Draft Lab Maintenance SOW.docx

Statement of Work

A. GENERAL GUIDANCE

1. Title: Full Service and Maintenance of VA Pittsburgh Medical Center owned Lab Equipment.

2. Scope of Work: The Contractor shall provide full service and maintenance for government owned Lab Equipment by the requirements stated herein. The facility is located at:

VA Pittsburgh Healthcare System University Drive C Pittsburgh, PA 15240

3. Background: This contract is issued to ensure the continuous reliability of the VA Pittsburgh owned Lab Equipment in this SOW. Due to the complexity of the systems, it requires repair and maintenance by trained personnel using manufacturer approved parts and specifications. The reliable and accurate operation of this equipment at all times is considered critical to the health of patients.

4. Performance period: Three years of maintenance determined at date of award.

5. Type of Contract: Firm-fixed-price.

B. GENERAL REQUIREMENTS

1. This agreement includes all preventive maintenance, corrective maintenance repairs and software updates to the ACIST Contrast Injector for continuous reliability.

a. Equipment to be Serviced:

i. Each of the following items are to be serviced in accordance with the specifications, terms and conditions of this contract.

ET82552301EP

5325/04.2007

51080773

CHM11222411EP

CHM11212411EPS17071543

SPA07182557

SPA07182556

SPA07182555

b. Corrective Maintenance:

i. The Contractor and Biomedical Engineering shall maintain the equipment in accordance with Section D Conformance Standards. Service for corrective maintenance will be provided per hours of coverage defined in Section B.1g. Contractor shall provide unlimited telephone technical support, labor, travel and parts, unless specifically excluded.

ii. Service calls to the Contractor requesting service are only authorized when they are received from the Program Manager, CO, or designated alternates.

iii. Unplanned repairs require remote troubleshooting session prior to Field Service Engineer dispatch.

iv. Outside of the Contract’s hours of coverage, emergency on-site services require authorization by the Program Manager (PM). The PM or a Biomedical Engineering Staff Member shall initiate these calls. If VA staff other than the PM or a Biomedical Engineering Staff Member place calls requesting services, the Contractor shall contact Biomedical Engineering services and verify the request. Service responses on calls from unauthorized personnel can result in nonpayment. The VA Administrative Officer of the Day is an authorized caller and can also be contacted for verification.

v. Uncorrected deficiencies or unfavorable histories of downtime can result in the termination of this contract under the Termination for Default clauses of the Federal Acquisition Regulations.

c. Preventive Maintenance:

i. The Contractor shall perform preventive maintenance service to ensure that equipment listed performs in accordance with original equipment manufacturer (OEM) specifications. Any exceptions to the maintenance schedule shall be arranged and approved in advance with the PM and provided in writing to the CO.

ii. The Contractor shall provide complete and original documentation indicating all maintenance work performed, referencing the procedures followed, actual tests and/or evaluation results obtained to the COR at the completion of the service.

iii. Parts, travel, and labor necessary for maintenance are provided by awarded contractor at no additional customer cost.

iv. Any materials such as lubricants, fluids, cleaning supplies, services, manuals, or tools required for the Contractor to successfully complete scheduled maintenance shall be provided by the Contractor and are included within this contract, and its agreed upon price.

v. Preventive maintenance will be provided at a scheduled time and must be scheduled at least one week in advance to minimize the impact on patient scheduling. All exceptions to the preventive maintenance schedule and procedure shall be addressed and approved in advance with the COR. A designated staff member will accompany the Contractor as an observer during the inspection. The inspection shall be thorough and shall conform to manufacturer and Industry Standards for the equipment. Sufficient time shall be allowed to permit a thorough inspection and test of each device comprising the overall system. Maintenance work and inspections may be combined with the approval of the PM or alternate PM if downtime is not considered significant.

vi. The Contractor shall immediately, but no later than 24 consecutive hours after discovery, notify the CO and PM, in writing, of the existence or the development of any defects in, or repairs required to the scheduled equipment which the Contractor considers they are not responsible for under the terms of the contract. The contractor shall furnish the CO and PM with a written estimate of the cost to make necessary repairs.

d. Parts and Software

i. The contract shall include coverage for all parts. All parts supplied shall be OEM and fully compatible with existing equipment. The determination of compatibility is at the discretion of the PM. All defective parts replaced become the property of the Contractor, unless otherwise specified by the CO or PM.

ii. Software patches and quality updates are included under the terms of this contract and shall be applied in accordance with manufacturer specifications.

e. Remote Service

i. The contractor must be able to provide remote support 24 hours per day, 7 days per week, as needed by phone for the equipment owned by VA Pittsburgh.

