N62645-16-R-0033_Amendment_0002.pdf

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

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 (Type or print)

30-105-04EXCEPTION TO SF 30

APPROVED BY OIRM 11-84

STANDARD FORM 30 (Rev. 10-83)

Prescribed by GSA

FAR (48 CFR) 53.243

The purpose of this amendment is to revise the CLIN descriptions and Statement of Requirements-Section 1-Equipment. There are no other changes. Below are the noted changes made to the Statement of Requirements-Section 1-Equipment:

FROM

The requirement is for a cost-per-reportable contract for one (1) hematology laboratory analyzer for Naval Hospital Guam, brand name or equal (BNE) to the Sysmex XN2000. The system shall be capable of performing at least the tests listed below for a minimum annual w orkload of 25,000 specimens for Complete Blood Counts, 500 for Body Fluids and 2,500 for Reticulocytes.

TO

The requirement is for a contract for one (1) hematology laboratory analyzer w hich includes equipment lease, maintenance support, and consumable supplies for Naval Hospital Guam, brand name or equal (BNE) to the Sysmex XN2000. The system shall be capable of performing at least the tests listed below for a minimum annual w orkload of 25,000 specimens for Complete Blood Counts, 500 for Body

Fluids and 2,500 for Reticulocytes.

1. CONTRACT ID CODE PAGE OF PAGES

J 1 6

16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)

16C. DATE SIGNED

BY 19-Jul-2016

16B. UNITED STATES OF AMERICA15C. DATE SIGNED15B. CONTRACTOR/OFFEROR

(Signature of Contracting Officer)(Signature of person authorized to sign)

8. NAME AND ADDRESS OF CONTRACTOR (No., Street, County, State and Zip Code) X N62645-16-R-0033

X 9B. DATED (SEE ITEM 11)

16-Jun-2016

10B. DATED (SEE ITEM 13)

9A. AMENDMENT OF SOLICITATION NO.

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

X The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offer is extended, X is not extended.

Offer 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:

(a) By completing Items 8 and 15, and returning 1 copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted;

or (c) By separate letter or telegram 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 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 telegram or letter, provided each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

12. ACCOUNTING AND APPROPRIATION DATA (If required)

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

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

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.

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation date, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(B).

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

D. OTHER (Specify type of modification and authority)

E. IMPORTANT: Contractor is not, is required to sign this document and return copies to the issuing office.

14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

10A. MOD. OF CONTRACT/ORDER NO.

2. AMENDMENT/MODIFICATION NO. 5. PROJECT NO.(If applicable)

6. ISSUED BY

3. EFFECTIVE DATE

19-Jul-2016

CODE

NAVAL MEDICAL LOGISTICS COMMAND

693 NEIMAN STREET

FORT DETRICK MD 21702-9239

N62645 7. ADMINISTERED BY (If other than item 6)

4. REQUISITION/PURCHASE REQ. NO.

CODE

See Item 6

FACILITY CODECODE

EMAIL:TEL:

N62645-16-R-0033

SECTION SF 30 BLOCK 14 CONTINUATION PAGE

SUMMARY OF CHANGES

SECTION SF 1449 - CONTINUATION SHEET

SUPPLIES OR SERVICES AND PRICES

CLIN 0001

The CLIN description has changed from CPRR HEMATOLOGY LABORATORY ANALYZER to

HEMATOLOGY LABORATORY ANALYZER.

CLIN 1001

CLIN 2001

CLIN 3001

CLIN 4001

The following have been modified:

STATEMENT OF REQUIREMENTS

1. Equipment

The requirement is for a contract for one (1) hematology laboratory analyzer which includes equipment lease, maintenance support, and consumable supplies for Naval Hospital Guam, brand name or equal (BNE) to the

Sysmex XN2000. The system shall be capable of performing at least the tests listed below for a minimum annual workload of 25,000 specimens for Complete Blood Counts, 500 for Body Fluids and 2,500 for Reticulocytes.

