36C25720Q0088-001.pdf

STATEMENT OF WORK

A. GENERAL INFORMATION

1. Title of Project: Draeger Anesthesia Units and Ventilators Preventive and Corrective Maintenance Contract for Biomedical Department, South Texas Veterans Health Care System.

2. Scope of Work: The Contractor shall provide semi-annual or annual preventive maintenance (PM) and unscheduled emergency repair services including replacement parts, labor, travel, tools, test equipment, transportation and other incidentals for the equipment located at the Audie L. Murphy Memorial VA Hospital at 7400 Merton Minter Blvd., San Antonio, TX, 78229.

The Contractor shall perform all maintenance procedures in accordance with the published manufacturers recommendations. The Contractor shall utilize the Original Equipment Manufacturers (OEM) established procedures and checklists, or a Contractor-supplied equivalent approved by the Contracting Officers Representative (COR).

The cost of any replacement parts and kits required to complete the PMs are included in the prices in the contract.

3. Preventive Maintenance:

Preventive maintenance shall include, but not be limited to the following:

General PM Procedures:

• The contractor shall ensure any replacement parts provided are new OEM factory approved parts.

• Cleaning of equipment (not housekeeping).

• Oversee installation of OEM field service updates in compliance with operational and reliability engineering change notices.

• Aligning, calibrating and lubricating the equipment.

• Performing remedial maintenance of non-emergent nature.

• Testing and replacing faulty and worn parts.

• Inspecting/replacing electrical wiring and cables for wear and fraying.

• Inspection of all mechanical components including, but not limited to, cables and mounting hardware for mechanical integrity, safety and performance to OEM specifications.

• Returning the equipment to operating condition as defined in OEM specifications.

• Replacing any OEM labels, decals, and/or warning tags that are not legible.

• Providing documentation to Biomed of services performed.

Equipment-Specific PM Procedures:

Evita Infinity V500 Ventilator:

• Replace diaphragm of the expiratory valve

• Exchange GS500: Air filter of blower unit

• Exchange GS500: Filter mat

• Check capacity of batteries and replace if necessary

• Exchange the air filter (in the air gas inlet)

• Exchange the O2 filter (in the O2 gas inlet)

Savina 300 Ventilator:

• Exchange the microfilter

• Exchange the dust filter set

• Exchange the diaphragm of the reusable expiratory valve

• Check capacity of internal battery and replace if necessary

• Check capacity of external battery and replace if necessary

Fabius GS, Premium, Tiro, and Apollo Anesthesia Units:

• Electrical safety

• System diagnostics

• Battery circuit

• Configuration

• Service data

• Calibrations

• Site configurations

• Scavenger, AGS

• Breathing system

• Vapor Interlock System

• Yokes & gauges

• Gas inlet regulator output

• Cylinder regulator & pipeline gauges

• High pressure leak

• Oxygen supply failure protection

• Flowmeters

• Oxygen monitor

• Oxygen concentrations

• SORC

• Pressure monitor

• Ventilator

• Volume alarms

• Audio silence

• Oxygen flush valve

• Final tests

The Contractor will notify the COR immediately of any defects or repairs needed to the equipment that is not covered under this contract, such as operator misuse. Before work can be done, the Contractor must provide the COR with a quote and a new purchase order issued.

