Attachment I - Statement of Work_Amendment 0001.pdf

ATTACHMENT I - STATEMENT OF WORK – AMENDMENT 0001

National Oceanic and Atmospheric Administration

Office of Marine and Aviation Operations Comprehensive COVID-19 Testing & Support Services

NM-AN-8200-21-00380

1) INTRODUCTION

The Department of Commerce (DOC), National Oceanic and Atmospheric Administration (NOAA), Acquisition and Grants Office (AGO), Eastern Acquisition Division (EAD), and Office of Marine and Aviation Operations (OMAO), have a requirement for Coronavirus (COVID-19) On-Site Testing and Support Services for the marine and aviation fleet passengers across North America, to include Alaska, Hawaii, Canada, and the Caribbean. NOAA maintains operational centers at ten (10) various locations across the nation, and has platforms scheduled to call in multiple locations in and beyond FY21. In addition, these services may be required by other NOAA Line Offices across the nation. The locations consist of, but are not limited to, the following:

● Aircraft Operations Center in Lakeland, FL

● OMAO Dive Center at Sand Point in Seattle, WA

● NOAA Ships ported at the following locations (to include but not limited to):

o Norfolk, VA o Newport, RI o Charleston, SC o Pascagoula, MS o New Castle, NH o Newport, OR o Seattle, WA o Tampa, FL o Galveston, TX o San Diego, CA o San Francisco, CA o Ketchikan, AK o Kodiak, AK o Port Angeles, WA o Seward, AK o Juneau, AK o Dutch Harbor, AK o Honolulu, HI.

● International Ports of call (For Example: South Africa, Bora Bora, Belize, etc.)

● US territories and commonwealths

OMAO manages and operates NOAA's fleet of fifteen (15) research and survey ships and ten (10) aircraft. Comprising civilians and officers of the NOAA Commissioned Officer Corps, OMAO also manages the NOAA Diving Program, NOAA Small Boat Program and NOAA Aviation Safety Program.

OMAO’s research and survey ships comprise the largest fleet of federal research ships in the Nation, ranging from large oceanographic research vessels capable of exploring the world’s deepest ocean, to smaller ships responsible for charting the shallow bays and inlets of the United States. The fleet supports a vast range of marine activities including fisheries research, nautical charting, as well as ocean and climate studies. OMAO’s aircraft operate throughout the world providing hurricane reconnaissance and research, marine mammal and fisheries assessment, coastal mapping, and other various imagery support services.

In addition to the critical research and monitoring activities conducted by OMAO’s fleet, OMAO ships and aircraft provide immediate response support for unpredictable, or urgent, events. For example, following a severe hurricane, NOAA ships will conduct emergency surveys for navigational hazards to assist in ensuring pathways are safe for quickly reopening port access within the area. In addition, aerial images of disaster-torn areas—taken by NOAA aircraft—enable residents and emergency workers to verify the condition of homes, bridges and roads.

2) SCOPE

The testing services provider must provide and use a COVID PCR test that is Food and Drug Administration (FDA) approved (or on the FDA emergency use approval list found here) with a percentage accuracy of 95%+ sensitivity and 98%+ specificity required at a minimum (MUST also provide information on the lowest copies/ particles of COVID virus per milliliter detected per test) and provide any relevant details regarding shipment/receipt of items.

PCR saliva testing is preferred because it allows for the opportunity for these PCR tests to be self-administered under clinical observation, however, nasopharyngeal, oropharyngeal, and anterior nares PCR tests are also acceptable. In addition, point of care rapid antigen test cards (anterior nare, CLIA waived) or rapid antigen test cards approved as home testing kits shall also be available. The testing service provider must also provide Rapid Antigen test kits/cards with sensitivity greater than 88%+ and specificity greater than 98%+ for use in deployed operational environments. Both COVID PCR and COVID antigen testing options are required.

If a vendor contractor is used to administer the PCR test, the test must be performed by properly trained medical personnel who will conduct on-site retrieval of the collected nasal swab, or saliva biological samples, for testing. All contractor personnel conducting the tests must be provided with Personal Protective Equipment (PPE) for retrieving the biological samples in accordance with the Centers for Disease Control and Prevention (CDC) and Occupational Safety and Health Administration (OSHA) guidelines for “Preferred PPE.” NOAA requires that all personnel conducting the tests use N95 high-grade masks, face shields, nitrile gloves, and protective gowns. Additional information regarding the required PPE can be found here, and must be adhered to regardless of the clinician’s vaccination status.

