Statement of Work.docx

STATEMENT OF WORK

Pathology & Laboratory Medicine Service Histology Reagent/Instrument Rental Contract

A. Scope of Work:

1. Cost Per Test (CPT) contract pricing to include

a) One (1) automated Hematoxylin & Eosin (H&E) stainers with in-line coverslipping

b) Two (2) automated Immunohistochemistry analyzers (IHC) that can also run in situ hybridization (ISH), both with in-line coverslipping

c) Two (2) automated Special Stains analyzers with in-line coverslipping

d) Consumables (reagents and other supplies), with an emphasis on pre-filled (e.g., not needing titration) antibody reagents for immunohistochemistry and in situ hybridization and special stains.

2. The vendor shall provide training for key operators at the main training site once per year, along with continuing education on-site as needed. Additionally, the vendor shall conduct on-site training for other staff as required. The vendor is permitted to conduct lunch and learn sessions throughout the year, provided the educational content aligns with the VA’s mission and scope of work.

3. Customer service by phone, emergency, and preventative service/repair: non-holiday Monday – Friday regular work hours (0700-1700).

4. The Certification & Accreditation (C&A) requirements do not apply, and a Security Accreditation Package is not required.

B. Location of the Work:

VA Palo Alto Health Care System Attn: Pathology & Laboratory Medicine Service 3801 Miranda Ave, Bldg. 100 E4-319 Palo Alto, CA 94304

C. Estimated Period of Performance:

D. Deliverables and Definitions:

Hematoxylin & Eosin Staining (H&E) is the principal method used in histology to differentiate between the nuclear and cytoplasmic parts of a cell. Overall patterns of coloration from the stain provide a general overview of a tissue sample’s structure under light microscopy, and are used to facilitate pathologic diagnosis.

Immunohistochemistry (IHC) is a technique for identifying cellular or tissue constituents (antigens) relating to cancer and other diseases by means of antigen-antibody interactions, with the antibody label coming from the reagent, which is conjugated with a chromagen detectable under light microscopy.

In Situ Hybridization (ISH) techniques allow the demonstration of specific nucleic acid sequences (genes) in their cellular environment, detectable with a chromogen under light microscopy.

Special Histologic Staining techniques demonstrate the presence (or absence) of a cellular component that helps a pathologist diagnose cancer or other diseases.

E. Analyzer for IHC-ISH must be able to:

1. Perform immunohistochemistry (IHC) and in situ hybridization (ISH) stains with the full range of immunohistochemical and in situ hybridization techniques simultaneously on one instrument.

2. Perform pre-processing (deparaffination, baking) on the analyzers

3. Preference for individual application slide staining over “dip and dunk” (preference for horizontal slide position versus vertical, to reduce slide breakage and cross-contamination)

4. Fully automated (robotic) after adding samples to unit (“walk-away” non-manual processes)

5. STAT capability for individual slide loading while other testing is in progress

6. Ability to add slides while instrument is running other tests

7. Ability to add or change reagents while instrument is running other tests

8. Have bar code tracking of samples and reagents

9. Preference for pre-filled reagent/antibody/hybridization probe kits not requiring manual titration

10. IHC turnaround time of 2.5 hours

11. Be a free-standing floor model not requiring construction (ventilation okay)

12. IHC-ISH stainer must fit within approximate dimensions of 44” W, 37 ”D, 64 ”H

13. Fit voltage requirements of ~ 110-230 V

14. At a minimum, support the current IHC test menu as detailed below and ISH for kappa, lambda and EBER1 (EBV):

15. The vendor is responsible for all costs associated with venting any instruments requiring ventilation. This includes, but is not limited to, installation, modifications, and compliance with all applicable safety and building codes.

16. See attached excel spread sheet.

F. Analyzer for Special Stains must be able to:

1. Perform special histology stains:

2. Special stains turnaround time of 20 slides in 20 minutes; maximum at 90 mins.

3. Perform any pre-processing (deparaffination, baking) on the analyzers

4. Preference for individual application slide staining over “dip and dunk” (preference for horizontal slide position versus vertical, to reduce slide breakage and cross-contamination)

5. Fully automated (robotic) after adding samples to unit (“walk-away” non-manual processes)

6. STAT capability for individual slide loading while other testing is in progress

7. Ability to add slides while instrument is running other tests

8. Ability to add or change reagents while instrument is running other tests

9. Have bar code tracking of slides

10. Be a free standing floor model not requiring construction (ventilation okay)

11. Special histology stainer must fit within approximate dimensions of 20” W, 25 ”D, 54 ”H

12. The vendor is responsible for all costs associated with venting any instruments requiring ventilation. This includes, but is not limited to, installation, modifications, and compliance with all applicable safety and building codes.

G. Analyzer for H&E stainer must:

1. Provide for single slide staining as needed and continuous loading with in-line coverslipping capability

2. Run/stain/coverslip a minimum of 200 slides per hour

3. Perform pre-processing (deparaffination, baking) on the analyzers

4. Preference for individual application slide staining over “dip and dunk” (preference for horizontal slide position versus vertical, to reduce slide breakage and cross-contamination)

5. Fully automated (robotic) after adding samples to unit (“walk-away” non-manual processes)

6. STAT capability for individual slide loading while other testing is in progress

7. Ability to add slides while instrument is running other tests

8. Ability to add or change reagents while instrument is running other tests

9. Have variable staining intensity options

10. Be a free standing floor model not requiring construction (ventilation okay)

11. H&E stainer must fit within approximate dimensions of 72” W, 30 ”D, 72 ”H

12. The vendor is responsible for all costs associated with venting any instruments requiring ventilation. This includes, but is not limited to, installation, modifications, and compliance with all applicable safety and building codes.

H. Reagents/Tests must allow for:

1. Large, current FDA approved menu of IVD antibodies for IHC-ISH tests that will detect breast, prostate, lung and hemopathology cancers (see above)

2. Ability to provide IHC-ISH reagent markers from specialized companies that sometimes have proprietary reagents

3. Large variety of special stains typically used in a histology laboratory (refer to section b above)

4. Fully automated assays without manual pre-treatment

5. Small pre-filled kit sizes available whenever possible (less than 50 tests) to eliminate wastage/expired reagents

I. Data & System Management/Interface must be able to:

1. Allow user to view status of patient tests during instrument operation

2. Lab instrument and vendor remote link support for troubleshooting and software upgrades

3. Connectivity of H&E, IHC-ISH and Special Stain analyzers to data management system

4. Test volume tracking and online entry/recording/archive of daily slide Quality Control (QC) results

J. Instrument Service and Support must be able to:

1. Provide on-site customer service and arrive within 4 hours of emergency call non-holiday Monday-Friday between 0700-1700

2. Provide off-site training for 1 key operator and on-site training as needed

K. Performance Standards – Contract will be monitored relative to:

1. Quality of stains

2. Pathologists monitor quality of stains through pathology reports.

3. Data is tracked via Quality Management Dashboard, convening monthly

4. Timeliness of supply delivery

5. Delivery of orders made prior to Fridays should be available within 2 business days. Deviations from expected timeframe are documented on a delivery log

6. Timeliness of service when required –

7. Field Service Engineer arrives within 72 hours or 3 business days of initial request. Deviations from expected timeframe are documented on a service log.

8. Technical Support (via telephone) available 24 hours a day, 7 days a week.

9. Submission of invoices – invoices tracked on COR invoice tracker The CORs for this contract hold a current COR certification. The COR will monitor performance using a standardized evaluation schedule. Significant problems will be reported to the Contracting Officer.

(End of SOW)