36C24219Q0393-0001000.docx

36C24219Q0393 Amendment 1 Questions and answers

5. PROJECT NUMBER (if applicable)

CODE

7. ADMINISTERED BY

2. AMENDMENT/MODIFICATION NUMBER

CODE

6. ISSUED BY

8. NAME AND ADDRESS OF CONTRACTOR

4. REQUISITION/PURCHASE REQ. NUMBER

3. EFFECTIVE DATE

9A. AMENDMENT OF SOLICITATION NUMBER

9B. DATED

PAGE OF PAGES

10A. MODIFICATION OF CONTRACT/ORDER NUMBER

10B. DATED

BPA NO.

1. CONTRACT ID CODE

FACILITY CODE

CODE

Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following methods:

The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers

E. IMPORTANT:

is extended,

(a) By completing Items 8 and 15, and returning __________ copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted; or (c) By separate letter or electronic communication which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY is not extended.

12. ACCOUNTING AND APPROPRIATION DATA

(REV. 11/2016)

is required to sign this document and return ___________ copies to the issuing office.

is not, A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NO. IN ITEM 10A.

15C. DATE SIGNED

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by letter or electronic communication, provided each letter or electronic communication makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER

Contractor

16C. DATE SIGNED

14. DESCRIPTION OF AMENDMENT/MODIFICATION

16B. UNITED STATES OF AMERICA

Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

15A. NAME AND TITLE OF SIGNER

16A. NAME AND TITLE OF CONTRACTING OFFICER

15B. CONTRACTOR/OFFEROR

STANDARD FORM 30

PREVIOUS EDITION NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.243 (Type or print) (Type or print) (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

(Number, street, county, State and ZIP Code) (If other than Item 6) (Specify type of modification and authority) (such as changes in paying office, appropriation date, etc.)

(If required)

(SEE ITEM 11)

(SEE ITEM 13)

(X)

CHECK

ONE

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS,

IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

(Signature of person authorized to sign) (Signature of Contracting Officer) 36C242 Department of Veterans Affairs Network Contracting Office 2 James J. Peters VA Medical Center 130 West Kingsbridge Road Bronx

NY

10468-3904 36C242 Department of Veterans Affairs James J. Peters VA Medical Center Network Contracting Office 2 130 West Kingsbridge Road Bronx

NY

10468-3904 To all Offerors/Bidders

36C24219Q0393

X x The purpose of this amendment is to answer a vendor question. (see attached, one page). A revised version of the statement of work is also included in this amendment (attached, eleven pages).

The due date for quotes remains May 1, 2019, at 10 AM EST.

Marshand Boone Contracting Officer

1. Question: There is a significant discrepancy in the SOW regarding onsite response time by the Contractor.

Page 8 states: Four (4) hours after receipt of notification

Page 10 states: eight (8) hours after receipt of notification

The standard onsite response time is twenty-four (24) hours after receipt of notification.

Answer: Please see the attached, revised statement of work. Changes to the statement of work are reflected in Section V. REPAIRS and Section VIII. SERVICE/REPAIR.

STATEMENT OF WORK

SERVICE CONTRACT:

Full Service contract for the period of 5/10/19 through 5/9/2020 for the following government owned equipment. This contract will have four one-year option periods.

Microbiology Sterilizers SN: 013030104, 11490305

Caviwave Pro Ultrasonic Cleaner, SPS, SN: 0515ST0100402

V-Pro Max, SD, 4th floor SN: 030431611

12 months

REQUIREMENTS:

Equipment to be serviced/maintained includes:

EAGLE 3000 STAGE 2 16" GRAVITY STEAM Q = 1 in OR

EAGLE 3000 STAGE 2 16" GRAVITY STEAM Q = 2 in MICROBIOLOGY

CAVIWAVE PRO ULTRASNC CLNER 17 GAL 208V/3PH/132HZ

V-PRO MAX, SD, CAB, 208/230V, 60HZ

Location at Manhattan VAMC:

MICROBIOLOGY

II. DEFINITIONS/ACRONYMS:

A. Biomedical Engineering - Chief or designee, at:

Manhattan VAMC, 212-686-7500 ext. 7309

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 incidence of malfunction or inoperative conditions.

Report. A documentation of the services rendered for each incidence of work performance under the terms and conditions of the contract.

Contract service shall ensure that the equipment functions in conformance with the latest published editions of NFPA-99, OSHA, CDRH, and [include performance standards and specifications used when the equipment were procured by VA National, Acquisition Center and any upgrades/updates].

