SPECIAL NOTICE
B -- Procurement of Services to Obtain Follow-up Procedures and Outcome Information on Women with Abnormal Screening Results from the STRIDES Study
- Notice Date
- 8/6/2021 12:17:50 PM
- Notice Type
- Special Notice
- NAICS
- 541990
— All Other Professional, Scientific, and Technical Services
- Contracting Office
- NIH National Cancer Institute Rockville MD 20850 USA
- ZIP Code
- 20850
- Solicitation Number
- 75N91021Q00212
- Response Due
- 8/13/2021 12:00:00 PM
- Archive Date
- 08/28/2021
- Description
- 1.0�� �DESCRIPTION The U.S. Department of Health and Human Services (DHHS), National Institutes of Health (NIH), National Cancer Institute (NCI), Division of Cancer Epidemiology and Genetics (DCEG), Clinical Genetics Branch, Clinical Epidemiology Unit plans to procure, on a sole source basis, Services to Obtain Follow-up Procedures and Outcome Information on Women with Abnormal Screening Results from the STRIDES Study from the University of Mississippi Medical Center, 2500 N. State Street, Jackson, MS 39216. The response close date of the notice for this requirement is in accordance with FAR 5.203(b). This acquisition will be processed under FAR Part 12 - Acquisition for Commercial Items and will be made pursuant to the authority in FAR Part 13.106-1(b)(1)(i); and is exempt from the requirements of FAR Part 6. The North American Industry Classification System code is 541990 and the small business size standard is $16.5 million. � It has been determined there are no opportunities to acquire green products or services for this procurement.� 2.0�� �BACKGROUND Cervical cancer screening has led to dramatic reductions in cervical cancer incidence and mortality over the past decades in the U.S.; however, thousands continue to develop and die from cervical cancer each year, with significant disparities observed by geographic region as well as race and ethnicity. Mississippi (MS), a state that is disproportionately affected by high rates of poverty, low educational attainment, and limited access to care, ranks among the top five states in the nation for cervical cancer incidence and mortality. Within the state, significant racial disparities exist, with higher cervical cancer incidence and mortality in black compared to white women. The underlying causes of these disparities are likely multi-faceted, involving factors related to access to care and potential differences related to HPV natural history. As the new cervical cancer screening and management guidelines are based on risk estimates generated from a large population undergoing screening within an integrated healthcare system, it is important to ensure that these risk estimates are portable in diverse populations and in different settings within the U.S. Moreover, as new human papillomavirus (HPV) based cancer prevention technologies are being evaluated, population-based studies of HPV prevalence in regions like MS are necessary to better understand how these tools will perform in racially diverse populations with high rates of cervical cancer.� The U.S. Department of Health and Human Services (DHHS), National Institutes of Health (NIH), National Cancer Institute (NCI), Division of Cancer Epidemiology and Genetics (DCEG), Clinical Genetics Branch, Clinical Epidemiology Unit developed a study, Studying Risk to Improve Disparities (STRIDES), in MS to address this gap. To evaluate risks of cervical precancer and cancer, diagnostic information from cervical biopsies and treatment procedures (i.e. histology results) are needed. These data are entered into the electronic medical record (EMR) and abstracted electronically by data informatics tools; however, DCEG requires histology results from approximately 50% of the STRIDES cohort who should have undergone diagnostic and/or treatment procedures, as this information is currently missing from the EMR. Information may be missing from the electronic EMR abstraction for several reasons including: Colposcopy performed without biopsy taken, diagnostic or treatment procedures performed in other clinics, and no procedures performed (i.e., delayed or loss to follow-up). Collecting this information requires extensive chart review and, in some cases, contacting patients and/or outside providers. � 2.1�� �OBJECTIVE The purpose of this acquisition is to obtain follow-up procedure and histology information data from 1,200 women who had abnormal screening results and should have undergone diagnostic and/or treatment procedures at screening and treatment clinics. 3.0�� �SCOPE The Contractor shall provide all personnel, labor, facilities, materials and equipment necessary to perform the required tasks described in section 4 below. In women who have abnormal cervical cancer screening results, the Contractor shall review patient charts and abstract subsequent follow-up procedure information and outcome data from the medical records, if available, including results from those performed at clinics outside of the study specific sites. If there is no procedure or outcome information found in the electronic medical record, the Contractor shall obtain the outcome information from the referring clinic. All data shall be coded and shall not contain any personally identifiable information (PII). 4.0�� �CONTRACT REQUIREMENTS/ AND PERSONNEL QUALIFICATIONS� The Contractor shall perform the following tasks:� 4.1�� �Review electronic and paper charts from patients identified as missing cervical histology results. Study-specific IDs for these patients will be sent by DCEG to the Contractor in an Excel database over a secure email exchange. All data shall be coded and shall not contain any personally identifiable information (PII). 