36C24218Q9433-001.docx

PERFORMANCE WORK STATEMENT (PWS)

VISN 2 SOUTH PATHOLOGY AND LABORATORY MEDICINE SERVICES

CARDIAC MARKERS

1) INTRODUCTION

This performance work statement will be issued for VISN 2 SOUTH Pathology and Laboratory Medicine Services facilities at the Bronx, Northport, New York Harbor (Brooklyn and Manhattan), Hudson Valley (Castle Point and Montrose), and New Jersey VA Medical Centers.

Patients who present with chest pains to the Emergency Department (ED) require fast and immediate evaluation to limit myocardial injury if in fact the patient is experiencing a myocardial infarction. The rapid availability of Troponin I with CK-MB option in the Emergency Department was mandated by Central Office in 2006. It is essential that every Emergency Department in VISN 2 SOUTH become equipped with a Point-of-Care (POC) instrument for the rapid measurement of Troponin I and CK-MB. The methodology must be designed to test for the quantitative measurement of Troponin I (Tnl) or CK-MB in whole blood or plasma samples with greater accuracy at low troponin or CK-MB concentrations, in relatively short period of time. The portable device should enable healthcare professionals to identify patients with a suspected heart attack in the emergency room, helping ensure correct diagnosis and fast, appropriate intervention. Each Emergency Department within VISN 2 SOUTH varies in structure, policies and procedures as to who physically performs the test; therefore a waived methodology is required.

2) SCOPE

VISN 2 SOUTH Pathology and Laboratory Medicine Services (PLMS) recognize the many advantages of standardization of equipment, bulk purchasing, state- of- the art technology and vendor supplied maintenance and repairs. This branch (PLMS) of the Department of Veterans Affairs (DVA) in an effort to give the best care to our veterans within a limited budget and with the ultimate goal to get the most work done for the lowest cost while maintaining the improved quality and turnaround time, hereby request the Indefinite Quality, Indefinite Delivery (IDIQ) contract method for equipment acquisition. This method allows pricing for test kits, quality control materials, and calibration materials that includes the meter/analyzer system (all the accessories/hardware of the analyzer already in use at VISN 2 South laboratories.

This contract will be for one base year and four option years. The contractor shall provide the analyzer, service, and all supplies to the Medical Centers as cost per test. The contractor shall perform to the standards in this contract.

a) 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.

b) ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS

1. 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.

2. 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.

3. 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.

4. 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.

c) VA INFORMATION CUSTODIAL LANGUAGE

1. 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).

2. 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.

3. 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.

4. 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.

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.

1. 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.

2. 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.

d) TRAINING

1. 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:

(i) 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;

(ii) Successfully complete the VA Cyber Security Awareness and Rules of Behavior training and annually complete required security training;

(iii) Successfully complete the appropriate VA privacy training and annually complete required privacy training; and

(iv) 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.]

2. The contractor shall provide to the contracting officer and/or the COTR a copy of the training certificates and certification of signing the Contractor Rules of Behavior for each applicable employee within 1 week of the initiation of the contract and annually thereafter, as required.

3. 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.

3) GENERAL REQUIREMENTS

A. Certain characteristics of analyzers greatly enhance user satisfaction and ease of operation in daily tasks. State clearly for each factor your ability to meet these desired characteristics.

1. Small bench style POC size with both power source options - 110 V electric and back-up/rechargeable batteries.

2. Operator Lockout

3. Steps required for daily performance of Quality Control.

4. Result hold when QC and/or calibration is timed-out.

5. Steps required for the performance of Calibration.

a. Preparation and/or readiness of calibration materials.

b. Calibration frequency, from shortest to longest times.

c. Steps required entering calibration set-point data into analyzer and/or middleware.

6. We require bar code scanning capabilities

7. We require printout of test result and quality control result.

8. Alert operator for short (insufficient) sample

9. Ability to erase Patient ID after every test

10. Clot detection

11. State the daily, weekly, monthly maintenance required.

12. Service of the analyzer must be included in the CPRR. This includes, but is not limited to:

a. Availability of Technical Service 24/7for telephone troubleshooting.

b. On-site service for repair within 24 hours of service call.

c. Replacement of analyzer within 24 hours if repair is not performed.

B. Analytical/Measurement Aspects:

1. Instrument must correlate and be accurate.

2. Provide list of interfering substances.

3. Quality Control (QC) Types:

a. State the frequency of Electronic Quality Control

b. State the frequency of external Liquid Quality Control

c. State if Quality Control materials are provided in the CPRR or a separate charge.

d. State the handling requirements of the Quality Control materials – liquid ready to use, lypholized, frozen, etc.

4. Assay time (time to result)

5. State the reagent storage requirements.

C. Post Analytical/Reporting Requirements:

1. Instrument must have a VA approved interface, that is, the interface has already been successfully implemented and is fully operational in a VA facility. A list of persons who can be contacted should also be furnished.

