18-235-SOL-00013_Complete_Document.pdf

18-235-SOL-00013

1. REQUEST NO.

5a. ISSUED BY

NAME

a. NAME

c. STREET ADDRESS

d. CITY

10. PLEASE FURNISH QUOTATIONS TO

THE ISSUING OFFICE IN BLOCK 5a ON

OR BEFORE CLOSE OF BUSINESS (Date)

2. DATE ISSUED 3. REQUISITION/PURCHASE REQUEST NO. 4. CERT. FOR NAT. DEF.

UNDER BDSA REG. 2

AND/OR DMS REG.1

RATING

6. DELIVERY BY (Date)

7. DELIVERY

9. DESTINATION

a. NAME OF CONSIGNEE

b. STREET ADDRESS

PAGE OF PAGES

5b. FOR INFORMATION CALL: (No collect calls)

TELEPHONE NUMBER

AREA CODE NUMBER

8. TO:

b. COMPANY

e. STATE f. ZIP CODE

c. CITY

d. STATE e. ZIP CODE

IMPORTANT: This is a request for information, and quotations furnished are not offers. If you are unable to quote, please so indicate on this form and return it to the address in Block 5a. This request does not commit the Government to pay any costs incurred in the preparation of the submission of this quotation or to contract for supplies or services. Supplies are of domestic origin unless otherwise indicated by quoter. Any representations and/or certifications attached to this Request for Quotations must be completed by the quoter.

11. SCHEDULE (Include applicable Federal, State and local taxes)

THIS RFQ

REQUEST FOR QUOTATION

(THIS IS NOT AN ORDER)

IS IS NOT A SMALL BUSINESS SET ASIDEX

07/17/2018

1 45

John E Moss Federal Bldg 650 Capitol Mall, Suite 7-100 Sacramento CA 95814

California Office of the Director Multiple

CORDELL BAILEY

08/07/2018 1400 PT

FOB DESTINATION

OTHER

(See Schedule)X

ITEM NO.

(a)

SUPPLIES/SERVICES

(b)

QUANTITY

(c)

UNIT

(d)

UNIT PRICE

(e)

AMOUNT

(f)

1 Diabetes Education Professional Consultant per the Special Diabetes Program for Indians to enhance GPRA reporting related to diabetes depression DV screening Immunizations and retinal screening Quotes packages MUST be submitted to the Contracting Officer via email Cordell.Bailey@ihs.gov and in the Subject Line insert, Response to Solicitation 18-235-SOL-00013.

12. DISCOUNT FOR PROMPT PAYMENT

a. 10 CALENDAR DAYS (%) b. 20 CALENDAR DAYS (%) c. 30 CALENDAR DAYS (%) d. CALENDAR DAYS

NUMBER PERCENTAGE

NOTE: Additional provisions and representations

13. NAME AND ADDRESS OF QUOTER

b. STREET ADDRESS

c. COUNTY

d. CITY e. STATE f. ZIP CODE

14. SIGNATURE OF PERSON AUTHORIZED TO

SIGN QUOTATION

16. SIGNER

a. NAME (Type or print)

c. TITLE (Type or print)

a. NAME OF QUOTER

AREA CODE

NUMBER

15. DATE OF QUOTATION

b. TELEPHONE are are not attached

AUTHORIZED FOR LOCAL REPRODUCTION

Previous edition not usable

STANDARD FORM 18 (REV. 6-95)

Prescribed by GSA - FAR (48 CFR) 53.215-1(a)

PERFORMANCE WORK STATEMENT DIABETES

EDUCATION PROFESSIONAL CONSULTANT

SECTION 1 GENERAL INFORMATION

1.1 Through the Special Diabetes Program for Indians (SDPI), the Indian Health

Service/California Area Office (IHS/CAO) is authorized to contract for a Diabetes Education Professional Consultant.