4.2�� �Abstract medical and pathology records to collect information on: -�� �Follow-up procedure information, including colposcopies and treatment procedures performed -�� �Histology information from cervical biopsies and excisional procedures 4.3�� �In the event that previously performed procedures were completed outside of the Contractor�s clinic, the Contractor shall obtain results/outcome information from the applicable referring clinic(s)/provider(s).� 4.4�� �Send NCI quarterly progress reports and one final dataset, through a secure portal including the abstracted information without personal identifiable information. �This task shall result in four progress reports and a final dataset. 5.0�� �TYPE OF ORDER This is a firm fixed price purchase order.� 6.0�� �NON- SEVERABLE SERVICES The services specified in each contract line item (CLIN) have been determined to be non-severable services - a specific undertaking or entire job with a defined end product of value to the Government. 7.0�� �PERIOD OF PERFORMANCE The anticipated period of performance shall be 12 months from the date of award. 8.0�� �PLACE OF PERFORMANCE Services shall be performed at the Contractor�s facility. 9.0�� �REPORT(S)/DELIVERABLES AND DELIVERY SCHEDULE All written deliverables shall be sent electronically to the NCI Technical Point of Contact (TPOC), TBD at award, in a Microsoft compatible format, such as Microsoft Excel or text file, unless approved by the TPOC. The TPOC shall review the contents of all draft deliverables. If no comments or requests for revisions are provided to the Contractor within 30 business days, the deliverables shall be considered acceptable. If revisions are required, NCI shall respond to the Contractor within five (5) business days of receiving the deliverable, specifying the required changes/revisions. Final copies of approved drafts shall be delivered to the NCI TPOC within five (5) business days after receipt of the Government�s comments. � DELIVERABLE� /� �DELIVERABLE DESCRIPTION -�FORMAT REQUIREMENTS� /� DUE DATE #1(Task 4.4):�Progress Reports / File containing abstracted follow-up information and notes on progress. Due�Quarterly #2 (Task 4.4):� Final clinical dataset containing clinical and histopathology data / Excel format. Due�30 business days prior to the purchase order expiration date. 10.0�� �PAYMENT Payment shall be made monthly in arrears. �Payment authorization requires submission and approval of an invoice to the NCI TPOC and NIH OFM, in accordance with the attached payment provisions listed below: The following clause is applicable to all Purchase Orders, Task or Delivery Orders, and Blanket Purchase Agreement (BPA) Calls: �Prompt Payment (Jan 2017) FAR 52.232-25. �Highlights of this clause and NIH implementation requirements follow: I.�� �Invoice Requirements A.�� �An invoice is the Contractor's bill or written request for payment under the contract for supplies delivered or services performed. �A proper invoice is an ""Original"" which must include the items listed in subdivisions 1 through 12, below, in addition to the requirements of FAR 32.9. �If the invoice does not comply with these requirements, the Contractor will be notified of the defect within 7 days after the date the designated billing office received the invoice (3 days for meat, meat food products, or fish, and 5 days for perishable agricultural commodities, dairy products, edible fats or oils) with a statement of the reasons why it is not a proper invoice. �(See exceptions under II., below.) �Untimely notification will be taken into account in the computation of any interest penalty owed the Contractor. 1.�� �Vendor/Contractor: �Name, Address, Point of Contact for the invoice (Name, title, telephone number, e-mail and mailing address of point of contact). 2.�� �Remit-to address (Name and complete mailing address to send payment). 3.�� �Remittance name must match exactly with name on original order/contract. �If the Remittance name differs from the Legal Business Name, then both names must appear on the invoice. 4.�� �Invoice date. 5.�� �Unique invoice #s for all invoices per vendor regardless of site.� 6.�� �NBS document number formats must be included for awards created in the NBS: �Contract Number; Purchase Order Number; Task or Delivery Order Number and Source Award Number (e.g., Indefinite Delivery Contract number; General Services Administration number); or, BPA Call Number and BPA Parent Award Number. 7.�� �Data Universal Numbering System (DUNS) or DUNS + 4 as registered in www.SAM.gov.� 8.�� �Federal Taxpayer Identification Number (TIN). �In those exceptional cases where a contractor does not have a DUNS number or TIN, a Vendor Identification Number (VIN) must be referenced on the invoice. �The VIN is the number that appears after the contractor�s name on the face page of the award document. 9.�� �Identify that payment is to be made using a three-way match. 10.�� �Description of supplies/services that match the description on the award, by line billed.* 11.�� �Freight or delivery charge must be billed as shown on the award. �If it is included in the item price do not bill it separately. �If identified in the award as a separate line item, it must be billed separately. 12.�� �Quantity, Unit of Measure, Unit Price, Extended Price of supplies delivered or services performed, as applicable, and that match the line items specified in the award.* NOTE: �If your invoice must differ from the line items on the award, please contact the Contracting Officer before submitting the invoice. �A modification to the order or contract may be needed before the invoice can be submitted and paid.� B.�� �Shipping costs will be reimbursed only if authorized by the Contract/Purchase Order. �If authorized, shipping costs must be itemized. �Where shipping costs exceed $100, the invoice must be supported by a bill of lading or a paid carrier's receipt. C.