P01 SON.pdf

Chemiluminescent Immunoassay Analyzer systems / Security Language

STATEMENT OF NEED

1. GENERAL: The James A. Haley Tampa VA Medical Center (JAH VAMC), Pathology and Laboratory Medicine Service, Hematology Department, has a requirement for FDA-approved chemiluminescent immunoassay (CLIA) analyzer systems capable of performing and providing FDA-approved assays for patient and employee testing. The systems must be fully automated, fully integrated, and random access, with walk-away and continuous feed capability offering high throughput and increased sensitivity for lower analytical concentration detection. The need is for a Cost-Per-Test (CPT) base year plus four option year solution to perform this testing.

Additional tests and/or testing site locations within JAH VAMC may be added as determined by VA care providers.

2. SCOPE: The CPT supply solution shall include the cost of equipment lease, including two precisely the same, FDA-approved chemiluminescent immunoassay analyzer systems, uninterruptable power supply (UPS), printer, equipment, parts, supplies, test kits, controls and consumables necessary to provide FDA-approved testing for Calprotectin, CMV IgG, CMV IgM, Aldosterone, C-peptide, Toxo IgG II, Toxo IgM II, and QuantiFERON-TB Gold Plus on patient samples; all maintenance, and service to keep the equipment in good operating condition, operational hardware and software upgrades, user training for government personnel, yearly preventive maintenance per manufacturer’s recommendations, complete service support and all shipping and handling delivery costs. The contractor must provide decontamination, de-installation, removal, and return of hard drives to VA IT, equipment removal, return packaging, and shipment of equipment at no additional charge at contract completion.

This will be a base year (12 MO) plus four (4) years (12 Mo) optional years:

- Base Year: 10/01/2023 – 09/31/2024

- Option #1: 10/01/2024 – 09/31/2025

- Option #2: 10/01/2025 – 09/31/2026

- Option #3: 10/01/2026 – 09/31/2027

- Option #4: 10/01/2027 – 09/31/2028

3. EQUIPMENT SPECIFICATIONS: Contractor shall provide two (2) new FDA-approved immunoassay analyzer systems with Chemiluminescent Immunoassay (CLIA) technology capable of performing FDA-approved testing for Calprotectin, CMV IgG, CMV IgM, Aldosterone, C-peptide, Toxo IgG II, Toxo IgM II, and QuantiFERON-TB Gold Plus on patient samples including specific functionality and performance-based requirements of the system. Refurbished or discontinued models are not acceptable. The instrument is based on an immunodiagnostic testing platform featuring samples-in and results-out capability necessary to operate the contractor’s equipment. The Contractor’s chemiluminescent immunoassay analyzer systems must meet or exceed the below salient characteristics:

a) To perform patient testing in a timely manner and provide backup system, the contractor must provide two (2) exactly the same, FDA-approved fully automated, random access, continuous feed CLIA instruments. No batch testing instrumentation will be considered.

b) The instrument systems must be capable of performing FDA-approved CLIA testing for Calprotectin, CMV IgG, CMV IgM, Aldosterone, C-peptide, Toxo IgG II, Toxo IgM II, and QuantiFERON-TB Gold Plus on patient samples.

c) To maximize incubator efficiency, test cuvettes must be individual, not linked together.

d) The analyzers must detect if each primary patient sample has inadequate volume for required testing and automatic clot detection.

e) The analyzers must sample directly from the primary patient tube.

f) The equipment must include automated processors and readers.

g) The system must be FDA-cleared to run FDA-approved chemiluminescent immunoassays

(CLIA) for Calprotectin, CMV IgG, CMV IgM, Aldosterone, C-peptide, Toxo IgG II, Toxo IgM II, and QuantiFERON-TB Gold Plus.

h) All results, samples, calibrations, and quality controls must be traced by (RFID) Radio Frequency Identification instead of barcoding for on-board tracking of the number of tests and calibrations, lot number, and integral stability on the instrument.

i) All the activities planned and scheduled must be continuously monitored by system including indication of run completion.

j) The instrument software must inform user about instrument status (Stand-By; Ready;

Running).

k) The software must give user upfront estimation of the consumables needed to perform a run and during a run.

l) The instrument must offer on-board User Manual with help feature icon that provides an Operator Guide.

m) The instrument must use disposable tips to eliminate patient sample carry-over risk.

