DRAFT_Biorepository_SOW.docx

Statement of Work (SOW) For Bacterial Disease Branch Bio-Repository

1. Background

Responding to the recent epidemic of Gram-negative multidrug-resistant organism (MDRO) nosocomial and wound infections in the U.S. Military Health System, the Walter Reed Army Institute of Research (WRAIR) launched the Multidrug-resistant Organism Repository and Surveillance Network (MRSN) in July 2009.

Until then, no agency within the Department of Defense collected and characterized these organisms across the enterprise to inform best clinical practices, influence policy, and enhance infection prevention and control efforts.

The MRSN currently comprises a microbiology laboratory, organism repository and a network of DoD hospitals, including those in combat zones. The network is available to Naval and Air Force medical facilities and will eventually expand to include all Army hospitals, and potentially all U.S. military hospitals.

Under a Defense Health Agency (DHA) Memorandum of Agreement (MOA), DoD hospitals submit targeted MDROs to the MRSN laboratory in Silver Spring, MD whenever these organisms are isolated from clinical infections or active surveillance programs. Associated clinical-demographic information is also submitted with each isolate.

At the laboratory, isolates undergo extensive antibiotic susceptibility testing, molecular fingerprinting and genomic analyses, followed by long-term storage. The MRSN then generates customized and global cumulative susceptibility reports (antibiograms) and will eventually post these on a secure website for availability to clinicians, infection preventionists, and policy makers. It provides epidemiologic reports and infection control information to hospitals, commanders, consultants to the Surgeon General, and the Tri-service Infection Prevention and Control Panel. Site assistance visits are also conducted.

2. Scope:

This Statement of Work (SOW) describes the performance requirements for storage and shipping services for isolates and reagents/consumables in support of the WRAIR located in Silver Spring, Maryland.

3. Objective:

The objective of this requirement is to provide shipping and storage for isolates and reagents/consumables in a controlled environment meeting WRAIR requirements.

4. Requirements/Minimum Essential Characteristics:

4.1 Isolates

The Contractor shall:

· Store 30-45K bacterial isolates (400 cryoboxes) in 2mL cryovial tubes in -80oC or lower freezers. 100 cyrovials to a box and each box is 5.5”x 5.5”x 2.25.” See Attachment 1 for additional storage requirements

· Store an anticipated growth of 100 cyroboxes per year.

· Provide 24 hours/day 365/year temperature monitoring and take any corrective action to ensure specimen integrity

· Provide backup generator power for storage facilities

· Provide cold chain logistics to ensure sample integrity at every point of transfer

· Provide a process to allow audits and outside agencies (i.e. FDA, CAP) to inspect sample storage conditions (Deliverable 2)

· Provide initial transportation of 30-45K isolates (400 cryoboxes) from WRAIR to new bio-repository facility

· Provide transportation of isolates from WRAIR quarterly

· Deliver requested isolates within 24 hours of a request. Requests for delivery to WRAIR will not exceed 12 per quarter. In the event WRAIR requires deliveries above this number annually, deliveries will be paid for via Government Purchase Card on an as-needed basis

· Send samples delivered in boxes via FedEx or equivalent overnight shipping company along with tracking information

· Ensure specimen integrity during all phases of possession

· Provide quarterly inventory and temperature monitoring reports (Deliverable 3)

· Confirm receipt of specimens when sent from WRAIR to new biorepository facility through FedEx or equivalent

· Notify the COR within one business day via email or phone if temperatures for any items stored fall below specifications for any amount of time

4.2 Reagents/Consumables

The Contractor shall:

· Provide storage for reagents and consumables used for patient testing. Reagents and consumables will be a combination of ambient, refrigerator, and freezer temperature stored reagents/consumables. See Attachment 1 for additional storage requirements

· Provide transportation of reagents/consumables to/from WRAIR on a quarterly basis

· Keep ambient temperature of consumables at a temp of 20-25oC and a humidity range of 10-80%

· Store freezer supplies or reagents at a temp of -20oC or colder

· Provide cold chain logistics to ensure supply integrity at every point of transfer

· Ensure supply integrity during all phases of possession.

· Provide 24 hours/day 365/year temperature monitoring and take any corrective action to ensure supply integrity

· Provide backup generator power for storage facilities

· Deliver requested reagents/consumables within 24 hours of a request. Requests for delivery to WRAIR will not exceed 12 per quarter. In the event WRAIR requires deliveries above this number annually, deliveries will be paid for via Government Purchase Card on an as-needed basis

· Notify the COR within one business day via email or phone if temperatures for any items stored fall below specifications for any amount of time

· Provide quarterly inventory and temperature monitoring reports (Deliverable 3)

4.3 Monthly Progress Report

The Contractor shall ensure that a MPR (Deliverable 1) is submitted outlining the expenditures, billings, progress, status, and any problems/ issues encountered in the performance of this task. The MPR shall include but not be limited to:

· Activities completed in reporting period

· Activities anticipated for the next reporting period

· New and ongoing issues/ problems

· Identified risks and mitigation

· Any government action needed

· Government furnished equipment issued during the reporting period. Government shall provide a format for the

· GFE information required

· Labor hours expended, by labor category for each task/sub-task

· Monthly Performance Metrics

· Trip report when travel is accomplished for the month reported Shall include but not limited to purpose,

· accomplishments, and findings

· Lessons learned

· A separate section for optional Contract Line Item Numbers (CLINs) exercised for surge support with the same

· Status of isolates/reagents and consumables - at a minimum include, monthly inventory, expiration dates, monthly temperature reports along with any corrective actions taken, delivery reports, and amount storage space used

4.4 Invoices

The contractor shall submit invoices monthly to Wide Area Work Flow (WAWF) with sufficient documentation to provide certification of invoice.

