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FBO DAILY - FEDBIZOPPS ISSUE OF AUGUST 09, 2015 FBO #5007
DOCUMENT

Q -- AutoTransfusionist Services and Equipment Rental - Attachment

Notice Date

8/7/2015
 

Notice Type

Attachment
 

NAICS

561320 — Temporary Help Services
 

Contracting Office

Department of Veterans Affairs;VA Sierra Pacific Network (VISN 21);VA Northern California HealthCare System;150 Muir Road;Martinez CA 94553-4668
 

ZIP Code

94553-4668
 

Solicitation Number

VA26115Q1016
 

Response Due

8/20/2015
 

Archive Date

9/19/2015
 

Point of Contact

Angela Oppenheimer
 

Small Business Set-Aside

N/A
 

Description

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotations are being requested and a written solicitation will not be issued. The commercial items procedures of FAR Part 12 will be used. NAICS code is 561320, size standard $27.5M. This solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2005-83 effective August 3, 2015. This is a small business set-aside. This acquisition is being conducted under the authority of the commercial item test program at FAR 13.5. Only electronic offers will be accepted. Offers are due to angela.oppenheimer@va.gov by 1:00 PM. Pacific Time, August 20th, 2015. CONTRACT ADMINISTRATION DATA 1. Contract Administration: All contract administration matters will be handled by the following individuals: a. CONTRACTOR: b. GOVERNMENT: Contracting Officer 00261 Department of Veterans Affairs VA Sierra Pacific Network (VISN 21) VA Northern California HealthCare System 150 Muir Road Martinez CA 94553-4668 2. CONTRACTOR REMITTANCE ADDRESS: All payments by the Government to the contractor will be made in accordance with: [X]52.232-34, Payment by Electronic Funds Transfer-Other Than System For Award Management, or []52.232-36, Payment by Third Party 3. INVOICES: Invoices shall be submitted in arrears: a. Quarterly[] b. Semi-Annually[] c. Other[X] Upon Government acceptance 4. GOVERNMENT INVOICE ADDRESS: All Invoices from the contractor shall be submitted electronically in accordance with VAAR Clause 852.232-72 Electronic Submission of Payment Requests. Department of Veterans Affairs FMS-VA-2(101) Financial Services Center PO Box 149971 Austin, TX 78714-9971 ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows: AMENDMENT NODATE Statement of Work Operating Room Cell Saver Service for Surgical Service VA Sierra Nevada Health Care System 654-15-3-441-0185 1.Scope of Work: The contractor shall provide cell saver perfusion service during certain surgical cases when a large blood loss from the procedure is anticipated. The contractor shall provide the Surgical Service, Patient Care Service and the P&LMS Blood Bank section their quality assurance reports including function validation test results, under an approved Quality Assurance policy and plan by the medical director of blood bank at VASNHCS. 1.1 The purpose of utilizing a Cell Saver is to suction blood from the patient using a heparinized suction tubing device, collected in a sterile bowl and gently wash and centrifuge red blood cells, then pump it into a blood administration bag for the anesthesiologist to infuse back to the patient. Cell Saver cannot be used on patient with cancer or infections because of the possibility of creating a systemic seeding. Infusing the patient's blood reduces the amount of banked blood the patient will need to receive. The Cell Saver blood has a lower volume of red blood cells and some of the red cells may sustain damage during the washing process. In cases of massive blood loss, patients will be receiving both cell saver blood as well as banked blood as means of stabilizing the patient. 1.2A leased Cell Saver Machine will be located the Operating Room with the sterile disposable supplies that are stocked by the Cell Saver Technician in suitable locked storage. The contractor is responsible for all maintenance as required to ensure the equipment is in proper working order. 2. Schedule for Service Performance: 2.1 This is to be initiated by Department of Surgery at VASNHCS on an as needed basis. The operating room procedure schedule will define the cases for the cell saver use. The cell saver may also be utilized for emergency procedures. The annual volume of use will be approximately four to six cases. The service is to be expected to commence in a timely manner, in accordance to the needs of the surgical procedure. 