36C25725Q0041.docx

SUBJECT*

Draeger Ventilators Service Agreement FY25-Base Plus 3

GENERAL INFORMATION

SET-ASIDE

VISN 17 Network Contracting Activity South Texas Veterans HCS 5441 Babcock Rd. STE 302 San Antonio, TX 78240

POINT OF CONTACT*

Contracting Specialist Tammy Wilson Tammy.Wilson5@va.gov

PLACE OF PERFORMANCE

7400 Merton Minter

San Antonio TX

COUNTRY

ADDITIONAL INFORMATION

AGENCY’S URL

URL DESCRIPTION

AGENCY CONTACT’S EMAIL ADDRESS

EMAIL DESCRIPTION

DESCRIPTION

Special Notice – Notice of Intent to Award a Sole Source Procurement The Department of Veterans Affairs (VA), Veterans Health Administration (VHA), Network Contracting Office (NCO) 17, for the South Texas Veterans Health Care System in San Antonio, Texas 78229, intends to issue a sole source award to Draeger, Inc., 3135 Quarry Rd., Telford, PA, 18969.

The procurement action requires the contractor to provide semi-annual and 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 in accordance with the specifications of the attached Statement of Work (SOW).

The VA intends to solicit for a sole source contract under the authority of FAR 13.501(a). The VA anticipates awarding a contract on or about December 18, 2019. The projected period of performance for the base year will be from December 17, 2024, through December 16, 2025, with three 12-month option periods.

The NAICS Code for this procurement is 811210 – “Other Electronic and Precision Equipment Repair and Maintenance” which has a Small Business Size Standard of $34M. This notice of intent to award a sole source contract is not a request for competitive proposals. However, in accordance with FAR 5.207 (c) (16) (ii), all responsible sources that feel they can fulfill this requirement may submit a capability statement which shall be considered by the VA. Responses to this notice shall contain sufficient information to establish the interested parties bona-fide capabilities for fulfilling the requirement, and include: Dun & Bradstreet Number, and the Taxpayer Identification Number, along with documentation that the vendor is an authorized service provider of the equipment listed. All respondents must have an active registration in the System for Award Management at www.sam.gov. Interested Service Disabled Veteran Owned Small Businesses (SDVOSB) and Veteran Owned Small Businesses (VOSB) must be listed as verified on the Vendor Information Pages (VIP) database located at www.vip.vetbiz.va.gov/ in order to receive contract awards under the Veterans First Contracting Program. A determination by the VA not to compete this proposed action based upon responses to this notice is solely within the discretion of the VA. In addition, the information received because of this notice of intent will be retained as market research only. If no affirmative written response is received by the response date and time, a sole source contract will be awarded to Draeger, Inc., 3135 Quarry Rd., Telford, PA, 18969 without any further notice.

All interested parties must submit information directly to Tammy.Wilson5@va.gov no later than October 21, 2024 by 2:00 P.M., CST. Please ensure that emails include solicitation number 36C25725Q0041 in the subject line.

Sources Sought Notice Sources Sought Notice

STATEMENT OF WORK

Sources Sought Notice

DREAGER ANESTHESIA UNITS AND VENTILATORS

PREVENTIVE & CORRECTIVE MAINTENANCE

SCOPE OF WORK/SPECIFICATIONS

1.0 DESCRIPTION OF SERVICES

The Contractor shall provide all materials, tools, labor, travel, and equipment necessary to provide preventive and corrective maintenance for the Dreager Ventilators located at Audie L. Murphy Memorial Veterans Hospital, San Antonio, TX as defined in the Scope of Work (SOW).

2.0 DESCRIPTION OF SERVICES

2.1 Equipment List/Locations

2.2 Preventive Maintenance

The Contractor shall perform semi-annual/annual preventive maintenance procedures in accordance with the published manufacturers recommendations. The Contractor shall utilize the Original Equipment Manufacturer’s established procedures and checklists, (or a Contractor-supplied equivalent approved by the COR).

The Contractor shall perform PM during the contract as arranged with the COR in the years prescribed in the table at the end of the statement of work. PM shall be in accordance with the published OEM PM manuals and checklists for the equipment listed above. The Contractor shall use the OEM's procedures and checklists. The cost of any replacement parts and kits required to complete the PMs are included in the prices in the contract.

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

General PM Procedures:

· The contractor shall ensure any replacement parts provided are new Original Equipment Manufacturer (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.

· Inspecting 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)

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 the existence or development 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 PO issued.

2.3 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.

2.4 Test Equipment

The Contractor shall provide all required test equipment, qualified competent personnel and Original Equipment Manufacturer (OEM) parts to repair and return this system to an 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 installation and calibration 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.

