B.01 Questions and Answers.docx

W91YTZ-24-R-0021

Chemistry/Immunochemistry Analyzers and Reagents Questions and Answers

Hepatitis A IgG is preferred, but Total Hepatitis A antibody can be used.

1. Respectfully requesting an extension of 5-business days for solicitation to ensure complete and accurate response – proposed due date of 10/21/24.

EHCB Response: The proposal due date will remain unchanged.

1. Respectfully request clarification on what patient types the 24 annual Troponin-I (High Sensitive) tests are tested on.

1. Are these assays for patients presenting to the ED with Chest Pain symptoms and if so, what is your current serial draw protocol or is the annual volume of 24 Troponin tests used for patients coming from the clinical practice?

EHCB Response: Troponin-I testing was discontinued after SOW was submitted. Troponin I (HS) test is no longer needed.

1. If the Troponin test volume is coming from the clinical practice, can you provide the clinical sensitivity preferred to properly evaluate these patients?

EHCB Response: Troponin-I testing was discontinued after SOW was submitted. Troponin I (HS) test is no longer needed.

1. Requirement: The system must be able to assess the level of common interferents (hemoglobin, lipemia, and icterus) for each sample without decreasing overall sample throughput.

2. Question: Is it the requirement that the Hemoglobin, Lipemia and Icterus detection process not take up additional sample processing time and that no additional sampling for Hemoglobin, Lipemia and Icterus detection be processed (example running separate test for HIL detection)?

EHCB Response: The system must be able detect hemoglobin, lipemia and icterus without impacting the overall sample throughput.

1. Requirement: The system must eliminate sample carryover error.

3. Question: Is it the requirement that all sample carryover be eliminated for chemistry and Immunoassay testing?

EHCB Response: The system must have a process that prevents/minimizes carryover.

1. Requirement: Instrumentation must have a maximum dead space volume of 40 uL.

4. Question: Is the maximum allowable sample dead volume inclusive of any over aspiration volume needed?

EHCB Response: Dead volume must be 40-50UL

1. Requirement: The system must possess the ability to monitor and report onboard inventory control for each assay and to be able to store calibrators and controls on-board.

5. Question: Can you elaborate on process and procedure to store and run quality control onboard given your on-board test capacity requirements. There are a total of 52 assays in the SOW, if the assays and QC share an onboard position on an analyzer, is it the lab’s intention to only store and run a fraction of the assays onboard?

EHCB Response: The system must be able to store calibrators and controls on-board, the system must have enough on-board space to store both reagents, calibrators and Quality control.

5. We request that this requirement be made preferred and not required. Our system has 6 months stability on most assays not requiring frequent calibrations, thus eliminating the need to store them on board. Additionally other manufactures cannot store all the needed controls and calibrators to run all testing requiring a manual interaction with the instrument.

EHCB Response: This is a preferred requirement, dependent on the systems stability of reagent.

1. Can you elaborate on your need / clinical importance of requesting A-HAV IGG assay vs. A-HAV Total assay? Only one vendor offers A-HAV IGG which would make this requirement unduly restrictive. We therefore request that this requirement be modified to preferred instead of required and or that A-HAV Total would be an acceptable alternative to A-HAV IGG. The QuidelOrtho A-HAV assay is clinically in use at multiple DOD/DHA facilities.

EHCB Response: Hepatitis A IgG is preferred as testing is utilized for the determination of immunization status, but Total Hepatitis A antibody test can be used.

1. Requirement: The Hepatitis A IgG and the Hepatitis B surface antibody assays turnaround test time (TAT) is required to be 30 minutes or less.

7. Question: With the requirement of Preanalytical automation the processing of all assays including Hepatitis assays can be improved, instead of providing a theoretical TAT for these two assays we recommend changing the requirement to the total processing time to complete the Hepatitis samples the present to the lab at a given time or changing the requirement to preferred instead of required.

EHCB Response: A Turnaround of approximately 30-45 minutes. Throughput for immunoassays must be a maximum of 200 tests per hour.

1. Can the offeror please clarify the requirement for item 19, requesting a front-end sample process in-put out-put module.

EHCB Response: The system must have a sample capacity of 250-300 samples, this may be in the form of a separate front end sample module in which samples can be loaded/ unloaded all at one time.

