Attachment F Sample ORDER PWS FINAL 0002.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

5202 Presidents Court, Suite 103 Frederick MD 21703

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

b. GOVERNMENT: Contracting Officer 36C10X Melissa Maloy Strategic Acquisition Center - Frederick Department of Veterans Affairs 5202 Presidents Court, Suite 103 Frederick MD 21703

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.

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.

Technology Sustainment - Safety

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).

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. Includes any significant reconfiguration of existing medical device/systems.

FABRICATION/ MODIFICATION

Work performed to design/create new equipment, assemblies, or apparatuses. Modification that alters a device/system to improve performance, reliability, or safety, or to add new functionality.

EDUCATION PROVIDED- CLINICAL USER

Providing training on the operation of medical equipment and technology systems. Includes training on operator-level maintenance and system administration. Includes time spent facilitating training with clinical educators, vendors, and other 3rd parties. Includes general training provided regarding medical equipment management, HTM services, equipment safety, new employee orientation, nurse staff meetings, etc., and mentoring of non-Biomedical Engineering personnel.

MEDICAL APPLICATION SUPPORT

Time spent on medical application changes. Work includes but not limited to adding/removing users, configuration changes, system application administration, regular medical device application software patching, clock resets, rebooting PCs, and interoperability verification.

Healthcare Consulting

Internal Operations

Table 2: Core Biomedical Engineering Functions

9.1. Planned Maintenance (PM)

Planned maintenance refers to a procedure ensuring proper medical equipment operation and calibration. This procedure includes inspection of the medical equipment for mechanical defects, cleaning of interior fans and filters, performance verification of operator controls and adjustments, calibration verification per original equipment manufacturers’ (OEM) specifications, inspection for ground integrity and current leakage, and documentation of all results. The Contractor shall have the appropriate level of training or OEM certification to perform PM services, and they shall not perform PM services on medical equipment that they are not fully trained or certified on. The Contractor shall submit training certificates to the COR when required for the equipment being maintained. The OEM’s specifications shall be used as the source document for all planned maintenance (unless otherwise instructed by the L-COR).

The Contractor shall ensure planned maintenance services support the VA facilities in preparation for The Joint Commission and other regulatory inspection surveys. The L-COR will notify the Contractor by the end of the month prior that Contractor support is required for PM services in the following month. The Contractor shall ensure all scheduled PM services are completed prior to the 15th day of the scheduled month. If PM services cannot be completed prior to the 15th day of the scheduled month due to the equipment not being located or in use on a patient, then the Contractor shall have until the end of the scheduled month to complete the PM services. If at the end of the month, the Contractor still cannot complete the PM, all efforts to complete the PM shall be documented on a field service report and the information provided to the L-COR. Contractor planned maintenance services shall include, but are not limited to the following:

· Performance verification

· Electrical safety inspection and testing

· Routinely scheduled service per OEM specifications

· Ensuring all equipment is maintained and repairing it to OEM standards if needed

· Documentation of all planned maintenance services upon completion or no later than the fifth (5th) business day of the subsequent month

9.2. Corrective Maintenance

Medical equipment repairs shall be facilitated by the Contractor to ensure equipment availability, to provide an optimum level of equipment performance, and to extend the useful life of the equipment. The Contractor shall have the appropriate level of training or OEM certification to perform corrective maintenance services, and they shall not perform corrective maintenance services on medical equipment that they are not fully trained or certified on. The Contractor shall submit training certificates to the COR when required for the equipment being repaired. When repairs are required to correct equipment malfunctions, the Contractor shall use industry accepted repair practices and maintain high standards of equipment performance and safety to complete corrective maintenance services in a timely manner. All efforts shall be made to meet an average corrective maintenance turn-around time of 8 days from the initiation of a work order from the VA to the completion of the work order by the Contractor. The Contractor corrective maintenance services shall include, but are not limited to the following:

· Performance analysis

· Troubleshooting and problem identification

· Decision-making regarding problem correction in the most pertinent, timely, and cost-effective manner

· Completing the repair

· Performance and electrical safety testing

· Documentation of all corrective maintenance services upon completion or within one day of job completion.

