Attachment 1 - Statement of Work - Revision 1.pdf

36C25624Q0375 0001 Attachment 1, Revision 1

SCOPE OF WORK

Medical Equipment Service and Support

(3/11/2024)

1) SCOPE

Services, non-personal: The contractor shall provide all parts, labor, tools, materials, equipment, transportation and supervision necessary to service and support the medical equipment listed in Appendix A in complete and strict accordance with the contract and all attachments thereto.

2) EQUIPMENT IDENTIFICATION AND COVERAGE

A. Support and Maintenance for:

• 375 Hill-Rom beds

• 226 Hill-Rom and Stryker stretchers

• 27 Lasers (various manufacturers)

See Appendix A for breakdown of equipment by manufacturer and model.

B. Support provided in the form of, but not limited to:

• Preventive maintenance (PM) services according to the OEM service manual

• Unlimited corrective maintenance services

• Technical Phone Support 24/7

• Reporting services including field service reports and on-time PM completion rates

• A plan to address deferred PMs

3) GENERAL REQUIREMENT

Michael E. DeBakey Medical Center is requesting for a contractor to provide preventative and corrective maintenance and support services to various equipment at 2002 Holcombe Blvd, Houston, TX 77030 with an uptime commitment of 90%. The full summary of the equipment can be found in Appendix A. The contractor shall furnish all personnel, equipment, tools, vehicles, materials, supervision, transportation, parts, and services necessary to effectively, economically, and satisfactorily perform all services outlined in this SOW. Service shall only be conducted by trained and “fully qualified” technicians. Preventive maintenance shall be performed as dictated by the OEM at the OEM required frequency.

Contractor will manage vendor relationships as necessary to maintain the functionality of medical equipment that requires maintenance services to be performed by OEM certified technicians, unless the contractor can fully support maintenance services.

Contractor shall act as a single point of contact for all services.

4) DEFINITIONS/ACRONYMS

A. Biomedical Engineer(ing) - Supervisor or designee.

B. CO - Contracting Officer C. COR - Contracting Officer's Representative D. 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 inoperative conditions.

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

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

G. Acceptance Signature - VA employee who is authorized to sign-off on the ESR which indicates that the PM has been concluded or is still pending completion, or that the Emergency Repair has been accomplished or is still in a pending status.

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

I. NFPA - National Fire Protection Association.

J. CDRH - Center for Devices and Radiological Health.

K. VAMC - Department of Veterans Affairs Medical Center L. VAH - Department of Veterans Affairs Hospital M. OEM - Original Equipment Manufacture

5) CONFORMANCE STANDARDS

Contract service shall ensure that the equipment functions in conformance with the specifications used when the equipment was procured by the VAMC, and any upgrades/updates, as well as following most current published standards/ specifications/regulations:

Manufacturer’s specifications, Association for the Advancement of Medical Instrumentation (AAMI), Joint Commission for the Accreditation of Healthcare Organizations (JCAHO), National Fire Protection Agency 99 (NFPA-99), Center for Device and Radiological Health (CDRH), Original Equipment Manufacturer (OEM), American Hospital Association (AHA), Institute of Electrical And Electronic Engineers (IEEE), Underwriters Laboratories (UL) ,Occupational Safety and Health Administration (OSHA), College of American Pathologists (CAP), VAMC standard operating procedures, and any other Federal, State, and Local regulations pertaining to the equipment listed for this contract.

Contract service shall ensure that the equipment functions in conformance with the latest published edition of NFPA-99, UL, OSHA, VA, and CDRH.

All work shall be performed to factory standards and the COR who will inspect the repairman’s work and indicate his approval on a signed statement prior to the repairman’s departure from the premises.

6) HOURS OF COVERAGE

A. Normal hours of coverage are Monday through Friday from 8:00 a.m. CT to 5:00 p.m. CT, excluding holidays. All service/repairs will be performed during normal hours of coverage unless requested or approved by COR or his designee. In the event a holiday falls on a Saturday, it will be observed by the facility on the preceding Friday. In the event a holiday falls on a Sunday, it will be observed on the following Monday.

