N02CP81000-87_Amendment_1_and_QA_FINAL_Package.pdf

Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following methods:

(a) By completing items 8 and 15, and returning or (c) By separate letter or telegram which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment your desire to change an offer already submitted, such change may be made by telegram or letter, provided each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

E. IMPORTANT: Contractor is not, is required to sign this document and return copies to the issuing office.

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT 1. CONTRACT ID CODE

2. AMENDMENT/MODIFICATION NO. 3. EFFECTIVE DATE 4. REQUISITION/PURCHASE REQ. NO. 5. PROJECT NO. (If applicable)

7. ADMINISTERED BY (If other than Item 6) CODE

STANDARD FORM 30 (REV. 10-83)

Prescribed by GSA FAR (48 CFR) 53.243

FACILITY CODE

9A. AMENDMENT OF SOLICITATION

NO.

9B. DATED (SEE ITEM 11)

10A. MODIFICATION OF CONTRACT/ORDER NO.

10B. DATED (SEE ITEM 13)

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers is extended, is not extended.

12. ACCOUNTING AND APPROPRIATION DATA (If required) copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted;

13. THIS ITEM ONLY APPLIES TO MODIFICATION OF CONTRACTS/ORDERS.

IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

CHECK ONE A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NO.

IN ITEM 10A.

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation date, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER (Specify type of modification and authority)

Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

15C. DATE SIGNED

15A. NAME AND TITLE OF SIGNER (Type or print)

16C. DATE SIGNED

16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)

14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

PAGE OF PAGES

6. ISSUED BY CODE

8. NAME AND ADDRESS OF CONTRACTOR (No., street, county, State and ZIP Code) (X)

CODE

15B. CONTRACTOR/OFFEROR

(Signature of person authorized to sign)

16B. UNITED STATES OF AMERICA

(Signature of Contracting Officer)

NSN 7540-01-152-8070

Previous edition unusable

Kathleen Sears

The purpose of this amendment is to: (1) update the date of the Statement of Work in Article C.1.; (2) modify M.5. Technical Evaluation Factor B. Technical Approach; (3) provide responses to questions received; (4) revise Attachment 3, SOW;

Proposal Due Date: April 6, 2018; 2:00PM Eastern (Changed)

Questions and Answers, and Attachments 3, follow.

National Cancer Institute Office of Acquisitions 9609 Medical Center Drive Bethesda, MD 20892-9705

To All Potential Offerors

N02CP81000-87

1 11

03/30/2018

03/05/2018

RFP N02CP81000-87

Amendment 1 Page 1 of 4

Integrative Epidemiological Studies

N02CP81000-87

AMENDMENT #1

SOLICITATION UPDATES:

1. Article C.1. Statement of Work is deleted in its entirety and revised as follows:

a. Independently and not as an agent of the Government, the Contractor shall be required to furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government, as needed to perform the Statement of Work, dated March 30, 2018, attached hereto and made a part of this Solicitation (See SECTION J - List of Attachments).

2. Section M.5. – Technical Evaluation Factor B. Technical Approach is deleted in its entirety and revised as follows:

B. TECHNICAL APPROACH (25 Points)

Demonstrate the following capabilities:

1. Approach for accomplishing each task in the Statement of Work, including a clear understanding of the nature of the work required, problems that may arise, and solutions for those problems.

2. Capability to respond quickly to requests for initiating a new study to address an urgent public health need as directed by the COR.

3. Approach for conducting and simultaneously managing multiple large epidemiologic studies (domestic and international) as described in the Statement of Work, and providing technical support for all phases of integrative epidemiologic studies.

4. Approach for developing, coordinating, and monitoring biologic sample programs for use in epidemiologic investigations as outlined in the Statement of Work.

5. Approaches for QA and QC for studies in recent studies and proposed approaches for new studies.

Amendment 1 Page 2 of 4

QUESTIONS AND ANSWERS:

The following are answers to questions received from potential offerors.

Question 1:

The Evaluation Criteria (RFP page 108) includes tasks that will be carried out for Genome-Wide Association Studies (GWAS). However, these tasks do not appear in the Statement of Work (Attachment #5). Please confirm that these tasks should be considered part of the Statement of Work.

Answer 1:

GWAS studies are an example of the type of study that the contractor will support. The specific tasks refer to GWAS studies outlined in the evaluation criteria have been removed. The technical evaluation criteria have been revised accordingly.

