A.09.03_W81K0218Q0007.pdf

W81K0218Q0007

SEE ADDENDUM

(No Collect Calls)

W81K0218Q0007 17-Aug-2018

b. TELEPHONE NUMBER

808-438-5105

8. OFFER DUE DATE/LOCAL TIME

10:00 AM 31 Aug 2018

5. SOLICITATION NUMBER 6. SOLICITATION ISSUE DATE

AUTHORIZED FOR LOCAL REPRODUCTION

PREVIOUS EDITION IS NOT USABLE

STANDARD FORM 1449 (REV. 2/2012)

Prescribed by GSA – FAR (48 CFR) 53.212

(TYPE OR PRINT)

(SIGNATURE OF CONTRACTING OFFICER)

ADDENDA X ARE

26. TOTAL AWARD AMOUNT (For Gov t. Use Only )

23.

CODE 10. THIS ACQUISITION IS

SUCH ADDRESS IN OFFER

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT

BELOW IS CHECKED

TELEPHONE NO.

W81K029. ISSUED BY

18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a. UNLESS BLOCK

7. FOR SOLICITATION

INFORMATION CALL:

a. NAME

TAE H. KIM

2. CONTRACT NO. 3. AWARD/EFFECTIVE DATE 4. ORDER NUMBER

(TYPE OR PRINT)

30b. NAME AND TITLE OF SIGNER 30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER

30a. SIGNATURE OF OFFEROR/CONTRACTOR 31a.UNITED STATES OF AMERICA

1 27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1. 52.212-4. FAR 52.212-3. 52.212-5 ARE ATTACHED.X

25. ACCOUNTING AND APPROPRIATION DATA

1. REQUISITION NUMBER

20.

ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED.

OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, AND 30

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

0011171882

ARE NOT ATTACHED

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA ARE ARE NOT ATTACHED

(BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE

SET FORTH HEREIN, IS ACCEPTED AS TO ITEMS:

. YOUR OFFER ON SOLICITATION

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN

% FOR:SET ASIDE:UNRESTRICTED ORX

SMALL BUSINESS

17a.CONTRACTOR/ CODE FACILITY

OFFEROR CODE

W40M REGIONAL HEALTH CONTRACTING OF

US MEDCOM HCAA JBLM HCC

POC: LEON SMITH

673 WOODLAND SQUARE LOOP SE, SUITE 101

LACEY WA 98503-1066

18a. PAYMENT WILL BE MADE BY CODE

RATED ORDER UNDER

DPAS (15 CFR 700)

13a. THIS CONTRACT IS A

13b. RATING

CODE15. DELIVER TO CODE W81C4T 16. ADMINISTERED BY

12. DISCOUNT TERMS11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

14. METHOD OF SOLICITATION

RFQ IFB RFPX

W0EE USA MEDDAC ALASKA

W0EE USA MEDDAC ALASKA

BLDG 3567 NEELY ROAD

USA MED DEPT ACTV IMSA

FORT WAINWRIGHT AK 99703-7490

TEL: 210-221-7928 FAX:

FAX:

TEL: 360-486-9800 SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

8(A)

HUBZONE SMALL

BUSINESS

SIZE STANDARD:

1,000

NAICS:

334516

OFFER DATED

29. AWARD OF CONTRACT: REF.

DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND

EMAIL:

TEL:

31c. DATE SIGNED

SEE SCHEDULE

SCHEDULE OF SUPPLIES/ SERVICESITEM NO. QUANTITY UNIT UNIT PRICE AMOUNT

24.22.21.19.

WOMEN-OWNED SMALL BUSINESS (WOSB)

ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

32g. E-MAIL OF AUTHORIZED GOVERNMENT REPRESENTATIVE

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

(CONTINUED)

PAGE 2 OF69

ACCEPTED, AND CONFORMS TO THE CONTRACT, EXCEPT AS NOTED: ______________________________________________________

32a. QUANTITY IN COLUMN 21 HAS BEEN

RECEIVED INSPECTED

32b. SIGNATURE OF AUTHORIZED GOVERNMENT

REPRESENTATIVE

32c. DATE 32d. PRINTED NAME AND TITLE OF AUTHORIZED GOVERNMENT

REPRESENTATIVE

32e. MAILING ADDRESS OF AUTHORIZED GOVERNMENT REPRESENTATIVE 32f . TELEPHONE NUMBER OF AUTHORIZED GOVERNMENT REPRESENTATIVE

37. CHECK NUMBER

FINALPARTIALCOMPLETE

36. PAYMENT35. AMOUNT VERIFIED

CORRECT FOR

34. VOUCHER NUMBER

FINAL

33. SHIP NUMBER

PARTIAL

38. S/R ACCOUNT NUMBER 39. S/R VOUCHER NUMBER 40. PAID BY

41a. I CERTIFY THIS ACCOUNT IS CORRECT AND PROPER FOR PAYMENT

41b. SIGNATURE AND TITLE OF CERTIFYING OFFICER 41c. DATE

42a. RECEIVED BY (Print)

42b. RECEIVED AT (Location)

42c. DATE REC'D (YY/MM/DD) 42d. TOTAL CONTAINERS

STANDARD FORM 1449 (REV. 2/2012) BACK

Prescribed by GSA – FAR (48 CFR) 53.212

AUTHORIZED FOR LOCAL REPRODUCTION

PREVIOUS EDITION IS NOT USABLE

SEE SCHEDULE

20.

SCHEDULE OF SUPPLIES/ SERVICES

21.

QUANTITY UNIT

22. 23.

UNIT PRICE

24.

AMOUNT

19.

