36C10X21R0036 0001_1.docx

Contract Opportunity Amendment to a Previous Combined Solicitation

PRODUCT SERVICE CODE

SUBJECT

CONTRACTING OFFICE'S

ZIP-CODE

SOLICITATION NUMBER

BASE NOTICE TYPE

RESPONSE DATE/TIME/ZONE

ARCHIVE

DAYS AFTER THE RESPONSE DATE

RECOVERY ACT FUNDS

SET-ASIDE

NAICS CODE

CONTRACTING OFFICE

ADDRESS

POINT OF CONTACT

(POC Information Automatically Filled from User Profile Unless Entered)

DESCRIPTION

See Attachment

AGENCY'S URL

URL DESCRIPTION

AGENCY CONTACT'S EMAIL

ADDRESS

EMAIL DESCRIPTION

ADDRESS

POSTAL CODE

COUNTRY

ADDITIONAL INFORMATION

GENERAL INFORMATION

PLACE OF PERFORMANCE

* = Required Field Contract Opportunity Amendment to a Previous Combined Solicitation R425 National Biomedical Contractor Support Services

(VA-21-00021777)

21703 36C10X21R0036 07-12-2021 12:00

EASTERN TIME, NEW YORK, USA

N 541990 Strategic Acquisition Center - Frederick Department of Veterans Affairs 5202 Presidents Court, Suite 103 Frederick MD 21703 Contract Specialist Intern Melissa Maloy Melissa.Maloy@va.gov 202-815-9679

5. PROJECT NUMBER (if applicable)

CODE

7.

ADMINISTERED BY

2. AMENDMENT/MODIFICATION NUMBER

CODE

6. ISSUED BY

8. NAME AND ADDRESS OF CONTRACTOR

4. REQUISITION/PURCHASE REQ. NUMBER

3. EFFECTIVE DATE

9A. AMENDMENT OF SOLICITATION NUMBER

9B. DATED

PAGE OF

PAGES

10A. MODIFICATION OF CONTRACT/ORDER NUMBER

10B. DATED

BPA NO.

1. CONTRACT ID CODE

FACILITY CODE

CODE

Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following methods:

The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers

E. IMPORTANT:

is extended,

(a) By completing Items 8 and 15, and returning __________ copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted; or (c) By separate letter or electronic communication which includes a reference to the solicitation and amendment numbers. FAILURE

OF YOUR

ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY is not extended.

12. ACCOUNTING AND APPROPRIATION DATA

(REV. 11/2016)

is required to sign this document and return ___________ copies to the issuing office.

is not, A. THIS CHANGE ORDER IS ISSUED PURSUANT TO:

Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NO. IN ITEM 10A.

15C. DATE SIGNED

B. THE ABOVE NUMBERE

D CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES

SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

RESULT IN REJECTION OF YOUR

OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by letter or electronic communication, provided each letter or electronic communication makes reference to the solicitation and this amendmen t, and is received prior to the opening hour and date specified.

C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER

Contractor

16C. DATE SIGNED

14. DESCRIPTION OF AMENDMENT/MODIFICATION

16B. UNITED

STATES OF AMERICA

Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

15A. NAME AND TITLE OF SIGNER

16A. NAME AND TITLE OF

CONTRACTING OFFICER

15B. CONTRACTOR/OFFEROR

STANDARD FORM 30

PREVIOUS EDITION NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.243 (Type or print) (Type or print) (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

(Number, street, county, State and ZIP Code) (If other than Item 6) (Specify type of modification and authority) (such as changes in paying office, appropriation date, etc.)

(If required)

(SEE ITEM 11)

(SEE ITEM 13)

(X)

CHECK

ONE

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS,

IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF

SOLICITATIONS

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

(Signature of person authorized to sign) (Signature of Contracting Officer) 06-24-2021 36C10X Strategic Acquisition Center - Frederick Department of Veterans Affairs 5202 Presidents Court, Suite 103 Frederick MD 21703 36C10X Strategic Acquisition Center - Frederick Department of Veterans Affairs 5202 Presidents Court, Suite 103 Frederick MD 21703 To all Offerors/Bidders

36C10X21R0036 06-11-2021

X X X

The purpose of this amendment is to respond to vendor questions and revise the RFP and Attachment F.

Questions on 36C10X21R0036 VA Biomedical Support Services

PWS REFERENCE

(Paragraph/Page Number) ISSUE or CLARIFICATION Requested

Clarification: Can contractors use VA in-house test equipment if available?

Can the VA provide a list of the general test equipment required?