ii. Personnel with OEM equipment training will respond by phone. If situations are responded to by phone and do not resolve the service issue, OEM trained personnel will be required to provide on-site service call within two business days for an on-site visit after receipt of initial notification unless otherwise agreed upon, in writing, by the PM or Biomedical Engineering personnel. If the contractor cannot remediate the issues within this timeframe, the PM shall be notified immediately and provided with an estimated time for resolution.

f. System Uptime:

i. The contractor must guarantee a 98% uptime guarantee for each piece of equipment outlined in B.1a over the total number of hours that the system is typically used per quarter. If uptime calculation after each calendar quarter is less than the guaranteed value, the VA Pittsburgh Healthcare System shall be compensated with an additional week of coverage of a maximum of 1 week per calendar quarter.

ii. Uptime formula: ((T-TNF)x100)/T where:

1. T is the total number of hours per day that the system is typically in use by 13 weeks in a quarter – this shall be determined by VAPHS Pathology and Laboratory Service

2. TNF is the number of hours that the system was unable to run tests during the time T

iii. Downtime will be calculated from the time it is unable to run tests until the time of repair completion and the system can run tests.

iv. Downtime scheduled for preventive maintenance or any other scheduled event, including downtime scheduled by the customer, will not be included in the calculation.

g. Hours of Coverage:

i. The contractor will provide all required services within the normal business hours (8:00 AM to 5:00 PM (EST) M-F), excluding holidays.

ii. All services shall be performed during these normal hours of coverage unless one of the following conditions exists:

1. The contractor wishes to furnish services at a time that is outside of the normal hours of coverage, at no additional cost to the Government, the contractor submits a request to the PM prior to the proposed start of the work, and the request is approved in writing by the PM before work is begun.

2. The PM directs that the services be furnished at a time that is outside the normal hours of coverage and the additional cost is recommended by the PM and authorized by the CO.

iii. Work performed outside the normal hours of coverage must be preapproved by the CO or PM. The Contractor will provide a written estimate of the charges prior to approval of the work.

iv. Work performed outside the normal hours of coverage at the request of FSE/contractor will be considered service performed during normal hours of coverage.

v. There will be no additional charge for time spent waiting at the site during or after the normal hours of coverage for delivery of parts Note: Any hardware/software update/upgrade installations shall be scheduled and performed during normal hours of coverage at no additional charge to the government.

vi. Federal Holidays Observed by the VA Medical Center

President’s Day (Washington’s birthday), Memorial Day , Independence Day, Labor Day, Columbus Day, Veterans Day, Thanksgiving Day, Christmas Day, and any other day specifically designated by the President of the United States.

h. Customer Notification:

i. Contractor shall notify Biomedical Engineering and the Police service when they arrive on site. Contractor will schedule all preventative maintenance with Biomedical Engineering.

ii. When the service(s) is/are completed, the FSE shall document the services rendered on a legible ESR(s) per Section E.

iii. The FSE shall be required to check out with the Biomedical Engineering Department and submit the ESR(s) to the COR. All ESRs shall be submitted to the equipment user for an "acceptance signature" and to the COR for an "authorization signature." If the COR is unavailable, a signed accepted copy of the ESR will be sent to the COR within five business days of work completion.

iv. FAILURE TO COMPLY, EITHER IN WHOLE OR IN PART, WITH EITHER THE NOTIFICATION OR ESR REQUIREMENTS WILL BE DEEMED SIGNIFICANT NON-COMPLIANCE WITH THE CONTRACT AND MAY BE JUSTIFICATION FOR TERMINATION OF THE CONTRACT.

C. DEFINITIONS/ACRONYMS:

1. Biomedical Engineering - Supervisor or designee, Phone Number (412) 360-3780

2. CO - Contracting Officer.

3. PM – Program Manager.

4. PMi - Preventive Maintenance Inspection. Services which are periodic in nature and are required to maintain the equipment in such condition that it may be operated in accordance with its intended design and functional capacity with minimal incidence of malfunction or operative conditions. Service shall consist of calibration and testing in accordance with the manufacturer’s latest established service procedures to ensure operation of equipment within manufacturer’s or VA’s performance specifications, whichever is the most rigorous. PM includes cleaning, inspecting lubricating and testing all equipment. All equipment shall be operated at least one complete operating cycle at the end of each PM.

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

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

7. Acceptance Signature - VAPHS employee who indicates FSE demonstrated service conclusion/status and user has accepted work as complete/pending as stated in ESR.