3. Quality Assurance Plan: 3.1 A quality assurance plan and the required data must be submitted to Chief of Pathology and Laboratory Medicine at VASNHCS for approval and reviewed annually. This plan must meet the requirements of the College of American Pathologists. Changes to the quality assurance plan require the approval of Chief of Pathology and Laboratory Medicine at VASNHCS, who serves to monitor the contractor for compliance with the quality assurance plan and accreditation agencies. The contractor remains ultimately responsible for the operation and outcome of the procedure. The Departments of Surgery, Patient Care and Pathology of Laboratory Medicine are jointly responsible for monitoring the satisfactory performance of the contract by the contractor. 3.2 Sample of Quality Assurance Plan: 3.2.1A physician's request is required for procedure and entered in surgery schedule through CPRS. 3.2.2 Procedure is performed by credentialed autotransfusionist. This individual will be responsible for the operation of the Cell Saver and will accurately collect process and provide blood to be re-infused when using the Cell Saver according to the procedure outlined. 3.2.3 The patient will receive his/her own blood that has been salvaged and processed during the intra-operative phase in a safe and timely manner. 3.2.4 Quality Assurance monitoring will be done by performing the following: a. Ensuring clear color of the liquid in the waste line b. Hematocrit - washed salvaged blood has a hematocrit in the average range of 45- 60%; however, can be case and patient dependent c. Albumin <1.5 g/dL d. Potassium < 4.0 mmol/L e. Volume reinfused will be verified and documented. f. Visual inspection of equipment, its functional properties, and blood being processed, including clotting/debris will be observed. 3.2.5 Blood containing alcohol, iodofor, sterile water, peroxide, topical coagulation products, Avitene, nonparenteral irrigants, or topical antibiotics should not be aspirated into the reservoir. If these products are aspirated, then the reservoir must be discarded and not processed for patient administration. 3.2.6 Intraoperative blood salvage is contraindicated in the presence of bacterial contamination or malignancy. 3.2.7The blood temperature in the reservoir is not to exceed 37 degrees Celsius. 3.2.8 A regulated vacuum device must be used. The American Association of Blood Bank guideline recommends suction at levels of 150 mmHg or less to preserve RBC recovery. Discrepancy in any of the events described during machine start-up or if action taken to correct an alarm situation is unsuccessful, follow equipment failure in Safety Manual. See operating instructions attached to the machine. 3.2.8Blood must be collected in a sterile grade 6 plastic reservoir or cell saver cardiotomy. 3.2.10 Washed red cells will be accurately labeled with patient identification sticker on reinfusion bag. 4. Reports 4.1 Procedural documentation: 4.1.1The perfusionist operating the autotransfusion machine will be recorded in the patient record. 4.1.2 The perfusionist will document on the specified record the following information: a.Case number on label. b.Identification number of the piece of equipment used. c.Lot numbers and expiration dates of all soft goods and fluids used. d.Amount of volume, processed and re-infused. e.Reinfusion start and stop times. f.Type and amount of anticoagulant. g.Amount of wash solution. 4.1.3 Collected and processed units will be labeled as follows: a.The case number, operator initials, date, time, and physician. b.The unit must be labeled as an "Autologous unit". c.The label must also denote the volume of the unit. 4.2 A report of procedure quality assurance tests will be provided to the Chief of Pathology and Laboratory Medicine one work week after each procedure and summarized into quarterly reports submitted within two work weeks of each quarter, the first two weeks of January for the previous calendar quarter, etc. 5. Billing: 5.1 Monthly statements with charges including line item entry for service performed will be submitted following VA billing regulations using the OB-10 vendor process. 6. Credentialing: 6.1 The autotransfusionist must be credentialed and able to meet: Identify composition of whole blood Describe function of the red blood cell Explain coagulation components and process Identify replacement needs of coagulation components Describe blood replacement options Discuss benefits, risks, and cost for each option Demonstrate documentation of procedure Demonstrate set up and operation of autotransfusion unit 6.2 Autotransfusionist must demonstrate competency by: Perform 5 procedures to include collection and processing. All 5 cases will be supervised by a credentialed person. 6.3 To maintain credentialing the autotransfusionist must yearly: Perform a minimum of 3 autotransfusion cases a year. Demonstrate competency by performing on supervised procedure. 