Attachment_A_TITLE_IV_Hosp_Study_SOW_SOL_Att_A_08032018.pdf

Solicitation Attachment A

Statement of Work (SOW)

Title: Examine the Ecosystem of Title IV Health Care Entities

Dated: 08/03/2018

I. Background

The National Practitioner Data Bank (NPDB) was created by Title IV of the Health Care Quality

Improvement Act of 1986, Public Law 99-660 (HCQIA). The NPDB is overseen by the Health

Resources and Services Administration (HRSA), Bureau of Health Workforce (BHW), Division of Practitioner Data Bank (DPDB). The NPDB was established to improve the quality of health care, restrict the ability of practitioners to move from state to state or hospital to hospital without disclosing medical malpractice payments or adverse action histories, and encourage protected peer review. This is done by encouraging state licensing boards, hospitals, professional societies, and other health care entities to identify, discipline, and report those who engage in unprofessional behavior. Implemented in September 1990, the NPDB serves as an electronic repository to collect and release information related to the professional competence and conduct of physicians, dentists, and other health care practitioners. Establishing the NPDB represented an important step by the U.S. Department of Health and Human Services (HHS) to improve the quality of health care for all Americans.

The NPDB plays an important role in ensuring quality health care and a skilled health care workforce by providing critical information to health care entities about practitioners. The NPDB serves as an alert or flagging system intended to facilitate a comprehensive review of health care practitioners' professional credentials. The information contained in the NPDB directs discrete inquiry into, and scrutiny of, a practitioner's licensure, clinical privileges, professional society memberships, and medical malpractice payment history.

Congress passed Section 5(b) of Public Law 100-93, the Medicare and Medicaid Patient Program

Protection Act of 1987, as amended by Section 1921 of the Social Security Act, which broadened the types of information reported to NPDB. Section 1921 added reporting State licensure actions taken against all types of health care practitioners, not just physicians and dentists, to the NPDB. The section also expanded NPDB reporting requirements to include negative actions or findings by State licensing agencies, peer review organizations, and private accreditation organizations against all health care practitioners and organizations. Section 1921 was enacted to provide protection from unfit health care practitioners for beneficiaries participating in the Social Security Act’s health care programs and to improve the anti-fraud provisions of these programs. Congress later amended Section 1921 with the Omnibus Budget

Reconciliation Act of 1990, Public Law 101-508, to add reporting requirements for any negative action or finding. The NPDB implemented Section 1921 for reporting and querying on March 1, 2010.

The Health Insurance Portability and Accountability Act of 1996 (HIPAA), Public Law 104-191, enacted on August 21, 1996, required the Secretary of the HHS to create a national health care fraud and abuse control program. The statute also required the Secretary to implement the data collection for this program in such a manner as to avoid duplication with the reporting requirements established for the NPDB. This was accomplished through the implementation of the Healthcare Integrity and Protection Data Bank (HIPDB). The legislation that enacted the

HIPDB is referred to as Section 1128E of the Social Security Act.

The purpose of the HIPDB was to combat fraud and abuse in the health insurance industry and in health care delivery. HIPDB information was intended to be used in combination with information from other sources in making determinations on employment, affiliation, certification, licensure decisions, and exclusions from Medicare and Medicaid. The information in the HIPDB served as a flagging system to alert U.S. Government and State agencies and health plans that there may be a problem with the performance of a particular practitioner, provider, or supplier. HIPDB information was not to be used as the sole source verification of credentials for a practitioner, provider, or supplier.

Under Section 6403 of the Patient Protection and Affordable Care Act (ACA), Public Law 111-

148, which was signed into law on March 23, 2010, the NPDB and the HIPDB were merged into a single Data Bank, referred to as the NPDB. As of May 6, 2013, the NPDB and the HIPDB are now one Data Bank: the NPDB. All HIPDB data were transferred to the NPDB. The merged

Data Bank continues to operate under HCQIA, Section 1921, and Section 1128E rules and regulations. Responsibility for the implementation and operation of the Data Bank continues to reside within the Division of Practitioner Data Bank, Bureau of Health Workforce, Health

Resources and Services Administration, and the Department of Health and Human Services.

*For additional details, see background information (Attachment A).

II. Purpose

The purpose of this contract to investigate the ecosystem of Title IV health care entities to understand how different policies, programs, and the prevalent ethos in health care industry affects adverse action reports submitted to the NPDB. This study shall produce actionable information that can be used to inform recommendations for encouraging Title IV entities to perform peer review and fulfill their statutorily mandated obligation of reporting to the NPDB. In addition, this study shall provide evidence that can be used in the discussion and impetus for

Nurse Practitioners and Physician Assistants to be included in the requirements of hospital querying and reporting to the NPDB. The results will lead to better and more complete NPDB data, which is directly relevant to patient safety and quality care.

The study will focus on the following 4 major areas:

1. Examining whether hospitals in states with strong penalties for not reporting adverse clinical privileges actions differ from their counterparts in states with no penalty with regard to submitting reports to the NPDB. Most states have mandatory reporting laws governing hospitals’ clinical privilege actions. Some states require hospitals to report any action, regardless of the time period that the sanction covers. Other states mirror the

NPDB reporting requirement more closely, limiting reporting to actions involving competency or conduct and requiring the reporting of actions that affect privileges for over a certain number of days.

