Att 1 - N6264522R0017 Screening Analyzer Released clean 091222.pdf

SEE ADDENDUM

(No Collect Calls)

N6264522R0017 09-Sep-2022

b. TELEPHONE NUMBER

301-619-8895

8. OFFER DUE DATE/LOCAL TIME

02:00 PM 28 Sep 2022

5. SOLICITATION NUMBER 6. SOLICITATION ISSUE DATE

AUTHORIZED FOR LOCAL REPRODUCTION

PREVIOUS EDITION IS NOT USABLE

STANDARD FORM 1449 (REV. 2/2012)

Prescribed by GSA – FAR (48 CFR) 53.212

(TYPE OR PRINT)

(SIGNATURE OF CONTRACTING OFFICER)

ADDENDA ARE

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

23.

CODE 10. THIS ACQUISITION IS

SUCH ADDRESS IN OFFER

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT

BELOW IS CHECKED

TELEPHONE NO.

N626459. ISSUED BY

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

7. FOR SOLICITATION

INFORMATION CALL:

a. NAME

PHILMORE H. CRICHLOW

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

(TYPE OR PRINT)

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

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

0 27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1. 52.212-4. FAR 52.212-3. 52.212-5 ARE ATTACHED.

25. ACCOUNTING AND APPROPRIATION DATA

1. REQUISITION NUMBER

20.

ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED.

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

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

ARE NOT ATTACHED

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

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

SET FORTH HEREIN, IS ACCEPTED AS TO ITEMS:

. YOUR OFFER ON SOLICITATION

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN

% FOR:SET ASIDE:UNRESTRICTED ORX

SMALL BUSINESS

17a.CONTRACTOR/ CODE FACILITY

OFFEROR CODE

NAVAL MEDICAL LOGISTICS COMMAND

693 NEIMAN STREET

FORT DETRICK MD 21702-9239

18a. PAYMENT WILL BE MADE BY CODE

RATED ORDER UNDER

DPAS (15 CFR 700)

13a. THIS CONTRACT IS A

13b. RATING

CODE15. DELIVER TO CODE N62645 16. ADMINISTERED BY

12. DISCOUNT TERMS11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

X SEE SCHEDULE

14. METHOD OF SOLICITATION

RFQ IFB RFPX

NAVAL MEDICAL LOGISTICS COMMAND

SEE PWS

SEE PWS

SEE PWS MD

TEL: FAX:

FAX:

TEL: SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

8(A)

HUBZONE SMALL

BUSINESS

SIZE STANDARD:

1,000

NAICS:

334516

X

OFFER DATED

29. AWARD OF CONTRACT: REF.

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

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND

EMAIL:

TEL:

31c. DATE SIGNED

SEE SCHEDULE

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

24.22.21.19.

WOMEN-OWNED SMALL BUSINESS (WOSB)

ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

32g. E-MAIL OF AUTHORIZED GOVERNMENT REPRESENTATIVE

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

(CONTINUED)

PAGE 2 OF85

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

32a. QUANTITY IN COLUMN 21 HAS BEEN

RECEIVED INSPECTED

32b. SIGNATURE OF AUTHORIZED GOVERNMENT

REPRESENTATIVE

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

REPRESENTATIVE

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

37. CHECK NUMBER

FINALPARTIALCOMPLETE

36. PAYMENT35. AMOUNT VERIFIED

CORRECT FOR

34. VOUCHER NUMBER

FINAL

33. SHIP NUMBER

PARTIAL

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

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

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

42a. RECEIVED BY (Print)

42b. RECEIVED AT (Location)

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

STANDARD FORM 1449 (REV. 2/2012) BACK

Prescribed by GSA – FAR (48 CFR) 53.212

AUTHORIZED FOR LOCAL REPRODUCTION

PREVIOUS EDITION IS NOT USABLE

SEE SCHEDULE

20.

SCHEDULE OF SUPPLIES/ SERVICES

21.

QUANTITY UNIT

22. 23.

UNIT PRICE

24.

AMOUNT

19.

ITEM NO.

Section SF 1449 - CONTINUATION SHEET

IMMUN SCREENING ANALYZER PWS

PERFORMANCE WORK STATEMENT

IMMUNOCHEMISTRY SCREENING ANALYZER SYSTEMS

The Naval Medical Readiness Logistics Command Detachment (NMRLCD), previously designated as the Naval Medical Logistics Command (NMLC), on behalf of the Department of Defense (DoD) Drug Testing Program (DTP) has a requirement for six (6) high speed immunochemistry screening analyzer systems. Each system shall consist of the hardware and software required to process urine specimens with high throughput capacity, maintain the identity of each test performed on each sample, perform urinalysis testing, store the results, transmit the data via an interface to the DoD Drug Demand Reduction Program (DDRP) Laboratory Information Management System (LIMS), and print a report of results on command.

The requirement is for:

Two (2) systems at:

Navy Drug Screening Laboratory Great Lakes;

and one (1) system for each of the following four locations:

Navy Drug Screening Laboratory Jacksonville, Army Forensic Toxicology Drug Testing Laboratory Fort Meade, Army Forensic Toxicology Drug Testing Laboratory Tripler Army Medical Center, and Headquarters Air Force Drug Testing Laboratory Lackland Air Force Base.

The requirement includes two (2) options. Option 1 is for augmentation of an additional seven (7) high speed immunochemistry screening analyzer systems with reduced throughput capacity requirements. The systems must be the same manufacturer as the base requirement in order to rapidly augment the required systems. Six (6) systems shall provide 2/3 specimen throughput of the required systems, and one system shall provide 1/3 specimen throughout of the required systems. The option system(s) shall expand the production capability of the systems procured under the base contract.