1.2 The Diabetes Education Professional Consultant is a person with current knowledge and considerable experience that is acceptable by medical standards of practice. This Consultant is to be a reliable resource to the diabetes health educators and other medical providers working in California tribal or urban healthcare centers. To be qualified to fill the consultant position a current health occupations license or registration (such as Registered Nurse, Physician Assistant, and Registered Dietitian) is required, along with experience in diabetes care and education, knowledge of federally funded tribal and urban Indian healthcare clinics and considerable proficiency in providing diabetes care management and evaluation of the diabetes programs. As well as a demonstrated ability to teach these skills to others to support improving diabetes outcomes, prevent diabetes, improve efficiency, coordination of services and increasing resource utilization.

The contract involves close coordination with the IHS/CAO, IHS/ DGM and DDTP and has responsibility for monitoring the programmatic aspects diabetes education and diabetes clinical care among California Tribal and urban Indian healthcare centers. In coordination with the IHS/CAO and DDTP exercises responsibility for evaluation of the healthcare centers diabetes programs capacities and in sustaining compliance with the terms and conditions by the grant program. The work also involves provision of technical programmatic expertise regarding diabetes prevention, education, and treatment to California SDPI grantee programs. The IHS provides the SDPI grant funds to potentially thirty-seven (37) California tribal and urban healthcare centers.

The CAO and its contractors will be able to provide individualized assistance to the tribal and urban Indian healthcare programs during the application process. The Contractor will evaluate capacity of grantees and provide program feedback that can assist in strengthening submission of their continuation application. To continue to be eligible to receive the SDPI grant funds, these healthcare centers must:

1.2.1 Successfully apply annually via the Federal GrantSolutions System to IHS for their Continuation SDPI Community Directed grant or Grants.gov if the process becomes competitive Perform and submit an Annual Diabetes Care and Outcomes Audit to continue their eligibility for the SDPI grant

1.2.2 Create and maintain a current diabetes registry of their patients with a Diabetes diagnosis

1.2.3 Perform and submit an Annual Diabetes Care and Outcomes Audit to continue their eligibility for the SDPI grant

1.2.4 Concentrate grant effort on at least one of the IHS Diabetes Best Practices

1.2.5 Follow the IHS Diabetes Standards of Care

1.2.6 Participate in, and receive continuous training and technical assistance provided by IHS/DDTP to optimize diabetes care, to include California Area Native American Diabetes Organization (CAN-DO) conference calls that provide support and education on current diabetes topics and standards; facilitate sharing between tribal programs.

1.2.7. Provide mid-year and annual reports via GrantSolutions, including Narrative and Create and maintain a current diabetes registry of their patients with a Diabetes diagnosis Federal Financial Statement - SF 425 and comply with all grant regulations

1.2.8 Manage grant funds within IHS grant guidelines and comply with the IHS Diabetes Best Practice templates.

1.3 Period of Performance: One year from time of award.

SECTION 2 DEFINITIONS

The language in this section is suggested for use only as appropriate and necessary.

ADC Area Diabetes Consultant AI/AN American Indian/Alaska Native CAC Clinical Applications Coordinator CAN-DO California Area Native American Diabetes Organization CAO California Area Office CAO-ADC California Area Office Area Diabetes Consultant CDE Certified Diabetes Educator CQI Continuous Quality Improvement CRS Clinical Reporting System DDTP Division of Diabetes Treatment and Prevention DGM Division of Grants Management DM Diabetes Mellitus DP Diabetes Prevention Initiative GPRA Government Performance and Results Act HbA1c Hemoglobin A1c HH Healthy Heart Initiative IHS Indian Health Service IPC Improving Patient Care IT Information Technology ORC Objective Review

Committee PA Physician Assistant PCMH Patient Centered Medical Home QI Quality Improvement Q-Man Query Utility Manager RPMS Resource and Patient Management System SDPI Special Diabetes Program for Indians TA Technical Assistance Web Audit Diabetes Audit submitted via the internet to IHS

2.2 Area

A defined geographical region for Indian Health Service administrative purposes. There are 12 Areas in the IHS System, with California Area one of the 12 Areas.

