P09 Statement of Work - Maclab.docx

STATEMENT OF WORK – GE MacLab ComboLab

1.0 The contractor shall furnish labor, parts, supplies, and equipment necessary to provide support and service for the equipment listed below. Equipment is located within the Eastern Colorado Health Care System.

SPECIFIC SERVICE FOR

1.1 ComboLab/MacLab INW server

a. Serial Number: SPK17476729TA

b. VA Equipment Entry (EE) Number: N/A

1.2 ComboLab/MacLab Acquisition Station

a. Serial Number: SPH18149588TA

b. VA Equipment Entry (EE) Number: N/A

1.3 ComboLab/MacLab Acquisition Station

a. Serial Number: SPH18149588TA

b. VA Equipment Entry (EE) Number: N/A

1.4 ComboLab/MacLab Acquisition Station

a. Serial Number: SPH18149588TA

b. VA Equipment Entry (EE) Number: N/A

1.5 ComboLab/MacLab Review Station

a. Serial Number: SPJ18059391TA

b. VA Equipment Entry (EE) Number: N/A

1.6 ComboLab/MacLab Review Station

a. Serial Number: SPJ18059390TA

b. VA Equipment Entry (EE) Number: N/A

1.7 ComboLab/MacLab Review Station

a. Serial Number: SPJ18059386TA

b. VA Equipment Entry (EE) Number: N/A

1.8 ComboLab/MacLab Review Station

a. Serial Number: SPJ18059387TA

b. VA Equipment Entry (EE) Number:N/A

1.9 ComboLab/MacLab Review Station

a. Serial Number: SPJ18059384TA

b. VA Equipment Entry (EE) Number:N/A

1.10 ComboLab/MacLab Integrated Electronics Box (IEB)

a. Serial Number: JTD18110151SA

b. VA Equipment Entry (EE) Number: N/A

1.11 ComboLab/MacLab Integrated Electronics Box (IEB)

a. Serial Number: JTD18110152SA

b. VA Equipment Entry (EE) Number: N/A

1.12 ComboLab/MacLab Integrated Electronics Box (IEB)

a. Serial Number: JTD18130167SA

b. VA Equipment Entry (EE) Number: N/A

1.13 ComboLab/MacLab Patient Data Module (PDM)

a. Serial Number: SKR18071655TA

b. VA Equipment Entry (EE) Number: N/A

1.14 ComboLab/MacLab Patient Data Module (PDM)

a. Serial Number: SKR18071669TA

b. VA Equipment Entry (EE) Number: N/A

1.15 ComboLab/MacLab Patient Data Module (PDM)

a. Serial Number: SKR18071654TA

b. VA Equipment Entry (EE) Number: N/A

1.16 ComboLab/MacLab Patient Data Module (PDM) Nellcor SPO2

a. Serial Number: SA318070429SA

b. VA Equipment Entry (EE) Number: N/A

1.17 ComboLab/MacLab Patient Data Module (PDM) Nellcor SPO2

a. Serial Number: SA318070418SA

b. VA Equipment Entry (EE) Number: N/A

1.18 ComboLab/MacLab Patient Data Module (PDM) Nellcor SPO2

a. Serial Number: SA318070421SA

b. VA Equipment Entry (EE) Number: N/A

1.19 ComboLab/MacLab Respironics C5 CO2 Module

a. Serial Number: 163-082871

b. VA Equipment Entry (EE) Number: N/A

1.20 ComboLab/MacLab Respironics C5 CO2 Module

a. Serial Number: 163-082656

b. VA Equipment Entry (EE) Number: N/A

1.21 ComboLab/MacLab Respironics C5 CO2 Module

a. Serial Number: 163-082854

b. VA Equipment Entry (EE) Number: N/A

1.22 ComboLab/MacLab 128 Channel Module

a. Serial Number: RXJ18134002TA

b. VA Equipment Entry (EE) Number: N/A

1.23 ComboLab/MacLab 128 Channel Module

a. Serial Number: RXJ18134001TA

b. VA Equipment Entry (EE) Number: N/A

PLACES OF PERFORMANCE

2.0 HOURS OF COVERAGE

2.1 Normal hours of coverage are Monday through Friday from 8:00 a.m. to 5:00 p.m., excluding the federal holidays listed as follows:

Federal Holidays:

Any other day specifically declared a National Holiday by the President of the United States

2.2 When one of the above designated legal holidays falls on a Sunday, the following Monday will be observed as a legal holiday. When a legal holiday falls on a Saturday, the preceding Friday is observed as a holiday by US Government Agencies.