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

9. NFPA - National Fire Protection Association.

10. CDRH - Center for Devices and Radiological Health.

11. VAPHS - Department of Veterans Affairs Pittsburgh Healthcare System.

12. OEM - Original Equipment Manufacturer

D. CONFORMANCE STANDARDS:

Contractor shall provide services and material to ensure that the equipment functions in conformance with the latest requirements of NFPA-99, JC, NEC, OSHA, HIPAA, Federal and VA security specifications and requirements as applicable. The equipment shall be maintained such that it meets or exceeds the performance specifications as established in the OEM’s technical specifications. Additional performance specifications that exceed the OEM specifications shall be specified in writing by the VA.

E. DOCUMENTATION/REPORTS:

The documentation will include equipment down time and detailed descriptions of the scheduled and unscheduled maintenance procedures performed, including replaced parts and prices (for outside normal working hour services) required to maintain the equipment in accordance with conformance standards. Such documentation shall meet the guidelines as set forth in the Conformance Standards. In addition, each ESR must at a minimum document the following data legibly and in complete detail:

1. Name of Contractor

2. Name of FSE who performed services.

3. Contractor Service ESR Number/Log Number.

4. Date, Time (starting and ending), Hours-On-Site for service call.

5. VA Purchase Order Number(s) (if any) covering the call, if outside normal working hours.

6. Description of Problem Reported by PM/User.

7. Identification of Equipment to be serviced to include the following: Equipment ID # or EE# from the bar-code, Manufacturer's Name, Device Name, Model#, Serial #, and any other Manufacturer's identification numbers.

8. Itemized Description of Service(s) Performed (including Costs associated with after normal working hour services), including: Labor and Travel, Parts (with part numbers) and Materials and Circuit Location of problem/corrective action.

9. Total Cost to be billed.

10. Signatures from the following:

a. FSE performing services described.

b. VA Employee who witnessed service described.

11. Equipment downtime calculated in accordance with Conformance Standards.

Note: Any additional charges claimed must be approved by the COR before service is started.

F. SCHEDULE FOR DELIVERABLES

Draft copies of deliverables shall be provided to Biomedical Engineering staff at VAPHS before the contractor leaves the facility at each visit. If a final copy can be provided at that time, then a draft copy is not necessary, final copies must be provided within 5 business days of the time of each deliverable.

G. CHANGES TO STATEMENT OF WORK

Any changes to this SOW shall be authorized and approved only through written correspondence from the CO. A copy of each change will be kept in a project folder along with all other products of the project. Costs incurred by the contractor through the actions of parties other than the CO shall be borne by the contractor.

H. SERVICE MANUALS/TOOLS/EQUIPMENT

1. VAPHS shall not provide service manuals or service diagnostic software to the contractor for use in providing services under this contract. The contractor shall obtain, have on file, and make available to its FSE's all operational and technical documentation, (such as operational and service manuals, schematics, and parts list), which are necessary to meet the performance requirements of this contract. The location and listing of the service data manuals, by name, and/or the manuals themselves shall be provided to the CO upon request.

2. Prior to commencement of work on this contract, the contractor shall make available if requested a copy of the current calibration certification of all test equipment that is to be used by the contractor in performing work under the contract. This certification shall also be provided on a periodic basis when requested by VAPHS. Test equipment calibration shall be traceable to a national standard.

I. CONDITION OF EQUIPMENT:

The contractor accepts responsibility for the equipment described in this scope of work, in "as is" condition. Failure to inspect the equipment prior to contract award will not relieve the contractor of performance of the requirements of this contract.

J. CONTRACTOR EXPERIENCE REQUIREMENTS

1. Each respondent must have an established business, with an office and full-time staff. The staff includes a "fully qualified" FSE and a "fully qualified" FSE who will serve as the backup.

2. Fully Qualified" is based upon training and on experience in the field. For training, the FSE(s) shall have successfully completed a formalized training program, for the equipment or similar equipment identified in Section B.1a. The FSE(s) shall be authorized by the contractor to perform the maintenance services as required. All work shall be performed by "Fully Qualified" competent FSEs. The contractor shall provide written assurance of the competency of their personnel and a list of credentials of approved FSEs for each make and model the contractor services at VAPHS. The CO may authenticate the training requirements, request copies of training certificates or credentials from the contractor at any time for any personnel who are servicing or installing any VAPHS equipment. The CO and/or the PM specifically reserve the right to reject any of the contractor's personnel and refuse them permission to work on the VAPHS equipment.

3. Any Contractor personnel must provide a copy of: 1) Tuberculosis (Tb) vaccination documentation, 2) flu vaccination documentation and 3) copy of HIPAA compliance training certificate.

