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FBO DAILY - FEDBIZOPPS ISSUE OF OCTOBER 22, 2014 FBO #4715
DOCUMENT

65 -- 3 Renal Cryoablation Procedures - Attachment

Notice Date

10/20/2014
 

Notice Type

Attachment
 

NAICS

339112 — Surgical and Medical Instrument Manufacturing
 

Contracting Office

Department of Veterans Affairs;Network Contracting Office 9;1639 Medical Center Parkway;Suite 400;Murfreesboro TN 37129
 

ZIP Code

37129
 

Solicitation Number

VA24915Q0029
 

Response Due

10/21/2014
 

Archive Date

11/20/2014
 

Point of Contact

David Milner
 

E-Mail Address

milner@va.gov<br
 

Small Business Set-Aside

Total Small Business
 

Description

This solicitation is seeking quotes for three renal cryoablation procedures at Memphis VAMC, 1030 JEFFERSON AVE, MEMPHIS, TN 38104. The first procedure is scheduled for 10/28/2014. Other procedure dates are not scheduled at this time. 1.All Offers and responses must be submitted on or before the close out date and time 2.Preference: will be IAW FAR Part 13.003 (b)(1). 3.Include DUNS, POC and contact information (phone and email address) on the quote 4.FAR 52.211-6 and VAAR 852.211-73, Brand Name or Equal apply 5.Clearly identify which items are brand name and which are equal 6.Provide information/images of proposed offer. Website links are acceptable 7.Requesting Service will review submitted bids as Technical experts to determine if technical solution is acceptable. 8.At this time frame, no extension on closing date 9.This is an All or none purchase 10.Email instructions: Include in the subject line "Renal Cryoablation-614/company name" 11.Email to david.milner@va.gov 12.Provide unit price, extended price and total price Any questions please contact Dave Milner at: E-mail: david.milner@va.gov or Phone call: 615-225-5631 Fax: 615-225-5431 Descriptions and Specifications (CT Renal Cryoablation) I.Introduction and Scope of Work: The contractor shall provide to the Department of Veteran Affairs Medical Center (VAMC) at Memphis, Tennessee cryosurgical equipment and all related cryosurgical disposable probes required to perform cryosurgical procedures, and a technician trained in the services and operation of the CryoCare CS or Cryo 20 unit as required to perform targeted cryoblation of the kidney (TCAP) procedures for the treatment of localized adenocarcinoma of the kidney. Contractor technician shall assist the attending Interventional Radiologist or other physician in the operation of the Unit. II.Requirements: The contractor shall make the CryoCare CS or Cryo 20 unit and technician available to the VAMC Radiology Service CT Department in accordance with a schedule mutually agreed upon between the parties. In the event the facility requires the use of the Unit at an unforeseen time other than those scheduled, contractor will make every effort to provide the Unit to the facility upon 48 hours advance notice from facility personnel. A.The contracting technician, also known as a Clinical Applications Specialist shall be responsible for setting up the equipment, and will be responsible for the following criteria: 1.Proper sterilization and decontamination of the cryosurgical Cryo probes and temperature probes, the holders and the ultrasound probe. 2.Proper gas setup and power on sequence. 3.Connect cryosurgical probe and temperature probe to the cryosurgical system. 4.Run pre-test for the cryosurgical probe. 5.Properly will run mapping portions of the procedure unless dictated otherwise by the physician. 6.Demonstrate the ability to add or delete probes when needed. 7.Engage auto freeze or manual mode as needed. 8.Store case information. 9.Load printer paper. 10.Print case information. 11.Shut down and bleed the cryosurgical systems at termination of the case. B.The technician is also responsible for: 1.Identification cryosurgical machine and use of console components. 2.Have knowledge of the parameters of Auto freeze treatment modes (target temperature and safety stops, etc). 3.Turning the power on and off on the cryosurgical machine. 4.Attaching the Argon regulators. 5.Attaching the Helium gauge. 6.Being able to connect the Argon supply line to the cryosurgical system. 7.Connecting the Helium supply line to the cryosurgical system. 8.Being able to connect the Cryoprobes to the back of the Cryocare system. 9.Being able to attach the temperature probes and label according to the anatomy. 10. Accomplishing the breakdown of equipment, bleed and shutdown the cryosurgical system. 11.Operating the Cryocare keypad. 12.Identifying disposable supplies necessary for cryosurgery. 13.Making sure the Cryoprobe holder is affixed to a sterile drape fixture. 14.Ensuring the Cryoprobe is tested prior to patient use. 15.Knowing that one Argon tank should be regulated at 3000 psi and the other at 3200 psi, another Argon tank is considered empty once it reaches less than 3000 psi. 16.Having a Helium tank ready to be used which will be supplied by the hospital. 