The tests may either be processed using a PCR analyzer on-site or sent to a laboratory for processing and reporting results within 48 hours or less of receiving samples; however, a 24 hour turnaround time is preferred. Telehealth monitoring of self-administered tests must be approved in advance by Marine Operations, and must be made available by the vendor. There shall be a user friendly mechanism in place for the requesting providers, the medical clearance coordinator teams and the patient to be sent results.

Online portal required with, preferably, automated results being sent.

Firms must provide information on the availability of tests described above (PCR and Antigen), FDA Approval documents, proof of percentage accuracy (95%+ sensitivity and 98%+ specificity required at a minimum), as well as any relevant details regarding shipment/receipt of items and how test results are reported to the person tested and the organization requesting the test. Firms must also provide a clear description of the quality assurance procedures utilized to ensure sensitivity and specificity. The description must include how many times each sample is run before reporting any final results.

Inconclusives shall be run more than once before determining this as the final result.

Example Scenarios

1. Aviation: 14 day Shelter In Place (SIP) with self administered PCR testing on day 7 and day 12.

Additional weekly surveillance PCR testing occurs for 100 employees.

https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations-medical-devices https://www.cdc.gov/coronavirus/2019-ncov/downloads/A_FS_HCP_COVID19_PPE_11x17.pdf

2. Marine: Vendor clinical personnel, if requested, will meet the ship’s complement at the respective SIP location and perform up to 2 consecutive PCR tests (completed on the same day back to back) and take the specimens for processing. PCR testing must be completed on day 4-5 of SIP with results reported in less than 48 hours.

3. Diving: Self administered PCR testing and or rapid antigen tests for divers prior to diving projects.

4. Remote self administered: Both self administered PCR tests that can be mailed in with results reported within 48 hours and/or self-administered rapid antigen testing.

5. Symptom response while deployed: Rapid antigen tests for testing the entire crew in remote locations when someone presents with symptoms.

Firm responses must specify the intended location, process of conducting testing, as well as time for processing and providing results (less than 48 hours required). If vendors recommend an alternate testing location, the following details must be provided: the process of transporting sample tests to laboratory (must confirm the laboratory is certified under Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. § 263a to perform high complexity tests as an “authorized laboratory”), list of nearby location(s) within twenty (20) miles of each specified location above and details of the facility.

3) REQUIREMENTS

A. Laboratory Testing Seeking Analysis

1. SARS-CoV-2 COVID-19 Diagnostic Testing

a. PCR (administered by medical professionals)

b. PCR (home kits that are self administered)

2. SARS-CoV-2 Antigen testing (Clinical Laboratory Improvement Amendment (CLIA) Waived)

a. Test cards or similar

B. Testing Management

1. Web-based portal must be available for patient registration (either by the patient or by the provider), tracking results, and management of the tested workforce. It must be a mature graphic user interface program that has been tested and easy to use for medical and coordinating staff to see all results and the status of testing, and easy for the people being tested to see their individual results.

2. The tracking portal shall organize results by unit (by ship or by location) and by date.

3. The tracking/portal program must be HIPAA compliant and also allow for administrative oversight by NOAA Marine Health Services.

C. Materials/Test Media

1. Testing materials must be provided by the contractor.

2. If testing is being conducted on site, testing materials and PPE will be shipped to arrive at the testing location no later than 72 hours prior to the testing event, or will be brought to the site by the contractor supplied clinician.

3. All shipping supplies must be provided by the contractor for each individual kit provided, to include: shipping box, containers, return shipping labels, sample labels, instructions, patient portal instructions and links, *Circumstances may vary at the Task Order level, where the Government’s expectations and requirements are defined according to the specified need.

4. Any unused testing kits will be given to the NOAA medical point of contact at the location.

D. Volume

1. The expectation is to be able to handle up to 100 tests in one day per location. A total of 3,000 rapid antigen cards/cassettes will be needed per year with a shelf life greater than 12 months.

E. Turnaround Time

1. The contractor shall comply with the standard in which results are returned within 48hrs of receipt at the analyzing facility.

F. Testing Types

1. Vendors must provide both a medical clinician administered PCR swab test option and a patient self-administered PCR test that can be mailed or dropped off by the patient. In both cases, a computer-based patient portal (or other web-based tracking system) is required for accurate tracking and management of the tested workforce. This portal shall be HIPAA compliant.

2. The Contractor must also have the ability to support both PCR and Rapid Antigen testing at any location in the continental United States as well as Alaska, Hawaii, US territories and commonwealths, and international ports of call. This requirement can be met by expedited courier services set up by the vendor and recovered by the courier at the location testing takes place. Additional home PCR testing options in addition to onsite requirements are desirable.

