36C25021Q1005.docx

PAGE 1 OF

1. REQUISITION NO.

2. CONTRACT NO.

3. AWARD/EFFECTIVE DATE

4. ORDER NO.

5. SOLICITATION NUMBER

6. SOLICITATION ISSUE DATE

a. NAME

b. TELEPHONE NO. (No Collect Calls)

8. OFFER DUE DATE/LOCAL

TIME

9. ISSUED BY

CODE

10. THIS ACQUISITION IS

UNRESTRICTED OR

SET ASIDE:

% FOR:

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

8(A)

NAICS:

SIZE STANDARD:

11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

12. DISCOUNT TERMS

13a. THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13b. RATING

14. METHOD OF SOLICITATION

RFQ

IFB

RFP

15. DELIVER TO

CODE

16. ADMINISTERED BY

CODE

17a. CONTRACTOR/OFFEROR

CODE

FACILITY CODE

18a. PAYMENT WILL BE MADE BY

CODE

TELEPHONE NO.

DUNS:

DUNS+4:

PHONE:

FAX:

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER 18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW IS CHECKED

SEE ADDENDUM

19.

20.

21.

22.

23.

24.

ITEM NO.

SCHEDULE OF SUPPLIES/SERVICES

QUANTITY

UNIT

UNIT PRICE

AMOUNT

(Use Reverse and/or Attach Additional Sheets as Necessary)

25. ACCOUNTING AND APPROPRIATION DATA

26. TOTAL AWARD AMOUNT (For Govt. Use Only) 27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA

ARE

ARE NOT ATTACHED.

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA

ARE

ARE NOT ATTACHED

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN _______________

29. AWARD OF CONTRACT: REF. ___________________________________ OFFER

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND

DATED ________________________________. YOUR OFFER ON SOLICITATION

DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY

(BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE

ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED

SET FORTH HEREIN IS ACCEPTED AS TO ITEMS:

30a. SIGNATURE OF OFFEROR/CONTRACTOR 31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER) 30b. NAME AND TITLE OF SIGNER (TYPE OR PRINT) 30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (TYPE OR PRINT) 31c. DATE SIGNED

AUTHORIZED FOR LOCAL REPRODUCTION

(REV. 2/2012)

PREVIOUS EDITION IS NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

101-21-3-5209-0377 36C25021Q1005 08-05-2021 Kellie Konopinski 734-222-4330 08-13-2021 4:30 pm

EDT

36C506 Department of Veterans Affairs Ann Arbor Healthcare System Network Contracting Office 10 2215 Fuller Road Ann Arbor MI 48105 X 339112 1000 Employees N/A X Multiple - See Below

36C506 Department of Veterans Affairs Ann Arbor Healthcare System Network Contracting Office 10 2215 Fuller Road Ann Arbor MI 48105

Department of Veterans Affairs Financial Management System PO Box 149971 Austin TX 78714-9971 877-353-9791 512-460-5540 X See CONTINUATION Page RFQ for Codonics - Michigan Sites TMS 20939 Training Required Brand Name Only - Justification Attached See CONTINUATION Page

101-361/31123-5209-110600-3138 EHRB00000

X X X Kellie Konopinski Contracting Officer Table of Contents

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

1. Contract Administration: All contract administration matters will be handled by the following individuals:

b. GOVERNMENT: Contracting Officer 36C250 Kellie Konopinski Department of Veterans Affairs Ann Arbor Healthcare System Network Contracting Office 10 2215 Fuller Road Ann Arbor MI 48105

2. CONTRACTOR REMITTANCE ADDRESS: All payments by the Government to the contractor will be made in accordance with:

3. INVOICES: Invoices shall be submitted in arrears:

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 Financial Management System PO Box 149971 Austin TX 78714-9971 ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:

B.2 IT CONTRACT SECURITY

VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY

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 COR.

4. INFORMATION SYSTEM DESIGN AND DEVELOPMENT – N/A

5. INFORMATION SYSTEM HOSTING, OPERATION, MAINTENANCE, OR USE – N/A

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 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.

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 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.

8. SECURITY CONTROLS COMPLIANCE TESTING – N/A

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 COR 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.

