PWS CellaVision lab equipment service DRAFT.pdf

PERFORMANCE WORK STATEMENT (PWS)

CellaVision DM1200 Repair and Preventive Maintenance Services VA Central Iowa Health Care System

1. Scope

1.1. The contractor shall provide repair and preventive maintenance services for the CellaVision DM1200 hematology laboratory equipment identified in Section 2.1, located at the VA Central Iowa Health Care System (VACIHCS) in Des Moines, Iowa.

1.2. Services shall include, but are not limited to, software updates, periodic preventive maintenance (PM), performing repairs, and replacing parts of the CellaVision equipment necessary to keep the system operating within manufacturer specifications. Annual PM shall be completed within the window identified in Section 7.

1.3. The purpose of this contract is to ensure that VACIHCS's CellaVision DM1200 hematology equipment remains available and operating within manufacturer specifications to support patient care. The contractor's performance shall be measured against the standards in Section 11 (Performance Requirements Summary).

2. Equipment Covered

2.1. The equipment to be serviced/maintained includes:

3. Definitions and Acronyms

3.1. Acceptable Quality Level (AQL) The maximum error rate or minimum performance level at which the Government will accept contractor performance for a given standard.

3.2. Biomedical Equipment Support Specialist (BESS) VA employee responsible for vendor coordination of maintenance for VA-owned medical equipment.

3.3. Contracting Officer (CO) The Government official with authority to enter, administer, and terminate contracts on behalf of the VA.

3.4. Contracting Officer's Representative (COR) The individual designated by the CO to perform contract administration functions within the scope of authority delegated in writing.

3.5. Federal Acquisition Regulation (FAR) The primary regulation governing all executive-branch agencies' acquisition of supplies and services with appropriated funds.

3.6. Field Service Engineer (FSE) A person authorized by the contractor to perform services under this contract.

3.7. Original Equipment Manufacturer (OEM) The manufacturer of the equipment being serviced. For this contract, the OEM is CellaVision Inc. / Sysmex America, Inc.

3.8. Preventive Maintenance (PM) Services which are periodic in nature and are required to maintain the equipment in such condition that it may be operated in accordance with its intended design and functional capacity with minimal incidence of malfunction or inoperative conditions.

Manufacturer Equipment Model Serial Number

CellaVision Inc. CellaVision DM1200 34004

3.9. VA Central Iowa Health Care System (VACIHCS) The VA facility located in Des Moines, Iowa, where the equipment covered by this contract is installed.

3.10. Vendor Engineering Service Report (ESR) Documentation of the services rendered for each incidence of work performance under the terms and conditions of the contract.

4. Conformance Standards

4.1. The contractor shall ensure that the equipment functions in conformance with Original Equipment Manufacturer (OEM) documentation. System upgrades and updates shall be installed in strict accordance with manufacturer specifications, and the equipment shall operate within manufacturer specifications and parameters.

5. Hours of Coverage

5.1. Normal business hours are Monday through Friday, 8:00 AM to 5:00 PM Central Standard Time (CST), excluding Federal holidays.

5.2. All scheduled service and repairs shall be performed during normal hours of coverage unless the contractor requests, and the Contracting Officer's Representative (COR) approves in advance, work outside those hours at no additional cost to the Government.

5.3. Scheduling for unscheduled maintenance outside of normal hours shall be coordinated with, and require the approval of, the COR.

5.4. VACIHCS observes all Federal holidays established under 5 U.S.C. § 6103, as well as any other day designated as a holiday by Executive Order or Presidential Proclamation.

6. Unscheduled Maintenance

6.1. The contractor shall maintain the equipment in accordance with the conformance standards in Section 4.

6.2. Repair services may include calibration, adjustments, replacing and installing parts.

6.3. All travel, labor, and parts are included in this contract at no additional cost to the Government.

6.4. The Contracting Officer (CO), COR, and Biomedical Equipment Support Specialist (BESS) have the authority to approve or request a service call from the contractor.

6.5. Contractor response requirements are established in the Performance Requirements Summary in Section 11.

7. Scheduled (Preventive) Maintenance

7.1. The contractor shall perform Preventive Maintenance (PM) services to ensure the equipment operates in accordance with the Manufacturer's Maintenance Manuals.

7.2. Annual PM shall be performed at the manufacturer's recommended intervals and completed within the window of September 1 through November 30 to meet VA PM schedule requirements. Changes to this window require prior written approval by the COR.

7.3. The contractor shall provide and utilize procedures and checklists with worksheet originals indicating work performed and actual values obtained (as applicable), provided to the COR at completion of the PM.

