Hematology_and_Coagulation_Laboratory_Analyzers_PWS.doc

PERFORMANCE WORK STATEMENT (PWS)

Hematology & Coagulation Laboratory Analyzers NOTE TO OUR CUSTOMERS: THIS TEMPLATE MUST BE TAILORED FOR YOUR AGENCY BY INCLUDING YOUR UNIQUE REQUIREMENTS, QUANTITIES FOR WORKLOAD, SPECIFIC SURVEILLANCE TECHNIQUES, ETC. ANY QUESTIONS REGARDING THIS TEMPLATE SHOULD BE ADDRESSED WITH YOUR ASSIGNED ACQUISITION TEAM.

GENERAL INFORMATION IS PRESENTED IN BLUE ITALICS WITH PARENTHESIS BORDERS, WHILE FILL-IN GUIDANCE IS PRESENTED IN BLUE ITALICS WITH BRACKET BORDERS. PLEASE DELETE ALL BLUE ITALICS WHEN FINALIZING THE PWS.

Part 1 General Information

1. General: This is a non-personnel services contract to provide Hematology & Coagulation Laboratory Analyzers. The Government shall not exercise any supervision or control over the contract service providers performing the services herein. Such contract service providers shall be accountable solely to the Contractor who, in turn is responsible to the Government.

1.1 Description of Services/Introduction: The contractor shall provide all personnel, equipment, supplies, facilities, transportation, tools, materials, supervision, and other items and non-personal services necessary to perform Hematology & Coagulation Laboratory Analyzers as defined in this Performance Work Statement except for those items specified as government furnished property and services. The contractor shall perform to the standards in this contract.

1.2 Background: To fulfill its clinical mission to provide trusted laboratory results to 51st Medical Group (51 MDG) providers, the Laboratory Flight requires two separate fully-automated analyzers; one to perform hematology testing, including complete blood count (CBC), red blood cell indices, and automated 5-part white blood cell differential, and one to perform coagulation testing including PT/INR, aPTT, and D-dimer.

1.3 Objectives:

· The contractor shall provide by lease agreement one hematology analyzer and one coagulation analyzer of the latest technology available (no refurbished or remanufactured equipment allowed), test equipment and associated power ware, and all validation supplies and reagents, each capable of 50 tests per hour at a minimum.

· The contractor shall provide all support needed to include equipment repairs, labor, travel and materials not government furnished, necessary to keep both units operational to manufacturer’s specifications seven (7) days per week.

· The contractor shall provide new user manuals, or updates on user manuals, when changes are made.

· The contractor shall provide scheduled recurring/preventive maintenance inspections (PMIs); calibrations; on-site emergency services; and ensure equipment complies with all regulatory requirements.

· The analyzers shall meet the performance characteristics for accuracy and precision as defined by the College of American Pathologists (CAP), 1988 Clinical Laboratory Improvement Act (CLIA’88) and the Clinical and Laboratory Standards Institute (CLSI).

· Services shall be in accordance with (IAW) the requirements contained in this Performance Work Statement (PWS) and accreditation standards of CAP, Food and Drug Administration (FDA), The Joint Commission (TJC), the Health Services Inspections (HSI) as well as the current United States Air Force (USAF) Referral Management Guidelines.

1.4 Scope: The vendor shall provide laboratory services which cover all aspects of installation and validation of a hematology analyzer and coagulation analyzer capable of automated laboratory testing. Services include instrument training and support, repair and maintenance, delivery of reagents and supplies, and upgrade of equipment if applicable. The contractor shall accomplish initial validation of each instrument to include simple precision, accuracy, method comparison to in-house analyzers currently in use, instrument correlation to in-house analyzers currently in use, reference range studies, and training of at least two laboratory operators.

1.5 Period of Performance: The period of performance shall be for one (1) Base Year of 12 months and four (4) 12-month option years. The Period of Performance reads as follows:

Base Year

Option Year I

Option Year II

Option Year III

Option Year IV

1.6 General Information

1.6.1 Quality Control: not applicable

1.6.2 Quality Assurance: The government shall evaluate the contractor’s performance under this contract in accordance with the Quality Assurance Surveillance Plan. This plan is primarily focused on what the Government must do to ensure that the contractor has performed in accordance with the performance standards. It defines how the performance standards will be applied, the frequency of surveillance, and the minimum acceptable defect rate(s).