How will the VA handle the acquisition of specialty test equipment if required?

Will equipment costs be provided as part of the reimbursement as repair parts?

REPONSE: Please see revised section 9.5. The contractor will be required to provide their own general test equipment listed in section 9.5. Any specialized test equipment owned by the VA can be used by the contractor with approval from the L-COR. The Contractor shall notify the L-COR if any specialty test equipment is needed that is not available in-house, and if deemed necessary by the L-COR, the VA will procure the test equipment (same general process as repair parts).

Clarification: Will the VA consider equivalent experience in lieu of healthcare. PMs with experience in logistical, IT, and other similar fields could be equally effective in managing the scope of work in as described in the PWS?

REPONSE: The VA still requires hospital or healthcare experience for the project manager role, but we are willing to consider two years of experience in this setting instead of three. Please see revised section 14.2.e.

PWS Section E, para 8, page 72 Page Limitations

Issue: Page limitations for Volume I-III

Clarification: Will the VA allow cover pages and table of content not be counted against the page count?

Will the VA allow the executive summary for Volume I not be counted against page count?

REPONSE: Cover pages will not be considered part of the page count, however, an executive summary will be.

REPONSE: This will be held virtually. The anticipated award date is September 20, 2021

PWS Section E, para 8.b, page 73 Subcontractor Past Performance

Issue: Major subcontractors and limitation of 3 past performance

Clarification: Is there a limit of past performance for major subcontractors (>20% of total contract effort)?

Does the prime require to have majority?

Can major subcontractors provide 2 of the 3 past performance requirements?

REPONSE: There is no limit or percentage. However past performance of the prime will be considered first and hold more weight.

REPONSE: VA is looking for 3 references for recent, relevant work.

REPONSE: Similar work has been done at the regional level but not at the National level per this requirement.

REPONSE: Not necessarily, each TOPR will require a bid intention and response and we will take each response case by case.

“Remote Biomedical Engineering support is a valuable, feasible and timely alternative to onsite work in order to fulfill healthcare technology management needs.”

REPONSE: The share of work between onsite and remote work will vary by individual task order based on the needs. The type of work that is expected to be done onsite (cannot be done remotely) is described in section 9.4.

REPONSE: No, the duration for contractor personnel assignments at VA facilities will be based on the need of that facility.

REPONSE: Yes, all resumes should be a maximum of 1 page and included with Volume I, see revised Section E for details.

REPONSE: Pricing shall be submitted in one excel with a pdf to include backup, assumptions, clarifications.

REPONSE: All tasks within PWS (everything in the services section (section 9) should be responded to in technical capability.

REPONSE: The prime is the only vendor with privy to the Government and should be listed as the prime on the proposal.

REPONSE: There will no be teaming with more than one prime at the task order level.

RESPONSE: Yes, additional labor categories can be added to the proposal submission and reviewed as part of the price evaluation.

REPONSE: Yes, all resumes should be a maximum of 1 page and included with Volume I, see revised Section E for details.

REPONSE: It is VA’s intention to award the sample order at the time of IDIQ award.

RESPONSE: Yes

See attached document: 36C10X21R0036 FINAL with track changes 0001.

See attached document: Attachment F Sample ORDER PWS FINAL with track changes 0001.

image1.emf

36C10X21R0036 FINAL with track changes 0001.docx

36C10X21R0036

PAGE 1 OF

1. REQUISITION NO.

2. CONTRACT NO.

3. AWARD/EFFECTIVE DATE

4. ORDER NO.

5. SOLICITATION NUMBER

6. SOLICITATION ISSUE DATE

a. NAME

b. TELEPHONE NO. (No Collect Calls)

8. OFFER DUE DATE/LOCAL

TIME

9. ISSUED BY

CODE

10. THIS ACQUISITION IS

UNRESTRICTED OR

SET ASIDE:

% FOR:

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

8(A)

NAICS:

SIZE STANDARD:

11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

12. DISCOUNT TERMS

13a. THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13b. RATING

14. METHOD OF SOLICITATION

RFQ

IFB

RFP

15. DELIVER TO

CODE

16. ADMINISTERED BY

CODE

17a. CONTRACTOR/OFFEROR

CODE

FACILITY CODE

18a. PAYMENT WILL BE MADE BY

CODE

TELEPHONE NO.

DUNS:

DUNS+4:

PHONE:

FAX:

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER

18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW IS CHECKED

SEE ADDENDUM

19.

20.

21.

22.

23.

24.

ITEM NO.