Option 1 is for:

Two (2) systems with 2/3 specimen throughput at:

Navy Drug Screening Laboratory Jacksonville;

one (1) system with 2/3 specimen throughput for each of the following four locations:

Navy Drug Screening Laboratory Great Lakes, Army Forensic Toxicology Drug Testing Laboratory Fort Meade, Army Forensic Toxicology Drug Testing Laboratory Tripler Army Medical Center, and Headquarters Air Force Drug Testing Laboratory Lackland Air Force Base;

and one (1) system with 1/3 specimen throughput at:

Armed Forces Medical Examiner System (AFMES), Dover, DE.

Option 2 is for:

one (1) system with 2/3 specimen throughput for the following one location:

Army Forensic Toxicology Drug Testing Laboratory Fort Meade.

Definitions

Adulterant Testing. Analysis to determine whether or not a urine specimen is valid including, but not limited to, pH, specific gravity, creatinine, nitrites, and chromate tests.

Analyzer. Any single unit of the system that possesses all components necessary to perform urinalysis testing. This can take the form of a standalone analyzer, or a specific module or combinations of modules to perform this function.

Consumable Supplies. Items that are necessary for proper system function that are consumed, or rendered otherwise unusable, during operation of the system or require replenishment on a routine basis. This may include, but is not limited to, acid/base wash solutions, detergents, etc. This does not include immunoassay reagents.

Disposable Supplies. Items that are required to operate the system and requires replacement on a periodic basis due to wear or required replacement based upon samples processed. This may include but is not limited to lamps, probes, tips, pipettes, needles, stirrers, cuvettes, bottles, nozzles, sample cups, etc

DoD Cutoffs. The DoD established concentration of drug in urine (ng/mL) which serves as an administrative break point between a negative (below the cutoff) and a positive (at or above the cutoff) specimen. The current DoD DDRP immunoassay screening cutoff levels and calibrator compounds are:

Immunoassay Screening Cutoff (ng/mL) Amphetamines (Amphetamine/Methamphetamine) 500 Designer Amphetamines (MDMA) 500 Benzodiazepines (Oxazepam) 200 Cannabinoids (Δ9-THC-COOH) 50 Synthetic Cannabinoids (JWH-018) 10 Cocaine Metabolites (Benzoylecgonine) 150 Lysergic Acid Diethylamide (LSD) 0.5 Opioids (Morphine) 2,000 Opioids (6-Acetylmorphine) 10 Opioids (Oxycodone) 100 Opioids (Hydrocodone) 100 Opioids (Fentanyl) 1

LIMS. The DoD Drug Demand Reduction Program Forensic Toxicology Drug Testing Laboratory Information Management System.

Sample Processing Units. All components necessary for processing samples (specimens, controls, calibrators, blanks) on the analyzer. This includes, but is not limited to trays, sample/calibrator/control racks, carriages, tube holders, inserts, adapters, etc.

System. A system is comprised of the components necessary to satisfy all government requirements. A system may be comprised of multiple analyzers.

Warranty Repair Time. Time it takes to restore the system to full service.

Essential Characteristics: Minimum Requirements

1) General Requirements

1. The system shall be capable of randomly performing at least twelve (12) drug tests simultaneously on human urine samples including Cloned Enzyme Donor Immunoassay (CEDIA), Diagnostic Reagent Immunoassay (DRI), Enzyme Multiplied Immunoassay Technique (EMIT), Kinetic Interaction of Microparticles in Solution (KIMS), and Enzyme Immunoassay (EIA) tests for the current DoD urinalysis panel.

2. The system shall be capable of performing validity testing (adulterant testing).

3. The system shall be capable of conducting the required analyses without system modifications.

4. The system may consist of multiple analyzer modules or components to meet the throughput performance requirements of the government.

5. For installation, the system should be capable of fitting through a standard 42-inch doorway.

6. Option systems must meet all of system requirements unless otherwise specified and must be fully compatible with the base system requirements.

7. The electrical requirement is 120-240 VAC, 60 Hz.

8. The system shall utilize commercially available test tubes.

2) System Performance Requirements

1. The system shall be capable of processing at least 6,000 tests per hour (a minimum of 500 samples per hour for a minimum of 12 unique tests) and comply with DoD 1010.16 requirements (https://www.esd.whs.mil/Portals/54/Documents/DD/issuances/dodi/101016p.pdf) for military drug testing and National Laboratory Certification Program (NLCP) guidelines (https://www.federalregister.gov/documents/2017/01/23/2017-00979/mandatory-guidelines-for-federal-workplace-drug-testing-programs) for federal workplace drug testing.

2. Option systems shall be capable of processing at least 4,000 tests per hour (a minimum of 300 samples per hour for a minimum of 12 unique tests) for the 2/3 throughput option, or at least 2,000 tests per hour (a minimum or 150 samples per hour for a minimum of 12 unique test) for the 1/3 throughput option, and comply with DoD

1010.16 requirements for military drug testing and NLCP guidelines for federal workplace drug testing.

3. The system shall be designed such that, if any single modular component of the system fails, the throughput of the system shall remain at least 300 samples per hour with a minimum of 12 unique tests per sample.

4. Option systems with 2/3 throughput shall be designed such that, if any single modular component of the system fails, the throughput of the system shall remain at least 150 samples per hour with a minimum of 12 unique tests per sample.

5. The system shall be capable of operating for a minimum of eighteen (18) hours per day, for five (5) days per week, with an expected life cycle of at least seven (7) years.

6. The system shall allow authorized users to modify configurations for reagents, calibrators, controls, testing parameters, test channels, and statistical analysis modules.

7. The system shall include sufficient sample processing units (i.e. racks, trays, inserts, adaptors, etc.) to hold at least 10,000 samples during pre- and post-processing storage.