1.6.3 Recognized Holidays: The contractor is not required to perform services on the below holidays and recognized Korean holidays:

New Year’s Day

Labor Day

Martin Luther King Jr.’s Birthday

Columbus Day

President’s Day

Veteran’s Day

Memorial Day

Thanksgiving Day

Independence Day

Christmas Day

1.6.4 Hours of Operation: The contractor is responsible for conducting business, between the hours of 07:00 a.m. and 5:00 p.m. Monday thru Friday except Federal holidays or when the Government facility is closed due to local or national emergencies, administrative closings, or similar Government directed facility closings. For other than firm fixed price contracts, the contractor will not be reimbursed when the government facility is closed for the above reasons. The Contractor must at all times maintain an adequate workforce for the uninterrupted performance of all tasks defined within this PWS when the Government facility is not closed for the above reasons. When hiring personnel, the Contractor shall keep in mind that the stability and continuity of the workforce are essential.

1.6.5 Place of Performance: The work to be performed under this contract will be performed at the 51st Medical Group, Bldg. 777, Osan Air Base, Republic of Korea. This is a U.S. military facility with restricted access, and therefore vendors working under contract will need to be able to pass a background check and security clearance for temporary base pass.

1.6.6 Type of Contract: The government will award a (Type of contract to be determined by CCE and the customer).

1.6.7 Security Requirements: Contractor personnel performing work under this contract must be able to pass a background check at time of the proposal submission, and must maintain the level of security required for the life of the contract. The security requirements are in accordance with the attached DD254

1.6.7.1 PHYSICAL Security: The contractor shall be responsible for safeguarding all government equipment, information and property provided for contractor use. At the close of each work period, government facilities, equipment, and materials shall be secured.

1.6.7.2 Key Control: not applicable

1.6.7.2.1. In the event keys, other than master keys, are lost or duplicated, the Contractor shall, upon direction of the Contracting Officer, re-key or replace the affected lock or locks; however, the Government, at its option, may replace the affected lock or locks or perform re-keying. When the replacement of locks or re-keying is performed by the Government, the total cost of re-keying or the replacement of the lock or locks shall be deducted from the monthly payment due the Contractor. In the event a master key is lost or duplicated, all locks and keys for that system shall be replaced by the Government and the total cost deducted from the monthly payment due the Contractor.

1.6.7.2.2. The Contractor shall prohibit the use of Government issued keys/key cards by any persons other than the Contractor’s employees. The Contractor shall prohibit the opening of locked areas by Contractor employees to permit entrance of persons other than Contractor employees engaged in the performance of assigned work in those areas, or personnel authorized entrance by the Contracting Officer.

1.6.7.3 Lock Combinations: not applicable

1.6.8 Special Qualifications: Qualifications should be appropriate to manufacturer guidelines for instrument servicing

1.6.9 Post Award Conference/Periodic Progress Meetings: The Contractor agrees to attend any post award conference convened by the contracting activity or contract administration office in accordance with Federal Acquisition Regulation Subpart 42.5. The contracting officer, Contracting Officers Representative (COR), and other Government personnel, as appropriate, may meet periodically with the contractor to review the contractor's performance. At these meetings the contracting officer will apprise the contractor of how the government views the contractor's performance and the contractor will apprise the Government of problems, if any, being experienced. Appropriate action shall be taken to resolve outstanding issues. These meetings shall be at no additional cost to the government.

1.6.10 Contracting Officer Representative (COR): The (COR) will be identified by separate letter. The COR monitors all technical aspects of the contract and assists in contract administration The COR is authorized to perform the following functions: assure that the Contractor performs the technical requirements of the contract: perform inspections necessary in connection with contract performance: maintain written and oral communications with the Contractor concerning technical aspects of the contract: issue written interpretations of technical requirements, including Government drawings, designs, specifications: monitor Contractor's performance and notifies both the Contracting Officer and Contractor of any deficiencies; coordinate availability of government furnished property, and provide site entry of Contractor personnel. A letter of designation issued to the COR, a copy of which is sent to the Contractor, states the responsibilities and limitations of the COR, especially with regard to changes in cost or price, estimates or changes in delivery dates. The COR is not authorized to change any of the terms and conditions of the resulting order.