ITEM NO.

Section SF 1449 - CONTINUATION SHEET

ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

0001 12 Months

HEMATOLOGY ANALYZER & REAGENTS

FFP

Base Period: 01 October 2018 - 30 September 2019

* SUBJECT TO AVAILABILITY OF FY19 FUNDS *

Reference Attachment for Salient characteristics for analyzer and reagents.

** Price to include Analyzer and Reagents **

Coordinate Deliveries with Mr. Timothy Moore, 907-361-7440

FOB: Destination

NSN: HHEMOTOLOGYFY

MFR PART NR: NA

VENDOR PART NR: NA

PURCHASE REQUEST NUMBER: 0011171882

PSC CD: 6640

NET AMT

1001 12 Months

OPTION HEMATOLOGY ANALYZER & REAGENTS

FFP

1st Option Period: 01 October 2019 - 30 September 2020

Reference Attachment for Salient characteristics for analyzer and reagents.

** Price to include Analyzer and Reagents **

Coordinate Deliveries with Mr. Timothy Moore, 907-361-7440

FOB: Destination

NSN: HHEMOTOLOGYFY

MFR PART NR: NA

VENDOR PART NR: NA

2001 12 Months

OPTION HEMATOLOGY ANALYZER & REAGENTS

FFP

2nd Option Period: 01 October 2020 - 30 September 2021

Reference Attachment for Salient characteristics for analyzer and reagents.

** Price to include Analyzer and Reagents **

Coordinate Deliveries with Mr. Timothy Moore, 907-361-7440

FOB: Destination

NSN: HHEMOTOLOGYFY

MFR PART NR: NA

3001 12 Months

OPTION HEMATOLOGY ANALYZER & REAGENTS

FFP

3rd Option Period: 01 October 2021 - 30 September 2022

Reference Attachment for Salient characteristics for analyzer and reagents.

** Price to include Analyzer and Reagents **

Coordinate Deliveries with Mr. Timothy Moore, 907-361-7440

FOB: Destination

NSN: HHEMOTOLOGYFY

MFR PART NR: NA

4001 12 Months

OPTION HEMATOLOGY ANALYZER & REAGENTS

FFP

4th Option Period: 01 October 2022 - 30 September 2023

Reference Attachment for Salient characteristics for analyzer and reagents.

** Price to include Analyzer and Reagents **

Coordinate Deliveries with Mr. Timothy Moore, 907-361-7440

FOB: Destination

NSN: HHEMOTOLOGYFY

MFR PART NR: NA

INSPECTION AND ACCEPTANCE TERMS

Supplies/services will be inspected/accepted at:

CLIN INSPECT AT INSPECT BY ACCEPT AT ACCEPT BY

0001 Destination Government Destination Government 1001 Destination Government Destination Government 2001 Destination Government Destination Government 3001 Destination Government Destination Government 4001 Destination Government Destination Government

DELIVERY INFORMATION

CLIN DELIVERY DATE QUANTITY SHIP TO ADDRESS DODAAC /

CAGE

0001 POP 01-OCT-2018 TO

30-SEP-2019

N/A W0EE USA MEDDAC ALASKA

W0EE USA MEDDAC ALASKA

BLDG 3567 NEELY ROAD

USA MED DEPT ACTV IMSA

FORT WAINWRIGHT AK 99703-7490

210-221-7928 FOB: Destination

W81C4T

1001 POP 01-OCT-2019 TO

30-SEP-2020

N/A (SAME AS PREVIOUS LOCATION)

2001 POP 01-OCT-2020 TO

30-SEP-2021

N/A (SAME AS PREVIOUS LOCATION)

3001 POP 01-OCT-2021 TO

30-SEP-2022

N/A (SAME AS PREVIOUS LOCATION)

4001 POP 01-OCT-2022 TO

30-SEP-2023

N/A (SAME AS PREVIOUS LOCATION)

ATTACHMENT

Salient Characteristics

The Contractor shall provide one (1) fully automated, discrete random access hematology analyzer capable of providing a complete blood count (CBC) and all of the required assays as listed in Table 1. The entire analyzer system shall be serviced and supplied through a single Contractor (to whom the contract is awarded), including any parts, equipment, or supplies not manufactured, provided or serviced by the Contractor. The system shall provide redundancy (to ensure continuous operations). The Contractor shall provide the system, training, supplies, reagents, unscheduled maintenance, and preventive maintenance for the system. All equipment displays and supporting literature shall be in the English language. Contractor shall include delivery, installation, all calibrators/standards, reagents/reagent packs, and quality control materials necessary to perform the specified assays, initial Method Validations per the Clinical Laboratory Standards Institute (CLSI) guidelines and the DPALS Quality Manual (QM). The Contractor shall also provide analyzer removal at the termination of the contract. All costs shall be calculated on a cost per patient reportable or patient billable basis based on the number of patients listed for each Mandatory Test listed on Appendix 1.

Costs shall be amortized over the total number of tests described in this SOW and factored into the cost per reportable or patient billable.

Table 1.

