Attachment 1 - IDIQ SOW COVID-19 Testing.pdf

ATTACHMENT 1

DOCUMENT REFERENCE NO.

FDA-RFQ-1238058 Base IDIQ SOW / COVID-19 Testing for FDA Employees and Contractors

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BASE IDIQ

STATEMENT OF WORK (SOW)

COVID-19 Testing for FDA Employees and Contractors

I. GENERAL

The U. S. Food and Drug Administration (FDA) has an emergent need to offer voluntary COVID-19 testing for employees, performing mission-critical, non-portable duties onsite at FDA facilities, and employees who have volunteered and been approved to work onsite at FDA facilities to determine whether they are currently infected with COVID-19. The contractor shall provide at-home, unsupervised COVID-19 test sample collection to be submitted and laboratory tested via nucleic acid amplification test (NAAT) (e.g. real time polymerase chain reaction (RT-PCR)) that has been granted Emergency Use Authorization (EUA) by the FDA.

II. SCOPE OF WORK

The contractor shall provide COVID-19 testing of FDA employees and contractors who fit the criteria described above. These services shall include home collection kits for FDA employees and contractors, via nucleic acid amplification test (NAAT) (e.g., real time polymerase chain reaction (RT-PCR)) that has been granted an EUA, with no more than a 48-hour turn-around-time (TAT) from the time the specimen is received by the contractor or its testing laboratory. The contractor shall provide all personnel, equipment, supplies, facilities, tools, materials, supervision, and other items and services necessary to perform the requirements of this Statement of Work (SOW). Collection kits must be accessible to FDA employees throughout the country, including all states and U.S. territories.

A. General Requirements

• FDA anticipates that it will require up to 38,064 home collection kits during the period of performance. Monthly needs will vary according to FDA’s needs and CDC’s safety guidelines for COVID-19.

• The contractor shall provide:

o Home collection kits that are authorized for use with a nucleic acid amplification test

(NAAT) (e.g., real time polymerase chain reaction (RT-PCR)) that has been granted an Emergency Use Authorization (EUA) from the FDA for screening of asymptomatic individuals.

o Results available via an electronic, interactive portal to FDA and the employee who was tested within 48 hours of receipt at the contractor or its testing laboratory.

• The contractor shall state which authorized test is being provided. If there are multiple testing workflows under the EUA (e.g., pooling, different specimen collection methods), the contractor shall state which ones will or may be used.

• The contractor shall provide a link to the letter authorizing the test for emergency use under Section 564(c) of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. §360bbb-3) from FDA’s webpage.

• The test shall be used within the scope of the EUA.

FDA-RFQ-1238058 Base IDIQ SOW / COVID-19 Testing for FDA Employees and Contractors

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• The contractor shall be in compliance with all applicable conditions of the Emergency Use Authorization (EUA).

• The contractor shall provide authorization form (or language used in the electronic portal) which allows the release of employee test results to FDA/OHS.

B. Special Requirements

• Ordering Process

The contractor shall:

a. Provide an ordering process whereby FDA’s Occupational Health Services (OHS) will submit the physician and/or other authorized practitioner’s order for the test kit to the contractor electronically

b. Supply the test kit to the FDA employee’s home address or P. O. Box within 48 hours of receipt of the physician and/or other authorized practitioner’s order. The test kit shall include or be accompanied by a return label and all necessary packaging materials for the FDA employee to return the specimen via overnight shipping.

c. Provide a means of alerting FDA if a specimen is not returned to the contractor within 7 business days of the contractor distributing the test kit.

• Testing

The contractor shall:

a. Analyze samples utilizing a nucleic acid amplification test (NAAT) that has been granted an

Emergency Use Authorization (EUA) from the FDA for use with an unsupervised, home collection kit and for screening of asymptomatic individuals.

b. Carry out testing functions in full compliance with all federal, state and local, statutes and regulations.

c. Promptly notify the FDA Contracting Officer and Contracting Officer’s Representative (COR) if the EUA is revoked.

• Certify and ensure that all employees, officers, or agents comply with standards set forth in the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and the Administrative Simplification Provisions set forth at 45 CFR Parts 160, 162 and 164.