1.6.11 Key Personnel: The follow personnel are considered key personnel by the government: Contract Manager/Alternate Contract Manager. The contractor shall provide a contract manager who shall be responsible for the performance of the work. The name of this person and an alternate who shall act for the contractor when the manager is absent shall be designated in writing to the contracting officer. The contract manager or alternate shall have full authority to act for the contractor on all contract matters relating to daily operation of this contract. The contract manager or alternate shall be available between 8:00 a.m. to 4:30p.m., Monday thru Friday except Federal holidays or when the government facility is closed for administrative reasons.

1.6.12 Identification of Contractor Employees: All contract personnel attending meetings, answering Government telephones, and working in other situations where their contractor status is not obvious to third parties are required to identify themselves as such to avoid creating an impression in the minds of members of the public that they are Government officials. They must also ensure that all documents or reports produced by contractors are suitably marked as contractor products or that contractor participation is appropriately disclosed.

1.6.13 Contractor Travel: not applicable

1.6.14 Other Direct Costs: not applicable

1.6.15 Data Rights: The Government has unlimited rights to all documents/material produced under this contract. All documents and materials, to include the source codes of any software, produced under this contract shall be Government owned and are the property of the Government with all rights and privileges of ownership/copyright belonging exclusively to the Government. These documents and materials may not be used or sold by the contractor without written permission from the Contracting Officer. All materials supplied to the Government shall be the sole property of the Government and may not be used for any other purpose. This right does not abrogate any other Government rights.

1.6.16 Organizational Conflict of Interest: Contractor and subcontractor personnel performing work under this contract may receive, have access to or participate in the development of proprietary or source selection information (e.g., cost or pricing information, budget information or analyses, specifications or work statements, etc.) or perform evaluation services which may create a current or subsequent Organizational Conflict of Interests (OCI) as defined in FAR Subpart 9.5. The Contractor shall notify the Contracting Officer immediately whenever it becomes aware that such access or participation may result in any actual or potential OCI and shall promptly submit a plan to the Contracting Officer to avoid or mitigate any such OCI. The Contractor’s mitigation plan will be determined to be acceptable solely at the discretion of the Contracting Officer and in the event the Contracting Officer unilaterally determines that any such OCI cannot be satisfactorily avoided or mitigated, the Contracting Officer may effect other remedies as he or she deems necessary, including prohibiting the Contractor from participation in subsequent contracted requirements which may be affected by the OCI.

1.6.17 PHASE IN /PHASE OUT PERIOD: not applicable

PART 2

DEFINITIONS & ACRONYMS

2. Definitions and Acronyms:

2.1. DEFINITIONS:

2.1.1. CONTRACTOR. A supplier or vendor awarded a contract to provide specific supplies or service to the government. The term used in this contract refers to the prime.

2.1.2. CONTRACTING OFFICER. A person with authority to enter into, administer, and or terminate contracts, and make related determinations and findings on behalf of the government. Note: The only individual who can legally bind the government.

2.1.3. CONTRACTING OFFICER'S REPRESENTATIVE (COR). An employee of the U.S. Government appointed by the contracting officer to administer the contract. Such appointment shall be in writing and shall state the scope of authority and limitations. This individual has authority to provide technical direction to the Contractor as long as that direction is within the scope of the contract, does not constitute a change, and has no funding implications. This individual does NOT have authority to change the terms and conditions of the contract.

2.1.4. DEFECTIVE SERVICE. A service output that does not meet the standard of performance associated with the Performance Work Statement.

2.1.5. DELIVERABLE. Anything that can be physically delivered, but may include non-manufactured things such as meeting minutes or reports.

2.1.6. KEY PERSONNEL. Contractor personnel that are evaluated in a source selection process and that may be required to be used in the performance of a contract by the Key Personnel listed in the PWS. When key personnel are used as an evaluation factor in best value procurement, an offer can be rejected if it does not have a firm commitment from the persons that are listed in the proposal.

2.1.7. PHYSICAL SECURITY. Actions that prevent the loss or damage of Government property.

2.1.8. QUALITY ASSURANCE. The government procedures to verify that services being performed by the Contractor are performed according to acceptable standards.

2.1.9. QUALITY ASSURANCE Surveillance Plan (QASP). An organized written document specifying the surveillance methodology to be used for surveillance of contractor performance.