B. Federal Holidays observed by the VAMC are:

• New Years' Day

• Martin Luther King Day

• Washington’s Birthday

• Memorial Day

• Juneteenth

• Independence Day

• Labor Day

• Columbus Day

• Veterans' Day

• Thanksgiving Day

• Christmas Day

C. In addition to the days designated as holidays, the Government observes the following days:

• Any other day designated by Federal Statute

• Any other day designated by Executive Order

• Any other day designated by the Presidential Proclamation

7) EQUIPMENT INVENTORY

A. Contractor shall utilize and maintain a comprehensive inventory and service tracking database ("Maintenance Database"), which will be web-accessible by the Facility for the purpose of querying Maintenance Service status, Maintenance Service schedules, inventory lists and generating reports. The Maintenance Database shall be capable of generating an inventory list of all Equipment maintained pursuant to the Contract. Contractor’s Equipment inventory list shall include the Equipment’s description, manufacturer’s name, model number, serial number, Facility EE/MX inventory number, and specific location (e.g. address, room number).

B. Contractor’s Maintenance Database shall electronically manage all Repair

Services (emergency and non-emergency), Maintenance Services, and the

Facility’s Equipment inventory. Contractor shall provide an online method for the Facility to place maintenance orders and make its Maintenance Database available and accessible to the Facility online in read-only mode via the internet and be password protected or have individual login information for designated Facility personnel. This Maintenance Database shall be accessible twenty-four

(24) hours a day, seven (7) days a week, 365 days a year, with the exception of any scheduled and pre-approved maintenance downtime by Facility in writing.

Contractor shall provide the Facility with online query and report-generating functionality.

8) UNSCHEDULED MAINTENANCE (Repair Services)

A. Contractor shall maintain the equipment in accordance with the OEM’s latest specifications available in the OEM service manual. The Contractor will provide repair service which may consist of calibration, cleaning, oiling, adjusting, replacing parts, and maintaining the equipment, including all intervening calls necessary between regular services and calibrations. All required parts shall be furnished.

B. Response Time: - Contractor's FSE must respond with a phone call to the COR or his/her designee within two (2) hours after receipt of telephoned notification. If the problem cannot be corrected remotely, the FSE will commence work (on-site physical response) within four (4) hours after receipt of this second notification and will proceed progressively to completion without undue delay.

C. Any charges for parts, services, labor, travel, manuals, tools required to successfully complete unscheduled maintenance are included in the contract price, unless specifically stated in writing otherwise and approved by the CO.

D. Contractor shall provide mandatory safety and performance-related updates to covered equipment.

E. The Contractor must have the ability to concurrently address multiple emergency calls and unscheduled maintenance on different equipment.

F. Contractor shall promptly correct any improperly repaired Equipment, as determined by the Facility, correct any damage resulting therefrom, and supply all necessary parts, components, and materials, all at no additional cost to the Facility. Contractor's service personnel shall also repair any defective parts or components purchased and installed by such personnel and shall repair any damage to the Equipment resulting from, and to the extent of, Contractor's negligence, willful misconduct, or conduct inconsistent with the requirements of the Contract or industry standards, all at no additional cost to the Facility.

9) SCHEDULED MAINTENANCE

A. The Contractor shall perform PM service to ensure that equipment listed in the schedule performs in accordance with the Conformance Standards section. The PM must be done in accordance with the latest OEM maintenance procedures and protocols available in the OEM service manuals.

B. Contractor must adhere to the existing PM schedule for lasers. Contractor will establish a new PM schedule for beds and stretchers after contract award. PMs must be completed within the PM month +/- 20 days.

C. PMs may be deferred for reasons such as the equipment being in use or unable to locate. The field service report must show documentation of 3 attempts to perform a PM before the PM can be considered closed in deferred status. An action plan must in place to continuously re-visit deferred PMs until they can be completed.

D. PM services shall include, but need not be limited to, the following:

1) Cleaning of equipment.

2) Calibrating and lubricating the equipment.

