VISN 4 SOW Coag Instrumentation CPRR.docx

STATEMENT OF WORK: Clinical Laboratory Coagulation Instrumentation BPA Language:

Intent:

Pursuant to Federal Supply Schedule (FSS) and FSS Contract Clause I-FSS-646, it is the intent of the Department of Veterans Affairs, (herein afterwards referred to as VISN 4) to establish a Blanket Purchase Agreement (BPA) for Automated Coagulation Instrumentation. The BPA shall be under the FSS Contract, Federal Supply Class (FSC) Group 66 III Cost Per Test (CPT)/Cost Per Reportable Result (CPRR), Clinical Laboratory Analyzers. The government will award a CPRR BPA to a single Contractor for Automated Coagulation Instrumentation. Contractor agrees to the following terms of the BPA exclusively with the VISN 4 facilities listed by Attachment B/herein and awarded in the final BPA. However, as requirements change, facilities within VISN 4 may be added or deleted by supplemental agreement of the Government or Contractor. Additional tests/reagents/instrumentation may be added to the BPA as new technology becomes available on the market and added to the base FSS contract.

Orders:

All products ordered under this BPA, placed against the Federal Supply Schedule Award Contract(s), are subject to the terms and conditions of the FSS contract. This BPA does not obligate any funds. The Government is obligated only to the extent of authorized orders actually issued under the BPA by authorized individuals.

Prices and Terms:

VISN 4 will provide an estimated volume by test as reflected in Attachment A for each individual medical center and outpatient clinic laboratory. Pricing is based in the AVERAGE daily test volume per instrument/analyzer for each facility. The Government estimates the volumes per facility as listed in Attachment A but does not guarantee volumes as listed; they are estimates only.

Terms of Agreement:

This will be a single award, firm-fixed price BPA Bridge for 6-months and shall be effective for the term of the FSS Contract including additional FSS extensions. The Contractor is required to immediately notify the CO (Government Contracting Officer), in writing, if at any time the FSS contract upon which this BPA is based, is no longer in force. The resulting BPA shall be automatically extended for the remaining term of the BPA without modification upon any extensions of the contractor’s FSS contract. In addition, where a new FSS contract replaces Contractor’s current FSS contract, the resulting BPA may be reassigned under the new FSS contract for the remaining term of the BPA with written agreement between Contractor and the contracting officer. This BPA is not a contract. If the Contractor fails to perform in a manner satisfactory to the CO, this BPA may be canceled with thirty (30) days written notice to the Contractor by the CO. This Contractor shall also reserve the right to terminate this contract with 30 days notification to the CO.

VISN 4 intends to establish this bridge for the period of September 1, 2025, through February 28, 2026.

Identification:

Delivery Orders issued shall be identified by their applicable FSS Contract Number and BPA Number. FSS identification number is assigned through the VHA Procurement Activity, 36F797-18-D0351 Ordering Method:

The participating facilities may order products via Electronic Data Exchange (EDI), telephone, facsimile or other written communication, identifying the products by number, quantity, purchase price, address for delivery, and any special instructions.

Description/Specifications/Statement of Work Scope of Procurement:

1. The desired instrumentation shall have the capability of performing or reporting the clinical parameters as defined in the statement of work. The instrument shall have random access capability (if discrete testing is required) and be able to able to simultaneously perform the complete profile as described below 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). This is a 1-year bridge for the continuation of all current supplies and services until a long-term contract can be established.

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

3. If the Contractor offers a family of analyzers, VISN 4 technical panel will determine if instrumentation proposed meets the needs of the using facility.

4. Equipment shall be acquired for each of the clinical laboratories at the VISN 4 facilities listed in Attachment B.

5. The Contractor is required to provide a continuously stocked inventory of reagents, standards, controls, supplies, disposables, and any other materials required to properly perform test, complete lot conversions, and perform operator level maintenance on the equipment such that equipment operations are not interrupted. These items shall be of the highest quality, sensitivity, specificity and tested to assure precision and accuracy. Expiration date must be clearly marked on reagents, standards and control containers. Unexpected changes in methodology/technology shall be at the expense of the Contractor. 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.

6. Special handling for emergency orders of supplies: In the event 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. 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). 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.

Definitions:

1. Cost per Patient Reportable Result (CPRR) – as defined in the Federal Supply Schedule FSC Group 66, Part III, Cost-Per-Reportable Clinical Laboratory Analyzers- The per patient reportable result price shall include costs covering: (1) 5-year equipment use, (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 CLSI. (3) All necessary maintenance to keep the equipment in good operating condition. This element includes both preventive maintenance and emergency repairs, (4) and training for Government personnel. Contractors shall provide delivery, installation and removal of equipment at no additional charge.