10. Pg. 217/290

13. Instrumentation must have a maximum dead space volume of 40 uL. Due to high peak volumes automation line must be capable of up to 1500 tests per hour. Chemistry and Immunoassay instrumentation must have the ability to load samples and be ready to use reagents continuously, while the instrument is in operation, without interruption to patient testing. Requested change: Please change this requirement to 50uL to promote full and open competition.

EHCB Response: System must have 40-50 uL maximum of dead space volume.

11. Pg. 218/290 Statement 26: Authority to Operate: The proposed solution shall have a current Defense Health Agency Authority to Operate (ATO) for their proposed solution. The corresponding eMASS ID shall be provided by the quoter. The Government will confirm the Offeror’s proposed products are currently authorized to interface with Military Health System (MHS) Genesis. Clarifying question: Is this statement only applicable to the scope of the SOW or also to the other contract requirements?

EHCB Response: An ATO must be obtained within 12 months of the contract award (See Attachement 1 in SOW page 9, para. 1.10.)

12. Pg. 221 & 222/290 V. Maintenance

d. The vendor shall provide maintenance services Monday through Friday from 0730-1700 local time, excluding Federal Government holidays as seen at the following site: https://www.opm.gov/policy-data-oversight/pay-leave/pay-administration/fact-sheets/holidays-work-schedules-and-pay.

EHCB Response: Information is correct we are not opened on Federal Holidays or weekends.

13. VII. Corrective Maintenance

a. Vendor shall provide on-site corrective maintenance from 0730-1700 Local Time, Monday-Friday, to include unlimited service calls. Telephonic technical support shall be available 24 hours per day, 7 days per week. In the event of a hard system downtime that both analyzers (main and back-up) are down and cannot perform critical STAT testing, the vendor must provide emergency services, to include onsite emergency repair, twenty-four (24) hours a day, seven (7) days a week, to include federal holidays.

EHCB Response: EHCB Response: On-Site corrective maintenance from 0730-1700 Local time, Monday -Friday to include unlimited service calls. Telephonic technical support shall be available 24 hours per day, 5 days per week. In the event of a hard system downtime in which both systems are down and cannot perform testing, the vendor must provide emergency service to include onsite repair within 24 hours to exclude Federal holidays and weekends.

14. Clarifying question:

Please clarify if the onsite service coverage needs to be Monday through Friday 0730-1700 excluding federal holidays as indicated in V. Maintenance d. OR 24/7 including federal holidays as indicated in VII. Corrective maintenance a.

EHCB Response: Monday through Friday 0730-1700 excluding Federal holidays and weekends.

15. Pg. 223/290 Statement X:

X. System Interface Requirement / Cybersecurity Regulations and Guidance The instruments must have bidirectional capabilities and interface with MHS Genesis through Data Innovations (DI) middle-ware or other DHA CYBERLOG approved middle-ware with auto verification enhancement. Vendor must provide Laboratory Informatics System (LIS) support during initial LIS/Analyzer installation and thereafter when LIS system problems arise or an upgrade is required. Vendor must meet DHA and NH Jacksonville Information Technology (IT) requirements and must have an Authority to Operate (ATO) in place with CYBERLOG at time of vendor quote submission.

ATO is not supposed to be a disqualifying factor. Unless something has changed recently, we do not believe that Instrument Manager has an ATO.

Clarifying question, does the total solution need to be ATO approved or just the instrument? Guidance proved by CyberLOG is that new solutions can not go through the RMF process for ATO until a site purchases the software and then it will go through the process.

EHCB Response: Middleware and instrument must have an ATO. ATO must be obtained within 12 months of contract award (See Attachement 1 in SOW page 9, para. 1.10.)

16. Pg. 224/290 Army Cybersecurity/Risk Management Framework (RMF) Requirements System Security Requirements

0. The vendor shall submit to the Government, included in the offer/quote, all sections of the Medical Device Cybersecurity Assessment (Questionnaire), which is provided by the government. Additionally, a vulnerability assessment/report is required from a NESSUS scanner as this is the DoD standard, and Vendors must provide a NESSUS scan prior to award and throughout performance.

EHCB Response: Please submit exhibit 1 with proposal.

17. Clarifying question, can solutions that currently do not have ATO can be submitted for review? EHCB Response: Yes, although a current ATO is preferred. An ATO must be obtained within 12 months of the contract award (See Attachement 1 in SOW page 9, para. 1.10.)