RFQ-Attachment1_SOW.pdf

RFQ No. 75N95024Q00194 Statement of Work

RFQ – Attachment 1 – May 2024 Page 1 of 7

STATEMENT OF WORK

GENERAL INFORMATION

Title of Project:

Reference clinical laboratory testing and assay services for the Healthy Aging in Neighborhoods of Diversity across the Life Span (HANDLS) study.

Statement of Need and Purpose:

The purpose of this requirement is to obtain reference clinical laboratory services and assay services for samples collected via the HANDLS study.

Background Information and Objective:

The National Institute on Aging (NIA), one of the 27 Institutes and Centers of NIH, leads a broad scientific effort to understand the nature of aging and to extend the healthy, active years of life. The Intramural Research Program (IRP) of the National Institute on Aging (NIA) provides a stimulating setting for a comprehensive effort to understand aging through multidisciplinary investigator-initiated research, in this regard.

The Laboratory of Epidemiology and Population Sciences (LEPS), one of NIA IRP’s ten laboratories, plans, conducts, and directs epidemiology, demography, and biometry programs relevant to the mission of the NIA; collects and analyzes data regarding the distribution of the aged by such categories as sex, race, socioeconomic, and demographic characteristics and serves as a focal point for these data; and plans, initiates, coordinates, and analyzes national and international epidemiologic longitudinal studies and studies of special populations.

Within LEPS, the Health Disparities Research Section (HDRS) conducts interdisciplinary clinical and basic science research focused on examining the underlying cause of the disproportionate incidence, morbidity and mortality of age-related disease among minority and low socioeconomic status (SES) Americans. The approach provides a two-way bridge between basic science laboratory studies and clinical research that spans from the targeted epidemiologic population to the bench. Dissecting the interaction of race, socioeconomic status, culture, behavior, environmental exposure, biologic vulnerabilities, genetics, social environment, health care access, and quality of health care provides insight into how these interactions result in disproportionate rates of age-related disease and disability. The ultimate goal of this approach is to transform scientific discoveries arising from laboratory, clinical, or population studies into clinical applications to reduce incidence, morbidity, and mortality of age-associated diseases and health disparities. This is accomplished by the development and implementation of a clinical component (The Healthy Aging in Neighborhoods of Diversity across the Life Span (HANDLS) study) and a basic science laboratory component that are interdependent and pursuing related hypotheses.

HANDLS investigators conduct their research study on NIA’s mobile Medical Research Vehicles (MRVs) located throughout Baltimore City, MD. Participant samples and specimens are collected routinely during javascript:__doPostBack('ctl00$ctl00$body$homebody$RecentDocuments$C$RecentDocumentsControl$RecentDocumentResults$ctl00$DocumentNumberLink','')

RFQ – Attachment 1 – May 2024 Page 2 of 7 examinations performed daily. Additionally, and to avoid informative censoring (non-random missing data), NIA has also developed the HANDLS Home Visit Program (HHVP). This protocol is designed to allow participants who are home bound or disabled to continue to participate in the HANDLS study as scheduled. Providing an alternative to the examination visit on the MRVs allows NIA to continue to collect valuable data about the influences of race and socioeconomic status (SES) on the development of age-related health disparities and disability among socioeconomically diverse African Americans and whites in Baltimore.

Clinical lab testing and assay services are required for the participant visits at the MRVs as well as the HHVP. These assays are one basis for establishing participants’ health records. The data are used by investigators to assess change over time. These results are medico-legal documentation. They are retained in participants’ medical charts and participants are provided copies for their records and, if they choose, for their physicians’ records.

Period of Performance:

The base period of performance will be from July 24, 2024 through July 23, 2025, followed by four (4) consecutive 12-month option periods.

SCOPE OF WORK

General Requirements:

Independently and not as an agent of the Government, the contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government as needed to perform the requirements below.

Specific Requirements:

The contractor shall perform pre-analytic processing, analysis, and result interpretation for clinical and anatomical pathology specimens as requested by the NIA HANDLS physicians. Services shall include the transportation of clinical laboratory specimens to the contractor’s laboratory(ies) (including providing the shipping/pickup containers), the performance of analytical testing as defined by the contractor’s reference test manual, the reporting of analytical test results and consultative services as required to assimilate the full scope of its laboratory operations to the ordering facility.

• Specimen Pick-up: Laboratory shall provide a reference specimen pick-up service daily Monday-Friday of each week and selected weekend days except for holidays. The weekend days will include up to 2 per month and could occur on Saturday and/or Sunday. The specimens shall be picked-up between 1:00p-1:30pm daily and delivered to the contractor’s laboratory within 5 hours for processing. For the purposes of this SOW, holidays shall include: New Year’s Day, Memorial Day, Independence Day, Labor Day, Thanksgiving Day, and Christmas Day.