This task entails conducting an analysis to examine whether stiff sanctions for failure to report adverse actions to state and federal authorities affects hospitals’ reporting to the

NPDB. Because laws regarding reporting of adverse peer-review actions is, at times, ambiguous (e.g., how different hospitals in various states view different practitioner evaluations?), hospitals may interpret the law’s reporting requirements differently when significant sanctions for non-reporting adverse peer-review actions exist at the state level versus when there are no state sanctions.

2. Examining trends and differences, both overall and among specific individual cadres, in the number of adverse action reports submitted to the NPDB that may be attributed to industry changes. Specifically, the health care industry is experiencing a growing number of private practices being acquired by hospitals and using Nurse Practitioners (NP) and

Physician Assistants (PA) as primary care providers in place of physicians.

This task will examine the impact of changes that have occurred in the health care industry business models since the establishment of the NPDB in 1990 on reporting to the

NPDB. Hospitals have been acquiring a growing number of private practices. These acquisitions have affected the volume of credentialing and privileging of practitioners in these hospitals. At the same time, more of the previously uninsured population have become insured and eligible to access health care. In an attempt to eliminate health disparities, interventions, such as the use of NP and PA as primary care providers, are being implemented. While these practitioners are performing the same tasks as their physician counterparts, the current Federal regulations do not subject them to the same background querying and reporting requirements. In recent years, the NPDB has seen an increase in NP and PA reporting and querying. This study will evaluate this trend for the last 15 years. In addition, this study shall examine if differences exist over time in the propensity of hospitals and health plans taking administrative actions vs. clinical privilege actions against practitioners in certain circumstances. This information will inform the NPDB regarding its responsiveness to the structural shifts in the health care industry and its adherence to its original legislative intent.

3. Investigating whether state licensing board complaints (i.e., complaints against healthcare practitioners) are associated with NPDB reports.

This task will involve a) mining the narrative portion of the reports to determine the reason for the complaint, b) talking to the health care entities to ascertain why specific complaints have accompanying reports and some do not, and c) if differences in accompanying reports vary by state. The actionable information produced by this task will be used to inform recommendations for NPDB outreach to and education of health care entities to ensure accurate and complete reporting to the Data Bank.

4. Finally, using states that have profiles of physicians on their public websites, the study shall compare adverse action information available in the public domain to the reports residing in the NPDB to examine information gaps. Only aggregate level results will be reported.

This task will use information from states’ public websites on profiles of physicians. The study shall compare publicly available adverse action information (voluntarily provided by physicians) to the NPDB reports. This comparison will identify existing reporting gaps (if any) to the NPDB. Only aggregate level results will be reported. This task will help NPDB to determine the differences between the volume and types of reports that reside in the NPDB and those that are available on the public site.

III. Period of Performance / Place of Performance

The period of performance shall be for a 12 month base period. Exact dates to be entered at time of award.

All work shall be performed at the contractor’s facility/building.

IV. Tasks

The contractor shall perform and complete the following tasks:

Task 1 Revise Project Plan and Schedule

1. Convene a kick-off meeting within 7 days of Effective Date of Contract (EDOC), this meeting will be used to set the dates and deadlines and clarify any minor issues for the tasks.

2. Record the minutes of the kick-off meeting and submit the minutes within 7 business days of the meeting.

Deliverable: 1 electronic copy off meeting minutes.

3. Revise the project plan timeline (if necessary) based on the Contracting Officer

Representative (COR) technical direction and submit a draft within 3 weeks of (EDOC).

Deliverable: 1 electronic copy of revised final work plan timeline.

4. Submit a revised final project plan and schedule within 1 week of receipt of the COR comments on the project plan. The final plan shall be implemented within 1 week after

COR’s approval.

Deliverable: 1 electronic copy of final work plan 7 days after the COR’s comments.

Task 2 Submit Quarterly Reports

1. Submit quarterly technical progress reports to the COR via e-mail, by the 1st week of every quarter. These reports shall describe:

a. accomplishments during the quarter;

b. the status of the contract tasks in relation to the approved schedule;

c. any problems or barriers to completing the scheduled tasks (including personnel and resources problems), proposed methods for overcoming problems or barriers, the main goals for the upcoming month, findings to date, and other information as necessary to document performance.

Task 3 Meet with the COR

1. Throughout the term of the contract, convene the Project Director and Key Personnel to meet (via teleconference, and/or via email) with the COR and others designated by the

COR for performance updates and problem resolution. These meetings shall occur every week for the first two months and after that they shall change to twice per month.

Task 4 Conduct a Literature Review to Obtain Information about the States with Strong

Penalties for not Reporting Adverse Clinical Privileges Actions vs. States with no Penalties, and their Impact on Submitting Reports to the NPDB

1. Review and summarize the literature regarding states that have sanctions for failure to report adverse actions to state and federal authorities and the impact of these policies on hospitals/title IV entities’ reporting to the NPDB.

