A.01.02_Draft_PWS_Q&A_Part_2_22Mar2018.pdf
PDF 191 KB Posted
- 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 regarding a draft performance work statement for medical laboratory testing services for HIV. The performance work statement requires contractors to hold all legally required licenses and accreditations for the state in which their laboratory is located, with no requirement to perform testing within the state where samples originate. Electronic security requirements involve attaining an Authority to Operate under the Risk Management Framework and interfacing with the government's electronic health record within a six month testing phase-in period. Contractors will interface with multiple military medical sites through a single connection to the Defense Health Agency's business-to-business gateway, with the government managing connectivity beyond that point. No pricing or spending information was provided.
Questions and answers, Part 2 to draft PWS
View the file
Other files
Show all 21
On GovTribe
Work with this file
- Download the original file
- Contacts named in this file
- Similar government files
- Ask GovTribe AI about this file
Text version
Q1. Certain States and Countries have different testing requirements and licensure. As this testing will be coming from military installations, would we still be asked to match the requirements within each State or Country? As an example “Is it in keeping with your requirements that we conduct the testing on samples we receive from NY State, in NY State. Given the state of NY’s specific requirements which we do not adhere should we conduct the tests in either Texas or California?” We don’t typically keep to regulations in one state that pertain to another state.
R1. IAW Sec 4.5.9. the Contractor’s laboratory shall hold all legally required licenses (including State licenses), registration, and accreditation in accordance with Federal statutes and implementing regulations and those of the State in which the laboratory is located. There is no requirements for testing to be performed within the state from which the military installation is located.
Additionally, although limited OCONUS testing support is included within the requirement in Sec 1.3.2.
the above requirement would still be applicable (i.e., must comply with all Federal regulations as well as those of the state in which the testing laboratory is located.
Q2. Is the requirement that “NIST level security” be completed at time of award? If we are in progress, will we still be able to bid with an expected completion date, post award? (DFARS 252.204.7012)
R2. Electronic Security requirements are defined in Sec 1.5.5.5. and Sec 6 Applicable Regulations and Manuals (i.e., DODI 8510.01 March 12, 2014 Incorporating Change 2, July 28, 2017). The process of assessing compliance with DoD’s Information Assurance (IA) requirements and applicable NIST security requirements are formally defined within DODI 8510.01 Risk Management Framework for DoD Information Technology. Sec 1.6 provides for a six month “Testing Phase In Period” where the Contractor must achieve the ability to electronically interface to the Government’s Electronic Health Record (HER). A critical component of the interface is attainment of an Authority to Operate (ATO) or permission to connect to the DoD’s network under RMF.
Q3. Does the list of facilities for interfacing include the OCONUS facilities?
R3. All OCONUS facilities connect to the Government’s network via DHA’s Medical Communities of Interest (MEDCOI) via DoD’s EHR (e.g., CHCS or MHS Genesis). Contractor must be able to successfully interface to all submitting activities both CONUS and OCONUS.
Q4. Do we as a vendor interface to multiple sites or just to DHA?
R4. The Contractor will interface to multiple sites via a single connection point through DHA’s B2B gateway. The contractor is responsible for the connection from their LIS to the B2B gateway, and the Government is responsible for the connection from the B2B gateway to the submitting activities.
Q5. Do you have the amount spent on this testing last year?
R5. The information is not releasable for public dissemination.
File details come from the government source that posted it. Updated .