QASP_Attachment_J-9.pdf

ATTACHMENT J-9

QUALITY ASSURANCE SURVEILLANCE PLAN (QASP)

1. Introduction

a. Since this is a Performance Based Contract, the CDC must effectively validate in a timely manner the performance of the Contractor in meeting the services required. This QASP provides a systematic surveillance method for the services, and describes the methodology by which the Contractor’s performance will be monitored.

b. The principal focus of the surveillance system is the Contractor’s performance of the indicators identified in the Performance-Based Matrix in Section C.6 of the Performance Work Statement.

c. The contract will be surveilled with this Quality Assurance Surveillance Plan. Additional surveillance may be added as needed by the program office.

d. The plan references the Contractor Performance Assessment Reporting System (CPARS). The CPARS system allows the Contracting Officer or the Contracting Officer’s Representative to report Contractor and subcontractor performance on a national, easily accessible database. It requires the CDC to review the database prior to approving the use of a Contractor to ensure that the contractor or subcontractor has done a good job in the past. As a result, it is anticipated that the CPARS system should help motivate the contractor, wishing future work in the Federal Sector, on the current contract toward superior performance.

e. This QASP:

i. Identifies the services and products that will be measured.

ii. Establishes the specific standards of performance for each required output.

iii. Establishes the responsibilities for performing the measurement.

iv. Defines the CDC role in overseeing the performance.

v. Provides for feedback to the contractor regarding quality, quantity, and timeliness of the service outputs.

vi. Establishes timeframes for communicating performance improvements.

2. Methods of Surveillance

a. The Performance Based Matrix in Section C.6 lists the services to be monitored and the standards to be applied.

b. This QASP is based on the premise the CDC desires to maintain a quality standard for services to conduct assessments, studies, research and demonstration projects, consultation and technical assistance, health education activities and related support services.

c. The contractor and not the CDC is responsible for management and quality control actions to meet the terms of the contract. The role of the CDC is quality assurance to ensure contract standards are achieved.

d. In this contract the contractor quality control program is the basis for service quality. The contractor is required to only deliver services that conform to the requirements of the contract as defined in the Performance Work Statement.

3. Roles and Responsibilities

a. The contractor’s primary responsibility is to ensure all requirements are met at the required quality level.

The CDC shall ensure this responsibility has been met before payment is made to the contractor. The primary CDC team members are the Contracting Officer’s Representative (COR) and the Contracting Officer

(CO).

b. The CO has the overall responsibility for overseeing the Contractor’s performance. The CO is responsible for monitoring Contractor performance in the areas of contract compliance, contract management, and the resolution of all issues relative to the language of the contract.

c. The COR and the COR team are responsible for directly monitoring, assessing, recording, and reporting on the technical performance of the Contractor. The COR will have primary responsibility for signing off on all invoices and documenting the inspection and evaluation of the contractor’s performance.

d. The COR will work with staff and the Contractor to ensure good communication and resolve any problems not requiring the CO’s authority.

4. Surveillance

a. The COR will evaluate the performance objectives through periodic inspections during each service month.

b. All performance must be documented, whether acceptable or unacceptable. When unacceptable performance is documented, the COR or Technical Monitor shall take the following actions:

i. If the government actions caused the unacceptable performance, take steps to prevent it in the future.

ii. If the contractor’s performance is unacceptable, inform the contractor’s Program

Director of the unacceptable performance and the reasons why it is unacceptable.

iii. If the contractor wants to dispute the results of the surveillance, refer them to the CO for resolution.

iv. Performance should not be determined unacceptable until all possible contributing factors have been considered.

v. For required tasks not shown on the Performance Based Matrix, the CDC still retains the right to inspect any item included in the contract. These services will be inspected periodically and the results provided to the CO.

5. Standards

a. All standards in the Performance Based Matrix must be met. All deliverable dates and other contractual completion dates must also be met. If any of the standards are not met, the CDC shall receive consideration from the contractor for breach of contract.

b. Late performance is un-excusable unless the contractor can justify all the following:

i. The delay was not the contractor’s fault

ii. The delay was not foreseeable.

iii. It was beyond the contractor’s control to avoid the delay.

c. All work shall be performed in accordance with the Performance Work Statement. The COR shall not consider the services complete until all deficiencies have been corrected.

d. The COR shall determine whether the failure was a minor non-conformance or a substantive non-conformance.