Deliverable: 1 electronic copy of relevant literature review (30 days from the EDOC).

2. Meet via teleconference every other week with the COR (and other COR designated

DPDB SMEs) to collect information on the NPDB data set, policies, entity file/reporter information, and gain insight into project goals and risks.

3. Provide a list of states that have penalties and states with no penalties for reporting adverse actions (for details see attached background information).

Deliverable: 1 electronic copy of list of states that have penalties and states with no penalties (45 days from the EDOC).

4. Analyze the NPDB’s research file to identify reports that are coming from Title IV entities.

Task 5 Evaluate NPDB Data Based on the Literature Review of States with no Penalties vs.

State with Penalties

1. Evaluate trends for various Title IV entity reports (i.e., clinical privilege and medical malpractice payment reports).

2. Examine the reporting trends for all years for the Title IV entities.

Deliverable: 1 electronic copy of list of descriptive statistics for reporting trends for all years for the Title IV entities (90 days from the EDOC).

3. Compare clinical privilege actions from hospitals vs. health plans.

Deliverable: 1 electronic copy of descriptive data for clinical privilege actions from hospitals vs. health Plans (100 days from the EDOC).

4. Develop a methodology that shall examine states with no penalties vs. states with penalties.

a. Based on the literature review, develop an approach that includes the general analysis of Title IV entity report data. This document will be reviewed by the COR for approval.

b. Compare Title IV reports with state licensure reports.

c. Provide information about different state policies that impact Title IV entity reporting to the NPDB.

d. Compare peer review actions vs. administrative actions for Title IV and other health care entities and;

e. Based on above tasks, provide data for states that have penalties vs. states with no penalties.

Deliverable: 1 electronic copy of data that compares clinical privilege reports with state licensure, and administrative actions (130 days from the EDOC).

Task 6 Literature Review

1. Conduct a Literature Review to Obtain Information about the following changes that are taking place in the health care industry: 1) growing number of private practices being acquired by hospitals and 2) use of Nurse Practitioners and Physician Assistants as primary care providers in place of physicians.

Deliverable: 1 electronic copy of data that compares clinical privilege reports with state licensure, and administrative actions (160 days from the EDOC).

2. Meet via teleconference every other week with the COR to collect information on the

NPDB data set (both query and report data) to examine query and reports on the nurse practitioners and physician assistants.

Deliverable: 1 electronic copy of descriptive statistics for queries and reports on the nurse practitioners and physician assistants (180 days from the EDOC).

3. Provide a list of states that are using nurse practitioners and physician assistants as primary care providers with supervision or without supervision (see background information for details).

Deliverable: 1 electronic copy of list of states that are using nurse practitioners and physician assistants with supervision or without supervision as primary care providers

(200 days from the EDOC).

4. Analyze the NPDB’s research file to identify reports that are coming from Title IV entities for nurse practitioners and physician assistants vs. all reports for nurse practitioners and physician assistants in the NPDB data.

5. Develop a methodology that shall examine the impact of private practices being acquired by hospitals and the use of nurse practitioners and physician assistants as primary care providers in place of physicians on the NPDB reports.

a. Based on the literature review, develop an approach that includes the general analysis of Title IV entity report data for physicians, nurse practitioners, and physician assistants both generally and within the context of State supervision requirements of nurse practitioners and physician assistants. The approach shall include an examination of correlations between the supervision requirements and the pervasiveness of the use of nurse practitioners and physician assistants as primary care providers.

b. Compare Title IV reports for nurse practitioners and physician assistants with state licensure reports.

Deliverable: 1 electronic copy of descriptive statistics for Title IV reports for nurse practitioners and physician assistants (215 days from the EDOC).

c. Provide information about different state policies that require nurse practitioners and physician assistants be supervised by physicians to perform certain duties.

d. Compare peer review actions vs. administrative actions vs. state licensure actions for nurse practitioners and physician assistants and;

e. Based on above tasks, provide NPDB report data for states that have supervision vs.

no supervision for nurse practitioners and physician assistants.

Deliverable: 1 electronic copy of descriptive statistics and correlation results for peer review actions vs. administrative actions vs. state licensure actions for nurse practitioners and physician assistants within the context of supervision requirements

(245 days from the EDOC).

Task 7 Prepare and Submit Draft Final Report and Recommendations

Deliverable: 1 electronic copy of draft final report and recommendations (260 days from the EDOC).

Task 8 Prepare Final Report and Recommendations

1. Make changes to the draft final report as requested by the COR.

Deliverables: 1 electronic copy of the revised final report to the COR with copies of the

Executive Summary separately bound. The different data sets that were used shall be included in the final report as appendices. Three (3) paper copies shall be supplied in addition to one copy submitted on disk in a word processing format approved by the

COR (30 days before the end of contract).

2. Conduct a final briefing on the final report.

Deliverables: 1 electronic copy of the presentation, and provide a data file that contains all the analyses. This briefing shall be held in Rockville, Maryland and shall last from 1 to 2 hours (3 days before the end of the contract).