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RFQ – Attachment 1 – May 2024 Page 3 of 7

• Turnaround Time (TAT): Laboratory shall deliver or transmit results of a routine nature (general routine chemistries) to NIA within 24 hours from the time the specimen is received by the Laboratory’s testing facility. The Laboratory shall transmit or deliver results of tests performed on specimens of a special nature (special chemistries, tissues, etc.) to NIA within the times set forth in Laboratory’s then current turn-around-time schedule.

• Specimen Collection and Handling Requirements: Laboratory shall provide instructions for specimen collection, and handling and requirements that adhere to best practices and includes volume and storage temperature.

• Sample Preparation/Transport: The packaging and transportation procedures shall ensure the integrity of the specimen throughout the shipment process. A specimen collection and packaging guide shall be in place.

• Supplies: Laboratory shall provide, as part of its charges for the services, such items, devices or supplies that are used solely to collect, preserve, package, transport, process, or store specimens to be submitted to Laboratory for testing including, but not limited to:

o Forms o Specimen containers o Special media or culture tubes for samples o Specimen preservatives o Dry ice and appropriate container o Shipping and packaging containers o Specimen carriers o Labels and label printers as required by transportation guidelines o Centrifuge(s) o Printer and requisition paper

• Tracking of specimen: Tracking shall must be maintained from the initial pickup/shipping of the specimens from the ordering activity throughout the testing process at the contractor’s laboratory.

• Consultation: Contractor’s laboratory staff shall be available to NIA in person or by telephone during normal Laboratory working hours to discuss laboratory procedures and to provide the status of test results. The contractor shall provide telephone number(s) and contact personnel to be used by the ordering activity to address questions regarding their commercial services. The contractor shall include names and telephone numbers of technical directors and pathologists available for consultation.

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RFQ – Attachment 1 – May 2024 Page 4 of 7

• Testing: The testing methodology and reference ranges for a test shall be defined in the laboratory user manual. The contractor shall advise facility of any changes in methodology, procedure, reference ranges and any new tests introduced no later than two weeks prior to test change implementation.

In the event that the contractor discontinues and/or substitutes a new test, the contractor shall notify the Government POC prior to the intended change.

Any changes to the tests (HANDLS Lab Panel –Attached) may have a substantial impact on the program because study investigators require consistent methodology to make longitudinal comparisons which require stability in assay methods. Consequently, changes may invalidate these assays for research purposes. The contractor shall ensure that any substituted methods are equivalent to previous assays so as to avoid introducing longitudinal variation associated with methodological differences that are indistinguishable from true changes in study participants. Therefore, the government shall be notified if the contractor discontinues and/or substitutes any of the required tests.

All clinical reference laboratory testing shall be executed in accordance with standard industry practices. All test methods shall be FDA approved.

• Test Reporting:

• Participant formatted reports on website. The contractor shall provide access to a secure electronic health record website that provides formatted copies of laboratory reports including, but not limited to, test names, results, units, alert values, and reference ranges.

Reports shall be available within 24 hours of specimen receipt. Contractor shall provide information on its website for partial or complete reports as assay results become available.

Only final reports with all assay performed are considered completed deliverables. Any other reports are considered incomplete deliverables.

• Electronic results downloaded via HL7 protocol. The contractor shall provide an information system for downloading participant assay consistent with the Health Level Seven standard protocol for the transfer of clinical and administrative health data. The contractor shall provide access to their HL7 server and shall provide any necessary client software required for NIA to download and store these assay results in their database. The contractor shall provide all required hardware and software (including installation) and related consumable supplies to support the transmission of electronic data for each ordering activity. Any necessary “additional required connections” shall be the responsibility of the contractor.

• Critical Tests: The contractor shall immediately communicate with the NIA physician or requesting Clinician to report any Critical Value or test result that may indicate a life threatening condition.

• Procedure Guidance: The contractor shall make available either through its electronic catalog or upon request the following information:

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RFQ – Attachment 1 – May 2024 Page 5 of 7 o Specimen collection and handling requirements o Test reference intervals adjusted for ages, sex, or race, when required o Test specific sensitivity, specificity, and interferences, when required o Result code (electronic transmissions only) o Test critical values, if any o Location of test performance by test name (i.e. name of primary laboratory, name of separate branch division of primary lab, name and address of secondary/subcontracted laboratory must be cited)

• Documentation: The contractor shall ensure that all required documentation is, at a minimum, timely, legible, and accurate. Contract personnel shall indicate responsibility for the content and accuracy of all prepared and transcribed reports. The Contractor shall have a system in place to identify the personnel performing the test analysis.