n) The system must be pre-programmed and bi-directionally interfaceable with Veteran

Information System and Technology Architecture (VISTA).

o) System must include QuantiFERON (QFT) Software package that offers the following features: management of different workflows, sample monitoring via barcode labels, automated interpretation of labs data, retesting capabilities for single or multiple patient tubes.

p) Patient’s primary QFT-Plus blood collection tubes that can be loaded on and sampled directly from the random-access, automated, analyzer testing platform.

q) Offered equipment shall be new state-of-the art equipment. Discontinued models will not be accepted.

r) Only instruments, reagent cartridges, and supplies, which are FDA approved, will be considered.

4. TEST ASSAY SPECIFICATIONS: The contractor shall provide the Test Kits (includes reagents, calibrators and controls), supplies and consumables necessary to perform FDA-approved testing for Calprotectin, CMV IgG, CMV IgM, Aldosterone, C-peptide, Toxo IgG II, Toxo IgM II, and QuantiFERON-TB Gold Plus Kits on patient samples. The cost per test (CPT) solution allows for the ability to add new test assays. If any new tests are added as requested, the contractor shall provide test kits for the validation and implementation of new assays at no additional cost. Test assays must meet or exceed the below salient characteristics:

a) Contractor shall provide FDA-approved Calprotectin, CMV IgG, CMV IgM, Aldosterone, C-peptide, Toxo IgG II, Toxo IgM II test kits for automated patient testing and perform FDA-approved testing on QuantiFERON-TB Gold Plus patient test kits.

b) Contractor to assist with configuring and validating Contractor’s instrument system and testing, including providing test kits, calibrators, controls, supplies and consumables necessary to complete method validation studies.

c) Contractor Applications Specialists must be available for on-site assay implementation and validations.

d) The instrument system must be compatible with Data Innovations (DI) version 8.17 or newer middleware.

e) Contractor shall cover cost of analyzer/instrument DI middleware connectivity.

f) Ability to load up to 25 integrals and up to 4 ancillary reagents on the system at the same time.

g) All reagents must be ready-to-use and include the calibrator in the Integral.

5. GENERAL REQUIREMENTS: The contractor is required to maintain the equipment. All work shall be performed in accordance with the guidelines established by Federal, State, and local ordinances, FDA manufacturer’s guidelines, and with all terms, conditions, provisions, and specifications provide herein.

Delivery terms - Quality of Test Kits, Supplies and Consumables:

The VA shall require the delivery of test kits, supplies and consumables for all services required under this contract. The contractor shall deliver test kits, supplies and consumables, shipping and handling costs included, from monthly call orders placed by JAH VAMC representative. The contractor will assure that all supplies provided/ordered for use on their equipment will be of the quality necessary to produce high-quality, accurate patient test results. The FDA-approved reagent quality must be high enough to satisfy proficiency testing standards of the College of American Pathologists (CAP) and Joint Commission

(JC).

Installation procedures - The contractor shall be responsible for installation, which consists of in-house delivery, positioning, and mounting of all equipment listed on the delivery order and connections, as applicable. Upon receipt of notice to proceed with installation, it shall be the contractor's responsibility to inform the Contracting Officer Representative of any problems which may be anticipated in connection with installation, or which will affect optimum performance once installation is completed. In the event progress of the installation is interrupted through no fault of the contractor, the installation may be suspended until such time as the cause of delay has been eliminated. The Contractor shall resume the subject installation within 24 hours after the contractor has been notified.

The contractor will provide all operational upgrades to the equipment hardware and operating system software that materially affects the equipment’s performance, at no additional charge to the government. These enhancements to the contractor’s equipment shall be delivered to the government site and installed by the contractor within 60 days of their issuance or date of first commercial availability.

All models shall perform satisfactorily at any laboratory temperature between 59- and 86-degrees F (15 and 30 degrees Celsius). All models shall perform satisfactorily at any relative laboratory humidity between 10 and 70%. An electronic operator’s manual must be included with each model supplied.

Specified Site Location - The specified site location ensures the equipment installed operates efficiently and conforms to the manufacturer’s claimed specifications. Per the contractor’s specifications, the government prepared the site at its own expense. Any future alterations or modifications to the current site location, which attributes to incomplete or erroneous specifications provided by the contractor involving additional expense to the government, shall be made at the contractor’s cost.