2.1.10. QUALITY CONTROL. All necessary measures taken by the Contractor to assure that the quality of an end product or service shall meet contract requirements.

2.1.11. SUBCONTRACTOR. One that enters into a contract with a prime contractor. The Government does not have privity of contract with the subcontractor.

2.1.12. WORK DAY. The number of hours per day the Contractor provides services in accordance with the contract.

2.1.12. WORK WEEK. Monday through Friday, unless specified otherwise.

2.2. ACRONYMS:

ACOR

Alternate Contracting Officer's Representative

AFARS

Army Federal Acquisition Regulation Supplement aPTT

Activated Partial Thromboplastin Time

AR

Army Regulation

CCE

Contracting Center of Excellence

CFR

Code of Federal Regulations

CONUS

Continental United States (excludes Alaska and Hawaii)

COR

Contracting Officer Representative

COTR

Contracting Officer's Technical Representative

COTS

Commercial-Off-the-Shelf

DA

Department of the Army

DD250

Department of Defense Form 250 (Receiving Report)

DD254

Department of Defense Contract Security Requirement List

DFARS

Defense Federal Acquisition Regulation Supplement

DMDC

Defense Manpower Data Center

DOD

Department of Defense

FAR

Federal Acquisition Regulation

HIPAA

Health Insurance Portability and Accountability Act of 1996

INR

International Normalized Ratio

KO

Contracting Officer

OCI

Organizational Conflict of Interest

OCONUS

Outside Continental United States (includes Alaska and Hawaii)

ODC

Other Direct Costs

PIPO

Phase In/Phase Out

POC

Point of Contact

PRS

Performance Requirements Summary

PT

Prothrombin Time

PWS

Performance Work Statement

QA

Quality Assurance

QAP

Quality Assurance Program

QASP

Quality Assurance Surveillance Plan

QC

Quality Control

QCP

Quality Control Program

TE

Technical Exhibit

PART 3

GOVERNMENT FURNISHED PROPERTY, EQUIPMENT, AND SERVICES

3. GOVERNMENT FURNISHED ITEMS AND SERVICES:

3.1. Services: The Government will provide laboratory personnel to assist with initial analyzer set up, scheduling of periodic maintenance, and over-the-phone troubleshooting when needed.

3.2 Facilities: The Government will provide desk space if needed for contractor to utilize during work in the facility

3.3 Utilities: The Government will provide needed utilities, including water and electricity. The Contractor shall instruct employees in utilities conservation practices. The contractor shall be responsible for operating under conditions that preclude the waste of utilities, which include turning off the water faucets or valves after using the required amount to accomplish cleaning vehicles and equipment.

PART 4

CONTRACTOR FURNISHED ITEMS AND SERVICES

4. CONTRACTOR FURNISHED ITEMS AND RESPONSIBILITIES:

4.1 General: The Contractor shall furnish all supplies, equipment, facilities and services required to perform work under this contract that are not listed under Section 3 of this PWS.

4.2. Materials. The Contractor shall furnish materials, supplies, and equipment necessary to meet the requirements under this PWS.

4.4. Equipment. The Contractor shall furnish the equipment determined to best meet the needs of the specific tasks listed in this PWS which can be performed by one automated laboratory hematology analyzer and one automated laboratory coagulation analyzer.

PART 5

SPECIFIC TASKS

5. Specific Tasks:

5.1. General Tasks

5.1.1. The desired instrumentation shall have the capability to automatically repeat or reflex samples, without manual intervention, by use of user defined decision rules and without the need for additional hardware or middleware.

5.1.2. 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 Laboratory Standards Institute (CLSI).

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

5.1.3.1. Complete Blood Count (CBC) with indices

5.1.3.2. 5-Part White Blood Cell (WBC) Differential

5.1.3.3. WBC Count

5.1.3.4. Platelet Count

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

5.1.4.1. PT/INR

5.1.4.2. aPTT

5.1.4.3. D-dimer

5.1.5. The desired instrumentation, without the use of additional middleware, shall indicate to the user when quality control (QC) values exceed the acceptable range set by the user, and must block the user from performing patient testing until such a time where QC is performed and values are within range.