Equipment List

EE# SERIAL # MODEL # PM PERIOD

117673 ASDN-0072 APOLLO SEMI-ANNUAL

117671 ASDN-0073 APOLLO SEMI-ANNUAL

117670 ASDN-0074 APOLLO SEMI-ANNUAL

139759 ASJJ-0524 D-VAPOR 2000 ANNUAL

139760 ASJJ-0525 D-VAPOR 2000 ANNUAL

139761 ASJJ-0526 D-VAPOR 2000 ANNUAL

139762 ASJJ-0527 D-VAPOR 2000 ANNUAL

139763 ASJJ-0528 D-VAPOR 2000 ANNUAL

139764 ASJJ-0529 D-VAPOR 2000 ANNUAL

139765 ASJJ-0530 D-VAPOR 2000 ANNUAL

139766 ASJJ-0531 D-VAPOR 2000 ANNUAL

139767 ASJJ-0532 D-VAPOR 2000 ANNUAL

139768 ASJJ-0533 D-VAPOR 2000 ANNUAL

139769 ASJJ-0534 D-VAPOR 2000 ANNUAL

139770 ASJJ-0535 D-VAPOR 2000 ANNUAL

139771 ASJJ-0536 D-VAPOR 2000 ANNUAL

139772 ASJJ-0537 D-VAPOR 2000 ANNUAL

139773 ASJJ-0538 D-VAPOR 2000 ANNUAL

139774 ASJJ-0539 D-VAPOR 2000 ANNUAL

139775 ASJJ-0540 D-VAPOR 2000 ANNUAL

139776 ASJJ-0541 D-VAPOR 2000 ANNUAL

139777 ASJJ-0542 D-VAPOR 2000 ANNUAL

139778 ASJJ-0543 D-VAPOR 2000 ANNUAL

139779 ASJJ-0544 D-VAPOR 2000 ANNUAL

139780 ASJJ-0545 D-VAPOR 2000 ANNUAL

125415 ASEJ-0048 EVITA INFINITY V500 ANNUAL

125416 ASEJ-0049 EVITA INFINITY V500 ANNUAL

125417 ASEJ-0050 EVITA INFINITY V500 ANNUAL

125418 ASEJ-0051 EVITA INFINITY V500 ANNUAL

125419 ASEJ-0052 EVITA INFINITY V500 ANNUAL

125420 ASEJ-0053 EVITA INFINITY V500 ANNUAL

125421 ASEJ-0054 EVITA INFINITY V500 ANNUAL

125422 ASEJ-0055 EVITA INFINITY V500 ANNUAL

125423 ASEJ-0056 EVITA INFINITY V500 ANNUAL

125424 ASEJ-0057 EVITA INFINITY V500 ANNUAL

125425 ASEJ-0058 EVITA INFINITY V500 ANNUAL

125426 ASEJ-0059 EVITA INFINITY V500 ANNUAL

125427 ASEJ-0060 EVITA INFINITY V500 ANNUAL

125428 ASEJ-0061 EVITA INFINITY V500 ANNUAL

125429 ASEJ-0062 EVITA INFINITY V500 ANNUAL

125430 ASEJ-0063 EVITA INFINITY V500 ANNUAL

125431 ASEJ-0064 EVITA INFINITY V500 ANNUAL

125432 ASEJ-0065 EVITA INFINITY V500 ANNUAL

125433 ASEJ-0066 EVITA INFINITY V500 ANNUAL

125435 ASEJ-0067 EVITA INFINITY V500 ANNUAL

125440 ASEJ-0068 EVITA INFINITY V500 ANNUAL

125442 ASEJ-0069 EVITA INFINITY V500 ANNUAL

125444 ASEJ-0070 EVITA INFINITY V500 ANNUAL

125446 ASEJ-0071 EVITA INFINITY V500 ANNUAL

125450 ASEJ-0072 EVITA INFINITY V500 ANNUAL

125456 ASEJ-0073 EVITA INFINITY V500 ANNUAL

125458 ASEJ-0074 EVITA INFINITY V500 ANNUAL

125459 ASEJ-0075 EVITA INFINITY V500 ANNUAL

125463 ASEJ-0076 EVITA INFINITY V500 ANNUAL

125466 ASEJ-0077 EVITA INFINITY V500 ANNUAL

81231 ARXM-0166 FABIUS GS SEMI-ANNUAL

92129 ARZK-0017 FABIUS GS SEMI-ANNUAL

92130 ARZK-0018 FABIUS GS SEMI-ANNUAL

128749 ASFE-0262 FABIUS GS PREMIUM SEMI-ANNUAL

128750 ASFE-0263 FABIUS GS PREMIUM SEMI-ANNUAL

128751 ASFE-0264 FABIUS GS PREMIUM SEMI-ANNUAL

128752 ASFE-0265 FABIUS GS PREMIUM SEMI-ANNUAL

139756 ASJM-0035 FABIUS GS PREMIUM SEMI-ANNUAL

139757 ASJM-0044 FABIUS GS PREMIUM SEMI-ANNUAL

139758 ASJM-0045 FABIUS GS PREMIUM SEMI-ANNUAL

125115 ASDL-0193 FABIUS TIRO SEMI-ANNUAL

139754 ASJM-0020 FABIUS TIRO SEMI-ANNUAL

139755 ASJM-0021 FABIUS TIRO SEMI-ANNUAL

125404 ASEL-0268 SAVINA 300 ANNUAL

