Statement of Work Laerdal Medical Corporation.pdf

Performance Work Statement

Laerdal Medical Corporation

Introduction/Background

The VA Southern Nevada Healthcare System (VASNHS) Education Simulation Department, located at 6900 North Pecos Road, North Las Vegas, Nevada, is seeking to establish a partnership with a reputable company to provide software solutions, preventive maintenance, and warranty services for one ALS 5000 Lung Simulator, three Laerdal ALS manikins, one Laerdal 3G manikin, and 3G Critical Care Manikin. This partnership is aimed at enhancing healthcare training and improving patient safety through the optimization of simulation tools. By collaborating with a qualified partner, we aspire to elevate the quality and realism of medical education offered in Southern Nevada. This initiative is expected to yield operational efficiencies by guaranteeing reliable software updates, maintenance, and warranty services, thereby reducing equipment downtime and ensuring consistent training availability.

Scope of Work

Our current agreement with IngMar Medical, established in November 2021, expired in 2022, necessitating a new contract. The VA Southern Nevada operates one ASL 5000 respiratory simulation device, crucial for training healthcare professionals with realistic respiratory scenarios. This device enhances skills in airway management, ventilator settings, and emergency response, thus improving patient safety and clinical competence. To maintain optimal performance and reliability, we seek a yearly warranty and service plan for the ASL 5000. This plan will ensure regular maintenance and timely repairs, reducing downtime and unexpected costs. Furthermore, it will allow staff to focus on training objectives, enhancing the overall effectiveness of our simulation program.

VA Southern Nevada utilizes one ASL 5000 respiratory simulation device, with the Laerdal 3G manikin. This combination creates realistic training scenarios, allowing healthcare professionals to effectively simulate complex respiratory conditions and enhance their skills in airway management and emergency response. In pursuit of further improvement in our simulation program, VA Southern Nevada seeks to acquire a software subscription service for the Laerdal ALS manikins. This subscription would provide access to Laerdal's SimStore or similar cloud-based simulation software, offering a range of scenario modules, updates, and digital resources. The incorporation of such software is essential for enhancing the flexibility and realism of training sessions, ensuring they remain current with the latest educational tools and best practices. Ultimately, this initiative aims to enrich the training experience for healthcare professionals and improve patient care outcomes.

Continuing the warranty for three Laerdal ALS and one 3G manikin is essential for the Southern Nevada Healthcare System's Education Simulation Department. It ensures equipment reliability, providing consistent, high-fidelity training experiences while minimizing disruptions from failures and supporting timely maintenance. Safeguarding these manikins, especially the advanced Laerdal 3G, allows for comprehensive training that enhances healthcare skills and improves patient safety. Having a yearly service plan for the Laerdal PM service is crucial, as it ensures regular maintenance and updates, keeping the equipment performing at its best. This proactive strategy reduces unexpected downtimes, preserves realism in simulations, extends manikin lifespan, and ultimately contributes to safer patient care outcomes by maintaining reliable training tools.

VA Southern Nevada Healthcare System will add an additional warranty and preventive maintenance services for the Laerdal 3G Critical Care Manikin to our existing contract, Laerdal 36C26126P0274 at the beginning Option Period 1. This enhancement is crucial for ensuring the continued operational readiness of the Laerdal 3G Critical Care Manikin, which supports ongoing simulation training for staff at the VA Southern Nevada Healthcare System.

The VASNHS service lines are listed below for inclusion in work to be performed by the contractor:

• Office of the Associate Director for Patient Care Services

• Office of the Associate Director for Patient Care Services – Education Service

• Office of the Associate Director for Patient Care Services – Education Simulation

Place of Performance

The monitoring service requested will be for the VA Southern Nevada Healthcare

System located at 6900 N. Pecos Rd. North Las Vegas, NV 89086.

Specific Requirements/Tasks and Associated Deliverables

1. The contractor shall provide a warranty and service plan for the ASL 5000 Respiratory Simulator includes comprehensive coverage for repairs arising from manufacturer’s defects or workmanship issues. The services provided will encompass a thorough inspection of the ASL 5000, calibration with data verification to ensure optimal performance, replacement of piston seals if deemed necessary during inspection, and lubrication of all moving parts to maintain smooth operation. This plan aims to ensure the continued accuracy, reliability, and longevity of the simulator, thereby supporting effective respiratory training and simulation activities.

2. The contractor is required to provide an on-site service plan along with updated software for the three Laerdal SimMan ALS manikins and the one Laerdal 3G manikin. This includes the replacement of essential parts and components as necessary. Additionally, the contractor will conduct routine head-to-toe care and cleaning, perform software updates, carry out testing, and address any other work as recommended by the Field Service Engineer on-site.