36C25021Q1005

(End of Clause) Page 1 of Page 1 of

B.3 PERFORMANCE WORK STATEMENT

VISN 10-MICHIGAN SITES, Anesthesia Medication Safe Labeling System- Codonics/Omnicell and Codonics/BD Integration

Contract Title. Veterans Integrated Service Network (VISN 10)-MICHIGAN Sites, Anesthesia Medication Safe Labeling System

1. Background. VISN 10 is responsible for providing health care to Veterans in the states of Indiana, Ohio and Michigan. Veterans Integrated Service Network (VISN) 10 is the result of the integration of VISNs 10 and VISN 11 as part of VA’s MyVA Transformation plan. The newly integrated VISN 10 is comprised of 10 medical centers and the independent Columbus, OH Ambulatory Care clinic and a network of 63 Community Based Outpatient Clinics. VISN 10 provides personalized, proactive, patient-centered care to more than 685,000 Veterans throughout the lower peninsula of Michigan, Ohio/Northern Kentucky and Indiana.

Like all health care facilities, VISN 10 is moving from the legacy VistA EMR and moving to an Enterprise Cerner EMR. This move will require legacy systems to have their existing medical and laboratory devices interfaced and configured to communicate with Cerner.

VISN 10 requires a Safe Label System that will integrate with Cerner via HL7 messages at nine (9) sites to maximize patient safety as it relates to Anesthesia management. This system will allow for compliance in medication labeling and documentation within the Cerner SA Anesthesia charting module. This interfacing allows for reduction of human errors and automates the workflow for Anesthesia providers during care.

2. Scope. The contracted vendor shall provide hardware, software, software licenses, installation services, project management services, training services, and maintenance and support services to interface the current and new Codonics Safe Label System (SLS) and SLS WAVE Barcode scanners with the Cerner Anesthesia charting system, SA Anesthesia. The contracted vendor’s technical and clinical teams will work with VISN 10 engineers, technicians, anesthesia providers, and pharmacy staff, to setup, configure, and test the SLS and SLS WAVE to ensure proper documentation of medications within the SA Anesthesia charting system. Work will be performed both remotely and on site at each location at the VA facilities in Table 1.

VISN 10 is seeking a firm fixed price contract for the Safe Labeling System (SLS), barcode scanners, backend servers, and professional services to install these systems at the sites of care below.

Each deployment is outlined as below by location:

2.1. John D. Dingell Detroit VA Medical Center

2.1.1. Codonics SLS WAVE – Barcode Medication Administration (BCMA) Scanner

2.1.1.1. QTY: 11

2.1.1.1.1. Provide all necessary software and labor for installation, configuration, testing, and training of the Codonics SLS WAVE with Cerner SA Anesthesia.

2.1.1.1.2. 5-year warranty shall be included for hardware.

2.1.2. Codonics SLS 550i – Safe Label System for Medications

2.1.2.1. QTY: 12

2.1.2.1.1. Provide all necessary software and labor for installation, configuration, testing, and training of the Codonics SLS Units.

2.1.2.1.2. Shall include a standard 12-month warranty, with optional 2-5 year additional warranty.

2.1.3. Codonics SLS 550i – Mounting Shelf to Anesthesia Utility Cart

2.1.3.1. QTY: 11

2.1.3.1.1. Provide all necessary labor for installation and mounting of SLS support shelves.

2.1.4. Codonics SLS 550i – Spare Ink and Labels

2.1.4.1. QTY: 11

2.1.4.1.1. Provide replacement ink and labels for SLS 550i printers.

2.1.5. Codonics AT – Administration Tool Application

2.1.5.1. QTY: 1

2.1.5.1.1. Provide all necessary software and labor for installation, configuration, testing, and training of the Codonics SLS Administration Tool.

2.1.6. Codonics AT – Administer Mode

2.1.6.1. QTY: 12

2.1.6.1.1. Enables SLS system to confirm a drug prior to administration.

2.1.7. Codonics AT – Administration Tool Accessory Kit

2.1.7.1. QTY: 1

2.1.7.1.1. Provide barcode scanner for pharmacy staff input of new medications into the Codonics Administrative Tool.

2.1.8. Codonics AT – SLS Operating Software

2.1.8.1. QTY: 1

2.1.8.1.1. Newest revision of SLS software

2.2. Ann Arbor VA Medical Center

2.2.1. Codonics SLS WAVE – Barcode Medication Administration (BCMA) Scanner

2.2.1.1. QTY: 20

2.2.1.1.1. Provide all necessary software and labor for installation, configuration, testing, and training of the Codonics SLS WAVE with Cerner SA Anesthesia.

