W81K00-21-Q-0052 - Hematology Solicitation Amendment 0001.pdf

W40M USA HLTH CONTRACTING ACT

REGIONAL HEALTH CONTRACT OFF CENTRAL

POC: MEDINA L. WOODSON

3551 ROGER BROOK DR BLDG 3600

FORT SAM HOUSTON TX 78236-6200

0011592813

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

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

15A. NAME AND TITLE OF SIGNER (Type or print)

30-105-04EXCEPTION TO SF 30

APPROVED BY OIRM 11-84

STANDARD FORM 30 (Rev. 10-83) Prescribed by GSA

FAR (48 CFR) 53.243

The purpose of this Amendment 0001 is to:

A. Incorporate changes (highlighted in yellow ) into the statement of Work resulting from the question & answ er segment in sections 2.1.1,

2.3.4 and 3.4.

B. Include the Government answ ers to questions received in response to this solicitation that does not require any SOW revisions.

C. Extend the solicitation closing date/time to 18 June 2021, 4:00 PM CST.

All other terms and conditions remain the same.

See SUMMARY OF CHANGES

1. CONTRACT ID CODE PAGE OF PAGES

1 16

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

16C. DATE SIGNED

BY 11-Jun-2021

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 W81K0021Q0052

X 9B. DATED (SEE ITEM 11)

25-May-2021

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 X 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 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

11-Jun-2021

CODE

W40M USA HLTH CONTRACTING ACT

REGIONAL HEALTH CONTRACT OFF CENTRAL

2539 GARDEN AVENUE

FT SAM HOUSTON TX 78234-0000

W81K00 7. ADMINISTERED BY (If other than item 6)

4. REQUISITION/PURCHASE REQ. NO.

CODE W81K00

FACILITY CODECODE

EMAIL:TEL:

W81K0021Q0052

SECTION SF 30 BLOCK 14 CONTINUATION PAGE

SUMMARY OF CHANGES

SECTION SF 30 - BLOCK 14 CONTINUATION PAGE

The following have been added by full text:

STATEMENT OF WORK

Hematology Cost Per Reportable Agreement

1. Scope of Work

The Contractor shall provide Hematology instrumentation and reagents used in support of the Hematology mission at Brooke Army Medical Center (Brooke Army Medical Center) / Joint Base San Antonio (JBSA) and its surrounding clinics/healthcare network, located at or near Joint Base San Antonio, TX 78234.

1.1 Description of Work

The Contractor shall provide Hematology Testing under a Cost Per Reportable Result (CPRR) agreement to include equipment, reagents, tools, materials, training, peripherals (e.g. instrument specific computer terminals and CPUs, printers, etc.), Uninterruptable Power Supply (UPS), Robotic Automation System integration, Automated Integrated Track System, and Automated Post-analytical system and services necessary to meet the Hematology testing and analysis requirements for Brooke Army Medical Center (BAMC), JBSA, Fort Sam Houston, TX and its outlying clinics. The analyzers shall be located in (6) six separate locations: 1) Main Core Hematology Laboratory of BAMC; 2) BAMC Emergency Department STAT Lab; 3) CPT Jennifer M. Moreno Primary Care Clinic Lab at Fort Sam Houston; 4) Schertz Medical Home; 5) Taylor J. Burk Health Clinic at Camp Bullis; 6) Westover Medical Home. Contractor shall include delivery, installation, all calibrators/standards, reagents/reagent packs, and quality control materials necessary to perform the required testing. The Offeror’s product solution shall provide redundancy (to ensure continuous operations) in the Main Core Laboratory, training, supplies, unscheduled maintenance, and preventive maintenance for the equipment in all locations. Initial Method Validations per Clinical Laboratory Improvement Amendments (CLIA)/National Committee for Clinical Laboratory Standards (NCCLS)/Department of Pathology and Area Laboratory Services Quality Management (DPALS QM) guidelines, will include method correlation to existing systems as well as between each new system from each location to the Main Core Lab instruments, linearity verification to maximum dilution, precision, carry-over, normal reference range validation, tube conversion validations, blood and body fluid validations, initially and with each new application and/or conversion and for trouble-shooting purposes. Validation Study criteria will be established by a Medical Director.

