6515--Total Small Business Set-aside Brand Name Only - Leica Biosystems - CM1860 Configuration US Cryostat.

The VA Pittsburgh Healthcare System (VAPHS) Histology Department

STATEMENT OF WORK (SOW)

Leica - CM1860 Configuration US Cryostat.

Contract Number:

Task Order Number:

IFCAP Tracking Number:

646-24-2-233-0251

Follow-on to Contract and Task Order Number:

N/A

1. Contracting Officer s Representative (COR).

Name:

Cathy Noble

Section:

Lab Contracting Manager

Address:

University Drive, Pittsburgh, PA 15240

Phone Number:

412-360-1524

Fax Number:

E-Mail Address:

Cathy.Noble@va.gov

2. Contract Title. Leica Biosystems - CM1860 Configuration US Cryostat.

3. Background. The VA Pittsburgh Healthcare System (VAPHS) Histology Department requires a new replacement Brand Name Only Leica CM1860 Configuration US Cryostat to replace the existing Cryostat End of Life (EOL).

4. Scope.

The Histology Department uses Leica cryostats to preserve frozen tissue samples, slice tissue sections thin enough for microscopic examination, and provide a quick diagnosis for a variety of diseases and medical conditions, including neuromuscular disease. The Leica CM 1860 delivers quality reproducible sections for in surgery cancer diagnoses, has several safety features such as a blade ejector, magnetic brush, and finger guards to protect and reduce the risk of cutting injuries. The Leica CM 1860 has designated storage shelves for samples, tools, and an accessible ambient temperature storage on top of the instrument. The Leica CM 1860 has a quick turnaround time with no need to adjust the instrument before use, and the microtome is encapsulated, thus providing for easy cleaning and maintenance. The Leica CM 1860 has a readable LED display and can perform relevant functions by pushing one button.

Historically, the Leica s we have had in the past required little to no service because they are High-quality instruments.

5. Specific Tasks.

The VA Pittsburgh Healthcare System (VAPHS) Histology Department is in need of a high- quality replacement Brand Name Only: Leica CM1860 Configuration US Cryostat to continue the quality of care that the Veterans are currently receiving.

Specific criteria the cryostat must meet:

Equipment identification

Instrument type

Model numbers 14 0491

CM1860

46884

CM1860UV

46888

Electrical specifications

Nominal voltage (+10 %)

120 VAC

Nominal frequency

60 Hz

Power consumption

1440 VA

Power supply

IEC 60320-1 C-20

Max. start-up current for 5 sec.

45 A eff.

Mains input fuse (automatic circuit breaker)

T12A M3

Secondary fuses

F2: T1,6A L250 VAC (6.3x32)

F3: T1,0A L250 VAC (6.3x32)

F4: T6.25A L250 VAC (6.3x32)

F5: T4A L250 VAC (6.3x32)

Dimensions and weight specification

Overall size of device, without handwheel (width x depth x height)

600 x 722 x 1206 mm

Overall size of device, with handwheel (width x depth x height)

730 x 722 x 1206 mm

Working height (armrest)

1025 mm

Overall size of packaging (width x depth x height)

960 x 820 x 1400 mm

Empty weight (without accessories)

135 kg

Environmental specification

Operating altitude

Max. 2000 m above sea level

Operating temperature

+18 °C to +35 °C

Relative humidity (operation)

20 to 60 % RH non condensing

Transport temperature

-29 °C to +50 °C

Storage temperature

+5 °C to +50 °C

Relative humidity (transport / storage)

10 to 85 % RH non condensing

Minimum distance to walls

Back: 150 mm Right: 300 mm Left: 150 mm

Emissions and boundary conditions

Overvoltage category according to IEC 61010-1

II

Pollution degree according to IEC 61010-1

2

Means of protection according to IEC 61010-1

Class 1

Degree of protection according to IEC 60529

IP20

Heat emission

1440 J/s

A weighted noise level, measured at 1 m distance

< 70 dB (A)

EMC class

B (FCC Rules part 15) B (CISPR 11, IEC 61326, CAN ICES-3 (A)/NMB)

Chamber cooling

Temperature range

0 °C to -35 °C ±3 K, adjustable in 1 K increments, at ambient temperature of 22 °C

Cooling time to -35 °C

Max. 6 h, at starting point and ambient temperature of 22 °C and 60 % relative humidity

Max. operating pressure

25 bar

Refrigerant*

315 g, refrigerant R-452A*

Defrosting

Hot gas defrosting

Manual defrosting

Yes

Automatic defrosting

Yes

Programmable

Yes (hot gas defrost), selectable time

Defrosting intervals

1 defrost in 24 h or manual hot gas defrost

Defrost duration

12 minutes

Automatic turn-off defrost

At chamber temperature of more than -5 °C At evaporator temperature of more than +38 °C

Quick-freeze shelf

Lowest temperature

-40 °C (+3/-5 K), at chamber temperature of -35 °C and at ambient temperature of 22 °C

Number of freezing stations

8+2

Defrosting

Hot gas defrosting

Defrost duration

12 minutes

Automatic turn-off defrost

At chamber temperature of more than -5 °C At evaporator temperature of more than +38 °C

