36C24422Q1258_1.docx

Special Notice Special Notice

GENERAL INFORMATION

Network Contracting Office 4 1010 Delafield Road Pittsburgh, PA 15215

POINT OF CONTACT*

Contract Specialist Jacquelyn Mazurek jacquelyn.mazurek@va.gov

ADDITIONAL INFORMATION

AGENCY CONTACT’S EMAIL ADDRESS

EMAIL DESCRIPTION

DESCRIPTION

Please see attached document.

Notice of Intent to Sole Source

The VA Pittsburgh Healthcare System (VAPHS) University Drive C, Pittsburgh, Pennsylvania 15215 has a request for RALS Data Management Services. The VAPHS has only located one vendor capable of providing the requested services and intends to issue a sole source contract to that vendor.

This notice is being posted so that any unknown vendors who are capable of providing this item may come forward and express their interest and capability in providing RALS services and Maintenance to VAPHS. If your company/organization is capable of providing the required item, provide your entities capability statement to Jacquelyn Mazurek, Contract Specialist by 09/28/2022 1:00 PM EST via email to Jacquelyn.mazurek@va.gov. In addition to your capability statement also provide any applicable distribution agreements regarding RALS services and Maintenance, the size and socioeconomic status of your company, proof of being an authorized distributor and any other information pertinent to this requirement.

***This is not a request for quote, no quotes should be sent in response to this notice.

STATEMENT OF WORK (SOW)

RALS-Web3

Contract Number:

Task Order Number:

IFCAP Tracking Number:

1. Contracting Officer’s Representative (COR).

2. Contract Title. RALS Web3

3. Background.

Service: Pathology and Laboratory Medicine Service, Ancillary Testing Requestor: Mercado-Carro, Johana <Johana.Mercado-Carro@va.gov>, LIM/ADPAC, 412.360.1652 Control point: 080

This request is for a base year with two option years.

The purpose of this contract is to acquire a data management interface that can act as the middleware between Siemens DCA Vantage analyzers, Roche Accu-Chek, Abbott I-Stat analyzers, BD Veritors and the VA Pittsburgh Healthcare System (VAPHS) laboratory information package. This contract is for one year with four option years.

· The Contractor should be compatible with all current data management systems that the VAPHS currently operates.

· The Contractor should offer service and support 24/7 to the ancillary testing department staff.

· Contractor should be aware of all Microsoft updates and have a procedure in place to test the updates to ensure installation will not affect the functionality of the interface and transfer of sensitive patient information.

· Operating system shall be Windows 10 compatible if applicable.

· Product should be able to track the certification of operators to ensure that an analyzer is not being used by unauthorized personnel without the appropriate qualifications.

· There should be available a system for setting criteria before information is passed into the patient record.

· The middleware must be able to interface at least 22 DCA meters to the laboratory information system (LIS).

· The middleware must be able to interface at least 12 Abbott i-STAT instruments to the LIS.

· The middleware must be able to interface at least 116 Accu-Chek instruments to the LIS.

· The middleware must be able to interface at least 5 BD Veritor analyzers to the LIS.

4. Salient Characteristics:

Afinion AS100 & Afinion 2 Module

Meters/Instruments/Analyzers

RALS-Web3 Browser Based Remote Access

LIS HL7 Un-Solicited Results

Abott i-STAT POC 1

Meters/Instruments/Analyzers

RALS-Web3 Browser Based Remote Access

LIS HL7 Un-Solicited Results

Roche ACCU-CHEK Inform II Module

Meters/Instruments/Analyzers

RALS-Web3 Browser Based Remote Access

LIS HL7 Un-Solicited Results

ADT In-Unit Patient Verification

Becton Dickinson Veritor Plus Module

Meters/Instruments/Analyzers

RALS-Web3 Browser Based Remote Access

LIS HL7 Un-Solicited Results

Module Add Implementation Fee

5. Specific Tasks:

The technology license will include service, support, updates and hardware maintenance.

6. Government Furnished Property:

The government will furnish no property to the vendor.

7. Term Of Contract:

This will be a one year contract with two option years to begin 10/1/22. No materials shall be sent by the contractor after the end date until the Contracting Officer authorizes such services in writing.

8. Contract Administration: Designation of Contracting Officer Representative (COR)

Jason C. Tedrow is designated as the COR in monitoring and certifying as to the receipt of services rendered under this contract. A formal Delegation letter outlining the responsibilities of the COR will be sent after award of contract.

Name: Jason C. Tedrow Title: Lead Medical Technologist Email: Jason.Tedrow2@va.gov Phone: 412.360-1534

9. Legal Requirements Related To Medical Records/Privacy And Confidentiality:

A. Contractor must adhere to the provisions of Public Law 104-191, Health Insurance Portability and Accountability Act (HIPAA) of 1996 and the National Standards to Protect the Privacy and Security of Protected Health Information (PHI). As required by HIPAA, the Department of Health and Human Services (HHS) has promulgated rules governing the security, use, and disclosure of protected health information by covered entities, including the Department of Veterans Affairs (VA).