SCHEDULE OF SUPPLIES/SERVICES

QUANTITY

UNIT

UNIT PRICE

AMOUNT

(Use Reverse and/or Attach Additional Sheets as Necessary)

25. ACCOUNTING AND APPROPRIATION DATA

26. TOTAL AWARD AMOUNT (For Govt. Use Only)

27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA

ARE

ARE NOT ATTACHED.

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA

ARE

ARE NOT ATTACHED

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN _______________

29. AWARD OF CONTRACT: REF. ___________________________________ OFFER

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND

DATED ________________________________. YOUR OFFER ON SOLICITATION

DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY

(BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE

ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED

SET FORTH HEREIN IS ACCEPTED AS TO ITEMS:

30a. SIGNATURE OF OFFEROR/CONTRACTOR

31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER)

30b. NAME AND TITLE OF SIGNER (TYPE OR PRINT)

30c. DATE SIGNED

31b. NAME OF CONTRACTING OFFICER (TYPE OR PRINT)

31c. DATE SIGNED

AUTHORIZED FOR LOCAL REPRODUCTION

(REV. 2/2012)

PREVIOUS EDITION IS NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

36C10X21R0036

06-11-2021

David Rupert

202-536-9972

07-12-2021

ET

36C10X

Strategic Acquisition Center - Frederick

Department of Veterans Affairs

5202 Presidents Court, Suite 103

Frederick MD 21703

X

541990

$16.5 Million

N/A

Set at IDIQ Task Order Level

36C10X

Strategic Acquisition Center - Frederick

Department of Veterans Affairs

VAFSC

U.S. Department of Veterans Affairs

Financial Services Center

PO BOX 149971

Austin TX 78714-8917

1-(877)-489-6135

See CONTINUATION Page

National Biomedical Contractor Support Services Indefinite

Delivery Indefinite Quantity (DIQ)

Submit proposal intentions to David.Rupert@va.gov and by

Melissa.Maloy@va.gov by June 28, 2021 at 12 noon EST.

Questions shall be submitted to David.Rupert@va.gov and by

Melissa.Maloy@va.gov by June 21, 2021 at 12 noon EST.

The result of this solicitation will be a multiple award

IDIQ contract.

This solicitation is set aside for Service-Disabled Veteran

Owned Small Businesses (SDVOSB)

All respondents must be verified in Veterans Information Pages

See CONTINUATION Page

Melissa Maloy

Contracting Officer

Table of Contents

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 GOVERNING LAW

Federal law and regulations, including the Federal Acquisition Regulations (FAR), shall govern this Order. Commercial license agreements may be made a part of this Order but only if both parties expressly make them an addendum hereto, as permitted by FAR 12.212. If the commercial license agreement is not made an addendum, it shall not apply, govern, be a part of or have any effect whatsoever on the Order; this includes, but is not limited to, any agreement embedded in the computer software (clickwrap), any agreement that is otherwise delivered with or provided to the Government with the commercial computer software or documentation (shrinkwrap), or any other license agreement otherwise referred to in any document. If a commercial license agreement is made an addendum, only those provisions addressing data rights regarding the Government’s use, duplication and disclosure of data (e.g., restricted computer software) are included and made a part of this Order, and only to the extent that those provisions are not duplicative or inconsistent with Federal law, Federal regulation, the incorporated FAR clauses and the provisions of this Order; those provisions in the commercial license agreement that do not address data rights regarding the Government’s use, duplication and disclosure of data shall not be included or made a part of the Order. Federal law and regulation including, without limitation, the Contract Disputes Act (41 U.S.C. § 7101 et seq.), the Anti-Deficiency Act (31 U.S.C. § 1341 et seq.), the Competition in Contracting Act (41 U.S.C. § 3301 et seq.), the Prompt Payment Act (31 U.S.C. § 3901 et seq.), Contracts for Data Processing or Maintenance (38 USC § 5725), and FAR clauses 52.212-4, 52.227-14, 52.227-19 shall supersede, control, and render ineffective any inconsistent, conflicting, or duplicative provision in any commercial license agreement. In the event of conflict between this clause and any provision in the Order or the commercial license agreement or elsewhere, the terms of this clause shall prevail. The Contractor shall deliver to the Government all data first produced under this Order with unlimited rights as defined by FAR 52.227-14. Claims of patent or copyright infringement brought against the Government as a party shall be defended by the U.S. Department of Justice (DOJ) in accordance with 28 U.S.C. § 516; at the discretion of DOJ, the Contractor may be allowed reasonable participation in the defense of the litigation. Any additional changes to the Order must be made by modification (Standard Form 30) and shall only be made by a warranted Contracting Officer. Nothing in this Order or any commercial license agreement shall be construed as a waiver of sovereign immunity.

