SOURCES SOUGHT
65 -- DEFIBRILLATORS - Brand Name Or Equal
- Notice Date
- 4/10/2023 10:59:53 AM
- Notice Type
- Sources Sought
- NAICS
- 339112
— Surgical and Medical Instrument Manufacturing
- Contracting Office
- 244-NETWORK CONTRACT OFFICE 4 (36C244) PITTSBURGH PA 15215 USA
- ZIP Code
- 15215
- Solicitation Number
- 36C24423Q0720
- Response Due
- 4/18/2023 9:00:00 AM
- Archive Date
- 06/17/2023
- Point of Contact
- Contracting Officer, Jennifer Cutshall, Phone: 814-943-8164
- E-Mail Address
-
jennifer.cutshall2@va.gov
(jennifer.cutshall2@va.gov)
- Awardee
- null
- Description
- The following is a Sources Sought/Request for Information notice. This posted notice is not a Pre- Solicitation or Solicitation document. The government is not currently soliciting bids, quotes or proposals at this time; however, reserves the right to do so at a later date. The James E. Van Zandt VA Medical Center, Altoona, PA, has a potential brand name or equal requirement for replacement of its defibrillators. The item provided for a brand name reference is as follows: Zoll R Series Plus Defibrillator with Expansion Pack, SpO2, One Step Pacing, EtCO2 The following items/equivalents are required with outlined salient characteristics. Equivalent products meeting listed salient characteristics will be considered. 25 ea - Zoll R Series Plus Defibrillator with Expansion Pack - SpO2, OneStep Pacing, EtCO2 (mainstream) (OR EQUIVALENT) 1 ea - SurePower Charging Station (OR EQUIVALENT) 29 ea SurePower Rechargeable Lithium Ion Battery Pack Training for staff in equipment operation Salient Characteristics: Defibrillator must have a FIPS compliant wireless VLAN connection The defibrillator shall provide multiple energy levels from 1 to 200J utilizing only Rectilinear biphasic waveforms. The defibrillator shall use one set of electrodes for EKG monitoring and energy delivery for both pacing and defibrillation The defibrillator shall have a built-in mechanism for storing paddles when not in use, e.g. when using disposable electrodes. Paddles shall fit snugly in the paddle receptacles. If the defibrillator is equipped with an internal test load, discharging the unit with the paddles in the receptacles shall be safe and easy. Internal paddles and their cables shall be easy to clean, sterilizable, well-constructed and shall have adequate strain reliefs. The internal paddle cables shall be straight, not coiled, so that the paddles can rest on a surgical field without being secured. Each set of internal paddles shall be permanently identified to uniquely identify it for tracking. The vendor shall provide Instructions for Use (cleaning instructions) for internal paddles. When internal paddles are connected, the defibrillator energy delivery shall be limited to 50J. The discharge buttons on paddles shall be well protected against inadvertent activation. Patient cables shall be flexible enough to easily reach a patient at least 2m (6.6ft) away. Operating instructions shall be placarded on the unit. These instructions shall be easy to read from a normal viewing angle and shall be easy to understand. The controls for the defibrillation sequence shall be clearly labeled in numeric order and shall be easy to activate. The defibrillator shall clearly indicate when the defibrillator is charging and when it is in the charge-ready state. The defibrillator shall provide time to charge that is <15 seconds for all starting battery levels except a depleted battery, and for AC powered device regardless of the battery state. The defibrillator shall be able to deliver a set of three shocks within 90 seconds. A fully charged defibrillator shall automatically disarm (i.e. dump its charge internally) if it is not intentionally discharged within 2 minutes of being charged. The defibrillator shall provide synchronous delivery capability. The defibrillator shall automatically revert to the defibrillate mode after a synchronous discharge. The defibrillator shall have external pacing capability The defibrillator shall remove CPR artifact from the ECG thus eliminating the need to pause CPR to visualize the patient s underlying heart rhythm. The defibrillator shall offer different modes for BLS rescuers vs. ACLS rescuers. The default mode at power-on shall be for the BLS rescuer with the capability to manually change to the ACLS rescuer mode. To prevent delays in initiating analysis, the unit shall start analysis automatically or shall prompt the operator to initiate analysis. The defibrillator shall have capability to monitor ECG, non-invasive blood pressure, pulse oximetry (compatible with Nellcor or Masimo probes) and End-tidal CO2. Initial or default alarm limits shall be set to values that are likely to provide reasonable protection for most patients. Both audible and visual indicators shall be present for any alarm condition that poses a significant risk to the patient. Visual indicators that accompany an alarm condition shall readily indicate which alarm has been violated and this feature shall not be capable of being disabled. The status (e.g. on, off, suspended) of the alarms shall always be clearly displayed regardless of which function screen is displayed. Audible alarms shall be clearly audible at any setting and shall continue to sound as long as the alarm condition is present or until the alarm is acknowledged/silenced by a clinician. Instances in which non-invasive blood pressure measurements cannot be made shall be indicated by an alarm. The pulse oximetry capability shall display either a pulse waveform or a signal-strength indicator. A recorder with good trace quality shall be provided with the defibrillator. The recorded strip shall include periodic annotation of at least the time, date, lead, gain, heart rate, and operating mode. The recorded strip shall indicate the occurrence of discharges and shall annotate the set energy. It is desirable for the recorded strip to include indications of charge and disarm status and transthoracic impedance. Batteries for the defibrillators shall provide at least four hours of monitoring time or 10 maximum energy shocks. Determining battery charge status shall be easy based on the availability of a battery status indicator. A battery charging station with