• Results Reporting

The contractor shall:

a. Provide test results to the FDA employee and FDA/OHS within 48 hours of the specimen being returned to the contractor through an electronic, interactive portal that, at a minimum, includes the following information:

• Employee’s Name

• Employee’s Center/Office (provided by FDA/OHS from the testing consent form)

• Date of specimen collection by employee

• Date of specimen receipt by contractor or testing laboratory

• Date of result provided by the contractor or testing laboratory

FDA-RFQ-1238058 Base IDIQ SOW / COVID-19 Testing for FDA Employees and Contractors

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• Test result

• Name and address of testing laboratory (if different than contractor)

• Any other information the contractor has that may indicate a questionable validity of test results

• Specimen inadequacy shall be reported with documentation supporting its unsuitability for testing

b. Provide a means of communication to permit immediate inquiry by the FDA employee and FDA OHS regarding the status of a pending test.

III. DELIVERABLES

The contractor shall provide:

A. Individual test results via the electronic portal within 48 hours of the specimen being returned to the contractor or testing laboratory.

B. A daily report, provided to the FDA/OHS, for tests completed to include:

• Employee Name

• Test ordered

• Date FDA/OHS sent physician and/or another authorized practitioner’s order to the contractor

• Date contractor sent the test kit to the FDA employee and FDA OHS

• Date contractor or testing laboratory received the specimen from the FDA employee

• Date contractor or testing laboratory provided test result to the FDA Employee and

FDA/OHS

• Test result

C. A monthly invoice for tests completed each month following the month in which the service was delivered, to include:

• Date contractor or testing laboratory received the specimen from the FDA employee

• Date contractor or testing laboratory provided test result to the FDA Employee and

FDA/OHS

IV. CUSTOMER SERVICE

The contractor shall provide customer service (24 hours a day, 7 days a week), that is accessible by both toll-free telephone, and on-line electronic services to assist FDA employee, OHS, and COR with tracking and resolving related issues/problems that may arise in the performance under this contract.

V. HIPAA COMPLIANCE

Contractor must adhere to the provisions of Public Law 104-191, Health Insurance Portability and Accountability Act (HIPAA) of 1996 and the Administrative Simplification Provisions set forth at 45 CFR Parts 160, 162 and 164.

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VI. PRIVACY ACT

It has been determined that this contract is subject to the Privacy Act of 1974, because this contract provides for the support or operation of a system of records about individuals. The contractor’s personnel will access data records subject to the Privacy Act.

• The System of Records Notices (SORNs) that are applicable to this contract are: OPM/GOVT- 10 (Employee Medical File Systems Records) and HHS 09-90-2001 (Records Used for Surveillance and Study of Epidemics, Preventable Diseases and Problems).

• The design, development, or operation work the Contractor is to perform is: the contractor’s personnel are expected to access data records subject to the Privacy Act in the course of their work.

• The disposition to be made of the Privacy Act records upon completion of contract performance is: Records will be managed in accordance with National Archives and Records Administration (NARA) General Records Schedules.

VII. CONTRACT PERFORMANCE MONITORING

A. Monitoring of contractor’s performance shall be demonstrated through administrative record reviews. Contracting Officer's Representative(s) (COR) will be responsible for verifying contract compliance.

1) Documentation of services performed will be reviewed prior to certifying payment. The COR will perform periodic spot checks and document with the using service to ensure records monitoring. FDA will pay only for services provided, and in strict accordance with the Price Schedule. Contract monitoring and recordkeeping procedures will be sufficient to ensure proper payment and allow audit verification that services were provided.

2) The contractor shall provide individual test results via the electronic portal within 48 hours of the specimen being returned to the contractor or testing laboratory, or the following price deductions will be made:

Timeframe Test Results are Provided After Specimen Receipt

Percent Deduction from Price of Test Kit

Between 48 and 72 hours 10% Between 72 and 80 hours 20% Greater than 80 hours 30%

3) If the contractor believes there are excusable circumstances, the contractor shall inform the Contracting Officer. Excusable circumstances may result in adjustment of the disincentives established in the Performance Matrix based upon the Contracting Officer’s Determination and Findings.