IV. HOURS OF COVERAGE:

A. Normal business hours of coverage are [Monday through Friday], [8:00am

- 4:30pm], excluding federal holidays. All service/repairs will be performed during the normal business hours of coverage unless requested and approved by the COR.

B. Preventive maintenance will be performed quarterly. Preventive maintenance is to be performed inside normal business hours.

Note: Hardware/software scheduled and performed outside normal hours of coverage at no additional charge to the Government (unless it would be detrimental to equipment up-time; to be determined by COR).

C. Federal Holidays observed by the VAMC are:

New Years Day Labor Day Martin Luther King Day Columbus Day President’s Day Veterans Day Memorial Day Christmas Day Thanksgiving Day Independence Day And any other day specifically declared by the President of the United States to be a national holiday.

IV. LABOR:

A. Unlimited labor is included within the hours of coverage noted above.

V. REPAIRS:

A. The contractor shall maintain the equipment in accordance with the Conformance Standards Section, by furnishing all necessary labor, unlimited technical phone support, equipment, tools, materials, repair service, shipping charges and all peripherals.

Equipment repairs/service as specified in Section C, in Section C, I, Equipment, software updates and parts for service in accordance with the terms, conditions and schedule of this agreement. The contractor will provide repair service which may consist of calibration, cleaning, oiling, adjusting, replacing parts and maintaining the equipment, including all intervening calls necessary between regular services calibrations.

D. Repair Up-Time: From the time when the FSE commences the on-site unscheduled maintenance, the repairs/service must be completed within are 24 hours (24 hours/day).

VI. SCHEDULED MAINTENANCE:

A. The contractor shall perform Preventive Maintenance (PM) service to ensure that equipment listed in the schedule performs in accordance with Section C, III, Conformance Standards. The contractor shall make thorough technical inspections of the equipment covered in the Schedule. Within ten (10) days after the award of the contract, the contractor shall submit a schedule of PMs and a PM checklist describing in detail the scheduled maintenance procedures for inspecting each piece of equipment listed. This checklist is subject to the approval of the COR. The contractor shall provide and utilize these procedures and checklists with worksheet originals indicating the work performed and actual values obtained (as applicable) provided to the COR at the completion of the PM. All equipment listed under Section C, I, Equipment, will have PM service performed quarterly.

PM services shall include, but need no be limited to, the following:

C, III,

Conformance Standards.

VII. PARTS:

The contractor shall furnish and replace parts to meet the repair up-time requirements as stated in Section C, V, Unscheduled Maintenance, D, Repair Up-time. If parts cannot be furnished by this time, the COR must be notified. The contractor has ready access to unique and/or high mortality replacement parts. All parts supplied shall be compatible with existing equipment. New parts shall be furnished by the contractor and guaranteed against defects and/or failure for a period of 1 year from of completion installation of the component.

VIII. SERVICE/REPAIR:

The VAMC shall not provide service manuals or service diagnostic software to the contractor. They 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.

X. DOCUMENTATION/REPORTS:

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

Equipment Downtime and Hours-On-Site for service call.

INV. ID#, Manufacturer’s Name, Device Name, Model #, Serial #, and any other Manufacturers identification numbers.

H. Itemized Description of Service Performed (including Cost associated with after normal working hour services), including:

Labor and Travel, Parts (with parts #) and Materials and Circuit Location of problem/corrective action.

K. Equipment downtime

Note: ANY ADDITIONAL CHARGES CLAIMED MUST BE APPROVED BY THE COR BEFORE SERVICE IS COMPLETED!

XI. REPORTING REQUIREMENTS:

A. The contractor shall be required to report to Biomedical Engineering and/or Surgical Service to log in.

This check in is mandatory, and each facility will designate the appropriate area to report to. When the service is completed, the FSE shall document services rendered on a legible ESR(s). The FSE shall be required to log out with and submit the ESR(s) to Biomedical Engineering and/or Surgical Service. 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 authorized copy of the ESR will be sent to COR by the contractor after the work can be reviewed (if requested or noted on the ESR).

B. The contractor is totally responsible for providing Service and Preventive Maintenance reports directly to the COR.

XII. PAYMENT:

A. Purchase Order Payment Procedures:

Payments will be made monthly in arrears upon receipt of properly prepared invoices which must show reference to the correct purchase order number issued upon the award of this contract. Each invoice must be provided in [triplicate] and must include the Service Reports (ESR’s) for work performed during that period.

