Loren Data's SAM Daily™

FBO DAILY - FEDBIZOPPS ISSUE OF OCTOBER 26, 2014 FBO #4719
DOCUMENT

65 -- Intra-Aortic Balloon Pumps and Catheters - Attachment

Notice Date

10/24/2014
 

Notice Type

Attachment
 

NAICS

339113 — Surgical Appliance and Supplies Manufacturing
 

Contracting Office

U.S. Department of Veterans Affairs;Strategic Acquisition Center;10300 Spotsylvania Ave;Fredericksburg VA 22408
 

ZIP Code

22408
 

Solicitation Number

VA11915N0021
 

Response Due

10/31/2014
 

Archive Date

11/30/2014
 

Point of Contact

Maurice D. Christian
 

E-Mail Address

maurice.christian@va.gov
(maurice.christian@va.gov)
 

Small Business Set-Aside

N/A
 

Description

REQUEST FOR INFORMATION #VA119-15-N-0021 1.0 DESCRIPTION The Department of Veterans Affairs' (DVA) Office of Acquisition Operations (OAO) Strategic Acquisition Center (SAC) on behalf of the Veterans Health Administration (VHA) is issuing this Request for Information (RFI) in accordance with the FAR 15.201(e) to determine the availability and technical capabilities of qualified sources to provide Intra-Aortic Balloon Pumps and Catheters. The applicable North American Industry Classification System (NAICS) code is 339113, Surgical Appliance and Supplies Manufacturing. The Product Service Code is 6515, Medical and Surgical Instruments. This notice is for planning purpose only and does not constitute a commitment on the part of the Government to award a contract, nor does the Government intend to pay for any information submitted as a result of this notice. This RFI is part of a continuous process for obtaining the latest information on the commercial status of the industry with respect to their current and near-term abilities. The information provided herein is subject to change and in no way binds the Government to solicit for, or award, a competitive contract. It is emphasized that this is a notice solely for planning and informational purposes. The SAC in conjunction with VHA is seeking qualified sources to provide Intra-Aortic Balloon Pumps and Catheters on an agency wide basis. The Intra-Aortic Balloon Pumps and Catheters have been identified as items for national purchase. The purpose is to obtain uniform and quality products at lower-than-current contract prices. The VHA Medical facility currently purchases the selected items through Federal Supply Schedule (FSS) contracts. This initiative is in accordance with VHA Directive 1761.1. The Intra-Aortic Balloon Pumps is a mechanical aid to the circulatory function of the heart. The devices act to provide internal counter-pulsation, by a pump connected to a balloon device inserted into the descending aorta, to provide temporary assistance to the heart in the management of left ventricular failure. The Intra-Aortic Balloon Catheter is designed with an inflatable tipped balloon that holds the catheter in place. The catheter is inserted, most commonly into the femoral artery, and threaded upward so that the distal tip of the catheter is in the thoracic part of the aorta just distal to the origin of the left subclavian artery. The proximal end of the catheter is connected to a balloon pump console that forces helium into and out of the balloon, inflating and deflating the balloon. 2.0 SCOPE The scope of the Intra-Aortic Balloon Pumps and Catheters procurement includes being able to provide devices that meet the specified technical requirements on an agency wide basis. Specifically DVA is seeking devices that meet the following Minimum Technical Requirements (MTRs) for both catheters and pumps, as indicated below: Balloon Pumps: MTR NumberMinimum Technical RequirementMethod of Evaluation MTR 1Electroluminescent (EL) Color DisplayLiterature Review/Physical Inspection & Evaluation 7.87" (20 cm)W x 5.91"(15 cm)H; 160o viewing angle; Rotates 330o, Tilts 180o; Detachable MTR 2Display Preference MenuLiterature Review/Physical Inspection & Evaluation User may select display sweep speed (25 or 50 mm/sec), brightness adjustments; balloon wave form (On/Off); Audible and flashing alarms (On/Off); ECG inflation markers (On/Off) MTR 3Electrocardiogram (ECG) TriggerLiterature Review/Physical Inspection & Evaluation Threshold dynamically adjusted by system for high sensitivity and selectivity of the R-wave detection; Minimum = 120?V ± 20?V at normal gain; 40?V at max. gain MTR 4Pressure TriggerLiterature Review/Physical Inspection & Evaluation Default trigger threshold is automatically adjusted. Should be capable of adjusting to a minimum of 40% of the difference between peak systolic and end diastolic (avg. over multiple cycles);In variable mode: User adjustable between 7 and 30mmHg ±3mmHg MTR 5Pacer A TriggerLiterature Review/Physical Inspection & Evaluation R-wave detection (as above) except pacer blanking is extended to 100 ms MTR 6Pacer V/A-V TriggerLiterature Review/Physical Inspection & Evaluation Pacer: fixed at rate up to 185 bpm (no demand pacing) A-V Pacer: fixed at rate up to 125 bpm (no demand pacing) with A-V intervals between 80-224 ms MTR 7Internal TriggerLiterature Review/Physical Inspection & Evaluation Variable mode: 40-120 bpm; Normal mode: 80 ± 1 bpm MTR 8 Tall T-Wave RejectionLiterature Review/Physical Inspection & Evaluation Rejects all T-Waves where Q-T interval is <300 ms and the amplitude is <70% of QRS input amplitude MTR 9Pacer RejectionLiterature Review/Physical Inspection & Evaluation Rejects all pulses of amplitude ± 2.0 mV to ± 700 mV (ECG) and durations between 0.1 ms to 2.0 ms with: 1) No tail 2) 100 ms time constant tail < 1 mV 3) 25 ms time constant tail < 1 mV 4) 4 ms time constant tail < 2 mV MTR 10ECG LeadsLiterature Review/Physical Inspection & Evaluation In Auto Operation Mode: I, II, III, External In Semi-Auto Mode: I, II, III, AVR, AVL, AVF, V, External (12 lead compatibility) MTR 11ECG Gain (default)Literature Review/Physical Inspection & Evaluation 1 V output per 1 mV input ±5% (waveform automatically scaled to occupy ECG display window) MTR 12Gain (variable)Literature Review/Physical Inspection & Evaluation 0.15 to 3.0 cm/mV ±20% (autoscaling disabled) MTR 13Frequency ResponseLiterature Review/Physical Inspection & Evaluation 0.5-12 Hz (display); 0.5-135 Hz (Output to Monitor) MTR 14 Defibrillator ProtectionLiterature Review/Physical Inspection & Evaluation Discharge levels < 360 J (trace returns to screen in 5 sec. max) MTR 15ESISLiterature Review/Physical Inspection & Evaluation Automatic suppression with internal ECG amplifier MTR 16AP Source SelectionLiterature Review/Physical Inspection & Evaluation Transducer/external (menu based) MTR 17AP Input Sensitivity 5.0?V/V/mmHg MTR 18ExcitationLiterature Review/Physical Inspection & Evaluation +5 VDC ± 5% @ 130 mA (max) MTR 19Frequency ResponseLiterature Review/Physical Inspection & Evaluation DC to 12 Hz (display) MTR 20External Mon. InputsLiterature Review/Physical Inspection & Evaluation ECG: 1 V/mV (nominal); AP: 1 V/100 mmHg (nominal) MTR 21ECG/BP OutputLiterature Review/Physical Inspection & Evaluation Phone Jack: ECG 1V / mV, BP 1V/100 mmHg MTR 22Mains VoltageLiterature Review/Physical Inspection & Evaluation 100-120 VAC ± 10% or 220-240 VAC ± 10% MTR 23Mains FrequencyLiterature Review/Physical Inspection & Evaluation 50/60 Hz ± 3 Hz MTR 24Internal BatteryLiterature Review/Physical Inspection & Evaluation 24 VDC (nominal), 17.2 Amp-hour, 3 hrs. (approx. @ 90 bpm) MTR 25Battery TypeLiterature Review/Physical Inspection & Evaluation Must be Maintenance free; Sealed lead-acid MTR 26System CompressorLiterature Review/Physical Inspection & Evaluation Dual head diaphragm pump with brushless DC motor MTR 27IAB Helium (He+)Literature Review/Physical Inspection & Evaluation Medical-grade; 0.5 L (2900 psi) or 0.69 L (2200 psi) MTR 28He+ Endurance (nominal)Literature Review/Physical Inspection & Evaluation 1.8 mo. (.5 L); 2 mo. (0.69 L): continuous operation -24 hrs./day MTR 29Condensate RemovalLiterature Review/Physical Inspection & Evaluation Fully automatic condensate removal and disposal MTR 30WIN-IABP (optional)Literature