17.Hooking up the helium tank and know that once it falls below 900 psi for 2500 psi tanks and below 3000 psi for 6000 psi tanks, it should be considered empty. C.The technician supplied by the contractor must demonstrate the ability to: 1.Turn the fluid warmer and circulating pump power on and off; 2.Insert the heat exchanger cassette in the fluid warmer; 3.. 4.Apply IV pressure cuff to fluid and maintain fluid between 100 mm Hg and 200 mm Hg. 5.Install tubing into circulating pump with proper placement of tubing between "A" and "B" indicators. 6.Prime tubing after opening all clamps and turn pump speed at "2", ensuring that all air bubbles are removed for proper priming. 7.Increase circulating pump speed to "3" and confirm with physician. 8.Set temperature to 37.5 C and verify temperature of fluid warmer with physician. 9.Increase and decrease temperature on fluid warmer. 10.Increase and decrease temperature on fluid warmer. 11.Knowing that If a leak does occur, notify physician immediately and replace Endocare urethral warming catheter, or any or all components of tubing set as necessary. 12.Handing off two distal ends of catheter tubing and separate spike tubing. 13.Securing tubing to OR field. The remainder of the case and the actual performance of the targeted cryoablation of the kidney cancer will be performed by a VA licensed Interventional Radiology Physician. D.The Contractor shall provide the following supplies: 1.CryoCare CS or Cryo 20 2.Argon & Helium regulator set 3.Stepper (check bed for compatibility) 4.Disposables a.(Renal: 2 R1.7, 2 R2.4L. 2 R 3.8 & 2 CRYO-55 temp probes) 5.Grid 6.Probe Holder 7.Laparoscopic or intra-operative US probe (renal) 8.Tank carts (Min. 2) E.Memphis VAMC shall provide the following supplies: 1.Gas requirements for the Cryocare system 2.ARGON: 99.998 pure or better 6000 PSI (grade 4.8 or better) Fitting: CGA677 3.HELIUM: 99.995 pure or better 6000 PSI (industrial grade or better) 4.Fitting: CGA677 5.Gas: per prostate procedure - Hospital should order all gases and have on-site 5 days prior to cases 1Tank Argon (Grade 4.8 - 99.998% Pure - 6000 PSI) 6.1 Tank Helium (6000 PSI) a.A back up of 1 Argon and 1 Helium should be on hand for each prostate procedure INSTRUMENTATION (Kidney) 1 ea. Hyperthermia Unit with upper body pad (Bair Hugger) 1 ea. Bowl set (1 large, 1 med., 1 small) 1 ea.Pressure bag for urethral warming system fluid 1 ea.Flexible Cystoscopy set 1 ea. Light source 1 ea. Video Set Up Minor Tray 6 ea. Hemostats 2 ea. Kelly 3 ea. Allis 2 ea. Std. Mayo (scissors) 1 ea. Short Needle Holder 2 ea. Tissue Forceps with teeth Suture 1 ea.Blade holder 4 ea.Towel clamps Drugs / Irrigation: 1 ea. 1-liter water bottles for probe testing Drapes: 1 ea. Back table cover Disposables: 1 pair Ted Hose, SCD's 2 Tubes KY jelly 2 ea. 10cc syringe 1 ea. 6Occ syringe (luer lock) 1 ea. 6Occ syringe (toomey) 1 ea. 18fr or 20fr Foley with balloon 1 ea. Amplatz Super Stiff Guidewire,.035 or.038. 1 pk. 4 X 4 1 pk. Towels 1 ea. Perineal prep. Kit 1 ea. Cysto tubing 1 ea.Microtek Sterile endocavity transducer cover PC3688 (prostate) Instrumentation Renal Set up as partial laparoscopic nephrectomy unless Surgery is specified as "open" Disposables: 2 ea.FloSeal or comparable hemostasis product (do not open) 1 ea.Civco Sterile laparoscopic transducer cover 610-941 (renal) The C&A requirements do not apply, and Security Accreditation Package is not required; Protected Health Information (PHI) and Personal Identifiable Information (PII) is not recorded or saved into IT equipment. Business Associate Agreement is not required Appendix C VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY LANGUAGE FOR INCLUSION INTO CONTRACTS, AS APPROPRIATE 1. GENERAL Contractors, contractor personnel, subcontractors, and subcontractor personnel shall be subject to the same Federal laws, regulations, standards, and VA Directives and Handbooks as VA and VA personnel regarding information and information system security. 2. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS a. A contractor/subcontractor shall request logical (technical) or physical access to VA information and VA information systems for their employees, subcontractors, and affiliates only to the extent necessary to perform the services specified in the contract, agreement, or task order. b. All contractors, subcontractors, and third-party servicers and associates working with VA information are subject to the same investigative requirements as those of VA appointees or employees who have access to the same types of information. The level and process of background security investigations for contractors must be in accordance with VA Directive and Handbook 0710, Personnel Suitability and Security Program. The Office for Operations, Security, and Preparedness is responsible for these policies and procedures. c. Contract