3.0 PARTS

3.1 The contractor shall provide all necessary spare and replacement parts to service the equipment. The price of all parts used to perform all scheduled preventive, and unscheduled maintenance shall be included in the coverage. The Government will not pay for any parts provided (during either scheduled or unscheduled maintenance) by the contractor during the period of the medical equipment being covered. Only new standard parts (manufactured by the maker of the equipment, or equal) shall be furnished to maintain the equipment. All unscheduled maintenance service costs should be noted on the quote for each successive year, The contractor is responsible for supplying all necessary spare and replacement parts to service the equipment. The cost of all parts used during both scheduled preventive maintenance and unscheduled maintenance must be included in the overall coverage. The Government will not pay for any parts provided by the contractor during the coverage period for the medical equipment. Only new standard parts—either manufactured by the equipment's maker or of equal quality—shall be supplied to maintain the equipment. Additionally, all unscheduled maintenance and services will not exceed the amount of $7,000.00 per year for the base and option years.

4.0 SERVICE MANUALS/TOOLS/EQUIPMENT

4.1 The contractor shall provide tools, (test) equipment, service manuals or service diagnostic software. 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) necessary to meet the performance requirements and repair of the medical equipment. A reference list of applicable service manuals and their respective locations shall be provided to the Biomedical Engineer upon request.

5.0 MAINTENANCE AND REPAIR

5.1 The contractor shall provide repair service which may consist of calibration, cleaning, oiling, adjusting, replacing parts, and maintaining the equipment. All required parts shall be furnished by the contractor to the VA at no cost. The contractor shall repair the equipment to functional level equivalent to the original manufacturer’s specifications.

5.2 The contractor shall provide as necessary on-site support coverage 24 hours per day, 7 days per week. For disabled systems, the Contractor shall have a 6-hour response time, for non-critical failures, the Contractor shall have a 24-hour response time.

5.3 The Contractor shall provide any necessary replacement parts to properly repair equipment. Replacement parts should be provided on-site within a 24-hour period from when the Contractor technician has determined the need.

5.4 The Contractor shall provide a 96% uptime commitment of all equipment listed.

5.5 All service/repairs shall be performed during normal hours of coverage unless requested or approved by the Biomedical Engineer. Work performed outside the normal hours of coverage, at the request of FSE, shall be considered service during normal hours of coverage and shall be exempt from an extra labor hour charge.

5.6 Only the Biomedical Engineer, Point of Contact, or Contracting Office Representative designated by the CO has the authority to approve/request a maintenance service call to the contractor.

5.7 There shall be no hourly charge to the Government for unscheduled service performed within the normal hours of coverage. Work performed outside the normal hours of coverage, at the request of the Biomedical Engineer, Point of Contact, or Contracting Office Representative, shall be invoiced separately and shall not have service rendered until Purchase Order is obtained. In the event of a Government caused delay, the VA will pay hourly labor charges for unscheduled service the inadvertently extends beyond the specified normal hours of coverage.

6.0 TELEPHONE AND REMOTE SUPPORT

6.1 The contractor shall provide 24 hours per day, 7 days per week, telephone support coverage. The Contractor shall have a response time of 30 minutes during normal hours of coverage (Monday – Friday 6AM – 6PM CST), and 2 hours outside of normal hours of coverage (Monday – Friday 6PM – 6AM CST, Saturdays and Sundays, and Holidays).

6.2 The Contractor shall provide remote software and interface diagnostics as necessary given the VA provides the proper access via a proactive remote through a secure server.

7.0 SOFTWARE UPGRADES AND UPDATES

7.1 The Contractor shall perform and provide any software updates and upgrades as necessary at no charge.

7.2 Software updates/upgrades shall be scheduled and performed during normal hours of coverage if there is no impact or downtime to the system and patient care. If system downtime is expected or patient care will be impacted, the software update/upgrade shall be scheduled and performed outside normal hours of coverage at no additional charge to the Government (to be determined by the Biomedical Engineer).

7.0 DOCUMENTATION/REPORTS

7.1 The documentation shall include 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 the specifications. Each Engineer Service Report (ESR) must, at a minimum, document the following data legibly and in complete detail:

a. Name of contractor and contract number

b. Name of FSE who performed services

c. Contractor service ESR number/log number

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

e. VA purchase order number(s) covering the call if outside normal working hours.

f. Description of problems reported by the POC/user (if applicable).

g. Identification of equipment to be serviced:

· Inventory ID number,

· Manufacturer's name, device name, model number & serial number,

· Any other manufacturer's identification numbers.

h. Itemized Description of Service Performed (including, if applicable, costs associated with after normal working hour services) including:

· Labor and Travel,

· Parts (with part numbers),

· Materials and Circuit Location of problem/corrective action.