Question 2:

The Evaluation Criteria (RFP page 108) includes tasks associated with developing, coordinating and monitoring biological sample programs. Some but not all of these tasks are included in the Statement of Work (Attachment #5). Please confirm that all tasks identified in the Evaluation Criteria should be considered part of the Statement of Work.

Answer 2:

These tasks have been added to the SOW document. The SOW and evaluation criteria attachments have been revised accordingly.

Question 3:

The Evaluation Criteria (RFP page 109), E. Facilities and Equipment, item 7 states that the contractor should demonstrate “adequacy of plan for tracking and retrieval of slides, blocks and photographs.” Please clarify whether the contractor will be responsible for storage of pathology slides and blocks and clinical photographs.

Answer 3:

No, the contractor will not be responsible for storage of these items.

Amendment 1 Page 3 of 4

Question 4:

Additional Business Proposal Instructions and Uniform Cost Assumptions (Attachment #17), 1) Meeting and Travel includes a table of activities and associated travel assumptions. We have the following questions:

a. For the Study Initiation and Liaison Meeting in Rockville, MD, should we assume that the 5 travelers are coming from U.S. locations?

b. For the Monthly Progress Status Meetings, are the 5 travelers coming from the U.S.

or international locations? Please also confirm that this is not a monthly meeting but is one 2-day meeting/year.

Answer 4:

a. Travelers will be from US locations for most meetings. However, please assume that one of the meetings will be for an international study (e.g. Italy).

b. The offeror shall assume that one monthly meeting per year may be at a location outside of the U.S. The other monthly meetings shall be held via conference call or some other means other than in person.

Question 5:

The uniform budget assumption for specimen shipments (Attachment #17: Additional Business Proposal Instructions and Uniform Cost Assumptions, 2) Special Shipping and Packing) indicate that we should assume 6 shipments of 100 samples per year. Should we assume the 6 shipments are from destinations in the U.S. or will any of these be international shipments?

Answer 5:

The shipments may be from international destinations or U.S. destinations. For estimating purposes, the offeror shall assume quarterly shipments with one being domestic and one being international.

Question 6:

The Additional Technical Proposal Instructions (Attachment 10, page 3 0f 5 of the RFP) indicate that the key personnel shall include 2 senior study managers. Given the relatively small estimated overall annual LOE for the contract, would it be acceptable to propose one individual who fulfills the position requirements?

Answer 6:

The offeror should provide justification for proposing one senior study manager in the technical proposal.

Amendment 1 Page 4 of 4

Question 7:

The Statement of Work (Attachment 3), Page 4 of 6, section 8: Computer Programming and Data Processing, section i states:

“Provide and maintain electronic system to allow investigators with role-based permission for data access, including but not limited to data queries, data access, data submissions, and data deliveries. In addition, it is anticipated that the program, study and project management IT infrastructure for DCEG shall evolve over the contract Period of Performance. The business process requirements for the contractor may include the use of and integration with, government provided information systems to request, track and report discrete work efforts. The contractor is expected to adopt a flexible and agile posture in its management, distribution and analysis of data to facilitate the continual improvement of the DCEG business processes.”

We have the following questions:

a. Can the government provide more detail on the project management and data systems that the contractor might be using?

b. Can the government clarify the staff positions and level of effort that would be required to carry out this task?

Answer 7:

a. NCI encourages offerors to consider how to be flexible as the IT infrastructure may evolve over the contract period of performance.

b. The exact number of staff positions and levels of effort to carry out this task is unknown at this time. For cost estimation purposes, offerors should assume no additional staff positions or additional level of effort than what is being proposed for data preparation and delivery related tasks.

Statement of Work – March 30, 2018 Attachment 3 N02CP81000-87 Page 1 of 6

STATEMENT OF WORK

Integrative Epidemiological Studies

Independently and not as an agent of the government, the Contractor shall be required to furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the government, as needed to perform the work identified herein. Types of support to be provided by the Contractor in the conduct of studies may vary. The timeline or schedule for support activities shall be specified by the NCI Contracting Officer’s Representative (COR) based on the study. The Contractor shall inform the NCI COR of any unforeseen circumstances that may delay timely completion or progress of study activities. All study activities, documents, and procedures shall be approved by the COR prior to implementation. The Contractor shall perform some or all of the following support activities as may be specified by the NCI COR in the conduct of each study.

