W91YTZ19Q0296_AMENDMENT_0001.pdf

W40M RHCO-ATLANTIC USAHCA

NORTHERN REG CONTR OFC NRCO

POC: HEIDI N. HOLLEY

6000 MACARTHUR BLVD, BASEMENT, RM B058

BETHESDA MD 20815-5003

0011352085

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

1. The purpose of this amendment is to revise the Statement of Work (SOW) and CLIN descriptions. SOW revisions are in paragraphs 1.1 (hours of operation); 1.2 (site visits), 1.35 (training); 1.4 (quality controls); 2.5 (differential); 2.7 (surface "plots" vice "plats"); and 3.1 (Reagents). See attached revised SOW. CLIN descriptions for 0001, 1001, 2001, 3001 and 4001 have been revised to include training.

2. All other terms and conditions remain the same.

3. See Summary of Changes for details.

1. CONTRACT ID CODE PAGE OF PAGES

J 1 9

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

16C. DATE SIGNED

BY 26-Jun-2019

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 W91YTZ19Q0296

X 9B. DATED (SEE ITEM 11)

19-Jun-2019

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, 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 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

25-Jun-2019

CODE

W40M RHCO-ATLANTIC USAHCA

NORTHERN REG CONTR OFC NRCO

6021 5TH ST BLDG 1467

FORT BELVOIR VA 22060-5580

W91YTZ 7. ADMINISTERED BY (If other than item 6)

4. REQUISITION/PURCHASE REQ. NO.

CODE W91YTZ

FACILITY CODECODE

EMAIL:TEL:

W91YTZ19Q0296

SECTION SF 30 BLOCK 14 CONTINUATION PAGE

SUMMARY OF CHANGES

SECTION SF 1449 - CONTINUATION SHEET

SUPPLIES OR SERVICES AND PRICES

CLIN 0001

The CLIN extended description has changed from:

The contractor shall provide all reagents, supplies, consumables, and maintenance for a Cost per Test lease of a hematology analyzer located at McDonald Army Health Center, Fort Eustis VA in accordance with the attached Statement of Work. Base Year POP: 1 October 2019 to 30 September 2020.

To:

The contractor shall provide all reagents, supplies, consumables, travel/training and maintenance for a Cost per Test lease of a hematology analyzer located at McDonald Army Health Center, Fort Eustis VA in accordance with the attached Statement of Work. Base Year POP: 1 October 2019 to 30 September 2020.

CLIN 1001

The contractor shall provide all reagents, supplies, consumables, and maintenance for a Cost per Test lease of a hematology analyzer located at McDonald Army Health Center, Fort Eustis VA in accordance with the attached Statement of Work. Option Year 1 POP: 1 October 2020 to 30 September 2021.

The contractor shall provide all reagents, supplies, consumables, travel/training and maintenance for a Cost per Test lease of a hematology analyzer located at McDonald Army Health Center, Fort Eustis VA in accordance with the attached Statement of Work. Option Year 1 POP: 1 October 2020 to 30 September 2021.

CLIN 2001

The contractor shall provide all reagents, supplies, consumables, and maintenance for a Cost per Test lease of a hematology analyzer located at McDonald Army Health Center, Fort Eustis VA in accordance with the attached Statement of Work. Option Year 2 POP: 1 October 2021 to 30 September 2022.

The contractor shall provide all reagents, supplies, consumables, travel/training and maintenance for a Cost per Test lease of a hematology analyzer located at McDonald Army Health Center, Fort Eustis VA in accordance with the attached Statement of Work. Option Year 2 POP: 1 October 2021 to 30 September 2022.

CLIN 3001

The contractor shall provide all reagents, supplies, consumables, and maintenance for a Cost per Test lease of a hematology analyzer located at McDonald Army Health Center, Fort Eustis VA in accordance with the attached Statement of Work. Option Year 3 POP: 1 October 2022 to 30 September 2023.

The contractor shall provide all reagents, supplies, consumables, travel/training and maintenance for a Cost per Test lease of a hematology analyzer located at McDonald Army Health Center, Fort Eustis VA in accordance with the attached Statement of Work. Option Year 3 POP: 1 October 2022 to 30 September 2023.

