ELS - Draft Performance Work Statement.docx

U.S. Department of State Enhanced Laboratory Services

SECTION C – PERFORMANCE WORK STATEMENT

C.1 PURPOSE

The U.S. Department of State (“DOS”, “State”, or “the Department”), Bureau of Medical Services (MED). has an immediate need for the collection and processing of biological specimens by a laboratory accredited by the Centers for Medicare and Medicaid Services as meeting the requirements of the Clinical Laboratory Improvements Amendments of 1998.

C.2 BACKGROUND

The Bureau of Medical Services executes the Department of State’s worldwide Medical Program, serving over 70,000 U.S. Government employees and family members (EFM) from more than 75 federal agencies engaged in the advancement of Americas interests and national security abroad. In order to protect the health of our globally distributed workforce, and comply with host nation requirements for pre-arrival laboratory evaluation, the Department requires the collection and analysis of certain biological specimens within very short timelines as well as very specific reporting mechanisms with which to transmit and receive results.

C.3 SCOPE

1. Under this contract vehicle, the Contractor shall provide ongoing medical laboratory testing support to the U.S. Department of State, including Reverse Transcriptase-Polymerase Chain Reaction, Antigen, and immunoglobin testing for the SARS-CoV-2 virus to sustain the Department’s diplomatic mission. The Department has a requirement for scalable testing capacity to meet the needs of the Diplomatic community.

1. At the task order level it is anticipated that the Contractor shall provide all personnel, durable equipment, and expendable supplies necessary to perform order entry, acquisition of biological samples, packaging of sample, and transportation of samples from the location of sample acquisition to the Contractor’s sample processing laboratory.

C.3.1 REQUIREMENTS

C.3.1.1 Collection of Biological Samples

1. Sample Acquisition: The Contractor shall provide all personnel, durable equipment, and expendable supplies necessary to perform order entry, acquisition of biological samples, packaging of sample, and transportation of samples from the location of sample acquisition to the Contractors sample processing laboratory.

1. Work Location – Pathway 1: In Pathway 1, samples are acquired by Contractor personnel in a Government-provided clinical location in the 20037 postal code between the hours of 0700hrs and 1100hrs local time seven days per week. The Contractor shall be responsible for the provision of all IT and procedural equipment and supplies necessary to perform sample acquisition activities during the operating hours and turn over the clinical space for other clinical use by the Government at the completion of each day. On-site storage areas for supplies will not be available.

1. Work Location – Pathway 2: In Pathway 2, samples are acquired by Contractor personnel at their registered place of business in a manner otherwise consistent with the Contractor’s normal operating procedures between the hours of 0830 and 1700 EST seven days per week. The Contractor location must be within a 20-mile radius from 2401 E Street, NW, Washington, DC 20037.

1. Sample Acquisition Capacity: The Contractor shall employ and provide sufficient personnel, equipment, and supplies to obtain and process 180 samples per day (3-hour accession period) under Pathway 1, and 180 samples per day under Pathway 2.

1. Sample Transportation: The Contractor shall transport all samples to their laboratory processing facility within one hour of the conclusion of daily activity under Pathway 1 and within 1 hour of sample acquisition under Pathway 2.

C.3.1.2 Laboratory Processing and Analysis

1. Geographic Restriction: Only fully licensed/accredited laboratories actively engaged in providing the specific services and laboratory testing outlined in this solicitation, with an accredited facility within 40 statute miles from 2401 E Street NW, Washington, DC 20037, and that are able to begin services under this contract within five calendar days of award will be considered.

1. Requirement for CLIA Accreditation: The Contractor must continuously hold a Certificate of Compliance or Certificate of Accreditation from the Centers for Medicare and Medicaid Services as meeting the requirements of the Clinical Laboratory Improvement Amendments of 1988 or must demonstrate accreditation by a regulatory agency with deemed status from the Centers for Medicare and Medicaid Services, e.g. The College of American Pathologists, and/or other state regulatory agencies, as appropriate, and as mandated by federal and state statues.