Required Tests (CBC) Units Other Required Tests Units

White Blood Cells (WBC) #/µL Reticulocytes #/µL Red Blood Cells (RBC) #/µL Reticulocyte % %

Platelets (PLT) #/µL Nucleated Red Blood Cells (NRBC) #/µL

Hemoglobin (HGB) g/dL

Hematocrit (HCT) %

Mean Corpuscular Hemoglobin pg

(MCH)

Mean Corpuscular Volume (MCV) fL

Mean Corpuscular Hemoglobin g/dLL

Concentration (MCHC)

Mean Platelet Volume (MPV) fL

Red Cell Distribution Width (RDW) %

Lymphocytes Number (LYMPH #) #

Lymphocyte Percentage (LYMPH %) %

Monocytes Number (MONO #) #

Monocytes Percentage (MONO %) %

Neutrophils Number (NEUT #) #

Neutrophils Percentage (NEUT %) %

Eosinophils Number (EOS #) #

Eosinophils Percentage (EOS %) %

Basophil Number (BASO #) #

Basophil Percentage (BASO %) %

The analyzer system shall include at a minimum:

Any and all analyzers Peripherals (e.g. Uninterruptable Power Sources (UPS), instrument specific computer terminals and CPUs, etc.)

Robotics/Automation System expansion capability Integrated automated digital cell morphology analyzer Pedestal (floor stand) capable of supporting the complete analyzer system.

The analyzer system will be located at:

Bassett Army Community Hospital 4076 Neely Road Ft. Wainwright, Alaska 99703

Within 10 working days after contract award, Contractor shall coordinate and conduct a post award site visit for the purpose of coordinating schedule for equipment installation.

Method Validation shall be conducted in accordance with method validation protocols established by the Department of Pathology’s Quality Management Program (these protocols are in concordance with applicable standards as described by the Clinical Laboratory Standards Institute (CLSI) and/or required by the College of American Pathologists (CAP)).

Relevant guidelines listed in Appendix 2 (below) are the minimum guidelines that shall be referenced when conducting method validation. Additional guidelines may be required, depending on regulatory requirements.

Method Validation shall include but not be limited to, normal range verification, demonstration of linearity, reportable range, correlation with current methods (comparison of methods study), validation of precision (replication study) and accuracy (recovery study), and establishment of initial control ranges using control materials, to include third party controls, as designated by the Laboratory Director.

The Method Validation shall be completed and approved by the Laboratory Director prior to reporting of patient results. Payment for services shall not begin until the analyzer system has been approved for reporting of patient results.

The Contractor shall provide a qualified Technical Service Representative, who possesses a thorough knowledge of method validation and is familiar with the use of statistical evaluation software as determined by the Laboratory Director (e.g. EP Evaluator®), to provide technical assistance for the method validation studies. The assigned Technical Service Representative shall be responsible for the entire Method Validation.

All reagents, calibrators and linearity materials used in the Method Validation Study shall be provided by the Contractor at no additional cost to the Government. These materials shall not be used in the analysis of specimens for patient care.

The Government’s Technical Supervisor shall obtain patient specimens for use in the Method Validation. In the event that specimen requirements for correlation studies cannot be met (e.g., insufficient number of patients to challenge the extremes of a curve), the Contractor shall assist in procuring additional specimens. These specimens may be obtained from other laboratories or from Contractor sources.

Both the Contractor and Contractor personnel at each location shall abide by all Health Insurance Portability & Accountability Act of 1996 (HIPAA) rules and regulations when conducting the Method Validation Study.

The Contractor shall 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. The level of detail required of appropriate instrument maintenance manuals extends only to routine maintenance procedures performed by the user. All instrumentation specified is non- Government owned leased equipment that is serviced and maintained by the Contractor.

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, identification of:

- The hazardous material

- The specific hazard

- The required practices for the safe use of the product

- First aid procedures

- What to do in the event of a spill or other mishap or accident.

The Contractor shall provide a water system (e.g. filtered, deionized etc.), IF required by the proposed analyzer.

The Contractor shall provide the reagents and shall coordinate exact quantities and shipment schedule with the government personnel prior to shipment IAW Deliveries (below).

The Contractor shall be responsible for the collection and transportation of equipment upon termination of the contract.

ANALYZERS:

Individual analyzers shall have fully automated, discrete random access capabilities within the same instrument.

There shall be a single point of specimen entry for the routine analysis of all required tests. There shall be an optional for priority analysis of STAT specimens.

The instruments provided shall be capable of the following:

The system shall 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”).

Five Part Differential that includes neutrophils, lymphocytes, monocytes, eosinophil and basophils, cell-by-cell analyses; reportable range from 0 to 300 Thousand cells/uL and indicators of white cell viability; in absolute and percentage numbers. With accuracy and precision listed in Table 2.

Table 2

Linearity Precision

Neutrophil × 103 µL ≤ 8.0 % Lymphocyte × 103 µL ≤ 8.0 %

Monocyte × 103 µL ≤ 8.0 %

Specimen analysis shall provide a technology with demonstrated performance that corrects for interfering substances, such as: NRBCs, platelet aggregation, cold agglutinins, fragmented RBC's, extreme sickle cell, ABN RBC fragility, spherocytosis, leukocytosis (>100,000/µL), bilirubin > 30 mg/dL, and lyse resistant RBC's.

Sample size is less than 200 µL (preferred = 175 µL) in all modes with a maximum dead volume of 500 µL.

The analyzer system shall have an interface that is compatible to the government system (CHCS) and shall be able to Recognize CHCS generated bar-code labels (code 128) on primary sample tubes.

Hemoglobin shall be determined by direct spectrophotometric analysis.

Shall provide for the direct measure of individual leukocyte population (vs. calculated parameters) and analyze leukocytes in their near-native state so as not too physically or biochemically alter their morphology.

Routine “hands-on” maintenance shall be minimized; no “hands-on” maintenance is preferred.

Shall provide surface plots to review WBC differential populations, NRBC and Retic populations.

Shall prepare microscope slides automatically or flags problems for slide prep.

Shall 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

The analyzer system shall provide users with rapid, reliable test results that are critical for patient care. The analyzer system shall 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/analytic measurement range.

