Amendment 0003 - Clarifications.pdf

5. PROJECT NUMBER (if applicable)

CODE 7. ADMINISTERED BY

2. AMENDMENT/MODIFICATION NUMBER

CODE

6. ISSUED BY

8. NAME AND ADDRESS OF CONTRACTOR

4. REQUISITION/PURCHASE REQ. NUMBER 3. EFFECTIVE DATE

9A. AMENDMENT OF SOLICITATION NUMBER

9B. DATED

PAGE OF PAGES

10A. MODIFICATION OF CONTRACT/ORDER NUMBER

10B. DATED

BPA NO. 1. CONTRACT ID CODE

FACILITY CODE CODE

Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following methods:

The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers

E. IMPORTANT:

is extended,

(a) By completing Items 8 and 15, and returning __________ copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted; or (c) By separate letter or electronic communication which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY is not extended.

12. ACCOUNTING AND APPROPRIATION DATA

(REV. 11/2016)

is required to sign this document and return ___________ copies to the issuing office. is not, A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NO. IN ITEM 10A.

15C. DATE SIGNED

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by letter or electronic communication, provided each letter or electronic communication makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER

Contractor

16C. DATE SIGNED

14. DESCRIPTION OF AMENDMENT/MODIFICATION

16B. UNITED STATES OF AMERICA

Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

15A. NAME AND TITLE OF SIGNER 16A. NAME AND TITLE OF CONTRACTING OFFICER

15B. CONTRACTOR/OFFEROR

STANDARD FORM 30 PREVIOUS EDITION NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.243

(Type or print) (Type or print)

(Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

(Number, street, county, State and ZIP Code)

(If other than Item 6)

(Specify type of modification and authority)

(such as changes in paying office, appropriation date, etc.)

(If required)

(SEE ITEM 11)

(SEE ITEM 13)

(X)

CHECK

ONE

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS,

IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

(Signature of person authorized to sign) (Signature of Contracting Officer)

1 15

0003 11-10-2025

N/A

None

36C244

Department of Veterans Affairs Network Contracting Office 4 1010 Delafield Rd Pittsburgh, PA 15215 Contract Specialist: Stanley Kwasny Stanley.Kwasny@va.gov

36C244

Department of Veterans Affairs Network Contracting Office 4 Same as Box 6

To all Offerors/Bidders

36C24426Q0032

10-31-2025

X

X X

See CONTINUATION Page

X 1

The purpose of this amendment 0003 is to provide the following:

1. Clarifications: All quantities listed in CLINs 0001 - 0003 are estimated based upon historical reports. All quantities are estimated for the full 5-year performance period. Strep Testing required should be priced and included In CLIN 0003 Combo Panels. Per Historical Reports, Wilkes-Barre and Philadelphia utilize CLIN 0003, Combo Panels.

i h il bili f f d Individual task orders for facilities will be placed contingent upon availability of funds.

2. PWS update - Section 11.4 Equipment Preventative Maintenance/Repair Service -updated to reflect: "11.4.1.3 Onsite equipment repair service shall be provided to facilities at least Monday - Saturday during normal working, business hours, 8am-5:30pm."

Please see attached updated PWS.

3. See PWS Section 7 for CPPR and what is required cost per testing. 4. CLIN 0004: is required for the MALDI system and maintenance monthly service.

CONTINUATION PAGE

A.1 PRICE/COST SCHEDULE

ITEM INFORMATION

ITEM

NUMBER

DESCRIPTION OF

SUPPLIES/SERVICES

ESTIMATED

5YR

QUANTITY UNIT UNIT PRICE AMOUNT

20,880.00 EA __________________ __________________

OVERNIGHT POSITIVE MIC TESTING PANEL (Cost Per Test Reportable)

POP Begin: 12-01-2025 POP End: 11-30-2030 PRINCIPAL NAICS CODE: 325413 - In-Vitro Diagnostic Substance Manufacturing PRODUCT/SERVICE CODE: Q301 - Medical - Reference Laboratory Testing

41,070.00 EA __________________ __________________

OVERNIGHT NEGATIVE MIC TESTING PANEL (Cost Per Test

Reportable)

