Qualified Suppliers Listing (QSL) for Med/Surg Hospital Beds

Amendment 0002 : A. Questions have been raised concerning the technical requirements of the QSL. Below are the questions and responses: 1. The June 12 Amendment of MedSurg Hospital Beds 050218 QSL Source Sought added the specification that any Med/Surg beds offered must meet IEC 60601-2-52 for electrically operated medical beds and patient weight. Answer: The IEC 60601-2-52 requirement must be met. 2. DLA's response to question 1a. states that to be considered either a vendor currently has an Authority to Operate ("ATO") OR agrees to go through the IA process and obtain a Risk Management Framework ("RMF") ATO. Yet, in the answer to question 1d. DLA indicates that a QSL vendor will be required to have an RMF ATO. Our interpretation is that by agreeing to go through the IA process and obtain an RMF ATO it will remain in consideration. Please advise if this interpretation is incorrect. Answer: The interpretation is correct. 3. Based on the criteria in the QSL FBO Vendor Response Worksheet, a bed meeting these requirements does not store or transmit uniquely identifiable patient information or connect to the facilities' information network. Therefore, it should not be necessary that the beds must comply with applicable cybersecurity requirements. We will look forward to receiving Amendment 0002 for the clarification confirming if any Risk Management Framework process applies. Answer: The Risk Management Framework applies for all medical equipment that is currently, or could be in the future, used to store or transmit uniquely identifiable PI through the facilities information network. B. Medical Device Risk Assessment Questionnaire and Cyber Security requirements are included in the attached document. C. The response date is hereby extended with a closing of 17 October 2018; 5:00PM Central Time.