4) Performing remedial maintenance of non-emergent nature.

5) Testing and replacing faulty and worn parts and/or parts likely to become faulty, fail or become worn.

6) Inspecting and replacing where indicated, electrical wiring and cables for wear and fraying.

7) Inspecting, and replacing where indicated, all mechanical components which may include, but is not limited to: cables and mounting hardware, chains, belts, bearings and tracks, interlocks, clutches, motors, and keyboards for mechanical integrity, safety, and performance.

8) Returning the equipment to the operating condition defined in the “Conformance Standards” section and in accordance with the OEM.

9) Providing documentation of services performed.

E. PM services shall be performed in accordance with, and during the hours defined in the “Hours of Coverage” section and the preventive maintenance schedule established herein. All exceptions to the PM schedule shall be arranged and approved in advance with the COR.

F. Any charges for parts, services, labor, travel, manuals, tools required to successfully complete scheduled PM are included within this contract, and its agreed upon price, unless specifically stated in writing otherwise and approved by the CO.

10) PARTS & TRAVEL

Only new, OEM parts may be used in performance of this contract. Used, refurbished, or remanufactured parts are unacceptable.

The Contractor shall furnish and replace parts in accordance with the manufacturer's specifications. The Contractor has ready access to all parts, including unique and/or high mortality replacement parts. All parts supplied shall be compatible with existing equipment. The contract shall include all parts [except -if applicable - those parts specifically listed as being EXCLUDED]. The contractor shall use new original equipment manufacturer (OEM) parts. All parts shall be of current manufacture and have complete versatility with the presently installed equipment. All parts shall perform identically to the original equipment specifications.

Travel for any and all services covered by this contract are included in the contract price.

11) SERVICE MANUALS/TOOLS/EQUIPMENT/TRAVEL

The VAMC shall not provide travel, tools, (test) equipment, service manuals or service diagnostic software to the contractor. The contractor shall obtain, have on file, and make available to its FSE's all travel, operational and technical documentation (such as;

operational and service manuals, schematics, and parts list) which are necessary to meet the performance requirements of this contract. The location and listing of the service data manuals, by name and/or the manuals themselves shall be provided to the CO upon request.

12) CONDITION OF EQUIPMENT

The Contractor accepts responsibility for the equipment in "as is" condition. Failure to inspect the equipment prior to contract award will not relieve the Contractor from performance of the requirements of this contract.

Contractor shall show to the COR that the required system components are in place and fully functional prior to COR acceptance explained in the Reporting Requirements Section.

13) TEST EQUIPMENT

Should the COR request it, prior to commencement of work on this contract, the Contractor shall provide the VAMC with a copy of the current calibration certification of all test equipment which is to be used by the Contractor on VAMC's equipment. This certification shall also be provided on a periodic basis when requested by the VAMC.

Test equipment calibration shall be traceable to a national standard.

Should the CO request it, the Contractor shall submit a sample of calibration certification of all test equipment to be used by the Contractor on MEDVAMC equipment. Failure to submit sample of calibration certification of all test equipment to be used by the Contractor on MEDVAMC equipment with technical proposal shall result a non-responsive technical proposal.

14) REMOVAL OF EQUIPMENT

Should a piece of equipment require repair at the Contractor ‘s facility, the Contractor shall coordinate the removal of equipment with the COR. Government property cannot be removed from the station without a signed Property Pass. This Property Pass may be obtained from Acquisition & Material Management Service, Personal Property Section, 4A-320 after removal is authorized by the COR. The Contractor may not remove equipment from Government site for minor repairs only. The Contractor shall be responsible for damage or loss of equipment while in the Contractor ‘s charge.

15) ONSITE REPORTING REQUIREMENTS

The Contractor shall be required to report to Biomedical Engineering to log in. This check in and check out is mandatory. Contractor’s repairman shall complete a full service report (FSR) after each service call (emergency or scheduled) and make an electronic copy of this report available to the COR within 5 business days after the service day.