B.2 CONTRACT ADMINISTRATION DATA

A. Contract Administration: All contract administration matters will be handled by the following individuals:

a. CONTRACTOR: TDB

b. GOVERNMENT: Contracting Officer 36C10X Melissa Maloy

Strategic Acquisition Center - Frederick

Department of Veterans Affairs

1. The IDIQ CO is responsible for providing overall scope oversight, maintaining communication between contractors and VA, ensuring contract compliance, administering base contract and modifications, and ensuring that annual performance evaluations are completed at the base contract level. Each task order (TO) will have an identified COR who will be responsible for ensuring that task orders are within the scope of the IDIQ base contracts, administering all task order awards, overseeing payment or rejection of invoices, and ensuring that annual performance evaluations are completed at the TO level.

1. The CO reserves the right to designate a Contracting Officer’s Representative (COR) at the IDIQ contract or individual task order level. The CO will issue a designation letter to the COR and the contractor to ensure that all parties understand the limited authority of the COR. The COR will also be responsible of overseeing payment of invoice or invoice rejection as described in B.g after acceptance of work.

B. Task Order Procedures

Contractors under the IDIQ shall provide services as requirements are identified throughout the ordering period. Each requirement will specify details as they relate to deliverables, performance, and other technical items. Contractors may be required to use the Acquisition Task Order Management System (ATOMS) for all task orders.

1. The IDIQ will follow ordering procedures as outlined in FAR 16.505. In accordance with FAR 16.505(b)(2), the CO will provide all awardees a fair opportunity to be considered for all awards under the IDIQ which exceed the micro-purchase threshold, unless one of the following exceptions applies:

0. The agency need for the supplies or services is so urgent that providing a fair opportunity would result in unacceptable delays;

0. Only one awardee is capable of providing the supplies or services required at the level of quality required because the supplies or services ordered are unique or highly specialized;

0. The order must be issued on a sole-source basis in the interest of economy and efficiency because it is a logical follow-on to an order already issued under the contract, provided that all awardees were given a fair opportunity to be considered for the original order; or

0. It is necessary to plan an order to satisfy a minimum guarantee.

Should one of these exceptions exist, the CO will execute the task order as a sole-source task order, seeking proper justifications in accordance with FAR and agency procedures.

1. As requirements for the Task Order Proposal Request (TOPR) are defined, the CO will determine the evaluation factors and issue a solicitation. Contractors will be given the fair opportunity to compete for task order awards, assuming one of the exceptions noted above does not exist. It should be noted that while the IDIQ contractors are not required to respond to all TOPRs for which they are afforded the opportunity, they are expected to do so. Repeated failure to provide a response will be reflected in past performance evaluations at the IDIQ level and may be taken into consideration when deciding whether or not to exercise options. Contractors unable to perform the requirements as stated in a TOPR must submit a “no-bid” to the CO with a brief, yet specific, explanation.

1. Each TOPR will include, at a minimum:

2. The due date and instructions for proposal submission,

2. A Statement of Work (SOW), Statement of Objectives (SOO), or Performance Work Statement (PWS) with a description of the requirements, including deliverables, minimum qualifications, and applicable information,

2. The place and period of performance, and

2. Any additional information deemed necessary by the CO.

1. Each TOPR will have a unique evaluation plan that will be developed by the CO and detailed. Factors, with the exception of Price, will be assigned an adjectival rating. In general, TOPRs will be evaluated by analysis of the following factors:

3. Technical Capability: The contractor will be asked to discuss their plan for accomplishing the work of the requirement. This factor may include subfactors such as a management plan, staffing plan, or key personnel.

3. Past Performance: The contractor will be asked to provide narratives of recent and relevant references and past performance questionnaires which confirm a level of quality. The CO may consider relevant performance on task order awards under this IDIQ and any other information available from Government sources.

3. Price: The Government will evaluate price reasonableness using price analysis techniques as prescribed in FAR 15.404-1(b). When competing for Labor Hour type TO awards, contractors are permitted to propose labor rates that are equal to or lower than those as listed in their contract. The Government will ensure that rates are not reduced to a level that risks nonperformance by requiring justification for the reduced rate at the time of proposal. Contractors may be requested to identify labor categories, number of hours, and labor rates in their price proposal for performance of each task.