8. Option systems shall include sufficient sample processing units (i.e. racks, trays, inserts, adaptors, etc.) to hold at least 6,000 samples (2/3 throughput option) or 3,000 samples (1/3 throughput option) during pre- and post-processing storage.

9. The system shall include an uninterrupted power supply (UPS) that will provide sufficient power for the system to complete the operation in progress and allow the operator sufficient time to properly shut down the system without loss of data.

10. The system shall require a maximum work area of no greater than 25 feet by 12 feet (300 sq ft). This includes all workspace required for the system, for technicians to perform operations at or above the required throughput, for preventive and corrective maintenance, and for ancillary equipment while meeting all environmental conditions for optimal operation of the system.

11. The system shall include all hardware, software, and firmware capable of unambiguously identifying the sample throughout the testing process, and to maintain the results of each sample without confusion with other samples or other tests being conducted on the same sample.

12. The system shall have barcode reader capability (Code 3 of 9 and Code 128) which ensures the sample and data are uniquely identified. The barcode reader shall accurately read an 11-character alpha-numeric identifier printed on a label (using a 300 DPI printer) and placed on the sample tube. The system shall be capable of testing a sample even if it is unable to read the barcode.

13. The system shall permit the user to define the nominal cutoff value (i.e., a value that distinguishes a negative from a positive sample).

14. The system shall provide refrigeration for the reagent reservoirs.

15. The system shall have reagent reservoir capacity to process 2,500 samples for a minimum of 12 tests without refill.

16. Option systems shall have reagent reservoir capacity to process at least 1,600 samples (2/3 throughput option) or at least 800 samples (1/3 throughput option) for a minimum of 12 tests without refill.

17. The system shall be capable of being safely operated without operator contact with hazardous materials.

3) Warranty and Maintenance Requirements

1. The Contractor shall provide a commercial warranty with terms at least as favorable to the Government as the most favorable terms offered to any other purchaser.

2. The warranty coverage shall include semi-annual preventive maintenance of the entire system.

3. The system shall be within manufacturer service life (i.e., parts and maintenance available) for a minimum of 7 years from the date of installation.

4. Contractor shall provide information on service and maintenance plan options for all proposed equipment.

4) User Security Access Requirements

1. The system shall include software with multiple password protected security access levels to data files and parameters. Security access levels shall either be configured by the laboratory or by the contractor upon request during the warranty period to meet the requirements of the government.

2. The system shall include a minimum of two (2) security access levels: Operator and Supervisor/Administrator.

3. The system shall include an audit trail capable of tracking the date, time, and edits (including values before and after the edit). The audit trail information shall be capable of being transmitted across the interface to the LIMS.

5) LIMS Interface Requirements

1. The contractor shall provide all necessary hardware and software to interface the system with the existing military drug testing LIMS through the laboratory’s Data Innovations Instrument Manager v8.17.20 or Greater.

Each Lab utilizes DI Instrument Manager and we want to keep this as an Essential Characteristic.

2. The contractor shall provide to the government or its designated representative the operational and technical support to interface the system with the existing military drug testing LIMS until successful validation is complete. This support shall be provided for the duration of the warranty period.

3. The contractor shall provide initial responses to the government’s questions about the system/LIMS interface within 3 business days of receipt. This support shall be provided for the duration of the warranty period.

4. Successful completion and validation of the interface shall occur no later than 30 days after installation of the first system. The implementation of the interface is required as part of the system installation for subsequent laboratories.

5. The contractor shall provide full user guide documentation and interface specifications (including hardware and software specifications) to the government.

6. If the system/computer controller has a macro or a programming language, the vendor shall provide documentation on the language to include a manual on all macro/program language commands and syntax.

7. The system/LIMS interface should provide a means to identify the sequence in which all samples, standards, controls, and blanks were loaded, run, processed, and results transmitted via the interface to the LIMS (i.e., date/time/unique identifier stamp).

8. The system/LIMS interface should accept test requests from the LIMS to include discrete sample testing requests as well as a batch/sample organization of test requests.

9. The system/LIMS interface should have the ability to package and send test results in real time; identifiers will include Laboratory Accession Number (LAN) and batch number.

10. The System/LIMS interface should print results upon command.

6) Other Contract Requirements

1. The Contractor shall complete a site survey of each laboratory site at least two months prior to delivery to verify utilities (power, water, sewer, ventilation, heating, air conditioning) and other requirements are available and meet the contractor’s specification prior to installation. All associated costs to meet this requirement shall be included in contractor proposals within the cost of the system.

2. Upon award, the Contractor shall provide a tentative scheduling timeline for site surveys, delivery, installation, and validation/check-out at each site, however, the contractor must agree to work within the scheduling timeline approved by the government.

3. The Contractor shall deliver, setup, install, and validate performance of all system components prior to government acceptance of the system.

4. The Contractor shall provide all cables needed to interface the system to the LIMS. Any additional equipment, identified during installation or during the first year of operation, necessary for optimal operation shall be provided to the government at no additional cost.

5. The Contractor shall provide the technical support necessary to set-up and configure the system to operate optimally with all reagent kits and meet the stated throughput requirements.

6. The Contractor shall provide a list of which vendor reagents by drug class are compatible with the contractor’s system.

7. The Contractor shall provide a list of all consumable supplies and their estimated replenishment frequencies, based upon the government’s defined annual workload of 1 million specimens per a lab.

8. The Contractor shall provide a list of all disposable supplies and their estimated replacement frequencies, based upon the government’s defined annual workload of 1 million specimens per a lab.

9. The Contractor shall preclude backorders of necessary material required to operate the systems by maintaining sufficient availability of the materials required to support the 6 laboratory sites.

10. The Contractor shall provide supplies in accordance with the material requirements and specifications of the original equipment manufacturer (OEM).