personnel who require access to national security programs must have a valid security clearance. National Industrial Security Program (NISP) was established by Executive Order 12829 to ensure that cleared U.S. defense industry contract personnel safeguard the classified information in their possession while performing work on contracts, programs, bids, or research and development efforts. The Department of Veterans Affairs does not have a Memorandum of Agreement with Defense Security Service (DSS). Verification of a Security Clearance must be processed through the Special Security Officer located in the Planning and National Security Service within the Office of Operations, Security, and Preparedness. d. Custom software development and outsourced operations must be located in the U.S. to the maximum extent practical. If such services are proposed to be performed abroad and are not disallowed by other VA policy or mandates, the contractor/subcontractor must state where all non-U.S. services are provided and detail a security plan, deemed to be acceptable by VA, specifically to address mitigation of the resulting problems of communication, control, data protection, and so forth. Location within the U.S. may be an evaluation factor. e. The contractor or subcontractor must notify the Contracting Officer immediately when an employee working on a VA system or with access to VA information is reassigned or leaves the contractor or subcontractor's employ. The Contracting Officer must also be notified immediately by the contractor or subcontractor prior to an unfriendly termination. f. Contractor will comply with VA Handbook 6500.6 that states they will ensure VA sensitive information will be protected 3. VA INFORMATION CUSTODIAL LANGUAGE a. Information made available to the contractor or subcontractor by VA for the performance or administration of this contract or information developed by the contractor/subcontractor in performance or administration of the contract shall be used only for those purposes and shall not be used in any other way without the prior written agreement of the VA. This clause expressly limits the contractor/subcontractor's rights to use data as described in Rights in Data - General, FAR 52.227-14(d) (1). b. VA information should not be co-mingled, if possible, with any other data on the contractors/subcontractor's information systems or media storage systems in order to ensure VA requirements related to data protection and media sanitization can be met. If co-mingling must be allowed to meet the requirements of the business need, the contractor must ensure that VA's information is returned to the VA or destroyed in accordance with VA's sanitization requirements. VA reserves the right to conduct on site inspections of contractor and subcontractor IT resources to ensure data security controls, separation of data and job duties, and destruction/media sanitization procedures are in compliance with VA directive requirements. c. Prior to termination or completion of this contract, contractor/subcontractor must not destroy information received from VA, or gathered/created by the contractor in the course of performing this contract without prior written approval by the VA. Any data destruction done on behalf of VA by a contractor/subcontractor must be done in accordance with National Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and Information Management and its Handbook 6300.1 Records Management Procedures, applicable VA Records Control Schedules, and VA Handbook 6500.1, Electronic Media Sanitization. Self-certification by the contractor that the data destruction requirements above have been met must be sent to the VA Contracting Officer within 30 days of termination of the contract. d. The contractor/subcontractor must receive, gather, store, back up, maintain, use, disclose and dispose of VA information only in compliance with the terms of the contract and applicable Federal and VA information confidentiality and security laws, regulations and policies. If Federal or VA information confidentiality and security laws, regulations and policies become applicable to the VA information or information systems after execution of the contract, or if NIST issues or updates applicable FIPS or Special Publications (SP) after execution of this contract, the parties agree to negotiate in good faith to implement the information confidentiality and security laws, regulations and policies in this contract. e. The contractor/subcontractor shall not make copies of VA information except as authorized and necessary to perform the terms of the agreement or to preserve electronic information stored on contractor/subcontractor electronic storage media for restoration in case any electronic equipment or data used by the contractor/subcontractor needs to be restored to an operating state. If copies are made for restoration purposes, after the