W91YTZ22Q0049-0002.pdf

W40M RHCO-ATLANTIC USAHCA

NORTHERN REG CONTR OFC NRCO

POC: FRANK A. WHORTON

6000 MACARTHUR BLVD

BETHESDA MD 20816

0011768731

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 reason for this amendment is to revise the Statement of Need, paragraph 3.12. and to extend the due date for responses to the RFQ.

1. CONTRACT ID CODE PAGE OF PAGES

J 1 10

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

16C. DATE SIGNED

BY 19-Apr-2022

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 W91YTZ22Q0049

X 9B. DATED (SEE ITEM 11)

07-Apr-2022

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 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

19-Apr-2022

CODE

W40M RHCO-ATLANTIC USAHCA

NORTHERN REG CONTR OFC NRCO

6021 5TH ST BLDG 1467

FORT BELVOIR VA 22060-5580

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

4. REQUISITION/PURCHASE REQ. NO.

CODE W91YTZ

FACILITY CODECODE

EMAIL:TEL:

W91YTZ22Q0049

SECTION SF 30 BLOCK 14 CONTINUATION PAGE

SUMMARY OF CHANGES

SECTION SF 1449 - CONTINUATION SHEET

SOLICITATION/CONTRACT FORM

The required response date/time has changed from 29-Apr-2022 04:00 PM to 02-May-2022 04:00 PM.

The following have been modified:

STATEMENT OF NEED

STATEMENT OF NEED

CHEMISTRY/IMMUNOASSAY ANALYZERS

1. GENERAL REQUIREMENTS: The manufacturer shall provide all laboratory equipment, tools, materials, training and additional items and services necessary to provide two (2) fully automated integrated laboratory analyzer(s), clinical chemistry/immunoassay analyzer systems, reagents, and data management system as required. The manufacturer shall be responsible for furnishing equipment maintenance, preventive services, unscheduled repairs and parts as required in order to maintain the systems in optimal conditions in accordance with vendor specifications. The analyzer will comply with the specific requirements listed below.

2. DESCRIPTION: The contractor shall provide two (2) fully automated integrated platform, discrete random-access chemistry/immunoassay analyzer systems, training, supplies, reagents, unscheduled maintenance and preventive maintenance for the equipment. The analyzer will be located at the following location:

Kenner Army Health Clinic Clinical Laboratory Services (1st Floor) 700 24th Street – BLDG. 8130 Fort Lee, VA 23801

2.1. Lease of this equipment shall include all required installation processes to make the equipment fully operational; all calibrators/standards, reagents/reagent packs and quality control materials necessary to perform the specified assays, initial method validations per the Centers for Medicare & Medicaid Services (CMS) Clinical Laboratory Improvement Amendments (CLIA) and the National Accreditation Agency for Clinical Laboratory Sciences (NAACLS) guidelines, including but not limited to normal range verification, demonstration of linearity with establishment of reportable ranges, correlation with current methods (comparison studies), validation of analytical measurement range (AMR), validation of precision (replication studies) and accuracy (recover study), carryover studies, and establishment of initial control ranges. All required reagents, calibrators and linearity materials will be provided by the manufacturer through the course of the validation process.

2.2. The contract period will be for one base period and four option periods.

2.3. Monthly billing by the vendor will be based on the number of monthly patient reportable and submitted through Wide Area Work Flow (WAWF). The vendor will obtain the number of monthly patient reportable through the capability of the analyzer or through the middleware.

The vendor will provide a courtesy copy of each monthly payment invoice to the operating facility’s Contracting Officer Representative (COR).

2.4. If in the event the contract is terminated for any reason, the manufacturer must allow the analyzer(s) to remain in place for a period not to exceed 60 days at no additional cost to the Government beyond the contracted price, for the purpose of meeting regulatory requirements of performing correlation and validation studies.

3. PRICE QUOTED: The price quoted is to be on a “Cost per Reportable Result” (CPRR). The pricing quoted should include all reagents/reagent packs, calibrators and quality control materials required to produce the cost per reportable result.. All reagent usage to perform quality control and/or calibration must be included in the price quoted and is not to be counted in the monthly usage volumes. The cost per reportable results that shall include costs that cover:

3.1. Equipment utilization.

3.2. Data management system.

3.3. Reagents, calibrators, repeats, waste, consumables, accessories, standards, miscellaneous supplies, and the costs associated with normal shipment of those products. Controls will be included for all chemistry and immunoassay analytes.