POP Begin: 12-01-2025 POP End: 11-30-2030 PRINCIPAL NAICS CODE: 325413 - In-Vitro Diagnostic Substance Manufacturing

6,540.00 EA __________________ __________________

Combo Panel ID/Susceptibility (Cost Per Test Reportable)

POP Begin: 12-01-2025 POP End: 11-30-2030 PRINCIPAL NAICS CODE: 325413 - In-Vitro Diagnostic Substance Manufacturing

60.00 MO __________________ __________________

MALDI (for all 6 sites) PER PWS

BPA Period POP Begin: 12-01-2025 POP End: 11-30-2030

PRINCIPAL NAICS CODE: 325413 - In-Vitro Diagnostic Substance Manufacturing

3.00 MO __________________ __________________

Optional 90-day Transition Period

POP Begin: 12-01-2025 POP End: 03-31-2030 PRINCIPAL NAICS CODE: 325413 - In-Vitro Diagnostic Substance Manufacturing

GRAND TOTAL __________________

PERFORMANCE WORK STATEMENT

1. TITLE OF PROJECT: VISN 4 Microbiology Testing Services

2. INTRODUCTION

2.1 The Veterans Affairs Medical Center (VAMC) within Veterans Integrated Network Services (VISN) 4, comprises of (9) VA Medical Centers located throughout Pennsylvania and extending into Delaware, will need a qualified contractor to provide automated microbial identification and anti-microbial susceptibility testing services. Implementing this testing is essential for effectively reducing and managing life-threatening infections that may spread within the facilities if not adequately addressed. The purpose of this contract is to secure a reliable contractor who will supply the necessary FDA approved analyzers, reagents, consumables, and support to facilitate advanced testing. It is crucial that physicians receive accurate results to mitigate the development of antimicrobial resistance and to ensure timely identification of infections and their sensitivities.

Failure to achieve this could significantly compromise the patient’s condition.

3. SCOPE OF WORK:

3.1 The desired instrumentation shall have the capability of performing or reporting the clinical parameters as defined in the Performance Statement of Work (PWS). The instrument shall be able to simultaneously perform the testing as described below and meet the performance characteristics for accuracy and precision as defined by the 1988 Clinical Laboratory Improvement Act (CLIA) and the Clinical and Laboratory Standards Institute (CLSI).

3.2 Equipment must maintain or preferably reduce the number of workstations or overall labor required to accomplish the required testing by each laboratory.

3.3 If Contractor offers a family of analyzers, VISN 04 technical evaluation panel will determine if instrumentation proposed meets needs of using facility.

3.4 Equipment shall be acquired for each of the clinical laboratories located at the listed VISN facilities.

4. TYPE OF CONTRACT/ PERFORMANCE PERIOD:

4.1 The period of performance is for a 5-year Blank Purchase Agreement (BPA) from December 1, 2025-November

30, 2030.

5. DESCRIPTION/SPECIFICATIONS:

5 . 1 Quality/Expectations: The Contractor is required to provide a continuously stocked inventory of reagents, standards, controls, supplies, disposables and any other materials required to properly perform tests on the equipment such that equipment operations are not interrupted.

5 . 1 . 1 The facilities will provide an estimated volume by test for their facility and outpatient clinic laboratories. The VA does not guarantee volumes as listed; they are estimates only. As the requirements change, the facilities may be added or deleted by supplemental agreement of the VA and the Contractor. Additional tests/reagents/instrumentation may be added to the contract as new technology becomes available.

5 . 1 . 2 These items shall be of the highest quality, sensitivity, specificity and tested to assure precision and accuracy.

5 . 1 . 3 The expiration date must be clearly marked on reagent, standards and control containers. Unexpected changes in methodology/technology shall be at the expense of the Contractor.

5.2 Delays: Alert/Notification of any delays in shipment as well as any or all technical advisory/recalls/alerts, prior to or simultaneously with field alerts should be forwarded to the designated individuals determined at contract award.

5.3 Special handling for emergency orders of supplies: In the event that the supplies are found to be defective and unsuitable for use with the Contractor’s equipment, or the Contractor has failed to comply with the requirements for routine supply delivery, the Contractor is required to deliver the supplies within 24 hours of receipt of a verbal order for emergency delivery.