125405 ASEL-0269 SAVINA 300 ANNUAL

125406 ASEL-0270 SAVINA 300 ANNUAL

125407 ASEL-0271 SAVINA 300 ANNUAL

125408 ASEL-0272 SAVINA 300 ANNUAL

125409 ASEL-0273 SAVINA 300 ANNUAL

125410 ASEL-0274 SAVINA 300 ANNUAL

125411 ASEL-0275 SAVINA 300 ANNUAL

125412 ASEL-0276 SAVINA 300 ANNUAL

125413 ASEL-0277 SAVINA 300 ANNUAL

N/A ASDK-0040 SCIO ANNUAL

139781 ASJL-0036 VAPOR 2000-SEVO ANNUAL

139782 ASJL-0037 VAPOR 2000-SEVO ANNUAL

139783 ASJL-0111 VAPOR 2000-SEVO ANNUAL

139784 ASJL-0112 VAPOR 2000-SEVO ANNUAL

139785 ASJL-0113 VAPOR 2000-SEVO ANNUAL

139786 ASJL-0114 VAPOR 2000-SEVO ANNUAL

139787 ASJL-0115 VAPOR 2000-SEVO ANNUAL

139788 ASJL-0116 VAPOR 2000-SEVO ANNUAL

139790 ASJL-0118 VAPOR 2000-SEVO ANNUAL

139791 ASJL-0119 VAPOR 2000-SEVO ANNUAL

139792 ASJL-0120 VAPOR 2000-SEVO ANNUAL

139793 ASJL-0121 VAPOR 2000-SEVO ANNUAL

139794 ASJL-0122 VAPOR 2000-SEVO ANNUAL

139795 ASJL-0123 VAPOR 2000-SEVO ANNUAL

139796 ASJL-0124 VAPOR 2000-SEVO ANNUAL

139797 ASJL-0125 VAPOR 2000-SEVO ANNUAL

139798 ASJL-0126 VAPOR 2000-SEVO ANNUAL

139799 ASJL-0127 VAPOR 2000-SEVO ANNUAL

139802 ASJL-0130 VAPOR 2000-SEVO ANNUAL

3.1 Parts

Contractor is to provide 95 percent or more of all services, parts hardware, proprietary software, and labor. Contractor shall provide a 20 percent discount on parts, travel and labor outside of agreement coverage. The contractor stipulates that they have ready access to new parts (manufactured by or supplied by the manufacturer, or equal thereto). All parts supplied shall be of current manufacture and be fully compatible with existing equipment. Documentation of intended parts source(s) shall be provided to the COR upon request. All parts necessary for the maintenance and repair of this equipment shall be furnished as part of this service agreement.

Any refurbished parts the contractor may propose to use are subject to the same inspection and QC procedures as all other materials used in the manufacture of products and shall be warranted to the same extent as all other components under warranty.

3.2 Test Equipment

The Contractor shall provide all required test equipment, qualified competent personnel and OEM parts to repair and return system to operable condition in accordance with Sterrad specifications and Federal Drug Administration’s 21 Code of Federal Regulations (21 CFR). The Contractor shall use the OEM established procedures and checklists, (or Contractor-supplied equivalent deemed satisfactory to the COR). A Field Service Report shall be supplied to the COR at the completion of maintenance to include a detailed check list of procedures performed.

Upon request from the COR or the CO, the contractor shall provide a copy of current Calibration Certifications of all test equipment which is to be used by the contractor to perform services under this contract. Calibration of equipment shall be traceable and in conformance with test equipment original equipment manufacturers standards.

3.3 Troubleshooting and Repair

Any problems with the system must be isolated and repaired by the Contractor. The Contractor will trouble shoot the hardware, software, and communications equipment to determine the best method of repair. If problems are found, the Contractor shall contact the appropriate and authorized maintenance organization or company and track the trouble call until it is resolved.

The Contractor shall notify the COR of the existence or development of any defects in, or repairs to the equipment covered under this contract which the Contractor considers he/she is not responsible for under the terms of the contract (such as operator misuse).

3.4 Contractor Responsibilities

During the term of this contract, the Contractor will provide support at the Customers request and will use its best efforts to provide prompt software support services to the Customer by telephone. The Contractor will provide telephone support to Customers between the hours of 8:00 am and 5:00 pm Central time, Monday through Friday, excluding holidays recognized by the VA. The Contractor will use its best efforts to respond promptly to all inquiries by the customer within one (1) hour of notification that service is required.

4. Protection of Government Property

4.1 During work execution, the Contractor shall take special care to protect Government property including furniture, walls, baseboards, and other surfaces. Accidental splashes shall be removed immediately. Damage resulting from the Contractor operations shall be repaired by the Contractor, including painting, refinishing, or replacement, if necessary, at no additional cost to the Government. The Contractor shall be responsible to meet Occupational Safety and Health Administration (OSHA)/Safety requirements in the performance of the work. This shall include, but not limited to, taking all the necessary precautions to protect the patients, visitors, and/or staff at each location. The Contractor shall be held responsible for any injuries and /or damage, which may be caused as a result of the Contractors failure to adhere to these requirements.

5. Damage

Extreme caution shall be exercised to prevent damage to the building and its contents. Any damage must be reported to the COR immediately for appropriate action. Any damage caused by the Contractor will be repaired and/or replaced to the satisfaction of the VA at the Contractor’s expense.

6. Safety

In the performance of this contract, the Contractor shall take such safety precautions as the Contracting Officer may determine to be reasonably necessary to protect the lives and health of occupants of the building. The Contracting Officer shall notify the Contractor of any safety issues and the action necessary to correct these issues. Such notice, when served on the Contractor or his representative at the work site, shall be deemed sufficient for the corrective actions to be taken. If the Contractor fails or refuses to comply promptly, the Contracting Officer may issue an order stopping all or part of the work and hold the Contractor in default.

7. Conformance Standards

7.1 As a minimum, work shall be completed as required and in accordance with the following:

1. National fire Protection Association – Standard for Health Care Facilities, NFPA- 99, or latest edition

2. Manufacturer’s Requirement and Specification on the maintenance and servicing of each model of equipment listed in this SOW

3. Adherence to Joint Commission Accreditation Healthcare Organization (JCAHO) and Original Equipment Manufacturer’s standards is mandatory

4. Submission of detailed reports of Inspection and Maintenance

The Contractor shall ensure that the equipment functions in conformance with the latest published edition of the applicable Environmental Protection Agency (EPA), Underwriters Laboratories (UL), OSHA, VA, JCAHO, state, local, federal, and all applicable regulations for the work identified herein, whichever is more stringent.

7.2 Contractor shall provide all resources required in performing these maintenance services and inspections, including parts, materials, lubricants, cleaning fluids, equipment, tools, shipping, travel, and labor. Contractor is responsible to determine the nature and extend of any work required to restore equipment to satisfactory condition and operation, as determined by the VA, replacing parts if conditions warrant.

7.3 Covered equipment encompasses all systems components and associated apparatus as normally supplied and required for operation by the manufacturer(s) in the currently installed configuration, including integrity of connections to building utilities, excluding building utility supply lines up to the point of manufacturer provided hardware.

7.4 No later than two (2) months before the expiration of each contract period of performance, a joint inspection will be made by the Contractor and the COR or his designee. All defective parts normally found during this inspection will be replaced within thirty (30) days, except for parts requiring purchase and delivery; such parts will be replaced within sixty (60) days.