3.4. Delivery and installation of equipment.

3.5. All necessary maintenance to keep the equipment operational. This includes both preventative maintenance, unscheduled repair, and equipment troubleshooting. When the Government performs troubleshooting with the Contractor, the Contractor shall replace all reagents, calibrators, controls and any other materials used at no additional cost to the Government.

3.6. Training for equipment and instrumentation operators prior to the first day of the contract’s period of performance begins.

3.7. Additional supplies required for commencing operations and performing required correlation, precision, carryover, validation and population studies.

3.8. The water filtration and management system required to run the analyzers.

3.9. Any service, maintenance, and equipment service charges required for operation.

3.10. Bio-Rad quality control kits within the same lot used within the laboratory to run the required 20 and 30 day quality control validations. The contractor will not need to run the 20 and 30 day quality control validations, but will be required to run all other validation requirements listed in subparagraph 2.1.

3.11. Safety data sheets (SDS) for each item delivered under this contract that is considered to be hazardous material by the United States. The SDS shall contain information on the hazards associated with each specific chemical or material. The SDS shall contain, as a minimum, identification of the hazardous material and the specific hazard, the required practices for the safe use of the product, first aid precautions, and what to do in the event of a spill or other mishap or accident.

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

4. ANALYZER TESTING SYSTEM:

4.1. The physical limitations of the facility prevent major renovations to the existing structures. Due to the two analyzers with on-board water systems currently in place and the fact that our current analyzers cannot be removed until the new analyzers are installed, validated, and ready for use the provided area in which all required equipment must be able to physically fit is described as follows. A single analyzer must have on-board water systems and the width cannot exceed 3ft. by 10 ft. The two analyzers together must not exceed 6 ft. by 20 ft. This allotted space does not include space for a separate water system. Due to the space limitations there isn’t room for the water system to be directly next to the analyzers. The water system must be on-board the analyzers.

4.2. The analyzer must be fully automated to allow walk-away operations. The analyzer must be an integrated platform that will perform both the chemistry and immunoassay tests on a single instrument (i.e. the chemistry and immunoassay capabilities cannot be provided via the provision of two separate analyzer systems).

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

4.4. The contractor must have acceptance by the Defense Health Agency (DHA) for the Authority to

Operation (ATO) on a Government network and must provide eMass numbers.

4.5. The analyzer system must include a data management system for control of the operation of the analyzer system, management of the quality control program, management of the on-instrument useful life of the reagents/reagent packs, and management of patient results; and a printer for the production of hard copy patient reports and other reports generated via the analyzer system's data management system. The data management system's quality control program must include the ability to apply Westgard quality control result decision rules in real-time, with the ability of the user to individually select the rules to be applied.

4.6. The Data Management system will have a comprehensive, fully integrated QC software module that stores and evaluates quality control results. Results can be viewed in a variety of formats including Levy-Jennings charts and statistical summaries. The application will validate QC results by checking them against user-selected rules and automatically alert the operator when a rule violation has occurred.

4.7. The middleware shall provide an integrated QC package with the ability to import and export results through Bio-Rad Unity Real (URT). Bio-Rad URT is QC data management program that provides statistical review, documentation, analysis and monitoring across all controls within the laboratory. It will provide a networkable QC program to cover all areas tested chemistry and immunoassay analytes and provide external peer group analysis for comparison across laboratories utilizing Bio-Rad quality control products.

4.8. At a minimum, the Bio-Rad URT software program will provide the capability to upload monthly data to Bio-Rad’s online/on-board QC analysis package, UnityTM Inter-Laboratory Program and Unity QC Data Management Solutions.

4.9. The middleware should be able to provide lab custom programming to communicate via our interface to our CHCS LIS as well as our future LIS system, MHS Genesis. If our lab must move to MHS Genesis during the life of the contract, contractor will be on site during go-live to help mitigate any interface issues and to help verify all rules and results are still coming across to the new LIS, to include auto-verification of results, without error.