5.3.1 If either circumstance has occurred, the Contractor shall deliver to the Government site in the most expeditious manner possible without additional cost to the Government, the necessary consumables in sufficient quantity as required to allow operation of the Contractor’s equipment for one week (under normal Government test load volume).

5.3.2 If additional requests for emergency supply delivery are required by the Government, they shall be honored by the Contractor until the arrival at the laboratory of the monthly standing order/routine supplies delivery.

6. GENERAL REQUIREMENTS:

6.1 Primary analyzer(s)– Base equipment offered that shall fully support the scope of operations (minimal requirements). Depending upon the technical functionality and the capabilities of the individual manufacturer’s instrumentation, one analyzer or multiple analyzers may be required to meet the productivity specifications defined herein. In those instances, the additional analyzer(s) shall, likewise, be considered primary instrumentation and shall meet all the technical specifications of this solicitation.

6.1.1 Those additional analyzer(s) offered meeting the definition of a primary analyzer shall be equivalent to a back-up analyzer (see definition below) and shall replace the requirement for offering that category of equipment

6.1.2 The system shall provide self-contained, automated identification and antibiotic susceptibility testing (AST)system for minimally aerobic, facultative, and fastidious microorganisms. Panels for ID/Susceptibility must include Gram Positives, Gram Negatives and Streptococcal if applicable.

6.1.3 The vendor will supply an additional identification system that uses matrix- assisted laser desorption/ionization (MALDI) technology for identification of microbial organisms for all participating sites within VISN 4 to assist with microbiology identification

7. DEFINITIONS:

7.1 Cost per Patient Reportable Result (CPRR)- Contractors is to provide a price for a reportable patient result.

The per patient reportable result price shall include costs covering:

7.1.1 Five-year equipment uses.

7.1.2 All reagents, standards, quality controls, supplies, consumable/disposable items, parts, accessories and any other item required for the proper operation of the Contractor’s equipment and necessary for the generation of a patient reportable result. This per patient reportable result price shall also encompass all costs associated with dilution; repeat and confirmatory testing required producing a single patient reportable result. It shall also include the material to perform as well as all other costs associated with quality control, calibration and correlation study testing that is prescribed by the Clinical and Laboratory Standards Institute (CLSI).

7.1.3 All necessary maintenance to keep the equipment in good operating condition (This element includes both preventive maintenance and emergency repairs).

7.1.4 Training for Government personnel. Contractors shall provide delivery, installation and removal of equipment at no additional charge.

7.2 The price of all consumables must be incorporated into the CPRR. There will be no other supplies needed outside of the CPRR. The CPRR will allow each facility to determine which panels are applicable to their needs.

8. FEATURES:

8.1 Operational Features- The instrumentation offered shall have the following:

8.1.1 The capability of performing analysis on 100% of the tests listed.

8.1.2 Sufficient capacity and throughput to meet the volume and service demands.

8.1.3 Safety features to avoid unnecessary exposure to biohazardous and chemical material.

8.1.4 The exposure to and the volume of biohazardous and chemical material generated by the equipment must be minimal and require a minimum amount of handling.

8.1.5 A bi-directional, bar-coded computer interface compatible with the current VA laboratory information system.

8.1.6 The fully operational interface (both hardware and software) shall be immediately available for implementation to the VA computerized hospital information system.

8.1.7 The accuracy of the barcode reading must have less than a 1% failure rate.

8.1.8 Equipment must be able to support multiple barcode formats (Code 39, Code 128) that may be enabled concurrently.

8.1.9 Equipment must accept, at a minimum 10 characters in specimen identifier that is alpha and/or numeric depending on site.

8.1.10 Minimal daily, monthly, and periodic maintenance.

8.1.11 Ability to store and retransmit records (24 hours of maximal instrument throughput) in case of interface outage.

8.2 Technical Features- The instrumentation must be approved by the Food and Drug Administration (FDA) and shall have the following:

8.2.1 The capability of accurately and reliably identifying both gram negative and gram-positive bacteria and fungi.

8.2.2 FDA-approved instruments/methods required

8.2.3 The capability of reporting susceptibility tests in accordance with FDA/CLSI guidelines.

8.2.4 At a minimum, the equipment must provide Minimum Inhibitory Concentrations (MIC) values for the following antibiotic-organism combinations.