Contractor shall provide review to Medical Director for acceptability and approval of all validations prior to proceeding with Clinical Testing. Contractor will include official documentation of confirmation of safety of waste disposed into a sink or floor drain from the analyzers, analyzer decontamination when necessary, and removal of all instruments and peripherals (e.g. instrument specific computer terminals and CPUs, printers, toner, etc.) at the termination of the contract. The analyzer systems shall provide users with rapid, reliable test results that are critical for patient care. The Contractor shall be responsible for maintenance service, on-site repair, and parts as required in order to maintain a minimum 98% uptime for all instrumentation. All testing materials to include reagents, equipment, consumables and products associated with testing, must be FDA approved. Costs will be all inclusive based on cost per reportable structure to include provisions for reagents and consumables required to perform testing throughout the period of performance. See estimated patient volume and test type listed in Appendix A.

All supplies and equipment outlined in this Statement of Work (SOW) must be supplied and serviced through a single Contractor (to whom the contract is awarded, to include any parts, equipment, or supplies not manufactured, provided or serviced by the Contractor).

2. Equipment/Reagent Requirements – Core Laboratory

2.1 Equipment/Reagents

2.1.1 CBC analyzers will perform the required testing listed in Table 1. System redundancy in the Core Laboratory is required. At least (1) primary CBC analyzer will be required in each of the (5) five remaining locations listed in 1.1 Description of Work.

Individual analyzers must have fully automated, discrete random access capabilities.

There must be a single point of specimen entry for the routine analysis of all required tests. There must be capability for priority analysis of STAT specimens.

Each analyzer must be equipped to perform continuous, random statistical analysis using common statistical control rules as well as patient-derived quality control procedures (e.g., X- bar B analysis).

The analyzers must have an interface that is compatible to the current Government Laboratory Information System (LIS), Composite Health Care System (CHCS), and new Government LIS, Military Health System (MHS) Genesis. Each interface must allow for recognition and interpretation of CHCS and MHS Genesis generated bar-code labels on all sample tube types. Connectivity between the Contractors instrument systems and middleware to each LIS will be required at varying times during the contracted period of performance.

Each analyzer must be able to provide for auto-validation of results using internal rule sets to be configured by the vendor in collaboration with section.

BAMC Main Core Laboratory requires a fully automated system that includes pre and post analytic specimen processing with scalable, connected analytics to meet testing needs with highest efficiency with the following requirements:

Pre and Post Analytic System requirements:

• Automated/semi-automated systems to support pre- and/or post-analytical processing of specimens (as appropriate)

• The instrument systems should be able to interconnect with the major pre-analytical, analytical, and post-analytical components included in this SOW, providing for full walk-away automation (i.e., an automation/robotic line) and possible connection to the existing BAMC Core Laboratory Chemistry/Immunoassay automation line in a configuration that meets the section-specific space requirements. See Appendix A for existing pre and post analytic instruments and designated area for Hematology Analytic line.

• The systems must provide the vast majority of pre-analytical sample handling, transporting specimens from a start point to an appropriate instrument without manual intervention by a technician, as well as provide post-analytical computer controlled sample archiving/storage/racking through connectivity to integrated tube sorter with archiving capabilities for post–analytic tube management

BAMC (6) Site CBC Instrument System requirements:

Fully automated, discrete random access capabilities

Closed tube sampling required for Main Core Laboratory, ED STAT

Laboratory, and CPT Jennifer M. Moreno Primary Care Clinic with automated instrument barcode alignment (no pre-alignment necessary)

Single point of specimen entry for routine analysis of all required tests with single aspiration pathway

STAT specimen prioritization capabilities

Minimal aspiration volumes desired, aspirating < 100 µL for full hematology profile

Ability to perform continuous, random statistical analysis using common statistical control rules as well as patient-derived quality control procedures (e.g., X- bar B analysis)

Clot detection, liquid level detection, and abnormal descent detection

Use of fluorescent flow cytometry for WBC, WBC differential, NRBC, reticulocyte and platelet identification and enumeration preferred

Must have no significant intra-lipid interference for WBCs

Use of non-cyanide reagent for Hemoglobin required

Minimum throughput per location:

• Main Core Laboratory: 200 tests per hour;

redundancy required (throughput includes primary and secondary systems)

• ED STAT Laboratory: 200 tests per hour (primary only)

• CPT Jennifer M. Moreno Primary Care Clinic: 60 tests per hour (primary only)

• Schertz Medical Home: 60 tests per hour (primary only)

• SPC Taylor J. Burk Clinic at Camp Bullis: 60 per hour (primary only)

• Westover Medical Home: 60 tests per hour (primary only)

Clinical parameters – Main Core Laboratory, ED STAT Laboratory, CPT Jennifer M. Moreno Primary Care Clinic:

• Measured Hematocrit strongly encouraged. Ideally should be able to achieve HCT linearity (Analytical Measurement Range) of 0.0 – 75.0% and a Reportable Range (Limit of Quantitation) of

0.1 – 75.0%.

• Ability to identify immature granulocytes per

CBC differential analysis.

• Ability to identify nucleated RBCs per CBC analysis to include anemia management parameters, potentially to include the reticulocyte hemoglobin listed in the “VA Guidelines for the Management of Chronic Kidney Disease” to efficiently screen for anemia, and immature reticulocyte fraction.

• Ability to potentially identify immature platelet fraction and provide fluorescent platelet count for low platelet counts.

• Instrument must provide platelet enumeration using a methodology that would reduce the number of platelet flags requiring manual confirmatory procedures. Dual platelet methodologies are preferable in order to reduce manual confirmations with extended platelet parameters for the determination of thrombopoiesis.

• Potentially achieve PLT linearity

(Analytical Measurement Range) of 0 – 5000 x 103/µl and a Reportable Range (Limit of Quantitation) of 2 – 5000 x 103/µl .

• Required test parameters listed below in Table 1.

Table 1. Required Test Parameters

1. COMPLETE BLOOD COUNT (CBC) to include the following:

a. White Blood Cells (WBC)

b. Red Blood Cells (RBC)

c. Platelets (PLT)

d. Hemoglobin (HGB)

e. Hematocrit (HCT)

f. Mean Corpuscular Hemoglobin (MCH)

g. Mean Corpuscular Volume (MCV)

h. Mean Corpuscular Hemoglobin

Concentration (MCHC)

i. Mean Platelet Volume (MPV)

j. Red Cell Distribution Width (RDW)

k. Lymphocytes Number (LYMPH #)

l. Lymphocyte Percentage (LYMPH %)

m. Monocytes Number (MONO #)

n. Monocytes Percentage (MONO %)

o. Neutrophils Number (NEUT #)

p. Neutrophils Percentage (NEUT %)

q. Eosinophils Number (EOS #)

r. Eosinophils Percentage (EOS %)

s. Basophil Number (BASO #)

t. Basophil Percentage (BASO %)

u. Nucleated Red Blood Cells (NRBC) #

v. Immature Granulocytes, Absolute (IG #)

w. Immature Granulocytes, Percent (IG %)

2. Reticulocyte # and Reticulocyte %

a. Immature Reticulocyte Fraction

b. Reticulocyte Hemoglobin Equivalent

3. Body Fluid Counts (Serous; Synovial;

CSF)

4. Reticulocyte and Body Fluid counts required in Main Core Laboratory only

Additional Main Core Laboratory Requirement Only –

• Instrument must provide body fluid cell enumeration with the large linear range with the following parameters: WBC, RBC, and Total nucleated count with potentially a 2-part differential (polymorphonuclear %/# and mononuclear %/#) with each body fluid analysis for the following types:

Serous Synovial Cerebrospinal Fluid

• System should have the lowest possible linearity on WBC-BF and Total Nucleated Count-BF linearity (Analytical Measurement Range) on all body fluids of 0.000 – 10.000 x 103/µl and a Reportable Range (Limit of Quantitation) of 0.003

– 10.000 x 103/µl.

• Must achieve RBC-BF linearity (Analytical Measurement Range) on all body fluids of 0.000 –

5.000 x 106/µl and a Reportable Range (Limit of Quantitation) of 0.002 – 5.000 x 106/µl.