Task 9: Federal Records Management

The contractor shall manage and maintain Federal records, including electronic records, ensuing from this contract in accordance with all applicable records management laws and regulations, including but not limited to:

The Federal Records Act (44 U.S.C. Chapters. 21, 29, 31, 33); 36 CFR,

1236.20 “What are appropriate recordkeeping systems for electronic records?”, and

1236.22 “What are the additional requirements for managing electronic mail records?”

(http://www.ecfr.gov/cgi-bin/text-idx?rgn=div5&node=36:3.0.10.2.25);

NARA Bulletin 2013-02, August 29, 2013, “Guidance on a New Approach to Managing

Email Records”

(https://www.archives.gov/records-mgmt/bulletins/2013/2013-02.html); and

NARA Bulletin 2010-05 September 08, 2010, “Guidance on Managing Records in Cloud

Computing Environments”

(http://www.archives.gov/records-mgmt/bulletins/2010/2010-05.html).

Managing the records includes, maintaining records to retain functionality and integrity throughout the records’ full lifecycle including: (1) maintenance of links between records and metadata, and (2) categorization of records to manage retention and disposal, either through transfer of permanent records to NARA or deletion of temporary records in accordance with

NARA-approved retention schedules.

Task 10: Baseline Security Requirements

1. Applicability. The requirements herein apply whether the entire contract or order

(hereafter “contract”), or portion thereof, includes either or both of the following:

http://www.ecfr.gov/cgi-bin/text-idx?rgn=div5&node=36:3.0.10.2.25 https://www.archives.gov/records-mgmt/bulletins/2013/2013-02.html http://www.archives.gov/records-mgmt/bulletins/2010/2010-05.html

a. Access (Physical or Logical) to Government Information: A Contractor employee will have or will be given the ability to have, routine physical (entry) or logical

(electronic) access to government information.

b. Operate a Federal System Containing Information: A Contractor will operate a federal system and information technology containing data that supports the HHS mission. In addition to the Federal Acquisition Regulation (FAR) Subpart 2.1 definition of “information technology” (IT), the term as used in this section includes computers, ancillary equipment (including imaging peripherals, input, output, and storage devices necessary for security and surveillance), peripheral equipment designed to be controlled by the central processing unit of a computer, software, firmware and similar procedures, services (including support services), and related resources.

2. Safeguarding Information and Information Systems. In accordance with the Federal

Information Processing Standards Publication (FIPS)199, Standards for Security

Categorization of Federal Information and Information Systems, the Contractor shall:

a. Protect government information and information systems in order to ensure:

Confidentiality, which means preserving authorized restrictions on access and disclosure, based on the security terms found in this contract, including means for protecting personal privacy and proprietary information;

Integrity, which means guarding against improper information modification or destruction, and ensuring information non-repudiation and authenticity; and

Availability, which means ensuring timely and reliable access to and use of information.

b. Provide security for any Contractor systems, and information contained therein, connected to an HHS network or operated by the Contractor on behalf of HHS regardless of location per FAR clause 52.239-1, Privacy or Security Safeguards. In addition, if new or unanticipated threats or hazards are discovered by either the agency or contractor, or if existing safeguards have ceased to function, the discoverer shall immediately, within one (1) hour or less, bring the situation to the attention of the other party.

c. Adopt and implement the policies, procedures, controls, and standards required by the

HHS Information Security Program to ensure the confidentiality, integrity, and availability of government information and government information systems for which the Contractor is responsible under this contract or to which the Contractor may otherwise have access under this contract. Obtain the HHS Information Security

Program security requirements, outlined in the HHS Information Security and Privacy

Policy (IS2P), by contacting the CO/COR or emailing fisma@hhs.gov.

mailto:fisma@hhs.gov

d. Comply with the Privacy Act requirements and tailor FAR clauses as needed.

3. Information Security Categorization. In accordance with FIPS 199 and National Institute of Standards and Technology (NIST) Special Publication (SP) 800-60, Volume II:

Appendices to Guide for Mapping Types of Information and Information Systems to

Security Categories, Appendix C, and based on information provided by the ISSO, CISO, or other security representative, the risk level for each Security Objective and the Overall

Risk Level, which is the highest watermark of the three factors (Confidentiality, Integrity, and Availability) of the information or information system are the following:

Confidentiality: [X] Low [ ] Moderate [ ] High

Integrity: [X] Low [ ] Moderate [ ] High

Availability: [X] Low [ ] Moderate [ ] High

Overall Risk Level: [X] Low [ ] Moderate [ ] High

Based on information provided by the ISSO, Privacy Office, system/data owner, or other security or privacy representative, it has been determined that this solicitation/contract involves:

[X] No PII [ ] Yes PII

Personally Identifiable Information (PII). Per the Office of Management and Budget

(OMB) Circular A-130, “PII is information that can be used to distinguish or trace an individual's identity, either alone or when combined with other information that is linked or linkable to a specific individual.” Examples of PII include, but are not limited to the following: social security number, date and place of birth, mother‘s maiden name, biometric records, etc.

