Industry_Day_Q&A.pdf

Questions and Comments from Industry Day, 9 Nov 2017

• Will there still be a requirement to perform Quality Control testing equal 10% of all testing?

Given that the PWS now only requires an initial screen be performed by the contractor, and all initially reactive samples shall be forwarded to HDRL for duplicate testing the requirement to maintain external QC would be an excessive and unnecessary expense to the USG.

• Can the pickup from the serum repository be scheduled more or less often?

Due to the logistics and costs associated with pick-up/transport of samples by the DODSR, and based upon recent communication the applicable section (Sec 5.10.2) has been revised to shipments “shall be accomplished every 60 calendar days or more often as agreed upon between the contractor and DoDSR representative.”

• Would RMF cover both CHCS and Genesis?

Separate RMF submissions for the two systems would not be required. The Risk Management Framework replaced the DOD Information Assurance Certification and Accreditation Process (DIACAP) as the process to obtain authorizations to operate (ATO) or connect to the Government’s network. The RMF ATO would authorize the connection of the Contractor’s Laboratory Information System to the Government’s network, and the required connections would be identified within the RMF submission.

• 1.7 mentions 1 March 2018 as go live? Is that still applicable?

The current projected start date is 1 March 2018, however the official effective start date would be the effective date published in the final, official solicitation on FedBizOps.

• Appendix F paragraph 5 B states, "No more than 20% of rejected specimens submitted to HDRL for additional testing should be reportable via the Government's in-house testing platform." Does this requirement mean that if the contractor sends 100 rejected samples, no more than 20 can be tested and resulted by HDRL or the contractor will be in default of the contract?

This is an accurate interpretation of the requirement although the use of the terminology “in default of the contract” may not be the most appropriate. Exceeding this threshold would result in non-compliance with PWS/PRS requirements, and would be addressed IAW FAR and applicable guidelines. The intent of this requirement is to promote vendor implementation of standardized rejection criteria in order to reduce variability in the rejection process and minimize unnecessary rejections.

Additionally, when analyzers possess the ability to evaluate specific indexes for sample acceptability preference should be given to that method over visual discrimination which tends to be more subjective/non-standardized.

This question plays into not only the "discordant results" issue between platforms but also the next question.

• Appendix F paragraph 7 C states, "Contractor shall maintain a 30% confirmation rate as calculated by HDRL using percentage of initial tests that screen Positive that are confirmed Positive through confirmatory testing IAW approved algorithm." Is this requirement attainable by the contractor given that initial Positive samples on the Architect system are not being retested in duplicate after centrifugation at a minimum of 10,000 RCF(G)? With no repeat testing the contractor will be at a disadvantage. This brings up the point that the contract requires to follow an FDA approved product insert, if the repeat test is not performed this could be considered a deviation from the product insert and cause CLIA compliance issues.

Given that the PWS now only requires an initial screen be performed by the contractor, and all initially reactive samples shall be forwarded to HDRL for duplicate testing the requirement to maintain a 30% confirmation rate has been removed.

• Our system allows for clarification of samples in the product insert on page 3 in the second part of the paragraph "Preparation for Analysis". Can wording and compensation be added to the contract to allow the Contractor to pour-off and spin down samples that would otherwise be rejected for improper centrifugation?

Sec 5.5.1.4.6.requires that hemolyzed, coagulated, lipemic, quantity of serum not sufficient and unreadable test specimens shall be forwarded to HDRL within 24 hours of rejection. It is permissible to further process samples, IAW regulatory requirements, manufacturer’s instructions and the contractor’s local policies and procedures, to allow for testing of certain samples that would otherwise be rejected. Currently, the contractor cannot bill the government for a rejected sample, and the Government believes it is in the contractor’s best interest to perform testing when appropriate within the limitations defined above. The Government doesn’t believe it is commercial standard practice to bill for additional sample processing which may be required in these instances to allow for testing.

• How long will it take to get the new interface with Cerner established? Can it be done in conjunction with getting the ATOc and the RMF or do we have to wait until after the ATOc and RMF have been approved to begin the process?

Since Cerner is a Commercial of the Shelf system (COTS) if the contractor’s system already has an established interface to Cerner the required lead time should be minimal.

If it requires establishment of an entirely new interface then the contractor’s historical interface development lead times would likely provide the best estimate as it would be based primarily upon the contractor’s available assets. Per MEDCOM CyberSecurity it would potentially be permissible for portions of these two processes to occur in tandem.

• According to the PWS there is a 180 day ramp up. Would testing need to begin on the date of award or would the 180 days be provided to get prepared?

The 180 day phase in period (“ramp up”) is intended to provide sufficient time for the contractor to attain an authority to operate (ATO) and establish interface(s) to CHCS and MHS Genesis. The contractor should be prepared to assume testing NLT the end of the phase in period; however if the contractor is able to meet all requirements, achieve an ATO and assume testing prior to the completion of the 180 phase in period then that is permissible.

