ATTACHMENT_5-Domain_5_Sample_RFTOP.docx

ATTACHMENT 5 SAMPLE TASK ORDER 5

DOMAIN 5- RFTOP 2016-5-Task Order 001 RFTOP Title: Assessing Reporting Specifications that Call for Use of Healthcare Data in Electronic Form and Healthcare Information Technology for Purposes of National Healthcare Safety Network (NHSN) Surveillance

Multiple task orders may be awarded subject to availability of funds and that contractors should prepare technical proposals that are priced no higher than $300,000 in order to be considered for award.

PROPOSED PERIOD OF PERFORMANCE: Work shall begin from date of award of the task order and shall continue for a period of 24 months. This project is a non-severable and will be funded fully at the time of award. Multiple task orders may be awarded under this RFTOP. Anticipated date of award on or before 9/30/2016.

PAGE LIMIT: The Contractor shall limit the proposal for this task order to 10 single-spaced pages.

OVERVIEW

The National Healthcare Safety Network (NHSN) is a web-based system developed and maintained by CDC and used by CDC and its partners in healthcare and public health to track healthcare-associated infections (HAIs), antimicrobial use (AU) and antimicrobial resistance (AR), and adherence to prevention practices and antimicrobial stewardship. Data are reported to the system via manual data entry at a web interface or by means of electronic messages produced by electronic health record systems (EHRs) or infection surveillance systems and transmitted to NHSN. NHSN is the main HAI reporting system in the United States, and over 18,000 healthcare facilities participate in the system, including over 5,000 hospitals, as of 2015.

The NHSN Patient Safety Component is the most widely used part of the system; it enables hospitals to report central line-associated bloodstream infections (CLABSIs), catheter-associated urinary tract infections (CAUTIs), surgical site infections (SSIs), and other HAIs. Antibiotic susceptibility data are included in the HAI records submitted to NHSN, enabling CDC to estimate antibiotic resistance prevalence and trends nationally among these HAIs. Antimicrobial Use (AU) and Antimicrobial Resistance (AR) also can be reported to the NHSN Patient Safety Component, specifically the NHSN AUR Module. AU and AR data are reported to the AUR Module via electronic messages; there is no manual entry of AU and AR data into the AUR Module. All supporting documentation along with startup guides, FAQs and pointers to Implementation Guides for AU and AR reporting may be found at the

NHSN CDA Submission Support Portal (http://www.cdc.gov/nhsn/cdaportal/index.html). NHSN’s emergence as a widely used platform for surveillance of healthcare outcomes, e.g. HAIs, and care processes, e.g., AU, provides precedence and opportunities to extend use of NHSN for new purposes, including surveillance of (1) new HAI events, such as late onset neonatal sepsis and meningitis, (2) sepsis among pediatric and/or adult patients, regardless of whether an HAI led to the sepsis, (3) new HAI event indicators or proxies, i.e., markers for infection that may be useful for surveillance but may not be specific enough to correspond to a specific disease condition; (4) non-HAI adverse events, such as adverse drug events (e.g., hypoglycemia following administration of drugs used for glycemic control) or new and emerging blood safety events; (5) use or insertion of devices intraoperatively, tracked by means of the device’s Unique Device Identifier (UDI).

PROJECT GOALS

The goal of this task order is to fund activities that will assess the technical feasibility of introducing new surveillance reporting specifications to NHSN that will extend the scope of NHSN’s surveillance coverage to additional healthcare outcomes or processes, not currently in scope, that call for detection and reporting using healthcare data in electronic form and healthcare information technology.

CDC is requesting proposals in which the Contractor:

· Identifies a healthcare process or outcome that will be brought under surveillance using NHSN that is either a new HAI event,such as late onset neonatal sepsis or meningitis; sepsis among all patient age groups or a specific patient age group regardless of whether the sepsis is caused by an HAI; new HAI event indicator, such as a proxy or marker for an infection; a non-HAI adverse event, such as an adverse drug event or blood safety incident; or use or insertion of an intraoperative device.