PII Confidentiality Impact Level has been determined to be:

[X] Low [ ] Moderate [ ] High

4. Controlled Unclassified Information (CUI). CUI is defined as “information that laws, regulations, or Government-wide policies require to have safeguarding or dissemination controls, excluding classified information.” The Contractor () must comply with

Executive Order 13556, Controlled Unclassified Information, (implemented at 3 CFR, part 2002) when handling CUI. 32 C.F.R. 2002.4(aa) As implemented the term

“handling” refers to “…any use of CUI, including but not limited to marking, safeguarding, transporting, disseminating, re-using, and disposing of the information.” 81

Fed. Reg. 63323. All sensitive information that has been identified as CUI by a regulation or statute, handled by this solicitation/contract, shall be:

a. marked appropriately;

b. disclosed to authorized personnel on a Need-To-Know basis;

c. protected in accordance with NIST SP 800-53, Security and Privacy Controls for

Federal Information Systems and Organizations applicable baseline if handled by a

Contractor system operated on behalf of the agency, or NIST SP 800-171, Protecting

Controlled Unclassified Information in Nonfederal Information Systems and

Organizations if handled by internal Contractor system; and

d. returned to HHS control, destroyed when no longer needed, or held until otherwise directed. Destruction of information and/or data shall be accomplished in accordance with NIST SP 800-88, Guidelines for Media Sanitization.

5. Protection of Sensitive Information. For security purposes, information is or may be sensitive because it requires security to protect its confidentiality, integrity, and/or availability. The Contractor shall protect all government information that is or may be sensitive in accordance with OMB Memorandum M-06-16, Protection of Sensitive

Agency Information by securing it with a FIPS 140-2 validated solution.

6. Confidentiality and Nondisclosure of Information. Any information provided to the contractor by HHS or collected by the contractor on behalf of HHS shall be used only for the purpose of carrying out the provisions of this contract and shall not be disclosed or made known in any manner to any persons except as may be necessary in the performance of the contract. The Contractor assumes responsibility for protection of the confidentiality of Government records and shall ensure that all work performed by its employees and subcontractors shall be under the supervision of the Contractor. Each

Contractor officer or employee or any of its subcontractors to whom any HHS records may be made available or disclosed shall be notified in writing by the Contractor that information disclosed to such officer or employee can be used only for that purpose and to the extent authorized herein.

The confidentiality, integrity, and availability of such information shall be protected in accordance with HHS and HRSA policies. Unauthorized disclosure of information will be subject to the HHS/HRSA sanction policies and/or governed by the following laws and regulations:

a. 18 U.S.C. 641 (Criminal Code: Public Money, Property or Records);

b. 18 U.S.C. 1905 (Criminal Code: Disclosure of Confidential Information); and

c. 44 U.S.C. Chapter 35, Subchapter I (Paperwork Reduction Act).

7. Internet Protocol Version 6 (IPv6). All acquisitions using Internet Protocol shall comply with FAR sections: FAR 7.105(b)(5), FAR 11.002(g), and FAR 12.202(e).

8. Government Websites. All new and existing public-facing government websites must be securely configured with Hypertext Transfer Protocol Secure (HTTPS) using the most recent version of Transport Layer Security (TLS). In addition, HTTPS shall enable HTTP

Strict Transport Security (HSTS) to instruct compliant browsers to assume HTTPS at all times to reduce the number of insecure redirects and protect against attacks that attempt to downgrade connections to plain HTTP. For internal-facing websites, the HTTPS is not required, but it is highly recommended.

9. Contract Documentation. The Contractor shall use HRSA-provided templates, policies, forms and other documents to comply with contract deliverables as appropriate.

10. Standard for Encryption. The Contractor shall:

a. Comply with the HHS Standard for Encryption of Computing Devices and

Information to prevent unauthorized access to government information.

b. Encrypt all sensitive federal data and information (i.e., PII, protected health information [PHI], proprietary information, etc.) in transit (i.e., email, network connections, etc.) and at rest (i.e., servers, storage devices, mobile devices, backup media, etc.) with FIPS 140-2 validated encryption solution.

c. Secure all devices (i.e.: desktops, laptops, mobile devices, etc.) that store and process government information and ensure devices meet HHS and HRSA specific encryption standard requirements. Maintain a complete and current inventory of all laptop computers, desktop computers, and other mobile devices and portable media that store or process sensitive government information (including PII).

d. Verify that the encryption solutions in use have been validated under the

Cryptographic Module Validation Program to confirm compliance with FIPS 140-2.

The Contractor shall provide a written copy of the validation documentation to the

COR.

e. Use the Key Management system on the HHS personal identification verification

(PIV) card or establish and use a key recovery mechanism to ensure the ability for authorized personnel to encrypt/decrypt information and recover encryption keys.

Encryption keys shall be provided to the COR upon request and at the conclusion of the contract.

11. Contractor Non-Disclosure Agreement (NDA). Each Contractor employee having access to non-public government information under this contract shall complete the HRSA non-disclosure agreement (Attachment B), as applicable. A copy of each signed and witnessed

NDA shall be submitted to the Contracting Officer (CO) and CO Representative (COR) prior to performing any work under this acquisition.