restoration is complete, the copies must be appropriately destroyed. f. If VA determines that the contractor has violated any of the information confidentiality, privacy, and security provisions of the contract, it shall be sufficient grounds for VA to withhold payment to the contractor or third party or terminate the contract for default or terminate for cause under Federal Acquisition Regulation (FAR) part 12. g. If a VHA contract is terminated for cause, the associated BAA must also be terminated and appropriate actions taken in accordance with VHA Handbook 1600.01, Business Associate Agreements. Absent an agreement to use or disclose protected health information, there is no business associate relationship. h. The contractor/subcontractor must store, transport, or transmit VA sensitive information in an encrypted form, using VA-approved encryption tools that are, at a minimum, FIPS 140-2 validated. i. The contractor/subcontractor's firewall and Web services security controls, if applicable, shall meet or exceed VA's minimum requirements. VA Configuration Guidelines are available upon request. j. Except for uses and disclosures of VA information authorized by this contract for performance of the contract, the contractor/subcontractor may use and disclose VA information only in two other situations: (i) in response to a qualifying order of a court of competent jurisdiction, or (ii) with VA's prior written approval. The contractor/subcontractor must refer all requests for, demands for production of, or inquiries about, VA information and information systems to the VA contracting officer for response. k. Notwithstanding the provision above, the contractor/subcontractor shall not release VA records protected by Title 38 U.S.C. 5705, confidentiality of medical quality assurance records and/or Title 38 U.S.C. 7332, confidentiality of certain health records pertaining to drug addiction, sickle cell anemia, alcoholism or alcohol abuse, or infection with human immunodeficiency virus. If the contractor/subcontractor is in receipt of a court order or other requests for the above mentioned information, that contractor/subcontractor shall immediately refer such court orders or other requests to the VA contracting officer for response. l. For service that involves the storage, generating, transmitting, or exchanging of VA sensitive information but does not require C&A or an MOU-ISA for system interconnection, the contractor/subcontractor must complete a Contractor Security Control Assessment (CSCA) on a yearly basis and provide it to the Program Manager. 5. INFORMATION SYSTEM HOSTING, OPERATION, MAINTENANCE, OR USE a. All electronic storage media used on non-VA leased or non-VA owned IT equipment that is used to store, process, or access VA information must be handled in adherence with VA Handbook 6500.1, Electronic Media Sanitization upon: (i) completion or termination of the contract or (ii) disposal or return of the IT equipment by the contractor/subcontractor or any person acting on behalf of the contractor/subcontractor, whichever is earlier. Media (hard drives, optical disks, CDs, back-up tapes, etc.) used by the contractors/subcontractors that contain VA information must be returned to the VA for sanitization or destruction or the contractor/subcontractor must self-certify that the media has been disposed of per 6500.1 requirements. This must be completed within 30 days of termination of the contract. b. Bio-Medical devices and other equipment or systems containing media (hard drives, optical disks, etc.) with VA sensitive information must not be returned to the vendor at the end of lease, for trade-in, or other purposes. The options are: (1) Vendor must accept the system without the drive; (2) VA's initial medical device purchase includes a spare drive which must be installed in place of the original drive at time of turn-in; or (3) VA must reimburse the company for media at a reasonable open market replacement cost at time of purchase. (4) Due to the highly specialized and sometimes proprietary hardware and software associated with medical equipment/systems, if it is not possible for the VA to retain the hard drive, then; c. The equipment vendor must have an existing BAA if the device being traded in has sensitive information stored on it and hard drive(s) from the system are being returned physically intact; and d. Any fixed hard drive on the device must be non-destructively sanitized to the greatest extent possible without negatively impacting system operation. Selective clearing down to patient data folder level is recommended using VA approved and validated overwriting technologies/methods/tools. Applicable media sanitization specifications need to be preapproved and described in the purchase order or contract. e. A statement needs to be signed by the Director (System Owner) that states that the drive could not be removed and that (a) and (b) controls above are in place and completed. The ISO needs to maintain the documentation. 