1. Initial Transition

The Contractor shall provide initial transition activities that include but are not limited to:

a. Safely and efficiently assume the activities from the incumbent Contractor to ensure a seamless transition without loss of time or resources, so that the transition does not pose obstacles to the conduct of ongoing services. Complete the transition within the first 30 business days following the effective date of the contract.

b. Plan and execute transition meeting(s) with the NCI COR and Contracting Officer within 5 business days following the effective date of the contract. If the NCI COR deems that one meeting is not sufficient for the transition, the COR will direct the contractor to plan and conduct additional meetings. The meeting(s) shall take place in Bethesda, Maryland with the expected attendance of the Principal Investigator and Project Manager.

c. Within 10 business days of the award, develop and implement an Initial Transition Plan, approved by the COR, including the tasks that are associated with the relocation effort from the current contractor, and the type and manner of operations required by the Contractor during the transition period. This shall include safe and effective coordination with the current Contractors at the start of the new contract period for transfer of contract-related materials. This should include all medical records, specimens (such as blood, urine, saliva, and pathology specimens), questionnaires, abstract forms, tracking records, and primary data sources for the studies conducted during the contract.

2. Study Initiation and Liaison

As indicated by the COR, the Contractor shall support study initiation and liaison activities that include but are not limited to:

a. Determine the parties whose cooperation and approval is necessary for implementation of the study (e.g., federal or state agencies, universities, hospitals, medical offices, laboratories, other NCI Contractors, etc.).

b. Arrange for communication and meetings between the NCI research investigators and agents for those parties whose cooperation or approval is needed.

c. Attend such meetings, provide background information required, and take appropriate action on recommendations as applicable. Document proceedings and action items as requested by the NCI

COR.

d. Plan the method of identification of study subjects and make recommendations on the feasibility of alternative sampling designs. Typical study subjects include:

N02CP81000-87 Page 2 of 6

i. All members of families in which several members have a particular tumor or condition of interest identified by the investigators.

ii. All patients with a newly-diagnosed cancer of a designated type or with a specific medical condition occurring in a particular group of hospitals or clinics.

iii. Patients diagnosed with designated control diagnoses or exposures occurring in designated hospitals or clinics, sometimes matched on age, sex, race, diagnosis date or other characteristics.

iv. All patients with a newly diagnosed cancer or tumor of a designated type occurring in a defined geographic area (population-based ascertainment).

v. A random sample, usually stratified on age and other demographic characteristics, of the general population living in a defined geographic area.

vi. Groups of individuals with a particular specified medical condition or treatment or other exposures.

vii. Patients treated for an initial cancer who are being followed for the occurrence of second cancers.

viii. Volunteers for participation in pilot investigations for evaluation of methodologic issues.

ix. Volunteers from specified groups to participate in etiologic research.

3. Preparation of Study Materials and Procedures

The Contractor shall prepare study material and procedures and implement study procedures. These activities include but are not limited to:

a. Prepare, pretest, and produce data collection forms (e.g., abstract forms, follow-up forms, coding forms, questionnaires and exposure assessment forms).

b. Prepare training programs and materials. Conduct training for new staff in a timely manner and update training for all staff as needed, but not less than annually.

c. Prepare procedure manuals for nurses, research assistants, abstractors, coders, interviewers, tracers, supervisors, data editors, and other personnel as needed.

d. Prepare procedure manuals for the collection of biological specimens, shipment of biological specimens, submission of specimens to repositories, and tracking of specimens and laboratory results. Implement standard procedures, including quality assurance/quality controls, adaptable to each field site and documenting procedures in field manuals.

e. Prepare manuals for obtaining and handling medical records, pathology specimens and reports, submission of pathology specimens for review, and collection of death certificates or cause of death.

f. Prepare and update manuals of usual operating procedures in evaluating high risk families.

g. Contribute to preparation of newsletters and brochures for informing participants of study findings and eligibility.

h. Prepare large mailings for family members or other study subjects participating in ongoing studies.

i. Assist in the preparation of study-specific packages for OMB, IRB, and/or OHSR reviews.

4. Subject Identification, Selection, and Tracing

The Contractor shall identify, select and trace study subjects. These activities include but are not limited to:

a. Identify study subjects who meet NCI criteria for being included in studies, particularly women, minorities, and children, as appropriate. This includes methods of selecting controls from the general population and from hospitals or clinics.

b. Trace study subjects and locate them or their next of kin for interview or examination.