3. Any other factors as determined appropriate by the CO.

1. The CO is not required to prepare formal evaluation plans, evaluate offers, post notice on the Federal Business Opportunities webpage or hold discussions or negotiations with each offeror. The CO will, however, maintain an internal record of the award decision and supporting information.

1. In accordance with FAR 16.5, the CO has broad discretion in determining which contractor should be awarded a task order. The CO will issue a task order to the contractor whose proposal is most advantageous to the Government considering the evaluation factors specified in the TOPR. The CO reserves the right to withdraw or cancel the TOPR. In such event, the contractor will be notified, via email, of the CO’s decision. This decision shall be final and conclusive and shall not be subject to the Disputes Clause or the Contract Disputes Act.

1. Upon TO award, the TO will be sent via email to the contractor. The contractor is not authorized at any time to commence TO performance prior to issuance of a signed TO or other written approval provided by a CO. The contractor’s failure to begin performance within the time frame required may result in termination of the task order and reconsideration of the other task order proposals received in response to the TOPR.

1. In accordance with FAR 16.505(b)(6), contractors may request a post-award debriefing for orders exceeding $10 million. The TO CO will conduct post-award debriefings in accordance with FAR 16.505(b)(6)(ii) and FAR 15.506. Issues arising from the placement of orders are not protestable to the Government Accountability Office unless the protest alleges that the order exceeded the value, scope, or period of the contract or in the case where a single task order exceeds $10 million.

1. Task orders may only be modified by written modification, executed by a warranted CO. The contractor shall not perform or provide services that are not expressly stated in the contract or TO. A Contracting Officer’s Representative (COR) does not have the authority or means to obligate the Government or change the terms and conditions of the contract or TO.

1. Work orders may be issued by the Local COR (L-COR) under the awarded task orders to further clarify and detail specific services, once the exact known need for the service arises. Each work order issued, will always be within scope of the awarded task order it falls under.

1. Upon work order service(s) completion, a review and/or examination and a determination of acceptance will be made by the TO COR..

1. Minimum Guaranteed Amount and Maximum Value

1. The minimum guaranteed amount for this contract is $2,500.00, which will be obligated at the time of IDIQ award. Orders beyond the minimum will be determined by department needs and the results of fair opportunity competitions, other than exceptions as noted in section B.1.B.(1) above. The Government has no obligation to award TOs beyond the minimum guaranteed amount.

1. The maximum aggregate value of all awards and task orders under this IDIQ is $200,000,000.00. This ceiling is neither divided nor multiplied by the number of awardees.

1. Interrelationships of Contractors

The Government has entered into other contractual relationships in order to provide technical services throughout VA. These services are separate from this IDIQ, but may be related to or in close proximity to those provided under this IDIQ. Contractors may be required to coordinate with other contractors in providing their services. All contractors shall sign a non-disclosure agreement (NDA), Attachment G, prior to commencing services under the base contract or a TO award.

1. Future Competitions

In performing services of this IDIQ, contractors may gain access to procurement sensitive information or be asked to provide support services in developing acquisition packages. Contractors are advised that such access or support deems the contractor ineligible for award as a prime contractor, subcontractor, or teaming partner on those procurements. Contractor’s failure to recuse itself from future competitions or present a mitigation plan in light of an Organizational Conflict of Interest, where applicable, may be grounds for termination under this contract and non-selection for future contracts in accordance with FAR Part 9.5.

1. Options

In accordance with FAR 17.2, the Government may contemplate the use of options in each task order. Inclusion of options at the task order level will be properly documented and approved in accordance with FAR and agency procedures and will be clearly stated in the TOPR. FAR 52.217-9 will be included in any task orders that include options.

1. Invoicing

1. All payments by the Government to the contractor will be made in accordance with 52.232-33, Payment by Electronic Funds Transfer – System for Award Management.

1. Specific invoicing instructions will be specified at the TO level.

1. On-Ramping/Off-Ramping

Contractors are required to submit proposals for at least 50% of TOPRS for which they are eligible on an annual basis. Contractors not meeting these requirements may be “off-ramped” via termination for convenience at no cost to the Government.

The Government reserves the right to “on-ramp” additional contractors throughout the ordering period to ensure adequate competition in each task order. Should the Government exercise this right, a new solicitation with identical requirements, terms, and conditions will be issued via the Government Point of Entry. Awardees will be added to the pool of contractors for future competitions. Contracts awarded via the “on-ramp” process will share in, but not increase, the previously established ceiling. The “on-ramping” process will not extend the ordering period.

“On-ramping” and “off-ramping” processes may occur independently and are not guaranteed as a result of the other. The decision to “on-ramp” and “off-ramp” is at the sole discretion of the Government.