2.3 Annual Diabetes Outcomes Audit

Data entered during the calendar year for diabetes care.

2.4 Best Practices

Indian Health Services approach to Quality Diabetes Care

2.5 Contracting Officer (CO)

A government employee authorized and warranted to issue contracts, and to make subsequent modification(s). The CO has full authority to make determinations on all changes and disputes regarding the contract.

2.6 Contractor

The individual awarded a legal binding contract to provide supplies and/or services.

2.7 Diabetes Registry

A registry of patients served by the program and maintained through RPMS or other software.

2.8 Defective Service

A service output that does not meet the standard of performance requirement specified in the contract for that service.

2.9 Inspector

A government employee authorized to provide verbal and written performance direction to the Contractor that the Contractor must follow without exception.

2.10 Performance Requirement

The point that divides acceptable and unacceptable performance of a task according to the PRS And the Inspection of Services Clause.

2.11 Performance Requirements Summary

A listing of the service outputs under the contract that are to be evaluated by the project officer on a regular basis, the surveillance methods to be used for these outputs, and the performance requirements of the listed outputs.

2.12 Pre-Diabetes

The metabolic condition that exists prior to diabetes

2.13 Project Officer

A government representative appointed by the IHS/CAO to assist in the management of the contract. The project officer will work cooperatively under the direction of the contracting officer.

2.14 Quality Assurance

A planned and systematic pattern of all government actions necessary to provide confidence that adequate technical requirements are established; products and services conform to established technical requirements; and satisfactory performance is achieved. Quality assurance refers to actions by the government assurance functions for a contracted service.

2.15 Quality Control

Those actions taken by a contractor to control the production of outputs to ensure that they conform to the contract requirements.

2.16 Standards of Care

IHS evidence based standards of Quality Diabetes Care

SECITON 3 GOVERNMENT FURNISHED INFORMATION AND

PROPERTY

None

SECTION 4 CONTRACTOR FURNISHED PROPERTY

The contractor shall provide all equipment, material, and supplies necessary to provide Diabetes Management services described herein.

SECTION 5 SPECIFIC REQUIREMENTS

5.1 This Performance Work Statement (PWS) is to provide virtual technical assistance to each of the 39 California Indian Health clinic sites during the period of performance (37 SDPI funded sites currently and 2 non-funded sites with diabetes programs). On-site visits will be provided to the programs requiring increased assistance as determined by the Contractor and CAO-ADC. Provide one on-site visit to at least 11 of the Tribal or urban Indian healthcare centers diabetes programs as required during the period of performance, and broader in scope as outlined in section 5.3. The goal of the IHS/CAO is to improve diabetes outcomes, prevent diabetes, and improve efficiency, coordination of services and increasing resource utilization. This may include promotion of the Improving Patient Care (IPC) IHS initiative and Patient Centered Medical Home models.

5.2. The contractor will provide services to the following programs: Urban Programs

5.2.1 American Indian Health and Services Corp. (Santa Barbara)

5.2.2 Bakersfield American Indian Health Project (Bakersfield)

5.2.3 Fresno American Indian Health Project (Fresno)

5.2.4 Native American Health Center (Oakland)

5.2.5 San Diego American Indian Health Center (San Diego)

5.2.6 United American Indian Involvement, Inc. (Los Angeles)

5.2.7 Indian Health Center of Santa Clara Valley (San Jose)

5.2.8 Sacramento Native American Health Center (Sacramento)

Tribal Programs:

5.2.9 Central Valley Indian Health Center

5.2.10 Chapa-De Indian Health Program, Inc.

5.2.11 Colusa Indian Community Council

5.2.12 Consolidated Tribal Health Project, Inc.

5.2.13 Feather River Tribal Health, Inc.

5.2.14 Greenville Rancheria

5.2.15 Hopland Band of Pomo Indians

5.2.16 Hoopa Valley Tribe (Kima:w)

5.2.17 Indian Health Council, Inc.

5.2.18 Karuk Tribe of California

5.2.19 Lake County Tribal Health Consortium

5.2.20 M. A. C. T. Health Board

5.2.21 Northern Valley Indian Health

5.2.22 Pit River Health Services, Inc. (CRIHB)

5.2.23 Quartz Valley Indian Reservation, ANAV (CRIHB)

5.2.24 Redding Rancheria

5.2.25 Riverside-San Bernardino County Indian Health Inc.

5.2.26 Rolling Hills Clinic (Corning)

5.2.27 Round Valley Indian Health Center

5.2.28 Santa Ynez Tribal Health

5.2.29 Shingle Springs Tribal Health

5.2.30 Sonoma County Indian Health Project, Inc. (CRIHB)

5.2.31 Southern Indian Health, Inc.

5.2.32 Strong Family Health Center (Modoc Indian Health)

5.2.33 Susanville Indian Rancheria Health Center (Lassen Indian Health Center)

5.2.34 Table Mountain Rancheria

5.2.35 Toiyabe Indian Health Project

5.2.36 Tule River Indian Health Center, Inc.

5.2.37 Tuolumne Me-Wuk Indian Health Center

5.2.38 United Indian Health Services, Inc. (CRIHB)

5.2.39 Warner Mountain (CRIHB)

5.2.40 Wilton Rancheria

5.3 The Contractor will coordinate site visits with the Tribal and Urban Indian Health clinic staff; specifically the Diabetes Coordinator, GPRA Coordinator (if applicable), Executive Director and/or Medical Director. The contractor will coordinate site visits following a successful continuation grant application, when the Tribal and urban Indian programs continues to be a grantee. Site visits will be coordinated with the Tribal and Urban Indian Health clinic staff; specifically, the Diabetes Coordinator, Grant Writer (if applicable), GPRA Coordinator (if applicable), Medical Director and/or Executive Director. The site visits may be coordinated with the Diabetes Education Consultant Contractor and report all activity to the ADC. During the site visit, the Contractor will address current issues with the program’s SDPI grant, planning for the future, evaluating the current goals and objectives.

5.4 The Contractor will be responsible to provide technical assistance through web conferences, in person, and by phone to the above listed sites.

5.4.1 This includes Diabetes Case Management

5.4.2 Diabetes program management

5.4.3 Healthcare systems improvement and Quality Improvement

5.4.4 Program evaluation using the Diabetes Audit and GPRA reports as Quality Assurance benchmarks

5.4.5 Provide an assessment tool to evaluate effectiveness of TA

5.5 The IHS Resource and Patient Management System (RPMS) is utilized solely by IHS as its patient data base system. The Contractor must be able to provide TA to the Tribal or urban Indian healthcare center’s diabetes program coordinator and/or designee in the following tasks using the RPMS User Guide:

5.5.1 Reports using the Clinical Reporting System (CRS)

5.5.2 Navigate the Diabetes Management System (DMS) Package

5.5.3 Create all reports in the DMS package

5.5.4 Generate IHS “Annual Diabetes Care & Outcomes Audit” via the Web Audit

5.5.5 Ability to correct errors in data entry

5.5.6 Provide an assessment tool to evaluate effectiveness of TA

5.5.7 The Contractor is NOT expected to have expert knowledge on other soft ware

Electronic Medical Record Systems

5.6 The Contractor will develop an assessment tool to evaluate the understanding of the individuals he/she is providing in-depth training to during a site visit on these topics:

5.6.1 Diabetes case management, quality improvement, and program management

5.6.2 RPMS – DMS data entry and report generation

5.6.3 Diabetes audit

5.7 Provide diabetes support to California tribal health care programs to improve patient care and outcomes. This task will include the following measures:

5.7.1 On-site visits to at least 11 out of 39 tribal/urban programs and subsequent written reports within 45 days of the visit. Site visits to include: evaluation of the existing diabetes program, clinic capacity, diabetes education, IHS Diabetes Care and Outcomes Audit and GPRA results with a focus on the above Targeted Diabetes Audit Measures, and over-all quality improvement process measures when applicable.