2. Cost per Test (CPT) - as defined in the Federal Supply Schedule FSC Group 66, Part III, Cost-Per-Test Clinical Laboratory Analyzers- Contractors are required to provide a price for each test that can be performed on its equipment. The per test price shall include costs covering (1) 5-year equipment use, (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 and reporting of a test result, (3) all necessary maintenance to keep the equipment in good operating condition (This element includes both preventive maintenance and emergency repairs) and (4) training for Government personnel. Contractors are required to provide delivery, installation and removal of equipment at no additional charge.

3. Business Associate Agreement (BAA)‐ A business associate is an entity, including an individual, company, or organization that, on behalf of VHA, performs or assists in the performance of functions or activities involving the use or disclosure of PHI, or that provides certain services involving the disclosure of protected health information (PHI). VHA is a covered entity under the HIPAA Privacy Rule (Privacy Rule). HIPAA regulations require VHA to execute HIPAA‐compliant BAAs with certain entities that receives, uses, or discloses VHA PHI, in order to perform some activity for VHA. These BAAs obligate VHA business associates to provide the same protections and safeguards to PHI that is required of VHA under the Privacy Rule.

4. Parameter definitions

a. PT: Prothrombin Time

b. APPT: Activated Partial Thromboplastin Time

c. INR: International Normalized Ratio

d. ISI: International Sensitivity Index

e. Fibrinogen

f. D-Dimer

g. Anti-Factor Xa Test Menu: Refer to Attachment A for desired test menu and estimated annual volumes.

General Requirements:

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 of the technical specifications of this solicitation. 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.

2. (Applies only if selected) Back‐up Analyzer(s)‐ Equipment required in support of operations for the VA laboratories in the event the primary analyzer(s) becomes non‐operational/non‐functional. This category of equipment shall only be operated during periods of time when the primary instrumentation is not available for use. As such, the requirements for consumable supplies, i.e. reagents, quality control material, calibrators, etc., shall be minimal and corollary to the successful operation of the primary instrumentation. Specific tests that require back‐up performance are listed in Attachment A.

3. The contractor shall provide quality control material at a minimum of two levels; normal and elevated/abnormal levels.

4. All reagents, controls, calibrators, linearity material, lot verification/conversion material, and normal donor plasma (for annual lot changes) will be of the same lot number for all users. Lot numbers will be in use at least fifteen (15) months. All sites covered under this BPA will convert to the new yearly lot number within 2 months of each other.

5. Assayed control plasma for PT and APTT are the preferred products to assess test quality. If assayed controls are no offered/available, the Contractor shall either:

a. Furnish assayed control plasmas to be run concurrently until a range can be established for the assayed material or

b. Provide documented peer review of unassayed control data.

6. The product information must specify an appropriate ISI for the instrument and reagent lot number combination.

7. The ISI value for PT reagents must be between 1.0 – 1.3. The variance of the ISI value between reagents lots must not exceed 0.2.

8. Electronic barcode technology must be used to enter the ISI value.

9. Documentation must be provided regarding the effect of lupus anticoagulants in the therapeutic monitoring of warfarin.

10. Interference of heparin in the PT reagent must be minimal.

11. Operational features - The instrument shall have the following:

a. The capability of performing analysis on 100% of the tests listed in Attachment A.

b. Sufficient capacity and throughput to meet the volume and service demands as defined in Attachment A.

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

d. A bi-directional, barcoded computer interface compatible with the current VA laboratory information system. The fully operational interface (both hardware and software) shall be immediately available for implementation to the VA computerized hospital information system.

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

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

3) Equipment must accept, at a minimum, BARC characters in specimen identifier that is all numeric.

e. Ability to prioritize STAT testing without compromising existing programmed testing.

f. Minimal daily, weekly, monthly, and periodic maintenance.

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

h. Capability to store a minimum of 4000 patient records in a database for immediate recall.

i. Ability to accept various types of sample containers.

j. Ability to handle lipemic or icteric samples.

k. An on-board refrigeration system for reagents.

l. Minimum 24-hour on-board stability of PT and APTT reagents.

m. Minimum 8-hour stability of quality control (QC) materials.

n. Capability to detect out of range QC.

o. Ability to automatically program the performance of QC testing.

p. On-board reagent stability sufficient to accommodate both high and low volume use. Contractor to provide expiration dates of at least 12 months for reagents.