Ownership of Equipment - Ownership of the Equipment shall remain with the contractor. All equipment accessories (hardware and software) furnished by the contractor shall accompany the equipment when returned to the contractor other than hard-drive to be removed and turned-in to VA IT. Upon expiration of order(s) at termination and/or replacement of equipment, the contractor will remove the equipment. The contractor will be responsible for all packing and shipping required to remove the equipment within ten business days.

Standard and Acceptance of Performance - The performance period shall begin at award effective date.

Operational use time for performance testing for a system is defined as the accumulated time during which the machine is in actual use. System failure downtime is that period when any device in the system is inoperable due to equipment failure. Downtime for each incident shall start from when the government makes a bona fide attempt to contact the contractor’s designated representative at the prearranged contact point until the system or machine(s) is returned to the government in proper operating condition.

During the performance period for a system, a minimum of 100 hours of operational use time with productive or simulated work will be required to computation the effectiveness level. However, in computing the effectiveness level, the actual number of operational use hours shall be used when more than a minimum of 100 hours. The government shall maintain appropriate daily records to satisfy the requirements of this paragraph. It shall notify the contractor in writing of the first day of the successful performance period.

Operations use time and downtime shall be measured in hours and whole minutes.

Government’s Responsibility - The user will perform daily routine operator maintenance and cleaning as required in the manufacturer’s operation and maintenance instructions.

6. MAINTENANCE: The contractor shall provide maintenance (includes all labor and parts) to keep the equipment in good operating condition and subject to security regulations. The government shall provide the contractor access to the equipment to perform maintenance services. The contractor’s preventive maintenance will provide regular, scheduled maintenance to ensure the equipment’s continued reliable operation. These preventative maintenance visits shall be of a frequency that conforms to the manufacturer’s operation and maintenance instructions for the supported equipment.

7. TRAINING: The contractor shall provide supplemental operating training to the government assigned key-operator personnel, at no additional charge to the government upon installation, or when upgrading equipment hardware or operating system software connected with the operation of an instrument already furnished.

8. SERVICE: Emergency repairs shall be performed within 48 hours after notification that the equipment is inoperative. The scheduled maintenance and service shall be repaired by a qualified engineer with notice to the Contracting Officer Representative (COR). JAH VAMC regular business hours are (6:00 a.m. - 6:00 p.m., excluding weekends and holidays).

Telephone response does not satisfy this requirement. The contractor shall provide the government with a designated point of contact and arrange to enable his maintenance representative to receive such notification. The contractor will provide all parts, and labor needed to repair the malfunction. Any travel, per diem and other expenses associated with the repair will be borne by the contractor. Otherwise, all services will be performed at no charge to the government during contract period of performance.

The contractor shall provide a malfunction incident report to the government lab point of contact upon completion of each maintenance call. The report shall include, as a minimum, the following: (a) date and time of notification, (b) date and time of arrival, (c) serial number type and model number(s) of equipment, (d) time spent for repair, (e) description of malfunction and

(f) proof of repair. Parts (e) and (f) shall be written verification of quality control for a sample run.

9. WARRANTY OF EQUIPMENT: The government requirement for standard manufacturer industry warranty term shall remain active. The government does not accept the extended warranty, which requires advance payment.

10. ORDERING/DELIVERY: All equipment to be delivered within sixty (60) days. The contractor shall deliver test kits, supplies, disposables within 7 days of order placement, FOB destination shipping and handling cost included.

11. PLACE OF PERFORMANCE: James A. Haley VA Medical Center, 13000 Bruce B. Downs Blvd, Tampa, FL 33612.

Additional Security Language

1. 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. chs. 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.

2. 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.

3. In accordance with 36 CFR 1222.32, 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.

4. James A Haley Veterans’ Hospital and Clinics 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 James A. Haley Veterans’ Hospital and Clinics 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, Contractor must report to James A. Haley Veterans’ Hospital and Clinics. The agency must report promptly to NARA in accordance with 36 CFR 1230.

5. The Contractor shall immediately notify the appropriate Contracting Officer 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 vehicle]. 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 James A. Haley Veterans’ Hospital and Clinics 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 Contracting Officer or address prescribed in the [contract vehicle]. Destruction of records is EXPRESSLY PROHIBITED unless in accordance with Paragraph (4).