11. The Contractor shall provide supplies that are new, not refurbished/reissued, and free of defect in manufacture or workmanship unless approved by the Government.

12. The Contractor shall replace, at no cost to the Government, any supplies returned by the laboratories due to defects in manufacture, workmanship, or shipment from the contractor's origination site.

13. The Contractor shall immediately notify the laboratories and contracting office of any recall notification of materials found to be defective.

14. The Contractor shall be responsible for repairs associated with damage to a system due to defective contractor-supplied materials used in the routine maintenance and operation.

15. The Contractor shall not assume a verbal or written inquiry as authorization to provide services not specifically covered by the terms of the contract.

16. The Contractor shall provide documentation of ISO 9001 or ISO 13485 certification with the proposal and maintain certification for the duration of the warranty period.

17. The Contractor shall provide Operator Training onsite at each DoD laboratory in association with system installation and will accommodate the number of laboratory personnel requiring training. The number of laboratory personnel requiring training should not exceed 15 people per laboratory. After training, government personnel shall be capable of carrying out normal system operation.

18. The Contractor shall provide an Operator Training Manual with the proposal and with each system.

19. Option Systems shall include Operator Training for two people per system at the vendor facility (travel expenses excluded) deliverable within seven (7) years of system installation. After training, government personnel shall be capable of carrying out normal system operation.

20. The Contractor shall provide Training Course Descriptions with the proposal.

21. Determine barcode read accuracy per 100,000 reads provide this information as raw data and in graphic format to the government.

22. The Contractor should provide documentation of carryover study data with the proposal. At a minimum, the studies shall show the system’s profile of carryover from at least 10 replicates of a series of positive urine samples at 100X, 1,000X, 10,000X, and 100,000X the cutoff concentrations for each drug class as listed in the Definitions (DoD Cutoffs). This information shall be provided as raw data and in graphic format.

7) The system shall be compliant with the Food and Drug Administration (FDA) requirements to market and deliver medical products for use in the United States of America, even should delivery be requested outside of the United States. The claims made for the product shall comply with the regulations of the FDA with respect to products for marketing and delivery of a medical product for use in the United States of America, even should delivery be requested outside of the United States. The system shall be installed in compliance with OSHA requirements.

8) Vendor shall be an Original Equipment Manufacturer (OEM) authorized dealer, authorized distributor or authorized reseller for the proposed equipment/system such that OEM warranty and service are provided and maintained by the OEM. All software licensing, warranty and service associated with the equipment/system shall be in accordance with the OEM terms and conditions.

9) Upon delivery, the vendor shall be responsible for uncrating the unit/system and transporting it through the facility to the location of intended use for installation. If interim storage is required, the vendor shall arrange the storage.

Enhancing Factors

1. The system should be capable of performing more than twelve (12) tests simultaneously without reduction of sample throughput.

2. The system should be capable of performing supplemental reflex testing. The reflex test should report the timestamp (or other sequence identifier) based on the physical order of the samples.

3. The system should be equipped with reagent reservoir capacity to process more than 5,000 samples for a minimum of twelve (12) tests without requiring refill.

4. The system should have more than ten (10) and preferably more than twenty (20) open channels.

5. The system instrument database should be capable of capturing at least five (5) discreet analytical runs for a single sample that is labeled with the same identifier.

6. The system should permit on-screen review of calibration and quality control information in real-time.

7. The system should automatically transmit all quality control and reagent information (i.e., lot numbers, expiration dates, etc) to the LIMS.

8. The system should permit either single point or multipoint best fit curve calibration.

9. The system should permit drug analyses in qualitative and semi-quantitative modes. Specimens and controls shall be compared to the calibration for determination of drug presence in quantitative and semi-quantitative modes. All data needed to perform these functions shall be transmitted to the LIMS.

10. The system should have automated startup, shutdown, and maintenance procedures, such that the operator does not have to return to the system to input individual instructions/commands.

11. The system should have an integrated wash function and perform cuvette integrity checks (when applicable).

12. The system should have an audible and visual alarm to alert the operator of operational failures. The alarm notification should be captured in the data printout and saved to the database.

13. The system should be capable of operating at no less than the minimum sample throughput (described above) for

95% of each laboratory’s production hours each month (i.e., at least 19 of 20 workdays per month).

14. The system/LIMS interface should have bidirectional, real-time data transfer capability and batch processing functionality.

15. The system/LIMS interface should be robust enough to withstand government security scanning and patch management by Information Assurance (IA) and continue to transmit test requisitions and sample test results.

16. The system/LIMS interface should transmit data between the analyzer system and the interface via TCP/IP-Ethernet.

17. The system/LIMS interface should allow real-time transmission of all Calibration, Quality Control, individual sample test results data, and all applicable error codes (flags) to the LIMS.

18. The system/LIMS interface should allow processing of samples even if the LIMS is offline. If the LIMS is off line, the interface should save test results until LIMS is available and then allow result transmission.

19. The system should allow full data review if data is stored in a vendor supplied database.

20. The required Operator and Supervisor/Administrator security levels should have permissions as follows:

i) Level 1 – Operator

(1) Able to operate the system for calibration/processing/reprocessing samples and controls

(2) Able to acknowledge alarms and warnings but, not able to clear alarm logs

(3) Able to perform user maintenance procedures

(4) Not able to change configuration options

ii) Level 2 – Supervisor/Administrator

(1) All Operator attributes

(2) Able to add/change reagents

(3) Able to perform database backups and export data

(4) Able to modify configurations for reagents, calibration, controls, testing parameters, and statistical analysis modules

(5) Able to configure user access for Level 1

(6) Able to access all modes, configurations, and parameters

(7) Able to clear alarm logs

21. The system should include more than 2 security access levels.

22. The system/LIMS interface should be capable of transmitting and receiving system control commands.

23. The system/LIMS interface should have redundant capacity; the failure of a single component of the interface should not prevent the operation of the interface or should allow the recovery of the interface within two (2) hours.