8.3 The information below must be updated as new versions of standards are released:

8.3.1 Antibiotics (Please see appendix A):

8.3.1.1 The capability of detecting emerging antimicrobial resistance.

8.3.1.2 Comprehensive and extensive database of bacteria and yeast species that is consistent with FDA/CLSI guidelines.

8.3.1.3 Software or equipment modifications as needed and, when commercially available, to comply with changes in standards for identification or susceptibility testing established by CLSI, Center for Disease Control (CDC) and other governing or authoritative bodies.

8.3.1.4 Allow for manual modification of susceptibility breakpoints to comply with new CLSI guidelines until such time as the Contractor applies necessary software upgrades.

8.3.1.5 Comprehensive array of bacterial antimicrobial susceptibility panels which each individual facility may select to meet individual needs.

8.3.1.6 Contractor shall supply a list of available susceptibility panels as well as a list of antibiotic exceptions for their methodology at time of proposal.

8.3.1.7 Capability to detect organisms that carry a carbapenemase enzyme.

8.3.1.8 Capability of producing an anti-biogram of organisms by selected body sites.

8.3.1.9 Built-in quality control program to regularly monitor system performance.

8.3.2 Data Management- The System shall have the following:

8.3.2.1 Capability to provide varied options for analysis and reporting/review of cumulative patient data on organisms isolated and antimicrobial profiles.

8.3.2.2 Capability to record, store and print the following information:

8.3.2.3 Required quality control and instrument maintenance information Patient demographic information and specimen results

8.3.2.4 Capability of manipulating/sorting the patient demographic information and patient microbiology test results to generate epidemiological reports, i.e. antibiograms, etc.

8.3.2.5 Sufficient memory to store patient information and test results with downloading capability to an external medium for long term storage of patient records and other information.

9. DELIVERABLES:

9.1 Hardware Features- The contractor is to supply the hardware listed below at no additional cost to the VA.

The instrumentation should include the following specifications:

9.1.1 A total equipment footprint that when installed in the laboratory shall not impact on the functionality/operations of that laboratory.

9.1.2 An on-board monitor/screen that is easily readable.

9.1.3 A printer that has the capability of printing a patient report with patient demographic information that includes minimally the patient’s name and accession or unique identifier number (UID).

9.1.4 An uninterruptible power supply with line conditioner for each instrument provided.

9.1.5 The Contractor shall assist the Government with validation and method comparison studies.

9.1.6 All materials and reagents needed for such correlation shall be provided at no cost to the Government.

9.1.7 The Contractor shall perform all of the statistical analysis and report data in an organized, clearly comprehensible format.

9.1.8 This process shall be completed within two weeks of installation of the analyzer at each site and shall be consistent with current CLSI and related documents, CAP Standards and Federal Regulations.

9.1.9 The vendor is required to update MIC breakpoints to apply with the current CLSI standards within 30 days of FDA approval.

9.2 Reports- The Contractor shall provide to the Contracting Officer and other individuals (designated post-award) a copy of a quarterly report of sales, by ordering facility, upon request.

9.2.1 Reports are to reflect, at a minimum, total net sales amounts before discount, and discount amounts by ordering facility as well as the raw data used to develop these reports.

9.2.3 These reports shall be used to monitor the commitment of each facility, reporting the savings realized and shall be shared with each participating facility, personnel associated with acquiring the products, and respective laboratory personnel.

9.2.4 Additional invoice charges associated with reagent and/or supply wastage, or repair parts included at no charge shall not be accepted.

9.2.5 There will be no additional charges for any reports required as part of the contract.

9.3 Malfunction Incident Report – A malfunction incident report shall be furnished to the Laboratory upon completion of each repair call as mentioned in section 11.4.1.6 below.

9.3.1 The report shall include, as a minimum, the following:

9.3.1.1 date and time notified date and time of arrival

9.3.1.2 serial number, type and model number of equipment time spent on repair, and

9.3.1.3 proof of repair that includes documentation of a sample run of quality control verifying acceptable performance.