5.7.2 At least Quarterly California Area Native American Diabetes Organization (CAN-DO) conference calls to provide support and education on current diabetes topics and standards; facilitate sharing between tribal programs.

5.7.3 Provide oversight of the Web Audit submission of the Annual Diabetes Care and Outcomes Audit by all Tribal/Urban healthcare centers for the 2019 audit year (calendar year January thru December).

5.7.4 Create a year-by-year cumulative Diabetes Audit report for all of the California Area using aggregated data based on the final audit data submitted into Web Audit.

5.7.5 The Contractor will assist in planning, coordinating, and attending the Annual Diabetes Day and Best Practices Medical Conference in Sacramento May 2019.

5.7.6 The Contractor will attend the annual IHS National Diabetes Conference September 2017.

5.8 Assist the Diabetes Program Coordinators in promoting positive health outcomes for their population of patients with diabetes. Sourcing IHS Diabetes Standards of Care, Diabetes Case Management and performing evaluation by using the cumulative California Area Diabetes Audit data. Coordination with the CAO, ADC and Diabetes SDPI Grant Contractor is necessary to provide training on the Annual Diabetes Care and Outcomes Audit performed via Web Audit. Every SDPI grantee is required to include their Annual Diabetes Audit to show improvements or declines in their SDPI Best Practice required key measure. Assist the CAO with the following 6 targeted activities, set as goals for the entire region:

5.8.1 Update individual program Diabetes Audit multi-year tables

5.8.2 Continue CAN-DO conference calls at least quarterly

5.8.3 Diabetes contractors to continue on-site technical assistance

5.8.4 Annual Diabetes Day for California programs in May

5.8.5 Continue to provide information to programs on the new individualized goals for glycemic control and blood pressure

5.8.6 Continue focus on diabetes care management and assisting California programs in identifying at-risk clients (HbA1c>=9, Uncontrolled BP > 150/90, Statin prescribed) and implementing patient-centered care plans

5.9 The Contractor shall provide the following processes:

5.9.1 Participate in a multi-disciplinary team in the California Area Office. Fill the role as “Recorder” to write the meeting minutes and goals/plans pertaining to the Area-wide approaches discussed in the following meetings or the role as “Time Keeper” to keep the meeting on time.

5.9.1.1 One meeting will be held at the IHS CAO located at 650 Capitol Mall, Suite 7-100, Sacramento, CA 95814. The contractor is expected to attend this meeting. All travel costs shall be included in the contractor total price.

5.9.1.2 One meeting will be held via web-conference.

5.9.1.3 At least four hours per month collaborating via phone or email with

CAO,

ADC and Diabetes SDPI Grant Consultant

5.9.1.4 Participate in the CAO targeted activity goals

5.9.1.5 Attend the Annual National IHS Diabetes Conference. All travel costs shall be included in the contract total price

5.9.2 Promote and teach concepts of Diabetes Case Management to all tribal/urban health programs with basic evaluation of the Diabetes Program Coordinator’s capacity to be reported to the CAO-ADC in the monthly reports.

5.9.3 Participate via teleconference on training sessions provided from the CAO to the

Health Programs and email reminders to the California programs of the DDTP Required Training webinars.