3. The contractor shall provide an extended warranty for three Laerdal SimMan ALS manikins. This warranty covers materials, manufacturing, and workmanship issues, as well as return-to-bench service. It includes packaging materials for returning the devices to Laerdal and covers shipping costs for repairs (ground freight from and to the customer's facility). Additionally, there will be an extended warranty for one Laerdal 3G manikin, which includes a SimMan 3G PLUS extended warranty for one year. This warranty also covers materials, manufacturing, and workmanship issues, return-to-bench service, packaging materials for return to Laerdal, and shipping costs for repairs (ground freight from and to the customer's facility).

Contract Performance Monitoring

The Contracting Officer’s Representative (COR), Alternate COR (ACOR) or CO shall be the VA official responsible for monitoring contract compliance.

SECURITY REQUIREMENTS FOR UNCLASSIFED INFORMATION TECHNOLOGY

SECURITY RESOURCES

a. The contractor and their personnel shall be subject to the same Federal laws, regulations, standards and VA polices as VA personnel, regarding information and information system security. These include, but are not limited to, Federal Information Security Management Act

(FISMA), Appendix III of OMB Circular A-130, and guidance and standards, available from the

Department of Commerce’s National Institute of Standards and Technology (NIST). This also includes the use of common security configuration available from NIST’s Web site at:

http://checklists.nist.gov.

b. To ensure that appropriate security controls are in place, contractors must follow the procedures set forth in “VA Information and Information System Security/Privacy Requirements for IT Contractors” located at the following site: http://www.iprm.oit.va.gov.

c. These provisions shall apply to all contracts in which VA sensitive information is stored, generated, transmitted, or exchanged by VA, a contractor, subcontractor or a third-party, or on behalf of any of these entities regardless of format or whether it resides on a VA system or contractor/subcontractor’s electronic information system(s) operating for or on the VA behalf.

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.

http://checklists.nist.gov/ http://www.iprm.oit.va.gov/

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.

e. The contractor or subcontractor must notify the COR 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 COR must also be notified immediately by the contractor or subcontractor prior to an unfriendly termination.

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 COR 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. In accordance with 45 CFR 164.502(e), the Privacy Rule includes exceptions to the Business

Associate Standard. This requirement meets the exception and does not require a Business

Associate agreement in order for Covered Entity to disclose Protected Healthcare Information to the contractor for treatment.

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. The records created in accordance with this contract belong to the VASNHS and should be returned to the VASNHS and/or destroyed in accordance with VHA RCS 10-1. Destruction should only occur with advance notice and guidance from the Records Management Officer at the VASNHS. Records shall be safeguarded in accordance with the Privacy Act, Health

Insurance Portability and Accountability Act (HIPAA) and the VASNHS Release of Information

Unit. Patient Medical information is considered privileged and shall not be disclosed or revealed in any way without prior written permission from the VA Chief, Health Information

Management Section.

k. The Contractor shall only release medical information obtained during the course of this contract to those VA staff members involved in the necessary management and treatment of that individual patient. Patient list and name of patients are considered privileged information and shall not be disclosed or revealed in any way for use outside the Contractor without prior written permission from the referring VA Chief of Staff. Veterans requesting copies of medical information generated by the contractor will be referred to the VASNHS Release of Information

Unit.

l. 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 VASNHS Release of Information Unit for response.

m. 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 VASNHS Release of Information Unit for response.

n. 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

6500.1requirements. This must be completed within 30 days of termination of the contract.

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

Ensure that a Contractor Security Control Assessment (CSCA) is completed within 30 days of contract approval and yearly on the renewal date of the contract.

Ensure that the CSCA is sent to the ISO and the OCS Certification Program Office for review to ensure that appropriate security controls are being implemented in service contracts.

Ensure a copy of the CSCA is maintained in the Security Management and Reporting Tool

(SMART) database. COR will provide a copy of the completed CSCA to ISO for uploading into

SMART database.

HEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY ACT (HIPAA):

Contractor shall take reasonable measures to ensure patient privacy and confidentiality. The contractor agrees to take all reasonable precautions to safeguard patient information from unauthorized access or modification, in both electronic and hard-copy formats. This includes not only electronic security measures such as “strong” user passwords on computer systems, but also physical barriers to prevent unauthorized use of computer work-stations; that hard copy patient files are in secured lockable areas, that files are in lockable cabinets, that the cabinets can in fact be locked, i.e., keys are available, and the locking mechanisms work properly. This precaution also includes the proper transfer of patient information via electronic means, such as faxing or system to system transmission.