B.3 PERFORMANCE WORK STATEMENT (PWS)

1. Introduction

VHA Office of Healthcare Technology Management (HTM) develops and guides the comprehensive management of healthcare technologies to assure safe, available, and innovative medical technology used to deliver exceptional health care for Veterans. HTM’s vision is to be an efficient, innovative and customer-oriented Center of Excellence that continually enhances VHA’s ability to deliver world class health care for our nation’s Veterans through exceptional management of healthcare technology as well as position VHA as the national leader in healthcare technology management. HTM/Biomedical Engineering at the medical facilities and VISNs direct the medical equipment management program and support clinical care through providing preventive and corrective maintenance, healthcare consulting, and professional services for the technology assessment, implementation and sustainment of medical equipment and clinical systems.

1. Scope of Work

The purpose of this contract is to provide technical and professional support to Biomedical Engineering departments at Department of Veterans Affairs (VA) medical centers, outpatient clinics, VISN offices, and the HTM Program Office to accomplish corrective and planned maintenance, professional Biomedical Engineering services, and project management work. Contract resources may be required to accomplish routine operational tasks (e.g. maintenance, patient safety recall investigation), as well as unexpected or time-limited tasks (e.g. COVID-19 pandemic support, operational readiness services for OEHRM/Cerner deployment). There are many competing priorities for Biomedical Engineering staff in today’s environment, and the support services shall provide interim Biomedical Engineering services either onsite or remotely while full-time positions are recruited and hired to fill permanent roles in Biomedical Engineering departments, as needed. When Contractor support services are required by a VA medical facility, a local VISN or facility VA Contracting Officer Representative (L-COR) will be designated to monitor and provide oversight to the contractors at that facility.

Successful offeror(s) may have to execute a Business Associate Agreement (BAA).

These services are non-personal. Contractor personnel shall serve in a support role; final decisions regarding VA business will always be made by Government personnel. Contractor personnel are not subject to the supervision and control of a Government officer or employee in accordance with (IAW) FAR 37.104(a) (1) (ii). Rather, contractor personnel shall perform their duties IAW specific tasks outlined in the PWS. Supervisory functions such as hiring, directing, counseling, and firing of contractor personnel are not performed by the Government. Contractor personnel shall at no time allow an employer-employee relationship to develop with VA organizations or their staff. VA organizations will refrain from any activities that create the appearance of such a relationship. Contractor personnel who furnish services under this contract are subject to Government technical oversight of the services provided. The Government retains the right to reject nonconforming services.

Contractors shall not perform inherently governmental functions including: decision-making, supervision of Government employees, supervision of other contractors on other contracts, and activities that create the appearance of performing such functions.

1. Period of Performance

The anticipated period of performance of this IDIQ contract is 5 years from the award date.

1. Place of Performance

This is a nationwide contract to include United States and Puerto Rico for all VA medical centers and outpatient clinics where Biomedical Engineering currently provides support. Attachment A: List of Facilities identifies all main facilities where work may be performed as part of this contract. The Contractor can determine how to service the outpatient clinics associated with main facilities. The Government retains the right to add or subtract facilities as needed, and this will be done via a modification to the contract.

1. Hours of Performance

Normal working hours will range between 7:00 AM to 5:00 PM, Monday through Friday, excluding federal holidays, although there may be some working-hours flexibility. This will be further defined in each task order. Occasional overtime may be needed and will be billed at the agreed upon rate. Contractor hours will be monitored by the L-COR and verified prior to billing and payment.

1. Travel

Some tasks may require travel. This travel must be pre-approved by the Local Contracting Officer’s Representative (L-COR) and will be reimbursed in accordance in accordance with Federal Travel Regulations (FTR) and Federal Acquisition Regulations (FAR) 31.205-46. Each Contractor invoice shall include copies of all receipts that support the travel costs claimed in the invoice. Local travel within a 50-mile radius from the duty location noted in the task order, is considered the cost of doing business and will not be reimbursed. Travel performed for personal convenience and daily travel to and from work at the Contractor’s facility will not be reimbursed. General and Administrative (G&A) fees will not be reimbursed.

1. Scheduling and Status Reports

The Contractor shall designate a Project Manager for the entire contract as well as for each task order to address contract/task order needs. The Contractor shall provide an availability calendar 60 (sixty) days out indicating the number of qualified personnel available each week through the course of the year to aid in scheduling activities.