Instrument system placements at Schertz Medical Home, SPC

Taylor J. Burk Clinic, and Westover Medical Home must be identical to maintain consistency of operations. These systems must provide the same differential capabilities as proposed systems at BAMC Core, ED Stat Lab, and the CPT Jennifer M.

Moreno Primary Care Clinic.

Annual volume requirements listed below in Tables 2 – 4:

Annual volumes may fluctuate within +/- 5% of stated volumes in Tables 2 – 4. Tiered pricing above and below stated minimum and maximum volumes will be considered.

CBC Differential Instrument System requirements – Main Core Laboratory only:

• Integrated digital imaging device for automated digital cell morphology required for whole blood and body fluids; sufficient to automate the performance of manual differentials and cell counts; potentially connect directly to analytical instrument line.

• The system must provide automated slide evaluation using photomicroscopy with computerized image analysis of photomicrographs.

• The contractor must provide a minimum of (12) twelve remote review software packages for the system, providing for remote review of cell morphology by clinical staff not collocated within the main laboratory.

Slidemaker/Stainer System requirements – Main Core

Laboratory only:

• Potentially be physically connected to the analytical instrument line to include direct connection to the CBC analyzer and digital imaging device.

• The slide-maker/stainer should be integrated with analyzer decision rules to reduce operator hands-on intervention and should act as part of line and independent from line as needed.

• Automated slidemaker and slidestainer for smears with minimum throughput of 75 tests per hour.

• System redundancy is required.

• Daily system maintenance should not exceed 20 minutes.

• Must have ability to differentiate stat from routine smears.

• Must have onboard decision-making capabilities which initiate preparation of smears based on specific analysis results and/or user-defined criteria.

• Positive sample identification prior to smear preparation required.

• Automated slide stainers must use a Wright- Giemsa or Wright stain. If the stains provided by the Contractor are deemed insufficient by the Medical Director, the Contractor must provide at no additional cost an alternative stain from a 3rd party source that is acceptable to the Medical Director.

Pedestal(s) and/or carts capable of supporting each workcell system as appropriate, to include computer terminals or other automated instruments/peripherals as appropriate, providing a neat work area (e.g., reagent, cable and tubing control/maintenance).

Peripherals, to include Uninterruptable Power Sources (UPSs), electrical line conditioners as required, instrument-specific computer terminals/CPUs, printers to include toner for each as needed, and other equipment where required.

2.2 Information Technology and Data Management System

2.2.1 A data management system, to include middleware, not contained within the CBC analyzers (e.g., Data Innovations).

2.2.2 Data management system requirements – Main Core Laboratory and ED Stat Lab:

The system must provide a central data management hub, to which the major systems included in this SOW connect. This must include a connection to the digital cell morphology analyzer in Core.

The system must have the ability to manage critical values and delta checks.

The system must have the ability to interface with slide maker/stainer to support differentiation of stat from routine smears.

The system must not require remote communication to outside sources to be functional.

The system must be capable of interfacing with the CHCS and MHS Genesis. The analyzers must have an interface that is compatible to the current Government Laboratory Information System (LIS), Composite Health Care System (CHCS), and new Government LIS, Military Health System (MHS) Genesis. Each interface must allow for recognition and interpretation of CHCS and MHS Genesis generated bar-code labels on all sample tube types. Connectivity between the Contractors instrument systems and middleware to each LIS will be required at varying times during the contracted period of performance.

The system must include at least (12) twelve remote review stations (e.g., Thin Clients) to allow access to the digital imagery system and at least (5) remote review stations for access to instrument and middleware from centralized and decentralized locations.

Systems that provide the ability to control instrument software from remote locations are preferred.

The middleware should include a decision logic software that can filter information from analysis and enable reflex and rerun testing, generation of manual differential smears, auto-verification, and body fluids using rule sets that have been prepared by the vendor in collaboration with sections.

Pre-defined rule set must indicate International Society for Laboratory

Hematology specific rules.

To include Consulting Services that encompass the development and validation of auto-verification rules to include the use of delta checks, critical values, measuring ranges, and section specific rules.