B. Records created by the Contractor in the course of treating patients under this contract are the property of VA and shall not be accessed, released, transferred or destroyed except in accordance with applicable federal law and regulations.

C. The treatment and administrative patient records created by, or provided to, the Contractor under this contract are covered by the VA system of records entitled “Patient Medical Records – VA” (24VA19), which is available at http://www.rms.oit.va.gov/SOR_Records/24VA19.asp

D. The Contractor is required to comply with Title 48 of the Code of Federal Regulations, Part 24.101-24.104 “Protection of Privacy and Freedom of Information”. When responding to a veteran’s request that copies of records is released to a third party, the Contractor shall refer the veteran to VA for release of records. The Contractor is responsible for complying with VHA, Joint Commission, HIPAA, and other applicable external regulatory agency regulations.

E. Neither the VA nor the Contractor has the legal authority to require that a patient provide his/her Social Security Number to the VA as a condition for receiving medical care under Title 38, United States Code. If the patient does not provide a Social Security Number, the VA will assign a unique identification number to the patient.

10. Deliver Location

Items are to be delivered to the shipping dock at:

VA Pittsburgh Healthcare System University Drive C Pittsburgh, PA 15240

11. Additional Requirements

Symplr The vendor will be required to register on the Symplr website https://www.symplr.com/. Symplr will be used to monitor vendor compliance with vaccination and HIPPA requirements listed below.

1. All on-site contractor representatives agree to follow VA Pittsburgh Policy LD-073 medical center policy (MCP) Vendor Access. This includes all on-site contractor representatives shall be ‘greenlighted’ in VA Pittsburgh’s Vendor Credentialing System Symplr which includes an up-to-date flu vaccination, Tb test, Covid-19 vaccine, and HIPPA certification at a minimum. The government shall not provide any additional compensation for cost to register staff in Symplr. Vendor shall follow most updated guidelines from the Occupational Safety & Health Administration (OSHA), Center for Disease Control (CDC), and Food & Drug Administration (FDA).

2. If onsite work is necessary, contractor shall notify Biomedical Engineering and the Police service when they arrive on site. Failure to do so more than twice will result in permanent denial of access to facility.

Influenza Vaccination VHA Directive 1192 requires all health care personnel (HCP) to participate in the seasonal influenza prevention program and outlines the key implementation steps. Health care personnel is defined in VHA Directive 1192 as all VA licensed and unlicensed, clinical and administrative, paid and unpaid, full- and part-time employees, intermittent employees, fee basis employees, VA contractors, students, researchers, volunteers, and trainees who work in VHA locations. HCP covered by the policy are expected to receive annual influenza vaccination. This requirement is extended to all Contractor personnel with potential to come into minimal contact (passing in the corridor) with any patients, visitors, or staff members at VAPHS.

Those individuals unable or unwilling to be vaccinated are required to wear a face mask throughout the influenza season. Masks are available at entrances throughout the medical center.

It is the responsibility of the contractor to ensure that all contract staff is compliant with the requirements outlined in VHA Directive 1192. The contractor shall maintain the following documentation:

- Documentation of vaccination, e.g., signed record of immunization from a health care provider or pharmacy, or a copy of medical records documenting the vaccination.

- Completed Health Care Personnel Influenza Vaccination Form (Attachment B of VHA Directive 1192) if unwilling or unable to receive the vaccine.

The contractor is required to submit annual certification in the form of a memorandum to the Contracting Officer’s Representative (COR) that all contract staff performing services at VA facilities is in compliance with VHA Directive 1192.

Tuberculosis Prevention Standard Personnel Testing (PPD, etc.): Contractor shall provide proof of the following tests for personnel within five (5) calendar days after contract award and prior to the first duty shift to the COR and Contracting Officer. Tests shall be current within the past year.

TUBERCULOSIS TESTING: Contractor shall provide proof of a negative reaction to PPD testing for all contract personnel. A negative chest radiographic report for active tuberculosis shall be provided in cases of positive PPD results. The PPD test shall be repeated annually.

COVID 19

Contractor shall provide evidence of vaccination records or a negative COVID testing result within 72 hours of planned onsite visitation. This is to include installation, training, maintenance and repairs.

Emergency repairs will be evaluated on a case by case situation.

HIPAA Training Certificates If Contractor will be working onsite for installation and activation of equipment, all HIPAA training completion documentation must be provided to the COR listed in the awarded contract.

Smoking All VA Pittsburgh property is smoke-free. Contractor personnel will comply with VA Pittsburgh smoking policies. Violations will result in a warning and possible citation.

END

End of Document

Special Notice