Sebia SOW DRAFT 10MAY22.docx

STATEMENT OF WORK FOR CORE LABORATORY HEMOGLOBIN ELECTROPHORESIS REAGENTS

1. SCOPE OF WORK.

a) The Contractor shall provide Hemoglobin Electrophoresis reagents for government owned Sebia Octa capillary zone electrophoresis analyzers at Madigan Army Medical Center, Joint Base Lewis McChord, Washington.

b) The Contractor shall provide reagents, calibrators, quality control, consumables, maintenance and repairs services, support, and Original Equipment Manufacturer (OEM) parts/OEM approved parts as required in order to maintain the systems in optimal operating conditions.

c) The list of reagents, calibrators, quality control, and consumables is not an all-inclusive list. The list of reagents, calibrators, quality control, consumables could grow based on equipment upgrades, software upgrades, and firmware upgrades and other technical advancements/refinements to the equipment, reagents, calibrators, quality control, and consumables.

d) The Contractor shall perform to the standards of this Product Work Statement (PWS).

2. GOVERNMENT-FURNISHED FACILITIES, EQUIPMENT, MATERIAL AND SERVICES. None.

3. SPECIFIC TASKS

3.1 DESCRIPTION. This is a follow-on contract request for Hemoglobin Electrophoresis reagents including reagents, calibrators, quality control, consumables, maintenance, service, repairs, support, and parts as required in order to maintain the system in optimal operating condition.

3.1.1 The Contractor shall provide the reagents and shall coordinate exact quantities and shipment schedule with COR prior to shipment.

3.1.2 All assays must be FDA approved.

3.1.3 The Contractor shall be responsible for the decontamination, collection, and transportation of equipment upon termination of the contract.

3.2 REAGENT MATERIALS

3.2.1 The workload listed in Appendix 1 (not all inclusive) is an estimate based on projected patient workload. Actual workload may vary. The workload numbers represent patient reportable results, and do not include calibrators, controls, or re-runs due to troubleshooting.

3.2.1.1 Reagents must have a shelf life not less than six (6) months upon receipt at the Receiving activity (consignee), or as stated within the individual line item (i.e.

delivery ticket, invoice).

3.2.1.2 Controls will have a shelf life of not less than six (6) months.

3.2.1.3 An alternate quality control material must be provided by the Contractor if the new lot of controls cannot be delivered two (2) weeks prior to the expiration date of the lot currently in use.

3.2.1.4 Delivered on time, at the appropriate storage temperature, and marked with any required temperature controls as necessary.

3.2.1.5 Routine or scheduled orders will arrive within one (1) week before or after the scheduled date of delivery. Emergency orders will be delivered within 24 hours after the order is placed.

3.2.1.6 All reagents provided will be identical to those used in the FDA 510K approval application. If the bulk reagents are produced overseas, they will be manufactured in conformance with ISO or CE standards and must be equal to or better than the U.S.

products in quality/manufacturing. Documentation of item equivalency must be provided.

4. MAINTENANCE AND REPAIR SERVICE

4.1 The Contractor shall be responsible for furnishing maintenance and repairs services, and parts as required in order to maintain the system, to include peripheral equipment, in optimal operating conditions. Parts will be Original Equipment Manufacturer (OEM) parts/OEM approved parts.

4.2 Upon notification of equipment failure, the Contractor shall establish telephonic contact within 60 minutes of the Government notification to the Contractor’s Customer Service “Hotline’ and shall be on site to provide unlimited emergency services within four (4) hours of establishing telephonic contact.

4.3 The Contractor shall provide all reagents, calibrators, controls, and any other materials necessary to troubleshoot the reason for the equipment (analyzer[s]) failure at no additional cost.

4.4 Within one working day after completion of repair, the Contractor shall furnish a report for all services performed. The service report shall contain, at a minimum, the following:

4.4.1 Nomenclature and serial number

4.4.2 Date

4.4.3 Description of services performed

4.4.4 Location of services performed

4.4.5 Name of technician

4.5 The Contractor shall provide direct customer service and support 24 hours/7 days a week, to include hotline telephone service and on call emergency repair service and support.