6. Procedures

a. The CDC will inspect performance requirements to ensure contractor compliance and record results of inspection. Unacceptable performance and complaints shall be referred to the CO for investigation and validation. The CO will investigate and validate the unacceptable performance or customer input. The contractor shall be given a reasonable amount of time after notification to correct the unacceptable performance and report to the CO that the deficiency has been corrected. If deficiencies are not corrected the COR will notify the CO and recommend a course of action.

b. The contractor’s overall Monthly Progress Report will be used to provide assurance that the contractor is working to maintain quality control and to keep on schedule.

7. Contract Performance Evaluation

a. FAR 42.15 – Contractor Performance Information establishes the CDC responsibility for recording and maintaining contractor performance information.

b. FAR 42.1501 – Past Performance information is relevant information for future source selection purposes, regarding a contractor’s actions under previously awarded contracts. It includes, for example, the contractor’s record of conforming to contract requirements and standards of good workmanship; the contractor’s record of forecasting and controlling costs; the contractor’s adherence to contract schedules, including the administrative aspects of performance; the contractor’s history of reasonable and cooperative behavior and commitment to customer satisfaction; and generally, the contractor’s business-like concern for the interest of the customers.

c. The general procedures to be used are addressed in FAR 42.1503: Agency procedures for the past performance evaluation system shall generally provide for input to the evaluations from the technical office, contracting office and, where appropriate, end users of the product or service. Agency evaluations of contractor performance prepared under this subpart shall be provided to the contractor as soon as practicable after completion of the evaluation. Contractors shall be given a minimum of 30 days to submit comments, rebutting statements, or additional information. Agencies shall provide for review at a level above the contracting officer to consider disagreements between the parties regarding the evaluation. The ultimate conclusion on the performance evaluation is a decision of the contracting agency. Copies of the evaluation, contractor response, and review comments, if any, shall be retained as part of the evaluation.

These evaluations may be used to support future award decisions, and should therefore be marked “Source Selection Information.”

d. The CPARS form will be completed at least annually and more frequently if necessary to motivate or reward the contractor.

8. Performance Based Matrix

Desired Outcomes Required Services SLA Performance

Standard (completeness, cost, reliability, accuracy, timeliness, quality)

Acceptable

Quality

Level (AQL)

Monitoring

Method

(Quality Assurance

Surveillance

Plan/QASP)

Incentives/

Disincentives

Base Period

Kick-off meeting Per Section C.4: 1.1

The contractor shall meet with CDC project staff via net meeting to discuss the scope of work and delivery schedule.

Draft meeting minutes shall be provided to CDC within 1 week from the date of the meeting.

No deviation Review of draft meeting minutes

Favorable or unfavorable performance evaluation

Weekly conference calls for protocol development Per Section C.4: 1.2

The contractor shall coordinate and participate in weekly telephone conference calls with CDC staff.

Draft meeting minutes and actions steps within 2 business days of the call.

No deviation Review of draft meeting minutes

Favorable or unfavorable performance evaluation

Revisions to draft study protocol Per Section C.4: 1.3

The contractor shall independently prepare written modifications to the draft protocol to accommodate clinic-specific issues in integrating all aspects of the protocol into their clinic setting(s).

Per section C.4: 1.3 No deviation without COR approval

Review of protocol Favorable or unfavorable performance evaluation

Revisions to questionnaires Per Section C.4: 1.4

The Contractor shall independently prepare written comments and modifications regarding the questions, response alternatives, and formats in questionnaires for Part 1 and Parts 2/3.

Per section C.4: 1.4 No deviation without COR approval

Review of questionnaires

Favorable or unfavorable performance evaluation

Standard operating procedures Per Section C.4: 1.5

The Contractor shall provide standard operating procedures for collection, labeling, processing,storage and shipment of all specimens to be collected in Part 2.

Completeness of procedures for elements described in section C.4:

1.5.