• Retention of Specimens: Upon completion of the testing, the contractor shall retain all specimens as required by regulatory agencies.

• Utilization Reports: The contractor, upon request, shall provide to each ordering activity at a minimum, the utilization reports customarily provided to commercial customers. The report shall at minimum identify the test code, test name, YTD volumes, unit cost, YTD expenditures, and turnaround times.

• Contract Quality Assurance/ Quality Control: The contractor facilities, test methodologies (defined as the principle of the method), validation studies, and quality control information may be examined by representatives of the Government at any time during the life of the contract. The contractor shall comply with all applicable OSHA, Federal, State, laws, and regulations as required for performing the type of services required.

• HIPAA Compliance: Contractor must acknowledge it is a “covered entity” under the Health and

Portability and Accountability Act of 1996 (HIPAA) and agree to comply with the requirements thereof, as well as all other applicable laws and regulations pertaining to patient privacy. See 45 CFR 160.103 for definition of “covered entity”.

• CLIA Compliance: The contractor must be licensed to perform laboratory testing under the Clinical Improvement Amendments (CLIA) of 1988, and perform testing in accordance with the CLIA regulations.

• Licensing and 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 javascript:__doPostBack('ctl00$ctl00$body$homebody$RecentDocuments$C$RecentDocumentsControl$RecentDocumentResults$ctl00$DocumentNumberLink','')

RFQ – Attachment 1 – May 2024 Page 6 of 7 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, mandated by federal and state statues. The Contractor must maintain valid certifications throughout the performance period of this contract.

The contractor shall provide a copy of all relevant permits/licenses and certifications inclusive of any sanctions current or pending throughout the United States of America. In addition, the contractor shall be responsible for providing a written guarantee or evidence that all subcontractors have appropriate licensure and accreditation to perform tests that the primary contractor cannot perform prior to performance.

The contractor shall maintain current accreditation and notify the government 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. Immediate (within 24 hours) notification must be given to ordering activity upon adverse action by a regulatory agency.

GOVERNMENT RESPONSIBILITIES

• The government will grant the contractor access to the MRVs in Baltimore City, MD when specimens are picked up.

• The collection of samples by the government complies with all applicable federal, state, and local statues and regulations, government guidelines, any internal research policies (e.g. Institutional Review Board (IRB) or Privacy Board approval), and any consent, informed consent, or authorization requirements appropriate to the research effort its conducting relative to specimens tested under this Agreement.

DELIVERY OR DELIVERABLES

Test results shall be available electronically within 24 hours from the time the specimen is received by the Laboratory’s testing facility.

REPORTING REQUIREMENTS

See above guidelines under “Scope of Work, Specific Requirements”.

OTHER CONSIDERATIONS

Travel:

Not Applicable. The principal place of performance is the contractor’s work site. Travel expenses related to the sample collection sites shall not be reimbursed.

Key Personnel:

Contractor shall provide a dedicated project manager to the government as a contact point for the services.

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RFQ – Attachment 1 – May 2024 Page 7 of 7

SECURITY REQUIREMENTS

Information System Security Plan:

HHS sensitive information applies to the service described above. This includes HHS proprietary information; records about individuals requiring protection under laws and regulations such as the E- Government Act, Privacy Act, and the HIPAA Privacy Rule, or based on a data use agreement or a promise or assurance of confidentiality; etc. Therefore, security requirements in accordance with regulation will apply.

Data Rights:

The National Institute on Aging shall have unlimited rights to and ownership of all deliverables provided, including clinical laboratory test results. Contractor shall not release or share data without government approval. Contractor will not use data for scientific investigation and will have no right to work with these data or publish using these data. FAR clause 52.227-14, Rights in Data-General, shall be applicable.

Section 508—Electronic and Information Technology Standards:

The contractor shall comply with Section 508 of the Rehabilitation Act (29 U.S.C. § 794d), as amended by the Workforce Investment Act of 1998 (P.L. 105-220), August 7, 1998.

Publications and Publicity:

Contractor shall not publish any articles of data as a result of fulfilling this requirement. Samples provided shall not be utilized without written consent of the Government.

Confidentiality of Information:

Protected health information (PHI) subject to the HIPAA Privacy Rule applies to this requirement. (45 CFR 160.103). Therefore, contractor must comply with all HHS information security and privacy program policies, procedures, practices and related contract requirements, specifications, and clauses.

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