VA Biomedical Contact Info: VHAHOUBIOMED@va.gov Location (Building/Room Number): BA-200 Telephone Number & Extension(s): 713-791-1414 x27270

16) DOCUMENTATION/REPORTS

A. FSRs: The documentation shall include detailed descriptions of the scheduled and unscheduled maintenance procedures performed, including replaced parts required to maintain the equipment in accordance with the "Conformance Standards" section or the manufacturer's specifications. Such documentation shall meet the guidelines as set forth in the Conformance Standards section.

Each FSR must, at a minimum, document the following data legibly and in complete detail:

1) Name of contractor and contract number.

2) Name of FSE who performed services.

3) Contractor service FSR number/log number.

4) Date, time (starting and ending), equipment downtime and hours on-site for service call.

5) Description of problem reported by COR.

6) Identification of equipment to be serviced:

a) Inventory ID number,

b) Manufacturer's name,

c) Device name,

d) Model number,

e) Serial number,

f) Any other manufacturer's identification numbers.

7) Itemized Description of Service Performed (including, if applicable, Costs associated with after normal working hour services) including:

a) Labor and Travel,

b) Parts (with part numbers),

c) Materials and Circuit Location of problem/corrective action.

8) Signature of the FSE performing services described.

B. Contractor shall report monthly on PM completion percentages.

17) REPORTING REQUIRED SERVICES BEYOND THE CONTRACT SCOPE

The Contractor shall immediately, but no later than 24 (twenty-four) consecutive hours after discovery, notify the CO and COR (in writing) of the existence or the development of any defects in, or repairs required, to the scheduled equipment which the Contractor considers he/she is not responsible for under the terms of the contract. The Contractor shall furnish the CO and COR with a written estimate of the cost to make necessary repairs.

18) COMPETENCY OF PERSONNEL SERVICING EQUIPMENT

A. The contractor must have and maintain an established business, with an office and full-time staff who can meet the required response times. The staff must include two (2)fully qualified FSE (primary and backup).

B. "Fully Qualified" is based upon training and on experience in the field. For training, the FSE(s) has successfully completed a formalized training program, for the equipment. OEM certification is required to service lasers, as they are considered high-risk. OEM certification is highly preferred to service beds and stretchers. For field experience, the FSE(s) has a minimum of two years of experience (except for equipment newly on the market) with respect to scheduled and unscheduled preventive and remedial maintenance, on the listed equipment.

C. All work shall be performed by "Fully Qualified", competent FSEs. The

Contractor shall provide written assurance of the competency of their personnel and a list of credentials of approved FSEs for each make and model the Contractor services at the VAMC prior to award. The COR may authenticate the training requirements, request locations, training certificates or credentials, and technician location from the Contractor at any time for any personnel who are servicing or installing any equipment. The CO and/or COR specifically reserve the right to reject any of the Contractor's personnel and refuse them permission to work on the VAMC equipment if evidence is not provided when requested.

D. If subcontractor(s) are used, they must be approved by the COR; the Contractor shall submit any proposed change in subcontractor(s) to the CO for approval/disapproval.

19) SAFETY REQUIREMENTS

In the performance of this contract, the Contractor shall take such safety precautions as the Contracting Officer, or his/her designee, may determine to be reasonably necessary to protect the lives and health of occupants of the building. The VAMC, CO, COR or any of its and/or their associates, employees or descendants under any conditions or circumstances shall not be held responsible for any safety incident or any injury or any inconvenience experienced by the Contractor, their associates, or subcontractors while performing the services, labor, travel, maintenance included within this contract to the extent applicable by federal, local and state law with federal law taking precedence.

20) CONTRACTOR CONDUCT REQUIREMENTS

A. The contractor shall obtain all necessary licenses and/or permits required to perform this work. Contractor shall take all precautions necessary to protect persons and property from damage during performance of this contract.

Contractor shall be responsible for any injury to himself or his employees, or others, as well as for any damage to personal property that occurs during the performance of this contract that is caused by him/her or his/her employee’s fault or negligence

B. All employees and subcontractors must wear a visible name and company identification when onsite. When more than one person is onsite performing work under this contract, one must be designated as a supervisor and must be fully responsible for the work to be performed.