24. The system/LIMS interface should be capable of operating over a wide area network (WAN).

25. The LIMS Interface Software will be capable of installation onto a DHA Hardened Microsoft 2016 Server or

Greater Operating System.

26. The temperature of the reagent compartments and the charge status of the UPS can be monitored remotely using an

Ethernet connection.

27. The system audit trail should be capable of tracking the user.

28. The system should be capable of utilizing barcode labels in current use at the 6 DoD lab sites without modification to the system or labels.

29. The warranty response time should ensure that a service technician is capable of on-site response within 12 business hours (six [6] business hours for Great Lakes) of notification of a system malfunction.

30. The warranty repair time should not exceed 24 business hours (16 business hours for Great Lakes) from notification of a system component failure.

31. Permit the use of two- and three-component reagent assay kits. The use of a combination of two and three component reagent assay kits must maintain the required throughput.

32. Require no more than 2 technicians per 8-hour shift to achieve the specified throughput.

33. Be capable of storing a minimum of 1,000,000 test results. It shall also provide utilities to backup and restore the database within 24 hours.

34. The system/LIMS interface should occur through an encryption or authentication communication.

Certification and Accreditation (C&A) Requirements for Information Assurance (IA):

1. The system, including all contractor and sub-contractor-provided hardware and software, shall undergo Information

Assurance (IA) Certification and Accreditation (C&A) for the Drug Demand Reduction Program (DDRP) Enclave.

The system shall successfully receive Authority to Operate (ATO) or Access and Incorporate (A&I) into the DDRP Enclave Accreditation Boundary. If the C&A process identifies issues which would lead to denial of ATO, or failure to meet A&I requirements contractor shall remedy the issues to the satisfaction of the government within six

(6) months of notification. If the C&A or A&I process identifies issues which would lead to denial of Interim Authority to Operate (IATO), contractor shall remedy the issues to the satisfaction of the government within six (6) months of notification. The vendor shall meet with the government to provide a plan to address the issues identified.

The vendor shall provide a monthly status report on the progress addressing the issues.

2. The contractor shall comply with the enclosed other contracting requirements. As part of the proposal, the contractor shall submit the enclosed Naval Medical Logistics Command (NMLC) C&A Initial Technical Questionnaire with the Blue Section completely filled out.

3. Remote Connectivity or Remote Administration of any kind into a DOD Drug Screening/Testing Lab is strictly prohibited. Vendor must perform all IT administration on-site.

4. Contractor will be responsible for complying with all current and future versions of the DISA Security Technical Implementation Guides (STIGS) for Hardware and Software that supports vendor’s system

5. Vendor is responsible to perform Operating System Upgrades as required by DOD.

6. Vendor will allow DOD Vulnerability Scanner to Scan Workstation and Peripheral Devices for Information

Assurance and Vulnerability Analysis.

7. Vendor is responsible to ensure continued compliance with Information Vulnerability Security Alerts, Security

Patches and Security Compliance Settings to maintain acceptable IA Posture inside the DDRP Enclave. Vendor will perform all Patches, Security Configurations, Upgrades required within 30 Days of notification of a Vulnerability discovered, CONTRACT ADMINISTRATION

1. Contract Administration

(a) The name, address and telephone number of the Contract Specialist responsible for administering this contract is:

Naval Medical Readiness Logistics Command Detachment (NMRLCD) Attn: Philmore Crichlow, Jr.

693 Neiman Street Fort Detrick, Maryland 21702

(301) 619-8895 Email: philmore.h.crichlow.civ@mail.mil (After 01 October 2022 philmore.h.crichlow.civ@health.mil )

(b) Unless otherwise stated herein, any correspondence or discussion regarding this contract will be directed to the Contract Specialist in (a) above.

2. Communications

(a) Except as specified in paragraph (b) below, no order, statement, or conduct of Government personnel who visit the contractor's facility or in any other manner communicate with contractor personnel during the performance of this contract shall constitute a change under the "Changes" clause of this contract.

(b) The contractor shall not comply with any order, direction or request of Government personnel unless it is issued in writing and signed by the Contracting Officer, or is pursuant to specific authority otherwise included as a part of this contract.

(c) The Contracting Officer is the only person authorized to approve changes in any of the requirements of this contract and, notwithstanding provisions contained elsewhere in this contract, the said authority remains solely the Contracting Officer's. In the event the contractor effects any change at the direction of any person other than the Contracting Officer, the change will be considered to have been made without authority and no adjustment will be made in the contract price to cover any increase in charges incurred as a result thereof.

C ONTRACTOR SUPPORT

Notice: Navy Use Of Support Contractor For Contract Closeout Functions

Naval Medical Readiness Logistics Command Detachment (NMRLCD) uses two private contractors in support of the contract closeout process. Those companies are Contracting Resources Group (CRG) of Federal Hill, MD, doing business under the authority of the Small Business Administration’s 8(a) program and the Ability One Program, doing business under the authority of the Javits-Wagner O’Day Act (41 U.S.C. § 47).

The contract closeout process includes activities such as processing deobligation modifications, obtaining contractor and requiring activity concurrence, preparing the DD-Form 1594 (Contract Completion Statement), and preparing closed files for archiving. Support contractors may perform additional administrative duties, including filing and processing simple administrative modifications. Performing these functions require the contractor employees to have access to the contract file. Therefore, information you provide to the Government or information already in the possession of the Government may be viewed by these support contractors in the course of performing contract close-out functions. The information that may be made available to the contractor may include pricing and technical proposals and performance information.