Minimum actual through-put shall be 100 whole blood counts per hour, and 50 reticulocyte counts per hour with both open mode (manual sampling) and closed mode sampling to include micro-sampling for “pedi-tubes” used for NICU patients.

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

Initial startup from the shutdown state shall not exceed 20 minutes.

Each analyzer system shall come equipped with an un-interruptible power supply (UPS) capable of providing all necessary electrical power to each analyzer system, to include the data management system for 15 to 20 minutes.

The analyzer systems and all reagents shall be approved by the Food & Drug Administration (FDA). All analyzers and associated parts and accessories shall be new. No used, refurbished, or like-new equipment shall be provided in support of this contract at any time.

Shall be capable of handling 75mm X 13mm or 100mm X 13mm standard or Hemaguard (or equivalent) test tubes in the open or closed mode in a single cassette.

Shall have FDA Clearance on Body Fluids for serous (including pleural, peritoneal and pericardial), synovial (pretreated with hyaluronidase), and cerebrospinal fluid (CSF).

Shall be able to provide platelet count by size, impedance, and/or alternate method, auto-verification of results at critical ranges and reportable range from 0 to 3 million cells/uL. Mean platelet volume (MPV). Capable of determining platelet clumping, enlarged platelets, and can differentiate between a large platelet and small red blood cell without a manual differential to confirm.

REAGENTS:

The analyzer shall have the on-board ability to maintain reagents at the proper storage temperatures for the assays listed in Appendix 1.

The workload listed in Appendix 1 is an estimate based on projected patient workload. Actual workload may vary. The workload numbers represent patient reportable results, and do not include calibrators, controls, or re-runs due troubleshooting.

The actual workload may fluctuate in the first year of the contract due to changes in the distribution of patient care. In addition, workload may expand in subsequent option years due to fluctuations in patient volume, and with the inclusion of other locations within the USA MEDDAC-AK. Appendix 1 provides the estimated workload for Contract Year 1 as well as an estimated workload for each option year. All workload numbers represent total estimated patient reportable/billable results for the indicated year.

To account for expected fluctuations in workload, the Contractor shall provide a “volume discount” based on exceeding the planned patient load each period of performance. As workload increases, the cost per reportable patient result should decrease. The workload shall be based on the total number of patient reportable results covered under the provisions of this SOW.

The Contractor shall provide an estimate of the yearly quantities of reagent/reagent packs, calibrators/standards, and quality control materials required to perform the volume of patient reportable tests for each assay as provided in Appendix 1.

The Contractor shall provide quality control materials IAW requirements outlined in the Laboratory QA program and approved by the Laboratory Director. This includes third-party controls where requested/required by the laboratory.

The Contractor shall ensure that requirements for routine quality control runs (as defined by the Laboratory Director and outlined in the Laboratory QA program), routine calibration, and periodic calibration/calibration verification (i.e., each assay must be calibrated or have calibration verification performed at intervals not to exceed a 6-month period of time), and for troubleshooting of out-of-control assays be considered when calculating the yearly requirements.

The Contractor shall estimate the volume of user-replaceable maintenance items that shall 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 in Appendix 1. An operator level maintenance tool/spare parts kit shall be provided and replenishment of all expended items shall be made by the contractor, at no additional cost to the Government. Replenishment shall be made as needed or on a periodic basis not to exceed the normal preventive maintenance cycle.

Reagents shall have a minimum shelf life of three (3) months, and controls shall have a minimum shelf life of four (4) weeks upon receipt by the Government. If this shelf life requirement cannot be met, the Contractor shall identify the guaranteed shelf life after receipt that can be accommodated in their response to the Request for Quote.

The Contractor shall sequester the required quality control materials and test reagents.

All reagents provided shall be identical to those used in the FDA 510K approval application. All reagents/reagent packs shall be provided as follows:

Shall be provided by the manufacturer of the equipment.

Shall be marked with the required storage temperature.

Shall be inclusive of an English language package inserts.

If the bulk reagents are produced overseas, they shall be manufactured in conformance with ISO or CE standards AND shall be equal to or better than the U.S. products in quality/manufacturing. Documentation of item equivalency shall be provided.

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.

Shall 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.

The Contractor shall provide the reagents/reagents packs, calibrators/standards, quality control materials, user- replaceable maintenance items, and analyzer specific tools/supplies as outlined in the Schedule of Supplies/Services.

Deliveries. Deliveries of required items shall be per monthly periodic orders called in to the Contractor by the government personnel as identified in the contract. Orders shall arrive within one week of requested date of delivery. Any supplies that are placed on back order shall be clearly identified on the shipping documents and shall be delivered in a timely manner, not to exceed ten (10) working days. In the instance a back-order exceeds 10 working days, the Contractor shall provide testing services through local sub-contract at their cost.

An alternate quality control material shall be provided by the contractor if the new lot of controls cannot be delivered two weeks prior to the expiration date of the lot currently in use.

Routine or scheduled orders shall arrive within one week before or after the scheduled date of delivery. Emergency orders shall be delivered within 24 hours after the order is placed.

Emergency orders shall 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.

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. All packaging and shipping information shall be clearly marked as to contents on both the shipping documents and the shipping container/box. All deliveries shall be made Tuesday through Thursday, to exclude Federal Holidays.