K. COMPLIANCE WITH OSHA BLOODBORNE PATHOGENS STANDARD:

1. The contractor shall comply with the Federal/California OSHA Bloodborne Pathogens Standard. The contractor shall:

a. Have methods by which all employees are educated as to risks associated with bloodborne pathogens.

b. Have policies and procedures that reduce the risk of employee exposure to bloodborne pathogens.

c. Have mechanisms for employee counseling and treatment following exposure to bloodborne pathogens.

d. Provide appropriate personal protective equipment/clothing such as gloves, gowns, masks, protective eyewear, mouthpieces for the employee during performance of the contract.

L. INFLUENZA PREVENTION PROGRAM:

1. VHA Directive 1192 requires all health care personnel (HCP) to participate in the seasonal influenza prevention program and outlines the key implementation steps. Healthcare personnel is defined in VHA Directive 1192 as all VA licensed and unlicensed, clinical and administrative, paid and unpaid, full- and part-time employees, intermittent employees, fee basis employees, VA contractors, students, researchers, volunteers, and trainees who work in VHA locations. HCP covered by the policy are expected to receive annual influenza vaccination. Those HCP unable or unwilling to be vaccinated are required to wear a face mask throughout the influenza season. Masks are available at entrances throughout the medical center.

2. It is the responsibility of the contractor to ensure that all contract staff is compliant with the requirements outlined in VHA Directive 1192. The contractor shall maintain the following documentation:

a. Documentation of vaccination, e.g., signed record of immunization from a healthcare provider or pharmacy, or a copy of medical records documenting the vaccination.

b. Completed Healthcare Personnel Influenza Vaccination Form (Attachment B of VHA Directive 1192) if unwilling or unable to receive the vaccine.

3. The contractor is required to submit annual certification to the Contracting Officer’s Representative (COR) that all contract staff performing services at VA facilities are in compliance with the VHA Directive 1192.

M. CONFIDENTIALITY AND NONDISCLOSURE

It is agreed that:

1. The preliminary and final deliverables, and all associated working papers, application source code, and other material deemed relevant by VA which have been generated by the contractor in the performance of this task order, are the exclusive property of the U.S. Government and shall be submitted to the CO at the conclusion of the task order.

2. The CO will be the sole authorized official to release, verbally or in writing, any data, draft deliverables, final deliverables, or any other written or printed materials pertaining to this task order. No information shall be released by the contractor. Any request for information relating to this task order, presented to the contractor, shall be submitted to the CO for response.

3. Press releases, marketing material, or any other printed or electronic documentation related to this project, shall not be publicized without the written approval of the CO.

N. IDENTIFICATION, PARKING, SMOKING, CELLULAR PHONE USE AND VA REGULATIONS:

1. The contractor's FSE shall wear visible identification at all times while on the premises of VAPHS. Identification shall include, as a minimum, the employee’s name, position, and the contractor’s trade name.

2. It is the responsibility of the contractor to park in the appropriate designated parking areas. Information on parking is available from the VA Police-Security Service. VAPHS will not invalidate or make reimbursement for parking violations of the contractor under any conditions.

3. Smoking is prohibited inside any buildings and on premise at VAPHS. This covers all smoking and tobacco products, including but not limited to:

a. Cigarettes

b. Cigars

c. Pipes

d. Any other combustion of tobacco

e. Electronic nicotine delivery systems (ENDS), including but not limited to electronic or e-cigarettes, vape pens, or e-cigars.

f. Chewing tobacco

4. Cellular phones and two-way radios are not to be used within six feet of any medical equipment.

5. Possession of weapons is prohibited. Enclosed containers, including tool kits, shall be subject to search. Violations of VA regulations may result in a citation answerable in the United States (Federal) District Court, not a local district state, or municipal court.

O. CONTRACTOR PERSONNEL SECURITY REQUIREMENTS[footnoteRef:1] [1: ]

If working on-site, contractor will be required to comply with security guidelines. Contractor is required to:

Contractor may not have access to the VA network or any VA sensitive information under this contract.

Contractor owned computer equipment including laptops are not permitted to be connected to the VA network. Any removable storage device used in medical equipment must be scanned by Biomed or OIT.

All Contractors must receive Privacy training annually using one of the following methods:

1. Complete “VA Privacy Training for Personnel without Access to VA Computer Systems or Direct Access to or Use to VA Sensitive Information” training by using VA’s TMS system (https://www.tms.va.gov/). Contractors may use the TMS Managed Self Enrollment method to complete the training in TMS. The COR must ensure that all contractors are validated in the PIH domain.

2. Complete the hard copy version of “VA Privacy Training for Personnel without Access to VA Computer Systems or Direct Access to or Use to VA Sensitive Information”. Signed training documents must be submitted to the COR.

Training must be completed prior to the performance of the contract and annually thereafter. Proof of training completion must be verified and tracked by the COR.

End Scope of Work