NMRLCD has signed Non-Disclosure Agreements with each support contractor employee and has required both contractors to provide a Conflict of interest Mitigation Plan to ensure these employees are firewalled from all business development activity.

By receipt and acceptance of a contract, the awardee and its subcontractors consent to access of their business sensitive/confidential or proprietary data by the Government’s support contractor personnel in order to perform close out services.

SYSTEM DIMENSIONS

The maximum dimensions of any one system cannot exceed the following:

Maximum Dimensions Screening Analyzer System Device mm m feet inches

Length: 4750 4.75 15.58 187

Height: 1650 1.65 5.41 65

Depth: 1600 1.60 5.25 63

Also devices should be able to fit through a maximum doorway of 42 inches.

(End of Clause)

ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

6 immunochemistry screening analyzer sys

FFP

Six (6) high-speed immunochemistry screening analyzer systems for Navy Drug Navy Drug Screening Laboratory (NDSL), Army Forensic Toxicology Drug Testing Laboratory (AFT DTL) and Headquarters Air Force Drug Testing Laboratory (HAFDTL) **** Analyzers, Laboratory, Clinical Chemistry, Automated [Device Code: 16-298] for the Drug Demand Reduction Program (DDRP) Locations: Navy Drug Screening Laboratory Great Lakes (Qty 2) Navy Drug Screening Laboratory Jacksonville (Qty 1) Army Forensic Toxicology Drug Testing Laboratory Fort Meade (Qty 1) Army Forensic Toxicology Drug Testing Lab Tripler Army Base (Qty 1) Headquarters Air Force Drug Testing Lab Lackland Air Force Base (Qty 1) FPOC: Melissa Lynn (melissa.a.lynn.civ@mail.mil) TPOC: Daniel Duben (Daniel.A.Duben.ctr@mail.mil) WAWF POC: Melissa Lynn (melissa.a.lynn.civ@mail.mil)

NET AMT

0001AA 2 Each high-spd immunochem screening anlyzr

FFP

NDSL Great Lakes -high-speed immunochemistry screening analyzer system capable of processing at least 6,000 tests per hour (a minimum of 500 samples per hour for a minimum of 12 unique tests) and comply with Department of Defense Instruction (DoDI) 1010.16 requirements for military drug testing and National Laboratory Certification Program (NLCP) guidelines for federal workplace drug testing.

FOB: Destination

PSC CD: 6630

0001AB 1 Each high-spd immunochem screening anlyzr sys

FFP

NDSL Jacksonville -High-speed immunochemistry screening analyzer system capable of processing at least 6,000 tests per hour (a minimum of 500 samples per hour for a minimum of 12 unique tests) and comply with Department of Defense Instruction (DoDI) 1010.16 requirements for military drug testing and National Laboratory Certification Program (NLCP) guidelines for federal workplace drug testing.

0001AC 1 Each high-spd immunochem screening anlyzr

FFP

AFT DTL Ft Meade -high-speed immunochemistry screening analyzer system capable of processing at least 6,000 tests per hour (a minimum of 500 samples per hour for a minimum of 12 unique tests) and comply with Department of Defense Instruction (DoDI) 1010.16 requirements for military drug testing and National Laboratory Certification Program (NLCP) guidelines for federal workplace drug testing.

0001AD 1 Each high-spd immunochem screening anlyzr

FFP

AFT DTL Tripler Army MC -high-speed immunochemistry screening analyzer system capable of processing at least 6,000 tests per hour (a minimum of 500 samples per hour for a minimum of 12 unique tests) and comply with Department of Defense Instruction (DoDI) 1010.16 requirements for military drug testing and National Laboratory Certification Program (NLCP) guidelines for federal workplace drug testing.

0001AE 1 Each high-spd immunochem screening anlyzr

FFP

HAFDTL Lackland -high-speed immunochemistry screening analyzer system capable of processing at least 6,000 tests per hour (a minimum of 500 samples per hour for a minimum of 12 unique tests) and comply with Department of Defense Instruction (DoDI) 1010.16 requirements for military drug testing and National Laboratory Certification Program (NLCP) guidelines for federal workplace drug testing.

7 Immunochem screenng anlyzr low thruput

FFP

Seven (7) high-speed immunochemistry screening analyzer systems with reduceded capacity for Navy Drug Navy Drug Screening Laboratory (NDSL), Army Forensic Toxicology Drug Testing Laboratory (AFT DTL) and Headquarters Air Force Drug Testing Laboratory (HAFDTL)

0002AA 2 Each OPTION 7 Immunochem screenng anlyzr low thruput

FFP

NDSL Jacksonville -option for augmentation of an additional high speed immunochemistry screening analyzer system with reduced throughput capacity requirements. The systems must be the same manufacturer as the base requirement in order to rapidly augment the required systems. Two (2) of six (6) systems shall provide 2/3 specimen throughput of the required systems.

0002AB 1 Each OPTION 7 Immunochem screenng anlyzr low thruput

FFP

NDSL Great Lakes -option for augmentation of an additional high speed immunochemistry screening analyzer system with reduced throughput capacity requirements. The systems must be the same manufacturer as the base requirement in order to rapidly augment the required systems. Third of six (6) systems shall provide 2/3 specimen throughput of the required systems.

0002AC 1 Each OPTION 7 Immunochem screenng anlyzr low thruput

FFP

AFT DTL Ft Meade -option for augmentation of an additional high speed immunochemistry screening analyzer system with reduced throughput capacity requirements. The systems must be the same manufacturer as the base requirement in order to rapidly augment the required systems. Six (6) systems shall provide 2/3 specimen throughput of the required systems, and one system shall provide 1/3 specimen throughout of the required systems.