CLIN 4001

The contractor shall provide all reagents, supplies, consumables, and maintenance for a Cost per Test lease of a hematology analyzer located at McDonald Army Health Center, Fort Eustis VA in accordance with the attached Statement of Work. Option Year 4 POP: 1 October 2023 to 30 September 2024.

The contractor shall provide all reagents, supplies, consumables, travel/training and maintenance for a Cost per Test lease of a hematology analyzer located at McDonald Army Health Center, Fort Eustis VA in accordance with the attached Statement of Work. Option Year 4 POP: 1 October 2023 to 30 September 2024.

The following have been modified:

STATEMENT OF WORK

HEMATOLOGY ANALYZER COST PER TEST LEASE

McDonald Army Health Center

Fort Eustis, VA

1.0 DESCRIPTION

1.1. The contractor shall provide all reagents, supplies, consumables, and maintenance for a Cost per Test lease of a hematology analyzer located at McDonald Army Health Center

(MCAHC), Fort Eustis VA. Hours of operation are Monday through Friday, 0700 to 1700, excluding federal holidays.

1.2 The contractor must conduct a site visit to the MCAHC Department of Pathology, Building 576, 1st Floor, for the purpose of surveying and assessing current laboratory set-up, laboratory environmental control, and available utilities with regard to placement of their instrument in the laboratory. Any changes to the layout of the laboratory, environmental control, or to utilities as currently in existence to accommodate placement of their proposed instrument must be identified in the Contractor's proposal/quote (i.e., must identify all site preparation requirements necessary for potential placement of their instrument in the laboratory). Site visits shall be coordinated with Heidi Holley, Contract Specialist, via email at heidi.n.holley.civ@mail.mil.

1.3. The contractor shall provide on-site technical support for installation of the analyzer to bring the system to a fully operational status at MCAHC.

1.4. Method Validation will include, but not be limited to, normal range verification, demonstration of linearity with establishment of limits of quantitation (reportable range), correlation with current method (comparison of method study), validation of analytical measurement range (AMR), validation of precision (replication study) and accuracy (recovery study), and establishment of initial control ranges using contractor supplied controls. All reagents, calibrators and linearity materials will be provided by the contractor. Quality control will be done once per shift or every 8 hours if recommended by the manufacturer, 3 levels.

1.5. The Contractor will provide two (2) paper and two (2) CD copies of the Operator's and Maintenance manuals and a statement of the warranty terms in the English language.

1.6. The analyzer system must be capable of interfacing with the military hospital computer system, i.e., the Composite Health Care System (CHCS) and MHS Genesis. The Contractor must have an established driver compatible for interfacing the analyzer with the CHCS and MHS Genesis and will be able to Recognize CHCS generated bar-code labels (code 128) on primary sample tubes. The interface between the LIS and the analyzer must be bi-directional. See Attachment 1, Army Cybersecurity-RMF Requirements.

1.7. The analyzer will have a Data Management system that provides on-line Levy-Jennings graphs and applies Westgard Quality Control Rules as selected by the user and delta checks. Also required is a large capacity to store graphics and results, cumulative patient reports and quality control files with statistics - all available to user; capable of downloading the QC data to a disk which can then be used to submit the file for analysis against a QC peer group.

1.8. The Contractor shall provide material safety data sheets (MSDS) for each item delivered under this contract that is considered to be HAZARDOUS MATERIAL by the United States or the Contractor's representative government.

The MSDS shall contain information on the hazards associated with each specific chemical or material. The MSDS shall be printed in the English language and shall contain, as a minimum, the following information: identification of the hazardous material and the specific hazard, the required practices for the safe use of the product, first aid procedures, and what to do in the event of a spill or other mishap or accident.

1.9. The Contractor shall provide a water system (e.g. filtered, deionized etc.), if required by the analyzer, that will provide uninterrupted service for a minimum of three (3) days of operation.

1.10. The Contractor shall provide the reagents as outlined below. Delivery of the reagents will be done by a schedule approved by MCAHC.

1.11. The contractor shall be responsible for the collection and transportation of equipment upon termination of lease period.

1.12. The completion of the initial correlation validation studies to include the completion of the Heparin Curve.

1.13. The contractor shall provide all personnel, equipment, tools, supervision and other items necessary to maintain leased equipment.

1.14. The contractor's representative shall perform preventive maintenance inspections (PMI), calibrations and unscheduled repair services in accordance with procedures and practices prescribed by the manufacturer of the equipment.