4.10. The data management system shall offer software management features with rules capable of preparing data for auto validation prior to host transmission. The software shall have the following capabilities: to write and validate user defined auto verification/auto result validation rules that can hold transmission of results for review by the user, to write and validate user defined order/request rules such as daily reminders to take temperatures at 1300, to support patient delta checks as part of the auto-verification process, to manage rules for optimal specimen handling with the ability to send automated comments based on the rules to patient host record, to support rules that recognize linearity limits, repeat for critical value tests, review for specimen integrity, serum indices, and delta checks on previous patient results, etc., to support specimen integrity and serum indices based rules to cancel/edit tests based on the test performed and the interfering substance. Cancelled test must be able to transmit to the host along with the appropriate comment, and ability to lock out or suppress test analytes if QC performance is unacceptable. The analyzer must have the capability to suppress test analytes if QC performance is unacceptable as well.

4.11. The system must have a data management system for storage of patient results, quality control and preventative maintenance data. System will have a bi-directional interface to the analyzer and to the hospital information system Composite Health Care System (CHCS) and Military Health System-Genesis (MHS-Genesis).The Data management system must have sufficient data storage and printing capability to accommodate and provide immediate access to more than 2,000 patient records per day. The vendor shall provide back-up network data management handling. The Data management system must include control of the operation of the analyzers, management of the quality control program, management of the on-instrument useful life of the reagents/reagent packs, patient results, and a printer for the production of hard copy patient reports and other reports generated via the data management system.

4.12. The manufacturer is required to maintain existing equipment for duration of period of performance. The manufacturer will provide all upgrades to the equipment hardware and operating system software without additional charge to the Government. These enhancements to the equipment shall be delivered to the Government site and be installed by the manufacturer within 60 days of their issuance date of first commercial availability. Subject to mutual agreement between the Government and the Contractor, instrumentation may be upgraded within the specifications of the contract as new technology may become available.

Additionally, the Government will add reagents through the life of this contract as a result of advances in technology or changes to clinical practice standards. Any such change to the reagents shall be mutually agreed upon by the contractor and the Government through a bilateral modification.

4.13. The instrument manufacturer will provide the purchasing customer the following support and services to ensure a guaranteed uptime of at least 97% on each analyzer. 24/7 telephonic technical support. We require two identical analyzers to provide redundancy so that NEVER should both analyzers be down/inoperable at the same time.

4.14. The Contractor shall provide an on-board water system (e.g. filtered, deionized etc.), if required by the analyzer, that shall provide uninterrupted service for a period of time to be determined by the Laboratory Director. The contractor must provide any and all parts, filters, salt, supplies that are required to operate the water system in order to operate the instruments. If system requires additional water treatment, vendor will supply system and all components, accessories, maintenance service, and maintenance items/supplies, to maintain in good operating condition at no cost to the Government. The contractor will supply an annual water testing analysis and report to ensure compliance with manufacturer and CLIA specifications of water quality to include microbial testing.

4.15. The instrument must be a random access, discrete analyzer system with STAT interrupt capability and a primary tube sampling system capable of handling 100mm x 13mm, 75mm x l 2mm and 64mm x 10.25 BD Vacutainer ® or Griener Bio-One ® test tubes with standard or HemogardTM tops. KAHC clinical laboratory services (CLS) will utilize pour off tubes as needed should a specimen tube not conform to instrument rack requirements.

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

4.17. Patient samples must not require off-board pre-treatment prior to testing and must allow for automated onboard dilutions performed directly while processing on the analyzer. No manual dilutions will be required.

4.18. The vendor shall perform linearity studies on all analytes initially and every 6 months for the duration of the contract period to include providing all linearity materials required at no cost to the Government and providing the statistical reports to the supervisor for review.

4.19. Provide automated assay linearity with no manual steps is preferred to perform linearity studies.

4.20. Provide automated unloading of empty reagent containers; instrument must be able to hold sample aliquot on board for up to 2 hours for add-ons and test re-run.

4.21. Release of primary sample tube < 5 minutes for STAT and < 15 minutes for Routines for sample re-testing or add-on tests.

4.22. The analyzers must provide the ability to test hemolysis, icterus, and lipemia (HIL) indices and have the ability to determine interference by the result produced.

