DRAFT VISN 4 GE Anesthesia Machine Maintenance PWS.docx

PERFORMANCE WORK STATEMENT

FULL-SERVICE MAINTENANCE FOR GE ANESTHESIA MACHINES

VISN 04 VETERANS AFFAIRS MEDICAL CENTER

Table of Contents:

Section 1 – General Information Section 2 – Scope of Work Section 3 – Contractor Qualifications and Provisions Section 4 - Training Section 5 – Security Requirements Section 6 – Records Management Attachments

1. GENERAL INFORMATION

1.1 Purpose: This is a services BPA to provide full preventative maintenance and repairs to government owned GE anesthesia machines and associated accessories described herein.

1.2 Description of Services: The Contractor must provide all personnel, transportation, equipment, parts, supplies, facilities, supervision, and other items and services necessary to perform the preventative maintenance and repair services as defined in this Performance Work Statement (PWS). The Contractor assumes all liability risks for work performed under this BPA. The Contractor must assume total liability for all contract employees. The Contractor will perform to the standards of the BPA.

1.3 Physical Security: The Contractor will be responsible for safeguarding all government equipment, information, and property provided to Contractor personnel while performing the services described herein.

1.4 Period of Performance: August 1, 2026 – July 31, 2031

1.5 Type of Agreement: The government will award a Blanket Purchase Agreement (BPA).

1.6 Contracting Officer Representative (COR): The COR will be identified by a separate letter. The COR monitors all technical aspects of the BPA and assists in contract administration. A letter of designation issued to the COR, a copy of which will be provided to the Contractor, states the responsibilities and limitations of the COR, especially with regard to changes in cost or price, estimates, or changes in delivery dates. The COR is not authorized to change any of the terms and conditions of the resulting order.

1.7 Contract Administration: The Contracting Officer (CO) is the only person authorized to approve changes or modify any of the requirements under this BPA. The Contractor shall communicate with the CO on all matters pertaining to contract administration. Only the CO is authorized to make commitments or issue changes that will affect price, quantity, or quality of performance in this BPA. In the event the Contractor effects any such change at the direction of any person other than the CO, the change shall be considered to have been made without authority, and no adjustment will be made in the BPA price to cover any increase in costs incurred as a result thereof. All changes to the BPA will be issued via an amendment and/or modification in writing from the CO to the Contactor.

1.8 Invoices: Invoices are to be submitted monthly in arrears. The COR or facility Point of Contact (POC) is responsible for acceptance of services and/or the processing of any reports for the services provided to the government.

2. SCOPE OF WORK

2.1 REQUIREMENTS

2.1.1 The Contractor must furnish all labor, materials, and travel to provide full preventative maintenance and repair services for thirty-six (36) Government owned anesthesia machines and associated accessories located at three (3) separate Veterans Affairs (VA) facilities. Below are the facilities currently maintaining GE Anesthesia Machines:

· ALTOONA VAMC

James E. Van Zandt VA Medical Center 2907 Pleasant Valley Boulevard Altoona, PA 16602

· ERIE VAMC

Erie VA Medical Center 135 East 38th Street Erie, PA 16504

· PITTSBURGH

2.1.2 The equipment inventory is located in Attachment 2 of this document. Veterans Affairs Medical Centers (VAMC), as well as the equipment itself, may be added to or removed from that attachment. A few reasons for the modification of the inventory include, but are not limited to:

· Facilities obtaining new anesthesia machines

· Warranty expiration of anesthesia machines

· The end of the life cycle of the equipment

2.2 SERVICES TO BE PROVIDED

2.2.1 Preventive Maintenance: Preventive maintenance/calibration inspections will be coordinated with the Anesthesiology Service and/or Biomedical Engineering at each facility. Preventive Maintenance will comply with all applicable regulations and manufacturers specifications, and it will include, but is not limited to the following:

· Reviewing operating system diagnostics to ensure that the equipment is operating within its specifications.

· Calibrating and cleaning.