�� �The Contractor shall submit invoice to the National Institutes of Health (NIH)/Office of Financial Management (OFM) via email at invoicing@nih.gov with a copy to the approving official, as directed below. The Contractor must follow step-by-step instructions as stated in the NIH/OFM Electronic Invoicing Instructions for NIH Contractors/Vendors, which is included as an attachment on the website at https://oamp.od.nih.gov/DGS/DGS-workform-information/attachment-files. The invoice shall be transmitted as an attachment via email to the address listed above in one of the following formats: Word, or Adobe Portable Document Format (PDF). The Contractor must submit only one invoice per email. Do not submit supporting documentation (e.g., receipts, time sheets, vendor invoices, etc.) with your invoice unless specified elsewhere in the contract or requested by the Contracting Officer. The Contractor shall submit a copy of the electronic invoice to the Contracting Officer�s Representative (COR): Name- ___TBD at Award_________Email Address- ___TBD at Award___ See Attachment 1 � Instructions_Electronic Invoices For inquiries regarding the status of invoices, contact OFM Customer Service via email at ofm_customer_service@incontactemail.com or via phone at 301-496-6088. To send your inquiries via other available communication methods refer to the OFM Customer Service website at https://ofm.od.nih.gov/Pages/Customer-Service.aspx.� Note: The OFM Customer Service is open Eastern Standard Time Monday � Friday from 8:30 a.m. to 5:00 p.m. and is closed between 12:00 p.m. to 1:00 p.m. II.�� �Invoice Payment A.�� �Except as indicated in paragraph B., below, the due date for making invoice payments by the designated payment office shall be the later of the following two events: 1.�� �The 30th day after the designated billing office has received a proper invoice. 2.�� �The 30th day after Government acceptance of supplies delivered or services performed. B.�� �The due date for making invoice payments for meat and meat food products, perishable agricultural commodities, dairy products, and edible fats or oils, shall be in accordance with the Prompt Payment Act, as amended. III.�� �Interest Penalties A.�� �An interest penalty shall be paid automatically, if payment is not made by the due date and the conditions listed below are met, if applicable. 1.�� �A proper invoice was received by the designated billing office. 2.�� �A receiving report or other Government documentation authorizing payment was processed and there was no disagreement over quantity, quality, or contractor compliance with a term or condition. B.�� �In the case of a final invoice for any balance of funds due the contractor for supplies delivered or services performed, the amount was not subject to further settlement actions between the Government and the Contractor. C.�� �Determination of interest and penalties due will be made in accordance with the provisions of the Prompt Payment Act, as amended, the Contract Disputes Act, and regulations issued by the Office of Management and Budget. IV.�� �PROVIDING ACCELERATED PAYMENT TO SMALL BUSINESS SUBCONTRACTORS, FAR 52.232-40 (DEC 2013) a)�� �Upon receipt of accelerated payments from the Government, the Contractor shall make accelerated payments to its small business subcontractors under this contract, to the maximum extent practicable and prior to when such payment is otherwise required under the applicable contract or subcontract, after receipt of a proper invoice and all other required documentation from the small business subcontractor.� b)�� �The acceleration of payments under this clause does not provide any new rights under the prompt Payment Act. c)�� �Include the substance of this clause, include this paragraph c, in all subcontracts with small business concerns, including subcontracts with small business concerns for the acquisition of commercial items.� 11.0�� �UNIQUE QUALIFICATIONS OF THE CONTRACTOR Obtaining information on cervical histology results is necessary for calculation of risk estimates, and therefore this acquisition is critical for NCI investigators to accomplish the aims of the STRIDES study. UMMC is the only entity with full access to the required databases and clinical charts of patients in the STRIDES study attending screening clinics. External sites may have information on a select number of UMMC patients, in the event that a patient procedure was completed outside of the UMMC clinic; however, only UMCC has access to the full population of patients enrolled in the STRIDES study. UMMC has sole ownership of the clinical data from these patients. Due to HIPPA rules, no other vendor is authorized to access the information from patients in the study, nor follow up on patient outcomes, which is required under this acquisition.� 12.0�� �SUBMISSION INSTRUCTIONS This notice is not a request for competitive quotations. However, if any interested party believes it can meet the above requirements, it may submit a proposal or quote for the Government to consider. The response and any other information furnished must be in writing and must contain material in sufficient detail to allow NCI to determine if the party can perform the requirement. �All responses and questions must be sent via email to Contracting Officer, Megan Kisamore, at megan.kisamore@nih.gov by no later than 3:00 PM EST, on Friday, August 13, 2021 (8/13/21). A determination by the Government not to compete this proposed requirement based upon responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. In order to receive an award, Contractors must be registered and have valid certification through SAM.gov. Reference: 75N91021Q00212 on all correspondence.
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