4.23. The analyzers must accept multiple specimen types on a single carrier simultaneously.

4.24. The analyzers shall be fully automated with direct loading and unloading capabilities for samples and include barcode reading for all reagents and samples. All analyzers and associates parts and accessories will be new.

4.25. The analyzer must come equipped with an uninterrupted power supply (UPS) capable of providing all necessary electrical power to each analyzer system to include the data management system, for a minimum of 15 minutes.

4.26. The analyzer system must allow for growth (i.e., numbers of patient tests increasing or the addition of additional assays in the future).

4.27. Emergency Repairs and service concerns/questions shall be responded to within 24-48 hours of notification which may include having a field service engineer on-site within this time period.

5. REAGENTS

5.1. The analyzers must have the on-board stability to maintain reagents at the proper storage temperatures for the assays listed in Appendix 1. The analyzer must be capable of maintaining calibration curves for all of the assays listed in Appendix 1 simultaneously. There must be the capability to load and process STAT specimens ahead of routine specimens regardless of when the STAT specimens are put on and how many routines are currently processing on the analyzers.

5.2. All reagents need not be maintained on an analyzer at the same time, but the analyzer provided must have the capability to add/change out reagents/reagent packs with only a minimal calibration/quality control requirement, i.e., must allow the user to calibrate any assay, remove the assay reagents/reagent packs without the need for recalibration in most instances, thereby allowing the user to meet the work testing scheduling requirements specific to the work site.

5.3. The Contractor will optimize the specific arrangement of the reagents/reagent packs for assays that are routinely maintained on the analyzer during the initial installation of the analyzer and when a new assay is added to the test menu. The Contractor must ensure that all required reagents/reagent packs are accounted for in the loading plan for the assays that are routinely maintained on the analyzer (assays to be routinely maintained on each of the analyzers to be specific at the time of installation).

5.4. At least two (2) weeks prior to the start of the contract, the Contractor will provide an estimate of the yearly quantities of reagent/reagent packs, calibrators/standards and quality control materials required to perform the volume of tests for each assay as provided in Appendix 1 .

The Contractor will ensure that requirements for routine quality control runs (as defined by KAHC CLS QC program), routine calibration, 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 will also estimate the volume of user-replaceable maintenance items that will be required to support the analyzer and any analyzer specific tools/supplies necessary to perform operator-level periodic maintenance tasks at the level of use specified in Appendix 1.

5.5. Upon receipt by the Government, reagents must have a minimum shelf life of at least 3 months, or if this shelf life requirement cannot be met, the Contractor must identify the guaranteed shelf life after receipt that can be accommodated in their response to the solicitation for bid.

5.6. Efforts will be made to ensure all reagents, and/or calibrators of a specific type or for a specific assay in a single shipment be of the same lot. It is understood that periodically shipments may contain different lots for a specific assay due to manufacturer needs or requirements.

5.7. The assays listed in Appendix 1 (KAHC Test Menu and Workload) must be FDA approved and testable on the associated body fluid.

6. UNSCHEDULED REPAIRS: Unscheduled repairs shall be performed by the manufacturer after notification that equipment is inoperative. The manufacturer shall provide the Government with a designated point of contact and shall make arrangements to enable their maintenance representative to receive such notification and be on site within 24 hours. The Government may incur labor and/or travel expenses if the repair is required outside of normal business hours (published by the manufacturer). In the event that two similar components (i.e. chemistry or immunoassay) of both analyzers are unable to perform minimum testing requirements established by the Government, regardless of holidays, weekends, or hour, the manufacturer will provide immediate repair service at no cost to the Government.

6.1. The manufacturer shall furnish a malfunction incident report to the Contracting Officer

Representative upon completion of any maintenance call. The report shall include, as a minimum, the following: (a) date and time of notification, (b) date and time of arrival, (c) type and model number(s) of equipment, (d) time spent for repair, (e) description of malfunction and

(f) proof of repair. An initial handwritten report is acceptable.

7. SITE PREPARATION: The manufacturer as a part of the equipment proposal, for any equipment not already in place, shall furnish site preparation specifications in writing. These specifications shall be in such detail as to ensure that the equipment to be installed shall operate and conform to the manufacturer's specifications.