9.3.1.4 Each notification for an emergency repair service call shall be treated as a separate and new service call.

10. CONTRACTED EMPLOYEES:

10.1 All contract personnel assigned to work for or on behalf of VA must undergo a background investigation commensurate with the risk and sensitivity level designation associated with the work to be performed, at the level indicated in the contract, through the use of the Position Designation Tool.

10.2 All contracted employees entering VA facilities are required to:

10.2.1 Coordinate visits with the designated facility points of contact.

10.2.2 Check in with the VA Police Service to present a Real ID to obtain a visitor's pass

10.2.3 A compliant ID badge/pass must be worn by Contractors at all times while on VA premises.

10.2.4 Refrain from accessing any VA sensitive materials.

10.3 Contractor must meet all VA requirements to obtain/maintain computer access. If remote access is required, contractor must remotely connect via the VA’s Citrix Access Gateway (CAG) if not using Government Furnished Equipment (GFE). Contractor must complete “VA Privacy and Information Security Awareness and Rules of Behavior” and “Privacy and HIPAA Focused Training” courses prior to the performance of the contract and annually thereafter. Training must be completed in VA’s TMS system (https://www.tms.va.gov/).

Contractors must use the TMS Managed Self Enrollment method to complete the training in TMS. The COR must ensure that all contractors are validated in the PIH domain. Proof of training completion must be verified and tracked by the COR.

11. SUPPORT FEATURES:

11.1 Commercial Marketing-The equipment models being offered shall be in current production as of the date this offer is submitted. For purposes of this solicitation, “current production” shall mean that the clinical laboratory analyzer model is being offered as new equipment. Discontinued models that are only being made available as remanufactured equipment are not acceptable.

11.2 Start-Up Reagents -The Contractor shall provide all reagents, calibrators, controls, consumable/disposable items, parts, accessories and any other item included on the list of supplies defined in the Federal Supply Schedule contract and required to establish instruments for operation for performance of acceptance testing.

11.3 Training-The Contractor shall provide an instrument training program that is coordinated with and timely to the equipment installation, sufficient to the size and scope of the facility’s services and minimally equivalent to the terms and conditions for training defined in the Contractor’s Federal Supply Schedule FSC Group 66, Part III, Cost-Per-Test Clinical Laboratory Analyzers contract.

11.3.1 This shall include training on the operation of the system, data manipulation, and basic trouble shooting and repair. This training shall be included in the contract at no additional cost to the VA.

11.3.2 Thereafter, the Contractor shall provide training for minimally one operator per facility per year at the discretion of the Government for each model of instrumentation placed. Utilization of the training slots shall be mutually agreed upon between the VA and the Contractor.

11.4 Equipment Preventative Maintenance/Repair Service-The Contractor will provide emergency equipment repair and preventative maintenance on all primary and back-up instrumentation and any incremental support equipment, e.g. water system, offered according to the following terms:

11.4.1 Service Requirements- If an identification system from a different vendor is supplied by the awarded vendor, then the vendor must cover any additional cost of any service contract.

11.4.1.1 All instruments provided by the vendor shall have service covered by the vendor at no additional cost to the VA.

11.4.1.2 A technical assistance center shall be available by telephone 24 hours per day, 7 days per week with a maximum callback response time of 24 hours.

11.4.1.3 Onsite equipment repair service shall be provided to facilities at least Monday – Saturday during normal business hours, 8am – 530pm EST.

11.4.1.4 Equipment repair response time shall be no more than 24 hours from first communication.

11.4.1.5 Preventative maintenance will be performed as frequently as published in manufacturer’s operator’s manual and within 2 weeks of the scheduled due date.

11.4.1.6 A malfunction incident report shall be furnished to the Laboratory upon completion of each repair call.

The report shall include the stated above in section 9.3.1 and provided to respective facility POC.

11.4.2 Upgrades - The Contractor shall provide upgrades to both the equipment hardware and software in order to maintain the integrity of the system and the state-of –the art technology, at no additional charge to the Government.

11.4.2.1 These shall be provided as they become commercially available and at the same time as they are being provided to commercial customers.

11.4.2.2 This requirement only applies to “system upgrades” that enhance the model of equipment being offered, i.e. new version of software, correction of hardware defect, upgrade offered to commercial customers at no additional charge, upgrade to replace model of equipment no longer Contractor supported, etc.