1.15. The contractor shall maintain the leased equipment in proper operating condition as described in the manufacturer's literature. The contractor shall provide: One safety test and preventive maintenance service to be performed every six months and all unscheduled routine and all emergency services as required. The scheduled preventive maintenance shall include written documentation of servicing, cleaning, lubrication, adjustments, and operational tests in accordance with manufacturer's specification and all applicable government and Army regulations.

1.16. Preventive maintenance shall include the exchange of defective parts and modules, a complete inspection, cleaning, and preventive maintenance of the unit, the exchange of missing or defective covers, lamps, and keys, an inspection or repair of cables, plugs, and wiring, a thorough function test of the input- and safety circuits, checking the topicality of the operator manuals, and information and training of new personnel. The safety inspection shall include a mechanical check (examination of the casing, the readings, user interfaces, connections, cables, labeling, soiling which would affect safety, etc.), a function test, as services include written documentation of servicing, cleaning, lubrication, adjustments, operational tests, and calibration/verification in accordance with the manufacturer's specifications and all applicable U.S. government and Army regulations.

1.17. The preventive maintenance inspection shall include, but is not limited to safety, complete operational testing, lubrication, adjustments, and cleaning of equipment to which the operator does not have access. This also includes the installation of all non-operator parts required to ensure proper operation.

1.18. All preventive maintenance inspections/verifications/calibrations shall be performed in accordance with the manufacture's service manual, which will be located with the equipment, or provided by the contractor.

1.19. Safety testing shall be performed in accordance with NFPA 99, Chapter 7. This regulation can be reviewed in full text at the Medical Maintenance Division.

1.20. Prior to performing work the contractor's representative shall report to the Medical Maintenance Division (Building 576). Repairs that cannot be performed at the Government site may be performed at the contractor's site provided the COR approves removal of the equipment. The contractor's representative shall sign a receipt for the equipment. The repaired equipment shall be returned to the original premises within two (2) working days, or the contractor shall provide a temporary replacement at no additional cost to the government.

1.21. The contractor shall notify the COR (Contracting Officer Representative) of the exact date and time within ten

(10) days prior to the scheduled preventive maintenance services.

1.22. All unscheduled repairs shall be verified by a MER (Medical Equipment Repairer) prior to notification of the contractor by the COR.

1.23. The contractor shall respond to unscheduled repair service calls from the COR telephonically within two hours, Monday through Friday between the hours of 0800 and 1630 excluding local national holidays. Unscheduled repair service calls shall be accepted only from the COR.

1.24. Completion of Unscheduled Repairs. The contractor's technician must be on site and commence repair services within 24 hours.

1.25. In accordance with MEDCOM directives and extracted from TB 38-750-2, the contractor performing the calibration, verification, or certification (CVC) action will complete a Field Service report within 24 hours of completion of services.

1.26. The Field Service Report entries will be legibly made with a blue, blue-black, or black ballpoint pen. It is acceptable for the report to be e-mailed also. The following information must be included:

1 ID NUMBER. Enter the ID number of the equipment assigned by the government.

2 MODEL NO. Enter the model number of the equipment as assigned by the manufacturer.

3 SERIAL NUMBER. Enter the serial number assigned to the equipment by the manufacturer.

4 AUTHORITY. Enter the authority authorizing the CVC. If unsure of the authorizing authority, seek guidance from Clinical Engineering Branch personal.

UIC. Enter the name of the company with whom the contractor is affiliated.

CERTIFIED BY. Enter the initials of the person performing the CVC.

DATE COMPLETE. Enter the calendar date (MMM/YY) on which the CVC was completed.

DATE DUE. Enter the calendar date (MMMNY) on which the next CVC procedure is due.

1.27. System damage due to non-performance of routine maintenance procedures or improper handling by the customer is not covered by the contract unless it is modified to include such repairs. Accessories and manuals are not covered under the contract. If the contractor finds that damage is due to improper handling or non-performance of routine maintenance procedures, the contractor's representative shall within one (1) working day report the extent of the damage and submit a cost estimate for the repair work to the Contracting Officer. The repair shall not be performed without a written modification to this contract or a purchase order authorizing such repair. The Contracting Officer Representative (COR) will review the estimate and submit a separate repair request (as processed to include the funding) to the Contracting Officer, in order that the contract can be modified or another purchase order issued to authorize such repair. If these types of repairs are performed without the prior approval of the Contracting Officer; the contractor shall not be paid by the U.S. government.