7.1 Kick-Off Meeting:

The contractor shall participate in Technical Kick-Off Meeting within ten calendar days after contract award. The technical kick-off meeting shall occur in conjunction with the post award conference. The contractor shall present, for review and approval by the Government, the details of the intended approach, work plan, and projected schedule for this effort. The contractor shall provide an agenda at least five calendar days prior to the meeting, and document meeting minutes within three calendar days after the meeting. The contractor shall invite the CO, COR, and the HTM/Biomedical Engineering’s operations staff.

7.2 Monthly Status Reports:

The Contractor shall conduct monthly status report meetings with the facility-COR detailing, at a minimum, the previous month’s achievements, work planned for the current month, identified risks and recommendations to mitigate risk, staffing plans and forecasts, and a financial analysis of contract expenditures for the month (and year-to-date), including variance analysis compared to baseline and forecasted plans.

1. List of Equipment

All medical equipment listed in Attachment B: List of Types of Medical Equipment are included within the scope of this contract. Medical equipment covered under the manufacturer’s warranty or covered under a service contract with another vendor are excluded from this contract. The Government retains the right to add or subtract equipment as needed, and this will be done via a modification to the contract.

1. Services Overview

At a high level, the tasks within the requirement include planned maintenance; corrective maintenance; and professional services for the technology assessment, implementation, and sustainment of medical devices and clinical systems, as well as healthcare consulting/internal operation support regarding medical equipment management. The core functions are described in more detail as listed in Table 2: Core Biomedical Engineering Functions.

Technology Assessment

TECHNOLOGY ASSESSMENT (PRE-PURCHASE)

This work is performed following local approval and stated intent to acquire a medical device/system and extends through issuance of purchase order/contract. Includes all work performed related to supporting technology assessment and requirements definition prior to new equipment purchase order or contract award.

· Support of Market Research: what features and functions are currently available; who are the manufacturer/suppliers; what are important design considerations; what the integration considerations are; cost considerations, support of IGCE formulation, etc.

· Support of Requirements Definition: assistance determining “must have” and “desired” features/functions and level of technology; systems engineering design; support of writing technical specifications and RFP development

· Support of usability testing and human factors design; assessing ease of use

SPACE AND UTILITIES CERTIFICATION

Space & utilities assessment and certification of availability or identification of needed space and utilities. Includes scoping and/or preliminary design of site prep construction associated with pre-purchase activities. For example, drafting the scope or preliminary design of a space to prepare it for medical equipment to be installed.

SECURITY RISK ASSESSMENT

All work performed prior to new equipment purchase order or contract award related to Pre- Procurement Risk Assessment for information security (e.g., Directive 6550, MDS2, etc.), data protection, and privacy. Includes assessment work regarding networked medical devices such as bandwidth and connectivity requirements for local area, wide area, and wireless networks.

Technology Implementation

SITE PREP SUPPORT

Work pertaining to site preparation support and space planning activities for the implementation of new equipment. This work generally follows issuance of purchase order/contract award for new medical equipment/systems and extends through the installation phase into initial clinical use. Includes site preparation planning, design, coordination, and execution, including collaboration with architects, engineers, equipment vendors, construction contractors, and clinical departments.

PROJECT MANAGEMENT

Overall project management. Project management, coordination, and system configuration design with clinicians and vendors to implement new equipment/clinical systems. Includes preparation, participation, and leadership of meetings, conference calls, and communications. Includes creation, development, and upkeep of project documentation. This work is generally performed following issuance of purchase order or contract award for new equipment/systems and extends through first clinical use and transitions to operational sustainment.

PRE-IMPLEMENTATION SECURITY

Work associated with Information Security and Network Attached Medical Equipment Pre-Implementation Checklist (e.g., VA Directive 6550) and implementation of new equipment on medical Virtual Local Area Network (VLAN) with appropriate network isolation and protection. Includes design and configuration of Access Control Lists (ACL). This work is performed following issuance of purchase order or contract award for new equipment and generally extends through first clinical use and system optimization.

INSTALLATION

Installation work associated with implementation of new equipment/systems. Assembly and installation of new equipment items includes hardware and software installation. Includes systems integration and connectivity testing.

INCOMING INSPECTION

Initial inspections and acceptance inspections to validate specifications and performance levels of new equipment, including owned, rental, loaner, and demo equipment. Includes safety inspection prior to first clinical use. This includes functional testing, user acceptance testing, and formal acceptance actions (per contract). Includes design and assignment of operations and maintenance strategy, developing O&M plan and maintenance standard operating procedures. Establishing inventory record(s) and assigning maintenance schedule(s) for new equipment.