· Specifies the the data requirements for the healthcare outcome or process that would be brought under surveillance using NHSN and develops a plan for systematically evaluating the technical feasibility of implementing those requirements by using healthcare data in electronic form and healthcare information technology to automate surveillance processes.

1. Scope of Work

The contractor should describe a health care process or outcome, not currently reported to NHSN, that would be brought under surveillance using NHSN and systematically assess the technical feasibility of using existing healthcare data in electronic form and healthcare information systems to implement the surveillance requirements for the specified process or outcome.

a. Candidate process or outcome events for assessment include but are not limited to (1) new healthcare-associated infection (HAI) events, such as late onset neonatal sepsis and meningitis, (2) new HAI event indicators or proxies, i.e., markers for infection that may be useful for surveillance but may not be specific enough to correspond to a specific disease condition; (3), sepsis, regardless of whether an HAI led to sepsis, (4) new HAI event indicator, non-HAI adverse events, such as adverse drug events (e.g., hypoglycemia following administration of drugs used for glycemic control) or new and emerging blood safety events; (5) insertion of devices intraoperatively, tracked by means of the device’s Unique Device Identifier (UDI).

b. Candidate healthcare data sources and systems include but are not limited to electronic health record systems (EHRs), EHRs components or modules, laboratory information systems, medication administration systems, and infection control surveillance systems.

c. The Contractor shall systematically evaluate the technical feasibility of using systems for surveillance purposes that are already in operational use in healthcare and that can provide data for electronic detection and reporting of a specified process or outcome.

2. Each assessment shall evaluate the extent to which healthcare data are available in standardized and structured electronic form for a new surveillance purpose; the technical implementation opportunities and challenges of using healthcare information technology for that surveillance purpose, including the opportunities or challenges of automating surveillance processes; and the clinical or record keeping implications—if any—at the healthcare facility level of implementing the new set of NHSN surveillance reporting requirements.

Task A: Communication

Task A1: Start Up Meeting

· The Contractor shall arrange and conduct an initial meeting (by teleconference) with the CDC Contracting Officer Representative, (COR), and other relevant staff within two weeks of the effective date of the task order. The purpose of the meeting will be to confirm critical contract performance milestones and roles and responsibilities that will be taken on by the Contractor, and to establish communication protocols (such as a regular call schedule). Each task and deliverable will be reviewed.

· The Contractor shall submit an agenda for the above meeting within one week of the effective date of the task order.

Task A2: Maintain Communication with CDC Staff

· The Contractor shall organize a second meeting (via webinar) to review and discuss with CDC staff the technical approach and systems they will use to assess reporting specifications that call for use of healthcare data in electronic form and healthcare information technology to extend use of NHSN for surveillance purposes.

a. The Contractor shall review the new surveillance use of NHSN will be assessed, i.e.,either a new HAI event, sepsis regardless of etiology, a new HAI event indicator, a non-HAI adverse event, or intraoperative device uses and insertions.

b. The Contractor shall discuss the data requirements for the new surveillance use of NHSN, and the plan that wil be used for systematically evaluating the technical feasibility of those requirements.

· The Contractor shall coordinate with the Contracting Officer Representative, (COR)/Science Officer a monthly teleconference. The Contractor shall maintain regular communications with the Contracting Officer Representative (COR)/Science Officer staff involved with the project.

· The chief means of communication will be via conference calls that will be scheduled every month throughout the project period required to complete the project.

· Additional calls will be scheduled as needed.

· The Contractor shall provide an agenda and meeting minutes for each call. All conference calls shall be scheduled and administered by the Contractor.

· The Contractor shall respond to all emails and telephone communications from the Contracting Officer Representative, (COR)/Science Officer, within three business days.