No deviation without COR approval

Review of standard operating procedure

Favorable or unfavorable performance evaluation

Description of database for demographic and questionnaire data

The Contractor shall provide a description of the database for demographic and questionnaire data collected on each participant, including

Data elements as described in section C.4: 1.6, including unique study identification number and accurate linkage between data collected on

Modification of contractor’s existing electronic database or

Review of database description

One transmission

Favorable or unfavorable performance evaluation

Standard (completeness, cost, reliability, accuracy, timeliness, quality)

Acceptable

Quality

Level (AQL)

Monitoring

Method

(Quality Assurance

Surveillance

Plan/QASP)

Incentives/

Disincentives

Per section C.4: 1.6 all data elements agreed to under C.4:

1.4, including consent.

participants in Parts 2 and 3, where applicable.

electronic medical record system is allowable to meet this requirement of dummy data to CDC to test system out prior to data collection

Description of database for HIV test results Per section C.4: 1.7

The Contractor shall provide a description of the database for collecting individual-level HIV test results for all tests conducted on all patients. This will include patients screened in Part 1 as well as all Part 2 participants.

Database developed based on specifications outlined in C.4: 1.7.

Modification of contractor’s existing electronic database or electronic medical record system is allowable to meet this requirement.

Review of database description

One transmission of dummy data to CDC to test system out prior to data collection

Specimen respository database Per section C.4: 1.8

The Contractor shall provide a description of the database for documenting all samples for storage and future testing.

Database developed based on specifications outlined in C.4: 1.8.

Modification of contractor’s existing electronic database or electronic medical record system is allowable to meet this requirement.

Review of database description

One transmission of dummy data to CDC to test system out prior to data collection

Favorable or unfavorable performance evaluation

Local IRB submission and approval Per section C.4: 1.9

The contractor shall submit the completed protocol for local IRB approval.

IRB approval shall occur within 4 months of receipt of the CDC-approved protocol (as per section C.4: 1.3).

No deviation without COR approval

IRB approval letter and IRB-approved consent form with approval and date indicated

Approval required to proceed with study protocol

Conference calls during study implementation Per section C.4: 1.10

The contractor shall coordinate and participate in twice monthly telephone conference calls with CDC staff to communicate progress.

Draft meeting minutes and actions steps within 2 business days of the call.

No deviation Review of draft meeting minutes

Favorable or unfavorable performance evaluation

Monthly progress report Per section C.4: 1.10.1

The Contractor shall provide CDC a monthly progress report.

The report shall be provided 2 business days before the last conference call of the month using

No deviation without COR approval

Review of monthly progress report

Favorable or unfavorable

Standard (completeness, cost, reliability, accuracy, timeliness, quality)

Acceptable

Quality

Level (AQL)

Monitoring

Method

(Quality Assurance

Surveillance

Plan/QASP)

Incentives/

Disincentives template provided by CDC (Appendix C).

The progress report shall include data on cumulative number of patients offered and accepting enrollment into the study, number of persons tested with all screening assays, number with a positive result on one but not all screening assays, number with positive results on all screening assays, and number with all supplemental assays completed.

CDC site visit Per section C.4: 1.11

The contractor shall meet with CDC project staff to discuss their final site preparation for integrating the study into the clinic setting and delineate roles and responsibilities.

Within 60 days of completion of IRB/OMB approval, meet with CDC staff at each clinical site.

Provide draft agenda 30 days prior to site visit.

Within 1 week of site visit, provide CDC with draft meeting minutes and finalize meeting minutes within a week of receiving feedback from

CDC.

No deviation Review of draft agenda

Review of draft meeting minutes

Favorable or unfavorable performance evaluation

Evaluate questionnaire and study procedures Per section C.4: 1.12.1

For each clinical site, the contractor shall identify a minimum of 500 participants for Part 1, for a total of 3,000 participants across all sites.

For those not considered high-risk

Data collection shall occur over a 3 month period after IRB/OMB approval and include all data elements specified in C.4: 1.12.1.

The evaluation of the questionnaire

Per section C.4:

1.12.1, the contractor shall conduct up to three additional months of data

Review of data transmitted to CDC via the Secure Access Management System (SAMS)

Favorable or unfavorable

Standard (completeness, cost, reliability, accuracy, timeliness, quality)

Acceptable

Quality

Level (AQL)

Monitoring

Method

(Quality Assurance

Surveillance

Plan/QASP)

Incentives/

Disincentives based on the screening questionnaire, the Contractor will also provide the HIV test results conducted under the clinic’s current standard of care HIV testing procedures.

will be based upon the proportion of the 3,000 deemed eligible for Part 2 based on results of the Part 1 screener, and yield of HIV infections and acute HIV infections across all clinical sites.

collection at a particular site if a revised screening questionnaire is required

Updates from weekly conference calls per section C.4: 1.10

Review of monthly progress report per section C.4: 1.10.1

Conduct Part 1 screening Per section C.4: 1.12.2

The contractor shall utilize the screening questionnaire on a minimum of 2,000 participants in Part 1 at each clinical site for a minimum total of 12,000 participants across all sites, and provide basic demographic, HIV testing, prophylaxis and risk history data on all participants.

For those not considered high-risk based on the screening questionnaire, the Contractor will also provide the HIV test results conducted under current standard of care HIV testing for the clinical site. The cost of standard of care testing for participants not considered high-risk is not part of this contract.

Conducted over 12 month period after section 1.12.1 is completed and shall include all data elements specified in C.4: 1.12.2.

No deviation Review of data transmitted to CDC via the Secure Access Management System (SAMS)

Updates from weekly conference calls per section C.4: 1.10

Review of monthly progress report per section C.4: 1.10.1

Transmit Part 1 data to CDC Per section C.4: 1.13

The contractor shall transmit Part 1 data to CDC.

Data transmissions will occur monthly for the first 6 months, then quarterly thereafter.

Data shall be compiled in the

100% complete consent information and 100% complete data on Part 1

Receipt of data via the Secure Access Management System (SAMS)

Favorable or unfavorable

Standard (completeness, cost, reliability, accuracy, timeliness, quality)

Acceptable

Quality

Level (AQL)

Monitoring

Method

(Quality Assurance

Surveillance

Plan/QASP)

Incentives/

Disincentives required format as specified in Tasks 1.4-1.7 and transferred using the CDC Secure Access Management System

(SAMS).

screener for all participants

Administer Part 2 specimen collection, testing and questionnaire Per section C.4: 1.14

The contractor shall enroll all clients deemed high-risk based on the Part 1 screening questionnaire, and all low-risk clients with a reactive HIV screening test result from standard of care HIV testing at the clinic into Part 2.

The contractor shall collect and store specimens from all Part 2 participants with at least one reactive HIV screening test and 1,000 participants with concordant negative results on all tests for future testing.

The Contractor shall collect a short behavioral questionnaire from all participants in Part 2 and provide these data as described in section C.4: 1.15.

Per clinical site, enroll a minimum of 400 participants, including 40 previously undiagnosed participants determined to be HIV-infected, annually.

Collect and store specimens from all Part 2 participants with at least one reactive HIV screening test and 1,000 participants with concordant negative results on all tests.

All activities in section C.4: 1.14 should be completed 2 months prior to the end of the Base Period.

No deviation without COR approval

Review of data transmitted to CDC via the Secure Access Management System (SAMS) per section C.4: 1.15

Updates from conference calls per section C.4:

1.10

Review of monthly progress report per section C.4: 1.10.1

Favorable or unfavorable performance evaluation

Transmit Part 2 questionnaire data Per section C.4: 1.15

The contractor shall transmit Part 2 questionnaire data to CDC.

Data transmissions will occur monthly for the first 6 months, then quarterly thereafter.

Data shall be compiled in the required format as specified in Tasks 1.4-1.7 and transferred using the CDC Secure Access Management System

(SAMS).

100% complete consent information and 80% completeness of questionnaire data

Receipt of data transmitted via the Secure Access Management System (SAMS)

Standard (completeness, cost, reliability, accuracy, timeliness, quality)

Acceptable

Quality

Level (AQL)

Monitoring

Method

(Quality Assurance

Surveillance

Plan/QASP)

Incentives/

Disincentives

All data collected through the time of transmission, including data transmitted previously, should be transmitted at each time point.

Transmit Part 2 HIV test result data Per section C.4: 1.16

The contractor shall transmit Part 2 HIV test result data to CDC.

quarterly thereafter.

Data shall be compiled in the required format as specified in Tasks 1.4-1.7 and transferred using the CDC Secure Access Management System (SAMS) to upload data.

All data collected through the time of transmission, including data transmitted previously, should be transmitted at each time point.

100% complete data on all test results, including standard of care results

Secure Access

Favorable or performance evaluation

Identify and enroll Part 3 participants in serial follow-up Per section C.4: 1.17

All Part 2 participants with a reactive result on one or more but not all HIV tests under evaluation shall be enrolled in Part 3.

A minimum of 400 Part 2 participants enrolled at each clinical site, with a minimum of 2 participants with early HIV infection identified in the first year at each clinical site.

To ensure completion of follow-up in time for contract close out, Part 3 enrollment should end 2 months prior to the end of the 24 month base period.

No deviation without COR approval

Review of data transmitted to CDC via the Secure Access Management System (SAMS) per section C.4: 1.15

Updates from conference calls per section C.4:

1.10

Review of monthly

Favorable or unfavorable

Standard (completeness, cost, reliability, accuracy, timeliness, quality)

Acceptable

Quality

Level (AQL)

Monitoring

Method

(Quality Assurance

Surveillance

Plan/QASP)

Incentives/

Disincentives progress report per section C.4: 1.10.1

Conduct follow-up with Part 3 participants Per section C.4: 1.18

The contractor shall conduct follow-up with Part 3 participants.

The behavioral questionnaire will be collected from Part 3 participants again at the last follow-up visit.

The follow-up schedule will involve return visits at 3, 7, 10, 14, 21, 28, 42, 56, and 70 days after the initial visit.

The Contractor must include a plan for re-contacting participants who fail to return for a scheduled follow-up visit, and document how the plan was implemented when necessary.

At each follow-up visit the contractor will collect EDTA whole blood and Oral fluid specimens for same day testing with the HIV tests under evaluation.

Additional specimens, including a minimum of 4ml of EDTA plasma, 2 oral fluid collection tubes and DBS, will be collected from all Part 3 participants at each visit for storage and use in future HIV test evaluations. will be collected from all Part 3 participants for storage and future testing of novel HIV tests.

Participants enrolled in the follow-up study will receive a quantitative viral load after seroconversion with all HIV tests or at 70 days.

No deviation without COR approval

Review of data transmitted to CDC via the Secure Access Management System (SAMS) per section C.4: 1.15

Updates from conference calls per section C.4:

1.10

Review of monthly progress report per section C.4: 1.10.1

Favorable or unfavorable

Standard (completeness, cost, reliability, accuracy, timeliness, quality)

Acceptable

Quality

Level (AQL)

Monitoring

Method

(Quality Assurance

Surveillance

Plan/QASP)

Incentives/

Disincentives

Transmit Part 3 questionnaire data Per section C.4: 1.19

The contractor shall transmit Part 3 questionnaire data to CDC.

Data transmissions will occur monthly for the first 6 months, then quarterly thereafter.

Data shall be compiled in the required format as specified in Tasks 1.4-1.7 and transferred using the CDC Secure Access Management System (SAMS) to upload data.

All data collected through the time of transmission, including data transmitted previously, should be transmitted at each time point.

100% complete consent information and 80% completeness

Secure Access performance evaluation

Transmit part 3 HIV test result data Per section C.4: 1.20

The contractor shall transmit Part 3 HIV quarterly thereafter.

Data shall be compiled in the required format as specified in Tasks 1.4-1.7 and transferred using the CDC Secure Access Management System (SAMS) to upload data.

All data collected through the time of transmission, including data transmitted previously, should be transmitted at each time point.

100% complete data on all test results, including

Secure Access performance evaluation

Transmit specimen repository data for Parts 2 and 3 Per section C.4: 1.21

The database developed for Task 1.8 shall be maintained by the contractor for the duration of the study.

monthly for the first 6 months; after this time the Contractor shall transmit the data after completion of

100% complete data

Receipt of data transmitted via the Secure Access Management

Favorable or unfavorable

Standard (completeness, cost, reliability, accuracy, timeliness, quality)

Acceptable

Quality

Level (AQL)

Monitoring

Method

(Quality Assurance

Surveillance

Plan/QASP)

Incentives/

Disincentives

The contractor shall transmit data from the repository database to CDC.

follow-up with each Part 3 participant.

Data shall be compiled in the required format as specified in Tasks 1.4-1.8 and transferred using the CDC Secure Access Management System (SAMS) to upload data.

All data collected through the time of transmission, including data transmitted previously, should be transmitted at each time point.

Transmit repository specimens to CDC Per section C.4: 1.22

The Contractor shall transmit to CDC all specimens collected and stored as part of Parts 2 and 3, including specimens collected during all pilot activities per section C.4: 1.12.1.