0002AD 1 Each OPTION 7 Immunochem screenng anlyzr low thruput

FFP

AFT DTL Tripler Army MC -option for augmentation of an additional high speed immunochemistry screening analyzer system with reduced throughput capacity requirements. The systems must be the same manufacturer as the base requirement in order to rapidly augment the required systems. Six (6) systems shall provide 2/3 specimen throughput of the required systems, and one system shall provide 1/3 specimen throughout of the required systems.

0002AE 1 Each OPTION 7 Immunochem screenng anlyzr low thruput

FFP

HAFDTL Lackland -option for augmentation of an additional high speed immunochemistry screening analyzer system with reduced throughput capacity requirements. The systems must be the same manufacturer as the base requirement in order to rapidly augment the required systems. Six (6) systems shall provide 2/3 specimen throughput of the required systems

0002AF 1 Each OPTION 7 Immunochem screenng anlyzr low thruput

FFP

AFMES Dover -option for augmentation of an additional high speed immunochemistry screening analyzer system with reduced throughput capacity requirements. The systems must be the same manufacturer as the base requirement in order to rapidly augment the required systems. One (1) system shall provide 1/3 specimen throughput of the required systems

1 Immunochem Screenng Anlyzr low thruput

FFP

One (1) option for augmentation of an additional high speed immunochemistry screening analyzer system with reduced throughput capacity requirements for AFT DTL Ft Meade.

0003AA 1 Each OPTION 1 Immunochem Screenng Anlyzr low thruput

FFP

AFT DTL Ft Meade - Option for augmentation of an additional high speed immunochemistry screening analyzer system with reduced throughput capacity requirements. The systems must be the same manufacturer as the base requirement in order to rapidly augment the required systems. One (1) systems shall provide 2/3 specimen throughput of the required systems.

CONTRACT MINIMUM/MAXIMUM QUANTITY AND CONTRACT VALUE

The minimum quantity and contract value for all orders issued against this contract shall not be less than the minimum quantity and contract value stated in the following table. The maximum quantity and contract value for all orders issued against this contract shall not exceed the maximum quantity and contract value stated in the following table.

MINIMUM

QUANTITY

MINIMUM

AMOUNT

MAXIMUM

QUANTITY

MAXIMUM

AMOUNT

6.00 13.00

CLIN DELIVERY/TASK ORDER MINIMUM/MAXIMUM QUANTITY AND CLIN ORDER VALUE

The minimum quantity and order value for the given Delivery/Task Order issued for this CLIN shall not be less than the minimum quantity and order value stated in the following table. The maximum quantity and order value for the given Delivery/Task Order issued for this CLIN shall not exceed the maximum quantity and order value stated in the following table.

CLIN

MINIMUM

QUANTITY

MINIMUM

AMOUNT

MAXIMUM

QUANTITY

MAXIMUM

AMOUNT

0001AA

0001AB

0001AC

0001AD

0001AE

0002AA

0002AB

0002AC

0002AD

0002AE

0002AF

0003AA

INSPECTION AND ACCEPTANCE TERMS

Supplies/services will be inspected/accepted at:

CLIN INSPECT AT INSPECT BY ACCEPT AT ACCEPT BY

0001 N/A N/A N/A N/A

0001AA N/A N/A N/A Government 0001AB N/A N/A N/A Government 0001AC N/A N/A N/A Government 0001AD N/A N/A N/A Government 0001AE N/A N/A N/A Government 0002 N/A N/A N/A N/A 0002AA Destination N/A Destination Government 0002AB N/A N/A N/A Government 0002AC N/A N/A N/A Government 0002AD N/A N/A N/A Government 0002AE N/A N/A N/A Government 0002AF N/A N/A N/A Government 0003 N/A N/A N/A N/A 0003AA N/A N/A N/A Government

DELIVERY INFORMATION

CLIN DELIVERY DATE QUANTITY SHIP TO ADDRESS DODAAC /

CAGE

0001 N/A N/A N/A N/A

0001AA POP 01-JAN-2023 TO

31-DEC-2025

N/A NAVAL MEDICAL LOGISTICS COMMAND

SEE PWS

SEE PWS

SEE PWS MD

N62645

0001AB N/A N/A N/A N/A

0001AC N/A N/A N/A N/A

0001AD N/A N/A N/A N/A

0001AE N/A N/A N/A N/A

0002 N/A N/A N/A N/A

0002AA N/A N/A N/A N/A

0002AB N/A N/A N/A N/A

0002AC N/A N/A N/A N/A

0002AD N/A N/A N/A N/A

0002AE N/A N/A N/A N/A

0002AF N/A N/A N/A N/A

0003 N/A N/A N/A N/A

0003AA N/A N/A N/A N/A

CLAUSES INCORPORATED BY REFERENCE

52.203-3 Gratuities APR 1984 52.203-6 Alt I Restrictions On Subcontractor Sales To The Government

(JUN 2020) -- Alternate I

NOV 2021

52.203-11 Certification And Disclosure Regarding Payments To Influence Certain Federal Transactions

SEP 2007

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

JUN 2020

52.204-6 Unique Entity Identifier OCT 2016 52.204-10 Reporting Executive Compensation and First-Tier

Subcontract Awards

JUN 2020

52.204-16 Commercial and Government Entity Code Reporting AUG 2020 52.204-17 Ownership or Control of Offeror AUG 2020 52.204-18 Commercial and Government Entity Code Maintenance AUG 2020 52.204-25 Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment

NOV 2021

52.209-6 Protecting the Government's Interest When Subcontracting With Contractors Debarred, Suspended, or Proposed for Debarment

NOV 2021

52.209-9 Updates of Publicly Available Information Regarding Responsibility Matters