8. Parts

8.1. The contractor shall provide all replacement parts needed to keep the equipment in operating condition as originally designed by the manufacturer.

8.2. All parts used shall be OEM parts. Reverse-engineered and refurbished parts shall not be utilized without explicit written permission from the CO.

9. Contractor Qualifications

9.1. The contractor shall maintain sufficient qualified personnel to meet the performance standards in Section 11, including during primary technician unavailability.

9.2. All Field Service Engineers (FSEs) performing work under this contract shall have successfully completed the manufacturer's formalized training program for the equipment identified in Section 2.1. The contractor shall provide, upon request, documentation of factory-certified service and maintenance training for any FSE performing services under this contract.

10. Site Access and Reporting Requirements

Note: The requirements in this Section 10 are conditions of performance necessary for facility security and coordination;

they are not performance standards subject to the Acceptable Quality Levels (AQLs) in Section 11.

10.1. Upon arrival at VACIHCS, contractor personnel shall notify Biomedical Engineering of their arrival, check in with the VA Police Office, and receive a visitor badge.

10.2. When service is completed, the FSE shall document services rendered on a legible Vendor Engineering Service Report (ESR) and submit it to the BESS who set up the service. The ESR may be submitted by paper copy when logging out with Biomedical Engineering, or by email.

10.3. When after-hours work is necessary, contractor personnel shall check in with the VA Police, receive a visitor badge, and check in with Lab personnel for access. All after-hours work shall be pre-arranged with the COR or designee.

10.4. Documentation shall include detailed descriptions of the scheduled and unscheduled maintenance procedures performed, replaced parts, and prices required to maintain the equipment.

11. Performance Requirements Summary

The contractor's performance under this contract shall be measured against the following standards. Section 11.1 below describes how the Contracting Officer's Representative (COR) will monitor and document contractor performance against each standard.

# Required Service Performance Standard AQL Surveillance Method

1 Response to service call — phone

Contractor responds to phone calls within 4 hours during normal business hours

95% of calls Exception-based;

see Section 11.1

2 Response to service call — on-site

If problem cannot be resolved by phone, technician on-site not later than the next business day after the call is placed

95% of dispatches Exception-based;

see Section 11.1

3 Equipment availability

Equipment operational (available for clinical use) during normal business hours

95% monthly uptime Exception-based;

see Section 11.1

4 Annual PM completion

Annual PM completed within the September 1 – November 30 window

100% Exception-based;

see Section 11.1

5 ESR submission ESR submitted within 5 business days of service completion

95% of service events Exception-based;

see Section 11.1

6 Conformance to manufacturer specifications

Post-service equipment operates within OEM specifications and parameters

100% (no post-service out-of-spec conditions attributable to contractor work)

Exception-based;

see Section 11.1

7 Parts compliance All parts used are OEM parts (or CO-approved alternates)

100% Exception-based;

see Section 11.1

11.1. Surveillance method. The COR will use exception-based surveillance, supplemented by an annual review. This means the COR is not expected to conduct routine calculation of each performance metric; instead, the COR will act when a performance issue is reported or observed.

• Ongoing (as issues arise): Lab staff, Biomedical Engineering, or the BESS will notify the COR when they observe or experience a performance problem: equipment down longer than expected, contractor slow to respond to a service call, ESR not received, non-OEM parts noted on an ESR, or any other departure from the standards in Section 11. The COR will document the issue in a brief written note (email is sufficient) capturing what happened, when, and any information provided by the contractor.

• Annually, prior to option exercise: The COR will review the year’s service history (ESRs, downtime records, and any documented issues) and prepare a short-written summary for the CO indicating whether the contractor met the performance standards overall and whether any patterns of non-performance warrant action. This review supports the CO's decision on whether to exercise the next option period.

• When any issue is documented: The COR will notify the CO. The CO will determine what further action is warranted under Section 11.2, which may range from no action (isolated incident) to a Contract Discrepancy Report, cure notice, or non-exercise of options (pattern of non-performance).

11.2. Remedies for non-performance. Performance falling below the AQLs above may result in the remedies available to the Government under Federal Acquisition Regulation (FAR) 52.212-4, including but not limited to equitable price reduction, re-performance, and termination for cause. Repeated failure to meet AQLs across multiple surveillance periods may be considered in the Government's decision whether to exercise option periods.

12. Government-Furnished Property and Information

12.1. The Government will provide contractor personnel with access to the equipment location and reasonable working space to fulfill contract requirements, subject to the site access procedures in Section 10.

12.2. No other Government-furnished property, equipment, or software is provided under this contract.