That only the minimum necessary patient information is used to provide appropriate service to the correct patient.

That the undersigned understands that all parties are bound by the requirements of the “Health

Insurance Portability and Accountability Act of 1996” which provide guidance on the protection of patient privacy and confidentiality. This Act mandates that all government agencies, and those bodies with whom they contract, must be in compliance with the directives of the Act.

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

COR 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.

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.

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

Contractor/subcontractor employees requiring access to VA information shall complete privacy training annually as required for covered entities under the HIPAA.

The COR shall ensure employees complete training within 1 week of the initiation of the contract and annually thereafter, as required.

Failure to complete the mandatory annual training 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.

1. RECORDS MANAGEMENT LANGUAGE

Contractor shall comply with all applicable records management laws and regulations, as well as

National Archives and Records Administration (NARA) records policies, including but not limited to the Federal Records Act (44 U.S.C. Chapters. 21, 29, 31, 33), NARA regulations at 36

CFR Chapter XII Subchapter B, and those policies associated with the safeguarding of records covered by the Privacy Act of 1974 (5 U.S.C. 552a). These policies include the preservation of all records, regardless of form or characteristics, mode of transmission, or state of completion.

In accordance with 36 CFR 1222.32, all data created for Government use and delivered to, or falling under the legal control of, the Government are Federal records subject to the provisions of

44 U.S.C. chapters 21, 29, 31, and 33, the Freedom of Information Act (FOIA) (5 U.S.C. 552), as amended, and the Privacy Act of 1974 (5 U.S.C. 552a), as amended and must be managed and scheduled for disposition only as permitted by statute or regulation.

In accordance with 36 CFR 1222.32, the contractor shall maintain all records created for

Government use or created in the course of performing the contract and/or delivered to, or under the legal control of the Government and must be managed in accordance with Federal law.

Electronic records and associated metadata must be accompanied by sufficient technical documentation to permit understanding and use of the records and data.

The VA Southern Nevada Healthcare System (VASNHS) and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Records may not be removed from the legal custody of VASNHS or destroyed except for in accordance with the provisions of the agency records schedules and with the written concurrence of the Head of the Contracting Activity. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701.

In the event of any unlawful or accidental removal, defacing, alteration, or destruction of records, the contractor must report to VASNHS. The agency must report promptly to NARA in accordance with 36 CFR 1230.

The contractor shall immediately notify the appropriate Contracting Officer (CO) upon discovery of any inadvertent or unauthorized disclosures of information, data, documentary materials, records or equipment. Disclosure of non-public information is limited to authorized personnel with a need-to-know as described in the contract documents. The contractor shall ensure that the appropriate personnel, administrative, technical, and physical safeguards are established to ensure the security and confidentiality of this information, data, documentary material, records and/or equipment is properly protected. The contractor shall not remove material from

Government facilities or systems, or facilities or systems operated or maintained on the

Government’s behalf, without the express written permission of the Head of the Contracting

Activity. When information, data, documentary material, records and/or equipment is no longer required, it shall be returned to VASNHS control or the contractor must hold it until otherwise directed. Items returned to the Government shall be hand carried, mailed, emailed, or securely electronically transmitted to the CO or address prescribed in the contract documents. Destruction of records is EXPRESSLY PROHIBITED unless in accordance with Paragraph (4).

The contractor is required to obtain the CO's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under, or relating to, contracts. The contractor

(and any sub-contractor) is required to abide by Government and VASNHS guidance for protecting sensitive, proprietary information, classified, and controlled unclassified information.

The contractor shall only use Government IT equipment for purposes specifically tied to or authorized by the contract and in accordance with VASNHS policy.

The contractor shall not create or maintain any records containing any non-public VASNHS information that are not specifically tied to or authorized by the contract.

The contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected from public disclosure by an exemption to the FOIA.

VASNHS owns the rights to all data and records produced as part of this contract. All deliverables under the contract are the property of the U.S. Government for which VASNHS shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest. Any contractor rights in the data or deliverables must be identified as required by FAR 52.227-11 through FAR 52.227-20.

Training. All contractor employees assigned to this contract who create, work with, or otherwise handle records are required to take VHA-provided records management training. The contractor is responsible for confirming training has been completed according to agency policies, including initial training and any annual or refresher training.

Flowdown of requirements to Subcontractors:

The contractor shall incorporate the substance of this clause, its terms and requirements including this paragraph, in all subcontracts under this contract document, and require written subcontractor acknowledgment of same.

Violation by a subcontractor of any provision set forth in this clause will be attributed to the contractor.