deliverables shall be provided to Biomedical Engineering staff before the contractor leaves the facility at each visit. If a final copy can be provided at that time then a draft copy is not necessary, final copies must be provided within 5 business days of the time of each deliverable.

H. 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.

I. CONTRACTOR EXPERIENCE REQUIREMENTS

1. Each respondent must be an authorized provider of service and support from the original equipment manufacturer.

2. Contractor personnel coming on-site must provide a copy of:

a. Tuberculosis (Tb) vaccination documentation,

b. Flu vaccination documentation, and

c. Copy of HIPAA compliance training certificate.

J. COMPLIANCE WITH OSHA BLOODBORNE PATHOGENS STANDARD:

1. The contractor shall comply with the Federal OSHA Bloodborne Pathogens Standard. The contractor shall:

a. Have methods by which all employees are educated as to risks associated with bloodborne pathogens.

b. Have policies and procedures that reduce the risk of employee exposure to bloodborne pathogens.

c. Have mechanisms for employee counseling and treatment following exposure to bloodborne pathogens.

d. Provide appropriate personal protective equipment/clothing such as gloves, gowns, masks, protective eyewear, mouthpieces for the employee during performance of the contract.

K. INFLUENZA PREVENTION PROGRAM:

1. VHA Directive 1192 requires all health care personnel (HCP) to participate in the seasonal influenza prevention program and outlines the key implementation steps. Healthcare personnel is defined in VHA Directive 1192 as all VA licensed and unlicensed, clinical and administrative, paid and unpaid, full- and part-time employees, intermittent employees, fee basis employees, VA contractors, students, researchers, volunteers, and trainees who work in VHA locations. HCP covered by the policy are expected to receive annual influenza vaccination. Those HCP unable or unwilling to be vaccinated are required to wear a face mask throughout the influenza season. Masks are available at entrances throughout the medical center.

2. It is the responsibility of the contractor to ensure that all contract staff is compliant with the requirements outlined in VHA Directive 1192. The contractor shall maintain the following documentation:

a. Documentation of vaccination, e.g., signed record of immunization from a healthcare provider or pharmacy, or a copy of medical records documenting the vaccination.

b. Completed Healthcare Personnel Influenza Vaccination Form (Attachment B of VHA Directive 1192) if unwilling or unable to receive the vaccine.

3. The contractor is required to submit annual certification to the Contracting Officer’s Representative (COR) or designee that all contract staff performing services at VA facilities are in compliance with the VHA Directive 1192.

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 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, draft deliverables, 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.

M. IDENTIFICATION, PARKING, SMOKING, CELLULAR PHONE USE AND VA REGULATIONS:

1. The contractor's FSE shall wear visible identification at all times while on the premises of VAPHI. Identification shall include, as a minimum, the employee’s name, position, and the contractor’s trade name.

2. It is the responsibility of the contractor to park in the appropriate designated parking areas. Information on parking is available from the VA Police-Security Service. VAPHI will not invalidate or make reimbursement for parking violations of the contractor under any conditions.

3. Smoking is prohibited inside any buildings and on premise at VAPHI. This covers all smoking and tobacco products, including but not limited to:

a. Cigarettes

b. Cigars

c. Pipes

d. Any other combustion of tobacco

e. Electronic nicotine delivery systems (ENDS), including but not limited to electronic or e-cigarettes, vape pens, or e-cigars.

f. Chewing tobacco

4. Cellular phones and two-way radios are not to be used within six feet of any medical equipment.

5. Possession of weapons is prohibited. Enclosed containers, including tool kits, shall be subject to search. Violations of VA regulations may result in a citation answerable in the United States (Federal) District Court, not a local district state, or municipal court.

N. CONTRACTOR PERSONNEL SECURITY REQUIREMENTS

1. Contractor may not have access to the VA network or any VA sensitive information under this contract.

2. Contractor owned computer equipment including laptops are not permitted to be connected to the VA network.

3. All removable storage devices used in medical equipment (USB drives, CDs, DVDs, etc.) must be scanned by Biomed before use.

4. Contractors shall not remove from the facility any equipment containing patient information and shall not disclose any patient information.

5. The following language from VA Handbook 6500.6 is required in this contract:

Appendix C: Paragraphs #3a, #5h, #6a, #7a, #7d, #9(all)

3. VA INFORMATION CUSTODIAL LANGUAGE: (a) 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).

5. INFORMATION SYSTEM HOSTING, OPERATION, MAINTENANCE, OR USE: (h) Bio-Medical devices and other equipment or systems containing media (hard drives, optical disks, etc.) with VA sensitive information must not be returned to the vendor at the end of lease, for trade-in, or other purposes. The options are: (1) Vendor must accept the system without the drive; (2) VA’s initial medical device purchase includes a spare drive which must be installed in place of the original drive at time of turn-in; or (3) VA must reimburse the company for media at a reasonable open market replacement cost at time of purchase. (4) Due to the highly specialized and sometimes proprietary hardware and software associated with medical equipment/systems, if it is not possible for the VA to retain the hard drive, then; The equipment vendor must have an existing BAA if the device being traded in has sensitive information stored on it and hard drive(s) from the system are being returned physically intact; and Any fixed hard drive on the device must be non-destructively sanitized to the greatest extent possible without negatively impacting system operation. Selective clearing down to patient data folder level is recommended using VA approved and validated overwriting technologies/methods/tools. Applicable media sanitization specifications need to be pre-approved and described in the purchase order or contract. A statement needs to be signed by the Director (System Owner) that states that the drive could not be removed and that (a) and (b) controls above are in place and completed. The ISO needs to maintain the documentation.