11.4.2.3 This does not refer to replacing the original piece of equipment provided under the contract;

however, it does refer to significant changes in the hardware operational capability.

11.4.3 Ancillary support equipment - The Contractor shall provide, install and maintain through the life of the contract, as indicated, any and all ancillary support equipment to fully operate the analyzer as defined in these specifications, e.g. cabinetry to support/house the analyzer (if necessary), water systems (including consumable polishers, filters, etc.), and universal interface equipment, etc. In addition, the Contractor shall include all ancillary components that are customarily sold or provided with the model of equipment proposed, e.g. starter kits, tables/stands, etc.

11.4.4 Interface Requirements- The Contractor shall be responsible for providing all hardware required for the connection, implementation, and operation of the interface to the universal interface and any incremental fee that is required each time an instrument is added to an existing universal interface system.

11.4.5 The Contractor shall provide any and all necessary software support for ensuring that successful interfacing has been established. Specific requirements for the communication of the data streams will be unique to the instrument system involved and dictated by the manufacturer itself. Information necessary to make the determination for type and amount of interfacing equipment is supplied.

11.4.6 The contractor’s AST system shall fully integrate with the provided MALDI system and shall be accessible from multiple workstations.

11.4.7 If a site already has a universal interface box, the Contractor is responsible for everything leading up to the box including any incremental fee required to add additional equipment (e.g. licenses, ports/cards, cables, software, etc.) to the universal interfacing system.

11.4.8 If a site does not have a universal interface and one is needed to optimally interface the instrument, then the Contractor is responsible for the acquisition of the universal interface box and everything else needed to connect with VA computerized hospital information system.

11.4.9 If there are any software upgrades in the instrument during its life, the Contractor is responsible for seeing that the interface can accommodate any changes in the data stream going to the VA computerized hospital information system.

11.4.10 Commercial offerings - The Contractor shall provide any additional support material that is routinely provided to equivalent commercial customers and assists in regulatory compliance, e.g. Computer disc containing their procedure manual in CSLI format or an on-line procedure manual in the instrument software.

11.10 Characterization of waste – The Contractor shall provide documentation that it has characterized the hazardous nature of all wastes produced by all equipment, devices, reagents, and discharges in accordance with the requirements of the Code of Federal Regulations Title 40 “Protection of the Environment” Part 261 et seq. and applicable state and local requirements.

11.10.1 Documentation shall include a description of the characteristics of the hazardous waste produced as a byproduct of the instrument operations, Safety Data Sheets (SDS) meeting the requirements of the Occupational Safety and Health Administration (OSHA) and Environmental Protection Agency (EPA), the analytical process used to determine the hazardous nature and characteristics of the waste, and the analytical test results. Testing of hazardous waste is to be done in accordance with testing protocol specified for each individual waste as described in the Code of Federal Regulations Title 40 to make a determination if the waste is a hazardous waste or otherwise regulated.

11.10.2 The determination and description shall address the following:

11.10.2.1 Waste toxicity (Reference 40 CFR §261.11 and 40 CFR §261.24) Waste ignitability (Reference 40

CFR §261.21)Waste corrosivity (Reference 40 CFR §261.22) Waste reactivity (Reference 40 CFR §261.23) Hazardous waste from non-specific sources (F-listed) (Reference 40 CFR §261.31)

Discarded commercial products (acutely toxic or P-listed and toxic or U-listed) (Reference 40 CFR §261.33)Solid Waste (Reference 40 CFR §261.2) Exclusions (Reference 40 CFR §261.4)

11.10.2.2 The Contractor will provide written instructions and training material to ensure VHA laboratory staff are trained as needed to properly operate devices with special emphasis to managing and disposing of hazardous waste in accordance with EPA and state requirements. Additionally, the training provided by the Contractor must fulfill Resource Conservation and Recovery Act (RCRA) requirements for training as applicable to devices.