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

a. On-board QC data management system with a minimum storage capacity of QC files including Levy-Jennings graphs. Analyzer must have the ability to capture, store, and electronically transfer QC data.

b. Ability to monitor instrument performance.

c. On-board reagent inventory system.

d. Minimal carryover.

e. Long calibration stability.

f. Minimal reagent, calibrator, and control preparation.

g. No specimen pre-treatment required for PT and APTT testing.

h. Ability to accommodate the use of third-party reagents for specialized testing.

13. Hardware Features – The instrumentation shall have the following:

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

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

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

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

e. Primary tube sampling.

14. Specific Equipment Requirements – The instrumentation shall have the following:

a. Mechanical clot detection is the required method for clotting-based assays. Must be able to offer chromogenic and immunologic methods on the same analyzer.

b. Ability to perform calibration curves on other assays during test run without aborting the run.

c. Ability to store, print, and retrieve calibration curves where applicable. The instrument must store, print, and retrieve curves for factor assays such that using the same lot numbers and patient specimens may be run rapidly and in a STAT basis.

d. Ability for the curve dilutions to be defined by the operator and the curves should be stable for a minimum of three days.

e. D-Dimer testing must be FDA approved for exclusion of PE and DVT.

f. Ability to accept and test closed tube sample (ie. Cap piercing technology)

g. Ability to create automatic rerun/ reflex rules

h. Ability to replenish reagents while the analyzer is in operation.

i. Ability to comment on QC points to document troubleshooting and QC review.

j. Extended read times for prolonged clotting times

k. Dilutions of samples on-board

l. Analyzer utilizes windows operating software

15. Method Performance/Validation – The instrumentation shall have the following:

a. Method performance/comparison will be at the expense of the Contractor and will include linearity materials and reagents as required and based on manufacturer’s specifications and be consistent with Clinical Laboratory Standards Institute (CLSI) guidelines and related documents, College of American Pathologists (CAP) standard, and Federal regulations. Acceptable accuracy and precision for PT, APTT, Heparin Xa, and Fibrinogen will be <10% CV and D-Dimer will be <5% CV.

b. The method validation will include the following:

1) Correlations will be performed for each analyte using a minimum of 40 samples that span the reportable range and shall be run by the current and proposed methods.

2) The Contractor will analyze results and provide statistical data to support acceptance. Statistics include at least the mean, bias, slope, y-intercept, correlation coefficient and meet current standards defined by CLSI.

3) Analytical Measurement Range (AMR) validation will be performed on the instrument for each analyte.

a) AMR will be performed when applicable to validate the reportable range when applicable.

b) The material must have defined values near the low, mid, and high values of the AMR and be the appropriate matrix for the clinical specimens assayed by that method.

c) At a minimum, a 5-point linearity analysis that adheres to Beer-Lambert Law and spans the entire range will be performed.

4) Precision study using normal and abnormal material will be performed and shall consist of a within run precision study of 10 normal and 10 abnormal controls and a day-to-day precision study of normal and abnormal controls for 10 days (may be run twice a day) for a total of 20 values per level. Where applicable, intra-VISN facility variations should be kept at an absolute minimum.

5) Sensitivity may be validated concurrently with correlation studies. Mathematical calculations to determine efficiency, sensitivity, false positive rates and false negative rates are applied.

6) Specificity studies will be done by review of product literature and assay inserts to determine adverse effects for increased bilirubin, hemolysis, lipemia, or other interrupting substances.

7) Carryover Studies are required to ensure instrument properly flushes probes between specimens.

16. Reference Range – A reference range must be determined for each test following CLSI guidelines. Samples used for the reference range study must be representative of the patient population being tested. Reference range assessment must be performed for each lab. One of the following protocols shall be used:

a. A verification of the manufacturer’s suggested reference range may be performed as long as the suggested range is based on a comparable population of test subjects. The manufacturer shall provide specific information defining how the suggested range was determined. A minimum of 20 reference individuals shall be used to verify the manufacturer’s range. Any apparent outliers should be discarded and new specimens obtained to provide a statistically valid verification.

b. If the suggested manufacturer’s range is not appropriate for the patient population, a reference range shall be established. Establishing a reference must follow CLSI guidelines. This requires a minimum of 120 reference individuals to be used to establish a reference range. The reference interval should be determined using the nonparametric method.

c. If a laboratory is currently using the proposed instrument/reagent system, the “in-use” reference range can be transferred to the “new” system if a method comparison study between the two systems proves to be acceptable. If comparison studies are not acceptable, one of the two above items must be performed.

