A.02 SOW - Reagents STD Molecular Testing Cepheid GX-revised 4-7-21.docx

STATEMENT OF WORK (SOW)

STD AND EMERGING PATHOGENS MOLECULAR TESTING

WOMACK ARMY MEDICAL CENTER (WAMC)

FORT BRAGG, NORTH CAROLINA 28310

1. SCOPE OF WORK.

1.1. The Vendor shall provide supplies listed in the provided Exhibits to support a Cepheid GeneXpert platform for the FDA-approved in vitro diagnostic testing of Methicillin-resistant Staphylococcus aureus (MRSA) and Group A and Group B Strep, among other pathogens (listed in 2.1). This testing is for the Department of Pathology, WAMC, Building 4-2817 Reilly Road, Fort Bragg, NC 28310. The period of performance is shown in the Table below.

1.2. The contract pricing must be an all-inclusive price with-in the Cost Per Kit (CPK).

2. REAGENTS.

2.1. Contractor shall provide reagents and calibrators at agreed upon pricing to support FDA-approved in vitro diagnostics molecular testing for group A Streptococcus, group B Streptococcus, Clostridium difficile, Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, Mycoplasma genitalium, Methicillin-resistant Staphylococcus aureus (MRSA), Influenza A, Influenza B, Respiratory syncytial virus (RSV), Sars-CoV-2, and Mycobacterium tuberculosis (MTB). Additionally, the vendor will provide reagents to support molecular testing for SARS-CoV-2 that possess at least an FDA EUA. These products must be manufactured by the Contractor and not by a third party. All assays must be Food & Drug Administration (FDA) approved or be under an Emergency Use Authorization (EUA). All reagents provided will be identical to those used in the FDA 510K approval application. For reagents with hazardous constituents, Contractor must provide a mechanism for the Laboratory to meet local discharge requirements. Unexpected changes in methodology/technology shall be at the expense of the Contractor. Alerts and notifications of all technical advisory/recalls/alerts, prior to or simultaneously with field alerts should be forwarded to the COR, Microbiology Supervisor and Lead Medical Technologist.

2.2. Contractor shall make available any reagents for an emerging pathogen that obtains FDA approval or EUA at government pricing.

2.3. Delivery of the reagents will be on an as needed basis. Individual orders will be placed by the COR or other designated authorized government personnel. Name and point of contact of authorized personnel will be provided to the Contractor.

2.4. Any workload provided is an estimate based on projected annual volume. Orders of required items will be called or emailed to the Contractor. Deliveries shall arrive within five working days after the order is placed. No deliveries shall be accepted on weekends or federal holidays. Emergency orders placed before 2:00 PM Eastern Standard Time (EST) will be delivered within 24 hours after the order is placed.

2.5. All reagents/reagent packs will be provided as follows:

· Be provided by the manufacturer of the equipment.

· Possess at least two months of the expiration date remaining at the time they are received in the laboratory

· Be marked with the required storage temperature.

· Be maintained at the proper storage temperature during transportation from the Contractor’s storage facility to the Government acceptance site and be delivered on time at the appropriate storage temperature.

2.6. Specimen collection kits must be offered by the Contractor for use with their molecular assays. If the specimen collection kits differ from those currently in use, the Contractor will work with the laboratory and field personnel to ensure that an acceptable plan is in place to replace existing specimen collection kits with new specimen collection kits. Specimen collection kits should not require refrigeration for storage.

2.7. In the event that the supplies are found to be defective and unsuitable for use with the Cepheid GeneXpert or the Contractor has failed to comply with the requirements, the Contractor shall replace the supplies within 24 hours of receipt of the order.

2.8. Safety Data Sheets (SDS). For all products the Contractor must provide a mechanism for the laboratory to meet local discharge requirement. The Contractor shall provide one set of paper copy and an electronic copies of SDS of all reagents and consumables to be used on the system.