2.2.1.1.2. 5-year warranty shall be included for hardware.

2.2.2. Codonics SLS 550i – Safe Label System for Medications

2.2.2.1. QTY: 21

2.2.2.1.1. Provide all necessary software and labor for installation, configuration, testing, and training of the Codonics SLS Units.

2.2.2.1.2. Shall include a standard 12-month warranty, with optional 2-5 year additional warranty.

2.2.3. Codonics SLS 550i – Mounting Shelf to Anesthesia Utility Cart

2.2.3.1. QTY: 20

2.2.3.1.1. Provide all necessary labor for installation and mounting of SLS support shelves.

2.2.4. Codonics SLS 550i – Spare Ink and Labels

2.2.4.1. QTY: 21

2.2.4.1.1. Provide replacement ink and labels for SLS 550i printers.

2.2.5. Codonics AT – Administration Tool Application

2.2.5.1. QTY: 1

2.2.5.1.1. Provide all necessary software and labor for installation, configuration, testing, and training of the Codonics SLS Administration Tool.

2.2.6. Codonics AT – Administer Mode

2.2.6.1. QTY: 21

2.2.6.1.1. Enables SLS system to confirm a drug prior to administration.

2.2.7. Codonics AT – Administration Tool Accessory Kit

2.2.7.1. QTY: 1

2.2.7.1.1. Provide barcode scanner for pharmacy staff input of new medications into the Codonics Administrative Tool.

2.2.8. Codonics AT – SLS Operating Software

2.2.8.1. QTY: 1

2.2.8.1.1. Newest revision of SLS software

2.3. Aleda E. Lutz Saginaw VA Medical Center

2.3.1. Codonics SLS WAVE – Barcode Medication Administration (BCMA) Scanner

2.3.1.1. QTY: 4

2.3.1.1.1. Provide all necessary software and labor for installation, configuration, testing, and training of the Codonics SLS WAVE with Cerner SA Anesthesia.

2.3.1.1.2. 5-year warranty shall be included for hardware.

2.4. Project Management

2.4.1. The Contractor shall draft a Contractor Project Management Plan (CPMP) that lays out the Contractor’s approach, timeline, and tools to be used in execution of the contract. The PMP should take the form of both a narrative and graphic format that displays the schedule, milestones, risks, and resource support. The CPMP shall include the contractor’s plans for managing all subcontractors.

2.4.2. Topic areas to be addressed shall include oversight and communications with subcontractors while onsite at VA locations, as well as executing the timely distribution and delivery of all materials to subcontractor personnel. The CPMP shall also include how the Contractor shall coordinate and execute planned, routine, and ad hoc data collection reporting requests as identified. The initial baseline CPMP shall be concurred upon and updated monthly thereafter. The Contractor shall update and maintain the VA Contracting Officer’s Representative (COR) approved CPMP throughout the period of performance. The CPMP will include, but not be limited to:

2.4.2.1. Project Schedule to include Milestones, Deliverables, and Critical Path

2.4.2.2. Verification & Validation (V&V) Plan

2.4.2.3. Training Plan

2.4.2.4. Risks Management Plan

2.4.2.5. Project Closeout Activities/Procedures

2.4.3. The Contractor shall provide weekly progress reports, to include schedule updates, to the VA COR and shall cover all work completed during the reporting period and work planned for the subsequent reporting period. The reports shall also identify any problems that arose and a description of how the problems were resolved. If problems have not been completely resolved, the Contractor shall provide an explanation. The Contractor shall monitor performance against the CPMP and report any deviations. It is expected that the Contractor will remain in communication with the VA accordingly so that issues that arise are transparent to both parties to prevent escalation of outstanding issues.

2.4.4. The Contractor shall provide the COR with Weekly Installation Progress Reports in electronic form in Microsoft Word, Project formats or PDF. The report shall include detailed instructions/explanations for each required data element, to ensure that data is accurate and consistent. These reports shall reflect data as of the last day of the preceding Month. These reports shall include a summary of the task order deliverables.