APPENDIX 1

Mandatory Tests and Estimated Patients/Year MANDATORY TESTS Estimated

Base # Patients

Estimated Option 1 # Patients

Estimated Option 2 # Patients

Estimated Option 3 # Patients

Estimated Option 4 # Patients

1 Complete Blood Counts (CBC) 14,620 15,620 16,620 17,620 18,620

2 Reticulocyte Counts 150 175 200 225 250

3 Hemoglobin/Hematocrit 14,900 15,900 16,900 17,900 18,900

4 Platelet Count 14,620 15,620 16,620 17,620 18,620

5 Nucleated Red Blood Cells (NRBC) 450 550 650 750 850

Total 44,740 47,865 50,990 54,115 57,240

APPENDIX 2 - Relevant CLSI Standards Auto-verification of Clinical Laboratory Test Results; Approved Guideline (AUTO10-A)

Body Fluid Analysis for Cellular Composition; Approved Guideline (H56-A)

Calibration and Quality Control of Automated Hematology Analyzers; Proposed Edition (H38-P)

Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline— Third Edition (C28-A3)

Determination of Serum Iron, Total Iron-Binding Capacity and Percent Transferrin Saturation; Approved Standard (H17-A)

Estimation of Total Analytical Error for Clinical Laboratory Methods; Approved Guideline (EP21-A) Evaluation of Matrix Effects; Approved Guideline—Second Edition (EP14-A2)

Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline-Second Edition

(EP05-A2)

Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach; Approved Guideline

(EP06-A)

Fetal Red Cell Detection; Approved Guideline (H52-A)

IT Security of In Vitro Diagnostic Instruments and Software Systems; Approved Standard (AUTO11-A)

Laboratory Automation: Bar Codes for Specimen Container Identification; Approved Standard (AUTO02-A2)

Laboratory Automation: Communications With Automated Clinical Laboratory Systems, Instruments, Devices, and Information Systems; Approved Standard—Second Edition (AUTO03-A2)

Laboratory Automation: Data Content for Specimen Identification; Approved Standard (AUTO07-A)

Laboratory Automation: Specimen Container/Specimen Carrier; Approved Standard (AUTO01-A)

Laboratory Automation: Systems Operational Requirements, Characteristics, and Information Elements; Approved Standard (AUTO04-A)

Laboratory Statistics — Standard Deviation; A Report (EP13-R)

Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline—Second Edition (EP09-A2) Methods for Reticulocyte Counting (Automated Blood Cell Counters, Flow Cytometry, and Supravital Dyes);

Approved Guideline—Second Edition (H44-A2)

Performance Goals for the Internal Quality Control of Multichannel Hematology Analyzers; Approved Standard (H26-A)

Preliminary Evaluation of Quantitative Clinical Laboratory Measurement Procedures; Approved Guideline-Third Edition (EP10-A3)

Procedure for Determining Packed Cell Volume by the Microhematocrit Method; Approved Standard—Third Edition (H07-A3)

Protocols for Determination of Limits of Detection and Limits of Quantitation; Approved Guideline (EP17-A)

Reference and Selected Procedures for the Quantitative Determination of Hemoglobin in Blood; Approved Standard—Third Edition (H15-A3)

Reference Leukocyte (WBC) Differential Count (Proportional) and Evaluation of Instrumental Methods; Approved Standard—Second Edition (H20-A2)

Remote Access to Clinical Laboratory Diagnostic Devices via the Internet; Approved Standard (AUTO09-A)

Risk Management Techniques to Identify and Control Laboratory Error Sources; Approved Guideline—Second Edition (EP18-A2)

Specification for Low-Level Protocol to Transfer Messages Between Clinical Laboratory Instruments and Computer Systems; Approved Standard—Second Edition (LIS01-A2)

Specification for Transferring Information Between Clinical Laboratory Instruments and Information Systems;

Approved Standard—Second Edition (LIS02-A2)

Standard Guide for Coordination of Clinical Laboratory Services within the Electronic Health Record Environment and Networked Architecture (LIS09-A)

Standard Guide for Functional Requirements of Clinical Laboratory Information Management Systems (LIS08-A)

Standard Guide for Selection of a Clinical Laboratory Information Management System (LIS03-A)

Standard Practice for Reporting Reliability of Clinical Laboratory Information Systems (LIS06-A)

Standard Specification for Use of Bar Codes on Specimen Tube in the Clinical Laboratory (LIS07-A)

User Verification of Performance for Precision and Trueness; Approved Guideline-Second Edition (EP15-A2)

Validation, Verification, and Quality Assurance of Automated Hematology Analyzers; Proposed Standard—Second Edition (H26-P2)

CLAUSES INCORPORATED BY REFERENCE

52.212-4 Contract Terms and Conditions--Commercial Items JAN 2017

52.212-4 ADDENDUM

ADDENDUM TO 52.212-4

(w) UNILATERAL MODIFICATIONS

In addition to 52.212-4(c), the Government may make unilateral modifications considered administrative in nature.

These include, but are not limited to, changes in the accounting and appropriation data, payment and issuing office addresses, and other corrections that have no effect on the terms and conditions of the contract.

(x) The non-FAR Part 12 discretionary FAR and DFARS clauses included herein are incorporated into this contract either by reference or in full text. If incorporated by reference, see clause 52.252-2 herein for locations where full text can be found.

(y) OTSG/MEDCOM Policy Memo 13-062 Implementation.

The contractor shall comply with OTSG/MEDCOM Policy Memo 13-062, Policy for Reporting Incidents of Sexual Assault and Sexual Harassment under the Sexual Assault Prevention and Response Program (SHARP), 12 Nov 2013. The SHARP reporting requirements apply only to knowledge obtained by contractor personnel while providing the required supplies under this contract.