5.9.4 The contractor shall provide a minimum of two hours collaborative work per month with the Grants Consultant and ADC

5.10 The contractor shall meet the following qualifications:

5.10.1 The contractor shall be a licensed Registered Nurse, Registered Dietitian, Physician Assistant, or Physician, and maintain the distinction of being a Certified Diabetes Educator (CDE)

5.10.2 The contractor shall satisfactorily demonstrate expert level knowledge of working with Diabetes programs.

5.10.3 The contractor shall satisfactorily demonstrate knowledge of working with

AI/AN

programs.

5.10.4 The contractor shall satisfactorily demonstrate knowledge of the IHS Quality

Improvement initiative: Improving Patient Care (IPC).

5.10.5 The contractor shall satisfactorily demonstrate advanced working knowledge of

RPMS the IHS Resource and Patient Management System software.

5.10.5 The contractor is not required to have knowledge of other software programs used by health care programs if they are not using RPMS.

5.10.6 The contractor shall have advanced working knowledge of:

5.11.6.1 The IHS Diabetes Standards of Care

5.11.6.2. The IHS Diabetes Best Practices

5.11.6.3. The diabetes education curriculum “Balancing Your Life and Diabetes”

5.11 The contractor shall demonstrate working knowledge of RPMS to be able to utilize the

Diabetes Management System, iCare, and/or CRS that are sub-programs of the IHS software.

5.11.1 The contractor is not required to have knowledge of other software programs used by health care programs if they are not using RPMS

5.12 The contractor shall have working knowledge of:

5.14.1 GrantSolutions System and Grants.Gov

5.14.2 The IHS Diabetes Standards of Care

5.14.3 The IHS Diabetes Best Practices

5.14.4 Microsoft Power Point, Word, and Excel

SECTION 6 APPLICABLE PUBLICATIONS

6.1 AADE Guidelines for the Practice of Diabetes Self-Management Education and

Training (DSME/T) at:

http://www.diabeteseducator.org/DiabetesEducation/position/Practice_Guidelines.html

6.2 AADE7 System Self-Care

http://www.diabeteseducator.org/ProfessionalResources/AADE7/A7S.html

6.3 IHS Diabetes Best Practices:

http://www.diabeteseducator.org/DiabetesEducation/position/Practice_Guidelines.html http://www.diabeteseducator.org/ProfessionalResources/AADE7/A7S.html http://www.ihs.gov/MedicalPrograms/Diabetes/index.cfm?module=toolsBestPractices

6.4 IHS Balancing Your Life and Diabetes, available on the IHS.gov website at:

http://www.ihs.gov/MedicalPrograms/Diabetes/RESOURCES/Catalog/index.cfm?modu l e=productList&productNameApprox=Balancing%20Your%20Life%20and%20Diabete s

6.5 Standards of Care and Clinical Practice Recommendations: Type 2 Diabetes/ Diagnosis of Type 2 Diabetes and Prediabetes:

http://www.ihs.gov/MedicalPrograms/Diabetes/index.cfm?module=SOCDiagnosisDM

SECTION 7 ATTACHMENT/TECHNICAL EXHIBIT LISTING

7.1 Performance Requirements Summary

7.2 Reports, Data and Other Deliverables

7.3 Directory of Health Programs

http://www.ihs.gov/MedicalPrograms/Diabetes/index.cfm?module=toolsBestPractices http://www.ihs.gov/MedicalPrograms/Diabetes/RESOURCES/Catalog/index.cfm?module=productList&productNameApprox=Balancing%20Your%20Life%20and%20Diabetes http://www.ihs.gov/MedicalPrograms/Diabetes/RESOURCES/Catalog/index.cfm?module=productList&productNameApprox=Balancing%20Your%20Life%20and%20Diabetes http://www.ihs.gov/MedicalPrograms/Diabetes/RESOURCES/Catalog/index.cfm?module=productList&productNameApprox=Balancing%20Your%20Life%20and%20Diabetes http://www.ihs.gov/MedicalPrograms/Diabetes/RESOURCES/Catalog/index.cfm?module=productList&productNameApprox=Balancing%20Your%20Life%20and%20Diabetes http://www.ihs.gov/MedicalPrograms/Diabetes/index.cfm?module=SOCDiagnosisDM