Table 1: Safe Label System, Places of Performance

Detroit, MI 48201

Ann Arbor, MI 48105

Saginaw, MI 48602

3. Performance Period. Period of performance shall start immediately after award is issued.

4. Place of Performance. Contract performance shall take place at the contractor’s location(s) and at the locations in Table 1.

5. Travel for Installation, Implementation and Training. The Government anticipates Contractor travel under this contract. All travel shall be incorporated into the price schedule for the contract. No travel costs will be reimbursed by VA

5.1. Travel is anticipated for on-site installation, configuration, implementation, training, and end-to-end testing. The Government acknowledges the possible use of remote access for installation and implementation purposes, within the constraints of all applicable VA Information Security Requirements

6. Government Furnished Equipment/Information. The Contractor shall be allowed access to Government equipment including servers and network infrastructure. Information on Government equipment and systems shall be provided as necessary. No Government-owned property will be transferred into the Contractor’s control. Additional software products may be provided by the Government as identified to facilitate Contractor access, e.g. Microsoft Terminal Services.

7. Invoicing. Invoices shall be submitted electronically via the Financial Services Center Mandatory Electronic Invoice System. Invoices must include, at a minimum, the following information: Contractor name, purchase order number, period of service the billing covers, and a list of equipment items covered during the stated period of performance.

This requirement is in accordance with VARR Clause 852.232-72 Electronic Submission of Payment Requests: http://www.fsc.va.gov/einvoice.asp. Electronic payments are net 30 days.

8. Security Requirements. All contractor employees are subject to the same level of investigation as VA employees who have access to VA sensitive information or access to VA facilities. The background investigation includes the following requirements: 1) Completed documentation 2) Fingerprints 3) Completion of OPM’s e-QIP Questionnaire. The Contractor is required to fulfill all the security requirements. The Contractor, upon completion of fingerprinting, and an initial suitability determination, may be authorized tentative access to start the performance period of the contract, but only on condition of completion of all security requirements. This requirement is applicable to all subcontractor personnel requiring the same access.

9. Hours of Coverage & Federal Holidays. Maintenance Service will be provided during regular coverage hours of 8:30am to 5:30pm, Monday through Friday, excluding federal holidays. The contractor shall contact the POC or his/her designee prior to commencing any work on the premises.

Federal Holidays are:

Christmas Day

B.4 PRICE/COST SCHEDULE

ITEM INFORMATION

IR114.14b- HTM VISN 10 - Medical Devices - Codonics Michigan- 21-IJP-304- 21REQ0293 2021-OIT-EHRM-137678-Infra-N/A 2021-OEHRM-340-3 SLS Wave-ANN

SLS-WAVE hands-free scanner integrates with Anesthesia Information management systems to extend BCMA to the operating room. A mounting bracket and a five-year Depot Swap Warranty are included.

Contract Period: Base POP Begin: 08-27-2021 POP End: 12-31-2021 PRINCIPAL NAICS CODE: 339112 - Surgical and Medical Instrument Manufacturing PRODUCT/SERVICE CODE: 6515 - Medical and Surgical Instruments, Equipment, and Supplies

MANUFACTURER PART NUMBER (MPN): SLS-WAVE

SLS 550i-ANN Safe Label System® SLS 550i™ - The SLS 550i is an FDA Class II integrated solution for safe, fast, compliant labeling of medication. It incorporates a touch screen computer, barcode scanner and a full-color label printer into a compact easy-to-use system. Includes User's Manual, US power cord and one-year RTF warranty.

Contract Period: Base POP Begin: 08-27-2021 POP End: 12-31-2021 PRINCIPAL NAICS CODE: 339112 - Surgical and Medical Instrument Manufacturing

MANUFACTURER PART NUMBER (MPN): SLS550

SLS Administration Tool-ANN SLS Administration Tool software application, Site License - This software application includes multiple modules which enable configuration of the SLS system, preparation of SLS formularies and updates to the SLS system as required. A Site License provides for an unlimited number of units at a healthcare facility whose constituent buildings and support personnel are physically and logistically proximate to each other. Only one AT is deployed for all units covered by the Site License. The system is compatible with Windows 7, 8, and as well as Windows Server 2008, 2012 R2 and 2016. Comes with one SLS500-AT-KIT-##.# * which contains an application CD and documentation. (Note: 2D barcode scanner recommended for barcode data verification.)