· In the event of multiple awards, the Contractor shall participate on multi-contractor calls coordinated by the CDC COR/Science Officer on validation with other contractors working on similar initiative with different hospitals and overall coordination of purpose and direction of this task order.

Task B: Contractor shall complete an assessment project

· The contractor shall specify a health care process or outcome, not currently reported to NHSN, and assess the technical feasibility of using existing healthcare data in electronic form and healthcare information systems to implement the surveillance requirements for the specified process or outcome.

· Candidate process or outcome events for assessment include but are not limited to (1) new healthcare-associated infection (HAI) events, such as late onset neonatal sepsis and meningitis, (2) new HAI event indicator or proxy, i.e.,a marker for infection that may be useful for surveillance purposes but may not be specific enough to correspond to a specific disease condition ; (3) sepsis regardless of whether an HAI led to sepsis, (4) non-HAI adverse events, such as adverse drug events (e.g., hypoglycemia following administration of drugs used for glycemic control) or new and emerging blood safety events; (5) insertion of devices intraoperatively, tracked by means of the device’s Unique Device Identifier (UDI).

· Candidate healthcare data sources and systems include but are not limited to electronic health record systems (EHRs), EHRs components or modules, laboratory information systems, medication administration systems, and infection control surveillance systems.

· The contractor shall systematically evaluate the technical feasibility of using systems for surveillance purposes that are already in operational use in healthcare and that can provide data for electronic detection and reporting of a specified process or outcome.

Task C: Reporting

Task C1: Quarterly Progress Reports On the 10th day following the three months being reported, the Contractor shall prepare and submit a quarterly progress report containing the current status of work . The report shall contain, at a minimum, the current progress on each of the requirements set forth below, the problems encountered during the month, solutions implemented, planned activity for the upcoming month, and any other information mutually agreed upon between the contractor and the CDC Contracting Officer Representative (COR).

Task C2: Final Report The contractor will provide CDC with quarterly and a final report. Metrics for all reports shall include, but not limited to, a description of all tasks and deliverables completed during the funding period. The final report shall include feedback and recommendations to healthcare facilities and partners

Deliverables Summary Table The following deliverables shall be provided to the Contracting Officer Representative, (COR) and Science Officer no later than the dates specified below:

Frequency Due Date

· Meeting within 2 weeks of task order award

· Meeting minutes within 1 week of conference call

· Responses to emails and telephone communications within 3 days

1-2 months after award

1 draft report

9 months after award

3. General Information

A. Place of Performance: The work to be performed under this contract will be performed at the Contractor’s facility and associated academic, healthcare or research facilities as required.

B. Type of Contract: The government will award a Firm-fixed price contract.

C. Contractor Travel: Contractor may be required to travel to Atlanta, GA for a face-to-face meeting during the first year of the project to discuss project implementation. The need for travel shall be determined by CDC, and may be substituted with a teleconference not requiring travel. Contractor may be required to travel during the performance of this task order for meetings during the base period to discuss project implementation. Travel shall be in accordance with the Federal Travel Regulation (FTR).

D. Data Rights 52.227-14 Rights in Data-General, Alternate IV (Dec 2007). As prescribed in 27.409(b)(5), substitute the following paragraph (c)(1) for paragraph (c)(1) of the basic clause: (c) Copyright—(1) Data first produced in the performance of the contract. Except as otherwise specifically provided in this contract, the Contractor may assert copyright in any data first produced in the performance of this contract. When asserting copyright, the Contractor shall affix the applicable copyright notice of 17 U.S.C. 401 or 402, and an acknowledgment of Government sponsorship (including contract number), to the data when such data are delivered to the Government, as well as when the data are published or deposited for registration as a published work in the U.S. Copyright Office. For data other than computer software, the Contractor grants to the Government, and others acting on its behalf, a paid-up, nonexclusive, irrevocable, worldwide license for all such data to reproduce, prepare derivative works, distribute copies to the public, and perform publicly and display publicly, by or on behalf of the Government. For computer software, the Contractor grants to the Government and others acting on its behalf, a paid-up, nonexclusive, irrevocable, worldwide license for all such computer software to reproduce, prepare derivative works, and perform publicly and display publicly (but not to distribute copies to the public), by or on behalf of the Government.