Manual start

Yes

Automatic start

No

Manual abort

Yes

Peltier station / Quick-freeze shelf

Max. difference in temperature to quick-freeze shelf

Min. 17 K, at chamber temperature of -35 °C

Number of freezing stations

2

Duration of active time

10 minutes (turn-off possible after 6 minutes)

Defrosting

Together with quick-freeze shelf

Microtome

Type

Rotary microtome, encapsulated

Section thickness range

1 m to 100 m

Horizontal specimen feed

25 mm +3 mm

Vertical specimen stroke

59 mm ±1 mm

Specimen retraction

20 m (can be deactivated)

Maximum specimen size

55 mm x 55 mm or 50 mm x 80 mm

Specimen orientation

±8 ° (x-, y-axis)

Coarse feed

Slow: max. 600 m/s Fast: min. 900 m/s

UVC lamp (only CM1860UV)

Manual start

Yes

Automatic start

No

Manual abort

Yes

Duration cycle

Short cycle: 30 minutes Long cycle: 180 minutes

Must have maximum cooling temp up to -40°C

Must be able to cut slide thickness range spans from 1 to 100 m

Must have a cutting speed range of 0.5 to 25 mm/s

Weigh no more than 298 lbs.

Must have measurements of 28.7 in W x 28.7 in D x 44.8 in H

6. Place of Performance.

Government site: VA Pittsburgh Healthcare System, University Dr, Pittsburgh, PA 15240

Histology Lab

7. Period of Performance. One-time equipment purchase.

8. Delivery Location.

VA Pittsburgh Healthcare System

University Drive C,

Pittsburgh, PA 15240

Histology Lab U2NE117

GOVERNMENT RESPONSIBILITIES: The Government shall provide the following: The authorized COR, will assume responsibility for the installation and performance of all other equipment and work necessary for completion of this project:

(1) Provide site access and escorts to the customer's location to where the equipment is located.

(2) Provide adequate space for the work to be performed.

(3) Provide the contractor with contact information and the necessary authorization to coordinate connectivity issues with applicable U.S. Government POC's.

CONTRACT ADMINISTRATION:

The VISN 4 Veterans Administration Contracting Office is responsible for the sole administration for this contract.

6.1 Contract Administrator: Contract administrator shall be designated at time of contract award.

6.2 The Contracting Officer Representative (COR) will be identified by separate letter. The COR is responsible, as applicable, for: receiving all deliverables, inspecting, and accepting the supplies or services provided hereunder in accordance with the terms and conditions of this contract; providing clarification to the contractor, fills in details or otherwise serves to accomplish the contractual Scope of Work; evaluating performance; and certifying all invoices/vouchers for acceptance of the supplies or services furnished for payment.

6.3 The COR does not have the authority to alter the contractor's obligation under the contract, and/or modify any of the expressed terms, conditions, specifications, or cost of the agreement. If as a result of technical discussions, it is desirable to alter/change contractual obligations or the Scope of Work, the Contracting Officer shall issue such changes.

CONTRACTOR PERFORMANCE ASSESSMENT REPORTING SYSTEM (CPARS)

The services, although not directly supervised, shall be reviewed by the Department of Veterans Affairs staff to ensure contract compliance. The contractor's performance will be evaluated in accordance with FAR 42.15. Contract monitoring reports will be prepared by the Contracting Officer's Representative (COR) and maintained in the contract file.

In accordance with FAR 42.1502 and 42.1503, agencies shall prepare an evaluation of contractor performance and submit it to the Contractor Performance Assessment Reporting System (CPARS). The VAMC utilizes the Department of Defense (DOD) web-based Contractor Performance Assessment Reporting System (CPARS) to provide contractor performance evaluations. The contractor shall provide and maintain a current e-mail from the Focal Point thru the following website address webptsmh@navy.mil when the contractor is registered in CPARS. The contractor must be registered to access and review its evaluation and/or provide a response.

IF Vendor will be on station:

Contractor will be on station to provide service and therefore required to take the generalized privacy training: Privacy Training for Personnel Without Access to VA Computer Systems or Direct Access to or the Use of VA Sensitive Information. Copies to be maintained by COR.

Government Furnished Information or Material:

a. This acquisition does not include Government-furnished property (GFP), identify in the Statement of Need all available information on GFP to be provided, including the make, model, bar code number and serial number, if available, of all accountable assets with an acquisition cost of $500 or more.

b. This acquisition does not include Contractor-acquired property (CAP).

c. "No Government personnel, other than the Contracting Officer, have the authority to change or alter these requirements. The COR shall clarify technical points or supply relevant technical information, but no requirements in this scope of work may be altered as a sole result of such verbal clarification."

5. Period of Service:

Delivery shall occur within 30 days of receipt of contract or must occur within the timeframe designated by the Federal Government.

6. Security/National Agency Check Requirements:

No special security requirements are anticipated.

Influenza Vaccination:

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

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

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

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

- Completed Health Care Personnel Influenza Vaccination Form (Attachment B of VHA Directive 1192) if unwilling or unable to receive the vaccine. The contractor is required to submit annual certification in the form of a memorandum to the Contracting Officer s Representative (COR) that all contract staff performing services at VA facilities is in compliance with VHA Directive 1192.

Tuberculosis Prevention:

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

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

COVID 19:

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

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

HIPAA Training Certificates:

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

Smoking:

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