8. Safety Data Sheets

Prior to commencement of services, the Contractor shall provide Safety Data Sheets to the COR in accordance with VA and OSHA regulations.

B. GENERAL REQUIREMENTS

9. Hours of Operation

Normal hours of operation are Monday through Friday from 8:00 a.m. to 5:00 p.m. excluding holidays. All services shall be performed during normal hours of coverage unless requested and approved by the COR.

Federal and National Holidays observed by Audie L. Murphy Memorial VA Hospital are:

National Holidays Federal Holidays

New Year's Day Labor Day Memorial Day Thanksgiving Day Christmas Day

M L King's Birthday Columbus Day President's Day Veterans Day Independence Day

Also included would be any other day specifically declared by the President of the United States to be a National Holiday.

When a holiday falls on a Sunday, the following Monday shall be observed as a legal holiday by U.S. Government agencies. When a holiday falls on a Saturday, the preceding Friday shall be observed as a legal holiday.

10. Additional Charges

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

11. Emergency Services

11.1 The contractor shall respond via phone in less than two (2) hours after the COR requests the contractor provide on-site unscheduled emergency repair service On-site unscheduled emergency repair services shall be provided no later than the next day after the request is made. Such service shall be provided during either normal working hours or after normal working hours; if required. If the contractor is unable to complete repairs within 8 working hours the contractor shall obtain OEM technical assistance at his own expense and not separately chargeable to the contract.

11.2 For all work performed outside the normal hours of coverage, the COR shall review all work performed to ensure that it was performed commensurate with the cost and contact the Contracting Officer the next business day.

12. Facility Check-In Requirements

The Contractor must be required to report to the Audie L. Murphy, Biomedical Engineering Services to log in for services performed under this contract. This check in is mandatory.

Audie L. Murphy Contact Person(s): Katherine Navarro Telephone Number & Extension: 210-949-3997

13. Reports

A written Employee/Vendor Service Report (ESR) report shall be provided to the COR upon completion of each visit. The report shall include a detailed description of the process used including a complete list of acceptable cleaning agents. The report shall also include, but not limited to, manufacturer of products used, UL classification, and a copy of any Safety Data Sheets previously submitted as required by the specifications and OSHA. In addition, each ESR must, at a minimum, document the information listed below legibly and in complete detail. A written report is required upon completion of all work performed under this agreement. Failure to provide written reports could result in delay in payments. Reports must be submitted in original copy. Carbon copies will not be accepted.

1. Name of Contractor and name of FSE who performed services

2. Contractor service ESR number/log number

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

4. VA purchase order number (Using the incorrect number could delay processing of invoices)

5. Identification of equipment to be serviced: ID number, manufacturers name, model, and serial numbers, room location, and any other manufacturer’s identification numbers

6. Itemized description of services performed including location of access panels and documenting of discrepancies, system impairments, and recommendations

7. Signatures of the FSE performing the services and the VA employee who witnessed the services described

PLEASE NOTE: Any charges claimed must be approved before service has begun. Any additional work performed or parts replaced, if applicable, without the written approval of the CO will be performed or furnished at the Contractor’s expense.

The ESR must be submitted with your invoice on Tungsten and be signed by a VA employee.

Failure to upload the ESR could delay payment of invoices.

14. Quality Assurance

The Government will periodically evaluate the Contractor’s performances.

15. Government Remedies

The Contracting Officer shall follow the requirements of FAR 52.212.4, contract Terms and Conditions for Commercial Items, for Contractor’s failure to correct non-conforming services.

16. Technical Requirements

1. The contractor shall be able to provide all services performed on this contract using

OEM's performance and technical specifications.

2. Contractor shall be able to provide all OEM software upgrades and updates as they are issued.

3. The contractor shall be able to access and use Draeger Service Connect.

4. The contractor shall be able to provide only Draeger manufactured PM kits and parts.

5. The contractor shall be able to perform preventive maintenance using calibrated test equipment which can be audited arid traced back to the OEM's specifications

C. INFORMATION SYSTEMS OFFICER, INFORMATION PROTECTION:

17. SECURITY REQUIREMENTS

17.1 Information Systems Officer, Information Protection

The contractor will not have access to VA Desktop computers nor will they have access to online resources belonging to the government while conducting services. If removal of equipment from the VA is required, any memory storage devices, such as hard drives, solid state drives and non-volatile memory units will remain in VA control and will not be removed from VA custody.