· Replacing any worn or defective parts.

· Repairing or replacing any vaporizer specifically listed below that fails the vaporizer efficacy test.

· Installing and maintaining all software updates/upgrades.

2.2.2 Preventive Maintenance Schedule: Preventive maintenance will be conducted according to the Original Equipment Manufacturer (OEM) in the months designated by the Biomedical Engineering section at each VAMC. Within 30 days of award of BPA, Contractor shall contact Biomedical Engineering at each VAMC to coordinate and schedule the dates and times for the various preventive maintenance inspections.

· Parts: The Contractor will furnish and replace all necessary parts as required to return equipment to full manufacturers published specifications. All parts supplied will be GE parts and compatible with existing equipment. The Contractor will use new parts only. Re-built or backward-engineered parts are not permitted.

· Technical Support: Telephone service for technical support will be provided twenty-four (24) hours per day, seven (7) days per week. Contractor will provide appropriate telephone number(s) for 24-hour access.

· Remedial Services and Emergency Repairs: Contractor will provide unscheduled remedial services and emergency repairs. Biomedical Engineering will contact the Contractor to request remedial service or emergency repairs when equipment is operating with diminished capacity or is deemed by Biomedical Engineering to be inoperable. Contractor will acknowledge receipt of a service call for remedial service and emergency repairs within four (4) hours and shall arrive on site to inspect the equipment within twenty-four (24) hours of the original call.

2.3 SERVICE SCHEDULE

2.3.1 All services will be performed during normal working hours of coverage unless authorized by the COR.

2.3.2 Normal hours of coverage are Monday through Friday, 8:00 a.m. to 4:30 p.m., excluding federal holidays.

2.4 SERVICE CALLS

2.4.1 After checking with VA Police to receive a VA Badge, Contractor personnel will report to the Biomedical Engineering office prior to performance of services. In the event that the Contractor reports after normal working hours, the Contractor will report to the supervising official of the equipment to be serviced. Payment for services may be held up if the Contractor does not follow proper reporting procedures.

2.4.2 Routine service calls are hereby defined as necessary to diagnose and repair equipment problems which can be performed during normal working hours. Response time of the Contractor for routine service calls shall be within twenty-four (24) hours after being officially notified.

2.4.3 Emergency service calls are defined as services required to safeguard the health and well-being of VA patients and will be responded to within six (6) hours of being officially notified.

2.4.4 The term “Response time of the Contractor” indicates the physical presence of a fully qualified technician on station within the specified time frame.

2.4.5 “Official notification” is hereby defined as the time a service call is placed with the Contractor.

2.5 DOCUMENTATION

2.5.1 The Contractor shall provide individual service reports that reference services performed on the equipment. The following information must be provided in each service report:

· Date of service

· Summary of problem and action taken

· Equipment details (description, equipment ID, serial number, etc.)

· Labor hours

· Parts and other expenses

· Purchase order number

· Certificate of safety to use anesthesiology equipment following a PMI or repair activity

2.5.2 The service report must be approved and signed by the Biomedical Engineering section representative. A copy of each report must be left with Biomedical Engineering section representative at the time the services are completed. In the event that a Biomedical Engineering section representative is not available to receive the service report (outside normal working hours), the service report will be left with the supervising official of the designated equipment.

2.6 REPAIRS AND SERVICES NOT COVERED BY BPA

Those costs for repairs and corrections that are not inclusive must be approved by the CO before performance of the service and will be approved by order modification. Inadequate or improper repairs performed by the Contractor shall be resolved at no additional cost to the Government.

2.7 GOVERNMENT FURNISHED PROPERTY AND SERVICES

2.7.1 Government Furnished Property: None

2.7.2 Government Furnished Services: The Contractor may use the available utilities (gas, electricity, water, etc.) while in the performance of the services defined in this PWS.