4. SECURITY INCIDENT INVESTIGATION a. The term "security incident" means an event that has, or could have, resulted in unauthorized access to, loss or damage to VA assets, or sensitive information, or an action that breaches VA security procedures. The contractor/subcontractor shall immediately notify the Program Manager and simultaneously, the designated ISO and Privacy Officer for the contract of any known or suspected security/privacy incidents, or any unauthorized disclosure of sensitive information, including that contained in system(s) to which the contractor/subcontractor has access. b. To the extent known by the contractor/subcontractor, the contractor/subcontractor's notice to VA shall identify the information involved, the circumstances surrounding the incident (including to whom, how, when, and where the VA information or assets were placed at risk or compromised), and any other information that the contractor/subcontractor considers relevant. c. With respect to unsecured protected health information, the business associate is deemed to have discovered a data breach when the business associate knew or should have known of a breach of such information. Upon discovery, the business associate must notify the covered entity of the breach. Notifications need to be made in accordance with the executed business associate agreement. d. In instances of theft or break-in or other criminal activity, the contractor/subcontractor must concurrently report the incident to the appropriate law enforcement entity (or entities) of jurisdiction, including the VA OIG and Security and Law Enforcement. The contractor, its employees, and its subcontractors and their employees shall cooperate with VA and any law enforcement authority responsible for the investigation and prosecution of any possible criminal law violation(s) associated with any incident. The contractor/subcontractor shall cooperate with VA in any civil litigation to recover VA information, obtain monetary or other compensation from a third party for damages arising from any incident, or obtain injunctive relief against any third party arising from, or related to, the incident. 5. SECURITY CONTROLS COMPLIANCE TESTING On a periodic basis, VA, including the Office of Inspector General, reserves the right to evaluate any or all of the security controls and privacy practices implemented by the contractor under the clauses contained within the contract. With 10 working-days' notice, at the request of the government, the contractor must fully cooperate and assist in a government-sponsored security controls assessment at each location wherein VA information is processed or stored, or information systems are developed, operated, maintained, or used on behalf of VA, including those initiated by the Office of Inspector General. The government may conduct a security control assessment on shorter notice (to include unannounced assessments) as determined by VA in the event of a security incident or at any other time. TRAINING a. All contractor employees and subcontractor employees requiring access to VA information and VA information systems shall complete the following before being granted access to VA information and its systems: (1) Successfully complete the VA Privacy and Information Security and Rules of Behavior Training. (2) Contractor will acknowledge and sign the VA Privacy for Personnel without Access to VA Computer Systems or Direct Access or Use to VA Sensitive Information (a) The contractor shall provide to the contracting officer and/or the Program Manager a copy of the training certificates and certification of signing the Contractor Rules of Behavior for each applicable employee within 1 week of the initiation of the contract and annually thereafter, as required. (b) Failure to complete the mandatory annual training and sign the Rules of Behavior annually, within the timeframe required, is grounds for suspension or termination of all physical or electronic access privileges and removal from work on the contract until such time as the training and documents are complete.
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/VA/NaVAMC/VAMCCO80220/VA24915Q0029/listing.html)
 

Document(s)

Attachment
 

File Name: VA249-15-Q-0029 VA249-15-Q-0029.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=1687086&FileName=VA249-15-Q-0029-000.docx)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=1687086&FileName=VA249-15-Q-0029-000.docx

 

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

Place of Performance

Address: MEMPHIS VA MEDICAL CENTER;1030 JEFFERSON AVE;MEMPHIS, TN

Zip Code: 38104
 

Record

SN03554247-W 20141022/141020234420-b5fff62704f876d81a76335f94259bba (fbodaily.com)
 

Source

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

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