4.6 During any period when both analyzers are inoperable, the Contractor shall pay all costs associated with the provision of alternative testing, including those for delivery of hardcopy patient results by express courier, directly to the laboratory, for as long as both analyzers remain inoperable.

5. TRAINING

5.1 The Contractor will provide initial onsite training to all technicians assigned to the Government site prior to initiation of use of the analyzer for patient testing.

5.2 The Contractor shall provide additional on-site training per year at no additional cost to the Government.

6. INFORMATION MANAGEMENT

6.1 The analyzers must be capable of interfacing with the DIIM. The Contractor must have an established driver compatible for interfacing the analyzer with DIIM.

6.2 The analyzer shall have a large capacity to store calibrators, graphics, results, cumulative patient reports and quality control files with statistics (all available to the user).

6.3 All software must be the most up to date version of the software (i.e. Windows 10) that has the most current security upgrades and security patches.

7. DEFENSE HEALTH AGENCY AUTHORITY TO OPERATE

7.1 The Contractor shall provide an up to date operating system that includes all software patches and updates for all programs installed on the operating system. The operating system and all programs on the operating system must stay up to date with all software patches and updates throughout the lifecycle.

7.2 The Contractor shall include all costs to achieve the initial Authority to Operate (ATO) and maintain it during the lifecycle.

7.3 The Contractor shall pass pre-validation technical screening (vulnerability scans utilizing NESSUS, Security Content Automation Protocol (SCAP) scans, and Security Technical Implementation Guides (STIGs) checklists) within six (6) months of contract award.

8. ANTITERRORISM/OPERATIONS SECURITY

8.1 AT Level I Training. All contractor employees, including subcontractor employees, requiring access to Army installations, facilities, and controlled-access areas shall complete AT Level I awareness training within 30 calendar days after the contract start date or effective date of incorporation of this requirement into the contract, whichever is applicable. The Contractor shall submit certificates of completion for each affected contractor employee and subcontractor employee, to the COR or to the contracting officer, if a COR is not assigned, within 30 calendar days after completion of training by all employees and subcontractor personnel. AT Level I awareness training is available at the following website: http://jko.jten.mil.

8.2 Access and general protection/security policy and procedures. Contractor and all associated sub-contractors employees shall provide all information required for background checks to meet installation access requirements to be accomplished by installation Provost Marshal Office, Director of Emergency Services or Security Office. Contractor workforce must comply with all personal identity verification requirements (FAR clause 52.204-9, Personal Identity Verification of Contractor Personnel) as directed by DOD, HQDA and/or local policy. In addition to the changes otherwise authorized by the changes clause of this contract, should the Force Protection Condition (FPCON) at any individual facility or installation change, the Government may require changes in contractor security matters or processes.

8.3 For contractors requiring Common Access Card (CAC). Before CAC issuance, the contractor employee requires, at a minimum, a favorably adjudicated National Agency Check with Inquiries (NACI) or an equivalent or higher investigation in accordance with Army Directive 2014-05. The contractor employee will be issued a CAC only if duties involve one of the following: (1) Both physical access to a DoD facility and access, via logon, to DoD networks on-site or remotely; (2) Remote access, via logon, to a DoD network using DoD-approved remote access procedures; or (3) Physical access to multiple DoD facilities or multiple non-DoD federally controlled facilities on behalf of the DoD on a recurring basis for a period of 6 months or more. At the discretion of the sponsoring activity, an initial CAC may be issued based on a favorable review of the FBI fingerprint check and a successfully scheduled NACI at the Office of Personnel Management.

8.4 For contractors that do not require CAC, but require access to a DoD facility or installation. Contractor and all associated sub-contractors employees shall comply with adjudication standards and procedures using the National Crime Information Center Interstate Identification Index (NCIC-III) and Terrorist Screening Database (TSDB) (Army Directive 2014-05/AR 190-13), applicable installation, facility and area commander installation/facility access and local security policies and procedures (provided by government representative), or, at OCONUS locations, in accordance with status of forces agreements and other theater regulations.