OCT 2018

52.209-10 Prohibition on Contracting With Inverted Domestic Corporations

NOV 2015

52.211-5 Material Requirements AUG 2000 52.211-17 Delivery of Excess Quantities SEP 1989 52.212-4 Contract Terms and Conditions--Commercial Products and

Commercial Services

NOV 2021

52.214-34 Submission Of Offers In The English Language APR 1991 52.214-35 Submission Of Offers In U.S. Currency APR 1991 52.219-8 Utilization of Small Business Concerns OCT 2018 52.219-9 Small Business Subcontracting Plan NOV 2021 52.222-1 Notice To The Government Of Labor Disputes FEB 1997 52.222-19 (Dev) Child Labor - Cooperation with Authorities and Remedies

(DEVIATION 2020-O0019)

JAN 2022

52.222-21 Prohibition Of Segregated Facilities APR 2015 52.222-24 Preaward On-Site Equal Opportunity Compliance Evaluation FEB 1999 52.222-26 Equal Opportunity SEP 2016 52.222-35 Equal Opportunity for Veterans JUN 2020 52.222-37 Employment Reports on Veterans JUN 2020 52.222-40 Notification of Employee Rights Under the National Labor

Relations Act

DEC 2010

52.222-50 Combating Trafficking in Persons NOV 2021 52.222-54 Employment Eligibility Verification MAY 2022 52.223-18 Encouraging Contractor Policies To Ban Text Messaging

While Driving

JUN 2020

52.224-1 Privacy Act Notification APR 1984 52.224-2 Privacy Act APR 1984 52.225-13 Restrictions on Certain Foreign Purchases FEB 2021 52.225-18 Place of Manufacture AUG 2018

52.225-25 Prohibition on Contracting with Entities Engaging in Certain Activities or Transactions Relating to Iran-- Representation and Certifications.

JUN 2020

52.227-1 Authorization and Consent JUN 2020 52.227-2 Notice And Assistance Regarding Patent And Copyright

Infringement

JUN 2020

52.228-5 Insurance - Work On A Government Installation JAN 1997 52.229-11 Tax on Certain Foreign Procurements--Notice and

Representation

JUN 2020

52.232-1 Payments APR 1984 52.232-11 Extras APR 1984 52.232-17 Interest MAY 2014 52.232-22 Limitation Of Funds APR 1984 52.232-28 Invitation to Propose Performance-Based Payments MAR 2000 52.232-34 Payment By Electronic Funds Transfer--Other Than System for Award Management

JUL 2013

52.233-3 Protest After Award AUG 1996 52.237-1 Site Visit APR 1984 52.237-2 Protection Of Government Buildings, Equipment, And

Vegetation

APR 1984

52.237-3 Continuity Of Services JAN 1991 52.242-13 Bankruptcy JUL 1995 52.243-6 Change Order Accounting APR 1984 52.244-5 Competition In Subcontracting DEC 1996 52.246-2 Inspection Of Supplies--Fixed Price AUG 1996 52.246-16 Responsibility For Supplies APR 1984 52.246-25 Limitation Of Liability--Services FEB 1997 52.247-34 F.O.B. Destination NOV 1991 52.249-8 Default (Fixed-Price Supply & Service) APR 1984 52.253-1 Computer Generated Forms JAN 1991 252.203-7000 Requirements Relating to Compensation of Former DoD

Officials

SEP 2011

252.204-7021 Contractor Compliance with the Cybersecurity Maturity Model Certification Level Requirement

NOV 2020

252.209-7004 Subcontracting With Firms That Are Owned or Controlled By The Government of a Country that is a State Sponsor of Terrorism

MAY 2019

252.209-7999 (Dev) Representation by Corporations Regarding an Unpaid Delinquent Tax Liability or a Felony Conviction under any Federal Law (Deviation)

JAN 2012

252.211-7008 Use of Government-Assigned Serial Numbers SEP 2010 252.219-7004 Small Business Subcontracting Plan (Test Program) MAY 2019 252.223-7004 Drug Free Work Force SEP 1988 252.225-7001 Buy American And Balance Of Payments Program-- Basic JUN 2022 252.225-7002 Qualifying Country Sources As Subcontractors MAR 2022 252.225-7012 Preference For Certain Domestic Commodities APR 2022 252.225-7013 (Dev) Duty-Free Entry (DEVIATION 2020-O0019) MAR 2022 252.225-7016 Restriction On Acquisition Of Ball and Roller Bearings JUN 2011 252.232-7003 Electronic Submission of Payment Requests and Receiving

Reports

DEC 2018

252.232-7010 Levies on Contract Payments DEC 2006 252.243-7001 Pricing Of Contract Modifications DEC 1991

CLAUSES INCORPORATED BY FULL TEXT

52.203-2 CERTIFICATE OF INDEPENDENT PRICE DETERMINATION (APR 1985)

(a) The offeror certifies that --

(1) The prices in this offer have been arrived at independently, without, for the purpose of restricting competition, any consultation, communication, or agreement with any other offeror or competitor relating to –

(i) Those prices,

(ii) The intention to submit an offer, or

(iii) The methods of factors used to calculate the prices offered:

(2) The prices in this offer have not been and will not be knowingly disclosed by the offeror, directly or indirectly, to any other offeror or competitor before bid opening (in the case of a sealed bid solicitation) or contract award (in the case of a negotiated solicitation) unless otherwise required by law; and

(3) No attempt has been made or will be made by the offeror to induce any other concern to submit or not to submit an offer for the purpose of restricting competition.

(b) Each signature on the offer is considered to be a certification by the signatory that the signatory --

(1) Is the person in the offeror's organization responsible for determining the prices offered in this bid or proposal, and that the signatory has not participated and will not participate in any action contrary to subparagraphs (a)(1) through (a)(3) of this provision; or

(2) (i) Has been authorized, in writing, to act as…