EDUCATION PROVIDED-IMPLEMENTATION/ USER

Provide or facilitate initial user training associated with new equipment implementation. Includes arranging vendor applications training and providing system “Go-Live” assistance and support. Includes training on operator-level maintenance and administration of equipment/system.

Technology Sustainment - Safety

HAZARD REMEDIATION

Actual corrective action and/or coordination of corrective actions for affected or recalled medical devices and associated items.

HAZARD/RECALL INVESTIGATION

Hazard/Recall review, discovery, and identification of affected devices and related reporting. Incident Investigation (separate from Information Security incidents): investigation of incidents internal to VAMC(s), including forensic activities, formal root cause analyses, healthcare failure mode and effects analysis (HFMEA), and SMDA/MedWatch reporting, etc.

MEDICAL DEVICE SECURITY INCIDENT

Medical device security incident investigation, corrective action, and reporting/documentation. Includes responses to incidents such as malware intrusions, unauthorized/unsuccessful group policy pushes, and unauthorized/unexplained ACL change.

DE-INSTALLATION/ DECOMMISSIONING

Physical de-installation of a medical device/system. Decommissioning activities include sanitization of stored sensitive information as appropriate (e.g., physical destruction), reviewing maintenance history for completeness, assisting logistics with condition coding, removing from maintenance schedule, and other associated turn-in activities (abiding with Decommissioning standard operating procedures).

Technology Sustainment - Planned Maintenance

PLANNED MAINTENANCE

Routine support and planned maintenance of medical devices and medical systems (includes medical servers and other computer-based systems), including hardware, software, or communications networks. Typically performed according to defined procedures and on a scheduled basis, to minimize a device or system’s risk of failure and/or to ensure continued operation, safety, and data security. Includes tasks such as adjusting, calibrating, lubricating, cleaning, and replacing parts. Includes electrical safety inspection and testing. Includes testing the resiliency of medical systems infrastructure and fault tolerance testing. Includes visual inspection. Includes overhauls that are extensive replacing or rebuilding of system components (separate from upgrades).

ELECTRICAL SAFETY INSPECTION

Performance of electrical safety evaluations and applicable electrical measurements per VA, NFPA 99, and manufacturer specified requirements.

PERFORMANCE VERIFICATION

Verify device or system (includes medical servers and other computer-based hardware/software systems) “to be” operating state according to manufacturer and other specifications, separate from restorative repairs. Inspection to verify that the physical integrity, safety, and performance of a device/system meets necessary functional requirements.

MEDICAL DEVICE/SYSTEM PROTECTION

Planned/proactive inspection and installation of medical device operating systems, and malware prevention/antivirus software, and updates of same. Planned review of ACL design and update as appropriate; consideration of data backup and disaster recovery processes; test updating of automatic failover functions; assessment of data storage capacity and security of sensitive data. Performance of both physical and logical security reviews. Preparation of IT Requests for MDIA actions, ACL Changes, new VLAN assignments, and associated network jack installation/activation. Also includes OS, malware protection/antivirus software patching, and planned ACL and MDIA work activities.

Technology Sustainment - Corrective Maintenance

GENERAL REPAIR

Work performed on equipment to restore to clinical operation. Generally, hardware related. Restore physical integrity, safety, and/or performance of a device/system after a failure. This work typically includes troubleshooting and determination of the actions to complete the necessary repair(s); researching and determining necessary replacement parts; routine purchasing procedures; receipt of parts; completion of repair; and any intra-facility travel associated with pickup or return of equipment. Includes problem identification and resolution of medical systems servers that is primarily hardware related (may include incidental running of software routines, reloading software, or connectivity assessment that is incidental to the hardware resolution).

SOFTWARE REPAIR

Work performed to repair/restore medical device software or systems to clinical operation after a failure via software related actions including reloads, re-imaging, and other corrective actions. Includes problem identification and resolution of medical systems servers that is primarily software related (may include incidental troubleshooting and correction of hardware routines, reloading hardware, or connectivity assessment that is incidental to the software resolution).

MEDICAL SYSTEMS CONNECTIVITY

Determination of cause and correction of a reported operational problem(s) with a network-connected medical device or system determined to be related to network, interoperability protocol, or other connectivity-based infrastructure. Includes troubleshooting and correcting reported problems associated with VLANs, ACLs, network port security, telecommunications, patch cable problems, HL7 outages, etc. Includes activities related to system connectivity or system wide related interoperability and interconnectivity issues.

Technology Sustainment

UPGRADES

Enhancement and upgrades for added functionality, greater reliability, and improved patient safety, including hardware and software improvement.