Performance Work Statement_ 26 AUG.docx

PERFORMANCE WORK STATEMENT (PWS)

FOR

AUTOMATED IHC STAINER

AT

88TH MEDICAL GROUP (MDG)

WRIGHT-PATTERSON AIR FORCE BASE, OH

PERFORMANCE WORK STATEMENT

TABLE OF CONTENTS

SECTION PAGE

This Blanket Purchase Agreement (BPA) establishes terms, conditions, firm-fixed prices, and a source of supply for the supplies and services described in this SOW. The BPA does not obligate Government funds and does not guarantee any minimum quantity, expenditure, or number of purchases. The Government is obligated only for authorized purchases actually made under the BPA by personnel authorized in writing by the Contracting Officer.

I. SCOPE OF WORK:

A. The Contractor shall provide, upon receipt of authorized calls under this Blanket Purchase Agreement (BPA), a fully automated immunohistochemistry/in situ hybridization (IHC/ISH) staining system for the 88th Medical Group, Laboratory Flight, Wright-Patterson Air Force Base, Ohio. The Contractor shall furnish the analyzer; compatible reagents, kits, controls, consumables, and validation materials; delivery; installation; calibration; validation support; initial operator training; preventive maintenance; corrective maintenance; technical support; software required for normal operation; and deinstallation and collection of the analyzer at the end of an authorized lease call, unless a requirement is specifically identified as a separately priced item in the BPA price schedule.

B. The Government will authorize the initial analyzer lease, delivery, installation, calibration, validation support, and initial training through an individual call placed by an authorized Government purchaser. The Contractor shall deliver, install, calibrate, and provide initial validation support for the analyzer within 30 calendar days after receipt of that authorized call, unless a different delivery date is stated in the call. The Contractor shall not ship the analyzer, begin installation, perform services, extend a lease, or invoice the Government without an authorized call.

C. The BPA shall establish firm-fixed monthly lease pricing for the analyzer and firm-fixed unit prices for the kits, reagents, controls, consumables, and any separately priced services identified in the BPA price schedule. All required prices shall include all labor, parts, tools, travel, lodging, shipping, handling, and other charges necessary to perform the requirements of this SOW, unless a charge is expressly identified as a separate firm-fixed-price item in the BPA price schedule.

D. The offered system, related equipment, and supplies shall support the Government laboratory’s compliance with applicable FDA, CLIA, CAP, TJC, CLSI, USAF, installation, and other applicable laboratory or accreditation requirements. The Contractor shall provide the equipment, documentation, training, maintenance, technical support, and materials necessary to meet the requirements of this SOW. The Government retains responsibility for clinical validation approval, laboratory operations, quality management, accreditation, and regulatory compliance.

II. GENERAL REQUIREMENTS:

A. The Government seeks a fully automated IHC/ISH system that performs bake, dewax, walk-away processing, integrated random-access operation, IHC single staining, IHC double staining, and ISH. The system shall process a minimum of 60 tests per day and shall require no more than one workstation analyzer to perform the required testing.

B. The BPA ordering period shall be five years from the BPA effective date, unless the BPA is completed earlier because authorized purchases reach the estimated BPA value or the BPA is terminated in accordance with its terms. This BPA contains no option periods. The Government may place authorized calls during the BPA ordering period, subject to the estimated BPA value, available funding, and the authority of the authorized purchaser. The Contracting Officer will review the BPA at least annually and update it when necessary. Annual review does not obligate Government funds, guarantee future purchases, extend the BPA ordering period, or authorize a lease, supply purchase, service, delivery, performance, or payment.

C. The desired instrumentation shall 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).

D. The desired instrumentation shall require no more than a single workstation analyzer to accomplish required testing listed below:

i. IHC single

ii. IHC double

iii. ISH

E. The desired instrumentation, without the use of additional middleware, shall be indicated to the user when quality control reagent has expired.

F. The desired instrumentation shall use less than 150ul of the antibody or probe per slide.

G. The desired instrumentation shall use a digital barcode reader to provide a positive identification for all specimen slide labels and reagent labels.

H. The desired instrumentation shall alert the user through the instrument interface when maintenance is due to be performed or is overdue.

I. The desired instrumentation shall not require a water source to function.

III. ORDERING, CALLS AND INVOICING:

A. Only Government personnel authorized in writing by the Contracting Officer and acting within delegated authority may place calls under this BPA. Each call shall identify the BPA number, authorized purchaser, item or service, quantity, unit price, total amount, delivery/performance period, and delivery/performance location.

B. The Contractor shall furnish the analyzer and included support only for the period stated in an authorized lease call. After completion of an authorized lease period, the Contractor may submit an itemized invoice identifying the BPA number, call number, lease period, analyzer identification, monthly lease charge, separately authorized supplies/services, and total amount due. Payment by Government purchase card is contingent upon Government verification and acceptance and applicable GPC procedures.

C. The Contractor shall not automatically renew or extend a lease period, charge the Government purchase card, continue performance beyond an authorized call period, or invoice for an unauthorized period. A new authorized call is required before the Contractor provides lease or included support for a subsequent period.

IV. INSTRUMENT TRAINING AND SUPPORT:

A. The Contractor shall provide instrument transportation, delivery, and installation, to include calibration and test and system validation support, within 30 calendar days after receipt of an authorized Government call for analyzer lease and installation.

B. The Contractor shall perform, at a minimum, the following initial instrument validation studies for each analyte listed in Required Assay/Reagent Menu (Attachment 2)

i. Simple Precision

ii. Accuracy

iii. Method Comparison

iv. Instrument Correlation

C. The Contractor shall provide initial on-site operator training to no less than three (3) instrument operators, prior to initiation and use of the instrument, and within seven (7) days of meeting the requirement stated in Section III, Par A.