N02CP81000-87 Page 3 of 6

5. Interview and Abstracting Data Collection

The Contractor shall interview and abstract data collection. These activities include but are not limited to:

a. Obtain the necessary permissions and/or consents and then interview subjects or their family members or other proxies using mail, telephone, or in-person questionnaires. Computer assisted interviews may be necessary, depending on the study. Verify a sample (determined with the NCI COR) of completed questionnaires. Questionnaire content shall be provided by the NCI COR and shall be jointly modified, if necessary.

b. Obtain, curate and manage medical record information from Electronic Medical Records or paper forms including pathology review. Code data for entry into electronic systems (including

FAIR/FAIRVIEW).

c. Abstract and photocopy records (clinic or office medical records, hospital charts, vital records, job records, etc.). Maintain quality control over the abstracting or copying process. Verify the accuracy of an appropriately sized sample of abstracts (determined by the NCI COR) through independent reabstracting. Accuracy is to be maintained at a 98% level.

d. Procure death certificates from state vital records departments as directed by the COR. The Contractor shall be responsible for determining details of and payment for death certificate procurement from each state. The Contractor shall also be responsible for complying with state requirements regarding retention of such records in consultation with the COR.

e. Purchase other data, materials, and/or services as necessary.

f. Validate exposure or disease histories obtained in interviews by obtaining copies of original records.

g. Obtain copies of imaging studies, radiographs, or other clinical tests (e.g. electrocardiograms) and the associated reports as needed for specific studies.

h. Perform linkages such as National Death Index for vital status, cancer status, medical history, census tract residence, etc. Obtain approvals to link data with state and national registries. Linking shall be done using a quality controlled method that has gone through rigorous testing. Linking shall be able to handle partial and fuzzy data.

6. Specimen Collection, Processing, Selection, and Shipment

The Contractor shall collect, process, select and ship specimens. These activities include but are not limited to:

a. Collect and deliver biologic specimens (e.g. blood, urine, tumor) in appropriate shipping containers and under appropriate shipping conditions with necessary documentation to designated laboratories or investigators for storage and/or analysis as directed by the COR. This includes transport of biologic specimens from international studies with necessary customs clearances.

Verify safe arrival of specimens to the destination.

b. Obtain original pathology slides and blocks with associated pathology reports, maintain up to date inventory of requested, received, and dispersed slides and tissue blocks.

c. Arrange for specimen storage and/or standard laboratory tests or assays on biologic specimens (in one or several laboratories or repositories)., as designated by the COR.

d. Perform other support activities involving specimen collection, selection, storage, tracking and/or dispersal to laboratories as requested by the COR.

e. Communicate and coordinate with repositories to determine appropriate sample receipt, handing, processing, and storage conditions.

N02CP81000-87 Page 4 of 6

f. Report to the appropriate COR or Alternate COR all irregularities, delays, losses, deteriorations, unplanned defrostings, accidents, mishandlings, errors, discrepancies, and inefficiencies connected with any specimen collection, handling, delivery, storage, or testing activity as soon as it becomes known to the Contractor.

g. Obtain all necessary laboratory reports of results or progress.

7. Data Preparation

The Contractor shall prepare data. These activities include but are not limited to:

a. Coordinate data collection and harmonization across studies.

b. Develop or select disease, occupation, industry, demographic, geographic, and exposure coding schemes in consultation with the NCI COR.

c. Develop and update family pedigrees in family-based studies.

d. Code information into computer readable form. Verify a 10 percent (or higher as requested by COR) sample for accuracy of the coding by independent recoding. Accuracy is to be maintained at 98% level.

8. Computer Programming and Data Processing

The Contractor shall provide computer programming and data processing. These activities include but are not limited to:

a. Use modifiable data management and tracking systems that can be applied across studies.

Minimize creation of unique study-specific management and tracking systems. Such systems shall be approved by the COR. Systems should be compatible with existing systems, such as Biospecimen Inventory II, Laboratory Information Management System of the Core Genotyping Facility, FAIR/FAIRVIEW or others as appropriate and specified by the COR.

b. Provide capability of creating large datasets in SAS, STATA, or other programs as requested by the COR. All data processing, storage, and transfer shall be in compliance with US Government standards of privacy and confidentiality.

c. Maintain adequate backup of study data and secure storage of backup media. Frequency of backup may vary by specific study, but shall be determined by COR.

d. Use the FAIR/FAIRVIEW for the maintenance of family studies data.

