Att 2 - Evaluation Factors - Screening Analyzer Revised 01 SEP 2022.pdf

SA EF v4

EVALUATION FACTORS

HIGH SPEED SCREENING ANALYZER

Technical proposals must include sufficiently detailed information to enable evaluation based on the six (6) factors listed below in order of decreasing priority:

1. Conformance to Essential Characteristics

2. Design, Quality and Capability

3. Information Assurance

4. Enhancing Factors

5. Past Performance/Contract Evaluation

6. Price

Evaluation Factor 1 and Evaluation Factor 2 will be evaluated individually on a pass/fail basis. If an Offeror’s technical proposal is judged to have failed under Evaluation Factors 1 or 2, either initially or following discussions (if they are conducted), the firm's offer will receive no further consideration for award;

unless there are no other technically compliant proposals. If an Offeror’s technical proposal is judged to have passed both Evaluation Factors 1 and 2, then the Offeror will subsequently be notified of Evaluation Factor 3, the information Assurance of their Screening analyzer, to determine compliance. If an Offeror’s technical proposal is judged to have failed under Evaluation Factor 3, the firm’s offer will receive no further consideration for award unless there are no other technically compliant proposals. If an Offeror is judged to have passed under all Evaluation Factors 1, 2, and 3 minimum requirements, then the firm’s offer will be further evaluated on a tradeoff basis taking into consideration Evaluation Factor 4, Enhancing Factors. In doing so, Factor 4, Enhancing Factors, is more important than Factor 5 Past Performance/Contract Evaluation. The combination of Evaluation Factors 4 and 5 will be more important than Factor 6, Price.

Conformance to Essential Characteristics – Evaluation shall include the ability to meet the essential characteristics for this requirement. Vendors not meeting all requirements will not be further considered for award unless there are no other technically acceptable Offerors. This will be rated either Pass or Fail.

Design Quality and Capability – The government will evaluate the design, quality and capabilities of the proposed system to meet the drugs of abuse detection requirements of the Drug Demand Reduction Program.

Vendors not meeting all requirements will not be further considered for award unless there are no other technically acceptable Offerors. This will be rated either Pass or Fail.

Essential Characteristics and System Design, Quality and Capability Requirements included in the Performance Work Statement:

1. Minimum Requirements

1.1. 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.

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

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

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

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

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

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

1.8. The system shall utilize commercially available test tubes.

2. System Performance Requirements

2.1. 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.

2.2. 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.

2.3. 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.

2.4. 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.

2.5. 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.

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

2.7. 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.

2.8. 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.

2.9. 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.

2.10. 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.

2.11. 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.

2.12. 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.

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

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

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

2.16. 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.

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

3. Warranty and Maintenance Requirements

3.1. 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.

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

3.3. 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.

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

4. User Security Access Requirements

4.1. 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.

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

4.3. 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

5.1. 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.

5.2. 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.

5.3. 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.

5.4. 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.

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

5.6. 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.

5.7. 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).

5.8. 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.

5.9. 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.

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

Information Assurance - The government will evaluate the capability of the proposed system to meet Information Assurance (IA) requirements. This evaluation will be based on the information provided in the completed C&A Questionnaires.

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.

Past Performance The Government will evaluate the Offeror’s recent relevant past performance record as to (1) the functional performance of the proposed or screening analyzers that the Offeror has delivered to previous customers, and

(2) the quality and timeliness of the technical assistance, hardware and software updates/upgrades that the vendor has supplied to its customers following the initial fielding of those systems.

(1) The government reserves the right to consider other past performance information at its disposal, in addition to any information obtained from the references provided above. The government is likely to randomly select references provided for contact and does not commit to contact every reference.

(2) Offerors shall provide past performance data for all similar contracts for the last 3 years, up to 4 data points, or 4 data points for delivery starting with the most recent contracts for which delivery occurred at least 3 months prior to the closing of this solicitation.

The data shall include:

a. Organization/Location,

b. POC/Number,

c. Contract Reference Number,

d. Contract Date,

e. Value of the Contract (rounding to the nearest $5K is acceptable), .f. and “Has the POC agreed to be contacted as a reference?”

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Commented [CPHCN1]: I don’t understand this part of the sentence, “proposed or screening”

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Commented [CPHCN2]: