2013-N-15720_Cytology_Workload_Assessment.doc

SOLICITATION, OFFER AND AWARD

1. THIS CONTRACT IS A RATED ORDER

UNDER DPAS (15 CFR 700)

RATING

PAGE OF

2. CONTRACT NO.

3. SOLICITATION NO.

2013-N-15720

4. TYPE OF SOLICITATION

X

NEGOTIATED (RFP)

5. DATE ISSUED

6. REQUISITION/PURCHASE NO.

000HCPGC-2013-60840

Centers for Disease Control and Prevention (CDC)

Procurement and Grants Office (PGO)

2920 Brandywine Rd, RM 3000

Atlanta, GA 30341-5539

Approved as to Form and Legality: _____________________________

NOTE: In sealed bid solicitations “offer” and “offeror” mean “bid” and “bidder.”

SOLICITATION

9. Sealed offers in original and handcarried, in the depository located in 08/21/2013formtext until 5:00pm local time

CAUTION -- LATE Submissions, Modifications, and Withdrawals: See Section L, Provision No. 52.214-7 or 52.215-1. All offers are subject to all terms and conditions contained in this solicitation.

10. FOR INFORMATION

CALL:

A. NAME

Lashanda N. Washington

B. TELEPHONE (NO COLLECT CALLS)

AREA CODE NUMBER: EXT:

(770) 488-2766

C. E-MAIL ADDRESS

lnwashington@cdc.gov

11. TABLE OF CONTENTS

(x)

DESCRIPTION

(x)

DESCRIPTION

X

REPRESENTATIONS, CERTIFICATIONS, AND

OFFER (Must be fully completed by offeror)

NOTE: Item 12 does not apply if the solicitation includes the provisions at 52.214-16, Minimum Bid Acceptance Period.

12. In compliance with the above, the undersigned agrees, if this offer is accepted within period is inserted by the offeror) from the date for receipt of offers specified above, to furnish any or all items upon which prices are offered at the price set opposite each item, delivered at the designated point(s), within the time specified in the schedule.

13. DISCOUNT FOR PROMPT PAYMENT

(See Section I, Clause No. 52-232-8)

10 CALENDAR DAYS

20 CALENDAR DAYS

30 CALENDAR DAYS

CODE

FACILITY

16. NAME AND ADDRESS OF PERSON AUTHORIZED TO SIGN OFFER

15B. TELEPHONE NO.

AREA CODE NUMBER EXT.

15C. CHECK IF REMITTANCE ADDRESS

SUCH ADDRESS IN SCHEDULE.

17. SIGNATURE

18. OFFER DATE

AWARD (To be completed by Government)

19. ACCEPTED AS TO ITEMS NUMBERED

20. AMOUNT

22. AUTHORITY FOR USING OTHER THAN FULL AND OPEN COMPETITION:

21. ACCOUNTING AND APPROPRIATION

23. SUBMIT INVOICES TO ADDRESS SHOWN IN

(4 copies unless otherwise specified)

ITEM

Centers for Disease Control and Prevention (CDC)

Procurement and Grants Office (PGO)

2920 Brandywine Rd, RM 3000

Atlanta, GA 30341-5539

Centers for Disease Control and Prevention (FMO)

PO Box 15580 404-718-8100

Atlanta, GA 30333-0080

26. NAME OF CONTRACTING OFFICER (Type or print)

27. UNITED STATES OF AMERICA

(Signature of Contracting Officer)

28. AWARD DATE

IMPORTANT -- Award will be made on this form, or on Standard Form 26, or by other authorized official written notice.

AUTHORIZED FOR LOCAL REPRODUCTION

STANDARD FORM 33 (REV. 9-97)

PREVIOUS EDITION IS UNUSABLE

Prescribed by GSA

FAR (48 CFR) 53.214©

Section B - Supplies Or Services And Prices/Costs

New Procurement Order for Cytology Workload Assessment and Measure.

Task 1- Survey and Assessment

This is a severable Line Item.

This is a Firm Fixed Price Line Item.

This contract is dollar base and will be invoiced monthly.

1 Task

New Procurement Order for Cytology Workload Assessment and Measure.

Task 2- Measurement Study

This is a Non-severable Line Item.

This is a Firm Fixed Price Line Item.

This contract is dollar base and will be invoiced monthly.

1 Task

There are no clauses/provisions included in this section.

Section C - Description/Specification/Work Statement Cytology Workload Assessment and Measure C1. Purpose

The purpose of this acquisition is twofold: 1) assess cytology laboratory practices related to workload for cytotechnologists and 2) to measure the actual amount of time spent by cytotechnologists in screening Pap test glass slides using an automated review microscope with both of the FDA-approved image-assisted slide screening systems. The contractor must have on-site access to cytology laboratories, as a CMS approved accrediting agency, CMS approved proficiency testing program, or have a formal arrangement with CMS to conduct on-site laboratory inspections or surveys. The results of this practice assessment and time study may be used by the Department of Health and Human Service agencies responsible for the Clinical Laboratory Improvement Amendments (CLIA) program to determine appropriate gynecologic cytology screening workload maximums using image-assisted devices.

C2. Background and Need The Clinical Laboratory Improvement Amendments of 1988 (CLIA) directed the Secretary of Health and Human Services to establish the maximum number of cytology slides that any individual may screen in a 24 hour period; to establish certain quality assurance standards; to set personnel standards; and to provide for periodic proficiency testing of cytotechnologists and pathologists involved in screening and interpreting cytological preparations. The regulations implementing CLIA, published in the Federal Register of February 28, 1992, established that the maximum number of slides examined by an individual in each 24 hour period was not to exceed100 slides and could not be examined in less than an eight hour day. The regulation further established that the technical supervisor is required to evaluate the performance of cytotechnologists at least every six months and determine their individual maximum daily workload limit.

In 1992, when the regulation was published, all Pap slides were conventional "Pap smears." In a conventional Pap smear, samples are smeared directly onto a glass microscope slide after collection. The cells are often obscured by blood or the smear may be too thick and contain contaminating artifacts. Today, almost all Pap tests in the U.S. are collected with a liquid-based method. Instead of "smearing" cervical cells directly onto a glass microscope slide, the cells are sent to the laboratory in a liquid preservative and processed by an automated processor. This processor disperses a uniform thickness representative sample on the slide that is free of obscuring blood, mucus, and non-diagnostic debris in a circle that covers less than one half of the slide.

The Federal Advisory Committee for CLIA, the Clinical Laboratory Improvement Advisory Committee (CLIAC) has discussed cytology workload on numerous occasions from 1996 until present. The first workgroup was convened in July 1999 to provide input on how to determine workload for liquid-based Pap slides. The workgroup suggested it would be impossible to select one number that would be appropriate for all technology since automated and image-assisted screening devices were in development and approval by FDA might occur in the near future. In 2003, the CLIA requirements were amended to require the manufacturer of an image-assisted screening device to include a maximum workload number in the product insert, rather than set a number in the CLIA regulations.

The same year the amended regulations were made final, the first image-assisted device was approved which further reduced the area of screening by the cytotechnologist by using an automated review microscope to present the cytotechnologist with a set number of fields of view (FOV). This further complicated workload counting since it should take less time to review the FOVS than it would take to manually review the entire circle of the liquid-based preparation. Currently, two systems are FDA-approved, the Hologic ThinPrep® Imaging System and Becton Dickinson's Focal Point ™ Guided Screening System. The product insert for both devices includes a method of counting slides where slides screened on the automated review microscope will be counted as half (.5) and a full manual review of the entire circle will be counted as one (1) slide.

CMS and FDA conducted an investigation into problems reported by surveyors of cytology laboratories regarding the two FDA-approved image-assisted screening devices. The investigation led to a different method for calculation of workload than the methods reported in the product inserts. This information was presented at the September 2010 CLIAC meeting and FDA issued an alert - How Laboratorians Can Safely Calculate Workload for FDA-Approved Semi-Automated Gynecologic Cytology Screening Devices. In this alert, it stated laboratories should have a clear standard operation procedure documenting the method of workload counting and explaining how the Technical Supervisor should establish workload limits for each individual. Also, the alert clarified how workload should be calculated when using either the Hologic's ThinPrep® Imaging System or Becton Dickinson's Focal Point ™ Guided Screening System:

· All slides with full manual review (FMR) count as 1 slide (as mandated by CLIA’s requirements for manual screening.

· All slides with only field of view (FOV) review count as 0.5 or ½ slide

· Then, slides with both FOV and FMR count as 1.5 or 1 ½ slides

· Use these values to count workload, which should not exceed the CLIA maximum limit of 100 slides in no less than an 8-hour day.

On August 29, 2011 the American Society of Cytopathology’s (ASC) Executive Board approved an ASC task force recommendation that the average laboratory cytotechnologist productivity should not exceed 70 slides and that an individual’s screening time should not exceed seven (7) hours in a 24 hour period. This recommendation was presented at the ASC 2011 annual meeting and was endorsed unanimously by the Cytology Education and Technology Consortium member organizations: American Society for Clinical Pathology, American Society for Cytotechnology, American Society of Cytopathology, and Papanicolaou Society of Cytopathology. The College of American Pathologists also acknowledged that the current workload limits for image assisted screening devices may be set too high for the average cytotechnologist, but that further study was needed to define best practices for image-assisted gynecologic workload limits.

The ASC Taskforce recommendation was presented at the February 2012 CLIAC meeting along with presentations describing workload studies and use of the workload limit as a target. The committee issued a recommendation that CLIAC supports the use of data from operational studies, such as those presented to CLIAC, to determine if the maximum workload limit using image-assisted screening instruments is appropriate and to discourage the use of regulatory maximum workload limits as productivity targets. CLIAC recommended that standardized criteria be developed for use in determining workload limits for each individual performing screening.

Due to ongoing concerns regarding the appropriateness of the regulatory 100 slide maximum workload limit and lack of a standardized method for counting slides using the image-assisted screening devices, a study is needed to directly assess actual practice. The study needs to include an evaluation of laboratory practices related to setting individual workload limits and time and motion studies to determine the actual time spent screening slides. The time and motion studies need to also assess other factors, such as time of day, length of time spent screening, and an evaluation of the accuracy of diagnosis.

References ASC’s Workload Recommendation for Automated Pap Test Screening. http://www.cytopathology.org/website/download.asp?id=6429 February 2012 CLIAC Summary, see section on Semi-Automated Cytology Workload, http://wwwn.cdc.gov/cliac/cliac0212.aspx September 2010 CLIAC Summary, see section on Workload Recording for Semi-automated Cytology Screening Devices (FDA) under Cytology Proficiency Testing, http://wwwn.cdc.gov/cliac/cliac0910.aspx BD FocalPoint™ GS Imaging System Product Insert, http://www.bd.com/tripath/downloads/msds_pi/focalpoint/focalpoint_gs_pi.pdf Thin Prep Imaging product insert, http://www.thinprep.com/pdfs/thinprep_package_insert.pdf C3. Scope and Requirements:

C3.1 Project Objectives:

Project objectives are twofold: 1) conduct an assessment of cytology laboratory practices related to workload for cytotechnologists and 2) measure the amount of time spent by cytotechnologists screening Pap test glass slides using an automated review microscope with the two FDA-approved image-assisted slide screening systems (the Hologic Thin Prep Imaging System and the Becton Dickinson Focal Point GS Imaging System).

C3.2 Scope of Work:

Except where noted, the contractor shall, as an independent organization, and not as an agent for the government, furnish all labor, materials, facilities and equipment necessary to perform the following tasks. The contractor must have on-site access to cytology laboratories performing Pap tests using image-assisted screening devices, as a CMS approved accrediting agency, CMS approved proficiency testing program, or have a formal arrangement with CMS to conduct on-site laboratory inspections or surveys.

C3. 3 Tasks:

1) Conduct a survey of all cytology laboratories to assess laboratory practices related to workload for cytotechnologists.

2) Conduct a study to measure the amount of time spent screening Pap test glass slides using an automated review microscope with the two FDA-approved image-assisted slide screening systems.

C3.4 Detailed Technical Requirements:

Task 1: Conduct a survey of all cytology laboratories in the U.S. with a CLIA Certificate of Accreditation or Certificate of Compliance to assess cytology laboratory practices related to workload for cytotechnologists.

The contractor will –

a. Develop a protocol for conducting the survey using the survey questions provided by CDC. The protocol should address how the awardee will distribute the survey and collect the information to maximize the response rate.

b. Develop a database that will store the information collected from the survey questions in a format that is agreeable with CDC. The information collected should not include names or unique identifiers that link the laboratory or individuals to the data set.

c. Distribute the survey to all laboratories in the U.S. that hold a CLIA Certificate of Accreditation or Certificate of Compliance for cytology and to the cytotechnologists that work in those laboratories.

d. Collect and analyze the survey responses.

e. Validate a statistically representative sample of survey responses by performing on-site laboratory visits to confirm that the data collected using the survey instrument reflects actual practice in the laboratories. The contractor must have onsite access to cytology laboratories in order to validate information provided in the survey. Ability to access laboratories must be demonstrated by proof of CMS approval as an accrediting agency; CMS approved proficiency testing programs for cytology, or other arrangement with CMS that allows entry into the laboratory with access to individual and laboratory workload information. In addition the contractor must use cytopathologists and/or cytotechnologists to perform the validation.

f. Provide CDC with a copy of the survey response database and data analysis.

g. Using information obtained from the survey regarding laboratory practices for setting individual workload limits develop a draft guidance document to aid technical supervisors in evaluating and setting individual daily workload limits.

h. Collaborate with CDC to publish the results of the survey in a peer-reviewed journal.

CDC will--

a. Develop the survey questions and obtain necessary clearances (OMB, human subjects, etc.).

Task 2: Conduct a study to measure the amount of time spent screening Pap test glass slides using an automated review microscope with the two FDA-approved image-assisted slide screening systems.

The contractor will –

a. Develop a protocol to be approved by CDC (see f below) to conduct the study that will achieve the following goals:

1. Measure the amount of time cytotechnologists spend in an 8 hour day screening the FOV on Pap tests using one of the two FDA-approved image-assisted slide screening systems. Pap tests may be from the laboratories current workload (not screened previously) or from a standardized set provided by the contractor.

2. Measure the amount of time cytotechnologists spend in an 8 hour day on FMR of Pap tests that have previously been screened for FOV using one of the two FDA-approved image-assisted slide screening systems.

3. Determine the percent of slides cytotechnologists screened for FOVs that require a FMR.

4. Determine if any cells were missed and if the cytotechnologist’s interpretation matched a target interpretation on any of the Pap test screened in steps 1 and 2.

b. Develop a plan for analysis of the data elements collected. CDC must agree with the plan before use. The analysis plan should include the following;

1. Comparison of the time measurement data recorded during the study with the information collected from the survey in task 1.

2. Comparison of the screening rate in hourly increments throughout the period of screening (at least 8 hours).

3. Review of missed cells in hourly increments throughout the period of screening (at least 8 hours).

4. Flow diagram showing the sequence of events accompanied with cost curves per sample size, and a description of the methods chosen to conduct the study and analysis plan.

c. Design and provide work aids to guide the study volunteers in performing the time/motion studies and collect any additional information on the time required for various screening components that are not performed using the automated review microscope during the day of the study. This may include time spent reviewing the patient history, entering data in a separate LIS, assessing other cytotechnologist performance using quality measures, on break or lunch, preparing specimens or slides, and collecting or screening non-gynecologic specimens.

d. Solicit participation in the study from CLIA-certified cytology laboratories that use one or both of the FDA-cleared image-assisted slide screening systems. The survey conducted in task one will identify which laboratories are using image assisted screening systems. The laboratory must agree to allow at least one cytotechnologist to use the automated review microscope to screen slides for one full workday and to allow the contractor to conduct the study. The solicitation should also collect the number of cytotechnologists willing to volunteer for the study and the Laboratory Director’s approval for study participation.

e. Conduct a pilot of the study plan utilizing at least five (5) but no more than nine (9) cytotechnologists.

f. Within six (6) weeks of initiating the pilot deliver to CDC a report that summarizes the results of the pilot and includes any recommendations for additional revisions. When the protocol is agreed upon by the contractor and CDC, the contractor will proceed with the conducting the remainder of the study.

g. Enroll at least 100 volunteer cytotechnologists in the study. The sample must include 50 volunteers that use the Hologic Thin Prep Imaging System and 50 volunteers that use the Becton Dickinson Focal Point GS Imaging System. The criteria for selection of volunteers will be established using data collected in the survey from task one and must be agreeable with CDC. Criteria for inclusion must include cytotechnologists--

a. working in small, mid, and large sized labs

b. working in independent and hospital - based labs, if possible, and

c. who have variable screening workload limits.

h. After selection of volunteers and laboratories, submit a timeline and schedule for conducting the study.

i. Using the schedule developed in (h) above, conduct the study in the laboratories where the study volunteers work.

j. Upon completion of data collection, data will be identified by code or number that does not include names or unique identifiers that link the laboratory or individuals to the data set before transmittal to CDC in a format greed upon after award of the contract. The contractor must ensure that the identifiable data for the purpose of the contract will be maintained only for the time period necessary to obtain sufficient data and perform quality control tasks.

k. Collaborate with CDC to analyze and publish the results of the study in a peer-reviewed journal.

CDC will provide assistance in developing a tool to collect the cytotechnologists’ time measurements and interpretation of the Pap tests screened.

C4. Government provided equipment: No GPE/GFP/GFF/GFI will be issued to the contractor. The contractor will provide all time and materials needed for the two tasks.

C5. Deliverables: The contractor will provide the time measures, data analysis, practice survey results analysis, draft guidelines, manuscript drafts, and reports as listed under the item 10 below.

C6. Reporting Schedule C6.1 Quarterly Status Report. The quarterly status report, due three months after award and then every three months until completion, includes task expenditures versus planned expenditures, technical progress made, schedule status, status of collected data, issues and recommendations. Additionally, the quarterly status report will identify deliverables completed within the previous reporting period and will indicate what deliverables are scheduled to be delivered during the upcoming reporting period The quarterly status report will be in PDF format and e-mailed to the designated CDC Project Officer and Contracting Officer.

C6.2 Annual Status Report. The annual report includes the year-end task expenditures versus planned expenditures, technical progress made, schedule status, status of collected data, issues and recommendations. The annual report will be in PDF format and will be e-mailed to the designated CDC Project Officer. The Contractor shall deliver an electronic copy of the draft final report to the CDC Project Officer (PO) 30 days prior to end of contract year. The Government will require 15 days for review and comment on the draft version allowing Contractor 15 subsequent days to incorporate government comments. The final annual status report is due upon end of contract year.

C6.3 Final Technical Report. Final detailed written technical report shall include task background, objectives, assumptions, specific data collected, analyses conducted, results, and conclusions. The report shall be delivered to the CDC Project Officer prior to the expiration of the period of performance. The contractor shall deliver an electronic copy of the draft final report to the CDC Project Officer 60 days prior to task end. The Government will require 15 days for review and comment on the draft version allowing Contractor 15 subsequent days to incorporate government comments. The final technical report is due upon contract expiration.

C7. Special Considerations

a. CDC will work with cytology subject matter experts to develop the practice survey questionnaire. A survey instrument with no more than 25 questions will be provided to the contractor.

b. CDC will provide the database program to collect the study participant’s interpretation and the time data. The contractor will provide a laptop or suitable platform agreed upon by CDC for running the database program.

C8. Types of personnel and experience required

a. Project management expertise.

b. Experience in conducting surveys and conducting performance studies

c. Experience developing assessment tools and providing analysis of collected data

d. Knowledge of cytology, including practices in use of image-assisted screening devices to screen Pap test slides, developing referenced sets of Pap test slides, manually rescreening Pap test slides, adjudicating discrepancies in the interpretation of the Pap test slides, methods used by technical supervisors to evaluate and determine individual workload limits, and cytology laboratory work flow. [Note: Performing the validation of the survey data requires the abilities of a cytotechnologist and/or cytopathologist; if the staffing plan does not include cytotechnologist(s) and/or cytopathologist(s), the proposal will be given a zero (0) score for this element.] C9. Other requirements

a. Projects that involve the collection of information from 10 or more individuals and are funded by a contract will be subject to review and approval by the Office of Management and Budget (OMB) under the Paperwork Reduction Act.

b. CDC will obtain OMB approval of the survey.

C10. Specific Deliverables

Kick-off meeting with CDC investigators

14 days after award

Year 1

Complete protocol for survey distribution

60 days after award

Database for collection designed and operational

90 days after award

Surveys distributed

60 days after award

Data from survey collected

120 days after award

Validation of survey results completed

270 days after award

Complete protocol for time measure study finalized and initiate pilot study

180 days after award

Complete pilot study and provide report to CDC

210 days after award

Develop guidance document

300 days after award

Draft publishable manuscript with CDC

365 days after award

Year 2

Analyze data from survey validation, evaluation of accuracy and time measure study

360 days after start of Year 2

Draft publishable manuscript with CDC

365 days after start of Year 2

Section D - Packaging And Marking

There are no clauses/provisions included in this section.

Section E - Inspection And Acceptance E.1 Inspection and Acceptance

Inspection and acceptance of the articles, services, and documentation called for herein will be accomplished by the Contracting Officer, or his duly authorized representative (who for the purposes of this contract will be the Contracting Officer’s Technical Representative) (COR) at the destination of the articles, services or documentation.

(End of Clause)

Section F - Deliveries Or Performance F.1 Period of Performance (Jul 1999) The anticipated period of performance will differ for each line item. For Line Item 0001 the Period of Performance will be 08/30/2013-08/29/2014. For Line Item 0002 the Period of Performance will be 08/30/2013-08/29/2015.

F.2 Place(s) of Performance (Jul 1999) The contractor shall perform work either on contractor’s site or 2400 Century Center, Atlanta, GA.

F.3 Deliverable(s) Schedule (Jul 1999) The contractor shall deliver, within the time frames specified, to the Contracting Officer’s Representative (COR), at the address shown in Section G, and copies of items so specified, to the Contracting Officer at the address shown on the face page of the contract.

Section G - Contract Administration Data G.1 Contract Representative

Contracting Officer (CO) responsible for this contract:

Kristopher A. Lemaster

Centers for Disease Control and Prevention (CDC)

Procurement and Grants Office (PGO)

2920 Brandywine Road, MS K-69

Atlanta, GA 30341-5539

Telephone Number: 770-488-2671

Email: KLemaster@cdc.gov

Contract Administrator (CA) responsible for this contract:

LaShanda Washington

Centers for Disease Control and Prevention (CDC)

Procurement and Grants Office (PGO)

2920 Brandywine Road, MS K-69

Atlanta, GA 30341-5539

Telephone Number: 770-488-2766

Email: LNWashington@cdc.gov

Contracting Officer’s Representative (COR) responsible for this contract:

Maribeth Gagnon

Centers for Disease Control and Prevention (CDC)

2400 Rm 5204

CENT Bldg, MS E92

Atlanta, GA 30329

G.2 Contracting Officer (Jul 2012)

(a) The Contracting Officer is the only individual who can legally commit the Government to the expenditures of public funds. No person other than the Contracting Officer can make any changes to the terms, conditions, general provisions, or other stipulations of this contract.

(b) No information, other than that which may be contained in an authorized modification to this contract, duly issued by the Contracting Officer, which may be received from any person employed by the United States Government, or otherwise, shall be considered grounds for deviation from any stipulation of this contract.

(End of Clause)

G.3 Contracting Officer’s Representative (COR)

(a) A Contracting Officer’s Technical Representative (COR) as a minimum, and possibly a Technical Monitor (TM), will be assigned to this delivery order. The Contracting Officer will provide under separate cover the duties and responsibilities of the COR and Technical Monitor. This document will be provided to the COR, TM and the Contractor. The COR and/or the TM are not authorized to alter the requirements of this delivery order without written approval of the Contracting Officer. COR/TM is not authorized to obligate any funds.

(b) Performance of the work hereunder shall be subject to the technical directions of the designated Contracting Officer’s Technical Representative (COR) for this contract. Technical Monitors will report to the COR.

(c) For purposes of this agreement, Technical Monitor duties for individual delivery/task orders are the same as the COR’s duties. Hereinafter in this clause, the duties and responsibilities described for the COR also apply to the Technical Monitors under the individual delivery/task order for which the Technical Monitors are responsible.

(d) As used herein, technical directions are directions to the Contractor which fill in details, suggests possible lines of inquiry, or otherwise completes the general scope of work set forth herein. These technical directions must be within the general scope of work, and may not alter the scope or work or cause changes of such a nature as to justify an adjustment in the stated contract price/cost, or any stated limitation thereof. In the event that the Contractor feels that full implementation of any of these directions may exceed the scope of the contract, he or she shall notify the originator of the technical direction and the Contracting officer in a letter separate of any required report(s within two (2) weeks of the date of receipt of the technical direction and no action shall be taken pursuant to the direction. If the Contractor fails to provide the required notification within the said two (2) week period that any technical direction exceeds the scope of the contract, then it shall be deemed for purposed of this contract that the technical direction was within the scope. No technical direction, nor its fulfillment, shall alter or abrogate the rights and obligations fixed in this contract.

(e) The Government COR is not authorized to change any of the terms and conditions of this contract. Changes shall be made only by the Contracting Officer by properly written modification(s) to the contract.

(f) The Government will provide the Contractor with a copy of the delegation memorandum for the COR. Any changes in COR delegation will be made by the Contracting Officer in writing with a copy being furnished to the Contractor.

(End of Clause)

G.4 Evaluation of Contractor Performance (Service) ( July 2013)

(a) Purpose

In accordance with FAR 42.1502, the Contractor's performance will be periodically evaluated by the Government, in order to provide current information for source selection purposes. These evaluations will therefore be marked “Source Selection Information.”

(b) Performance Evaluation Period

The Contractor's performance will be evaluated at least annually.

(c) Evaluators

The performance evaluation will be completed jointly by the COR and the Contracting officer.

(d) Performance Evaluation Factors

The contractor's performance will be evaluated in accordance with the attachment listed in Section J titled Performance Evaluation Report.

(e) Contractor Review

A copy of the evaluation will be provided to the contractor as soon as practicable after completion of the evaluation. The contractor shall submit comments, rebutting statements, or additional information to the Contracting Officer within 30 calendar days after receipt of the evaluation.

(f) Resolving Disagreements Between the Government and the Contractor

Disagreements between the parties regarding the evaluation will be reviewed at a level above the Contracting Officer. The ultimate conclusion on the performance evaluation is a decision of the contracting agency. Copies of the evaluation, contractor's response, and review comments, if any, will be retained as part of the evaluation.

(g) Release of Contractor Performance Evaluation Information

The completed evaluation will not be released to other than Government personnel and the contractor whose performance is being evaluated. Disclosure of such information could cause harm both to the commercial interest of the Government and to the competitive position of the contractor being evaluated as well as impede the efficiency of Government operations.

(h) Source Selection Information

Departments and agencies may share past performance information with other Government departments and agencies when requested to support future award decisions. The information may be provided through interview and/or by sending the evaluation and comment document to the requesting source selection official.

(i) Retention Period

The agency will retain past performance information for a maximum period of three years after completion of contract performance for the purpose of providing source selection information for future contract awards.

(End of Clause)

G.5 Contract Communications/Correspondence (June 2012) The Contractor shall identify all correspondence, reports, and other data pertinent to this contract by imprinting thereon the contract number from Page 1 of the contract.

(End of Clause)

G.6 Payment by Electronic Funds Transfer (June 2012)

(a) The Government shall use electronic funds transfer to the maximum extent possible when making payments under this contract. FAR 52.232-33, Payment by Electronic Funds Transfer – Central Contractor Registration, in Section I, requires the contractor to designate in writing a financial institution for receipt of electronic funds transfer payments.

(b) In addition to Central Contractor Registration, the contractor shall make the designation by submitting the form titled “ACH Vendor/Miscellaneous Payment Enrollment Form” to the address indicated below. Note: The form is either attached to this contract (see Section J, List of Attachments) or may be obtained by contacting the Contracting Officer or the CDC Financial Management Office at (404) 498-4050.

(c) In cases where the contractor has previously provided such designation, i.e., pursuant to a prior contract/order, and been enrolled in the program, the form is not required unless the designated financial institution has changed.

(d) The completed form shall be mailed after award, but no later than 14 calendar days before an invoice is submitted, to the following address:

The Centers for Disease Control and Prevention

Financial Management Office (FMO)

P.O. Box 15580

Atlanta, GA 30333

Or – Fax copy to: 404-638-5342

(End of Clause)

G.7 Invoice Submission – Part 1 (Mar 2006)

(a) The Contractor shall submit the original contract invoice/voucher to the entity shown below:

The Centers for Disease Control and Prevention Financial Management Office (FMO) P.O. Box 15580 Atlanta, GA 3033

(b) Please submit a copy of each invoice directly to the COTR and Contracting Officer or Contract Administrator concurrently with submission to the Financial Management Office (FMO). The Contractor may submit the original invoice/voucher via facsimile or email to the three entities listed below.

Contract Specialist: LaShanda N. Washington, (770) 488-2766, Email: iyc5@cdc.gov, FAX: (770)488-2671 COR: Maribeth Gagnon Financial Management Office (FMO), Email: FMOAPINV@CDC.GOV, FAX: 404-638-5324

(c) The Contractor is required to submit a copy of each invoice directly to the COTR concurrently with submission to the Contracting Officer.

(d) In accordance with 5 CFR part 1315 (Prompt Payment), CDC's Financial Management Office is the designated billing office for the purpose of determining the payment due date under FAR 32.904.

(e) The Contractor shall include (as a minimum) the following information on each invoice:

(1) Contractor’s Name & Address

(2) Contractor’s Tax Identification Number (TIN)

(3) Purchase Order/Contract Number and Task Order Number, if Appropriate

(4) Invoice Number

(5) Invoice Date

(6) Contract Line Item Number and Description of Item

(7) Quantity

(8) Unit Price & Extended Amount for each line item

(9) Shipping and Payment Terms

(10) Total Amount of Invoice

(11) Name, title and telephone number of person to be notified in the event of a defective invoice

(12) Payment Address, if different from the information in (c)(1).

(13) DUNS + 4 Number

(End of Clause)

G.8 Prohibition on the Use of Appropriated Funds for Lobbying Activities (Jul 1999) The contractor is hereby notified of the restrictions on the use of Department of Health and Human Service's funding for lobbying of Federal, State and Local legislative bodies.

Section 1352 of Title 10, United Stated Code (Public Law 101-121, effective 12/23/89), among other things, prohibits a recipient (and their subcontractors) of a Federal contract, grant, loan, or cooperative agreement from using appropriated funds (other than profits from a federal contract) to pay any person for influencing or attempting to influence an officer or employee of any agency, a Member of Congress, an officer or employee of Congress, or an employee of a Member of Congress in connection with any of the following covered Federal actions; the awarding of any Federal contract; the making of any Federal grant; the making of any Federal loan; the entering into of any cooperative agreement; or the modification of any Federal contract, grant, loan, or cooperative agreement. For additional information of prohibitions against lobbying activities, see FAR Subpart 3.8 and FAR Clause 52.203-12.

In addition, the current Department of Health and Human Services Appropriations Act provides that no part of any appropriation contained in this Act shall be used, other than for normal and recognized executive-legislative relationships, for publicity or propaganda purposes, for the preparation, distribution, or use of any kit, pamphlet, booklet, publication, radio, television, or video presentation designed to support, or defeat legislation pending before the Congress, or any State or Local legislature except in presentation to the Congress, or any State or Local legislative body itself.

The current Department of Health and Human Services Appropriations Act also provides that no part of any appropriation contained in this Act shall be used to pay the salary or expenses of any contract or grant recipient, or agent acting for such recipient, related to any activity designed to influence legislation or appropriations pending before the Congress, or any State or Local legislature.

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G.9 CDC42.0002 Evaluation of Contractor Performance Utilizing CPARS (April 2013)

In accordance with FAR 42.15, the Centers for Disease Control and Prevention (CDC) will review and evaluate contract performance. FAR 42.1502 and 42.1503 requires agencies to prepare evaluations of contractor performance and submit them to the Past Performance Information Retrieval System (PPIRS). The CDC utilizes the Department of Defense (DOD) web-based Contractor Performance Assessment Reporting System (CPARS) to prepare and report these contractor performance evaluations. All information contained in these assessments may be used by the Government, within the limitations of FAR 42.15, for future source selections in accordance with FAR 15.304 where past performance is an evaluation factor.

The CPARS system requires a contractor representative to be assigned so that the contractor has appropriate input into the performance evaluation process. The CPARS contractor representative will be given access to CPARS and will be given the opportunity to concur or not-concur with performance evaluations before the evaluations are complete. The CPARS contractor representative will also have the opportunity to add comments to performance evaluations.

The assessment is not subject to the Disputes clause of the contract, nor is it subject to appeal beyond the review and comment procedures described in the guides on the CPARS website. Refer to: www.cpars.gov for details and additional information related to CPARS, CPARS user access, how contract performance assessments are conducted, and how Contractors participate. Access and training for all persons responsible for the preparation and review of performance assessments is also available at the CPARS website.

The contractor must provide the CDC contracting office with the name, e-mail address, and phone number of their designated CPARS representative who will be responsible for logging into CPARS and reviewing and commenting on performance evaluations. The contractor must maintain a current representative to serve as the contractor representative in CPARS. It is the contractor’s responsibility to notify the CDC contracting office, in writing (letter or email), when their CPARS representative information needs to be changed or updated. Failure to maintain current CPARS contractor representative information will result in the loss of an opportunity to review and comment on performance evaluations.

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Section H - Special Contract Requirements H.1 Data Subject To Confidentiality Requirements (May 1998)

The type(s) of data subject to the clause at 352.224-70, Confidentiality of Information, which has been incorporated by reference in Section I, are as follows:

All information pertaining to the strategic and operational planning, resourcing, and processing of Epi-X submitted / creating data.

Following are the requirements for handling these data:

The Contractor will develop procedures for maintaining the privacy and confidentiality of the data during data collection, analysis, process development and reporting to the CDC.

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H.2 Section 508 Accessibility Compliance Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d) requires Federal agencies to purchase electronic and information technologies (EIT) that meet specific accessibility standards. This law helps to ensure that federal employees with disabilities have access to, and use of, the information and data they need to do their jobs. Furthermore, this law ensures that members of the public with disabilities have the ability to access government information and services.

There are three regulations addressing the requirements detailed in Section 508. The Section 508 technical and functional standards are codified at 36 CFR Part 1194 and may be accessed through the Access Board’s Web site at http://www.access-board.gov. The second regulation issued to implement Section 508 is the Federal Acquisition Regulation (FAR). FAR Part 39.2 requires that agency acquisitions of Electronic and Information Technology (EIT) comply with the Access Board’s standards. The entire FAR is found at Chapter 1 of the Code of Federal Register (CFR) Title 48, located at http://www.acquisition.gov. The FAR rule implementing Section 508 can be found at http://www.section508.gov. The third applicable regulation is the HHS Acquisition Regulation (HHSAR).

Regardless of format, all Web content or communications materials produced for publication on or delivery via HHS Web sites - including text, audio or video - must conform to applicable Section 508 standards to allow federal employees and members of the public with disabilities to access information that is comparable to information provided to persons without disabilities. All contractors (including subcontractors1) or consultants responsible for preparing or posting content intended for use on an HHS-funded or HHS-managed Web site must comply with applicable Section 508 accessibility standards, and where applicable, those set forth in the referenced policy or standards documents below. Remediation of any materials that do not comply with the applicable provisions of 36 CFR Part 1194 as set forth in the SOW or PWS, shall be the responsibility of the contractor or consultant retained to produce the Web-suitable content or communications material.

The following Section 508 provisions apply to the content or communications material identified in this SOW: PWS: Access Board Final Rule 36 CFR Part 1194.22(a)-(p).

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H.3 Non-Disclosure Agreements for Contractor and Contractor Employees – Mar 2006

(a) The contractor shall prepare and submit a Non-Disclosure Agreement (NDA) to the Contracting Officer prior to access of government information or the commencement of work at CDC.

(b) The NDA made part of this clause, exhibit I and II, is required in service contracts where positions and/or functions proposed to be filled by contractor’s employees will have access to non-public and procurement-sensitive information. The NDA also requires contractor’s employees properly identify themselves as employees of a contractor when communicating or interacting with CDC employees, employees of other governmental entities (when communication or interaction relates to the contractor’s work with the CDC), and members of the public. The Federal Acquisition Regulation (FAR) 37.114 (c), states “All contractor personnel attending meetings, answering Government telephones, and working in other situations where their contractor status is not obvious to third parties are required to identify themselves as such to avoid creating an impression in the minds of members of the public or Congress that they are Government officials, unless, in the judgment of the agency, no harm can come from failing to identify themselves. They must also ensure that all documents or reports produced by contractors are suitably marked as contractor products or that contractor participation is appropriately disclosed.”

(c) The Contractor shall inform employees of the identification requirements by which they must abide and monitor employee compliance with the identification requirements.

(d) During the contract performance period, the Contractor is responsible to ensure that all additional or replacement contractors’ employees sign a NDA and it is submitted to the Contracting Officer prior to commencement of their work with the CDC.

(e) Contractor employees in designated positions or functions that have not signed the appropriate NDA shall not have access to any non-public, procurement sensitive information or participate in government meeting where sensitive information may be discussed.

(f) The Contractor shall prepare and maintain a current list of employees working under NDAs and submit to the Contracting Officer upon request during the contract period of performance. The list should at a minimum include: contract number, employee’s name, position, date of hire and NDA requirement.

EXHIBIT I

Centers for Disease Control and Prevention (CDC)

Contractor Non-Disclosure Agreement

I. Non-public Information [Name of contractor] understands that in order to fulfill the responsibilities pursuant to [Contract name and number] between the Centers for Disease Control and Prevention and [Name of CDC contractor] dated [date], employees of [contractor] will have access to non-public information, including confidential and privileged information contained in government-owned information technology systems. For purposes of this agreement, confidential information means government information that is not or will not be generally available to the public. Privileged information means information which cannot be disclosed without the prior written consent of the CDC.

In order to properly safeguard non-public information, [contractor] agrees to ensure that prior to being granted access to government information or the commencement of work for the CDC, whichever is applicable, all employees will sign a Non-Disclosure Agreement (NDA) provided by the CDC prior to beginning work for the CDC. Contractor agrees to submit to the contracting official the original signed copies of NDAs signed by the contractor’s employees in accordance with the instructions provided by the contracting official. Failure to provide signed NDAs in accordance with this agreement and instructions provided by the contracting official could delay or prevent the employee from commencing or continuing work at the CDC until such agreement is signed and returned to the contracting official.

Contractor further agrees that it will not cause or encourage any employee to disclose, publish, divulge, release, or make known in any manner or to any extent, to any individual other than an authorized Government employee any non-public information that the employee may obtain in connection with the performance of the employee’s responsibilities to the CDC.

II. Procurement-Sensitive Information Contractor further agrees that it will not cause or encourage any employee to disclose, publish, divulge, release, or make known in any manner or to any extent, to any individual, other than an authorized Government employee, any procurement-sensitive information gained while in…