11.10.2.3 Contractor shall provide a description of all wastes the process or equipment may discharge so that the facility can determine whether the discharge meets Local Publicly Owned Treatment Works (POTW), State and Federal discharge requirements. At a minimum the characteristics of ignitability, corrosivity, reactivity and toxicity as defined in 40 CFR §261 must be determined and documented. Any mercury containing reagents must be identified in any concentrations. All test results shall be provided. All listed chemicals (F, U, K and P) found in 40 CFR §261 shall be provided in product information and their concentrations documented. For those materials with a positive hazardous waste determination, a mechanism for the laboratory to meet local discharge requirements (i.e. mercury, thimerosal and formaldehyde) must be developed and SDS sheets must be provided in advance for review. At a minimum, documentation shall include, but not be limited to the concentration/measures of the elements and parameters listed below and must be included with vendor response:

Barium (Total) Cadmium (Total) Chromium (Total) Copper (Total) Cyanide (Total) Lead (Total) Mercury (Total) Nickel (Total) Silver (Total) Zinc (Total) Arsenic (Total) Selenium (Total) Tin (Total) pH (Total)

Flash point (to higher than 200 F)

BOD; biochemical oxygen demand

11.10.3 The documentation the contractor provides will be used to work with the VAMC and the public and/or private organization (e.g., POTW) to determine whether the waste from each device can legally be disposed of via the sewerage system.

11.12 Implementation/transition timeframe - The implementation of the services/requirements described in this solicitation shall be completed no later than 90 days after the award of the contract.

11.12.1 This timeline is based on a reasonable attempt of the Contractor to complete all the necessary implementation requirements within the stated timeframe. Contractor shall not be penalized for implementation timelines that extend beyond the 90-day timeframe, if the extension is through no fault of the Contractor and is a result of delays due to the Government.

11.12.2 Upon award of the contract, the transition period for the awarded contract to have all equipment and peripherals installed and operational shall be from date of award through 90 days. During this same period all initial training of VA personnel in the operation and maintenance of said award shall also be completed.

11.12.3 Contractor shall provide with its quotation an implementation plan for installation of new equipment.

Contractor’s submitted plan shall not exceed 90 days for the transition of all services under the awarded contract including installation and training of personnel, transition of all testing materials, reagents and supplies, etc., performance of all correlations and validations.

11.12.4 Failure of the Contractor to conform to the transition period shall be considered as sufficient cause to terminate contract for cause under the Termination for Cause clause of the contract.

11.12.5 At the end of 90 days from award of the contract, the awarded Contractor shall have full and sole responsibility for services under the awarded contract.

11.13 Standard and Quality of Performance- This paragraph establishes a standard of quality performance that shall be met before any equipment listed on the delivery order [or contract] is accepted by the Government.

This also includes replacement, substitute machines and machines that are added or field modified after a system has demonstrated successful performance.

11.13.1 The acceptance period shall begin on the installation date. It shall end when the equipment has met the standard of performance for a period of 30 consecutive calendar days by operating in conformance with the Contractor’s technical specification or as quoted in any contract] at an effectiveness level of 90% or more.

11.13.2 In the event that equipment does not meet the standard of performance during the initial 30 consecutive calendar days, the standard of performance tests shall continue on a day-by-day basis until the standard of performance is met for a total of 30 consecutive days.

11.13.3 If the equipment fails to meet the standard of performance after 90 calendar days from the installation date, the user may, at his/her option, request a replacement or terminate the order in accordance with the provisions of FAR 52.212-4 entitled “Termination for Cause.” (The Contractor shall receive revenue for tests reported during the 90-day acceptance period.)

11.13.4 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 of time when any machine in the system is inoperable due to equipment failure. Downtime for each incident shall start from the time 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.

11.13.5 During the performance period for a system, a minimum of 100 hours of operational use time with productive or simulated work shall be required as a basis for computation of the effectiveness level. However, in computing the effectiveness level, the actual number of operational use hours shall be used when in excess of the minimum of 100 hours.

11.13.6 The Government will maintain daily records to satisfy the requirements of this paragraph and shall notify the Contractor in writing of the date of the first day of the successful period of operation. Operations use time and downtime shall be measured in hours and whole minutes.

11.13.7 During the term of the contract, should the repair record of any individual piece of laboratory equipment reflect a downtime of 10% or greater of the normal working hours in one calendar month, a determination shall be made by the POC to replace the malfunctioning equipment with new equipment.