C. Employees and subcontractors working onsite must wear the VA Contractor badge. The COTR will be responsible for securing contractor badges for each contracted employee.

D. The Contractor shall provide all supplies, materials, equipment, qualified personnel, supervision, management, and transportation to perform all tasks as identified herein. All work is to be performed in accordance with the guidelines established by Federal, State, and local ordinances and The Joint Commission.

The Contractor’s procedures and quality control procedures shall conform to these guidelines.

E. The Contractor must make all subcontractors aware of the requirements of this contract.

F. Contractor personnel must conduct their work so as not to interfere with the normal functioning of the facility and will stop work if asked by medical center management personnel.

G. The Contractor shall take all precautions necessary to protect the lives and health of occupants of the building.

H. The Contractor must follow procedures required by Infection Control personnel and the construction safety committee, to include any required dust control.

I. The Contractor must state what efforts will be made to minimize noise during testing of equipment.

J. The Contractor shall immediately correct any fire and safety deficiencies caused by his personnel. If the contractor fails or refuses to correct deficiencies promptly, the Contracting Officer may issue an order stopping all or any part of the work and may hold the contractor in default of the contract.

K. The Contractor shall comply with applicable Federal, State, and local safety and fire regulations and codes which are in effect at the beginning of the contract period. The contractor shall keep abreast of any changes in these regulations and codes applicable to the contract.

L. All material and equipment will be removed from the facility or stored properly at the end of each workday and secured during the work day in the areas specified by the Contracting Officer’s Technical Representative.

M. The Contractor is responsible for supplying, completing, and submitting all reports required or requested by Federal, State, or local ordinances which pertain to any duties contained in the contract.

O. The Contractor will be required to follow all OSHA General Industry regulations.

P. No hot electrical work shall be performed. Any electrical work that is necessary must be coordinated with the facility electricians, and lockout/tagout provisions must be presented if electrical work is required.

Q. The Contractor’s personnel shall follow the applicable policies of the MEDVAMC, to include policies concerning fire and disaster preparedness programs.

R. The contractor shall furnish at his own expense all labor, materials, machinery, and appliances which may be necessary or appropriate in the performance of this contract.

S. Any accumulated rubbish is to be collected and placed in facility trash or dumpsters.

21) PRIVACY/SECURITY

The Contractor will not have electronic connectivity to the VA network. The Vendor will not have access to patient databases or PHI.

Any electronic or magnetic data storage devices requiring replacement such as hard drives, etc. shall be turned into the ISO. Electronic or magnetic data storage devices are not to be removed from VA property.

22) MOBILE MEDIA SCANNING

The Contractor will identify if removable media (i.e. USB or DVD/CD Device) is required to perform his/her duties. Personally-owned USB thumb drive utilization is prohibited.

Non-VA support personnel must furnish their own FIPS140-2 certified USB thumb drives, and only with the permission of a designated VA supervisor. All USB drives must be scanned with an antivirus program running current virus definitions by the local VA staff, prior to connection to any VA device. COR or designee will ensure the removable media is scanned with anti-virus software running current virus definitions prior to connection to any medical device system. The computer system for scanning removable media is located in the Biomedical Engineering shop, Building 100, Room

BA200.

23) ADDITIONAL CHARGES

There will be no additional charge for time spent at the site (during, or after the normal hours of coverage) awaiting the arrival of additional FSE and/or delivery of parts.

In any case, the VA shall be explicitly notified in advance that additional charges will be incurred, prior to beginning such work. In such instances that the VA agrees the work is not within the scope of the contract, and the VA desires the Contractor to perform service, a separate purchase order will be issued to the Contractor for the work. Any service required which the Contractor believes to be in excess of the contract provisions and requiring additional payment (e.g., work beyond normal work hours or work beyond scope) shall not be performed without prior written authorization from the CO, who will arrange a separate purchase order to pay for the additional service if desired by the VA.