6. The Contractor is required to obtain the Contracting Officer'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 James A.

Haley Veterans’ Hospital and Clinics guidance for protecting sensitive, proprietary information, classified, and controlled unclassified information.

7. The Contractor shall only use Government IT equipment for purposes specifically tied to or authorized by the contract and in accordance with James A. Haley Veterans’ Hospital and Clinics policy.

8. The Contractor shall not create or maintain any records containing any non-public James A.

Haley Veterans’ Hospital and Clinics information that are not specifically tied to or authorized by the contract.

9. 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 Freedom of Information Act.

10. The James A. Haley Veterans’ Hospital and Clinics 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 James A Haley Veterans’ Hospital and Clinics 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.

11. 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, Talent Management System (TMS) Item #4192704, Records Management for Everyone. The Contractor is responsible for confirming training has been completed according to agency policies, including initial training and any annual or refresher training.

[Note: To the extent an agency requires contractors to complete records management training, the agency must provide the training to the contractor.]

D. Flowdown of requirements to Subcontractors

1. The Contractor shall incorporate the substance of this clause, its terms and requirements including this paragraph, in all subcontracts under this [contract vehicle], and require written subcontractor acknowledgment of same.

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

VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY LANGUAGE

VA INFORMATION CUSTODIAL LANGUAGE:

a. 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.

b. 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.

c. 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.

d. 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.

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. However, it is the policy of VA to forgo collection of liquidated damages in the event the contractor provides payment of actual damages in an 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.

SECURITY CONTROLS COMPLIANCE TESTING:

On a periodic basis, VA, including the Office of Inspector General, reserves the right to evaluate any or all of the security controls and privacy practices implemented by the contractor under the clauses contained within the contract. With 10 working-days’ notice, at the request of the government, the contractor must fully cooperate and assist in a government-sponsored security controls assessment at each location wherein VA information is processed or stored, or information systems are developed, operated, maintained, or used on behalf of VA, including those initiated by the Office of Inspector General. The government may conduct a security control assessment on shorter notice (to include unannounced assessments) as determined by VA in the event of a security incident or at any other time.

TRAINING:

a. All contractor employees and subcontractor employees requiring access to VA information and VA information systems shall complete VA Privacy and Information Security Awareness and Rules of Behavior Training 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 Rules of Behavior before being granted access to VA information and its systems.

b. The contractor shall provide to the contracting officer and/or the COR a copy of the training certificates and certification of signing the 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.

The Certification and Accreditation (C&A) requirements do not apply and a Security Accreditation Package is not required for this Statement of Need (SON).

Records Management Contract Language

The following standard items relate to records generated in executing the contract and should be included in a typical Electronic Information Systems (EIS) procurement contract:

1. Citations to pertinent laws, codes and regulations such as 44 U.S.C chapters 21, 29, 31 and 33; Freedom of Information Act (5 U.S.C. 552); Privacy Act (5 U.S.C. 552a); 36 CFR Part 1222 and Part 1228.

2. Contractor shall treat all deliverables under the contract as the property of the U.S.

Government for which the Government Agency shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest.

3. Contractor shall not create or maintain any records that are not specifically tied to or authorized by the contract using Government IT equipment and/or Government records.

4. 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 by the Freedom of Information Act.

5. Contractor shall not create or maintain any records containing any Government Agency records that are not specifically tied to or authorized by the contract.

6. The Government Agency owns the rights to all data/records produced as part of this contract.

7. The Government Agency owns the rights to all electronic information (electronic data, electronic information systems, electronic databases, etc.) and all supporting documentation created as part of this contract. Contractor must deliver sufficient technical documentation with all data deliverables to permit the agency to use the data.

8. Contractor agrees to comply with Federal and Agency records management policies, including those policies associated with the safeguarding of records covered by the Privacy Act of 1974. These policies include the preservation of all records created or received regardless of format [paper, electronic, etc.] or mode of transmission [e-mail, fax, etc.] or state of completion [draft, final, etc.].

9. No disposition of documents will be allowed without the prior written consent of the Contracting Officer. The Agency and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. Records may not be removed from the legal custody of the Agency or destroyed without regard to the provisions of the agency records schedules.