Review/Physical Inspection & Evaluation Software for remote clinical assistance and training MTR 31Service DiagnosticsLiterature Review/Physical Inspection & Evaluation Built-in software for system analysis and troubleshooting MTR 32 Modem Data RateLiterature Review/Physical Inspection & Evaluation Up to 9,600 baud MTR 33Modem CertificationsLiterature Review/Physical Inspection & Evaluation Registered with FCC and accepted in > 89 countries MTR 34Size on CartLiterature Review/Physical Inspection & Evaluation Must not exceed 45"H x 18"W x 24"D (114cm x 45.7cm x 61cm) MTR 35Size off CartLiterature Review/Physical Inspection & Evaluation Must not exceed 28"H x 12"W x 22"D (71.1cm x 30.5cm x 55.9cm) MTR 36Total System Weight (Battery, Cart, Console, Display, cable, Helium tank and accompanying accessories)Literature Review/Physical Inspection & Evaluation Must not exceed 200 lbs.( 90.7 Kg) MTR 37Universal Transport System (UTS) VersionLiterature Review/Physical Inspection & Evaluation Rugged base which attaches to docking station (DS) MTR 38Lightweight DS (Optional)Literature Review/Physical Inspection & Evaluation 19"(48.3 cm) x 22"(55.9 cm) MTR 39Basic DSLiterature Review/Physical Inspection & Evaluation 23"(58.4 cm) x 23"(58.4 cm) MTR 40Ext Battery (Optional)Literature Review/Physical Inspection & Evaluation 24 VDC (nominal), 17.2 Amp-hour, 1.5 hrs. (min. @ 120 bpm) MTR 41Aux. DC InputLiterature Review/Physical Inspection & Evaluation 20.5-35.0 VDC MTR 42Shock and VibrationLiterature Review/Physical Inspection & Evaluation ECRI AIII.3.1, 3.2.2, 3.3, 3.4 Mil Std 810E method 514.4, Cat. I;RTCA DO-160C, 1989, Section B, Curve N MTR 43Operating TemperatureLiterature Review/Physical Inspection & Evaluation 10 °C - 40 °C MTR 44Operating HumidityLiterature Review/Physical Inspection & Evaluation 5 - 95% (R.H.) non-condensing MTR 45 Operating AltitudeLiterature Review/Physical Inspection & Evaluation Up to 12,000 feet (3,657 m); automatic altitude correction for IAB pressure MTR 46Printer TypeLiterature Review/Physical Inspection & Evaluation Thermal array - 50 mm wide MTR 47Printer MenuLiterature Review/Physical Inspection & Evaluation On-screen selection of waveforms; strip length; timed print; print on alarm; trend data; and alarm/trigger log MTR 48Waveforms (any 1 or 2)Literature Review/Physical Inspection & Evaluation ECG (lead number & size labeled), arterial pressure, BPW MTR 49Event MarkersLiterature Review/Physical Inspection & Evaluation Trigger pulse (upper), inflation interval MTR 50Trend GraphsLiterature Review/Physical Inspection & Evaluation ?8 hours of heart rate; peak systolic, end diastolic, mean, augmented diastolic MTR 51Additional DataLiterature Review/Physical Inspection & Evaluation Space for patient I.D.; Date; Time; Alarm and Advisory messages; Timing mode; Trigger; HR, Frequency; Syst/Dias (in 1:1); Assisted and Unassisted Syst/Dias (in 1:2 or 1:3); Augmented Pressure; Mean MTR 52 Minimal Alarm RequirementsLiterature Review IAB disconnected; Leak in IAB circuit; IAB overinflate; Rapid gas loss; Blood detected; No trigger; Systolic inflate; Check pacer timing; Auto fill required; Auto fill failure; Low vacuum; High pressure drive; Augmentation below set limit; Low battery; Poor signal quality; Unable to update timing; System Failure MTR 53 Compatible Helium Tanks: Maximum of 200 standard Liters Literature Review/Physical Inspection & Evaluation MTR 54Cables Minimum: 3 lead cable Types of cables external monitor EKG, Pressure, Vendor cable must be compatible with transducers Literature Review/Physical Inspection & Evaluation MTR 55Onsite Training for new equipment and vendor shall provide Competency Training Modules annually and thereafter; Annual (Online or Onsite) training for clinical staff Vendor shall provide Competency Training Certificate upon completion of said training. Literature Review/Physical Inspection & Evaluation MTR 56Catheter Anchoring DeviceLiterature Review/Physical Inspection & Evaluation MTR 57Automatic patient internal