Description
Department of Veterans AffairsVISN 16 Justification for Other Than Full and Open Competition 1. Identification of Agency and Contracting Activity Department of Veterans Affairs Central Arkansas Veterans Healthcare System (CAVHS) 4300 West 7th Street Little Rock, AR 72205 2. Nature/Description of Action Contract Award using the authority of 41 U.S.C. 253(c)(2) "Unusual and Compelling Urgency" to purchase replacement Heart Mapping Equipment for the Electrophysiology Laboratory at John L. McClellan Hospital in Little Rock Arkansas. 3. Description of Supplies/Services The equipment system purchased is an EnSite System manufactured by St. Jude Medical, Model # EE3000. Warranty, Installation and technical support for the first year are included in the cost. System functions to provide 3-D mapping of a patient's cardiac chamber allowing for physicians to locate and diagnose arrhythmias and confirm success of procedures. Estimated Value: $ 316,975.00 4. Identification of Statutory Authority ( ) 41 U.S.C. 253 (c) (1) Only One Responsible Source (X) 41 U.S.C. 253 (c) (2) Unusual and Compelling Urgency ( ) 41 U.S.C. 253 (c) (3) Industrial, Mobilization, Engineering, Developmental, or Research Capability or Expert Services ( ) 41 U.S.C. 253 (c) (4) International Agreement ( ) 41 U.S.C. 253 (c) (5) Authorized or Required by Statute ( ) 41 U.S.C. 253 (c) (6) National Security ( ) 41 U.S.C. 253 (c) (7) Public Interest 5. Rationale in support of citation in Paragraph 4 above: a. Description of contractor and or of acquisition action that demonstrates that the proposed contractor's unique qualifications or the nature of the acquisition requires use of the authority cited: St. Jude Medical has a system available and it can be delivered and installed in 2 weeks from date of order. There is no other current source known that can provide the equipment need on the urgent basis required. The existing Carto mapping system is 6 year old and has had three work orders for repairs during the past several months, plus the Cath Lab Technicians were able to get it going again themselves and didn't enter work orders when it malfunctioned two other times during that period. The computer "backs out" in the middle of an invasive interventional procedure to treat atrial fibrillation. It goes back to the default page, leaving the Cardiologist without 3-D images of the catheter in the patient's heart until the staff re-enter all the patient data and get the Carto back to the point where it failed. All the mapping recorded prior to the computer failure is lost, and depending upon how far along they were when the failure occurred, it can take as much as three or four hours to recreate that mapping in order to complete the case. A typical case using the Carto can expose a patient to several hours of radiation (much greater than with the EnSite system) and having to repeat much of the mapping compounds the risk to the patient from radiation exposure. Although it hasn't happened so far, procedures will have to be rescheduled if the Carto fails and cannot be restarted. If a procedure is aborted, the Cardiologist will be able to use fluoro imaging to remove the catheter, but the patient will have to be rescheduled for a repeat EP on a day when Anesthesiology is available to work in the lab. If the delay is more than three weeks, the patient will require a repeat MRI and a repeat TEE (Tran esophageal echo). All these extra procedures increase the inconvenience and risk for the patient and the cost to the VA, and they lengthen waiting times for other patients. The unreliability of the current mapping system poses multiple risks to patients in the EP Lab. The 3D images of the catheter are lost in the middle of an invasive procedure, excessive radiation exposure increases the risk of these procedures, and patients with artrial fibrillation are at risk of developing a life-threatening clot while they are waiting to be rescheduled. b. Efforts made to ensure that offers are solicited from as many potential sources as practical: Another system was considered by medical staff for possible use before the decision was make to use the Ensite System. The System manufactured by Siemens Medical named CARTO XP EP Navigation System was reviewed and found not to provide the same function advantages and requires additional per patient cost for disposables that the Ensite System does not require. In addition, the CARTO System specifications reviewed did not provide for the first year software and maintenance upgrade without additional cost that the Ensite System does. c. If the Sole Source Exception (c) (1) was chosen, state the date of synopsis or the basis for waivers. N/A d. If the Urgency Exception was chosen and this J&A was prepared after the procurement action was carried out, state the reasons. While other companies may have been able to meet the delivery requirements for the new system, the possible danger to patients and potential risk from exposure to radiation as stated above in paragraph 5a does not allow time to build a solicition, issue and receive and evaluate offers from multiple sources. The risk to patients while the acquisition process is being conducted is greater than the benefit to the VHA for increased competition. The above acquisition will be negotiated with: St Jude Medical #1 Lillehei Plaza St. Paul, MN 55117 6. Determination of a Fair and Reasonable Cost The Contracting Officer determines that the anticipated cost to the government isl be fair and reasonable. A comparison of previous equipment costs and other known manufacture system cost was made to determine the cost to be comparable with existing system cost and should result I some cost saving to the CAVHS in lower disposable costs and software upgrades for the first year (see Attached Price Analysis. 7. A description of the market research conducted (see Part 10) and the results or a statement of the reason market research was not conducted. A review on known sources of equipment of the type required was conducted and the two systems previously discussed where found to be capable of satisfy the VHA, additional sources are not known. 8. Additional Support for the use of other than full and open competition: c. When the urgency exception is cited provide the data, estimate of cost or other rationale as to the extent of harm to the government if the contract is not awarded expediently: As stated previously the continued use of the existing system poses unacceptable risks to patient health. The equipment itself is essential to current daily hospital operations and delay in award decreases the capabilities of the Electrophysiology Laboratory to provide veteran's safe, competent healthcare. 9. Sources expressing an interest: No additional Sources were solicited. 10. Actions, if any, being taken to remove barriers to full and open competition: Requirements personnel did not anticipate the problems with the current system. The new system will be included in the labs equipment replacement schedule and should be identified for future maintenance and upgrades and eventually replacement. 11. Delivery Requirements: System is required to be delivered installed as quickly as possible the current delivery schedule and installation completion date is May 8, 2009. 12. Acquisition Plan: An Acquisition Plan ( ) is (X) is not required for this acquisition. 13. IT Approval: IT Approval ( ) is (X) is not required for this acquisition. If it is, include appropriate approvals. Technical/Requirements Personnel Certification: I hereby certify that the supporting data forming the basis for this justification is complete and accurate.