E. Confidentiality of Information: Work on this project may require that personnel have access to Privacy Information. Personnel shall adhere to the Privacy act, Title 5 of the U.S. Code, Section 552a and applicable agency rules and regulations. The user agency will identify and provide direction and guidance for safeguarding all information subject to the Privacy Act. Reports and case files containing individual personal information are confidential. The CDC is not authorized to release individual case reports, and access to individual case data is strictly controlled. The contractor personnel are required to work with case records as well as databases. It is a requirement that the data remain in a controlled access environment.

F. Section 508: Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d) 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. Regardless of format, all Web content or communications materials produced for publication on or delivery via CDC 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 a CDC-funded or CDC-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. Checklists for various file formats are available at http://www.hhs.gov/web/508/index.html.

The following Section 508 provisions apply to the content or communications material identified in this SOW or PWS: 36 CFR 1194.21 (for software and programmatic elements in websites), 36 CFR 1194.22 (for documents and websites), and 36 CFR 1194.24 (for video and multimedia content) References: HHS Policy for Section 508 Electronic and Information Technology (E&IT) (January 2005): http://www.hhs.gov/od/Final_Section_508_Policy.html HHS Section 508 Web site: http://508.hhs.gov/ HHS ASPA Web Communications Division Web site: http://www.hhs.gov/web/policies/index.html US General Services Administration (GSA) Section 508 Web site: http://www.section508.gov/index.cfm 1 Prime contractors may enter into subcontracts in the performance of a Federal contract, but the prime remains obligated to deliver what is called for under the contract.

4. Government Furnished Property, Equipment, and Services Not Applicable

5. Payments: The government proposes that payments be submitted quarterly.

6. Special Clearances:

OMB

|_|Human Subjects

proprietary, sensitive, and Personally Identifiable Information (PII) the Contractor may come in contact with during the performance of this contract.

procedures. Based upon the scope of this contract, the SOW must include the appropriate language to address the following IT security topics:

Standard for Security Configurations; Standard for Encryption Language; and Security requirements for Federal Information technology Resources.

SPECIAL CLAUSES:

HHSAR 352.224-70, Privacy Act (Dec 2015) This contract requires the Contractor to perform one or more of the following:

(This contract requires the Contractor to perform one or more of the following: (a) design; (b) develop; or (c) operate a Federal agency system of records to accomplish an agency function in accordance with the Privacy Act of 1974 (Act) (5 U.S.C. 552a(m)(1)) and applicable agency regulations. The term system of records means a group of any records under the control of any agency from which information is retrieved by the name of the individual or by some identifying number, symbol, or other identifying particular assigned to the individual. Violations of the Act by the Contractor and/or its employees may result in the imposition of criminal penalties (5 U.S.C. 552a (i)).The Contractor shall ensure that each of its employees knows the prescribed rules of conduct in 45 CFR part 5b and that each employee is aware that he/she is subject to criminal penalties for violation of the Act to the same extent as Department of Health and Human Services employees. These provisions also apply to all subcontracts the Contractor awards under this contract which require the design, development or operation of the designated system(s) of records (5 U.S.C. 552a(m)(1)). The contract work statement: (a) Identifies the system(s) of records and the design, development, or operation work the Contractor is to perform; and (b) specifies the disposition to be made of such records upon completion of contract performance.

HHSAR 352.270-12 Needle Exchange (December 18, 2015) The Contractor shall not use any funds obligated under this contract to carry out any program of distributing sterile needles or syringes for the hypodermic injection of any illegal drug.