5.1.6. The desired instrumentation, without the use of additional middleware, shall indicate to the user when QC has expired (it has been more than eight (8) hours since the last acceptable QC) and must block the user from performing patient testing until such a time where QC is performed and values are within range.

5.1.7. The desired instrumentation shall have a bidirectional computer interface that is compatible with Composite Health Care System (CHCS).

5.1.8. The desired instrumentation shall have one single aspiration pathway, regardless of presentation mode, from point of aspiration to result.

5.1.9. The desired hematology instrumentation shall have FDA Clearance on the Body Fluid matrices listed below for red and white blood cell counts:

5.1.9.1. Serous (including pleural, peritoneal and pericardial)

5.1.9.2. Synovial (pretreated with hyaluronidase)

5.1.9.3. Cerebral Spinal Fluid (CSF)

5.1.10. The desired hematology instrumentation shall have the capability to auto correct WBC counts in the presence of interfering substances.

5.1.11. The desired hematology instrumentation shall have the ability to auto-correct red blood cell (RBC) counts, hemoglobin (HGB), hematocrit (HCT), mean corpuscular hemoglobin (MCH), and mean corpuscular hemoglobin concentration (MCHC) in patients with high WBC counts.

5.1.12. The desired instrumentation shall use a 2D compatible digital barcode reader to provide a positive identification for all specimen tube labels. Specimen barcodes shall be read a minimum of two times prior to analyzer aspiration.

5.1.13. The desired instrumentation shall have the capability to run automated closed tube and manual open tube samples.

5.1.14. The desired instrumentation shall have high sensitivity blood detectors around the blood sampling valve and aspiration probe to recognize abnormal flow or electrical signals that a clot could cause.

5.1.15. The desired coagulation instrumentation shall have state of the art technology featuring 671 nm LED-based clot detection, minimizing interference from lipemia, hemoglobin, and bilirubin.

5.1.16. The desired coagulation instrumentation shall have a quantitative D-Dimer assay with FDA exclusion of Deep Venous Thrombosis (DVT) and Pulmonary Embolism (PE).

5.1.17. The desired coagulation instrumentation shall utilize a universal calibrator of Unfractionated (UF) and Low Molecular Weight (LMW) Heparins for one calibration curve.

5.1.18. The desired instrumentation shall have extended on-board decision rules which are capable of using the following information:

5.1.18.1. Test Result

5.1.18.2. Test Panels

5.1.18.3. Test Flags and Codes

5.1.18.4. Delta Check State

5.1.18.5. Suspect Messages

5.1.18.6. Definitive Messages

5.1.18.7. Exceptions

5.1.18.8. Patient ID

5.1.18.9. Age

5.1.18.10. Gender

5.1.18.11. Ethnicity

5.1.18.12. Specimen Age

5.1.18.13. Physician

5.1.18.14. Location

5.1.18.15. Diagnosis

5.1.18.16. Priority

5.1.18.17. Specimen ID

5.1.19. The desired instrumentation shall display surface plots on a computer monitor designated for the instrument to view platelet population, WBC differential populations and RBC population.

5.1.20. The desired instrumentation shall directly measure each leukocyte population (vs. calculated parameters).

5.1.21. The desired instrumentation shall have the ability for the user to set the levels and sensitivities of a variety of flags and messages.

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

5.2. Instrument Training and Support:

5.2.1. The Contractor shall provide instrument transportation, delivery, and installation, to include calibration and test and system validation support, within 90 calendar days after contract award.

5.2.2. The Contractor shall perform, at a minimum, the following initial instrument validation studies for each analyte listed in Section 5.13 and 5.14 of this PWS:

5.2.2.1. Simple Precision

5.2.2.2. Accuracy

5.2.2.3. Method Comparison

5.2.2.4. Instrument Correlation

5.2.2.5. Reference Range

5.2.2.6. Reportable Range

5.2.3. The Contractor shall provide initial on-site operator training to no less than two (2) instrument operators all that is required for patient resulting and interpreting prior to initiation and use of the instrument.

5.2.4. 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.

5.3. Instrument Repair and Maintenance

5.3.1. The Contractor shall provide onsite maintenance (monthly, quarterly, annually, etc.) in accordance with manufactures guidelines, to include preventive maintenance.

5.3.2. The Contractor shall conduct periodic maintenance on the hematology analyzer every 6 months at a minimum, to include carryover tests, precision verification, calibration or calibration verification, and mode-to-mode comparability between instrument open and closed mode sampling.

