Atch 1 - Statement of Work.pdf

Statement of Work

For

Automated Chemistry/ Immunochemistry Analyzer

I. Background:

The 88th Medical Group Clinical Laboratory requires automated Chemistry/Immunochemistry analyzer. Our current contract will expire on 10/28/2026. The analyzers we currently lease have been serviced 25 times this year, causing treatment delays.

The current instrument does not have the middleware needed to manage auto-verification, QC fails, QC drift alters, or QC lockout allowing the possibility of verifying incorrect results. The chemistry department provides diagnostic laboratory tests critical to nearly every department in the hospital and is mandatory for all inpatient care settings.

The equipment use; equipment service, calibrators and reagents are to be included in the cost and proposal. This contract will include the performance of monthly maintenance on both chemistry analyzers, telephonic technical support available 24/7 and in-house service 247 on all products needed. The systems must be compatible with the current laboratory information system (LIS) which is Cerner Millenium/ Military Health System-Genesis (MHS-G) and must include Middleware with an approved Authority to Operate (ATO) between the Chemistry, immunochemistry, and hematology instruments and Genesis to prevent errors and critical values. The Contractor must provide a water system that they install and maintain.

Service contract covering the term of the agreement is the requirement of the Contractor.

II. Minimum Technical Requirements:

The following specification lists the minimum requirements for the Automated Chemistry/ Immunochemistry Analyzer:

a. The Contractor shall provide technical support and engineering staff that shall be responsible for any service conducted on the analyzer system. The Contractor shall designate these individuals in writing to the Contracting Officer before the contract start date. An alternate may be designated but the Contractor shall identify those times when the alternate shall be the primary point of contact.

b. Contractors Service, telephone support, and trainers shall be able to read, understand, fluently, speak and legibly write in English.

c. The Government will not be responsible for any reasonable damage or loss occurring to the analyzer system while performing under this contract. This does not include malicious, willful destruction of Contractor equipment.

d. The Contractor shall have the responsibility and prerogative of selection, assignment, transfer, supervision, management, and control of Contractor personnel in personnel in performance of this PWS. However, the Contractor by the Contracting Officer as a potential threat to health, safety, security, general wellbeing or operational mission of the population.

e. The Contractor shall not employ any person who is an employee of the Government if that person would create a conflict of interest nor shall the Contractor employ any person wo is an employee of the Department of the Air Force, either military or civilian, unless such person seeks and receives approval in accordance with DODD 5500-7. In addition, the Contractor shall not employ any person who is an employee of the

Department of the Air Force if such employment would be contrary to the policies contained in AFI 64-106.

f. The Contractor will provide reagents that can be shared across all proposed testing platforms regardless of size.

g. Contractor will provide a copy of the number of product recalls for the requested tests above within the last 12 months and within 14 days from the date of initiating recall.

All requested assays must be FDA approved.

h. The Contractor must replace any reagent and calibrator material at no cost if a recall or issues are encountered with the material (i.e., product recall).

i. Contractor shall provide any routine and special items required to operate and maintain the equipment in optimal condition such as linearity materials for initial integration, printers, a reagent grade water supply, consumable equipment parts, and required replacement parts for maintenance or service.

j. All deliveries must be within a week from the ordering date, tracked by the Contractor and provide the Government notification if excess is delivered. Any delays or unavailability must be immediately communicated (w/in 24 hours) to the Wright Patterson Air Force Base Laboratory. Additional compensation will not be provided to the Contractor for additional quantities shipped in error.

k. The Contractor shall ensure all reagents/supplies are delivered to 4881 Sugar Maple Dr., Wright-Patterson AFB, OH 45433, ATTN: 88 MDSS SGSLA, BLD 830 Area A.

The Contractor, or subcontractor if used, shall comply with installation entry procedures in accordance with AFFARS 532.242-900, Contractor Access to Air Force Installations

l. Billing will be provided in the Cost Per Reportable (CPR) format.

m. The Contractor must deliver and complete the initial validation/comparison studies for each analyzer in accordance with College of American Pathology (CAP) regulations and any other state requirements, provide to the laboratory a complete record of validation(s).

n. The Contractor will administer all corrective action for failed performance during initial validation until rectified and IAW CAP requirements.

o. The Contractor will pay for all validation samples (i.e., Maine Standards or other commercial CAP standards) to include linearity materials, quality control materials, reagents, and consumables.