2.2.3 Army Cybersecurity/Risk Management Framework (RMF) Requirements.

The Contractor shall establish appropriate administrative, technical, and physical safeguards to protect all Government data, to ensure the confidentiality, integrity, and availability of Government information. At a minimum, this shall include provisions for personnel security, electronic security and physical security. Vendors must insure ability to conform to all standards set forth by the Department of Defense Risk Management Framework for DoD IT (DoDI 8500.01, Cybersecurity, and DoDI 8510.01, Risk Management Framework for DoD Information Technology) or to be actively pursuing within the DoD. If the latter, at minimum, a Certificate of Networthiness (CoN), indicating that the organization’s products meet or exceed the Army’s standards for security, integration and reliability, is required. New and additional requirements may be required by DHA Cybersecurity in order to attain Authority to Operate.

2.3 Reagents

2.3.1 The Contractor must provide all reagents/reagent packs, calibrators/standards, quality control materials, user-replaceable maintenance items, and analyzer specific tools/supplies to support the ongoing delivery of laboratory services using the equipment outlined in this section sufficient to support testing in each area.

2.3.2 Reagents/consumables must meet the requirements of the 24/7 BAMC mission, workload, and test menu providing reagent packs containing a minimum of 500 tests and no less than 60 day open stability.

2.3.3 Preferred system would offer a means to reduce reagent handling and inventory levels.

2.3.4 A concentrated Reagent Delivery System is strongly recommended.

2.3.5 Should have reagent management technology, such as RFID reagent identification with on-board reagent inventory management and monitoring

2.3.6 Reagents used for troubleshooting analytical systems must be reimbursed (or replaced) by the Contractor at no additional cost. Reagents identified as substandard by the manufacturer must be reimbursed or replaced by the Contractor at no additional cost to BAMC and outlying Clinics.

2.3.7 The Contractor shall sequester lots of required test reagents where possible for all locations.

2.3.8 In determining reagent requirements, the Contractor must consider requirements for routine quality control runs (as defined by the Laboratory Director), routine calibration, periodic calibration/calibration verification in accordance with departmental policy, and troubleshooting of out-of-control assays.

2.3.9 The Contractor will provide, upon shipment, an electronic tracking mechanism whereby the Government is able to identify the shipping status of any equipment, reagents, or materials. Deliveries of required items must be in monthly drop shipments or as called in by the COR or ACOR. Large items (e.g., 20 L and above), must be shipped in a split order to arrive 2 weeks apart. Orders must arrive no later than one week from the requested date of delivery. Any supplies that are placed on back order shall be communicated electronically to the Government, clearly identified on the shipping documents and delivered in a timely manner, not to exceed seven (7) working days. In the instance a back-order exceeds seven (7) working days, the Contractor must provide testing services through local sub-contractor or alternate facility at their cost.

2.3.10 Standing orders for reagents and controls to be set up in collaboration with section. Emergency orders will be delivered within 24 hours of placement.

Provision for expedited shipments in contract expected.

3.0 Quality Control

3.1 The Contractor must provide (3) levels of quality control materials acceptable to the section Medical Director, sufficient to perform daily testing on all testing parameters 365 days per year in each section.

3.2 The Contractor shall sequester lots of required quality control materials for BAMC and Ancillary Clinic locations.

3.3 Open stability of quality control material must be a minimum of 7 days.

3.4 QC peer group data should ideally have real time, automatic electronic data upload capability to analyzer quality control.

3.5 Must provide 24-hour, 7-days a week immediate access to internet based QC peer review data (IQAP).

4.0 Service and Maintenance

4.1 The Contractor must meet the following service, and maintenance requirements for all testing locations at BAMC (except where specifically noted otherwise):

- Daily instrument maintenance should allow for system downtimes that do not exceed 20 minutes.

- The Contractor shall provide direct customer service and support, 24 hours/7 days a week, to include hotline telephone service (provided in English) and on-call emergency repair, to assist operators in correcting equipment problems.

- Onsite and online training required for all clinical staff at each location for each instrument system

- Provide for evidence-based calibration and calibration verification methodology performance

- Provide for manufacturer-assisted calibration verification onsite

- Provide for minimal disruptions and waste during automation system installation

4.2 The Contractor will maintain all equipment installed under this contract except for repairs necessitated by willful damage or negligence on the part of the Government.