12. Privacy Threshold Analysis (PTA)/Privacy Impact Assessment (PIA) – The Contractor shall assist the HRSA Senior Official for Privacy (SOP) or designee with conducting a

PTA for the information system and/or information handled under this contract to determine whether or not a full PIA needs to be completed.

a. If the results of the PTA show that a full PIA is needed, the Contractor shall assist the

HRSA SOP or designee with completing a PIA for the system or information within

60 days after completion of the PTA and in accordance with HHS policy and OMB

M-03-22, Guidance for Implementing the Privacy Provisions of the E-Government

Act of 2002.

b. The Contractor shall assist the HRSA SOP or designee in reviewing the PIA at least every three years throughout the system development lifecycle (SDLC)/information lifecycle, or when determined by the agency that a review is required based on a major change to the system, or when new types of PII are collected that introduces new or increased privacy risks, whichever comes first.

13. Training.

a. Mandatory Training for All Contractor Staff. All Contractor employees assigned to work on this contract shall complete the applicable HHS/HRSA Information Security

Awareness, Privacy, and Records Management training (provided upon contract award) before performing any work under this contract. Thereafter, the employees shall complete HHS/HRSA Information Security Awareness, Privacy, and Records

Management training at least annually, during the life of this contract. All provided training shall be compliant with HHS training policies.

b. Role-based Training. All Contractor employees with significant security responsibilities (as determined by the program manager) must complete role-based training annually commensurate with their role and responsibilities in accordance with HHS policy and the HHS Role-Based Training (RBT) of Personnel with

Significant Security Responsibilities Memorandum.

c. Training Records. The Contractor shall maintain training records for all its employees working under this contract in accordance with HHS policy. The training records shall be provided to the CO and/or COR within 30 days after contract award and annually thereafter or upon request.

d. Records Management Training. The contractor shall ensure that all employees having access to (1) Federal information or a Federal information system, or (2) personally identifiable information (PII), complete the HRSA Records Management Training before performing work under this contract, and thereafter completing the annual refresher course during the life of the contract. The training can be requested by emailing the records management team at recordsmanagement3@hrsa.gov. The listing of completed training shall be included in the first progress report. Any revisions to this listing as a result of staffing changes shall be submitted with next required progress report.

14. Rules of Behavior

a. The Contractor shall ensure that all employees performing on the contract comply with the HHS Information Technology General Rules of Behavior, the HRSA

Information Technology Rules of Behavior (included in the HRSA Information

Security and Privacy Awareness Training), and any applicable system-level rules of behavior.

b. All Contractor employees performing on the contract must read and adhere to the

Rules of Behavior before accessing Department data or other information, systems, and networks that store/process government information, initially at the beginning of the contract and at least annually thereafter, which may be done as part of annual

HRSA Information Security Awareness Training. If the training is provided by the contractor, the signed ROB must be provided as a separate deliverable.

15. Incident Response.

FISMA defines an incident as “an occurrence that (1) actually or imminently jeopardizes, without lawful authority, the integrity, confidentiality, or availability of information or an information system; or (2) constitutes a violation or imminent threat of violation of law, security policies, security procedures, or acceptable use policies. The HHS Policy for IT

Security and Privacy Incident Reporting and Response further defines incidents as events involving cybersecurity and privacy threats, such as viruses, malicious user activity, loss of, unauthorized disclosure or destruction of data, and so on.

A privacy breach is a type of incident and is defined by Federal Information Security

Modernization Act (FISMA) as the loss of control, compromise, unauthorized disclosure, unauthorized acquisition, or any similar occurrence where (1) a person other than an authorized user accesses or potentially accesses personally identifiable information or (2) an authorized user accesses or potentially accesses personally identifiable information for an other than authorized purpose. The HHS Policy for IT Security and Privacy Incident

Reporting and Response further defines a breach as “a suspected or confirmed incident involving PII”.

In the event of a suspected or confirmed incident or breach, the Contractor shall:

a. Protect all sensitive information, including any PII created, stored, or transmitted in the performance of this contract so as to avoid a secondary sensitive information incident with FIPS 140-2 validated encryption.

b. NOT notify affected individuals unless so instructed by the Contracting Officer or designated representative. If so instructed by the Contracting Officer or representative, the Contractor shall send notifications to affected individuals following specific instructions from the HHS Privacy Incident Response Team

(PIRT).

c. Report all suspected and confirmed information security and privacy incidents and breaches to the HRSA Security Operations Center (SOC), COR, CO, HRSA SOP (or his or her designee), and other stakeholders, including incidents involving PII, in any medium or form, including paper, oral, or electronic, as soon as possible and without unreasonable delay, no later than one (1) hour, and consistent with the applicable

HRSA and HHS policy and procedures, NIST standards and guidelines, as well as

US-CERT notification guidelines. The types of information required in an incident report must include at a minimum: company and point of contact information, contract information, impact classifications/threat vector, and the type of information compromised. In addition, the Contractor shall:

1. Cooperate and exchange any information, as determined by the Agency, necessary to effectively manage or mitigate a suspected or confirmed breach;

2. Not include any sensitive information in the subject or body of any reporting e-mail; and

3. Encrypt sensitive information in attachments to email, media, etc.

d. Comply with OMB M-17-12, Preparing for and Responding to a Breach of Personally

Identifiable Information, HHS, and HRSA incident response policies when handling

PII breaches.

e. Provide full access and cooperate on all activities as determined by the Government to ensure an effective incident response, including providing all requested images, log files, and event information to facilitate rapid resolution of sensitive information incidents. This may involve disconnecting the system processing, storing, or transmitting the sensitive information from the Internet or other networks or applying additional security controls.