17. Reportable Range Requirements

a. PT, APTT, Fibrinogen, D-Dimer, and heparin assays – Contractor shall provide accurate high and low reportable range limits for all clotting assays (ie. PT, APTT, and Fibrinogen), particle agglutination (immunological) assays, (ie. D-Dimer) and chromogenic assays (ie. Heparin Anti-Factor Xa assay and Antithrombin Activity).

b. Factor Assay Activity – Contractor shall determine a reportable range for all coagulation factors, exhibiting the lowest and highest level of factor activity that can be accurately reported. This reference plasma that is used should be calibrated to a World Health Organization (WHO) standard or a secondary standard. The reportable range determinations should be performed for all intrinsic, extrinsic, and common coagulation factors. The reportable range is determined by setting automatic re-dilutions at the highest standard curve point and the lowest standard curve point. The lowest valid point on the curve is used to define the sensitivity of the assay. The lower limit of detection must be <1%. This should apply to all activity assays.

c. Chromogenic Assays - Contractor shall provide or determine a reportable range for chromogenic assays. This study should define the lowest level to the highest level that can be accurately reported. The material used to calibrate the instrument must not be used to determine the reportable range. The sample material used must have a known reference value. A linearity study, if applicable, must be performed to verify the reportable range.

d. For all other tests determined at the site visit (immunological assay, vWF AG, PC, PS, etc.) Contractor shall provide or determine a reportable range following the protocols defined for Factor Assay Activity or Chromogenic Assays.

18. Therapeutic Range Requirements

a. An ex vivo range must be established. The therapeutic APTT range must be determined using plasma from patients on unfractionated heparin therapy. Slightly, moderately and very prolonged APTT values must be used. Anti-Xa must be performed to quantify the amount of heparin present relative to the APTT. A minimum of 50 patient samples must be used. An explanation of this protocol may be found in the current CLSI guideline on one-stage PT and APTT testing.

b. In changing APTT methods, preference is given to a reagent system that will provide the same (or nearly the same) heparin responsiveness as the one currently in use.

19. Reports – The Contractor shall provide to the Contracting Officer (CO) and other individuals (designated post award) a copy of a quarterly report of sales, by ordering facility, within 30 calendar days after the close of each quarter’s business. 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. 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. Additional invoice charges associated with reagent and/or supply wastage or repair parts included at no charge (per FSS awarded contract) shall not be accepted. There will be no additional charges for any reports required as part of the BPA. Attachment C may be used as a template to provide these quarterly reports.

20. Support Features

a. Commercial marketing – The equipment models being offered shall be 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.

b. 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 FSS contract and required to establish instruments for operation for performance of acceptable testing. The Contractor shall perform, to the satisfaction of the Government, all validation studies including precision, method comparison with current analyzer, accuracy (recovery), linearity (reportable range), calibration verification, verification of reference interval, and determination of sensitivity and specificity at no cost to the Government. The Contractor shall perform all the statistical analysis as stated in the Method Performance/Validation section above and report data in an organized, clearly comprehensible format.

c. 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. This shall include training on the operation of the system, data manipulation, and basic trouble shooting and repair. 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. A training program that involves off-site travel shall include the cost of airfare, room and board for each participant.

d. Equipment Preventative Maintenance/Repair Service - The Contractor shall be able to 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:

1) The Contractor will provide access to a technical assistance center that is available 24 hours per day, 7 days per week with a maximum call back response of two hours.

2) Equipment repair service call shall be provided during routine business hours which are typically 8a.m. to 430 p.m. Certain circumstances may dictate the need for repair service to be conducted outside routine business hours. The Contractor is required to maintain analyzers in working order (able to perform patient testing). The Contractor must be prepared to provide services outside of normal routine hours.

3) Preventive maintenance will be performed according to published manufacturer operator’s manual and within two weeks of the scheduled date.

4) Reports of service shall be furnished to the Laboratory upon completion of each repair call. The report shall include, as a minimum, the following:

a) Date and time notified,

b) Date and time of arrival,

c) Serial number, type, and model number of analyzer,

d) Time spent for repair and proof of repair that includes documentation of a sample run of quality control verifying acceptable performance.

e) Each notification of an emergency repair service call is treated as a new separate service call if both the primary and back-up analyzers are not functioning properly. Contractor is required to provide emergency service after core business hours and on weekends.

e. 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. These shall be provided as they become commercially available and at the same time as they are being provided to commercial customers. 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. This does not refer to replacing the original piece of equipment provided under the BPA; however, it does refer to significant changes in the hardware operational capability.

f. Ancillary support equipment - The Contractor shall provide, install and maintain through the life of the BPA, 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.

g. Interface requirements –

1) Contractor will provide 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 analyzer is added to the existing universal interface system.