This includes emergency repairs as well as routine Preventive Maintenance Services (PMS), safety tests, calibrations/calibration verifications, and unscheduled repair services in accordance with procedures and practices prescribed by the manufacturer of the equipment.

4.3 The Contractor must provide all personnel, equipment, tools, materials, supervision, parts, transportation, and other items and services necessary to perform all required repairs and scheduled preventive maintenance /safety inspections and calibrations of equipment. The performance of scheduled periodic preventive maintenance, safety checks, and calibrations that are not normally performed at the operator level must be performed by Contractor service personnel in accordance with requirements as specified in the Contractor’s instrument maintenance manual. Completion of analyzer installation will establish time-zero for determining the time frame for performance of periodic services.

Any service technician provided by the Contractor must adhere to all required reporting procedures for BAMC prior to reporting to the laboratory for work.

Current procedures will be available through the COR or ACOR.

For equipment supporting the Core Laboratory, the service technician must be on-site to provide unlimited service within twenty-four (24) hours of establishing telephonic contact. The equipment shall be repaired and operational within 48 hours after initial on-site response by the Contractor. Should all CBC analyzers become inoperable, the Contractor’s service technician must be on- site within four (4) hours of initial notification. The repair of at least one (1) analyzer must be completed within eight (8) hours of initial notification. If deemed necessary, after consultation with the COR, if at least one analyzer cannot be repaired within eight (8) hours of the initial notification, the Contractor shall, where requested, arrange the pickup and delivery of critical specimens to a College of American Pathologists accredited clinical laboratory, with priority testing service provided for STAT/ASAP specimens. The Contractor shall pay all costs associated with the provision of this alternative testing, including those for delivery of hardcopy patient results by express courier, directly to the laboratory, for as long as all analyzers remain inoperable.

For equipment supporting other locations, the service technician must be on-site to provide unlimited service (service requiring repair) within 24 hours establishing telephonic contact. The equipment shall be repaired and operational within 48 hours after initial on-site response by the Contractor.

In all cases, the Contractor shall provide all reagents, calibrators, controls, and any other materials necessary to troubleshoot instrument failure. Replacement parts used, as necessary, claimed from local operator-level maintenance kits as well as any reagents that may have been used must be replaced at no cost by the Contractor.

The Contractor shall notify the COR or ACOR of the exact date and time for performance of a preventive maintenance service no later than ten (10) days prior to the scheduled preventive maintenance services.

Within one (1) working day after completion of a repair, the Contractor’s representative shall furnish the COR one (1) copy of a service report for all services performed with a copy to the Equipment Management Branch and the Laboratory Representative for the MTF. The report shall be in English and shall contain, as a minimum, the following information:

Nomenclature and serial number

Date of service

Description of services performed (i.e., preventive maintenance service, or unscheduled repair service)

Location of services performed

Duration of performance (hours)

List of parts replaced or other actions taken to restore operability of the instrument

Name of technician

The Contractor must relocate/revalidate any instrument if requested by the Government at no additional cost. This includes any location within the BAMC healthcare network.

5.0 Training and Education

5.1 The Contractor must provide the following for all testing locations at BAMC:

- The Contractor must provide initial on-site and online operator training for all clinical staff assigned to the Government site normally assigned to perform the associated testing prior to implementation of the analyzer for patient testing. In addition, the Contractor must provide training for two (2) primary (key) operators, per major analyzer and automated system at the Contractor’s training site at no additional cost to the Government (including transportation airfare, rental car, per diem, etc.) prior to implementation of the analyzer.

5.2 All on-site training must include basic analyzer operation, troubleshooting procedures, performance of operator-level periodic preventive maintenance procedures, and use any data management/quality control software. Training will be provided prior to go-live and annually thereafter at the section supervisor’s discretion.

5.3 The Contractor must provide two primary (key) operator training slots per major analyzer and automated system per contract year, at the Contractor’s training site, at no additional cost to the Government (including transportation airfare, rental car, per diem, etc.). The Contractor may charge the Government only for training services that exceed the requirements for a given contract year.