• Software level of AT KIT must be specified.

Contract Period: Base POP Begin: 08-27-2021 POP End: 12-31-2021 PRINCIPAL NAICS CODE: 339112 - Surgical and Medical Instrument Manufacturing

MANUFACTURER PART NUMBER (MPN): SLS500-AT-S

Adminster Mode feature-ANN Administer Mode feature key enables SLS 500i to confirm a drug prior to administration.

POP Begin: 08-27-2021 POP End: 12-31-2021 PRINCIPAL NAICS CODE: 339112 - Surgical and Medical Instrument Manufacturing

MANUFACTURER PART NUMBER (MPN): SLS500KY-ADM

SLS 500i shelf with mountable drawer-ANN SLS 500i shelf with drawer for mounting on an anesthesia cart including mounting kit compatible with the Omnicell G4 Cabinet. Not compatible when optional side work table is installed Contract Period: Base POP Begin: 08-27-2021 POP End: 12-31-2021 PRINCIPAL NAICS CODE: 339112 - Surgical and Medical Instrument Manufacturing

MANUFACTURER PART NUMBER (MPN): SLS500-SHELF-05

SLS Starter Kit-ANN SLS Starter Kit (contains 1 roll of labels, 60 MM x 22 MM and 1 TYPE-2 ink cartridge)

POP Begin: 08-27-2021 POP End: 12-31-2021 PRINCIPAL NAICS CODE: 339112 - Surgical and Medical Instrument Manufacturing

MANUFACTURER PART NUMBER (MPN): SLS-TYPE2-STRKIT

SLS Operating Software-ANN SLS Operating Software (Required) Ordering Instructions: If the Site is a new USA SLS site generally the newest revision SLS software should be ordered. If additional units are being ordered for an existing site or for international shipments, your sales representative will assist you regarding the correct software level to order.

Contract Period: Base POP Begin: 08-27-2021 POP End: 12-31-2021 PRINCIPAL NAICS CODE: 339112 - Surgical and Medical Instrument Manufacturing

MANUFACTURER PART NUMBER (MPN): SLS-SW-2.5.0

SLS Administration Tool Accessory Kit-ANN SLS Administration Tool Accessory Kit. Includes Motorola DS4308-HC Healthcare handheld barcode scanner with USB connection, adjustable Intellistand, one-year warranty and custom firmware improving drug vial scanning performance.

Contract Period: Base POP Begin: 08-27-2021 POP End: 12-31-2021 PRINCIPAL NAICS CODE: 339112 - Surgical and Medical Instrument Manufacturing

MANUFACTURER PART NUMBER (MPN): AT-ACC-KIT-2

SLS Wave-DET SLS-WAVE hands-free scanner integrates with Anesthesia Information management systems to extend BCMA to the operating room. A mounting bracket and a five-year Depot Swap Warranty are included.

POP Begin: 08-27-2021 POP End: 12-31-2021 PRINCIPAL NAICS CODE: 339112 - Surgical and Medical Instrument Manufacturing

MANUFACTURER PART NUMBER (MPN): SLS-WAVE

SLS 550i-DET Safe Label System® SLS 550i™ - The SLS 550i is an FDA Class II integrated solution for safe, fast, compliant labeling of medication. It incorporates a touch screen computer, barcode scanner and a full-color label printer into a compact easy-to-use system. Includes User's Manual, US power cord and one-year RTF warranty.

POP Begin: 08-27-2021 POP End: 12-31-2021 PRINCIPAL NAICS CODE: 339112 - Surgical and Medical Instrument Manufacturing

MANUFACTURER PART NUMBER (MPN): SLS550

SLS Administration Tool-DET SLS Administration Tool software application, Site License - This software application includes multiple modules which enable configuration of the SLS system, preparation of SLS formularies and updates to the SLS system as required. A Site License provides for an unlimited number of units at a healthcare facility whose constituent buildings and support personnel are physically and logistically proximate to each other. Only one AT is deployed for all units covered by the Site License. The system is compatible with Windows 7, 8, and as well as Windows Server 2008, 2012 R2 and 2016. Comes with one SLS500-AT-KIT-##.# * which contains an application CD and documentation. (Note: 2D barcode scanner recommended for barcode data verification.)