3. The Contractor is required to be able to analyze work at the following locations (or have/arrange courier pick-up services). Note that ship and aviation operational locations can vary and include additional U.S. locations, such as those mentioned in Section 1 above.

a. Aircraft Operations Center

3450 Flightline Drive Lakeland, FL 33811

b. NOAA Dive Center 7600 Sand Point Way NE, Bldg 8 Seattle, WA 98115

c. Marine Operations Center - Atlantic 439 West York Street Norfolk, VA 23510

i. NOAA Ship Okeanos Explorer

ii. NOAA Ship Thomas Jefferson

iii. NOAA Ship Ronald H. Brown

d. Newport, RI

i. NOAA Ship Henry Bigelow

e. Charleston, SC

i. NOAA Ship Nancy Foster

f. Pascagoula, MS

i. NOAA Ship Gordon Gunter

ii. NOAA Ship Oregon II

iii. NOAA Ship Pisces

g. Portsmouth, NH

i. NOAA Ship Ferdinand Hassler

h. Marine Operations Center - Pacific 2002 SE Marine Science Drive Newport, OR 97365

i. NOAA Ship Bell M. Shimada

ii. NOAA Ship Hi’ialakai

i. Kodiak, AK

i. NOAA Ship Oscar Dyson

j. Ketchikan or Juneau, AK

i. NOAA Ship Fairweather

k. NOAA Western Regional Center

7600 Sand Point Way NE Seattle, WA 98115

l. Marine Operations Center – Pacific

1897 Ranger Loop Ford Island B184 Honolulu, HI 96818

i. NOAA Ship Rainier

ii. NOAA Ship Oscar E. Sette

4) QUALITY CONTROL

a. The contractor shall have a quality control in place to ensure that only high quality and accurate analysis is provided (98%+ or higher specificity and sensitivity for PCR testing and sensitivity greater than 88%+ and specificity greater than 98%+ for rapid antigen testing). MUST provide information on the lowest copies/ particles of COVID virus per milliliter detected per test.

5) ORDERING

a. Contractor must have a web based system for ordering and tracking tests and results.

6) CUSTOMER SERVICE

a. The contractor must have a designated account representative who will be the single point of contact for all questions and concerns. Account representatives may refer questions and concerns to other parties for reconciliation. Phone calls and voice or text messages submitted on a weekday will be responded to within an hour.

b. A representative with familiarity of the account must be available 24/7 for emergent concerns. This representative must have immediate access to account information, status of all shipments, status of all samples being tested and results of all tests. Phone calls and voice or text messages submitted on weekends, holidays, and after-hours shall be responded to within 2 hours.

c. The contractor shall only provide materials dated/shelf life of at least 12 months prior to their expiration date.

d. The contractor must provide next day shipping service for samples and provide shipping labels with testing kits. Tracking information for all sample shipments must be provided to contacts specified by the customer.

e. The contractor must arrange for samples to be picked up the day the test is administered via courier, pickup request (UPS, FedEx, etc.) or have the clinician drop ship samples.

f. The contractor will provide clinician contact information (name, email address and phone number) to the customer no later than 72 hours ahead of the testing event.

g. If at any point the scheduled clinician becomes unavailable, the contractor shall provide a replacement clinician without any delay of the event. If a replacement clinician cannot be provided for the scheduled date and time, then a clinician will be provided at the earliest possible opportunity agreed to by the customer.

7) LOCATION

a. Services will be at the locations specified above, as well as remote site testing around the nation. Lab requisitions will be submitted from those locations. The medical clinician will verify pick-up status.

Testing shall be administered in the following order of preference for Ship-Based Operations:

1. NOAA’s preferred location of on-site testing administered by the Contractor-provided laboratory personnel (clinician).

2. Self-administered tests under observation by the vendor telehealth clinician, or administered by NOAA Health Services, that can be picked up by courier service for analysis.

b. For Aviation Operations, the preference order is:

1. Testing kits available to be self-administered or administered by NOAA Health Services that can be picked up by courier service for analysis.

2. NOAA’s preferred location of on-site testing administered by the Contractor-provided laboratory personnel (clinician).

3. Provided that efforts for preferences 1 and 2 have been exhausted, a drive-up location where employees can be directed to go to have the test administered.

8) PRIVACY ACT REQUIREMENTS

The information provided in the collection of tests falls under the Privacy Act of 1974, as stated in clause FAR 224-1 Privacy Act Notification, FAR 52.224-2 Privacy Act and FAR 52.224-3 Privacy Training.

Accordingly, the vendor is required to maintain data collection, retention, access, and destruction of records in accordance with the Privacy Act, including access controls, and initial and recurring privacy training for employees accessing this data under FAR 52.224-3, which is attached in the terms and conditions.