A.01.02_Contractor_Questions_and_Answers_12Mar2018.pdf
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- Attached to
- Medical Laboratory Testing Services - HIV
- Solicitation number
- W81K04-18-R-0004
- Issued by
-
Department of the Army Medical Command
About this file
This document contains questions and answers related to a draft performance work statement for medical laboratory testing services for HIV. The performance work statement requires a contractor to provide HIV testing and reporting services for the U.S. Army Medical Command. It addresses background check requirements for contractor personnel, applicability of Army regulations, criteria for rejection of specimens, and acceptance of FDA-approved fifth generation HIV testing systems to replace the currently required fourth generation systems. Vendors had the opportunity to attend an industry day conference on November 9, 2017 to ask questions and provide feedback on the draft performance work statement prior to proposal submission.
Contractors questions and answers.
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Document Pg # Para # Question Answer
A.01.02_1- PWS_4th_ Gen_HIV_ Draft
Page 3 1.5.5.3.1 It is our understanding that anyone that has contact with any of the Army Specimens or information will need to have a backround check run by the government. Are we understanding this requirement correctly?
This specific citation is only applicable to individuals assigned to an ADP/IT position where their duties meet the criteria of the position sensitivity designations outlined in AR 25-2. As such this specific requirement would not be applicable to general laboratory personnel based strictly upon contact with Army specimens.
Personnel who require Common Access Cards (CAC) in order to access a Government network or system will require a background check. As part of this process a background check will be initiated through MEDCOM HQ Security Office. The only personnel who require CAC access will be those IT/IA personnel who will manage the contractor's RMF package within eMASS.
A.01.02_1- PWS_4th_ Gen_HIV_ Draft
Page 3 1.5.5.3.1 How long will it take to receive notification of "the Office of Personnel Management has scheduled the employee's investigation"?
Upon submission of the background investigation check by MEDCOM HQ Security Office the individual will receive an electronic communication from OPM regarding completion and submission of an Electronic Questionnaire of Investigations Processing (e-QIP). The investigation will not be initiated until the individual submits a complete form which is acceptable by OPM. Delays in this process are typically associated with missing or incomplete information provided in the submission.
Additional information can be found at the OPM Website or eQIP FAQs at the URL below.
https://nbib.opm.gov/e-qip-background-investigations/e-qip-faqs/
PWS_4th_ Gen_HIV_ Draft
Page 3 1.5.5.3.1 Employees shall (must) have at a minimum an ADP Sensitivity Designation of Level II to access the DOD Network. How long will it take to find out if an employee meets this requirement?
The ADP-I-IV designations within AR 25-2 are primarily for personnel who perform/manage IT related functions within the DOD's network.
Current PWS requirements do not include any contract personnel who would meet this criteria, however the requirements for a background check and CAC issuance for personnel who access the Government's network or system would still be applicable.
A.01.02_1- PWS_4th_ Gen_HIV_ Draft
Page 2 1.5.5.1.2 In this paragraph there are Army Regulation that must be followed.
Will this supercede any RMF criteria or will the RMF be the gold standard.
The referenced Army Regulations define the policies, procedures, and responsibilities for information assurance certification and accreditation (C&A) requirements. This process is currently implemented via the RMF, however changes in Army Regulations could result in changes to the approved C&A process. In this sense the Army Regulations are the "gold standard".
A.01.02_1- PWS_4th_ Gen_HIV_ Draft
Page
Attachem ent 1
QASP -
Exhibit F para B.5.b
The Requirement states no more than 20% of rejected specimens that meet PWS requirements for forwarding to HDRL should be reportable using Government's current in-house testing methods…Will the government's in house testing methods and criterea for rejection be shared with the company awarded the contract?
Following contract award information on the Government's in-house testing method and criteria for rejection can be shared with the Contractor upon request.
PWS_4th_ Gen_HIV_ Draft
Page
Attachem ent 1
QASP -
Para
4.2.10
What if the government in house testing method mentioned in Exhibit F para B.5.b and the company awarded the contracts testing method are different and the assay or testing method of the contractor does not allow for the specimen to be tested per FDA guidelines? If there is a difference in the criterea for testing between the government's and contractors methodology that does not allow the contractor to test the specimens because they will be out of compliance will this still be held against the contractor?
Testing will be performed in accordance with the manufacturer's package insert for theFDA approved 4th Generation HIV test method in use by the Contractor. Any conflicts between the Government's requirements indentified within the PWS and the manufacturer's package insert (e.g., specimen collection, preparation, and storage requirements) should be identified at time of contract award. In the event of differences in sample acceptability requirements between the manfacturer's methods in use by the Contractor and the Government's methods the Contractor shall minimally comply with the manufacturer's requirements.
In reference to the special notice (W81K04-18-R-0004), it is emphasizing the use of FDA approved 4th generation systems for HIV testing. Now there is a new FDA approved 5th generation system on the market? The question is this new system acceptable as a better replacement for the 4th generation system.
No. The Army's requirement at this time is for the 4th Gen HIV.
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