p. The Contractor will complete additional validation with upcoming laboratory move.

q. The Contractor will customize the software to meet specific customer requirements at no additional cost.

r. The Contractor will conduct scheduled preventive maintenance and cover the cost of items necessary to perform the scheduled preventive maintenance.

s. The Contractor shall deliver PM reports that outline the tasks completed in the PM, planned tasks for the next preventative maintenance, and issues and risks requiring government attention/assistance. Reports provided at the time of services and when requested.

t. Any time the analyzer is not functioning IAW the SOW, a 24-hour response time from an on-site field service engineer will be required to ensure continuous service to the medical providers.

u. All technical updates and software upgrades must be provided for the analyzers and the reagents as applicable/required with the shipment of the reagent(s).

v. The Contractor shall provide a comprehensive solution that addresses unscheduled downtime due to analyzer error, failure, etc., and the duration of downtime will be agreeable to the Government and based upon mission requirements at that time.

w. Contractor must provide middleware solution to manage all components of their solution that provides the following: auto-verification, QC fail alerts, QC drift alerts, QC lock out if QC not run at prescribed/designated intervals, supervisor review of QC daily, weekly, and monthly.

x. Contractor must provide middleware that is compatible with current Hematology analyzers.

y. Contractor must provide software that computes Exponentially Weighted Moving Averages on patient results and is able to alert lab technician of any drifts in patient results.

z. Contractor must provide the capability to remotely monitor and interact with all their chemistry, immunochemistry, and hematology middleware from multiple workstations, including the ability to monitor third party analyzers.

aa. Contractor must have the ability to customize real-time dashboards to include items such as turnaround times and auto-verification rates.

bb. Contractor must be able to directly provide rule-writing assistance and have a standard rules dictionary.

cc. Contractor must provide middleware with an approved ATO.

dd. Contractor must provide computer software integrated with on-board operational manual support to include management of quality control data, training, maintenance, and troubleshooting tips.

ee. Contractor must provide a written operational manual.

ff. Contractor must provide a Type II reagent grade water source and waste must have the ability to be self-contained.

gg. Contractor must provide water system maintenance, per contract, and supplies with all the costs to be included in the proposal.

hh. Contractor will provide a UPS for each analyzer capable to complete testing in progress and protect against electrical fluctuations.

III. Training:

a. The Contractor shall provide all necessary training required to operate the instruments to all laboratory personnel at time of delivery. Training and associated expenses (room, board, and airfare) for 2 key operator(s) per instrument for the base year of the contract and 1 key operator per instrument for each option year is included.

IV. Installation:

a. The Contractor must deliver and complete the initial validation/comparison studies for each analyzer in accordance with College of American Pathology (CAP) regulations and any other state requirements, provide to the laboratory a complete record of validation(s).

b. The Contractor will administer all corrective action for failed performance during initial validation until rectified and IAW CAP requirements.

c. The Contractor will pay for all validation samples (i.e., Maine Standards or other commercial CAP standards) to include linearity materials, quality control materials, reagents, and consumables.

d. The Contractor will customize the software to meet specific customer requirements at no additional cost.

V. Delivery:

SHIP TO DoDAAC: HT1135 POC: Kimberly Lillard, 88th MDG, 4881 Sugar Maple Dr. Bldg 830, Wright Patterson AFB, OH, 45433.

VI. Delivery Procedures – Commercial Vehicles:

The Contractor shall ensure all reagents are delivered to 4881 Sugar Maple Dr., Wright- Patterson AFB, OH 45433, ATTN: Kimberly Lillard BLDG 830 Area A. The Contractor, or subcontractor if used, shall comply with installation entry procedures in accordance with AFFARS 532.242-900, Contractor Access to Air Force Installations

VII. Lead Time:

The Contractor shall deliver ordered systems withing 90 days after contract approval.

VIII. Warranty:

The equipment provided under this lease is leased from a third-party manufacturer. The warranty for the equipment is provided by the manufacturer and is governed by the manufacturer’s published warranty terms, available at beckmancoulter.com. The warranty covers defects in material and workmanship under normal use and service, but excludes damage caused by misuse, neglect, or Government actions. The warranty period shall commence on the date of delivery and shall remain in effect for the duration of the lease term, or for the period specified by the manufacturer, whichever is longer. The lessor shall provide the lessee with the manufacturer’s warranty documentation and shall assist in coordinating warranty claims.