The systems shall be capable of performing general hematology and reticulocyte testing. The system shall be capable of providing automated results for complete blood counts, white blood cell differentials, reticulocyte counts, and body fluid counts with 2 part differentials. The system shall be capable of performing linearity for white blood cell (WBC), red blood cell (RBC), Platelet, and Body Fluids. The system shall be capable of providing a total count for body fluids, with a 2 part differential that includes both the absolute number and the percent of cells counted.

The system shall be capable of positively identifying patient samples using bar codes. The system shall be capable of performing differentials with histograms. The system shall be capable of flagging the user for immature cell lines and pediatric specimens. The system shall be capable of running specimens in an automated closed tube and manual open tube. The system shall be capable of performing and enumerating nucleated red blood cells. The system shall be capable of auto-correcting white blood cells, hemoglobin, hematocrit, mean corpuscular hemoglobin, and mean corpuscular hemoglobin concentration. The system shall be capable of differentiating between platelet clumps and giant platelets. The system shall be capable of using multiple size tubes including those with low volumes (i.e.

pediatric bullet tubes), using only a closed sampler mode. The system shall be capable of interfacing with the

Composite Health Care System (CHCS) and Cerner Millennium. The system shall be capable of performing priority

(STAT) testing and manual reflex testing. The system shall be capable of performing multiple tests on a single specimen sample. The system shall be capable of performing automated reticulocyte counts based on the parameters set by the manufacturer and the laboratory management. The system shall be bench-top with maximum dimensions of 38” height, 38” width, 35” depth, and 325 lbs. weight, and must include a movable reagent compartment for in use reagents. The electrical requirements are 110VAC, 60 Hz. An uninterruptible power supply (UPS) is required.

System installation, validation, correlation, onsite training, and preventive maintenance coverage shall be included.

Corrective system maintenance coverage shall include response times as specified in the Statement of Work, including 24-hour telephone support and on-site response within 24 hours. Annual onsite user training covering equipment operation is an enhancing factor.

The units shall be compliant with the Food and Drug Administration (FDA) requirements to market and deliver medical products for use in the United States of America, even should delivery be requested outside of the United

States. The claims made for the product shall comply with the regulations of the FDA with respect to products for marketing and delivery of a medical product for use in the United States of America, even should delivery be requested outside of the United States. The system shall be installed in compliance with OSHA requirements.

Contractor shall be an Original Equipment Manufacturer (OEM) authorized dealer, authorized distributor or authorized reseller for the proposed equipment/system such that OEM warranty and service are provided and maintained by the OEM. All software licensing, warranty and service associated with the equipment/system shall be in accordance with the OEM terms and conditions.

Upon delivery, the contractor shall be responsible for uncrating the unit/system, transporting it through the facility to the location of intended use for installation, and removing of all trash created in this process. If interim storage is required, the vendor shall make arrangements for the storage.

2. Reagent and supply delivery

a. All supplied items and reagents shall be certified for use with the Vendor equipment provided.

b. All supplied items and reagents that require special handling, e.g. refrigeration, time sensitive, open immediately, etc., will be marked in a clear manner with a label that is easily read, understandable and a minimum of 3” x 3” (9 sq. inches). The label will be placed in three (3) or more locations on the container

(top & sides). Supplies/items that require refrigeration will have both the required Celsius and Fahrenheit temperature identified.

c. The vendor shall maintain at least a 3-month inventory (including spare parts, necessary for analyzer maintenance) on island, with delivery of reagents within 24 business hours of request for reagents.

d. The vendor shall provide assistance with establishing new reference ranges when new QC materials are introduced.

d. The vendor shall provide deliveries to the delivery point identified below:

US Naval Hospital Guam

PSC 490, Box 7656

FPO, AP 96538-1600

3. Maintenance.

a. The Vendor shall provide trained, experienced, English-speaking personnel, labor, tools, diagnostic equipment, software, material, supplies, transportation, parts and equipment necessary to perform

Preventive Maintenance (PM), Calibration (CAL), Safety Testing (ST) and corrective maintenance.

b. The Vendor shall provide telephonic communications with the Government to discuss technical matters relating to the performance of this contract. A systems operator shall be made available to answer technical questions regarding system operations and applications.

c. Equipment listed in this contract will be maintained to meet and retain the original equipment manufacturer’s (OEM’s) specifications / equipment certification.

d. The vendor shall provide a Quality Assurance program for peer review.