(End of Clause)

CONTRACTING OFFICER REPRESENTATIVE: TBD

SCIENCE OFFICER: TBD

7. Technical Evaluation Criteria

Award: This task order will be awarded to the contractor whose proposal is considered to be the most advantageous to the Government, price and other factors identified below considered. Technical factors will be more important in the evaluation than price. The Government will not make an award at a significantly higher overall cost to the Government to achieve only slightly superior performance.

Technical Evaluation for this RFTOP is as follows:

A. Technical Plan (10)

a. The Contractor is to provide a discussion of their technical approach for assessing the technical feasibility of a new surveillance use of NHSN. Within the technical approach, the contractor shall:

a. Detail the services required for this task order including the ability to gain access to the required facilities as evidenced by a letter of support or Memorandum of Understanding.

b. Provide a timeline/milestone chart for the accomplishment of tasks and a risk management plan. The plan shall also detail project oversight.

b. Preference will be given to contractors who propose a systematic evaluation of a new HAI event, a new HAI event indicator or proxy, sepsis regardless of whether caused by an HAI, a non-HAI adverse event, or intraoperative device uses and implants that reflect an important public health concern. In three separate sections (minimum of one paragraph per section), the Contractor shall provide for an assessment project:

a. Heathcare process or outcome to be brought under surveillance - Description of a new HAI event, sepsis regardless of its relationship to an HAI, new HAI event indicator, non-HAI adverse event, or use or implant of intraoperative devices that would be brought under surveillance using NHSN or for an implementation project a description of the healthcare facilities where participation in an existing surveillance requirement would be extended.

b. Assessment strategy and methods - Description of the analytic strategy and methods that would be brought to bear in assessing the technical feasibility of a new surveillance requirement.

c. Assessment criterion - The criterion that will be applied to assess the feasibility of using healthcare data in electronic form and healthcare information technology to automate surveillance process and meet the new surveillance purpose identified by the Contractor.

B. Similar Experience (10)

a. The Contractors shall provide details on previous work performed in the area of surveillance or external reporting in healthcare settings and/or experience with creating electronic files using standards set by NHSN for submission of electronic files for reporting data to NHSN.

b. This criterion will be evaluated to determine appropriate experience of assigned personnel and of the company. The Contractor will further demonstrate previous experience performing similar research with proposed partnerships.

C. Staffing and Management Plan (10)

a. The Contractors shall provide a detailed statement of staffing and management approach for managing the work outlined in this task order by demonstrating their understanding of the labor requirements listed in this RFTOP. Contractors shall include:

a. Resumes from key personnel outlining the credentials and background of key management, professional, and technical personnel to be used for this task order, including the percent time on this and other projects

b. Detailed plan that describes current staff available for this task order and how the team will interface with CDC

c. Clear delineation of staff authorities and lines of responsibility with special emphasis on relationships with subcontractors, other Contractors, and CDC partners

d. Detailed description of how the project team will support clear communication and promote effective time management with staff, subcontractors, other Contractors, and CDC partners and maintain awareness of progress at the numerous sites involved

e. Detailed description of how conflicts are managed

f. Measurement of fiscal responsibility and accountability, paying particular attention to the deliverables timeline in this task order

2. Staffing to successfully accomplish the tasks of this acquisition shall include:

1. Project Manager with sufficient time devoted to overseeing the project. This person shall have experience in managing and executing surveillance system or healthcare information technology projects.

2. Subject Matter Expert/Technical Consultant (or Data Analyst) with experience in oversight of study and analysis of healthcare data in electronic form for surveillance purposes, such as HAI or other adverse event detection, use of antimicrobial susceptibility test result data from hospital laboratory information systems to monitor antimicrobial resistance, capturing healthcare process data for quality measurement or accountability. This person shall have experience in executing surveillance or reporting projects using healthcare data in electronic form and healthcare information technology.

3. The proposalwill be evaluated according to the soundness, practicality, and feasibility of the contractor’s staffing and management plan for this task order.