11.13.8 The responsibility for maintaining the equipment furnished in good condition in accordance with manufacturer’s instructions, shall be solely that of the Contractor. Each instrument provided by the Contractor shall maintain an uptime of 90% in each month of the term of the agreement for equipment.

11.13.9 Government’s Responsibility- The user will perform routine maintenance and cleaning as required in the manufacturer’s operation and maintenance instructions. The user shall maintain appropriate records to satisfy the requirements of this paragraph.

11.14 Ownership of Equipment- Title to the equipment shall remain with the Contractor. All accessories (unused consumables, etc.) furnished by the Contractor shall accompany the equipment when returned to the Contractor. The Contractor, upon expiration of order(s), at termination and/or replacement of equipment, shall remove the equipment. The Contractor shall disconnect the analyzer (gas, water, air, etc.) and shall be responsible for all packing and shipping required to remove the analyzer.

11.14.1 The Contractor will identify if removable media is required to perform their duties. The Clinical Engineering Department will ensure the removable media is scanned with anti-virus software running current virus definitions prior to connection to any medical device/system. Any Contractor with patient sensitive information that is imported into the removable media device for any reason must purge all patient sensitive information prior to departure from the facility.

11.14.2 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 or completion of the contract.

11.14.3 All electronic storage media used on non-VA leased or non-VA owned IT equipment that is used to store, process, or access VA information must be handled in adherence with VA Handbook 6500.1, Electronic Media Sanitization upon:

11.14.3.1 completion or termination of the contract or

11.14.3.2 disposal or return of the IT equipment by the Contractor/subcontractor or any person acting on behalf of the Contractor/subcontractor, whichever is earlier. Media (hard drives, optical disks, CDs, back-up tapes, etc.) used by the Contractors/subcontractors that contain VA information must be returned to the VA for sanitization or destruction, or the Contractor/subcontractor must self-certify that the media has been disposed of per 6500.1 requirements. This must be completed within 30 days of termination or completion of the contract or disposal or return of the IT equipment, whichever is earlier

11.14.4 Bio-Medical devices and other equipment or systems containing media (hard drives, optical disks, etc.) with VA sensitive information must not be returned to the Contractor at the end of lease, for trade-in, or other purposes.

11.14.5 The options are:

11.14.5.1 Contractor must accept the system without the drive;

11.14.5.2 VA’s initial medical device procurement includes a spare drive which must be installed in place of the original drive at time of turn-in; or

11.14.5.3 VA must reimburse the company for media at a reasonable open market replacement cost at time of purchase.

11.14.6 Due to the highly specialized and sometimes proprietary hardware and software associated with medical equipment/systems, if it is not possible for the VA to retain the hard drive, then;

11.14.6.1 The equipment Contractor must have an existing BAA if the device being traded in has protected health information stored on it and hard drive(s) from the system are being returned physically intact; and

11.14.6.2 Any fixed hard drive on the device must be non-destructively sanitized to the greatest extent possible without negatively impacting system operation. Selective clearing down to patient data folder level is recommended using VA approved and validated overwriting technologies/methods/tools. Applicable media sanitization specifications need to be pre- approved and described in the purchase order or contract.

11.14.6.3 A statement needs to be signed by the Director (System Owner) that states that the driver cannot be removed and that (a) and (b) controls above are in place and completed. The Information Security Officer (ISO) needs to maintain the documentation.

12. FACILITIES: POC’s to be provided upon award.

Altoona – James E. Van Zandt VA Medical Center 2907 Pleasant Valley Blvd, Altoona, PA 16602

Erie - Department of Veterans Affairs Medical Center 135 East 38th St. Blvd, Erie, PA 16504-1596

Philadelphia – Corporal Michael J. Crescenz VA Medical Center 3900 Woodland Ave., Philadelphia, PA 19104

Pittsburgh - VA Pittsburgh Healthcare System 4100 Allequippa St., Pittsburgh, PA 15240

Wilkes-Barre - Department of Veterans Affairs Medical Center 1111 East End Blvd., Wilkes-Barre, PA 18711

Wilmington- Department of Veterans Affairs Medical Center 1601 Kirkwood Hwy, Wilmington, DE 19805

End of Document

PERFORMANCE WORK STATEMENT