1.28. The contractor shall only accept calls for service/repairs from the COR.

1.29. Prior to, and upon completion of any scheduled or unscheduled service, the contractor service representative must report to the COR at.

Army Health Clinic Laboratory Bldg.576 Fort Eustis, Virginia 23604 Tel. (757)3147972

1.30. On the day of services (scheduled and/or unscheduled) are completed, the contractor's service technician shall prepare and initial, legible service report, and present it to the COR. This report shall include the following information:

Services performed What systems or components failed (reason for call) Start date/time and end date/time Name of service technician Numbers, quantities, and prices of replaced parts Travel time Repair time Travel, repair and parts cost

1.31. In the event that all the necessary information is not available to the service technician at the time of completion of service, the initial service report shall include all information available. The contractor shall provide/fax the remainder of the required information to:

Attn: Contracting Officer Representative Hematology Analyzer Cost per Test Lease McDonald Army Health Clinic Building 576 Fort Eustis, Virginia 23604 Fax: 757-314-7836

1.32. Receipt of services will be acknowledged after receipt of all complete service reports for any scheduled calibration, preventive maintenance and unscheduled routine and emergency services performed during the respective quarter. Receiving reports will not be prepared and submitted until all such completed service reports containing all required information are in the possession of the COR.

1.33. All replacement parts shall be certified, new and have the same material as the original part. The original design of the equipment shall not be changed, modified or the required functional capacities altered. Certified parts are parts that comply with the standards set forth in 21 CFR 1020.30 (applicable to radiation producing equipment only), installation in medical equipment. This regulation can be reviewed in full context at the Medical Maintenance Division.

1.34. In place of new parts, factory refurbished exchange parts as per spare parts policies and procedures may be used. The contractor's representative shall inform the COR and request his / her approval prior of the use of a refurbished part.

1.35. The contractor will provide advanced training on the equipment off-site at no additional cost to the government, to include travel, lodging, meals, and tuition, for one technician per analyzer per fiscal year.

SALIENT CHARACTERISTICS

2.0 ANALYZER

2.1 The analyzer must provide all required Hematology test menu capabilities on the same individual instrument platform. Additionally, each analyzer system must include a data management system for control of the operation of the analyzer system, management of the quality control program, and management of patient results; and a printer for the production of hard copy patient reports and other reports generated via the analyzer system's data management system. The data management system's quality control program must include the ability to apply Westgard quality control result decision rules in real-time, with the ability of the user to individually select the rules to be applied.

2.2 The analyzer system will provide users with rapid, reliable test results that are critical for patient care. The analyzer system must be capable of performing in low, medium, and high volume work periods to produce results that are accurate and precise throughout the manufacturer's stated linearity.

2.3 The system will come equipped to perform continuous, random and statistical analysis; capable of real time or (on-line) Quality Control. Provide QC assessment with comparison to a peer group on a daily, weekly, and monthly basis, to include QC Lot#s, means, ranges, SD, and %CVs. Changing or modifying existing QC parameters can be performed during instrument operation (e.g. “on-the-fly”).

2.4 The system must have positive patient identification via on-board barcode scanner.

2.5 The system must have a five part differential that includes neutrophils, lymphocytes, monocytes, eosinophils, basophils, with the capability to detect immature granulocytes, and cell-by-cell analyses; reportable range from 0 to

300 Thousand cells/uL and indicators of white cell viability; in absolute and percentage numbers. The accuracy of the automated differential as compared to manual differentials will be no less than the accuracy of the current system.

2.6 The system must be able to determine hemolysis, icterus, and turbidity levels without additional patient sample, reagents, consumables, and no effect on throughput. It must flag only assays affected by the interferent. It must send flags and levels to the LIS or data management system.

2.7 The system will provide surface plots to review WBC differential populations, NRBC and Retic populations.

2.8 The system must be capable of performing automatic NRBC differential and automatic correction of the white blood cell count, and capable of enumerating Nucleated Red Blood Cells (NRBCs) accurately without the need for additional on board reagents.

2.9 All analyzer/data management system displays and supporting literature must be in the English language.

2.10 The analyzer systems must come equipped with an un-interruptible power supply capable of providing all necessary electrical power to each analyzer system, to include the data management system, for 15 to 20 minutes.