10. Contractor is required to obtain the Contracting Officer'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, this contract. The Contractor (and any sub-contractor) is required to abide by Government and Agency guidance for protecting sensitive and proprietary information.

Compliance & Business Integrity (CBI) Language for Contracts

The ____________________________ has a CBI Program. If the contractor detects and/or suspects any noncompliance relative to the revenue cycle when providing treatment to our veterans, he/she is to notify the Contracting Officer’s Representative (COR) or the ________ CBI Officer. CBI Awareness training is available on the Talent Management System website. Any contract staff who does VA work is required to take basic compliance awareness training, annual CBI refresher training. Job-specific training may be required for staff in specific positions that relates to the revenue cycle.

Contact the ___________ CBI Officer or COR for examples of CBI training that would satisfy this requirement. The contractor is to show proof of completing this training by submitting a completed copy of the VISN 6 CBI Certification Form to the COR. You may contact the _________ CBI Officer for more information regarding CBI training.

All Contractor, Pharmaceutical Company Representative (PCR), and Healthcare Industry Representatives (HIR) will coordinate with Contracting Officer Representative for instructions so they are in compliance with James A. Haley Veterans’ Hospital policies:

HPM NO. 90-25; JANUARY 2014; HEALTHCARE VENDOR ACCESS AND

COMPETENCY

HPM NO. 132-04; DECEMBER 2012; SECURITY MANAGEMENT PROGRAM

HPM NO. 132-05; DECEMBER 2012; HOSPITAL IDENTIFICATION PROGRAM

HPM NO. 11-91; MAY 2013; PHARMACEUTICAL COMPANY REPRESENTATIVES

HIR are required to report to MSDU (Room GC-003), immediately after entering the facility. HIR will be required to sign into the monitoring system and print a badge for proper identification. . The Healthcare Industry Representatives for Nutrition and Food Services, Office of Information and Technology, and Social Work Services are in included in this policy; vendors (HIR) for Pharmacy Services are to follow (HPM 11-91) policy. HIR must be sponsored by a physician, a Service Chief, or their designee, for a specified date and a specified case. HIR are not permitted in patient care areas or clinics unless a prior appointment has been made.

Pharmaceutical Company Representative (PCR) refers to anyone acting on behalf of a pharmaceutical company or its business partners for the purpose of promoting the use of items managed under the VA formulary process. These items primarily include drugs, but to a lesser extent also include any medical supplies, nutritional supplements, and similar commodities managed under the VA formulary process.

a. Sign-In: PCRs may visit VA Medical care facilities no earlier than 8:00 a.m. and stay no later than 3:30 p.m., Monday through Friday, unless they receive prior approval from both the Chief of the Service that they will be visiting and the Chief of Pharmacy.

Representatives visiting the JAHVH must sign in at the Pharmacy Administrative Office (Located in Trailer 78) and wear a visitor’s badge as well as their company’s personal name badge while in the hospital.

Vendors: Reference Hospital Memorandum Policy Number 90-25 Healthcare Vendor Access and Competency.

Contractors and/or project managers: Will be issued a PIV/ID badge in accordance with the facility PIV Policy. Contactors will contact their assigned VA Contracting Officer Representative (COR) for coordination.

Contract Personnel/Sub-Contractors: Contractors are responsible for the daily accountability and identification of all personnel assigned to their respective contract including sub-contractors. Contractors will identify personnel using the following procedures as appropriate.

Construction Project contract personnel will report to the contractor for issuance of a temporary self-adhesive identification badge. This badge will be issued on a daily basis and must include the following information: Company name, project number, date and name of individual. Contractor will maintain a daily log of all personnel.

Contract personnel not involved in an actual construction project will report to police dispatch for issuance of a numbered badge. A driver’s license or photo ID will be required each day upon entering the facility, in exchange for the badge, and will be given back once the badge is returned to police dispatch.

The contractor will provide Police Service with a list of names for all sub-contract personnel requiring access to the facility. It is the responsibility of the contractor to update the list as necessary.

NPR OPC; CBOCs and Off-site Lease facilities with VA Police staffing: As above with check-in with VA Police.

Off-site Lease facilities w/o VA Police staffing: Coordinate with COR, Administrative Officer, or Service Point of Contact.

Please review the attachments: Appendix B_C_D_VA handbook 6500-6 Contract Security and Memo Change in Contract Security Language Requirement for Liquidated Damages.