16. Position Sensitivity Designations.

Contractor employees must obtain a background investigation commensurate with their position sensitivity designation that complies with Parts 1400 and 731 of Title 5, Code of

Federal Regulations (CFR). The following position sensitivity designation levels apply to this solicitation/contract:

This security designation is non-sensitive, and require a moderate risk investigation T2S.

17. Homeland Security Presidential Directive (HSPD)-12.

The Contractor (and/or any subcontractor) and its employees shall comply with

Homeland Security Presidential Directive (HSPD)-12, Policy for a Common

Identification Standard for Federal Employees and Contractors; OMB M-05-24; FIPS

201, Personal Identity Verification (PIV) of Federal Employees and Contractors; HHS

HSPD-12 policy; and Executive Order 13467, Part 1 §1.2.

Roster. The Contractor shall submit a roster by name, position, e-mail address, phone number and responsibility, of all staff working under this acquisition where the

Contractor will develop, have the ability to access, or host and/or maintain a government information system(s). The roster shall be submitted to the COR and/or CO within 14 days of the effective date of this contract. Any revisions to the roster as a result of staffing changes shall be submitted within 14 days of the change. The COR will notify the Contractor of the appropriate level of investigation required for each staff member.

If the employee is filling a new position, the Contractor shall provide a position description and the Government will determine the appropriate suitability level.

18. Contract Initiation and Expiration.

a. General Security Requirements. The Contractor shall comply with information security and privacy requirements, Enterprise Performance Life Cycle (EPLC) processes, HHS Enterprise Architecture requirements to ensure information is appropriately protected from initiation to expiration of the contract. All information systems development or enhancement tasks supported by the contractor shall follow the HRSA EPLC framework and methodology

(https://sharepoint.hrsa.gov/oo/oit/dcppm/pmo/Shared Documents/z Old PMO

Archives/Documents.aspx) and in accordance with the HHS Contract Closeout Guide

(2012).

b. System Documentation. Contractors must follow and adhere to NIST SP 800-64, Security Considerations in the System Development Life Cycle, at a minimum, for system development and provide system documentation at designated intervals

(specifically, at the expiration of the contract) within the EPLC that require artifact review and approval.

c. Sanitization of Government Files and Information. As part of contract closeout and at expiration of the contract, the Contractor shall provide all required documentation to the CO and COR to certify that, at the government’s direction, all electronic and paper records are appropriately disposed of and all devices and media are sanitized in accordance with NIST SP 800-88, Guidelines for Media Sanitization.

d. Notification. The Contractor shall notify the CO and COR and system ISSO within two weeks before an employee stops working under this contract.

e. Contractor Responsibilities Upon Physical Completion of the Contract. The contractor shall return all government information and IT resources (i.e., government information in non-government-owned systems, media, and backup systems) acquired during the term of this contract to the CO and COR. Additionally, the Contractor shall provide a certification that all government information has been properly sanitized and purged from Contractor-owned systems, including backup systems and media used during contract performance, in accordance with HHS and HRSA policies.

f. The Contractor shall perform and document the actions identified in the HRSA

Clearance Form for Separating Employees and Contractors (Form-419) when an employee terminates work under this contract within two weeks days of the employee’s exit from the contract. All documentation shall be made available to the

CO and COR upon request.

19. General Data Accessibility Requirements.

The contractor shall not have direct access to NPDB systems nor have access to individual reports. The contractor shall have access to and utilize a Secure File Transfer system (such as NIH secure file system), such as a password protected website, to be able to exchange protected information and to share files too large to email.

The contractor shall be required to submit a confidentiality statement regarding the use of

NPDB data. The contractor shall sign a specific data use agreement with the NPDB (see link: https://www.npdb.hrsa.gov/forms/NPDBResearchProposal.docx).

Optional Tasks

The following Optional Tasks may be exercised during the contract performance or after the base year. If exercised, Optional Tasks will have a 12 month period of performance. Exact dates to be noted when they are exercised. Optional Tasks will be exercised during the base period of performance if they are going to be exercised.