7.1. The Government shall prepare the site at its own expense and in accordance with the specification(s) furnished by the manufacturer.

7.2. Any alteration or modifications in site preparation, which are attributable to incomplete or erroneous specifications provided by the manufacturer, which would involve additional expense to the Government, shall be made at the expense of the manufacturer.

8. OWNERSHIP OF EQUIPMENT: Title to equipment shall remain with the manufacturer. All accessories furnished by the manufacturer shall accompany the equipment when returned to the manufacturer.

8.1. The manufacturer, at termination and/or replacement of equipment, will remove the equipment at no cost to the Government. The manufacturer will disconnect the equipment and will be responsible for all packing and shipping required to remove the equipment within seven (7) calendar days.

9. PREVENTIVE MAINTENANCE: The manufacturer will provide preventive maintenance at their recommended intervals to assure the continued reliable operation of the equipment.

Appendix 1 – Test Menu and Workload

Type of Test Plasma (P), Serum (S), Urine (U) Estimated # of Test

ALBUMIN S 10500

ALKA PHOSPHATATSE S 10500

ALINE TRANSAMINASE S 10500

AMPHETAMINE U 900

AMYLASE S 200

AST S 10500

B12 S 850

BARBITURATES U 900

BENZODIAZEPINES U 900

B-HCG S 1500

UREA NITROGEN (BUN) S 11000

CALCIUM S 11000

CANNABOIDS U 10000

CHLORIDE (CL) S 11500

CHOLESTEROL S 10500

CREATININE KINASE S 500

CO2 S 11000

COCAINE MET U 1000

CREATININE U 12500

DIRECT BILIRUBIN S 1200

ETHANOL P 500

FERRITIN S 700

FOLATE S 550

FT4 S 4500

GGT S 400

GLUCOSE S,P 12500

HDL S 10000

IRON S 900

LDL S 10000

LIPASE S 300

MAGNESIUM S 400

METHADONE U 900

MICROALBUMIN U 1350

OPIATES U 900

PHENCYCLIDINE U 900

PHOSPHORUS S 400

POTASSIUM (K) S 11500

PSA TOTAL S 2000

SODIUM (NA) S 11500

T BILIRUBIN S 10500

T PROTEIN S 10500

T3 UPTAKE S 200

T4, TOTAL S 200

TESTOSTERONE, T S 400

TIBC S 700

TRIGLYCERIDES S 10000

TSH S 7000

URIC ACID S 400

ESTIMATED TOTAL# OF TESTS 237550

Appendix 2 – Minimum Accecptable Standards for Performance of Regulated Analytes?

ANALYTE ACCEPTABLE LIMITS ("or" whichever is >)

ALBUMIN 10%

ALK PHOS 30%

ALT 20%

AMYLASE 30%

AST 20%

BUN 9% or 2.0 mg/dl

CALCIUM 1.0 mg/dl

CHLORIDE 5%

CHOLESTEROL 10%

CK 305

CREATININE (SERUM) 15% or 0.3 mg/dl

CREATININE (URINE) 17%

DIRECT BILIRUBIN 20% or 0.4 mg/dl

DIRECT HDL 30%

DIRECT LDL 30%

DIRECT TIBC 20%

ECO2 3.9 mmol/l

ETHANOL 25%

IRON 20%

FERRITIN 12%

FOLATE 30%

FREE T4 15%

GGT 7%

GLUCOSE 10% or 6.0 mg/dl

HCG 12% or ± 0.2

LIPASE 30%

MAGNESIUM 25%

MICROALBUMIN 30%

PHOSPHORUS 10.7% or 0.3 mg/dl

POTASSIUM 0.5 mmol/l

PSA 15% or ± 0.2

SODIUM 4.0 mmol/l

T3 UPTAKE 9%

TESTOSTERONE 10%

TOTAL BILIRUBIN 20% or 0.4 mg/dl

TOTAL PROTEIN 10%

TOTAL T4 ± 20% or ± 1.0 µg/dl

TRIGLYCERIDE 25%

TSH 15%

URIC ACID 17%

URINE PROTEIN 44%

VITAMIN B12 20%

(End of Summary of Changes)