DRAFT N6264522R0017 Essential Characteristics Screening Analyzer (DDRP) dtd 8-16-2022.pdf

Attachment 1: DRAFT N6264522R0017 Essential Characteristics Screening Analyzer

ESSENTIAL CHARACTERISTICS

HIGH SPEED IMMUNOCHEMISTRY SCREENING ANALYZERS

The requirement is for six (6) high speed immunochemistry screening analyzer systems. 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 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 analysis, store the results, transmit the data via an interface to the DoD DDRP laboratory information management system (LIMS), and print a report of results on command.

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

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 DoDI 1010.16 Revision June 15, 2020 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 DoDI 1010.16 revised June 15, 2020 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,