All contractor personnel with knowledge of an incident of sexual assault occurring on a Government facility, to include a Government leased facility, where the contractor is providing supplies under this contract shall immediately (within 24 hours) report the incident in writing to the government's contract POC. This reporting policy also applies to sexual assault incidents involving MEDCOM personnel that occur on the contractor’s owned or leased facility under this contract. All incidents shall be reported whether they involve contractor personnel or Government personnel, or other individuals, when the incidents occur on a Government facility or a Government leased facility.

All contractor personnel with knowledge of an incident of sexual harassment occurring on a Government facility, to include a Government leased facility, where the contractor is providing supplies under this contract shall immediately (within 24 hours) report the incident in writing to the government's contract POC. This reporting policy also applies to sexual harassment incidents involving MEDCOM personnel that occur on the contractor’s owned or leased facility under this contract. All incidents shall be reported whether they involve contractor personnel or Government personnel, or other individuals, when the incidents occur on a Government facility or a Government leased facility.

The contractor shall ensure contractor personnel associated with this contract receive Sexual Harassment/Assault Response and Prevention (SHARP) training not later than 60 calendar days after the effective date of this contract.

Training can be obtained either online or in person. If contract individuals have an AKO account, they can access online the Team Bound Self Study course through Army Learning Management System (ALMS) at http://www.atsc.army.mil/tadlp/delivery/alms.asp

Advisory Publications Army Regulation 600-20, Army Command Policy, 20 Sep 2012

Mandatory Publications OTSG/MEDCOM Policy Memo 13-062, Policy for Reporting Incidents of Sexual Assault and Sexual Harassment under the Sexual Assault Prevention and Responses Program (SHARP), 12 Nov 2013.

Deliverables due

Sexual Assault Reporting. The contractor will immediately (within 24 hours) submit a written report of an incident of sexual assault to the Government contract POC.

Sexual Harassment Reporting. The contractor will immediately (within 24 hours) submit a written report of an incident of sexual harassment to the Government contract POC.

(z) TAS Reporting For reporting purposes, FAR Clause 52.204-10 Reporting Executive Compensation and First Tier Subcontract Awards, the Treasury Account Symbol (TAS) is 97 0130.

(End Addendum 52.212-4)

CLAUSES INCORPORATED BY REFERENCE

52.203-3 Gratuities APR 1984 52.203-6 Restrictions On Subcontractor Sales To The Government SEP 2006 52.203-12 Limitation On Payments To Influence Certain Federal

Transactions

OCT 2010

52.203-17 Contractor Employee Whistleblower Rights and Requirement To Inform Employees of Whistleblower Rights

APR 2014

52.204-4 Printed or Copied Double-Sided on Postconsumer Fiber Content Paper

MAY 2011

52.204-10 Reporting Executive Compensation and First-Tier Subcontract Awards

OCT 2016

52.204-18 Commercial and Government Entity Code Maintenance JUL 2016 52.209-6 Protecting the Government's Interest When Subcontracting

With Contractors Debarred, Suspended, or Proposed for Debarment

OCT 2015

52.222-3 Convict Labor JUN 2003 52.222-19 Child Labor -- Cooperation with Authorities and Remedies JAN 2018 52.222-21 Prohibition Of Segregated Facilities APR 2015 52.222-26 Equal Opportunity SEP 2016 52.222-35 Equal Opportunity for Veterans OCT 2015 52.222-36 Equal Opportunity for Workers with Disabilities JUL 2014 52.222-37 Employment Reports on Veterans FEB 2016 52.222-50 Combating Trafficking in Persons MAR 2015 52.223-2 Affirmative Procurement of Biobased Products Under Service and Construction Contracts

SEP 2013

52.223-3 Hazardous Material Identification And Material Safety Data JAN 1997 52.223-5 Pollution Prevention and Right-to-Know Information MAY 2011 52.223-18 Encouraging Contractor Policies To Ban Text Messaging

While Driving

AUG 2011

52.225-13 Restrictions on Certain Foreign Purchases JUN 2008 52.228-5 Insurance - Work On A Government Installation JAN 1997 52.232-18 Availability Of Funds APR 1984 52.232-33 Payment by Electronic Funds Transfer--System for Award

Management

JUL 2013

52.232-39 Unenforceability of Unauthorized Obligations JUN 2013 52.232-40 Providing Accelerated Payments to Small Business

Subcontractors

DEC 2013

52.233-3 Protest After Award AUG 1996 52.233-4 Applicable Law for Breach of Contract Claim OCT 2004 52.242-13 Bankruptcy JUL 1995 252.203-7000 Requirements Relating to Compensation of Former DoD

Officials

SEP 2011

252.203-7002 Requirement to Inform Employees of Whistleblower Rights SEP 2013 252.204-7003 Control Of Government Personnel Work Product APR 1992 252.209-7004 Subcontracting With Firms That Are Owned or Controlled By

The Government of a Country that is a State Sponsor of Terrorism

OCT 2015

252.225-7002 Qualifying Country Sources As Subcontractors DEC 2017 252.225-7012 Preference For Certain Domestic Commodities DEC 2017 252.225-7021 Trade Agreements--Basic DEC 2017 252.225-7048 Export-Controlled Items JUN 2013 252.232-7003 Electronic Submission of Payment Requests and Receiving

Reports

JUN 2012

252.232-7006 Wide Area WorkFlow Payment Instructions MAY 2013 252.232-7010 Levies on Contract Payments DEC 2006 252.243-7001 Pricing Of Contract Modifications DEC 1991

CLAUSES INCORPORATED BY FULL TEXT

52.209-10 Prohibition on Contracting With Inverted Domestic Corporations. (NOV 2015)

(a) Definitions. As used in this clause--

Inverted domestic corporation means a foreign incorporated entity that meets the definition of an inverted domestic corporation under 6 U.S.C. 395(b), applied in accordance with the rules and definitions of 6 U.S.C. 395(c).

