A.09.03_W81K0218Q0007-0003.pdf

W81K0218Q0007

W40M REGIONAL HEALTH CONTRACTING OF

REGIONAL HEALTH CONTR OFC PACIFIC

POC: TAE H. KIM

BLDG 339 CLARK ROAD

FORT SHAFTER HI 96858-5098

0011171882

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

Solicitation is amended to update the Salient Characteristics. The analyzer system (1) does not need to include Automated Slide Maker, Automated Slide Stainer; (2) minimum actual through-put shall be 100 w hole blood count instead of 125; and (3) the requirement for an integrated automated differential analyzer is not required.

The solicitation closing date w ill not be extended and all other terms and conditions remain unchanged.

1. CONTRACT ID CODE PAGE OF PAGES

J 1 10

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

16C. DATE SIGNED

BY 23-Aug-2018

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 W81K0218Q0007

X 9B. DATED (SEE ITEM 11)

17-Aug-2018

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

23-Aug-2018

CODE

W40M REGIONAL HEALTH CONTRACTING OF

REGIONAL HEALTH CONTR OFC PACIFIC

BLDG 339 CLARK ROAD

FT SHAFTER HI 96858-5098

W81K02 7. ADMINISTERED BY (If other than item 6)

4. REQUISITION/PURCHASE REQ. NO.

CODE W81K02

FACILITY CODECODE

EMAIL:TEL:

SECTION SF 30 BLOCK 14 CONTINUATION PAGE

SUMMARY OF CHANGES

SECTION SF 1449 - CONTINUATION SHEET

The following have been modified:

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)

(End of Summary of Changes)