3. CONTRACTOR QUALIFICATIONS AND PROVISIONS

3.1 PERSONNEL QUALIFICATIONS

3.1.1 Contractor personnel performing work under this BPA must be trained and qualified to work on all components of the anesthesia machine equipment and the latest revisions of hardware and software as required by the GE OEM. Contractor personnel performing work under this BPA must be able to provide proof of successful completion of training and certification by the OEM.

3.1.2 The Contractor must not employ persons for work on this BPA if that employee is considered by the CO, COR, or facility POC to be a potential threat to the facility’s operational mission or the health, safety, security, or general well-being of the VAMC’s employees, facility population, or all Veteran beneficiaries.

3.1.3 Contractor personnel must be clean and present a neat appearance.

3.2 VA POLICY

3.2.1 ACCESSABILITY: Pass and badge requirements may vary amongst the VISN 4 facilities. To ensure compliance, the Contractor must obtain facility requirements from the COR or facility POC prior to work commencement. The Contractor must comply with all registering, credentialing, and identification procedures when entering any VA owned or controlled property, to include but not limited to, pre-registering and submitting a fee for credentialing to any third-party vendor(s) used to register, schedule, and identify contracted service providers.

3.2.2 PARKING: It is the responsibility of Contractor personnel to park only in designated parking areas. Parking information is available from the VA Police Service. The VA will not invalidate or make reimbursement for parking violations of the Contractor’s personnel under any circumstances.

3.3.3 SMOKING: Smoking is not permitted within or around the VA Healthcare System facilities.

3.3.4 INFECTION CONTROL: Contractor must comply with the applicable facility’s Infection Control Policy, Tuberculosis Surveillance Policy, Flu Policy, and Infectious Disease Policy. Guidance and policy requirements will be provided by the COR, facility POC, or the facility’s Infection Prevention and Control Office. Costs incurred to establish and maintain Contractor compliance will be borne by the Contractor.

4. TRAINING

4.1 All contractor employees and subcontractor employees requiring access to VA information and VA information systems will complete the following before being granted access to VA information and its systems:

· Sign and acknowledge (either manually or electronically) understanding of and responsibilities for compliance with the Contractor Rules of Behavior, Appendix E, relating to access to VA information and information systems;

· Successfully complete the VA Cyber Security Awareness and Rules of Behavior training and annually complete required security training;

· Successfully complete the appropriate VA privacy training and annually complete required privacy training; and

· Successfully complete any additional cyber security or privacy training, as required for VA personnel with equivalent information system access

4.2 The contractor will provide the CO, COR, and/or the facility POC with a copy of the training certificates and certification of signing the Contractor Rules of Behavior for each applicable employee within 1 week of the initiation of the BPA and annually thereafter, as required.

4.3 Failure to complete the mandatory annual training and sign the Contractor Rules of Behavior annually, within the timeframe required, is grounds for suspension or termination of all physical or electronic access privileges and removal from work on the BPA until such time as the training and documents are complete.

5. SECURITY REQUIRMENTS

5.1 All Contracted personnel shall have in their possession a cross-cut paper shredder to destroy any VA sensitive information the Contracted personnel write down while conducting telephonic interpretation to the customer. This information will be destroyed immediately upon completion of telephonic interpretation.

5.2 Contractor may not have access to the VA network. Contractor-owned computer equipment, including laptops, is not permitted to be connected to the VA network.

5.3 Contractor must complete VA Privacy and Information Security Awareness training prior to the performance of the BPA and annually thereafter. Training must be completed in VA’s Training Management System (TMS). Contractors must use the TMS Managed Self Enrollment method to complete the training in TMS.

5.4 The COR and/or facility POC must ensure that all contractors are validated in the Protected Health Information (PHI) domain. Proof of training completion must be verified and tracked by the COR and/or facility POC.