6. SECURITY INCIDENT INVESTIGATION: (a).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. The contractor/subcontractor shall immediately notify the COTR and simultaneously, the designated ISO and Privacy Officer for the contract 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 To the extent known by the contractor/subcontractor, the contractor/subcontractor’s notice to VA shall identify the information involved, the circumstances surrounding the incident (including to whom, how, when, and where the VA information or assets were placed at risk or compromised), and any other information that the contractor/subcontractor considers relevant. With respect to unsecured protected health information, the business associate is deemed to have discovered a data breach when the business associate knew or should have known of a breach of such information. Upon discovery, the business associate must notify the covered entity of the breach. Notifications need to be made in accordance with the executed business associate agreement. In instances of theft or break-in or other criminal activity, the contractor/subcontractor must concurrently report the incident to the appropriate law enforcement entity (or entities) of jurisdiction, including the VA OIG and Security and Law Enforcement. The contractor, its employees, and its subcontractors and their employees shall cooperate with VA and any law enforcement authority responsible for the investigation and prosecution of any possible criminal law violation(s) associated with any incident. The contractor/subcontractor shall cooperate with VA in any civil litigation to recover VA information, obtain monetary or other compensation from a third party for damages arising from any

7. LIQUIDATED DAMAGES FOR DATA BREACH: (a) 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. However, it is the policy of VA to forgo collection of liquidated damages in the event the contractor provides payment of actual damages in an amount determined to be adequate by the agency.

9. TRAINING: (a). All contractor employees and subcontractor employees requiring access to VA information and VA information systems shall complete the following before being granted access to VA information and its systems: (1) Sign and acknowledge (either manually or electronically) understanding of and responsibilities for compliance with the Contractor Rules of Behavior, Appendix E relating to access to VA information and information systems; (2) Successfully complete the VA Cyber Security Awareness and Rules of Behavior training and annually complete required security training; (3) Successfully complete the appropriate VA privacy training and annually complete required privacy training; and (4) Successfully complete any additional cyber security or privacy training, as required for VA personnel with equivalent information system access [to be defined by the VA program official and provided to the contracting officer for inclusion in the solicitation document – e.g., any role-based information security training required in accordance with NIST Special Publication 800-16, Information Technology Security Training Requirements.] The contractor shall provide to the contracting officer and/or the COTR a copy of the training certificates and certification of signing the Contractor Rules of Behavior for each applicable employee within 1 week of the initiation of the contract and annually thereafter, as required. Failure to complete the mandatory annual training and sign the Rules of Behavior annually, within the timeframe required, is grounds for suspension or termination of all physical or electronic access privileges and removal from work on the contract until such time as the training and documents are complete.

6. All Contractors must receive Privacy training annually using one of the following methods:

a. Complete “VA Privacy Training for Personnel without Access to VA Computer Systems or Direct Access to or Use to VA Sensitive Information” training by using VA’s TMS system (https://www.tms.va.gov/). Contractors may use the TMS Managed Self Enrollment method to complete the training in TMS. The COR or designee must ensure that all contractors are validated in the PIH domain.

b. Complete the hard copy version of “VA Privacy Training for Personnel without Access to VA Computer Systems or Direct Access to or Use to VA Sensitive Information”. Signed training documents must be submitted to the COR or designee.

7. Contractors may not leave tools and equipment unattended.

8. Biomedical Engineering staff must be made aware of any work performed within Information Technology Communication closets.

9. All contractors and contractor representatives must follow any Business Associate Agreement (BAA) their company has established with the VAMC.

O. DEFINITIONS/ACRONYMS:

1. Biomedical Engineering - supervisor or designee.

2. CO - Contracting Officer.

3. COR - Contracting Officer's Representative.

4. PM - Preventive Maintenance Inspection. Services which are periodic in nature and are required to maintain the equipment in such condition that it may be operated in accordance with its intended design and functional capacity with minimal incidence of malfunction or operative conditions. Service shall consist of calibration and testing in accordance with the manufacturer’s latest established service procedures to ensure operation of equipment within manufacturer’s or VA’s performance specifications, whichever is the most rigorous. PM includes cleaning, inspecting lubricating and testing all equipment. All equipment shall be operated at least one complete operating cycle at the end of each PM.

5. FSE - Field Service Engineer. A person who is authorized by the contractor to perform maintenance (corrective and/or preventive) services on the VA Medical Center premises.

6. ESR - Engineering Service Report. A documentation of the services rendered for each incidence of work performance under the terms and conditions of the contract.

7. Acceptance Signature - VAPHI employee who indicates FSE demonstrated service conclusion/status and user has accepted work as complete/pending as stated in ESR.

8. Authorization Signature - COR's signature; indicates COR accepts work status as stated in ESR.

9. NFPA - National Fire Protection Association.

10. CDRH - Center for Devices and Radiological Health.

11. VAPHI - Department of Veterans Affairs Philadelphia Medical Center.

12. OEM - Original Equipment Manufacturer

13. CEU – Continuing Education Credit

APPENDIX

APPENDIX A: Endoscope Inventory

End of Document