calibration systemLiterature Review/Physical Inspection & Evaluation MTR 58External DopplerLiterature Review/Physical Inspection & Evaluation Catheters: 3.0 RFI SUBMISSION INSTRUCTIONS Companies are encouraged to respond if they have the capability and capacity to provide either the pump or catheter, or both. However, be advised that generic capability statements are not sufficient for effective analysis of respondents' capacity and capability to provide the required product. If your firm has an interest in responding to the requirement described above, please provide the following: Corporate Capability Statement Information: Corporate Capability Statement; demonstrates capabilities, knowledge and experience related to the Intra-Aortic Balloon Pumps and Catheters described above (please detail if capability exists to meet each spec listed). If significant subcontracting or teaming is anticipated in order to deliver technical capability and scale, organizations should address the administrative and management structure of such arrangements. a) Provide a summary of your company's relevant experience in providing solutions that provide quick (real time) response to - what if - scenarios when schedule, technical changes, and financial changes occur with the program. b) Demonstrate ability to provide a significant increase or decrease of support (e.g., rapidly identify, equip and employ resources to support the Government in the event of an immediate surge or reductionin requirements.) Responses shall be: 1. Identified with the RFI number; and include: Company's name, mailing address, e-mail address, telephone and fax numbers, website address (if available), and the name, telephone number, and e-mail address of a point of contact having the authority and knowledge to clarify responses with Government representatives. 2. Interested parties shall submit a Corporate Capability Statement not exceeding 10 single-sided, type-written pages using 12-point type or larger. 3. The page limit does not apply to advertising material such as company brochures and catalogs. If there is any information you deem proprietary, please mark accordingly. SUBMISSIONS ARE DUE October 31, 2013, by 10:00AM, Eastern Standard Time. All responses under this RFI must be emailed to maurice.christian@va.gov Acknowledgement of receipt of responses will not be made, nor will respondents be notified of the OAO/SAC view of the information received. Do not send any material that requires a non-disclosure agreement or identify information that is business sensitive. Responses to this notice will not be returned. Telephone calls/questions or inquiries will not be accepted If you have any questions concerning this opportunity please contact Maurice D. Christian, maurice.christian@va.gov 4.0 DISCLAIMERS The government will evaluate market information to ascertain potential market capacity to: 1) Provide the commodity consistent in scope and scale with those described in this notice and otherwise anticipated; 2) Secure and apply the full range of corporate financial, human capital, and technical resources required to successfully perform similar requirements; 3) Implement a successful project management plan that includes: compliance with delivery schedules; and meeting the rigid listed specifications.
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/notices/2ecee349c1dd09a63743fc4f43ca9ebb)
 

Document(s)

Attachment
 

File Name: VA119-15-N-0021 VA119-15-N-0021_1.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=1697081&FileName=VA119-15-N-0021-000.docx)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=1697081&FileName=VA119-15-N-0021-000.docx

 

Note: If links are broken, refer to Point of Contact above or contact the FBO Help Desk at 877-472-3779.
 

Record

SN03558009-W 20141026/141024234029-2ecee349c1dd09a63743fc4f43ca9ebb (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
(may not be valid after Archive Date)

---

| FSG Index  |  This Issue's Index  |  Today's FBO Daily Index Page |