6 month intervals after beginning Part 1 data collection, the Contractor shall ship specimens to the CDC receiving address according to shipping protocols agreed upon under Tasks 1.3 and 1.5.

No deviation without COR approval

Receipt of data transmitted via the Secure Access Management System (SAMS)

Updates from conference calls per section C.4:

1.10 performance evaluation

Delivery of Final Report to CDC Per section C.4: 1.23

The contractor shall submit a final consolidated report to CDC.

The report shall be provided by the expiration date of the contract using the report template (Appendix C).

The final report shall include data on cumulative number of patients offered and accepting enrollment

No deviation Review of final progress report

Favorable or unfavorable

Standard (completeness, cost, reliability, accuracy, timeliness, quality)

Acceptable

Quality

Level (AQL)

Monitoring

Method

(Quality Assurance

Surveillance

Plan/QASP)

Incentives/

Disincentives into the study, number of persons tested with all screening assays, number with a positive result on one but not all screening assays, number with positive results on all screening assays, and number with all supplemental assays completed.

Delivery of final dataset per section C.4: 1.24

The contractor shall submit the final datasets. The dataset shall contain all data collected during the performance period including questionnaire data, HIV test results and specimen repository data. The Contractor shall also provide electronic copies of all source code, programs and documentation of programs used for analysis produced under this contract.

The contractor shall submit the final datasets by the expiration date of the contract.

Data quality shall adhere to AQL for the following tasks: C.4 sections 1.13, 1.15, 1.16, 1.19, 1.20, 1.21.

Receipt of data transmitted via the Secure Access performance evaluation

Option Periods 1 and 2

Local IRB renewal Per section C.4: 2.1

The contractor shall renew local IRB approval annually.

Approval shall occur within 12 months of section C.4: 1.9.

No deviation without COR approval

IRB approval letter and IRB-approved consent form with approval and date indicated.

Approval required to proceed with study protocol

Conference calls during study implementation Per section C.4: 2.2

The contractor shall coordinate and participate in twice monthly telephone conference calls with CDC staff to communicate progress.

Draft meeting minutes and actions steps within 2 business days of the call.

No deviation Review of draft meeting minutes

Favorable or unfavorable performance evaluation

Monthly progress report Per section C.4: 2.2.1

The Contractor shall provide CDC a monthly progress report.

The report shall be provided 2 business days before the last conference call of the month using template provided by CDC (Appendix

No deviation without COR approval

Review of monthly progress report

Favorable or unfavorable

Standard (completeness, cost, reliability, accuracy, timeliness, quality)

Acceptable

Quality

Level (AQL)

Monitoring

Method

(Quality Assurance

Surveillance

Plan/QASP)

Incentives/

Disincentives

C).

The progress report shall include data on cumulative number of patients accepting enrollment into the study, number of persons tested and identified as HIV-positive and number of completed supplemental assays.

CDC site visit Per section C.4: 2.3

The contractor shall meet with CDC project staff to discuss their final site preparation for integrating the study into the clinic setting and delineate roles and responsibilities.

Within 90 days of award of Option Period, meet with CDC staff at each clinical site.

Provide draft agenda 30 days prior to site visit.

Within 1 week of site visit, provide CDC with draft meeting minutes and finalize meeting minutes within a week of receiving feedback from

CDC.

No deviation Review of draft agenda

Review of draft meeting minutes

Favorable or unfavorable performance evaluation

Part 1 screening Per section C.4: 2.4

For each clinical site, the contractor shall utilize the screening questionnaire on a minimum of 2,000 participants in Part 1, and provide basic demographic, HIV testing, prophylaxis and risk history data on all participants.

For those not considered high-risk based on the screening questionnaire, the Contractor will also provide the HIV test results conducted under current

Conducted over each 12 month period after award of the Option period and shall include all data elements specified in C.4: 2.4.

No deviation Receipt of data transmitted via the Secure Access Management System (SAMS)

Updates from conference calls per section C.4: 2.2

Review of monthly

Favorable or unfavorable

Standard (completeness, cost, reliability, accuracy, timeliness, quality)

Acceptable

Quality

Level (AQL)

Monitoring

Method

(Quality Assurance

Surveillance

Plan/QASP)

Incentives/

Disincentives standard HIV testing for the clinical site.

The cost of standard of care testing for participants not considered high-risk is not part of this contract.

progress report per section C.4: 2.2.1

Transmit Part 1 data to CDC Per section C.4: 2.5

The contractor shall transmit Part 1 data to CDC.