17.2 Privacy Officer

The contractor will not have access to protected Patient Health Information (PHI) nor will they have the capability of accessing patient information during the services provided to the VA and if removal of equipment from the VA is required, any memory storage devices, such as hard drives, solid state drives and non-volatile memory units will remain in VA control and will not be removed from VA custody. All research data available for Contractor analyses is de-identified.

18.3 Records Manager

17.3 Records Management:

a. Contractor shall comply with all applicable records management laws and regulations, as well as National Archives and Records Administration (NARA) records policies, including but not limited to the Federal Records Act (44 U.S.C. chs. 21, 29, 31, 33), NARA regulations at 36 CFR Chapter XII Subchapter B, and those policies associated with the safeguarding of records covered by the Privacy Act of 1974 (5 U.S.C. 552a). These policies include the preservation of all records, regardless of form or characteristics, mode of transmission, or state of completion.

b. In accordance with 36 CFR 1222.32, all data created for Government use and delivered to, or falling under the legal control of, the Government are Federal records subject to the provisions of 44 U.S.C. chapters 21, 29, 31, and 33, the Freedom of Information Act (FOIA) (5 U.S.C. 552), as amended, and the Privacy Act of 1974 (5 U.S.C. 552a), as amended and must be managed and scheduled for disposition only as permitted by statute or regulation.

c. In accordance with 36 CFR 1222.32, Contractor shall maintain all records created for Government use or created in the course of performing the contract and/or delivered to, or under the legal control of the Government and must be managed in accordance with Federal law. Electronic records and associated metadata must be accompanied by sufficient technical documentation to permit understanding and use of the records and data.

d. STVHCS and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Records may not be removed from the legal custody of STVHCS or destroyed except for in accordance with the provisions of the agency records schedules and with the written concurrence of the Head of the Contracting Activity. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. In the event of any unlawful or accidental removal, defacing, alteration, or destruction of records, Contractor must report to STVHCS. The agency must report promptly to NARA in accordance with 36 CFR 1230.

e. The Contractor shall immediately notify the appropriate Contracting Officer upon discovery of any inadvertent or unauthorized disclosures of information, data, documentary materials, records or equipment. Disclosure of non-public information is limited to authorized personnel with a need-to-know as described in the [contract vehicle]. The Contractor shall ensure that the appropriate personnel, administrative, technical, and physical safeguards are established to ensure the security and confidentiality of this information, data, documentary material, records and/or equipment is properly protected. The Contractor shall not remove material from Government facilities or systems, or facilities or systems operated or maintained on the Government’s behalf, without the express written permission of the Head of the Contracting Activity. When information, data, documentary material, records and/or equipment is no longer required, it shall be returned to STVHCS control or the Contractor must hold it until otherwise directed. Items returned to the Government shall be hand carried, mailed, emailed, or securely electronically transmitted to the Contracting Officer or address prescribed in the [contract vehicle]. Destruction of records is EXPRESSLY PROHIBITED unless in accordance with Paragraph (4).

f. The Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under, or relating to, contracts.

The Contractor (and any sub-contractor) is required to abide by Government and STVHCS guidance for protecting sensitive, proprietary information, classified, and controlled unclassified information.

g. The Contractor shall only use Government IT equipment for purposes specifically tied to or authorized by the contract and in accordance with STVHCS policy.

h. The Contractor shall not create or maintain any records containing any non-public STVHCS information that are not specifically tied to or authorized by the contract.

i. The Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected from public disclosure by an exemption to the Freedom of Information Act.

j. The STVHCS owns the rights to all data and records produced as part of this contract. All deliverables under the contract are the property of the U.S. Government for which STVHCS shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest. Any Contractor rights in the data or deliverables must be identified as required by FAR 52.227-11 through FAR 52.227-20.