4. Preventive Maintenance Services.

a. Normal Business Hour Maintenance Coverage will be Monday through Friday, between 8:00 A.M. to

5:00 P.M. local. Vendor shall provide full service preventive maintenance.

b. Preventive maintenance shall be performed in accordance with OEM recommendations.

c. Must provide onsite assistance with the Bi-Annual Calibration of each analyzer, to include all Calibration supplies, per the requirements of the College of American Pathologists, and other Regulatory Agencies.

Calibration reports must be submitted to the laboratory, and any corrective actions must be taken to ensure that all calibration standards are acceptable.

5. Corrective Maintenance

a. Vendor shall provide on-site corrective maintenance between the hours of 8:00 A.M. and 5:00 P.M. PST, Monday-Friday with unlimited service calls. Telephonic support shall be available 24 hours per day, 7 days per week.

b. A vendor service technician shall respond via telephone within two (2) hours after receipt of trouble call, and provide on-site service within twenty four (24) hours. Equipment shall be operational within 48 hours.

c. Government request for corrective maintenance will be placed by Biomedical Engineering Division

(BIOMED) personnel, to the Vendor. Corrective maintenance shall be completed during the hours specified in the contract.

d. Vendor’s response to requests for service may include telephone consultation with the equipment user/operator and a Vendor Field Service Engineer (FSE). Telephone consultation 1) shall provide instruction in determining operator error; 2) shall determine the most likely cause of the problem; 3) shall determine if resolution of the problem requires the dispatch of a FSE; and 4) should identify replacement parts likely to be required in order to return the equipment to 100% operational condition as specified by the OEM.

e. Vendor’s pricing shall be inclusive of all costs including parts, consumables, labor, travel and shipping.

f. The Vendor shall have his/her own service manuals, specifications, schematic diagrams, and parts lists to assist in the evaluation/repair of all equipment included in this contract.

6. Replacement Parts/Upgrades.

a. The Vendor shall have ready access to unique and/or high mortality replacement parts.

All parts supplied shall be compatible with the existing system. In the event that replacement parts are required to be shipped, shipping shall be performed in the fastest reasonable means possible at no additional cost to the Government.

b. The Vendor shall replace all worn or defective parts necessary to restore the equipment to 100% operational condition as specified by the OEM.

c. Freight, postage, and storage charges associated with shipment and receipt of replacement parts and the return of parts shall be the responsibility of the Vendor.

d. All replacement parts shall be new and certified as OEM replacement parts. In the event that new parts are not available, rebuilt parts and sub-assemblies are allowed provided that they are warranted to be free of defects for a period of time that meets or exceeds warranties of similar replacement parts. The Vendor shall specifically annotate on the Field Service Report the use and identification of rebuilt parts and the period of warranty. When discrepancies occur, the Government will make the final determination on whether a replacement part is of equal or better quality.

e. The Vendor shall include software revisions and upgrades (field service changes), which are required due to FDA or manufacturer announced safety-hazard recall, to include FDA Year 2000 Compliance Directive, as part of the contract at no additional cost to the Government. Upgrades shall be performed as soon as possible after release, but no later than the first scheduled Preventative Maintenance inspection after release. For any updates that have been identified as critical, or required for the proper operation of equipment by the OEM, vendor shall provide installation within 30 days of release regardless of

Preventative Maintenance schedules.

f. With approval from the government, the vendor may perform hardware/software upgrades as they become available.

7. Government furnished property, Materials and Services.

a. The Government will be responsible for maintaining the proper environment, including utilities and site requirements necessary for the system to function properly as specified by the OEM.

b. The Government will operate the system in accordance with the instruction manual provided by the

OEM.

c. The Government will not be responsible for the damage or loss due to fire, theft, accident, or other disaster of Vendor supplies, materials, or for the personal belongings brought onto Government property by

Vendor’s personnel.