3. INITIAL SET UP.

3.1. Prior to reporting to the laboratory, the Contractor or Contractor’s representatives shall report to and obtain a visitor badge from the Equipment Maintenance Department of the facility. The badge must be returned to the department prior to departing the facility.

3.2. During the initial implementation of molecular assays, a technical representative must be available on site throughout the entire implementation period, ensuring validations be completed within 30 days of reagent availability. The same technical representative should be available throughout the entire implementation; there must be documentation of information "hand off" between the different Technical Representatives.

3.3. Upon completion of on-site training, Contractor personnel will assist with method validation studies and analytical measurement range/linearity verification within a period of time to ensure that the molecular assays are fully operational as negotiated.

3.4. Method Validation will be conducted in accordance with method validation protocols established by the Clinical Laboratory Standards Institute (CLSI) and/or required by the College of American Pathologists (CAP). Method Validation will include but not be limited to, correlation with current methods (comparison of methods study), validation of analytical measurement range (AMR), validation of precision (replication study) and establishment or verification of quality control ranges. The equipment is owned by Womack Army Medical Center (WAMC). The test assays will take one week to one month to validate. See Exhibit B. These materials will not be used in the analysis of specimens for patient care.

3.5. Contractor shall assist in all validation studies at no cost to the government, to include manpower, linearity material and reagents, calibrators, controls and be consistent with current CLSI Standards and related documents, CAP Standards and Federal Regulations, for the following:

· Correlation studies should include a minimum of 30 samples, spanning the reportable range, shall be run by the present and the new method. Contactor shall analyze numbers and provide statistical data to accept the new method. Statistics shall consist of at least mean, bias, slope, y-intercept, correlation coefficient, and meet current standards defined by CLSI.

· Linearity analysis shall be performed on new contracted instrument for each analyte to determine reportable range using statistical tool in accordance with CLSI.

· Precision study shall be performed utilizing normal an abnormal control material. This should consist of a within run precision study of 10 normal and 10 abnormal controls or patient samples.

· Carryover studies must be performed, as applicable, as part of the initial evaluation of the instrument. Contractor shall provide interpretation of raw data and validate no carryover exists within the testing system.

3.6. The Contractor will provide statistical reports of method validation study and all result print outs, package inserts of materials used for method validation study in an organized fashion to the Microbiology supervisor before using the analyzer systems for patient testing. In addition to the hard copy, the Contractor will provide method validation study results and reports electronically via online, email, or on physical media ( CD, DVD) . The Contractor will provide instrument settings and other configurations on a paper as well as electronically.

4. TRAINING.

The Contractor will provide initial on-site operator training (if needed) to as many as five technicians assigned to the Government. In addition, the Contractor will provide training for two primary operators at the Contractor’s training site at no additional cost to the Government. The Contractor will provide one training slot per contract year, at the Contractor’s training site at no additional cost to the Government. Operator training at the Contractor’s training site shall include all costs of off-site training, i.e., transportation (air and ground), room and board.

5. SPECIAL TASKS.

5.1. The Contractor will provide one paper and one electronic copy of Standard Operating Procedures (SOPs) for each and every methodology included under the Proposal. The SOPs will include all relevant technical information regarding the methodology and shall be provided in Microsoft Word, capable of being customized/modified by the end user.

5.2. Contractor shall provide, at no cost to the government, software updates that are required to support continued or expanded testing on the GeneXpert platform.

PERFORMANCE WORK STATEMENT – ADDENDUM FOR

ANTI-TERRORISM/OPERATIONS SECURITY

Access and general protection/security policy and procedures. This standard language is for Contractor employees with an area of performance within Army controlled installation, facility, or area. 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.

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.

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.

Threat Awareness Reporting Program. For all Contractors with security clearances. Per AR 381-12 Threat Awareness and Reporting Program (TARP), Contractor employees must receive annual TARP training by a CI agent or other trainer as specified in 2-4b.

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