SOW - COVID PCR TEST SERVICES.docx

STATEMENT OF WORK

COVID PSR TEST SERVICE

374TH MEDICAL GROUP YOKOTA AIR BASE, JAPAN

1. DESCRIPTION OF SERVICES/GENERAL INFORMATION.

Contractor shall provide testing services to 374th Medical Group/Laboratory (374 MDG) at Yokota Air Base, Japan (YOKOTA AB) for SARS-CoV-2 and related tests. Service shall include all travel, labor, materials (including user consumable supplies).

2. REQUIREMENT/TASKS.

2.1. Pick-up. Upon request from 374 MDG, the samples will be picked up by a currier and transported to a location where the test will be conducted. The samples will be handled by Contractor courier or by a contract logistics who are authorized to handle infectious items. The test requestor will be responsible to properly label each sample with Label Number and DODID and package the samples in triple container (clear plastic zip-lock bag as secondary container inside a carboard box as tertiary container) for shipping as specified in the guideline, “Sample Collection and Transportation of Suspected 2019-nCoV Infected Patient Samples” by the National Institute of Infectious Disease. A container with a virus transportation medium is used as the primary container to store the test sample.

2.2. The contractor shall be available from 0900 to 1630, Monday through Sunday and coordinated pickup on Sunday or on Japanese Holidays. If Sunday and Holiday pickup is desired, the designated contractor contact person must be notified in advance to arrange the pickup.

2.2.1. There will be no pickup from 30 December through 3 January. However, contractor representative shall check for pickup availability during this period. (There will be no pickup on 1st January.)

2.3. Requisition Method. Predesignated Excel format will be used for requesting test. The Excel sheet will contain the following information:

- Label Number

- Sample Collection Date

- Base Name

- Patient Name with DODID

2.3.1. The Excel file will be labelled with base location followed by date and submitted by e-mail to Contractor. The Excel sheet submitted by 374 MDG will be password protected. A hard copy of the file will accompany the box containing the samples.

* Examples of file name: YOKOTA20200925 (i.e. BASENAME+yyyymmdd)

2.3.1.1. Performing tests: Contractor will perform the requested test as soon as practical upon receiving the transported samples.

2.3.2. Testing Method. The test will be performed under the guideline specified by National Institute of Infectious Disease in the Manual for Detecting 2019-nCoV. The reagents to be used will be announced to 374 MDG prior to use. If reagents need to be changed, pre-approval from 374 MDG will be obtained before making the change. Further consideration will be made to provide new tests if requested by 374 MDG.

2.3.2.1. Test report. The individual test report will contain the following information: The result of the test Label Number, Sample Collection Date, Base Name, Patient Name and DODID. An Excel file with a redacted list of test result will be provided by e-mail to the prearranged address by 374 MDG. The Excel sheet with the results will be password protected with a common password for 374 MDG. Contractor will make best effort to provide the test report within 48 hours upon receiving the samples. If any trouble, such as delay in transportation due to weather or system malfunction or other unexpected problem arise, the contact person at corresponding 374 MDG will be notified immediately by the Contractor. 374 MDG must provide the information of contact person capable of communicating in Japanese.

2.4. The transportation costs required for retrieving the samples from the hospital and to the laboratory will be handled by the Contractor.

2.5. The contractor is responsible for cleaning the equipment and instruments used and the disposal of used containers for the test related to this Contract, and the contractor shall bear all such expenses.

2.6. 374 MDG need to notify the Contractor in advance of all US holidays observed and make necessary arrangements for sample pickup with the Contractor local representative.

2.6.1. Federal Holidays. 374 MDG observes the following holidays. Holidays falling on a Saturday will be observed on the preceding Friday, Holidays falling on a Sunday will be observed on the following Monday. Unscheduled closures may be declared by the 374 MDG Commander.

Juneteenth Day Third Monday in June

NOTE: Any of the above holidays falling on a Saturday will be observed on the preceding Friday; holidays falling on a Sunday will be observed on the following Monday.

2.7. Security Requirement. Only Contractor employees authorized by the 374 MDG authority maybe granted access to YOKOTA AB.

- All personal information will be protected.

- Samples provided will not be used for any purpose other than the requested test.

- Personal information will be handled according to the guideline “Special Notice in Handling of Personal Information.”

2.8. Compensation. Unless the fault is at 374 MDG or by a third party, intentionally or by negligence, the Contractor will be liable for the damage.

3. Miscellaneous.

- Provide up-to-date academic information on clinical tests as needed.

- The Contractor shall report the number of tests performed at the end of each month and submit the invoice within 60 days through Wide Area Workflow (WAWF).

- If any discrepancy regarding the contract should arise, clarification will be made upon mutual discussion.

2.8.7. HIPAA COMPLIANCE. The Contractor agrees to abide by all the requirements of the Health Insurance Portability and Accountability Act (HIPAA) as codified at 45 CFR Part 160 and Part 164, subparts A and E, and implemented by DoD 6025.18-R regarding the privacy and confidentiality of health records and information being provided and shared under the resulting contract. The Contractor shall also comply with the Business Associate Agreement under Privacy of Protected Health Information.

HIPAA is comprised of several different sections, each to be implemented by the Dept. of Health and Human Services. The medical facilities of the military services and the DOD health plans are specifically listed as covered by HIPPA. Currently, HIPAA Privacy and Security Rules, as set forth in the Code of Federal Regulations, are in effect for all MTFs. The specific implementation of HIPPA Privacy for DOD medical facility is set forth in DOD 6025.18-R, and for HIPAA Security, the requirements for AF MTF’s are contained in DOD 8580.02-R and AFI 41-217, which also contains additional Information Assurance requirements for all AF MTF’s. DOD 6025.18-R, DOD 8580.02-R and AFI 41-217 are incorporated herein by reference. MTRs are responsible to ensure overall compliance with HIPAA requirements, which includes incorporation of certain requirements in contracts entered or amended after the respective implementation dates.

IAW these regulations the Contractor and its employees meet the definition of Business Associates. Therefore, a Business Associate Agreement is required by law to comply with both the HIPAA Privacy and Security regulations. This clause serves as that agreement for each MTF, whereby the contractor and its employees agree to abide by all HIPAA Privacy and Security requirements regarding health information as defined in this clause, DOD 6025-18-R, DOD 8520.02-R and AFI 41-217. Additional HIPAA requirements will be addressed when implemented.