1. Maintenance of Accreditation: The Contractor must maintain valid certifications throughout the performance period of this contract. The Contractor shall notify the Contracting Officer of any lapse in state license, CLIA certification, or clinical pathology certification. The Contractor shall provide a copy of the renewed licenses/certificates to the Contracting Officer before expiration. Immediate (within 24 hours) notification must be given to ordering activity upon adverse action by a regulatory agency.

1. Sample Processing Time: For Reverse Transcriptase – Polymerase Chain Reaction (RT-PCR) testing for SARS-CoV-19, the Contractor shall provide final results within 24 hours 90% of the time, 30 hours 95% of the time, and 36 hours 100% of the time. For the purposes of contract performance monitoring, sample processing shall begin 2 hours after the conclusion of daily activity under Pathway 1, and within 2 hours of sample acquisition under Pathway 2.

1. Sample Reporting: The Contractor shall provide the Government access to a web-based HIPAA compliant portal with which to access laboratory results on a 24-hour/7-day per week basis, with results available not less than 60 days following sample processing. Daily batch results shall be provided to the Government in Microsoft Excel format, transmitted through a Government-directed secure portal.

C.3.2 ORDERING AND DELIVERY

1. The Department and Contractor shall negotiate delivery location and schedule prior to issuance of any Task Order for on-site services under CLIN X001.

1. The Government shall negotiate delivery schedules for unforeseen requirements at the time of the task order. The required service delivery date for unforeseen requirements for CLIN X001 services shall be within 5 calendar days of award unless otherwise agreed to by the Government in advance.

1. The Department and Contractor shall negotiate a Request for Equitable Adjustment in accordance with the Changes Clause when expected patient load will exceed the established parameters set forth in C.3.1.1(d) above.

1. The Contractor shall maintain temperature control and physical security of acquired biological specimens through the acquisition, transportation, and analysis process, and shall dispose of all biological specimens and waste in accordance with relevant local, state, and federal law and regulation.

C.4 AUDITS/SITE VISITS

1. Site Visit/Audits: The Contractor shall allow the Government access to all production and storage locations involved in the acquisition, processing, and disposal of biological specimens collected under this contract, including those of their subcontractors and agents, as deemed necessary throughout the period of performance of the contract.

1. All visits and audits shall be conducted during the Contractor’s normal business hours.

C.5 PROGRAM MANAGEMENT AND REPORTING

The Contractor shall provide comprehensive program management, including quality control, oversight, risk mitigation, and communication. The Contractor shall:

1. Obtain the necessary licenses and permits to perform all services contemplated under this contract and its resultant task or delivery orders and maintain strict compliance with all industry laws, regulations, and standards.

1. Satisfaction of tax liabilities for the performance of services under this contract is the responsibility of the Contractor.

1. Participate in meetings with the Government as requested to discuss performance under the contract. These meetings shall provide status updates and discuss ongoing supply chain, clinical, regulatory, and transportation issues as applicable. These meetings shall be coordinated by the COR.

C.6 CUSTOMER SERVICE AND SUPPORT

The Contractor is expected to maintain a customer-focused approach to the work, ensuring a high level of customer satisfaction while operating within the terms and conditions of the contract. The Contractor shall:

1. Return phone calls and emails from the CO, COR, or GTM within one business day. Calls placed by the Contractor in which the intended Government official cannot be reached shall be followed immediately by an email

1. Meet the contractual requirements for timeliness, quality, and cost efficiency.

1. Establish and implement quality control procedures by proactively identifying risks, issues, and problems, and implementing plans for mitigation, whether under Contractor or DOS control.

1. Refer issues and problems immediately to the CO, COR, or appropriate GTM as applicable.

C.7 MEETINGS

1. The Contractor shall attend a post-award orientation / “kick-off” meeting with the CO and the COR not later than three (3) business days after the date of award or a mutually acceptable date. At the direction of the Government, this may be conducted as a teleconference. The purpose of the meeting is to review the final technical and contracting objectives of the statement of work and review the Contractor's project plan.

