D.02.05_Modification_W81K00-18-Q-0078-P00001.pdf

W40M USA HLTH CONTRACTING ACT

REGIONAL HEALTH CONTRACT OFF CENTRAL

POC: GERALDINE I. HERNANDEZ

3551 ROGER BROOK DR BLDG 3600

FORT SAM HOUSTON TX 78234-6200

0011148528

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

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

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

30-105-04EXCEPTION TO SF 30

APPROVED BY OIRM 11-84

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

FAR (48 CFR) 53.243

The purpose of this amendment is to address the follow ing:

1. The follow ing document is hereby added to the Solicitation as Attachment 1 - Questions presented to the Government w ith Replies.

2. No further questions w ill be accepted and the Solicitation closing date remains unchanged.

3. A revised Statement of Objectives has been incorporated to reflect the clarif ication of questions asked as related to subject paragraph/section w hen possible.

4. All other terms and conditions remain unchanged.

1. CONTRACT ID CODE PAGE OF PAGES

1 10

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

16C. DATE SIGNED

BY 22-Jun-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 W81K0018Q0078

X 9B. DATED (SEE ITEM 11)

08-Jun-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 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

22-Jun-2018

CODE

W40M USA HLTH CONTRACTING ACT

REGIONAL HEALTH CONTRACT OFF CENTRAL

2539 GARDEN AVENUE

JBSA 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:

W81K0018Q0078

SECTION SF 30 BLOCK 14 CONTINUATION PAGE

SUMMARY OF CHANGES

SECTION SF 1449 - CONTINUATION SHEET

The following have been added by full text:

REPLY TO QUESTIONS

Attachment 1

W81K00-18-Q-0078 Molecular Diagnostics Equipment

Replies to Questions presented to the Goverment

Question 1: Page 35, Statement of Objectives, Instrument/Equipment does not state at any point that equipment must be new.

* Provided Equipment is included that meets the requirements of the objectives is it correct to interpret that equipment already on site can be quoted?

Answer: 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. In addition, the Statement of Objective's will be revised accordingly.

Question 2: From Page 36, xi. The testing system shall offer a fully automated pre-analytical component that standardizes sample handling and automates mixing and uncapping of PreservCyt containers and automated barcode check and sample alignment. This pre-analytical step shall have minimal hands-on time requiring less than 5 minutes of setup; and automated mixing and uncapping of 94 samples completed in less than 30 minutes (see also line xxii on page 36)

* Is it correct to interpret that BAMC wants the pre-analytical component quoted in addition to the [two (2) fully automated polymerase chain reaction (PCR) systems for the detection of Human? papillomavirus (HPV) DNA.] referred to at the top of page 35.

* Or, is the pre-analytical component to be considered as an "option" as outlined in Factor 3. Price, item (b) Options, on Page 65?

Answer: The term “fully automated” in this context means that the complete pre-analytical component is included.

There are also platforms available that have it as an optional add-on. Either method would meet our needs.

Question 3: Is there any missing content to this bid? In the document received it goes from Page 36 of 81 to page 40 of 81 and paging becomes inconsistent on the document from what is in the PDF reader. Page counting jumps again after the print shows page 45 - it reverts to 42 and begins counting up again, so there are duplicates on some page numbers. For the purpose of questions I have referred to the page numbers on the "printed" page itself.

Answer: Due to technical issues with the contract writing system, the Request for Proposal did not align properly.

The following documents will be uploaded to FedBizOpps to assist with interpretation:

‐‐ Conformed copy of the Request for Proposal including Attachment 1.

The following have been modified:

STATEMENT OF OBJECTIVES

STATEMENT OF OBJECTIVES

The successful offeror shall furnish all equipment [two (2) fully automated polymerase chain reaction (PCR) systems for the detection of Human papillomavirus (HPV) DNA.] reagents, consumables, controls, and any necessary services (e.g., maintenance of furnished equipment) to the Department of Pathology and Area Laboratory Services, Brooke Army Medical Center, JBSA - Fort Sam Houston, Texas for the purpose of Molecular Diagnostics testing under a Cost-per-Test (CPT) Agreement. All equipment and reagents/consumables shall be supplied and serviced through the Contractor to include all parts, equipment, supplies, and other services required to ensure SAMMC is able to meet its objectives as listed herein.

Period of Performance:

Base: 1 October 2018 – 30 September 2019 Option 1: 1 October 2019 – 30 September 2020 (CLIN 1001 and subCLINs) Option 2: 1 October 2020 – 30 September 2021 (CLIN 2001 and subCLINs) Option 3: 1 October 2021 – 30 September 2022 (CLIN 3001 and subCLINs) Option 4: 1 October 2022 – 30 September 2023 (CLIN 4001 and subCLINs)

The Government will order items on as-needed basis, and shall only pay for the actual number of tests ordered, received, and accepted by the Government. The quantities listed herein represent anticipated test volumes for the period of performance listed.