B. Payment Procedures:

Invoices must then be mailed to the corresponding VAMC the charge is applied to. Each invoice must be provided in [triplicate] and must include the Service Reports (ESR’s) for work performed. Invoices must show reference to the correct purchase order number and contract number issued upon the award of this contract. If there are any deductions to be made, or a credit card charge in was made in error, a credit will be due of the correct amount for the monthly payment in question. Notification of the credit, is to be made in writing for any adjustments that were made and then mailed to the corresponding VAMC.

XIII. ADDITIONAL CHARGES:

There will be no additional charge to the Government 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.

XIV. REPORTING REQUIRED SERVICES BEYOND THE CONTRACT SCOPE:

The Contractor shall immediately, but not later than 24 consecutive hours after discovery notify the COR, (in writing), of the existence or the development of any defects in, or repairs required to the scheduled equipment which the Contractor considers he/she is not responsible for under the terms of the contract. The contractor shall furnish the CO and COR with a written estimate of the cost to make necessary repairs.

XV. QUALIFICATIONS:

Offers will be considered only from offerors who are established in the business called for and whom in the judgment of the Contracting Officer (CO) are financially responsible and able to show evidence of their reliability, ability, experience, equipment, facilities and personnel directly employed or supervised by them to render prompt and satisfactory service.

All contractor employees and subcontractors under this contract or order are required to complete VA's Information Security and Privacy combined Awareness Training Course annually. Contractors must provide signed certifications of completion to the COR during each year of the contract. This requirement is in addition to any other training that may be required of the contractor and subcontractor(s).

VA INFORMATION CUSTODIAL LANGUAGE

a. Information made available to the contractor or subcontractor by VA for the performance or administration of this contract or information developed by the contractor/subcontractor in performance or administration of the contract shall be used only for those purposes and shall not be used in any other way without the prior written agreement of the VA. This clause expressly limits the contractor/subcontractor's rights to use data as described in Rights in Data - General, FAR 52.227-14(d) (1).

b. The contractor/subcontractor shall not make copies of VA information except as authorized and necessary to perform the terms of the agreement or to preserve electronic information stored on contractor/subcontractor electronic storage media for restoration in case any electronic equipment or data used by the contractor/subcontractor needs to be restored to an operating state. If copies are made for restoration purposes, after the restoration is complete, the copies must be appropriately destroyed.

c. If VA determines that the contractor has violated any of the information confidentiality, privacy, and security provisions of the contract, it shall be sufficient grounds for VA to withhold payment to the contractor or third party or terminate the contract for default or terminate for cause under Federal Acquisition Regulation (FAR) part 12.

d. 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:

(1) Vendor must accept the system without the drive;

(2) 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

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

(4) 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;

(a) 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

(b) 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 pre-approved and described in the purchase order or contract.

(c) 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.

TRAINING

a. All contractor employees and subcontractor employees requiring access to VA information and VA information systems shall complete the following before being granted access to VA information and its systems:

(1) 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; VA Handbook 6500.6, Contract Security APPENDIX C

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

(3) Successfully complete the appropriate VA privacy training and annually complete required privacy training; and

(4) Successfully complete any additional cyber security or privacy training, as required for VA personnel with equivalent information system access [to be defined by the VA program official and provided to the contracting officer for inclusion in the solicitation document – e.g., any role-based information security training required in accordance with NIST Special Publication 800-16, Information Technology Security Training Requirements.]

b. The contractor shall provide to the contracting officer and/or the COR 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 contract and annually thereafter, as required.

c. Failure to complete the mandatory annual training and sign the 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 contract until such time as the training and documents are complete.

XVI. CONDITION OF EQUIPMENT

The contractor accepts responsibility for the equipment described in Section C, I, in “as is” condition. Failure to inspect the equipment prior to contract award will not relieve the contractor from performance of the requirements of this contract.

XVII. COMPETENCY OF PERSONNEL SERVICES EQUIPMENT:

XVIII. TEST EQUIPMENT:

Prior to commencement of work on this contract, the contractor shall provide the VAMC with copy of current calibration shall perform and provided on an annual basis. Test equipment calibration shall be traceable to national standard.

XIX. IDENTIFICATION, PARKING, SMOKING, AND VA REGULATIONS:

The contractor’s FSE’s shall wear visible identification at all times while on the premises of the VAMC. Smoking is prohibited inside any buildings at the VAMC. Possession of weapons is prohibited. Enclosed containers, including tool kits, shall be subject to search. Violations of VA regulations may result in citation answerable in the United States (Federal) District Court, not a local district, state, or municipal court.

XX. INSURANCE

Contractors are required to have Property Damage Liability insurance coverage of at least $500,000.