• Software level of AT KIT must be specified.

Contract Period: Base POP Begin: 08-27-2021 POP End: 12-31-2021 PRINCIPAL NAICS CODE: 339112 - Surgical and Medical Instrument Manufacturing

MANUFACTURER PART NUMBER (MPN): SLS500-AT-S

Adminster Mode feature-DET Administer Mode feature key enables SLS 500i to confirm a drug prior to administration.

POP Begin: 08-27-2021 POP End: 12-31-2021 PRINCIPAL NAICS CODE: 339112 - Surgical and Medical Instrument Manufacturing

MANUFACTURER PART NUMBER (MPN): SLS500KY-ADM

SLS 500i shelf with mountable drawer-DET SLS 500i shelf with drawer for mounting on an anesthesia cart including mounting kit compatible with the Omnicell G4 Cabinet. Not compatible when optional side work table is installed Contract Period: Base POP Begin: 08-27-2021 POP End: 12-31-2021 PRINCIPAL NAICS CODE: 339112 - Surgical and Medical Instrument Manufacturing

MANUFACTURER PART NUMBER (MPN): SLS500-SHELF-05

SLS Starter Kit-DET SLS Starter Kit (contains 1 roll of labels, 60 MM x 22 MM and 1 TYPE-2 ink cartridge)

POP Begin: 08-27-2021 POP End: 12-31-2021 PRINCIPAL NAICS CODE: 339112 - Surgical and Medical Instrument Manufacturing

MANUFACTURER PART NUMBER (MPN): SLS-TYPE2-STRKIT

SLS Operating Software-DET SLS Operating Software (Required) Ordering Instructions: If the Site is a new USA SLS site generally the newest revision SLS software should be ordered. If additional units are being ordered for an existing site or for international shipments, your sales representative will assist you regarding the correct software level to order Contract Period: Base POP Begin: 08-27-2021 POP End: 12-31-2021 PRINCIPAL NAICS CODE: 339112 - Surgical and Medical Instrument Manufacturing

MANUFACTURER PART NUMBER (MPN): SLS-SW-2.5.0

SLS Administration Tool Accessory Kit-DET SLS Administration Tool Accessory Kit. Includes Motorola DS4308-HC Healthcare handheld barcode scanner with USB connection, adjustable Intellistand, one-year warranty and custom firmware improving drug vial scanning performance.

POP Begin: 08-27-2021 POP End: 12-31-2021 PRINCIPAL NAICS CODE: 339112 - Surgical and Medical Instrument Manufacturing

MANUFACTURER PART NUMBER (MPN): AT-ACC-KIT-2

SLS Wave-SAG SLS-WAVE hands-free scanner integrates with Anesthesia Information management systems to extend BCMA to the operating room. A mounting bracket and a five-year Depot Swap Warranty are included.

POP Begin: 08-27-2021 POP End: 12-31-2021 PRINCIPAL NAICS CODE: 339112 - Surgical and Medical Instrument Manufacturing

MANUFACTURER PART NUMBER (MPN): SLS Wave

SLS Installation-ANN SLS Installation by Codonics Personnel, USA only.

POP Begin: 08-27-2021 POP End: 12-31-2021 PRINCIPAL NAICS CODE: 339112 - Surgical and Medical Instrument Manufacturing

MANUFACTURER PART NUMBER (MPN): SLS-INSTALL

SLS Installation-DET SLS Installation by Codonics Personnel, USA only.

POP Begin: 08-27-2021 POP End: 12-31-2021 PRINCIPAL NAICS CODE: 339112 - Surgical and Medical Instrument Manufacturing