5.4 The Contractor must provide ongoing educational opportunities with provisions for documented continuing education credits.

6.0 Delivery and Installation

6.1 All systems must be delivered to the appropriate location indicated below within 90 calendar days after contract award or as negotiated with each section. Delays beyond 90 calendars days are to be documented with Government Contracting.

6.2 Delivery locations:

Brooke Army Medical Center – 4th Floor Department of Pathology and Area Laboratory Services Core Hematology/Chemistry Laboratory 3551 Roger Brooke Drive Fort Sam Houston, TX 78234

Brooke Army Medical Center – 1st Floor Department of Pathology Area Laboratory Services Emergency Department Stat Laboratory 3551 Roger Brooke Drive Fort Sam Houston, TX 78234

CPT Jennifer M. Moreno Primary Care Clinic – Laboratory 3100 Schofield Road Building 1179 Fort Sam Houston, TX 78234

Schertz Medical Home – Laboratory

17115 IH-35N

Suite 123 Schertz, TX 78154

SPC Taylor J. Burk Health Clinic at Camp Bullis USA Training Site – Laboratory Building 5026 Camp Bullis, TX 78257

Westover Medical Home 10010 Rogers Crossing San Antonio, TX 78251

The Point of Contact (POC) for all deliveries: NCOIC for each respective location.

Contact Core Laboratory Manager for contact information at 210-916-7471.

6.3 The Contractor must assign a Project Manager and IT Project Manager to oversee all operations until instrument go-live and all IT capabilities have been implemented.

6.4 During the initial implementation, a primary, dedicated technical representative must be assigned and available on site throughout the entire implementation period.

Substitutions must be coordinated with and approved by the COR or ACOR.

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

6.6 Method validation/verification will be conducted in accordance with procedures outlined in the Department of Pathology policies and standard operating procedures and as required by the CLIA and/or the College of American Pathologists (CAP).

6.7 Initial Method Validations per Clinical Laboratory Improvement Amendments

(CLIA)/National Committee for Clinical Laboratory Standards (NCCLS)/Department of Pathology and Area Laboratory Services Quality Management (DPALS QM) guidelines, to include method correlation to existing systems as well as between each new system from each location to the Main Core Lab instruments, verification of reportable range (AMR) (to include WBC, RBC, HGB, PLT and reticulocyte, as required) linearity verification to maximum dilution, precision, carry-over, normal reference range validation, tube conversion validations, blood and body fluid validations, initially and with each new application and/or conversion and for trouble-shooting purposes and establishment of initial ranges using control materials, to include third party controls where designated by the Laboratory Director. Validation Study criteria will be established by Medical Director. Contractor shall provide review to Medical Director for acceptability and approval of all validations prior to proceeding with Clinical Testing. Payment for services will not begin until the analyzer system has been approved for reporting of patient results.

6.8 The Contractor shall provide a qualified Technical Service Representative (TSR), who possesses a thorough knowledge of method validation/verification and is familiar with the use of clinical laboratory statistical evaluation software (e.g. EP Evaluator®), to provide technical assistance for the method validation/verification studies. The assigned TSR will be responsible for the entire method validation. Additional TSRs may be brought in to assist in method validations/verifications, but only the primary TSR will be responsible for the entire operation

6.9 All instrument reagents, calibrators, linearity materials and other required reagents/materials used in the method validation/verification study will be provided by the Contractor at no additional cost to the Government. These materials will not be used in the analysis of specimens for patient care.

7.0 Other Considerations

7.1 The Contractor must provide monthly invoices on a routine schedule. Monthly invoices must include itemized charges based on pre-defined Item Numbers (CLIN lines) listed in the Government issued contract. Itemized summary of monthly billings per pre-defined contract Item Numbers (CLIN lines) to be submitted to BAMC on a quarterly basis.

7.2 The Contractor must provide paper and electronic copies of material safety data sheets (MSDSs) for each reagent item delivered under this contract (as appropriate).

Appendix A

1. BAMC DPALS Core Laboratory area. Layout includes existing instrument configuration and designated area for Hematology analytic line.

Please see the Core Laboratory Area Layout Below:

(End of Summary of Changes)