Note: FAIR/FAIRVIEW is a proprietary relational database software package developed for use by DCEG investigators. The Government shall provide the FAIR/FAIRVIEW software and training for its use to the Contractor. The Contractor shall provide the appropriate personal computers and time for training of personnel to use

FAIR/FAIRVIEW.

e. Enter coded information into suitable computer devices. Verify entry by 100 percent rekeying and other Q/C measures. Evidence that double keying was not performed shall be considered poor performance by the Contractor and shall be reflected in performance evaluations.

f. Prepare edit programs, edit data, and correct computer files where necessary.

g. Update files with follow-up data, error corrections, and other edits or changes as directed by the

h. Prepare datasets suitable for analyses for transfer to computing platforms, as specified by the

i. Provide and maintain electronic system to allow investigators with role-based permission for data access, including but not limited to data queries, data access, data submissions, and data deliveries.

In addition, it is anticipated that the program, study and project management IT infrastructure for DCEG shall evolve over the contract Period of Performance. The business process requirements

N02CP81000-87 Page 5 of 6 for the contractor may include the use of and integration with, government provided information systems to request, track and report discrete work efforts. The contractor is expected to adopt a flexible and agile posture in its management, distribution and analysis of data to facilitate the continual improvement of the DCEG business processes.

9. Study Monitoring, Quality Control, and Reporting

Quality control of all aspects of data collection and management is a crucial activity. NCI shall carefully review studies to ensure that the data are sound. At the beginning of each study, the NCI investigator who is responsible for the study shall approve a plan prepared by the Contractor’s study manager for the schedule and contents of reports needed for quality control. Quality controls shall require that the Contractor provide activities including, but not limited to:

a. Document each step in a specific study and maintain, in an orderly arrangement, all relevant material so that any aspect of a study may be reviewed and evaluated by the NCI COR at any point in time. Involved are the following:

i. Type letters and prepare forms and other documents necessary in the conduct of a study.

ii. Duplicate study documents when the original sources cannot be retained.

iii. Maintain a filing system of all materials relevant to a particular study, cross referenced in a manner so as to make all of the material easily accessible. These materials shall be maintained under security in accordance with requirements of the Privacy Act as it applies to Contractors. Data for family studies shall be maintained in accordance with requirements of a Certificate of Confidentiality.

iv. Maintain a log of decisions made during each study that affect the design, conduct, or analysis. Each entry shall include a brief explanation and date of the problem, the decision made, and the name of the NCI staff member who authorized the change.

b. Develop and use internal record-keeping procedures for assessing the progress and status of data collection, preparation and entry. These record systems may be paper files or computer systems.

c. Monitor and document the performance and progress of any work done under subcontract in the performance of a study.

d. Develop quality control procedures for the handling of biologic specimens specific for needs of each study.

e. Report verification rates, discrepancy rates, and error rates for data collection, preparation and keying following the schedule agreed upon with the COR. Any unusual problems shall be brought immediately to the attention of the COR.

f. Provide monthly, semi-annual, and final technical progress reports and monthly budget reports, as specified by the NCI COR and/or designated representative.

g. Provide and maintain electronic system to allow investigators with role-based permission for various study monitoring, quality control and reporting activities, including but not limited to initiate and track requests and other communications, monitor billing, track project status. In addition, it is anticipated that the business and financial tracking and reporting requirements shall evolve over the contract Period of Performance. These requirements for the contractor may include the use of and integration with government provided information systems to request, track and report discrete work efforts. The contractor is expected to adopt a flexible and agile posture in its project management efforts in order to facilitate the continual improvement efforts of the

DCEG.

10. Final Transition:

The Contractor shall submit a Final Transition Plan to the NCI COR during the final year of the contract. At a minimum the plan must address how information will be successfully transitioned

N02CP81000-87 Page 6 of 6 to a subsequent contractor. A draft of this transition plan is due to the NCI COR 120 calendar days prior to the completion date of the contract. The final plan is due at least 90 calendar days prior to the completion date of the contract for final review and approval by the NCI COR.

The transition plan shall include recommended steps to sustain the routine daily activities to minimize any disruption of the contract activities during the transition. All required activities shall be maintained at a level specified by the COR including the tasks that are associated with the relocation effort to the NCI designee. In addition, inventory of all data collection instruments developed during the contract, all raw data, and all deliverables to the Government shall be completed. All study related materials, documentation, and archived records shall be transferred to the NCI designee prior to the end of the contract. The transition plan should include detailed descriptions of the security measures for protecting the privacy and confidentiality of the clinical and other records and data collected during the contract.