Data transmissions will occur on a quarterly basis.

Data shall be compiled in the required format as specified in Tasks 1.4-1.7 and transferred using the CDC Secure Access Management System

(SAMS).

All data collected through the time of transmission, including data transmitted previously, should be transmitted at each time point.

100% complete consent information and 100% complete data on Part 1 screener for participants eligible for Part 2

Receipt of data via the Secure Access Management System (SAMS)

Favorable or unfavorable performance evaluation

Administer Part 2 specimen collection, testing and questionnaire Per section C.4: 2.6

The contractor shall enroll all clients deemed high-risk based on the Part 1 screening questionnaire, and all low-risk clients with a reactive HIV screening test result from standard of care HIV testing at the clinic into Part 2.

During the option periods, the Contractor will collect and store specimens from HIV-infected Part 2 participants with concordant results on all Part 2 screening tests, aliquoted and stored for future testing.

Per clinical site, enroll a minimum of 400 participants, including 40 previously undiagnosed participants determined to be HIV-infected during any 12 month period covered by the option.

During the option periods, the Contractor will collect and store specimens from HIV-infected Part 2 participants with concordant results on all Part 2 screening tests, until specimens from a total of 600 such patients have been collected (across

No deviation without COR approval

Review of data transmitted to CDC via the Secure Access Management System (SAMS) per section C.4: 2.7

Updates from conference calls per section C.4: 2.2

Review of monthly progress report per

Favorable or unfavorable

Standard (completeness, cost, reliability, accuracy, timeliness, quality)

Acceptable

Quality

Level (AQL)

Monitoring

Method

(Quality Assurance

Surveillance

Plan/QASP)

Incentives/

Disincentives

CDC may change the tests under evaluation depending upon the performance of the tests during the Base Period and the availability of new tests over time.

The Contractor shall collect a short behavioral questionnaire from all participants in Part 2 and provide these data as described in section C.4: 2.7.

all sites), aliquoted and stored for future testing.

All activities in section C.4: 2.6 should be completed 2 months prior to the end of the Option Period.

section C.4: 2.2.1

Transmit Part 2 questionnaire data Per section C.4: 2.7

The contractor shall transmit Part 2 questionnaire data to CDC.

Data transmissions will occur on a quarterly basis.

Data shall be compiled in the required format as specified in Tasks 1.4-1.7 and transferred using the CDC Secure Access Management System

(SAMS).

All data collected through the time of transmission, including data transmitted previously, should be transmitted at each time point.

100% complete consent information and 80% completeness

Secure Access

Transmit Part 2 HIV test results data Per section C.4: 2.8

The contractor shall transmit Part 2 HIV

Data shall be compiled in the required format as specified in Tasks 1.4-1.7 and transferred using the CDC Secure Access Management System (SAMS) to upload data.

100% complete data on all test results, including

Secure Access

Standard (completeness, cost, reliability, accuracy, timeliness, quality)

Acceptable

Quality

Level (AQL)

Monitoring

Method

(Quality Assurance

Surveillance

Plan/QASP)

Incentives/

Disincentives

All data collected through the time of transmission, including data transmitted previously, should be transmitted at each time point.

Identify and enroll Part 3 participants Per section C.4: 2.9

All Part 2 participants with a reactive result on one or more but not all HIV tests under evaluation shall be enrolled in Part 3.

A minimum of 400 Part 2 participants enrolled at each clinical site, with a minimum of 2 participants with early HIV infection identified in the first year from each clinical site.

No deviation Review of data transmitted to CDC via the Secure Access Management System (SAMS) per section C.4: 2.7

Updates from conference calls per section C.4: 2.2

Review of monthly progress report per section C.4: 2.2.1

Favorable or unfavorable performance evaluation

Conduct follow-up with Part 3 participants Per section C.4: 2.10

The contractor shall conduct follow-up with Part 3 participants.

The behavioral questionnaire will be collected from Part 3 participants again at the last follow-up visit.

The follow-up schedule will involve return visits at 3, 7, 10, 14, 21, 28, 42, 56, and 70 days after the initial visit.

The Contractor must include a plan for re-contacting participants who fail to return for a scheduled follow-up visit, and document how the plan was implemented when necessary.