1. The Contractor shall attend an annual meeting, scheduled at the convenience of the Government and typically in the fourth quarter of each fiscal year (October-September) to review past performance and develop forecasts for the upcoming year’s production requirements.

1. The Contractor shall participate in a quarterly meeting with the Department to discuss performance under the contract. These meetings shall provide status updates and discuss on-going supply chain, clinical, regulatory, and transportation issues as applicable. These meetings shall be coordinated by the COR.

C.8 OTHER REQUIREMENTS

C.8.1 DATA COMPONENTS AND REPORTING

1. All data, databases, formatted reports, and answers to specific requests for information shall become the property of the Government, and shall be developed, transmitted, and maintained in a manner acceptable to the COR.

1. Unless otherwise specified, data shall be exportable to Microsoft Excel format, and responses to requests for data shall be transmitted in Microsoft Excel format, organized and labeled in a manner that is easily understood and formatted to print on standard letter paper unless otherwise specified by the COR.

1. Written reports and responses to requests for information shall be transmitted by the Contractor to the Government in (*.pdf) format unless otherwise specified by the COR.

C.8.2 SECURITY REQUIREMENTS

1. All information associated with this requirement and contract shall be considered Protected Health Information and Personally Identifiable Information, and shall not be disclosed without the expressed written permission of the Contracting Officer’s Representative.

C.8.3 SAFEGUARDING OF INFORMATION

1. The Contractor, including subcontractors, shall exercise the utmost discretion in regard to all matters relating to their duties and functions. They shall not communicate to any person any information known to them by reason of their performance of services under this contract which has not been made public, without written authorization from the COR.

1. All documents and records (including photographs) generated during the performance of work under this contract shall be for the sole use of and become the exclusive property of the Department. Furthermore, no information, article, book, pamphlet, recording, broadcast, speech, television appearance, film or photograph concerning any aspect of work performed under this contract shall be published or disseminated through any form of media (including the internet) without the prior written authorization of the COR.

1. The Contractor agrees that any violation of the certifications or restrictions of the conditions of nondisclosure shall constitute a material and substantial violation of the terms, conditions and provisions of the contract and that the Department may, in addition to any other remedy available, terminate this contract for default.

1. These obligations do not cease upon the expiration or termination of this contract. The Contractor shall include the substance of this provision in all contracts of employment and in all subcontracts hereunder.

C.8.4 RESTRICTED DISTRIBUTION OF DOCUMENTS

1. The Contractor, including its sub-Contractors, may be provided access to documents deemed “Sensitive” by the Department. Access to these documents, which must be appropriately labeled or marked as “sensitive,” shall be limited to members of the contract team on a need to know basis. The Department may limit the number of hard copies and prohibit electronic copies of such “Sensitive” documents. These documents shall be used on this contract only and shall not be used on any other contract or given or sold to another company, person(s) or entity.

1. The Contractor, including its sub-Contractors shall exercise the utmost discretion in regard to all matters relating to all Department documents. They shall not communicate to any person any information known to them because of their access to the Department documents. These documents are for use on this contract and are the exclusive property of the Department except as provided for elsewhere herein. Furthermore, no information, article, book, pamphlet, recording, broadcast, speech, television appearance, film or photograph concerning any aspect of these documents shall be copied, reproduced, published or disseminated through any media or the internet.

C.8.5 NOTIFICATION OF CONFIDENTIALITY

Notwithstanding any other provision or term of this agreement, it shall be the responsibility of the party seeking confidentiality as to any item of information, documents or things to notify the other party in advance and in writing as to same. Additionally, no restrictions shall apply to routine information or documents, or to information or documents provided to employees, agents and Contractors which are reasonably needed for the performance of duties.