36C26121Q0303.docx

Contract Opportunity Sources Sought Notice

PRODUCT SERVICE CODE

SUBJECT

CONTRACTING OFFICE'S

ZIP-CODE

SOLICITATION NUMBER

RESPONSE DATE/TIME/ZONE

ARCHIVE

DAYS AFTER THE RESPONSE DATE

RECOVERY ACT FUNDS

SET-ASIDE

NAICS CODE

CONTRACTING OFFICE

ADDRESS

POINT OF CONTACT

(POC Information Automatically Filled from User Profile Unless Entered)

DESCRIPTION

See Attachment

AGENCY'S URL

URL DESCRIPTION

AGENCY CONTACT'S EMAIL

ADDRESS

EMAIL DESCRIPTION

ADDRESS

POSTAL CODE

COUNTRY

ADDITIONAL INFORMATION

GENERAL INFORMATION

PLACE OF PERFORMANCE

* = Required Field Contract Opportunity Sources Sought Notice Q523 Perfusion Cell Saver Services and Equipment Lease 95652-2609 36C26121Q0303 01-28-2021 15:00

PACIFIC TIME, LOS ANGELES, USA

N 561320 Department of Veterans Affairs VA Sierra Pacific Network (VISN 21) VA Northern California HealthCare System 5342 Dudley Blvd, Bldg 209 McClellan CA 95652-2609 Contracting Officer Larry Facio larry.facio@va.gov

This is a Sources Sought only. The Department of Veterans Affairs (VA) is performing market research to determine if there are any vendors with economic status of Service Disabled Veteran Owned, Veteran Owned, Women Owned, and other Small Businesses that can provide Perfusion Services by a credentialed Autotransfusionist and equipment lease for VA Sierra Nevada Health Care System (VASNHCS). The procedure is performed approximately four to six times per year specifically for LivaNova Xtra ATS System.

There is no solicitation document as this time. The NAICS is 561320 with Small Business size of $8 million. NOTE: Please ensure that System For Award Management (SAM) (www.sam.gov) indicates this NAICS code if you are interested in the requirement.

Only firms interested and capable should send their information and/or capability statement and any questions by email to larry.facio@va.gov, no later than 3:00 PM Pacific Standard Time, January 28th, 2021.

If interested, please provide the following information:

· Name of Company

· Point of Contact Name, phone number, and email address

· DUNS number

· Socio-economic status such as Service Disabled Veteran Owned Small Business, VOSB, Women-Owned Small Business, etc. should be included. SDVOSB/VOSB status will be verified using VetBiz.

· Capability statements

· Any unique terms and conditions required for this requirement

· Describe experience providing Perfusion Services and equipment

· List company’s past experience doing business with the Federal government

· Price estimate of Cell Saver equipment lease, including all supplies, materials, and maintenance

· Identify an Hourly Price Estimate Or Per Procedure Price Estimate for the Perfusionist Services based on the requirements in the SOW. (Note, this is not a request for quote – it’s requesting pricing information for market research purposes only.)

Before responding please carefully read and consider the following:

As this is a service acquisition, the Small Business Administration and the Federal Acquisition Regulation have a Limitations on Subcontracting requirement. For all small businesses, to include SDVOSB and VOSB, “At least 50 percent of the cost of contract performance incurred for personnel shall be expended for employees of the concern.” See FAR 52.219-14 and FAR 52.219-27 available in full text at https://www.acquisition.gov/far/html/52_217_221.html Invoices will only be accepted on a monthly basis. Weekly invoices will not be accepted.

Please see the DRAFT Performance Work Statements attached for further details.

DISCLAIMER

This Sources Sought notice is issued solely for information and planning purposes only and does not constitute a solicitation. All information received in response to this request that is marked proprietary will be handled accordingly. The Government will not compensate an offeror for providing information in response to this sources sought. Furthermore, the Government reserves the right to cancel this requirement at its discretion. This is simply a sources sought notice.

Statement of Work Cell Saver for Pathology & Laboratory Medicine Service VA Sierra Nevada Health Care System

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.

1.2 A 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, or approved accreditation agency of VASNHCS. 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:

3.2.1 A 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.

3.2.7 The 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.

3.2.9 Blood 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:

4.1.1 The 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 Quarterly statements will be submitted by the vendor through IPPS for payment.

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. Maintenance:

7.1 Equipment shall be fully maintained in accordance to manufacturer specifications. Vendor will be responsible for any and all costs associated with maintenance and repairs. If vendor is unable to repair machine, a replacement will be provided at no additional cost to the facility.

8. Security:

8.1 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.

8.2. 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.

8.3 A 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,

9. Security

9.1. 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.

9.2. 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. 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.

9.3. 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. 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.

c. 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.

9.4. 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 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.

9.5. 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. However, it is the policy of the VA to forgo collection of liquidated damages in the event the contractor provides payment of actual damages in the amount determined to be adequate by the agency.

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.

9.6. 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.

9.7 Security Requirements for Unclassified Information Technology Resources

The contractor, their personnel, and their subcontractors shall be subject to the Federal laws, regulations, standards, and VA Directives and Handbooks regarding information and information system security as delineated in this contract.

9.8 Security Accreditation Package (C&A) –

The C&A requirements do not apply and a Security Accreditation Package is not required.

End of Statement