8. Vendor Furnished Property and Material.

a. The Vendor shall provide all service literature, reference publications, laptop computers and diagnostic software to be used by the Vendor service technicians and as required for the completion of the services in accordance with this contract.

9. Vendor Report Requirements.

a. During normal duty hours, Vendor FSE personnel shall check-in with the Biomedical Engineering

Division upon arrival at the Government site and again prior to departure. The Vendor FSEs shall personally notify BIOMED personnel of problems that result in the equipment being left disabled upon their departure. If equipment is left disabled, a method of physical use prevention of the disabled equipment shall be implemented, and the disabled equipment shall be locked out with a letter of intent in compliance with OSHA regulation to prevent any patient hazards. After normal duty hours, Vendor FSEs shall notify the Officer of the Day Desk and the systems operator designated by BIOMED personnel.

b. The Vendor shall provide to BIOMED personnel a full service report within two (2) days after completion of all services performed. Each service report shall at a minimum document the following data legibly and in complete detail:

i. Name of Vendor

ii. Contract Number

iii. Name of field service technician performing service

iv. Vendor log/control number

v. Date, time (beginning and ending), and hours on-site for service call

vi. Description of problem reported by user

vii. Equipment identification factors to include: manufacturer, make, model, serial number and

Facility Equipment Control Number (ECN)

viii. Itemized description of service performed to include: labor and travel costs, parts used, parts cost, parts number/nomenclature, part new or reconditioned, part manufacturer, and problem/corrective action taken or recommended

ix. Problem resolution or pending action

x. Total billing cost

xi. Signatures:

1. Field Service Technician performing services

2. BMET verifying service rendered (Identify Medical Treatment Facility)

xii. In the event that agents / sub-vendors are used in the performance of repairs, said agent shall be identified on the service report by company name and contact information (i.e., telephone number)

10. Vendor Responsibility.

a. The Vendor shall be responsible for the repair/replacement of damaged Government owned equipment and property due to the negligence of the Vendor or his representatives. All such replacement or repair shall be at the Vendor's expense and shall be inspected to the satisfaction of the Contracting Officer or appointed representative.

11. Removal of Government Property

a. No equipment shall be removed without the approval of the Contracting Officer’s Representative and

Materials Management Department of the Medical Treatment Facility (MTF). Property passes for equipment removal shall be obtained by the Vendor via the Materials Management Department of the

MTF. Any failure to obtain such passes which results in detainment or prosecution of service Vendor personnel are the sole responsibility of the service Vendor personnel.

b. The Vendor shall provide a detailed description of removed items in writing on the Vendor’s company letterhead. For associated items / accessories, Vendor to provide a detailed written description and quantities of items to be removed. Description to include, as a minimum, manufacturer’s serial numbers and equipment control numbers (ECNs) of all equipment / items removed. In the event that items / sub-assemblies / accessories are repaired via “Repair by Replacement,” a detailed description of replaced items is to be included upon return of repaired components.

c. No additional charge shall be allowed for work performed off-site, or any additional time required. All charges resulting from a Vendor determined requirement to transport Government owned property, covered by this contract, to and from an alternate repair location shall be the responsibility of the Vendor. The

Vendor shall provide insurance coverage for damage to or loss of equipment while in Vendor or service

Vendor’s custody.

d. In regards to patient information confidentiality and privacy, all vendors and/or service vendor shall not remove equipment containing patient information from the Government site. The equipment hard drive shall be removed at the MTF prior to removal. Furthermore, equipment removed from the MTF will be prorated from the date of removal for service maintenance fees. If hard drives are to be replaced, they shall be left at the MTF for disposal.

12. Service Beyond the Scope of the Contract

a. The Vendor shall immediately, but not later than 24 consecutive hours after discovery, notify BIOMED, in writing, of the existence or the development of any defects in, or repair required to the scheduled equipment which the Vendor considers they are not responsible for under the terms of this contract.

b. At the same time of the notification, the Vendor shall furnish BIOMED with written estimate of the cost to make the necessary repairs. Repairs considered by the Contracting Officer to be outside the scope of this contract shall not be covered under this contract, but shall be ordered under a separate purchase order.

(End of Summary of Changes)