5.5 The C&A requirements do not apply, and a Security Accreditation Package is not required.

6. RECORDS MANAGEMENT Verbiage from VA Handbook 6500.6, Appendix C, 5(h)

6.1 Bio-Medical devices and other equipment or systems containing media (hard drives, optical disks, etc.) with VA sensitive information must not be returned to the vendor at the end of lease, for trade-in, or other purposes. The options are:

· Vendor must accept the system without the drive;

· VA’s initial medical device purchase includes a spare drive which must be installed in place of the original drive at time of turn-in; or

· VA must reimburse the company for media at a reasonable open market replacement cost at time of purchase.

· Due to the highly specialized and sometimes proprietary hardware and software associated with medical equipment/systems, if it is not possible for the VA to retain the hard drive, then;

· The equipment vendor must have an existing BAA if the device being traded in has sensitive information stored on it and hard drive(s) from the system are being returned physically intact; and

· Any fixed hard drive on the device must be non-destructively sanitized to the greatest extent possible without negatively impacting system operation. Selective clearing down to patient data folder level is recommended using VA approved and validated overwriting technologies/methods/tools. Applicable media sanitization specifications need to be preapproved and described in the purchase order or BPA.

· A statement needs to be signed by the Director (System Owner) that states that the drive could not be removed and that (a) and (b) controls above are in place and completed. The ISO needs to maintain the documentation.

6.2 Citations to pertinent laws, codes and regulations such as 44 U.S.C chapters 21, 29, 31 and 33; Freedom of Information Act (5 U.S.C. 552); Privacy Act (5 U.S.C. 552a); 36 CFR Part 1222 and Part 1228.

6.3 Contractor shall treat all deliverables under the BPA as the property of the U.S. Government for which the Government Agency shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest.

6.4 Contractor shall not create or maintain any records that are not specifically tied to or authorized by the BPA using Government IT equipment and/or Government records.

6.5 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 by the Freedom of Information Act.

6.6 Contractor shall not create or maintain any records containing any Government Agency records that are not specifically tied to or authorized by the BPA.

6.7 The Government Agency owns the rights to all data/records produced as part of this BPA.

6.8 The Government Agency owns the rights to all electronic information (electronic data, electronic information systems, electronic databases, etc.) and all supporting documentation created as part of this BPA. Contractor must deliver sufficient technical documentation with all data deliverables to permit the agency to use the data.

6.9 Contractor agrees to comply with Federal and Agency records management policies, including those policies associated with the safeguarding of records covered by the Privacy Act of 1974. These policies include the preservation of all records created or received regardless of format [paper, electronic, etc.] or mode of transmission [e-mail, fax, etc.] or state of completion [draft, final, etc.].

6.10 No disposition of documents will be allowed without the prior written consent of the Contracting Officer. The Agency and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. Records may not be removed from the legal custody of the Agency or destroyed without regard to the provisions of the agency records schedules.

6.11 Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this BPA requiring the disclosure of information, documentary material and/or records generated under, or relating to, this BPA. The Contractor (and any sub-contractor) is required to abide by Government and Agency guidance for protecting sensitive and proprietary information.

ATTACHMENTS:

ATTACHMENT 1

QASP

Performance Requirements

Reviewing operating system diagnostics to ensure that the equipment is operating within its specifications.

Replacing any worn or defective parts.

Repairing or replacing any vaporizer specifically listed below that fails the vaporizer efficacy test.

Installing and maintaining all software updates/upgrades.

QASP

Monitoring Form

1. SERVICE or STANDARD:

2. SURVEY PERIOD:

3. SURVEILLANCE METHOD (check):

4. LEVEL OF SURVEILLANCE (check):

5. PERCENTAGE OF ITEMS SAMPLED DURING SURVEY PERIOD (%):

6. ANALYSIS OF RESULTS:

Observed Service Provider Performance Measurement Rate (%):

Service Provider’s Performance (check):

____ Meets Standards ____ Does Not Meet Standards Narrative of Performance During Survey Period:

Prepared By Date

ATTACHMENT 2

Inventory

ATTACHMENT 3

CLIN Structure

Attachment 1 Statement of Work VA257-15-N-1488 Page 1 of 5 Attachment 1 Statement of Work VA257-15-N-1488 Page 1 of 5