1. Instruments/Equipment and Reagents/Consumables (Subfactor 1A).

i. Instruments/Equipment. Testing system shall include testing for the following: HPV

High Risk pool plus HPV 16 & 18 Genotype simultaneously eliminating the need to re-run a sample; as well as a traditional High Risk pool (14 HR Genotypes) with no grey zone or indeterminate results.

ii. Testing shall be performed on a fully automated IVD platform. Each analyzer and all associated 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.

iii. Testing for HPV shall be FDA approved and meet HPV testing needs in Atypical Cells of Undetermined Significance (ASCUS) and Negative for Intraepithelial Lesion or Malignancy (NILM) as detailed in recent American Congress of Obstetricians and Gynecologists (ACOG) guidelines, and allowed to be used as a first-line primary cervical cancer screening test to detect high risk HPV including genotyping for 16 and 18.

iv. Testing shall contain an internal control for cellularity check such as β globin.

v. Testing shall detect HPV DNA

vi. Testing shall show no cross-reactivity with low-risk HPV genotypes.

vii. Testing shall accept multiple primary vial formats, including liquid-based cytology

PreservCyt containers, for automatic nucleic acid extraction so that no routine pipetting into secondary tubes is required.

viii. Automated pipetting of specimens shall have a system to prevent cross-contamination by securely locking pipette tips in place to avoid motions that could create aerosols of samples/reagents. Pipetting aspiration and dispensing shall be monitored by pressure within the tips to detect low volumes and clogs to ensure valid results. The system shall have criteria that exist to report an error when low volumes and/or clogs are detected.

ix. Testing shall offer detection and separation of multiple targets from 1 reaction tube.

x. The testing system shall provide bi-directional LIS communication with CHCS to simplify test ordering and support the integrity of results so that no manual data entry is required.

xi. The testing system shall offer a fully automated pre-analytical component that standardizes sample handling and automates mixing and uncapping of PreservCyt containers and automated barcode check and sample alignment. This pre-analytical step shall have minimal hands-on time requiring less than 5 minutes of setup; and automated mixing and uncapping of 94 samples completed in less than 30 minutes.

xii. Pipetting shall be performed utilizing aerosol barrier tips.

xiii. Platform shall be compatible with facility data transfer systems.

xiv. A data management system, to include middleware, not contained within the

Molecular analyzer

xv. The system shall provide a central data management hub, to which all major systems included in this SOW connect to Unit 1 - Sample processing/extraction unit; Unit 2 Amplification/detection unit.

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

xvii. The system shall be capable of interfacing with the CHCS.

xviii. Software shall track instrument maintenance requirements.

xix. Software shall have interface capabilities.

xx. The analyzers will have an interface that is compatible to the government system

(CHCS) and will be able to recognize CHCS generated bar-code labels (both code 39 and 128) on primary sample tubes.

xxi. 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.

xxii. Sample Processing System to perform the requested processing:

i. Processing shall be performed on a fully automated IVD platform.

ii. Offeror shall be able to perform automated uncapping of various samples to include PCR Media tubes, SurePath containers, and PreservCyt containers

iii. Shall be able to perform automated recapping of various samples to include PCR Media tubes, SurePath containers, and PreservCyt containers

iv. Shall perform standardized sample handling to include automated barcode check and alignment

v. Shall perform automated mixing produces consistent homogeneity

vi. Shall contain built in feature to reduce the risk of cross-contamination

vii. Shall decap or recap 94 samples in less than 30 minutes (walkaway time)

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

ix. Platform shall operate using one computer.

x. Software shall track instrument maintenance requirements.

xi. Pedestal(s) 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).

xxiii. The Instruments will be installed with backs of machines near wall. Each analyzer, including printer, monitor, UPS, and computer system, shall fit within the dimensions outlined in figure below and complete operations on one platform. Sufficient room for proper exhaust and heat clearance based on manufacture’s site specifications shall be maintained, with at minimum a 6” clearance between the existing wall and instruments. Any sliding compartments or access drawers for servicing cannot extend beyond the width of each individual unit outlined in figure below when fully expanded.

xxiv. Lab Layout. The offeror shall provide a diagram or other graphical representation demonstrating how its proposed equipment fits within the dimensions below with its quote.

All software updates or file exchange shall be completed using CD/DVDs only. At no time will USB, internet or cloud-based services be allowed.