At each follow-up visit the contractor will collect EDTA whole blood and Oral fluid specimens for same day

No deviation without COR approval

Review of data transmitted to CDC via the Secure Access Management System (SAMS) per section C.4: 2.7

Updates from conference calls per section C.4: 2.2

Review of monthly

Favorable or unfavorable

Standard (completeness, cost, reliability, accuracy, timeliness, quality)

Acceptable

Quality

Level (AQL)

Monitoring

Method

(Quality Assurance

Surveillance

Plan/QASP)

Incentives/

Disincentives testing with the HIV tests under evaluation.

Additional specimens, including a minimum of 4ml of EDTA plasma, 2 oral fluid collection tubes and DBS, will be collected from all Part 3 participants at each visit for storage and use in future HIV test evaluations.

Participants enrolled in the follow-up study will receive a quantitative viral load after seroconversion with all HIV tests or at 70 days.

To ensure completion of follow-up in time for contract close out, Part 3 enrollment should end 2 months prior to the end of any option period.

progress report per section C.4: 2.2.1

Transmit Part 3 questionnaire data Per section C.4: 2.11

The contractor shall transmit Part 3 questionnaire data to CDC.

Data transmissions will occur on a quarterly basis.

Data shall be compiled in the required format as specified in Tasks 1.4-1.7 and transferred using the CDC Secure Access Management System (SAMS) to upload data.

All data collected through the time of transmission, including data transmitted previously, should be

100% complete consent information and 80% completeness

Secure Access

Standard (completeness, cost, reliability, accuracy, timeliness, quality)

Acceptable

Quality

Level (AQL)

Monitoring

Method

(Quality Assurance

Surveillance

Plan/QASP)

Incentives/

Disincentives transmitted at each time point.

Transmit Part 3 HIV test data Per section C.4: 2.12

The contractor shall transmit Part 3 HIV

Data shall be compiled in the required format as specified in Tasks 1.4-1.7 and transferred using the CDC Secure Access Management System (SAMS) to upload data.

All data collected through the time of transmission, including data transmitted previously, should be transmitted at each time point.

100% complete data on all test

Secure Access performance evaluation

Transmit specimen repository data for Part 2 and 3 specimens Per section C.4: 2.13

The contractor shall transmit data from the repository database to CDC.

Data shall be compiled in the required format as specified in Tasks 1.4-1.8 and transferred using the CDC Secure Access Management System (SAMS) to upload data.

All data collected through the time of transmission, including data transmitted previously, should be transmitted at each time point.

No deviation Receipt of data transmitted via the Secure Access performance evaluation

Transmit repository specimens to CDC Per section C.4: 2.14

The Contractor shall transmit to CDC all specimens collected and stored as part of Parts 2 and 3, including specimens collected during the Option Periods.

Transmission should occur at the completion of 6 month intervals of activity during each Option Period.

The Contractor shall ship specimens

No deviation Receipt of data transmitted via the Secure Access Management System (SAMS)

Favorable or unfavorable

Standard (completeness, cost, reliability, accuracy, timeliness, quality)

Acceptable

Quality

Level (AQL)

Monitoring

Method

(Quality Assurance

Surveillance

Plan/QASP)

Incentives/

Disincentives to the CDC receiving address according to shipping protocols agreed upon under Tasks 1.3 and 1.5.

Updates from conference calls per section C.4: 2.2

Delivery of Final Report to CDC Per section C.4: 2.15

The contractor shall submit a final consolidated report to CDC.

The report shall be provided by the expiration date of the contract using the report template (Appendix C).

The final report shall include data on cumulative number of patients offered and accepting enrollment into the study, number of persons tested with all screening assays, number with a positive result on one but not all screening assays, number with positive results on all screening assays, and number with all supplemental assays completed.

No deviation Review of final progress report

Favorable or unfavorable performance evaluation

Delivery of final dataset per section C.4: 2.16

The contractor shall submit the final datasets. The dataset shall contain all data collected during the performance period including questionnaire data, HIV test results and specimen repository data. The Contractor shall also provide electronic copies of all source code, programs and documentation of programs used for analysis produced under this contract.

The contractor shall submit the final datasets by the expiration date of the contract.

Data quality shall adhere to AQL for the following tasks: C.4 sections 2.5, 2.7, 2.8, 2.11, 2.12, 2.13.

Receipt of data transmitted via the Secure Access