A1 - Statement of Work - B. Braun Maintenance Services.pdf

Attachment 1 Statement of Work 36C25724Q0904 Page 1 of 8

STATEMENT OF WORK

MAINTENANCE SERVICES - BRAUN DIALOG HEMODIALYSIS SYSTEMS

SOUTH TEXAS VETERANS HEALTH CARE SYSTEM

1.0 DESCRIPTION OF SERVICES

The contractor shall provide all tools, equipment, personnel, supervision, transportation, lodging, and non-personal services necessary for performing full corrective and preventive maintenance on the B. Braun Dialog+ and Dialog+ Evolution hemodialysis systems in use at the South Texas Veterans Health Care System (STVHCS) Audie L. Murphy Memorial Veterans Hospital at 7400 Merton Minter Blvd, San Antonio, TX 78229.

2.0 GENERAL REQUIREMENTS

Comprehensive Preventive and Corrective maintenance:

A. Contractor shall provide the following:

a. Corrective and Preventive Maintenance:

i. When requested by the STVHCS Biomedical Engineering Section, contractor shall visit STVHCS to provide full corrective and preventive maintenance service on the B. Braun Dialog+ and Dialog+ Evolution hemodialysis systems in use at the Audie L. Murphy Memorial Hospital (see list of covered equipment in Table A below). Contractor shall also provide unlimited phone support for STVHCS Biomedical Engineering under the contract period of a base plus four option years. After performing corrective maintenance, contractor shall ensure the equipment has been returned to optimum performance (according to the manufacturer’s service documentation manual) by checking mechanical and electrical safety, lubrication, functional testing, and adjusting for optimum performance as needed.

b. Replacement Parts:

i. Contractor shall provide all necessary parts for repair. These parts shall be new, standard OEM parts that comply with applicable performance and reliability specifications.

After preventative maintenance inspections are performed, a VA-provided inspection sticker will be placed on the equipment. The sticker will include the date the inspection was performed, the next due date for inspection, and the initials of the person who performed the inspection. All other non-VA, nonessential and expired stickers will be removed from the equipment by the contractor.

Contractor must provide preventative maintenance/ and incidental supplies and parts associated with normal wear and tear. Incidental supplies and parts include any lubricants, nuts, bolts, etc., or any parts the technician breaks during their preventive maintenance.

Contract includes full maintenance for the equipment listed in paragraph 4, consisting of scheduled preventive maintenance (PM) and corrective call back service for operational problems

36C25724Q0904 Page 2 of 8 not successfully preempted by PM, and corrective service for problems identified during preventive maintenance.

The contractor must, at a minimum, perform the corrective and preventive maintenance services per the manufacturers’ service manuals’ directions. Any tasks listed on a VA Checklist that are not included on Manufacturer PM Checklist must be performed in addition to tasks listed on Manufacturer PM Checklist.

3.0 SAFETY DATA SHEETS

Prior to commencement of services, the contractor must provide Safety Data Sheets to the Contracting Officer’s Representative (COR) in accordance with VA and OSHA regulations for any chemicals that are brought onsite, if necessary.

4.0 LIST OF EQUIPMENT AND LOCATIONS

Table A: Equipment to be Covered Under This Agreement.

Unit Equipment Model Serial Number 1 Dialog+ Evolution 108368 2 Dialog+ Evolution 108369 3 Dialog+ Evolution 108372 4 Dialog+ Evolution 108374 5 Dialog+ Evolution 108559 6 Dialog+ Evolution 230813 7 Dialog+ Evolution 230814 8 Dialog+ Evolution 230830 9 Dialog+ Evolution 230831 10 Dialog+ Evolution 230832 11 Dialog+ Evolution 233226 12 Dialog+ Evolution 233227 13 Dialog+ Evolution 233228 14 Dialog+ Evolution 233667 15 Dialog+ Evolution 233678 16 Dialog+ Evolution 265789 17 Dialog+ Evolution 265790 18 Dialog+ Evolution 265791 19 Dialog+ Evolution 265793 20 Dialog+ Evolution 265794 21 Dialog+ Evolution 265795 22 Dialog+ Evolution 265796 23 Dialog+ Evolution 265797 24 Dialog+ Evolution 265798 25 Dialog+ Evolution 265799 26 Dialog+ Evolution 265800

36C25724Q0904 Page 3 of 8

27 Dialog+ Evolution 265801

5.0 REPORTS

A written Equipment Service Report (ESR) with complete and documented preventive maintenance and repair work must be submitted at the completion of each visit. Report must be in format mutually acceptable to VA and contractor. The report must include a detailed description of the process used including a complete list of acceptable cleaning agents. The report must 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. Failure to provide written reports could result in delay of payments.

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 documentation of discrepancies, system impairments, and recommendations.

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

The contractor must maintain a complete orderly and chronological file including complete parts list and copies of all reports as required by these specifications. A record of all callbacks and repairs must be kept by the contractor indicating any difficulty experiences and the corrective measures taken to eliminate these difficulties. These files are to be maintained for the life of the contract.