The contractor is responsible for properly preparing and forwarding to the appropriate Government official, the invoice and receiving report for payment. The contractor shall attach back up information to receiving reports for direct labor and Other Direct Costs (ODCs). Direct labor backup information shall reflect the person’s name, job title and quantity of hours worked for each pay period at a minimum. Backup information for ODCs shall list all elements of costs, such as travel breakout backup, including itinerary, dates of travel, name of employees traveling plus per diem costs shall accompany the receiving report. All ODCs exceeding $3,000 requires that the contractor conduct appropriate competition and obtain approval from the COR prior to purchase. Equipment purchases are not authorized under this contract. The Wide Area Workflow – Receipt and Acceptance application is the required method of submission.

5. Period of Performance

Base period – Date of Award + 12 months Option Period one – 12 months Option Period two – 12 months Option Period three – 12 months Option Period four – 12 months

6. Deliverables

6.1. Delivery Address

All deliverables shall be submitted to the COR designated in the COR appointment letter CORT system.

6.2. Method of Delivery

Electronic copies shall be delivered using Microsoft Office suite of tools (for example, MS WORD, MS EXCEL, MS POWERPOINT, MS PROJECT, or MS ACCESS format), unless otherwise specified by the COR. Electronic submission shall be made via email, unless otherwise agreed to by the COR.

6.3. Shipping:

The Contractor shall use the U.S. Postal Service standard delivery for delivery of materials, equipment, or required hardcopy documents related to deliverables. The COR must approve all exceptions to this requirement. The Contractor shall deliver all deliverables to the Contracting Officer’s Representative at 503 Robert Grant Avenue, Silver Spring, MD 20910-7500.

6.4. Government Acceptance Period

The COR will have ten (10) workdays to review draft deliverables and make comments. The Contractor shall have five (5) workdays to make corrections. Upon receipt of the final deliverables, the COR will have two (2) workdays for final review prior to acceptance or providing documented reasons for non-acceptance. Should the Government fail to complete the review within the review period the deliverable will become acceptable by default, unless prior to the expiration of the ten (10) work days the Government notifies the Contractor in writing to the contrary. The final submission should be deemed approved if the Government has not rejected it in thirty (30) calendar days.

The COR will have the right to reject or require correction of any deficiencies found in the deliverables that are contrary to the information contained in the Contractor’s accepted quote. In the event of a rejected deliverable, the Contractor will be notified in writing by the COR of the specific reasons for rejection. The Contractor shall have five (5) workdays to correct the rejected deliverable and return it per delivery instructions.

6.5. Delivery Schedule Abbreviations

6.6. Deliverable/Delivery Schedule:

A summary of deliverables follows. Copies are to be provided to the Government officials indicated in electronic file (E), and/or hard copy (H).

6.7. Inspection and Acceptance

The COR delegated oversight of specific technical, functional and oversight responsiblities is responsible for inspection and acceptance of all services, incoming shipments, documents, and services.

6.8. Acceptance Criteria

Certification by the Government of satisfactory services provided is contingent upon the Contractor performing in accordance with the performance standards contained in the Performance Work Statement and all terms and conditions of this order, including all modifications.

7. Performance Requirements Summary Matrix

The Government will use the following performance requirements to measure the performance of the contractor. The contractor shall meet the Performance Objective(s) and Acceptable Quality Level(s) within the “Performance Requirements Summary Matrix” (PRS Matrix).

PERFORMANCE REQUIREMENTS SUMMARY MATRIX

8. Travel – NA

9. Government Furnished Items

The government will furnish appropriate samples which must be approved by the accepting laboratory prior to processing. Once accepted, the samples are in the custody but not the ownership of the receiving laboratory. Isolate ownership is solely that of the government. All marketing material that uses or springs from the data must be approved by the KO or his designated representative.

10. Work Schedule and Location

10.1. Federal Holidays

The following are Federal Holidays:

· New Year’s Day

· Birthday of Martin Luther King, Jr.

· Washington’s Birthday

· Memorial Day

· Independence Day

· Labor Day

· Columbus Day

· Veterans Day

· Thanksgiving Day

· Christmas Day

10.2. Work Locations

The primary place of performance will be at the contractor’s facilities. The Contractor shall be locally available within 50 miles driving distance.

The contractor shall deliver/pick up items at the WRAIR government sites at:

WRAIR

503 Robert Grant Ave Silver Springs, MD 20910 Hours of operation: Monday – Friday, 0700 – 1700

The Government will provide access to Government controlled facilities.

11. Compliance Documents

· Must comply with CFR 21 part 11

· Must comply with CAP Bio-repository regulations

· Must comply with DOT, OSHA, EPA, IATA shipping requirements for biological materials

· Must comply with CAP/CLIA regulations