2.5 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).

2.6 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.

3.0 PROTECTION OF GOVERNMENT PROPERTY

3.1 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 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.

3.2 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.

3.3 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.

4.0 CONFORMANCE STANDARDS

4.1 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 EPA, UL, OSHA, VA, JCAHO, state, local, federal, and all applicable regulations for the work identified herein, whichever is more stringent.

4.2 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.

4.3 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.

4.4 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.

5.0 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.

6.0 GENERAL INFORMATION

6.1 Hours of Operation

Normal hours of operation are Monday through Friday from 8:00 am to 5:00 pm CST, 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 the VAMC are:

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.

6.2 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 FSE and/or delivery of parts.

7.0 EMERGENCY SERVICES

7.1 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.

7.2 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.

8.0 FACILTY 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.

9.0 REPORTS

A written 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. No carbon copies will be accepted.

1. Name of Contractor

2. Name of FSE who performed services

3. Contractor service ESR number/log number

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

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

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

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

8. 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.

10.0 GENERAL INFORMATION

10.1 Quality Control

Contractor shall develop and maintain a quality program to ensure services are performed in accordance with the Conformance Standards and other commonly accepted commercial practices. The Contractor shall develop and implement procedures to identify and prevent defective services from reoccurring. These provisions shall be included in the Contractor’s Quality Control Program (QAP). At a minimum, the Contractor shall develop quality control procedures that address the areas identified in paragraph 3.0, 4.0. and 5.0. Contractor shall clearly define procedures, which will be used to complete the work and confirm the above meets the requirements of these specifications. The Government evaluator must have a specific Quality Control Inspector to notify in case of customer complaints. The Contractor’s QAP will be submitted within thirty (30) days of award.

10.2 Quality Assurance

The Government will periodically evaluate the Contractor’s performances.

10.3 Government Remedies

The Contracting Officer shall follow the requirements of FAR 42.212.4, contract Terms and Conditions for Commercial Items, for Contractor’s failure to correct non-conforming services.

11.0 TECHNICAL REQUIREMENTS

1. The contractor shall be able to provide all services performed on this contract using OEM's performance and technical specifications.

2. The 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 repair 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

12.0 TUBERCULOSIS SCREENING

All service contractor employees assigned to the work site shall have a certified tuberculin screening completed within 90 days prior to assignment at the work site. The certified tuberculin screening must be kept update every calendar year from the date submitted in the initial certified tuberculin screening documentation. NOTE: This can be the Center for Disease Control (CDC) and Prevention and two-step skin testing or a Food and Drug Administration (FDA)-approved blood test.

1. Contract employees manifesting positive screening reactions to the tuberculin shall be examined according to current CDC guidelines prior to working on VHA property.

2. Subsequently, if the employee is found without evidence of active (infectious) pulmonary TB, a statement documenting examination by a physician shall be on file with the employer (service contractor), noting that the employee with a positive tuberculin screening test is without evidence of active (infectious) pulmonary TB.

3. If the employee is found with evidence of active (infectious) pulmonary TB, the employee shall require treatment with a subsequent statement to the fact on file with the employer before being allowed to return to work on VHA property.

13.0 TRAINING REQUIREMENT

The Contractor will attend a pre-work orientation meeting prior to the commencement of work on site. The VA will schedule this meeting and it will include discussions of the following topics: (The VA will provide information to the Contractor regarding these topics and will document the meeting)

· Fire and Safety

· Infection Control

· Disaster Procedures

· Security

The Contractor will be responsible to ensure that Contractor employees coming to the work site will receive the information required above.

The Contractor will be responsible to ensure Contractor employees providing work on this contract are fully trained and completely competent to perform the required work.

14.0 SECURITY REQUIREMENTS

All contractors working under this contract must be fingerprinted prior to being allowed to work on campus. Contractor ID badges can be obtained from PIV office typically 3-5 days after approved SAC form is received and finger prints clear. ID badges are required for contractor employees working at Audie L Murphy and Kerrville locations.

15.0 DEFINITIONS/ACRONYMS

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.

Authorization Signature – the COR’s signature; indicates that the COR accepts work status as stated on the ESR.

CO – Contracting Officer

COR – Contracting Officer’s Representative

VAMC – Department of Veterans Affairs Medical Center

16.0 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.

17.0 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.

18.0 Records Manager

Records Manager:

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.

k. Training. All Contractor employees assigned to this contract who create, work with, or otherwise handle records are required to take VHA-provided records management training, Talent Management System (TMS) Item #10176, Privacy and Information Security, Rules of Behavior. The Contractor is responsible for confirming training has been completed according to agency policies, including initial training and any annual or refresher training.