MANUFACTURER PART NUMBER (MPN): SLS-INSTALL

B.5 DELIVERY SCHEDULE

2215 Fuller Road Ann Arbor, MI 48105 2303

USA

317-956-9269 Nicole.Patterson1@va.gov

2215 Fuller Road Ann Arbor, MI 48105 2303

USA

2215 Fuller Road Ann Arbor, MI 48105 2303

USA

2215 Fuller Road Ann Arbor, MI 48105 2303

USA

2215 Fuller Road Ann Arbor, MI 48105 2303

USA

2215 Fuller Road Ann Arbor, MI 48105 2303

USA

2215 Fuller Road Ann Arbor, MI 48105 2303

USA

2215 Fuller Road Ann Arbor, MI 48105 2303

USA

4646 John R. Street Detroit, MI 48201 1916

USA

4646 John R. Street Detroit, MI 48201 1916

USA

4646 John R. Street Detroit, MI 48201 1916

USA

4646 John R. Street Detroit, MI 48201 1916

USA

4646 John R. Street Detroit, MI 48201 1916

USA

4646 John R. Street Detroit, MI 48201 1916

USA

4646 John R. Street Detroit, MI 48201 1916

USA

4646 John R. Street Detroit, MI 48201 1916

USA

1500 Weiss Street Saginaw, MI 48602 5251

USA

2215 Fuller Road Ann Arbor, MI 48105 2303

USA

4646 John R. Street Detroit, MI 48201 1916

USA

36C25021Q1005

Page 1 of

SECTION C - CONTRACT CLAUSES

C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL ITEMS (OCT 2018)

(a) Inspection/Acceptance. The Contractor shall only tender for acceptance those items that conform to the requirements of this contract. The Government reserves the right to inspect or test any supplies or services that have been tendered for acceptance. The Government may require repair or replacement of nonconforming supplies or reperformance of nonconforming services at no increase in contract price. If repair/replacement or reperformance will not correct the defects or is not possible, the Government may seek an equitable price reduction or adequate consideration for acceptance of nonconforming supplies or services. The Government must exercise its post-acceptance rights—

(1) Within a reasonable time after the defect was discovered or should have been discovered; and

(2) Before any substantial change occurs in the condition of the item, unless the change is due to the defect in the item.

(b) Assignment. The Contractor or its assignee may assign its rights to receive payment due as a result of performance of this contract to a bank, trust company, or other financing institution, including any Federal lending agency in accordance with the Assignment of Claims Act (31 U.S.C. 3727). However, when a third party makes payment (e.g., use of the Governmentwide commercial purchase card), the Contractor may not assign its rights to receive payment under this contract.

(c) Changes. Changes in the terms and conditions of this contract may be made only by written agreement of the parties.

(d) Disputes. This contract is subject to 41 U.S.C. chapter 71, Contract Disputes. Failure of the parties to this contract to reach agreement on any request for equitable adjustment, claim, appeal or action arising under or relating to this contract shall be a dispute to be resolved in accordance with the clause at FAR 52.233-1, Disputes, which is incorporated herein by reference. The Contractor shall proceed diligently with performance of this contract, pending final resolution of any dispute arising under the contract.

(e) Definitions. The clause at FAR 52.202-1, Definitions, is incorporated herein by reference.

(f) Excusable delays. The Contractor shall be liable for default unless nonperformance is caused by an occurrence beyond the reasonable control of the Contractor and without its fault or negligence such as, acts of God or the public enemy, acts of the Government in either its sovereign or contractual capacity, fires, floods, epidemics, quarantine restrictions, strikes, unusually severe weather, and delays of common carriers. The Contractor shall notify the Contracting Officer in writing as soon as it is reasonably possible after the commencement of any excusable delay, setting forth the full particulars in connection therewith, shall remedy such occurrence with all reasonable dispatch, and shall promptly give written notice to the Contracting Officer of the cessation of such occurrence.

(g) Invoice.

(1) The Contractor shall submit an original invoice and three copies (or electronic invoice, if authorized) to the address designated in the contract to receive invoices. An invoice must include—

(i) Name and address of the Contractor;

(ii) Invoice date and number;

(iii) Contract number, line item number and, if applicable, the order number;

(iv) Description, quantity, unit of measure, unit price and extended price of the items delivered;

(v) Shipping number and date of shipment, including the bill of lading number and weight of shipment if shipped on Government bill of lading;

(vi) Terms of any discount for prompt payment offered;

(vii) Name and address of official to whom payment is to be sent;

(viii) Name, title, and phone number of person to notify in event of defective invoice; and

(ix) Taxpayer Identification Number (TIN). The Contractor shall include its TIN on the invoice only if required elsewhere in this contract.

(x) Electronic funds transfer (EFT) banking information.

(A) The Contractor shall include EFT banking information on the…