7. Security: 7.1 A prohibition on unauthorized disclosure: "Information made available to the contractor or subcontractor by VA for the performance or administration of this contract or information developed by the contractor 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." See VA Handbook 6500.6, Appendix C, paragraph 3.a. 7.2. A requirement for data breach notification: Upon discovery 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, the contractor/subcontractor shall immediately and simultaneously notify the COIR, the designated ISO, and Privacy Officer for the contract. 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. See VA Handbook 6500.6, Appendix C, paragraph 6.a. 7.3A requirement to pay liquidated damages in the event of a data breach: "In the event of a data breach or privacy incident involving any SPI the contractor processes or maintains under this contract, the contractor shall be liable to VA for liquidated damages for a specified amount per affected individual to cover the cost of providing credit protection services to those individuals." See VA Handbook 6500.6, Appendix C, paragraph 7.a., 7.d, 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. 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 COTR. 6. 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 COTR 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. 7. LIQUIDATED DAMAGES FOR DATA BREACH a. Consistent with the requirements of 38 U.S.C. §5725, a contract may require access to sensitive personal information. If so, the contractor is liable to VA for liquidated damages in the event of a data breach or privacy incident involving any SPI the contractor/subcontractor processes or maintains under this contract. b. The contractor/subcontractor shall provide notice to VA of a "security incident" as set forth in the Security Incident Investigation section above. Upon such notification, VA must secure from a non-Department entity or the VA Office of Inspector General an independent risk analysis of the data breach to determine the level of risk associated with the data breach for the potential misuse of any sensitive personal information involved in the data breach. The term 'data breach' means the loss, theft, or other unauthorized access, or any access other than that incidental to the scope of employment, to data containing sensitive personal information, in electronic or printed form, that results in the potential compromise of the confidentiality or integrity of the data. Contractor shall fully cooperate with the entity performing the risk analysis. Failure to cooperate may be deemed a material breach and grounds for contract termination. c. Each risk analysis shall address all relevant information concerning the data breach, including the following: (1) Nature of the event (loss, theft, unauthorized access); (2) Description of the event, including: (a) date of occurrence; (b) data elements involved, including any PII, such as full name, social security number, date of birth, home address, account number, disability code; (3) Number of individuals affected or potentially affected; (4) Names of individuals or groups affected or potentially affected; (5) Ease of logical data access to the lost, stolen or improperly accessed data in light of the degree of protection for the data, e.g., unencrypted, plain text; (6) Amount of time the data has been out of VA control; (7) The likelihood that the sensitive personal information will or has been compromised (made accessible to and usable by unauthorized persons); (8) Known misuses of data containing sensitive personal information, if any; (9) Assessment of the potential harm to the affected individuals; (10) Data breach analysis as outlined in 6500.2 Handbook, Management of Security and Privacy Incidents, as appropriate; and (11) Whether credit protection services may assist record subjects in avoiding or mitigating the results of identity theft based on the sensitive personal information that may have been compromised. d. Based on the determinations of the independent risk analysis, the contractor shall be responsible for paying to the VA liquidated damages in the amount of $37.50 per affected individual to cover the cost of providing credit protection services to affected individuals consisting of the following: (1) Notification; (2) One year of credit monitoring services consisting of automatic daily monitoring of at least 3 relevant credit bureau reports; (3) Data breach analysis; (4) Fraud resolution services, including writing dispute letters, initiating fraud alerts and credit freezes, to assist affected individuals to bring matters to resolution; (5) One year of identity theft insurance with $20,000.00 coverage at $0 deductible; and (6) Necessary legal expenses the subjects may incur to repair falsified or damaged credit records, histories, or financial affairs. 