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This document contains questions and answers related to a solicitation for Positive Airway Pressure (PAP) devices, focusing on device specifications and contract award details. The key points include:

The solicitation addresses technically acceptable PAP devices, specifically noting the inclusion of DreamStation 2 AutoTitrating CPAP devices for CLIN 0001, while DreamStation BiPAP devices are currently omitted due to potential FDA recall issues. The government's approach involves mitigating supply chain risks by potentially awarding contracts to multiple companies for the same device types. The Multiple Award Schedule (MAS) Indefinite Delivery/Indefinite Quantity (IDIQS) contract aims to provide flexibility for clinicians to order devices on a case-by-case basis, with the number of awards for a specific device to be determined by the Contracting Officer and Source Selection Board. Accessories not correlated with the FDA recall and currently on CSAS awards will be considered technically acceptable.

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• Regarding Attachment E TECHNICALLY ACCEPTABLE PAP DEVICES, it includes the DreamStation 2 part numbers DSX520H11C and DSX520T11C, for CLIN 0001, Auto- Titrating Continuous Positive Airway Pressure (APAP) Device. But for the other 3 PAP CLIN’s, the DreamStation BiPAP’s are not included, even though they are currently included in the existing Sleep contract through the DLS, 36C79121D0007.

o Is the reason the DreamStation BiPAP’s were not included due to an understanding that they have been discontinued?

o Is there any other reason the DreamStation BiPAP part numbers (listed below for reference) were omitted from Attachment E?

▪ DSX1030H11C Dreamstation BiPAP S/T with humidifier and cellular modem

▪ DSX1030T11C Dreamstation BiPAP S/T with humidifier , heated tubing and cellular modem

▪ DSX1130H11C Dreamstation BiPAP AVAPS with humidifier and cellular modem

▪ DSX1130T11C Dreamstation BiPAP AVAPS with humidifier, heated tubing and cellular modem

▪ DSX600H11C Dreamstation BiPAP Pro with Humidifier and cellular modem

▪ DSX600T11C Dreamstation BiPAP Pro with Humidifier, Heated Tubing and cellular modem

▪ DSX700H11C Dreamstation Auto BiPAP with humidifier and cellular modem

▪ DSX700T11C Dreamstation Auto BiPAP with humidifier, heated tubing, and cellular modem

▪ DSX900H11C Dreamstation AutoSV Advanced with Humidification and cellular modem

▪ DSX900T11C Dreamstation AutoSV Advanced with Humidification, Heated Tubing, and cellular modem

The government’s stance on the items listed is, if the FDA recall applies to them, they will have to be evaluated once they are reintroduced to the market.

• Regarding Attachment E TECHNICALLY ACCEPTABLE PAP DEVICES, can you confirm that the listed patient interface products within CLIN 0005-CLIN 0008, considered associated accessories and therefore already approved for this solicitation when released?

In line with the prior question and answer, accessories that are not correlated with the FDA stay and are currently on CSAS awards will be considered technically acceptable.

• Regarding section, B.15 PAP DEVICE/ASSOCIATED ACCESSORIES SELECTION (FAIR OPPORTUNITY PROCESS), how will it be determined if more than one offeror is awarded the same line item?

The purpose of MAS IDIQS is threefold for this requirement. First, the government intends to mitigate supply chain risk by awarding like devices to more than one company. Secondly, is to mitigate a supply chain bottleneck at the manufacturer level.

Finally, the invocation of 38 U.S.C § 8123 specifies that clinicians have the ability to order what they deem necessary in a case by case basis. This requires a multitude of devices, potentially across multiple manufacturers. Therefore, the number of awards for a device will be a judgement call by the Contracting Officer and Source Selection Board.

File details come from the government source that posted it. Updated .