2. Interface must have the ability to erase Patient Identification without user intervention.

3. The Ancillary Testing Coordinator (ATC) will set the parameters to purge data automatically.

4. Ability to INTERFACE with CPRS same day of switch over to whichever vendor is awarded after the given grace period of 30 days. ED and other users doing the test must not be subjected to any delays or disruption of patient care service.

5. The Data Manager must easily integrate to VISTA

6. Installation and Implementation of data management system - hardware, software (interfacing) must be included in Contractor’s offer.

7. Data Management system required specifications:

a. Patient archiving

b. Patient management

c. Quality control management

d. Regular system upgrades

e. Statistics and Graphic Designs for Regulatory Board Requirements

8. Vendor must provide on-site, hands-on training in the Data Management Software for the Ancillary Testing Coordinators.

9. Vendor must provide an on-going, on site hands-on training for users on the instrument and the Data Manager Software as needed

10. On-line/over the phone technical support including but not limited to communication problems and individual instrument problems.

11. Contractor and Vendor must go through the National Virtual Private Network (VPN) agreement

12. To remote into the provided instruments for technical support. Then vendor will not need access to CPRS-VISTA.

13. Provided instruments must not be able to capture or record electronic Patient Health Information

14. (ePHI) to removable media.

15. Provided instruments must not have wireless capability.

D. Infection Control Requirements

1. Must be easy to clean with an antibacterial wipe.

2. If possible a specimen should go directly into the machine without transfer of blood from one collection tube or device to another. If this is not possible there needs to be no exposure to the employee of any bloodborne pathogens when transferring blood from the specimen tube to the machine device.

E. Vendor Support Requirements

1. During the testing period – one to three weeks, time deemed by the user in each facility, the vendor will provide the meters and all materials required for testing.

2. Provide all reagents, QC and all needed supplies to all sites that would opt to carry validation studies correlation, linearity and/or precision) as part of their testing.

3. These sites must not be charged for any costs incurred during the trial/evaluation process.

4. Provide in-service to the POC Cardiac marker users (all) regarding operation, maintenance and trouble-shooting as needed and according to ED staff scheduling and convenience.

5. Technical support by way of training/demonstration to each user regardless of location - central or otherwise to be determined by each facility in VISN 2 South and respectively coordinated with the vendor’s technical representative.

6. ATC will call Technical support when needed and vendor to remote into the provided instrument for technical support, then follow VPN process.

7. Technical support by way of assisting each facility in the performance of bi-annual correlation and calibration verification to be in compliance with regulatory board requirement.

8. Must provide compliance reports, any CAP requirements

9. Provides CLSI (NCCLS) procedure on CD and on-line

10. Must provide information how the reference interval was established and assist the facility in the verification of such interval based on VISN 2 population.

11. Must provide Federal Information Processing Standards (FIPS) Compliance # 140-2 Validated Encryption for operating the device as needed.

12. Hot line availability for questions and/or problems 8AM – 4PM (Administrative- Hrs), 5 days, M-F during the patient testing period.

13. Vendor must provide semi-annual on-site preventative maintenance with written report

14. Must provide meter replacements when unresolved meter problems arise during the testing period.

15. All contractor employees who require access to the Department of Veterans’ Affairs Computer System shall be the subject of a background investigation and must receive a favorable adjudication from the VA Office of Security and Law Enforcement prior to contract performance. This requirement is applicable to subcontractor personnel requiring the same access.

16. Vendor must be in full compliance as applicable with VA Handbook 6500.6 “Contract Security”

4) SERVICE AND SUPPORT

As this service is critical to the support of providing excellent care to our nation's veterans, service and support to ensure continuous quality of care is needed. The vendor will detail the level of support available at the time of submission. The level of support will include but is not limited to customer service phone support ("hotline"), in-person field service support and a replacement device when the instrument cannot be repaired. Help desk personnel, field technicians, and access to this support are a critical element of this acquisition.

5) OBJECTIVES

· To procure a single platform analyzer capable of performing an in vitro diagnostic test for the quantitative measurement of cardiac troponin I (cTnl) or CK-MB in whole blood or plasma.

· To provide a cost-effective solution for this critical test utilizing the Cost Per Test (CPT) option.

6) PERIOD OF PERFORMANCE

The period of performance is from date of award to thru September 30, 2019 with four option years.

7) APPLICABLE DIRECTIVES

Clinical Laboratory Standards (NCCLS) for procedure manuals.

8) WORKLOAD STATISTICS

See Attachment B for a spreadsheet detailing the annual test volume performed by each facility in VISN 2 South laboratories. This annual test volume does not include the number of test devices utilized to perform calibrations, quality control, meter-to-meter correlations, and linearity. This additional test volume is reflected in the annual test kit number indicated for each facility.

ATTACHMENT A

CONTACT INFORMATION

ATTACHMENT B

VISN 2 SOUTH

Cardiac Marker Testing

ANNUAL TEST VOLUME