· Total Cost to be billed (if applicable - i.e., part(s) not covered or service rendered after normal hours of coverage).

i. Signatures:

· FSE performing services described.

· Authorized VA Employee who witnessed service described.

NOTE: - Any additional charges claimed must be approved by the COR or CO before service is completed

7.2 The Contractor shall log in with Biomedical Engineering prior to performing any services. When the service is completed, the FSE shall document services rendered on a legible ESR(s). The FSE shall log out with Biomedical Engineering and submit the ESR(s) to the Biomedical Engineer, or Point of Contact. All ESRs shall be submitted to the equipment user for an “acceptance signature” and then to the POC for an “authorization signature”. If the POC is unavailable, a signed, authorized copy of the ESR shall be sent to the contractor after the work can be reviewed (if requested or noted on the ESR).

8.0 ADDITIONAL CHARGES

8.1 There will be no additional charge for time spent at the site (during or after the normal coverage areas) awaiting the arrival of additional FSE and/or delivery of parts

9.0 REPORTING REQUIRED SERVICES BEYOND SERVICE SCOPE

9.1 The contractor shall immediately, but no later than 24 consecutive hours after discovery, notify the COR or POC, in writing, of the existence or development of any defects in, or repairs required, to the scheduled equipment which, the contractor does not consider his/her responsibility due to “abuse” or “damage” to the equipment. The contractor shall furnish the Government with a written estimate of the cost to make the necessary repairs.

10.0 ACCEPTANCE OF CONDITION OF EQUIPMENT

10.1 The contractor accepts responsibility for the equipment covered under this equipment in an “as is” condition. Inspection of the equipment by the contractor shall be done prior to coverage, if required by the contractor.

11.0 COMPETENCY AND CERTIFICATION OF PERSONNEL SERVICING EQUIPMENT

11.1 Each respondent must have an established business, with an office and full time staff. The staff shall include a fully qualified FSE and fully qualified alternate FSE.

11.2 “Fully Qualified” is based on successful completion of factory training and experience in the field. For training, the FSE shall have successfully completed a formalized training program for the equipment identified in the schedule. For field experience, the FSE(s) shall have a minimum of two years of experience (with the exception of equipment on the market less than two years) with respect to scheduled and unscheduled preventive and remedial maintenance, on the covered equipment.

11.3 The FSEs shall be authorized by the contractor to perform the maintenance services. All work shall be performed by fully qualified competent FSEs (GE Trained Contractors). The contractor shall provide copies of all factory certificates for FSEs showing types of equipment and dates of training for all equipment identified to be covered. When deemed appropriate, the COR or Contracting Office Representative reserve the right to prohibit contractor personnel from working on VAMC equipment.

12.0 CONTRACTOR TEST EQUIPMENT

12.1 The contractor shall ensure all contractor supplied test equipment is properly calibrated, and certified. If requested by the COR or POC, the contract shall be able to supply any certificates tied to the quality of the test equipment. Test equipment calibration shall be traceable to a national standard.

RECORDS MANAGEMENT OBLIGATIONS

A. Applicability This clause applies to all Contractors whose employees create, work with, or otherwise handle Federal records, as defined in Section B, regardless of the medium in which the record exists.

B. Definitions “Federal record” as defined in 44 U.S.C. § 3301, includes all recorded information, regardless of form or characteristics, made or received by a Federal agency under Federal law or in connection with the transaction of public business and preserved or appropriate for preservation by that agency or its legitimate successor as evidence of the organization, functions, policies, decisions, procedures, operations, or other activities of the United States Government or because of the informational value of data in them.

The term Federal record:

1. includes [Agency] records.

2. does not include personal materials.

3. applies to records created, received, or maintained by Contractors pursuant to their [Agency] contract.

4. may include deliverables and documentation associated with deliverables.

C. Requirements

1. 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.

2. 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.

3. 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.

4. [Agency] 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 [Agency] 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 [Agency]. The agency must report promptly to NARA in accordance with 36 CFR 1230.

5. 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 [Agency] 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).

6. 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 [Agency] guidance for protecting sensitive, proprietary information, classified, and controlled unclassified information.

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

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

9. 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.

10. The [Agency] 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 [Agency] 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.

11. Training. All Contractor employees assigned to this contract who create, work with, or otherwise handle records are required to take [Agency]-provided records management training. The Contractor is responsible for confirming training has been completed according to agency policies, including initial training and any annual or refresher training.

D. Flowdown of requirements to subcontractors

1. The Contractor shall incorporate the substance of this clause, its terms and requirements including this paragraph, in all subcontracts under this [contract vehicle], and require written subcontractor acknowledgment of same.

2. Violation by a subcontractor of any provision set forth in this clause will be attributed to the Contractor.