9.3. Professional Services

Professional services include any work related to supporting medical equipment or Biomedical Engineering department operations that is not planned or corrective maintenance. The Contractor shall provide professional services in the areas of technology assessment, implementation, and sustainment of medical devices and clinical systems; healthcare consulting; and internal operation support. Contractor services for Office of Electronic Health Record Modernization (OEHRM) deployments focus primarily on technology assessment, implementation, configuration management and healthcare consulting services. Contractor services for operational support of a VA medical center or VISN could include any of the services listed. Services breakdown will vary per location and Contractor skill level. Contractor-provided professional services shall include, but are not limited to the following:

· 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.

· Equipment and Systems Planning – Support assessing medical equipment and clinical systems portfolios, identify equipment approaching the end of its useful life, identify legacy systems, identify emerging or innovative technology/systems, support developing medical equipment and clinical systems strategic plans.

· Specification Development – Support defining and validating the requirements, compliance, features, and functions for medical equipment and clinical systems through extensive stakeholder interaction, technical subject matter expertise, and market research.

· Technical Analysis - Perform technical market analysis of medical equipment and clinical systems, considering clinical capabilities, technical performance, supportability, device integration, design and architecture, desired features, human factors design, ease of use, cost, and other factors.

· Risk Assessment - Perform risk assessments of medical equipment and clinical systems in collaboration with clinical stakeholders, patient safety personnel, and with IT for human factors design, reliability, information security, data protection, and connectivity requirements. Submit information required for Enterprise Risk Assessments (ERAs).

· Site Readiness - Collaborate with architects, engineers, equipment vendors, construction contractors, clinical services, IT, and others to ensure proper medical equipment and clinical systems siting, safety compliance, physical and remote connectivity, security documentation, and code compliance in preparation for major medical equipment and clinical system installations.

· Installation and Inspection - Ensure equipment and systems are inspected and approved for implementation by validating specifications, performance levels, and electrical code compliance; performing functional testing, user acceptance testing, formal acceptance actions (per contract), and work associated with documentation; designing the equipment lifecycle strategies; developing preventative and corrective maintenance plan and standard operating procedures; facilitating proper user training; evaluating needs for system access and ensuring that the need to perform a task, permission levels, and competency requirements are met; ensuring proper nomenclature categorization; and assigning maintenance schedule(s) for new equipment and systems.

· Systems Design and Integration - Address and evaluate multiple parameters to ensure that separate medical equipment and clinical systems work as complete, integrated systems (when necessary). Facilitate with Cerner-medical device integration parameter testing efforts, medical device configurations and Cerner Connectivity Engine (CCE) configurations required for BMDI solutions.

· Configuration - Arrange and document clinical system specifications, components, connectivity, and operating system and software versions; track and control changes; and validate and maintain consistency and completeness of the clinical system.

· Technical Training and Support - Provide or facilitate education and applications training for Biomedical Engineering staff and facilitate operator training around operating and maintaining medical equipment and clinical systems. Provide helpdesk and troubleshooting support for medical equipment and/or clinical systems.

· Safety Alerts, Recalls, and Incident Management - Manage, lead, and document activities associated with medical equipment and clinical systems safety, recalls, and incident investigations to prevent harm to patients, including proactive risk assessments, evidence preservation, data capture and analyses, root cause identification, corrective action development, solutions implementation, and disaster recovery. Set, monitor, and/or remediate clinical system alerts and failures, including performing remote monitoring and recovery.

· Cybersecurity Risk Management - Directly support and monitor medical equipment and clinical system cybersecurity compliance, including: ensuring proper medical network security operations, conducting planned and proactive updates of devices and systems, providing quality assurance on medical system compatibility, ensuring equipment inspections and calibrations do not degrade medical equipment performance, performing security incident investigation and corrective action, and testing device communication and system reporting to validate the expected level of integration and interoperability exists.

· Hardware and Software Upgrades - Proactively upgrade hardware and software to optimize patient safety and clinical efficacy through technology refresh cycles.

· Regulatory Compliance - Ensure compliance with VA and regulatory standards pertaining to medical equipment and clinical systems including those from VHA's Office of Healthcare Technology Management (HTM), The Joint Commission (TJC), National Fire…