2.11 The analyzer systems and all reagents shall be FDA approved. The analyzer and associated parts and accessories will be new. No used, refurbished, or like-new equipment will be provided in support of this contract at any time.

2.12 The analyzer must be held on a cart or similar standalone framework that also houses reagents underneath. The footprint of the cart should not exceed 5’ x 3.’

3.0 REAGENTS

3.1. The Contractor shall provide an estimate of the yearly quantities of reagent, calibrators/standards, and quality control materials required to perform the volume of tests for each assay as outlined in the supplied quote of Hematology Annual Tests. The Contractor will ensure that requirements for routine quality control runs (as defined by MCAHC QA program), routine calibration, periodic calibration/ calibration verification, and for troubleshooting of out-of-control assays be considered when calculating the yearly requirements. The Contractor will also estimate the volume of user-replaceable maintenance items that will be required to support the analyzer, and any analyzer specific tools/supplies necessary to perform operator-level periodic maintenance tasks, at the level of use specified.

ANNUAL TESTING VOLUME

CBC’s WITH DIFF 17,500

RETICS 1,500

3.2 The manufacturer will sequester the required quality control materials and test reagents and ensure that no more than one lot change occurs every 12 months.

3.3 Be provided by the manufacturer of the equipment.

3.4 Be marked with the required storage temperature.

3.5 Be maintained at the proper storage temperature during transportation from the Contractor's storage facility to the Government acceptance site and be delivered on time at the appropriate storage temperature.

3.6 The Contractor shall provide the reagents, calibrators/standards, quality control materials, user-replaceable maintenance items, and analyzer specific tools/supplies as required.

3.7 Deliveries of required items will be per monthly periodic orders called in to the Contractor by the designated Contracting Officer's Representative or others as identified in the contract. Orders will arrive within one week of requested date of delivery and have a shelf life of 3 months.

3.8 Emergency orders will be delivered within 24 hours after the order is placed and be of the same lot number of calibrators/standards, reagents/reagent packs, or quality control materials currently in use for the assay(s) for which supplies are being requested.

3.9 Preservation and packing - preservation and packing shall be performed in accordance with the best commercial practice and in such a manner to afford adequate protection against any damage during shipment from source to destination.

CONTRACTOR MANPOWER REPORT

4.0. Contractor Manpower Reporting (CMR). ACCOUNTING FOR CONTRACT SERVICES The Office of the Assistant Secretary of the Army (Manpower and Reserve Affairs) operates and maintains a secure Army data collection site where the contractor will report ALL contractor manpower (including subcontractor manpower) required for performance of this contract. The contractor is required to completely fill in all the information in the format using the following web address https://cmra.army.mil. The required information includes: (1) Contracting Office, Contracting Officer, Contracting Officer’s Technical Representative (COTR); (2) contract number, including task and delivery order number; (3) Beginning and ending dates covered by reporting period; (4) Contractor name, address, phone number, e-mail address, identity of contractor employee entering data; (5) Estimated direct labor hours (including sub-contractor); (6) Estimated direct labor dollars paid this reporting period (including sub-contractor); (7) Total payments (including sub-contractor); (8) Predominant Federal Service Code (FSC) reflecting services provided by contractor (and separate predominant FSC for each sub-contractor if different); (9) Estimated data collection cost; (10) Organizational title associated with the Unit Identification Code (UIC) for the Army Requiring Activity (the Army Requiring Activity is responsible for providing the contractor with its UIC for the purpose of reporting this information; (11) Locations where contractor and subcontractors perform the work (specified by zip code in the United States and nearest city, country, when in an overseas location, using Standardized nomenclature provided on website); (12) Presence of deployment or contingency contract language;

and (13) Number of contractor and sub-contractor employees deployed in theater this reporting period (by country).

As part of its submission, the contractor will also provide the estimated total cost (if any) incurred to comply with this reporting requirement. Reporting period will be the period of performance not the exceed 12 months ending September 30 of each government fiscal year and shall be reported by 31 October of each calendar year.

Contractors may use a direct XML data transfer to the database server or fill in the fields on the website. The XML direct transfer is a format for transferring files from a contractor’s systems to the secure website without the need for separate data entries for each required data element at the website. The specific formats for the XML direct transfer may be downloaded from the website.

(End of Summary of Changes)