2) Contractor will provide any, and all necessary software support for ensuring successful interfacing is established. Specific requirements for the communication of the data stream will be unique to the analyzers’ system involved and dictated by the manufacturer itself. The Contractor will supply the information necessary to make the determination for type and amount of interfacing analyzers to be supplied.

3) When the Government site has a universal box, the Contractor will be responsible for everything leading up to the box including any incremental fees required to add additional analyzers (ie. licenses, port/cards, cable, software, etc.) to the universal interfacing system.

4) When the Government site does not have a universal interface, and one is needed to optimally interface the analyzer, the Contractor will be responsible for the acquisition of the universal interface box and everything else needed to connect to the VA computerized hospital information system. If there are any software upgrades in the instrument during its life, the Contractor is responsible for ensuring the interface can accommodate any changes in the data stream going to the VA computerized hospital information system.

h. 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 CLSI format or an on-line procedure manual in the instrument software.

i. 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. 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 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.

1) The determination and description shall address the following:

a) Waste toxicity (Reference 40 CFR §261.11 and 40 CFR §261.24)

b) Waste ignitability (Reference 40 CFR §261.21)

c) Waste corrosivity (Reference 40 CFR §261.22)

d) Waste reactivity (Reference 40 CFR §261.23)

e) Hazardous waste from non-specific sources (F-listed) (Reference 40 CFR §261.31)

f) Discarded commercial products (acutely toxic or P-listed and toxic or U-listed) (Reference 40 CFR §261.33)

g) Solid Waste (Reference 40 CFR §261.2)

h) Exclusions (Reference 40 CFR §261.4)

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.

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 Contractor response:

a) Barium (Total)

b) Cadmium (Total)

c) Chromium (Total)

d) Copper (Total)

e) Cyanide (Total)

f) Lead (Total)

g) Mercury (Total)

h) Nickel (Total)

i) Silver (Total)

j) Zinc (Total)

k) Arsenic (Total)

l) Selenium (Total)

m) Tin (Total)

n) pH

o) Flash point (to higher than 200F)

p) BOD; biochemical oxygen demand

4) 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 or not the waste from each device can legally be disposed of via the sewerage system

j. Implementation/transition timeframe - The implementation of the services/requirements described in this solicitation shall be completed no later than DDDD days after the award of the BPA. This timeline is based on a reasonable attempt of the Contractor to complete all of the necessary implementation requirements within the stated timeframe. Contractor shall not be penalized for implementation timelines that extend beyond the DDDD day timeframe, if the extension is through no fault of the Contractor and is a result of delays due to the Government.

1) Upon award of a BPA, the transition period for the awarded BPA to have all equipment and peripherals installed and operational shall be from date of award through 120 days. During this same period all initial training of VA personnel in the operation and maintenance of said award shall also be completed.

2) Contractor shall provide with its quotation an implementation plan for installation of new equipment. Contractor’s submitted plan shall not exceed 120 days for the transition of all services under the awarded BPA including installation and training of personnel, transition of all testing materials, reagents and supplies, etc., performance of all correlations and validations. Failure of the Contractor to conform to the transition period shall be considered as sufficient cause to terminate BPA for cause under the Termination for Cause clause of the BPA.

3) At the end of 120 days from award of the BPA, the awarded Contractor shall have full and sole responsibility for services under the awarded BPA.

k. 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 BPA] 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. 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 BPA at an effectiveness level of 90% or more.

1) In the event the 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.

2) 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.)

3) 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.

4) 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. [reference: Master FSS]

5) The Government will maintain daily records to satisfy the requirements of the Standard and Quality of Performance section 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.

6) During the term of the BPA, should the repair record of any individual piece of laboratory equipment reflect a downtime of 10% or greater of the normal working days in one calendar month, a determination shall be made by the COR to replace the malfunctioning equipment with new equipment. The responsibility for maintaining the equipment furnished in good condition in accordance with manufacturer’s instructions, shall be solely that of the Contractor. [reference: Master FSS] Each instrument provided by the Contractor shall maintain an uptime of 90% in each month of the term of the agreement for equipment.

l. 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.

m. 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.

n. 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.

o. Prior to termination or completion of this BPA, Contractor/subcontractor must not destroy information received from VA, or gathered/created by the Contractor in the course of performing this BPA 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 BPA.

p. 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: (i) completion or termination of the BPA or (ii) 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 BPA or disposal or return of the IT equipment, whichever is earlier.

q. 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. The options are:

1) Contractor must accept the system without the drive;

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

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

r. 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;

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

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 BPA.

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