OPTIONAL TASKS

Optional Task 1 Investigate whether state licensing board complaints (i.e., complaints against healthcare practitioners) are associated with NPDB reports https://www.npdb.hrsa.gov/forms/NPDBResearchProposal.docx

1. Conduct literature review on relationship between board complaints and state licensing reports;

2. Provide a methodology explaining how complaint narratives will be examined to evaluate the state licensing reports;

3. Provide descriptive statistics on complaints, state board actions, and NPDB reports;

4. Develop a methodology that examine correlation between complaints, state licensing actions, and NPDB reports;

Optional Task 2 Utilizing states that have profiles of physicians on their public websites, the study shall compare adverse action information available in the public domain to the reports residing in the NPDB to examine any information gaps

1. Conduct literature review on the information available for physicians on the public websites (especially state board public sites) and how this information could be downloaded and analyzed;

2. Compare adverse action information available in the public domain to the reports residing in the NPDB and;

3. Based on comparison, the contractor shall provide descriptive statistics for the data (i.e., information gap) between NPDB reports and public websites.

Optional Task 3 Prepare and Submit Draft Final Report and Recommendations

Optional Task 4 Prepare Final Report and Recommendations

1. Make changes to the draft final report as requested by the COR and;

Deliverables: 1 electronic copy of the revised final report to the COR with copies of the Executive Summary separately bound. The different data sets that were used shall be included in the final report as appendices. Three (3) paper copies shall be supplied in addition to one copy submitted on disk in a word processing format approved by the COR (30 days before the end of contract)

2. Contractor shall conduct a final briefing on the final report.

Deliverables: 1 electronic copy of the presentation, and provide a data file that contains all the analyses. This briefing shall be held in Rockville, Maryland and shall last from 1 to 2 hours (3 days before the end of the contract).

V. Schedule of Deliverables

508 Compliance

All products and services delivered under this contract must be Section 508 compliant in accordance with the HHSAR provided. The Section 508 Standards applicable to this contract are:

1194.21, 1194.22, 1194.24, 1194.31 and 1194.41.

Regardless of format, all digital content or communications materials produced as a deliverable under this contract 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. Remediation of any materials that do not comply with the applicable requirements as set forth below, shall be the responsibility of the vendor.

HHS guidance regarding accessibility of documents can be found at http://www.hhs.gov/web/section-508/making-files-accessible/index.html.

The Contractor shall submit all items in the quantities and by the dates indicated to the COR.

Tasks Deliverable Description Quantity / Format Due Date

1.1 Convene kick off meeting 1 in person

Within 7 days

EDOC

1.2 Submit kick off meeting minutes 1 electronic copy

7 days after kick off meeting

1.3

Revise & submit work plan timeline 1 electronic copy

Within 21 days

EDOC

1.4 Submit revised final work plan 1 electronic copy

7 days after the

COR’s comments

2 Submit quarterly reports 1 electronic copy

1st Week of every quarter

4.1

Submit literature review relevant to the first task 1 electronic copy

30 days from the

EDOC

4.2

Submit for COR’s review the following

List of states that have penalties and states with no penalties for reporting adverse actions 1 electronic copy

45 days from the

EDOC

5.2

Provide descriptive statistics for reporting trends for all years for the

Title IV entities 1 electronic copy

90 days from the

EDOC

5.3

Provide descriptive data for clinical privilege actions from hospitals vs. 1 electronic copy

100 days from the

EDOC

health Plans

5.4

Provide data that compares clinical privilege reports with state licensure, and administrative actions 1 electronic copy

130 days from the

EDOC

Submit literature review relevant to the second task 1 electronic copy

160 days from the

EDOC

6.1

Provide descriptive statistics for queries and reports on the nurse practitioners and physician assistants 1 electronic copy

180 days from the

EDOC

6.2

Submit list of states that are using nurse practitioners and physician assistants with supervision or without supervision as primary care providers 1 electronic copy

200 days from the

EDOC

6.4.2

Provide descriptive statistics for

Title IV reports for nurse practitioners and physician assistants 1 electronic copy

215 days from the

EDOC

6.4.3

Provide descriptive statistics and correlation results for peer review actions vs. administrative actions

vs. state licensure actions for nurse practitioners and physician assistants within the context of supervision requirements 1 electronic copy

245 days from the

EDOC

Submit draft final report and recommendations

On disc in word processing format

260 days from the

EDOC

8.1

Revise and submit draft final report and recommendations to the COR with copies of the Executive

Summary separately bound. The different data sets that were used shall be included in the final report as appendices.

1 electronic copy for final report and 1 copy of data dictionary

Three (3) paper copies shall be supplied in addition to one copy submitted on disk in a word processing format approved by the COR

30 days before end of contract

8.2

Conduct final briefing at 5600

Fishers Lane, Rockville, MD 20833

1 electronic copy and in person presentation

3 days before end of contract

Roster

Within 14 days of the effective date of this contract

Contractor Employee Non-

Disclosure Agreement (NDA)

Prior to performing any work on behalf of HHS

Copy of training records for all mandatory training

In conjunction with contract award and annually thereafter or upon request

10 Signed ROB for all employees

Initiation of contract and at least annually thereafter

Incident Report (as incidents or breaches occur)

As soon as possible and without reasonable delay and no later than 1 hour of discovery

10 Incident and Breach Response Plan

Upon request from government

Onboarding documentation when beginning contract.

Prior to performing any work on behalf of HHS

Form or deliverables…