D. The Contractor shall provide supplemental operating training to Government personnel, without additional charge to the Government, upon installation of any upgrade in equipment hardware or operating system software connected with the operation of an instrument already furnished under this agreement.

V. INSTRUMENT REPAIR AND MAINTENANCE:

At a minimum, the Contractor will provide the following maintenance and repair services:

A. Must provide onsite maintenance (monthly, quarterly, annually, etc.) in accordance with manufacturer’s guidelines, to include preventive maintenance.

B. Must provide all required tools, parts and labor as necessary to keep the instrument operational.

C. Must provide over the phone, remote support, instrument technical support 24 hours a day, 7 days a week.

D. The Contractor shall provide onsite emergency repair within 8 hours of the time of notification of instrument malfunction. The Contractor is responsible for all tools, parts, travel/lodging and labor that are necessary to bring the instrument back online within 24 hours of the time of notification of the malfunction.

E. Scheduled routine services shall be performed between 0730-1630 Monday-Friday, excluding federal holidays.

F. Emergency services, to include onsite emergency repair, shall be performed twenty-four (24) hours a day, seven (7) days a week, to include Contractor and federal holidays.

G. The Contractor shall be responsible for the collection and transportation of equipment upon termination of the agreement.

H. The Contractor shall provide all reagents, calibrators, controls and any other materials necessary to troubleshoot the reasons for instrument failure at no additional cost to the Government.

I. The Contractor shall replace all reagents, calibrators, controls, and any other materials used by the Government in the process of troubleshooting instrument failure prior to the time of notification of the malfunction to the Contractor.

J. The Contractor shall furnish a malfunction incident report to the Government upon completion of each service call. The report shall include, at a minimum, date and time notified, date and time of arrival, serial number, type and model number of instrument, time spent for repair, description of malfunction and repair, and proof of repair that includes documentation of a sample run of quality control verifying acceptable performance.

K. When required, the Contractor shall comply with the Occupational Safety and Health Administration lockout and tag-out procedures while performing maintenance on electrical equipment.

L. The Contractor shall provide all material to verify analytical measurement range (AMR).

VI. REAGENT, CONTROL, CONSUMABLE, SUPPLY-CONTINUITY AND COMPATIBILITY REQUIREMENTS:

A. The Contractor shall provide a continuously stocked inventory of reagents, standards, controls, supplies, disposables, and any other materials required to properly perform tests on the instrumentation such that instrument operations are not interrupted. The contractor shall fulfill inventory orders in a timely manner with the items to be delivered no later than 2 weeks from the ordered date. If items are on backorder the contractor should notify the government supply chain to avoid a delay in operations. These items shall be of the highest quality, sensitivity, specificity, and tested to assure precision and accuracy per CAP guidelines. Expiration date(s) must be clearly marked on reagent, 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 Government.

The minimum shelf life of the reagents will be twelve (12) months after the date of delivery, when commercially available. When the manufacturer does not offer 12 months of remaining shelf life for a particular item, the Contractor shall identify the item and remaining shelf life before shipment and obtain Government acceptance before delivery.

B. All reagent kits must be approved for use as IVD.

C. Upon request or when a mandatory reagent changeover is required by the Contractor, a technical specialist and sufficient reagents shall be provided by the Contractor for in-house validation of new reagents that are added to the instrument during the term of this agreement.

D. Following the validation performed in Section III, Par B of this PWS each reagent shall exhibit at agreement with test reagents currently in use, or with outside laboratory where applicable, as in the case of a new test introduced on the instrument.

E. The Contractor shall provide manufacturer documentation, labeling, instructions for use, regulatory-status information, technical support, training, maintenance records, and other information reasonably necessary for the Government laboratory to operate, validate, maintain, and document use of the offered system and associated reagents in accordance with applicable requirements. The Contractor shall promptly notify the Government of applicable product recalls, field safety notices, technical advisories, software updates, or manufacturer-directed changes affecting the offered system, reagents, controls, or consumables. The Government retains responsibility for laboratory operations, clinical validation approval, quality management, accreditation, and regulatory compliance..

F. All reagents, and hardware must come from the specific manufacturer that produces the instrument. The reagents will be instrument specific and not outsourced by other companies.

VII. UPGRADE OF EQUIPMENT:

A. The instrumentation shall be new, or manufacturer-refurbished, at the time of installation

B. Instrumentation may be upgraded within the specifications of the agreement as new technology may become available with prior written Government approval and bilateral BPA modification for any change affecting scope, configuration, price, performance, or menu.

C. The Government may add reagents during the BPA ordering period as a result of advances in technology or changes to clinical practice standards. Any such change to the reagents shall be with prior written Government approval and bilateral BPA modification

VIII. CONTRACTOR PERSONNEL:

A. The Contractor shall not employ persons for work on this BPA or authorized calls if such employee is identified to the Contractor by the Contracting Officer as a potential threat to the health, safety, security, general well- being or operational mission of the installations and their population.

B. Contractor employees shall present a neat appearance. Contractor personnel shall either wear a distinguishable uniform or badge on the exterior of their clothing while performing any service at any Government facility.

C. The Contractor shall not employ any person who is an employee of the Department of Defense, either military or civilian, unless such person seeks and receives approval according to DOD 5500.7R, “Joint Ethics Regulation”.

IX. CONSERVATION OF UTILITIES:

A. Lights shall be used only in areas where work is actually being performed.

B. Employees shall not adjust mechanical equipment controls for heating, ventilation, and air conditioning systems.

C. Environmental and Hazardous Materials Handling. If the disposal of any waste or byproduct of the instrument cannot be safely dumped into the facility’s drain system, the Contractor must provide guidelines for safely disposing these wastes or byproducts in accordance with local and national guidelines.