2. Reagents/Consumables.

i. The contractor shall have FDA approved Reagents/consumables that shall meet the requirements of the Reference laboratory mission, workload, and test menu (see Tables 1 and 2).

ii. All related approvals or modifications to equipment, reagents, or parts of the assay related to the testing product shall be provided by the contractor in the event any changes are made during performance of the contract.

iii. The Contractor shall provide all reagents/reagents 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.

iv. Reagents/consumables shall meet the requirements of the 24/7 SAMMC mission, workload, and test menu.

v. The Contractor shall provide quality control materials acceptable to the section Medical Director. This includes third-party controls when requested/required by the laboratory.

vi. In determining reagent requirements, the Contractor shall 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 when calculating the yearly requirements.

vii. Reagents used for troubleshooting analytical systems shall be reimbursed (or replaced) by the Contractor at no additional cost.

viii. The Contractor shall sequester lots of required quality control materials and test reagents so that a change in lot will not be more frequent than once a year.

ix. The Contractor shall 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 shall be in monthly drop shipments on the second Wednesday of the month. Orders called in by the COR or ACOR shall 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 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.

x. Emergency orders shall be delivered within 24 hours after the order is placed.

xi. The Contractor shall provide paper and electronic copies of material safety data sheets

(MSDSs) for each reagent item delivered under this contract (as appropriate).

3. Service and Maintenance (Subfactor 1B) The Contractor shall meet the following service, and maintenance requirements for all testing locations at SAMMC (except where specifically noted otherwise):

i. 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.

ii. 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.

iii. The Contractor shall 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 shall 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.

iv. Any service technician provided by the Contractor shall adhere to all required reporting procedures for SAMMC prior to reporting to the laboratory for work. Current procedures will be available through the COR or ACOR.

v. For equipment supporting the Molecular Diagnostics Laboratory, the service technician shall be on-site to provide unlimited service within twenty-four (24) hours of establishing telephonic contact Monday through Thursday and within seventy-two (72) hours on Friday. 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 shall be replaced at no cost by the Contractor.

vi. 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.

vii. 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:

o Nomenclature and serial number o Date of service o Description of services performed (i.e., preventive maintenance service, or unscheduled repair service) o Location of services performed o Duration of performance (hours) o List of parts replaced or other actions taken to restore operability of the instrument o Name of technician

viii. In the event the laboratory is relocated, the Contractor shall relocate/revalidate any instrument if requested by the Government at no additional cost. The Government is requesting two (2) moves per the life of the contract. This includes any location within the SAMMC healthcare network. The Contractor shall provide product service and support to include updates to operational software throughout the life cycle of the equipment.

4. Training (Subfactor 1C) The Contractor shall provide the following for all testing locations at SAMMC:

The Contractor shall provide initial operator training (on or off-site) to all technicians 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 shall provide training for two (2) primary (key) operators, per analyzer prior to or no later than one week following implementation of the analyzer.

All training shall include basic analyzer operation, troubleshooting procedures, performance of operator level periodic preventive maintenance procedures, and use any data management/quality control software.

Upon renewal of the option year and in the case of any significant software or assay procedural updates, the Contractor shall provide one (1) primary (key) operator training slot per major analyzer. This training can be on or off-site at the Contractor’s full expense.

5. Delivery and Installation (Subfactor 1D)

i. All systems shall be delivered to the appropriate location indicated below within 90 calendar days after contract award.

San Antonio Military Medical Center Department of Pathology, Molecular Diagnostics Laboratory 3551 Roger Brooke Drive Fort Sam Houston, TX 78234

ii. The Point of Contact (POC) for all deliveries:

NCOIC, Molecular Diagnostics Laboratory Department of Pathology and Laboratory Services San Antonio Military Medical Center Tel: (210) 916-9772/0694

iii. The Contractor shall assign a Program Manager to oversee all operations required for successful implementation and execution of the requirement.

iv. During the initial implementation, a primary, dedicated technical representative shall be assigned and available on site throughout the entire implementation period. Substitutions shall be coordinated with and approved by the COR or ACOR.

v. 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.

vi. 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)). Method validation/verification will include, but not be limited to: normal range (reference interval) verification, verification of reportable range (AMR), correlation to current methods, verification of precision, carryover studies and establishment of initial ranges using control materials, to include third party controls where designated by the Laboratory Director.

vii. The method validation/verification will be completed and approved by the Laboratory Director prior to reporting of patient results. Payment for services will not begin until the analyzer system has been approved for reporting of patient results.

viii. 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.

ix. 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.

x. Provide a timeline identifying critical points in the delivery/installation phase, wherein Day 0 = Notice of Award. For example, if the offeror is notified that they are awarded the contract on 1 July 2017, delivery of the equipment would occur on 15 July 2017, with installation on 1 August 2017, the timeline would be: Day 0 = Notification of Award; Day 15 = Delivery of equipment; Day 33 = Installation.

Attachment 1 - Mandatory Test/Functions & Estimated Volumes

Table 1. Mandatory Tests

1. Human papillomavirus High Risk testing, detection, and genotyping (genotypes 16 & 18)

Table 2. Annual Volume – Molecular Diagnostics Laboratory

Test Base Option 1 Option 2 Option 3 Option 4

1. Human papillomavirus testing detection and genotyping

100,000 102,000 104,040 106,121 108,243

(End of Summary of Changes)