The Government shall not be responsible for incidental charges including, but not limited to, parking, tolls, mileage, phone, etc.

24) GOVERNMENT PARTY TO EXECUTE AND MODIFY THE CONTRACT

No government personnel other than the Contracting Officer can execute contract modifications on behalf of the government.

25) END OF SERVICE PERIOD

No service shall be performed under this agreement after the contract expiration date without written authority or direction from the Contracting Officer.

Contractor guarantees all equipment covered in this contract shall be in optimum working condition at the contract expiration date provided that the Contractor is notified of any deficiencies at least one (1) day before the contract expiration date to the COR. Any changes, updates or retrofits made on any component or system shall be reported to the COR for annotation on station equipment manuals and records. For any service call made during normal working hours, the Contractor’s repairman shall report their arrival and departure to the COR.

26) CONTRACTOR POINT OF CONTACT

Upon contract award, the Contractor must provide valid and reliable contact information for service, preventative maintenance, emergency and technical assistance requests.

Contractor will establish a comprehensive inventory database within 15 business days of contract award. Contractor will establish a PM schedule for beds and stretchers within 15 business days of award. Contractor will provide a plan to address deferred PMs with quantitative metrics within 15 business days of award.

Appendix A

LASERS: ALEXANDRITE: DERMATOLOGIC (1)

QTY 1 CYNOSURE PICOSURE

LASERS: CARBON DIOXIDE (2)

QTY 1 LUMENIS ULTRAPULSE DUO

QTY 1 LUMENIS ULTRAPULSE TOTALFX

LASERS: DIODE(13)

QTY 1 IRIDEX CYCLO G6

QTY 7 BIOLASE TECHNOLOGY EPIC 10

QTY 1 IRIDEX IQ 532

QTY 1 SCITON JOULE

QTY 1 CONVERGENT LASER TECHNOLOGIES LITETOUCH

QTY 1 IRIDEX OCULIGHT SLX

QTY 1 IRIDEX OCULIGHT TX

LASERS: ERCR-YSGG (1)

QTY 1 BIOLASE TECHNOLOGY WATERLASE IPLUS

LASERS: EXCIMER (4)

QTY 2 SPECTRANETICS CVX-300

QTY 1 RA MEDICAL SYSTEMS PHAROS EX-308

QTY 1 XTRAC VELOCITY 7

LASERS: HO-YAG (2)

QTY 1 LUMENIS PULSE 120H

QTY 1 COOK MEDICAL RHAPSODY H-30

LASERS: ND-YAG (3)

QTY 1 SCITON PROFILE MP

QTY 1 LUMENIS QX MAX

QTY 1 LUMENIS SELECTA DUET

LASERS: ND-YAP (1)

QTY 1 BRYAN CORP LOKKI LIS

BEDS (375)

QTY 8 HILL-ROM 71-314

QTY 2 HILL-ROM P1170B CAREASSIST

Appendix A

QTY 1 HILL-ROM P1180C01

QTY 1 HILL-ROM P1900P007328

QTY 1 HILL-ROM P1900Q007604

QTY 5 HILL-ROM P3200

QTY 1 HILL-ROM P3200K000567

QTY 38 HILL-ROM PRO-805

QTY 1 HILL-ROM TOTAL CARE SPO2RT

QTY 10 HILL-ROM VERSACARE

QTY 307 HILL-ROM VERSACARE P3200

STRETCHERS (226)

QTY 2 HILL-ROM P8000

QTY 12 HILL-ROM P8000H002969

QTY 3 HILL-ROM P8005

QTY 3 HILL-ROM PC-450

QTY 3 STRYKER 720

QTY 4 STRYKER 747

QTY 7 STRYKER 1089

QTY 6 STRYKER 1115

QTY 1 STRYKER 1125

QTY 2 STRYKER 738000000

QTY 6 STRYKER 1089000000

QTY 8 STRYKER 1115000030

QTY 2 STRYKER 1125000030

QTY 1 STRYKER 6086000000

QTY 146 STRYKER 1125E

QTY 20 STRYKER 115000000E