Subsidiary means an entity in which more than 50 percent of the entity is owned--

(1) Directly by a parent corporation; or

(2) Through another subsidiary of a parent corporation.

(b) If the contractor reorganizes as an inverted domestic corporation or becomes a subsidiary of an inverted domestic corporation at any time during the period of performance of this contract, the Government may be prohibited from paying for Contractor activities performed after the date when it becomes an inverted domestic corporation or subsidiary. The Government may seek any available remedies in the event the Contractor fails to perform in accordance with the terms and conditions of the contract as a result of Government action under this clause.

(c) Exceptions to this prohibition are located at 9.108-2.

(d) In the event the Contractor becomes either an inverted domestic corporation, or a subsidiary of an inverted domestic corporation during contract performance, the Contractor shall give written notice to the Contracting Officer within five business days from the date of the inversion event.

(End of clause)

52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000)

(a) The Government may extend the term of this contract by written notice to the Contractor within 30 days of contract expiration; provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least 60 days before the contract expires. The preliminary notice does not commit the Government to an extension.

(b) If the Government exercises this option, the extended contract shall be considered to include this option clause.

(c) The total duration of this contract, including the exercise of any options under this clause, shall not exceed 60 months.

52.219-28 POST-AWARD SMALL BUSINESS PROGRAM REREPRESENTATION (JULY 2013)

(a) Definitions. As used in this clause--

Long-term contract means a contract of more than five years in duration, including options. However, the term does not include contracts that exceed five years in duration because the period of performance has been extended for a cumulative period not to exceed six months under the clause at 52.217-8, Option to Extend Services, or other appropriate authority.

Small business concern means a concern, including its affiliates, that is independently owned and operated, not dominant in the field of operation in which it is bidding on Government contracts, and qualified as a small business under the criteria in 13 CFR part 121 and the size standard in paragraph (c) of this clause. Such a concern is ``not dominant in its field of operation'' when it does not exercise a controlling or major influence on a national basis in a kind of business activity in which a number of business concerns are primarily engaged. In determining whether dominance exists, consideration shall be given to all appropriate factors, including volume of business, number of employees, financial resources, competitive status or position, ownership or control of materials, processes, patents, license agreements, facilities, sales territory, and nature of business activity.

(b) If the Contractor represented that it was a small business concern prior to award of this contract, the Contractor shall rerepresent its size status according to paragraph (e) of this clause or, if applicable, paragraph (g) of this clause, upon the occurrence of any of the following:

(1) Within 30 days after execution of a novation agreement or within 30 days after modification of the contract to include this clause, if the novation agreement was executed prior to inclusion of this clause in the contract.

(2) Within 30 days after a merger or acquisition that does not require a novation or within 30 days after modification of the contract to include this clause, if the merger or acquisition occurred prior to inclusion of this clause in the contract.

(3) For long-term contracts--

(i) Within 60 to 120 days prior to the end of the fifth year of the contract; and

(ii) Within 60 to 120 days prior to the date specified in the contract for exercising any option thereafter.

(c) The Contractor shall rerepresent its size status in accordance with the size standard in effect at the time of this rerepresentation that corresponds to the North American Industry Classification System (NAICS) code assigned to this contract. The small business size standard corresponding to this NAICS code can be found at http://www.sba.gov/content/table-small-business-size-standards.

(d) The small business size standard for a Contractor providing a product which it does not manufacture itself, for a contract other than a construction or service contract, is 500 employees.

(e) Except as provided in paragraph (g) of this clause, the Contractor shall make the representation required by paragraph (b) of this clause by validating or updating all its representations in the Representations and Certifications section of the System for Award Management (SAM) and its other data in SAM, as necessary, to ensure that they reflect the Contractor's current status. The Contractor shall notify the contracting office in writing within the timeframes specified in paragraph (b) of this clause that the data have been validated or updated, and provide the date of the validation or update.

(f) If the Contractor represented that it was other than a small business concern prior to award of this contract, the Contractor may, but is not required to, take the actions required by paragraphs (e) or (g) of this clause.

(g) If the Contractor does not have representations and certifications in SAM, or does not have a representation in SAM for the NAICS code applicable to this contract, the Contractor is required to complete the following rerepresentation and submit it to the contracting office, along with the contract number and the date on which the rerepresentation was completed:

The Contractor represents that it ( ) is, ( ) is not a small business concern under NAICS Code 334516 - assigned to contract number .

(Contractor to sign and date and insert authorized signer's name and title).

52.222-40 NOTIFICATION OF EMPLOYEE RIGHTS UNDER THE NATIONAL LABOR RELATIONS ACT

(DEC 2010)

(a) During the term of this contract, the Contractor shall post an employee notice, of such size and in such form, and containing such content as prescribed by the Secretary of Labor, in conspicuous places in and about its plants and offices where employees covered by the National Labor Relations Act engage in activities relating to the performance of the contract, including all places where notices to employees are customarily posted both physically and electronically, in the languages employees speak, in accordance with 29 CFR 471.2(d) and (f).

(1) Physical posting of the employee notice shall be in conspicuous places in and about the Contractor's plants and offices so that the notice is prominent and readily seen by employees who are covered by the National Labor Relations Act and engage in activities related to the performance of the contract.