8.5 iWATCH Training. The Contractor and all associated sub-contractors shall brief all employees on the local iWATCH program (training standards provided by the requiring activity ATO). This local developed training will be used to inform employees of the types of behavior to watch for and instruct employees to report suspicious activity to the COR. This training shall be completed within 30 calendar days of contract award and within 30 calendar days of new employees commencing performance with the results reported to the COR NLT 30 calendar days after contract award.

8.6 For contracts that require OPSEC Training. Per AR 530-1 Operations Security, the contractor employees must complete Level I OPSEC Awareness training. New employees must be trained within 30 calendar days of their reporting for duty and annually thereafter.

Appendix 1 Workload Projections (Does not include Calibrators, Quality Control, Linearity)

The workload list is not all-inclusive and workload could grow based on equipment upgrades, software upgrades, and firmware upgrades and other technical advancements/refinements to the analyzers, reagents, calibrators, quality control, and consumables.

Appendix 2

Reagents, calibrators, quality control, and consumables

The reagents, calibrators, quality control, and consumables list is not all-inclusive and the list could grow based on equipment upgrades, software upgrades, and firmware upgrades and other technical advancements/refinements to the analyzers.

APPENDIX 3 - Relevant CLSI Standards

Laboratory Automation: Specimen Container/Specimen Carrier; Approved Standard (AUTO01-A) Laboratory Automation: Bar Codes for Specimen Container Identification; Approved Standard (AUTO02-A2) Laboratory Automation: Communications With Automated Clinical Laboratory Systems, Instruments, Devices, and Information Systems; Approved Standard—Second Edition (AUTO03-A2) Laboratory Automation: Systems Operational Requirements, Characteristics, and Information Elements; Approved Standard (AUTO04-A) Laboratory Automation: Data Content for Specimen Identification; Approved Standard (AUTO07-A) Remote Access to Clinical Laboratory Diagnostic Devices via the Internet; Approved Standard (AUTO09-A) Autoverification of Clinical Laboratory Test Results; Approved Guideline (AUTO10-A) IT Security of In Vitro Diagnostic Instruments and Software Systems; Approved Standard (AUTO11-A) Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline— Third Edition (C28-A3) Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline-Second Edition (EP05-A2) Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach; Approved Guideline (EP06-A) Interference Testing in Clinical Chemistry; Approved Guideline—Second Edition (EP07-A2) Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline—Second Edition (EP09-A2) Preliminary Evaluation of Quantitative Clinical Laboratory Measurement Procedures; Approved Guideline-Third Edition (EP10-A3) Laboratory Statistics — Standard Deviation; A Report (EP13-R) Evaluation of Matrix Effects; Approved Guideline—Second Edition (EP14-A2) User Verification of Performance for Precision and Trueness; Approved Guideline-Second Edition (EP15-A2) Protocols for Determination of Limits of Detection and Limits of Quantitation; Approved Guideline (EP17-A) Risk Management Techniques to Identify and Control Laboratory Error Sources; Approved Guideline—Second Edition (EP18-A2) Estimation of Total Analytical Error for Clinical Laboratory Methods; Approved Guideline (EP21-A) Determination of Serum Iron, Total Iron-Binding Capacity and Percent Transferrin Saturation; Approved Standard (H17-A) Specification for Low-Level Protocol to Transfer Messages Between Clinical Laboratory Instruments and Computer Systems; Approved Standard—Second Edition (LIS01-A2) Specification for Transferring Information Between Clinical Laboratory Instruments and Information Systems; Approved Standard—Second Edition (LIS02-A2) Standard Guide for Selection of a Clinical Laboratory Information Management System (LIS03-A) Standard Practice for Reporting Reliability of Clinical Laboratory Information Systems (LIS06-A) Standard Specification for Use of Bar Codes on Specimen Tube in the Clinical Laboratory (LIS07-A) Standard Guide for Functional Requirements of Clinical Laboratory Information Management Systems (LIS08-A) Standard Guide for Coordination of Clinical Laboratory Services within the Electronic Health Record Environment and Networked Architecture (LIS09-A)