5.3.3. The Contractor shall conduct periodic maintenance on the coagulation analyzer every 6 months at a minimum, to include carryover tests, precision verification, calibration or calibration verification, and INR verification is requested by the Government.

5.3.4. The Contractor shall provide all required tools, parts and labor as necessary to keep the instrument operational.

5.3.5. The Contractor shall provide over the phone, instrument technical support during all duty hours (24 hours a day, 7 days a week).

5.3.6. In the event of an instrument failure, the Contractor shall provide onsite emergency repair service within twenty-four (24) hours of the time of notification of the malfunction. The Contractor is responsible for all tools, parts, travel/lodging and labor that are necessary to bring the instrumentation back online.

5.3.7. 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 at the instrument back online within 24 hours of the time of notification of the malfunction.

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

5.3.9. 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.

5.3.10. 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.

5.3.11. 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.

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

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

5.4. Minimum Reagent Requirements

5.4.1. 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. These items shall be of the highest quality, sensitivity, specificity, and tested to assure precision and accuracy. 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.

5.4.2. The minimum shelf life of the reagents will be three (3) months after the date of delivery.

5.4.3. The Contractor shall be able to deliver one year’s worth of the same lot number of PT/INR and aPTT reagent at a minimum for Government usage at the time of reagent order.

5.4.4. All reagent kits must be FDA approved and will exhibit at least 95% sensitivity and 95% specificity.

5.4.5. 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.

5.4.6. Following the validation performed in 5.2.2 of this PWS each reagent shall exhibit at least 95% 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.

5.4.7. The vendor shall comply with all FDA regulations and the current edition of the College of American Pathologist (CAP) checklist.

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

5.5. Upgrade of Equipment

5.5.1. The instrumentation shall be new, not refurbished or reused, at the time of installation

5.5.2. Subject to mutual agreement between the Government and the Contractor, instrumentation may be upgraded within the specifications of the agreement as new technology may become available.

5.5.3. Additionally, the Government will add reagents through the life of this agreement as a result of advances in technology or changes to clinical practice standards. Any such change to the reagents shall be mutually agreed upon by the Contractor and the Government through a bilateral modification of the agreement.

PART 6

APPLICABLE PUBLICATIONS

6. Applicable Publications (Current Editions)

6.1. The Contractor must abide by all applicable Air Force Instructions, publications, manuals, and local policies and procedures applicable to maintaining the two analyzers leased under this agreement.

PART 7

ATTACHMENT/TECHNICAL EXHIBIT LISTING

7. Attachment/Technical Exhibit List:

7.1. Attachment 1/Technical Exhibit 1 – Performance Requirements Summary

7.2. Attachment 2/Technical Exhibit 2 – Deliverables Schedule

7.3 Attachment 3/Technical Exhibit 3 – Estimated Workload Data

TECHNICAL EXHIBIT 1

Performance Requirements Summary The contractor service requirements are summarized into performance objectives that relate directly to mission essential items. The performance threshold briefly describes the minimum acceptable levels of service required for each requirement. These thresholds are critical to mission success.

Performance Objective

(The Service required—usually a shall statement)

Method of Surveillance

PRS # 1.

Instrument Configuration and Testing PWS section 5.1 The contractor provided one hematology analyzer and one coagulation analyzer which meets all configuration specifics detailed in this PWS

PRS # 2

CLIA Compliance

PWS par. 5.1.2

PRS # 3

Quality Control Notification PWS par. 5.1.5, 5.1.6

PRS # 4

User Interface PWS par. 5.1.7

PRS # 5

FDA Compliance

PWS par. 5.1.2

PRS # 6

Installation

PWS par. 5.2.1

PRS # 7

Initial Training within 7 days

PWS par. 5.2.3

PRS # 9

Technical Support Over-the-Phone

PWS par. 5.3.5

TECHNICAL EXHIBIT 2

DELIVERABLES SCHEDULE

WILL BE ACCOMPLISHED ONCE QUOTES ARE RECEIVED FROM VENDORS, AND DELIVERABLE SCHEDULE IS SUBMITTED

TECHNICAL EXHIBIT 3

ESTIMATED WORKLOAD DATA

The estimated workload data below does