(2) If the Contractor customarily posts notices to employees electronically, then the Contractor shall also post the required notice electronically by displaying prominently, on any Web site that is maintained by the Contractor and is customarily used for notices to employees about terms and conditions of employment, a link to the Department of Labor's Web site that contains the full text of the poster. The link to the Department's Web site, as referenced in (b)(3) of this section, must read, ``Important Notice about Employee Rights to Organize and Bargain Collectively with Their Employers.''

(b) This required employee notice, printed by the Department of Labor, may be--

(1) Obtained from the Division of Interpretations and Standards, Office of Labor-Management Standards, U.S.

Department of Labor, 200 Constitution Avenue, NW., Room N-5609, Washington, DC 20210, (202) 693-0123, or from any field office of the Office of Labor-Management Standards or Office of Federal Contract Compliance Programs;

(2) Provided by the Federal contracting agency if requested;

(3) Downloaded from the Office of Labor-Management Standards Web site at http://www.dol.gov/olms/regs/compliance/EO13496.htm; or

(4) Reproduced and used as exact duplicate copies of the Department of Labor's official poster.

(c) The required text of the employee notice referred to in this clause is located at Appendix A, Subpart A, 29 CFR Part 471.

(d) The Contractor shall comply with all provisions of the employee notice and related rules, regulations, and orders of the Secretary of Labor.

(e) In the event that the Contractor does not comply with the requirements set forth in paragraphs (a) through (d) of this clause, this contract may be terminated or suspended in whole or in part, and the Contractor may be suspended or debarred in accordance with 29 CFR 471.14 and subpart 9.4. Such other sanctions or remedies may be imposed as are provided by 29 CFR part 471, which implements Executive Order 13496 or as otherwise provided by law.

(f) Subcontracts. (1) The Contractor shall include the substance of this clause, including this paragraph (f), in every subcontract that exceeds $10,000 and will be performed wholly or partially in the United States, unless exempted by the rules, regulations, or orders of the Secretary of Labor issued pursuant to section 3 of Executive Order 13496 of January 30, 2009, so that such provisions will be binding upon each subcontractor.

(2) The Contractor shall not procure supplies or services in a way designed to avoid the applicability of Executive Order 13496 or this clause.

(3) The Contractor shall take such action with respect to any such subcontract as may be directed by the Secretary of Labor as a means of enforcing such provisions, including the imposition of sanctions for noncompliance.

(4) However, if the Contractor becomes involved in litigation with a subcontractor, or is threatened with such involvement, as a result of such direction, the Contractor may request the United States, through the Secretary of Labor, to enter into such litigation to protect the interests of the United States.

52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es):

FAR: http://farsite.hill.af.mil/vffara.htm DFARS: http://farsite.hill.af.mil/vfdfara.htm

52.252-6 AUTHORIZED DEVIATIONS IN CLAUSES (APR 1984)

(a) The use in this solicitation or contract of any Federal Acquisition Regulation (48 CFR Chapter 1) clause with an authorized deviation is indicated by the addition of "(DEVIATION)" after the date of the clause.

(b) The use in this solicitation or contract of any DoD FAR Supplement (48 CFR Chapter 2) clause with an authorized deviation is indicated by the addition of "(DEVIATION)" after the name of the regulation.

252.204-7015 NOTICE OF AUTHORIZED DISCLOSURE OF INFORMATION FOR LITIGATION SUPPORT

(MAY 2016)

(a) Definitions. As used in this clause--

Computer software means computer programs, source code, source code listings, object code listings, design details, algorithms, processes, flow charts, formulae, and related material that would enable the software to be reproduced, recreated, or recompiled. Computer software does not include computer data bases or computer software documentation.

Litigation support means administrative, technical, or professional services provided in support of the Government during or in anticipation of litigation.

Litigation support contractor means a contractor (including its experts, technical consultants, subcontractors, and suppliers) providing litigation support under a contract that contains the clause at 252.204-7014, Limitations on the Use or Disclosure of Information by Litigation Support Contractors.

Sensitive information means controlled unclassified information of a commercial, financial, proprietary, or privileged nature. The term includes technical data and computer software, but does not include information that is lawfully, publicly available without restriction.

Technical data means recorded information, regardless of the form or method of the recording, of a scientific or technical nature (including computer software documentation). The term does not include computer software or data incidental to contract administration, such as financial and/or management information.

(b) Notice of authorized disclosures. Notwithstanding any other provision of this solicitation or contract, the Government may disclose to a litigation support contractor, for the sole purpose of litigation support activities, any information, including sensitive information, received—

(1) Within or in connection with a quotation or offer; or

(2) In the performance of or in connection with a contract.

(c) Flowdown. Include the substance of this clause, including this paragraph (c), in all subcontracts, including subcontracts for commercial items.

252.211-7003 ITEM UNIQUE IDENTIFICATION AND VALUATION (MAR 2016)

(a) Definitions. As used in this clause-

Automatic identification device means a device, such as a reader or interrogator, used to retrieve data encoded on machine-readable media.

Concatenated unique item identifier means--

(1) For items that are serialized within the enterprise identifier, the linking together of the unique identifier data elements in order of the issuing agency code, enterprise identifier, and unique serial number within the enterprise identifier; or

(2) For items that are serialized within the original part, lot, or batch number, the linking together of the unique identifier data elements in order of the issuing agency code; enterprise identifier; original part, lot, or batch number;

and serial number within the original part, lot, or batch number.

Data Matrix means a two-dimensional matrix symbology, which is made up of square or, in some cases, round modules arranged within a perimeter finder pattern and uses the Error Checking and Correction 200 (ECC200) specification found within International Standards Organization (ISO)/International Electrotechnical Commission (IEC) 16022.

Data qualifier means a specified character (or string of characters) that immediately precedes a data field that defines the general category…