multiple bays shall be available for charging spare batteries. The defibrillator shall have the capability to communicate wirelessly for data review of a resuscitation event and for synchronization of the clock. That wireless communication must be FIPS 140-2 and the vendor shall provide their FIPS certificate number. Stored information shall be retained in the defibrillator until intentionally erased. Exhaustion or removal of the primary battery shall not erase the information stored in memory. A fault condition related to the documentation feature (e.g., capacity full, tape door open, module removed) shall not prevent defibrillator operation. The defibrillators shall store data from each use and communicate wirelessly with vendor provided software to analyze that data and trend code information in order that Informatics and the Code Team can review and assess each cardiac arrest treatment as an important aspect of quality assurance as per requirements of VHA Directive 2001-059 2. Training On-site training of clinicians shall be provided for all shifts at all facilities as arranged with the facility coordinator. Set up/installation are not required; however, vendor will be required to perform equipment training for nursing staff. Technical training shall be provided for biomedical engineering staff to enable performance of preventive maintenance, troubleshooting, and repair in-house. Operator and technical manuals will be provided to each healthcare system. Electronic copies are preferred. 3. Security The defibrillators shall be FIPS 140-2 compliant. The vendor will identify the certificate number for FIPS compliance. The vendor shall comply with all security requirements of the VA s Office of Information Technology. The vendor shall complete and return separate 6550 forms (attached) for the analytics software and defibrillators. Additionally, the vendor shall provide each product s MSD2 and a diagram of data flow for each product. The analytics software shall be approved in the Office of Information Technology s Technical Resource Manual (TRM) or the vendor shall be willing to gain approval in TRM. The vendor shall minimize the number of staff members needing access to the VHA s network. Please indicate the number needed. These individuals shall return completed forms within 10 days of receipt from the VA. 4. Project Management The vendor shall assign one project manager for planning and completing the implementation work. The project manager shall schedule the replacement with the facility coordinator to minimize interruption of service. The vendor shall develop a project plan that includes timeline for deployment. The project plan must be provided to the COR within 1 month of contract award. The vendor shall execute the project plan. The vendor shall schedule periodic status update meetings. These meetings will be conducted throughout the period of performance on an as needed basis. 5. Maintenance & Support The defibrillators shall facilitate remote monitoring and troubleshooting, including battery status. The defibrillators shall perform daily self-checks without manual initiation and without the use of a separate test load. The results shall be stored for later viewing and download and shall also be made available through wireless communication. The defibrillator shall automatically synchronize its clock to that of the hospital network. The defibrillator shall have a warranty period of at least 1 year during which all service and software upgrades are provided at no additional cost to the VA. Longer warranty periods are preferred. Delivery and installation: All items must be FOB Destination Only to the following location: Altoona VA Medical Center Attn: (VA Purchase Order #) 2907 Pleasant Valley Blvd. Altoona, PA 16602 ALL INTERESTED PARTIES MUST ALSO HAVE AN ACTIVE REGISTRATION IN THE SYSTEM FOR AWARD MANAGEMENT (SAM) DATABASE. TO REGISTER, PLEASE VISIT WWW.SAM.GOV. Responses to this notice shall include: Company Name Address Point of Contact Phone Number Email Address DUNS Number CAGE Code Tax ID Number ** Note: In accordance with the U.S. Supreme Court decision regarding Kingdomware, service disabled veteran owned (SDVOSB) and veteran owned (VOSB), who are interested in this procurement and consider themselves to have the resources and capabilities necessary to provide these services shall be verified in the SBA s VetCert website at: https://veterans.certify.sba.gov . Please provide answers to all questions below regarding your firm s Socio-Economic status pursuant to North American Industrial Classification Code (NAICS) 339112: 1. Is your business a small business under NAICS 339112? YES ______ NO ______ 2. Is your firm a Veteran-Owned Small Business? YES ______ NO ______ 3. Is your firm a Service-Disabled Veteran-Owned Small Business? YES ______ NO ______ 4. Is you firm a certified HUB Zone firm? YES ______ NO ______ 5. Is your firm a Woman Owned business? YES ______ NO ______ 6. Is your firm a Large Business? YES ______ NO ______ 7. Do you have a GSA/FSS schedule for these items? YES______ NO______ Schedule Number: ___________________ Expiration Date: _____________________ Please provide a capability statement as well as any relevant literature addressing your organizations ability to supply the required items. Also, please include a point of contact name, phone number and email address. Note: Questions regarding this notice should be addressed to Jennifer Cutshall via email only. NO PHONE CALLS WILL BE ACCEPTED REGARDING THIS REQUIREMENT. Please submit all responses to this notice via e-mail to: Jennifer Cutshall Contracting Officer Jennifer.Cutshall2@va.gov Responses to this Sources Sought Notice are required by no later than Tuesday, April 18, 2023 at 12:00 PM EST. End of Document
- Web Link
-
SAM.gov Permalink
(https://sam.gov/opp/fb88eb85c84145a7a157fd09084eeb74/view)
- Place of Performance
- Address: Department of Veterans Affairs James E. Van Zandt VA Medical Center 2907 Pleasant Valley Blvd., Altoona 16602
- Zip Code: 16602
- Zip Code: 16602
- Record
- SN06646081-F 20230412/230410230113 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
(may not be valid after Archive Date)
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