• What staff/help will be available to the new contractor in regards to setting up and developing the interfaces with CHCS and or MHS Genesis? MEPCOM and another system with the NG and AR will also need to be established, what help is available for them also?

Interface development is a contractor responsibility and there is no Government assistance available. The Government would provide assistance in establishing connectivity, interface testing and validation, and RMF support (e.g., Assess & Authorize).

• How much notice will be given to implement the contingency testing for MEPCOM? They have an 8 hour turnaround time vs 24 hour turnaround time...how strict will that standard be?

By definition contingency testing is testing that is possible but cannot always be reliably predicted. For those instances where contingency testing requirements are known in advance (i.e., scheduled downtime) then advance notice would be provided commensurate with situational circumstances and timelines. In those instances where contingency testing requirements are not known in advance (i.e., unscheduled downtime) then it is likely minimal notice could be provided. Performance against this requirement would be measured in accordance with the QASP and PRS requirements.

• Could do DoDSR shipments be scheduled more often if needed?

Due to the logistics and costs associated with pick-up/transport of samples by the DODSR, and based upon recent communication the applicable section (Sec 5.10.2) has been revised to shipments “shall be accomplished every 60 calendar days or more often as agreed upon between the contractor and DoDSR representative.”

• P. 26: turnaround time discrepancy

The turnaround times identified on page 26 included 24 hours for USAR/RHRP (5.5.1.2.1), 24 hours for ARNG (5.5.1.3.1.) and 8 hours for USMEPCOM for contingency testing (5.5.1.4.3). These turnaround times are correct as written. USMEPCOM requires expedited testing of results due to strict timelines for accession (i.e., new recruit) processing.

● Quality assessment suggestion: given focus on negative predictive value at the contractor level, but be useful to relent on QC and allow randomized retesting of prev.

reported specimens

Additional Quality Control measures have been removed (10% quality control, 30% confirmation rate, etc). If indicated re-testing of samples would be considered a Government function, and is not incorporated as an explicit vendor requirement within the PWS.

● Can you clarify unusual requirement to deliver all instrument data including test results, DD readings etc in the order results are [illegible] into downstream systems? Instrument middleware vs LIMS considerations.

This requirement would be applicable to raw run data and associated demographic information (e.g., name, date of birth, date of draw, date of run, date of report, cut-off, signal/cutoff) for valid runs.

● PWS requires unsuitable specimens to be transmitted to HDRL. Can contractor salvage poorly processed specimens (from above lot, poor gel barrier etc)?

Sec 5.5.1.4.6.requires that hemolyzed, coagulated, lipemic, quantity of serum not sufficient and unreadable test specimens shall be forwarded to HDRL within 24 hours of rejection. It is permissible to further process samples, IAW regulatory requirements, manufacturer’s instructions and the contractor’s local policies and procedures, to allow for testing of these samples that would otherwise be rejected.

● Form and format of WRAIR results, feedback to contractor? This is important for ongoing system evaluation and QM.

Form and format of results will be IAW PWS. Requirements are identified within sec 5.5 under Reporting Test Results. The electronic format for results from HDRL,WRAIR are identified within Exhibit E.1. Electronic Data Formats.

● Can you provide more information about independent process to categorize and validate information systems to include approved vendors.

The processes and procedures associated with the RMF process are described within the PWS and applicable cited references. As mentioned during industry day the procedures for system categorization are described in NIST Special Publication 800-60 Volume II Revision 1. This system categorization forms the basis upon which specific security controls are applied to the vendor’s system.

● Verify requirement for frozen archiving “within four hours … conclusion of all specimen testing”.

The requirement is accurate. In accordance with Exhibit H and DODSR requirements upon completion of testing specimens shall be aliquoted and frozen at -30ºC or below.

• XX Laboratory is focused on delivering a cost efficient alternative to blood vial specimens to the U.S. Military: Dried Blood spot card specimens for HIV analysis

As outlined within the PWS the Government’s current requirements are not compatible with the use of dried blood technology due to multiple factors (supplemental confirmatory testing, shipment of residual serum to DODSR, etc).

• In regards to the various information technology (IT) / security elements, are there alternative models including a Government-recommended IT solution or pre-qualified solution which could significantly reduce time to start and overall project cost.

Unfortunately there are no prequalified Government solutions which could be leveraged outside of the use of the Government’s EHR and operation from within the Government’s network which is not feasible within the context of this requirement. This requirement will necessitate RMF compliance and attainment of an ATO unless a COTS system is selected which could streamline the process. This office is not aware of any COTS Laboratory Information Systems that currently possess either a DIACAP or RMF ATO.