6.0 DEFECTIVE EQUIPMENT

The contractor must immediately, but no later than twenty-four (24) consecutive hours after the discovery of, notify the COR in writing of the existence or the development of any defects in, or repairs required, to the government owned equipment, which is not covered under terms of this contract and is the responsibility of the government for repair.

7.0 PREVENTATIVE MAINTENANCE (PMI) PLAN

The contractor must develop a PMI plan in accordance with the manufacturer specifications for PM and the attached checklists that include all of the necessary services addressed in this

36C25724Q0904 Page 4 of 8 contract. The government estimates a one-hour minimum duration per unit. The completed PMI plan must be submitted for approval no later than 30 days after contract award. Once approved, the contractor must follow the schedule as close as possible to facilitate the government’s process.

8.0 TECHNICAL REQUIREMENTS

1. Minimum of three (3) years relevant and verifiable references, including contract number, dates of performance, point of contact, and telephone number.

2. These references should show ability to perform the services required by this contract.

3. Identify any Federal, State, Local Government, and private contracts that are similar in nature, scope and size.

4. References should include all on-going contracts or those completed within the last three

(3) years.

9.0 CONFORMANCE STANDARDS

All maintenance on included equipment must be performed in accordance with manufacturer guidelines and/or the following industry stands as applicable: The Joint Commission, OSHA, EPA and all state, local, federal and industry standards whichever is more stringent.

Covered equipment listed in the schedule encompass all system components and associated apparatus as normally supplied and required for operation by the manufacturer 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.

10.0 HOURS OF OPERATION

10.1. Normal hours of operation are Monday through Friday from 8:00 AM to 4:30 PM, excluding holidays.

10.2. The contractor shall provide a 2-hour phone response time and a 4-hour onsite response time when contacted by STVHCS Biomedical Engineering.

10.3. Federal and National Holidays observed by the VAMC are:

National Holidays Federal Holidays

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

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

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

36C25724Q0904 Page 5 of 8

11.0 SECURITY REQUIREMENTS

The contractor’s employees must wear visible identification and company uniforms, approved by the COR, at all times while on the premises of the VAMC. It is the responsibility of the contractor to park in the appropriate designated parking areas. Information on parking is available from the VA Police Section or the COR. The VAMC will not invalidate or make reimbursement for any parking violations of the Contractor under any conditions. Smoking is prohibited inside any buildings and on campus at the VAMC. Possession of weapons is prohibited. Enclosed containers, including tool kits, must be subject to a search. Violations of VA regulations result in citations answerable in the United States (Federal) District court, not a local district, state, or municipal court.

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 updated 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.

4. The contractor shall be required to also provide any other vaccine documentation deemed necessary by Infection Control, the Secretary of the VA or the President of the United Sates.

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.

36C25724Q0904 Page 6 of 8

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 2-4 weeks after approved SAC form is received and fingerprints clear. ID badges are required for contractor employees working at Audie L Murphy and Kerrville locations.

15.0 PROTECTION OF GOVERNMENT PROPERTY

During work execution, the contractor must take special care to protect government property including furniture, walls, baseboards, and other surfaces. Accidental splashes must be removed immediately. Damage resulting from the contractor operations must be repaired by the contractor, including painting, refinishing, or replacement, if necessary, at no additional cost to the government. The contractor must be responsible to meet OSHA/Safety requirements in the performance of the work. This must include, but not limited to, taking all the necessary precautions to protect the patients, visitors, and/or staff at each location. The contractor must be held responsible for any injuries and /or damage, which may be caused because of the contractor’s failure to adhere to these requirements.

Damage

Extreme caution must 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.

16.0 FACILTY CHECK-IN REQUIREMENTS

The Contractor is required to report to the Audie L. Murphy Biomedical Engineering Shop, Room E008 to log in for services performed under this contract. This check in is mandatory.

Audie L. Murphy Contact Person: REDACTED or REDACTED Telephone Number & Extension: 210-617-5300 x REDACTED, or REDACTED

17.0 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.

18.0 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.

36C25724Q0904 Page 7 of 8

19.0 Records Manager

Records Manager:

a. Contractor must 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 must 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 must 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 must 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 must 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 must be returned to STVHCS control, or the contractor must hold it until otherwise directed. Items returned to the government must 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

36C25724Q0904 Page 8 of 8 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 must only use government IT equipment for purposes specifically tied to or authorized by the contract and in accordance with STVHCS policy.

h. The contractor must 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 must 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 must 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 by the contractor.

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.

20.0 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.

CO – Contracting Officer

COR – Contracting Officer’s Representative

ESR – Employee/Vendor Service Report – A documentation of the services rendered for each incidence of work performance under the terms and conditions of the contract.

FSE – Field Service Employee - A person who is authorized by the Contractor to perform services on the VAMC premises.

PM – Preventive Maintenance

VA – Veterans Affairs

VAMC – Department of Veterans Affairs Medical Center

MAINTENANCE SERVICES - BRAUN DIALOG HEMODIALYSIS SYSTEMS