9. 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) Sign and acknowledge (either manually or electronically) understanding of and responsibilities for compliance with the Contractor Rules of Behavior, Appendix E relating to access to VA information and information systems; (2) Successfully complete the VA Cyber Security Awareness and Rules of Behavior training and annually complete required security training; (3) Successfully complete the appropriate VA privacy training and annually complete required privacy training; and (4) Successfully complete any additional cyber security or privacy training, as required for VA personnel with equivalent information system access [to be defined by the VA program official and provided to the contracting officer for inclusion in the solicitation document - e.g., any role-based information security training required in accordance with NIST Special Publication 800-16, Information Technology Security Training Requirements.] b. The contractor shall provide to the contracting officer and/or the COTR 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. c. 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. End of Statement ? Price / Cost Schedule This is a brand name or equal small business set-aside requirement. Preferred brand name is Perfusion.com, Inc., or equal. ? SOLICITATION PROVISIONS and CONTRACT CLAUSES: Clauses "FAR 52.252-2 - Clauses Incorporated by Reference (Feb 1998) For the purposes of this clause, the fill-in's are http://www.acquisition.gov/far/index.html and http://www.va.gov/oal/library/vaar/ respectively. "FAR 52.212-4 Contract Terms and Conditions -- Commercial Items (May 2015) "FAR 52.212-5 Contract Terms and Conditions Required To Implement Statutes Or Executive Orders -- Commercial Items (May 2015) For the purposes of this clause, items (b) 4, 8, 22, 25, 26, 27, 28, 29, 30, 31, 33, 40, 41, 44, and 51 are considered checked and applicable. "FAR 52.216-1 Type of Contract (April 1984) For the purposes of this clause, the fill-in is "Firm Fixed Price." "FAR 52.232-38 Submission of Electronic Funds Transfer Information with Offer (July 2013) "VAAR 852.203-70 Commercial Advertising (Jan 2008) "VAAR 852.211-70 Service Data Manuals (Nov 1984) "VAAR 852.211-73 Brand Name or Equal (Jan 2008) "VAAR 852.246-71 Inspection (Jan 2008) "VAAR 852.232-72 Electronic Submission of Payment Requests (Nov 2012) "VAAR 852.246-70 Guarantee (Jan 2008) For the purposes of this clause, the fill-in is "one year". 52.217-8 Option to Extend Services (Nov 1999). The Government may require continued performance of any services within the limits and at the rates specified in the contract. These rates may be adjusted only as a result of revisions to prevailing labor rates provided by the Secretary of Labor. The option provision may be exercised more than once, but the total extension of performance hereunder shall not exceed 6 months. The Contracting Officer may exercise the option by written notice to the Contractor within 30 days. 52.217-9 Option to Extend the Term of the Contract (Mar 2000) (a) The Government may extend the term of this contract by written notice to the Contractor within 30 days; provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least 30 days before the contract expires. The preliminary notice does not commit the Government to an extension. (b) If the Government exercises this option, the extended contract shall be considered to include this option clause. (c) The total duration of this contract, including the exercise of any options under this clause, shall not exceed five year (or five years and six months, if clause 52.217-8 is executed). Provisions "FAR 52.252-1 - Solicitation Provisions Incorporated by Reference (Feb 1998) For the purposes of this provision, the fill-in's are http://www.acquisition.gov/far/index.html and http://www.va.gov/oal/library/vaar/ respectively. "FAR 52.212-1 Instructions to Offerors - Commercial Items (April 2014) "FAR 52.212-2 Evaluation - Commercial Items (Oct 2014) "FAR 52.212-3 Offeror Representations and Certifications -- Commercial Items (Mar 2015) "FAR 52.217-5 Evaluation of Options (July 1990) ? ?
 

Web Link

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Document(s)

Attachment
 

File Name: VA261-15-Q-1016 VA261-15-Q-1016_1.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=2235762&FileName=VA261-15-Q-1016-000.docx)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=2235762&FileName=VA261-15-Q-1016-000.docx

 

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Record

SN03828557-W 20150809/150807234632-10b3889758687b4185bfbc7e5cd65e23 (fbodaily.com)
 

Source

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