Appendix___: Business Associate Agreement

I. Authority:

Pursuant to 45 C.F.R. § 164.502(e), the Indian Health Service (IHS), as a covered entity, is required to enter into an agreement with a “business associate,” as defined by 45 C.F.R. § 160.103, under which the business associate must agree to appropriately safeguard Protected Health Information (PHI) that it will use and disclose when performing functions, activities or services pursuant to its contract with the IHS. By signing Contract No. ________ (Contract), _______________ agrees that it is a Business Associate and will comply with the terms below, in addition to other applicable Contract terms and conditions, and applicable law, relating to the safekeeping, use, and disclosure of PHI. This Appendix comprises the Business Associate Agreement (Agreement).

II. Definitions:

The following terms shall have the same meaning as those terms in 45 C.F.R. Part 160 and Part 164, which are the federal regulations implementing the Health Insurance Portability and Accountability Act of 1996 (HIPAA), as amended: Breach, Designated Record Set, Disclosure, Health Care Operations, Individual, Minimum Necessary, Notice of Privacy Practices, PHI, Required by Law, Secretary, Security Incident, Subcontractor, Unsecured PHI, and Use.

A. Business Associate. “Business Associate” shall generally have the same meaning as the term “business associate” at 45 C.F.R. § 160.103, and in reference to the party to this Agreement shall mean ____________.

B. Covered Entity. “Covered Entity” shall generally have the same meaning as the term “covered entity” at 45 C.F.R. § 160.103, and in reference to the party to this Agreement, shall mean the IHS.

C. HIPAA Rules. “HIPAA Rules” shall mean the Privacy, Security, Breach Notification, and Enforcement Rules at 45 C.F.R. Part 160 and Part 164.

D. Master Patient Index (MPI). The “Master Patient Index” or “MPI” is composed of a unique list of patients and a current list of medical centers where each patient has been seen. This enables the sharing of patient data between operationally and regionally diverse systems. Each record (or index entry) on the MPI contains a small amount of patient data used to identify individual entries.

The mission of the MPI is to uniquely identify a patient and to “link” that patient’s data throughout the IHS facilities using the Integration Control Number (ICN). The MPI is the authoritative source of a patient’s ICN, the enterprise-wide identifier for IHS facilities and the key to accessing a patient’s record. The accuracy of patient information and patient identification directly affects clinical, administrative, billing, and interdepartmental processes.

III. Obligations and Activities of Business Associate:

A. Compliance: Business Associate agrees not use or disclose PHI other than as authorized by the Agreement or as required by law. Business Associate acknowledges that it is directly liable under the HIPAA Rules and subject to civil and, in some cases, criminal penalties for making uses and disclosures of PHI that are not authorized by the Agreement or required by law. Business Associate agrees that it will require all of its agents, employees, subsidiaries, and affiliates, to whom Business Associate provides PHI, or who create or receive PHI on behalf of Business Associate for Covered Entity, to comply with the HIPAA Rules and to enter into written agreements with Business Associate that provide the same restrictions, terms, and conditions as set forth in the Agreement.

B. Subcontractors: In accordance with 45 C.F.R. §§ 164.502(e)(1)(ii) and

164.308(b)(2), which govern relations with subcontractors, Business Associate agrees to ensure that any subcontractors that create, receive, maintain, or transmit PHI on behalf of Business Associate agree to the same restrictions, terms, and conditions that apply to Business Associate with respect to such PHI.

C. Safeguarding PHI: Business Associate shall develop and use appropriate procedural, physical, and electronic safeguards to protect against the use or disclosure of PHI in a manner not authorized by this Agreement or required by law. Business Associate will limit any use, disclosure, or request for use or disclosure of PHI to the minimum amount necessary to accomplish the intended purpose of the use, disclosure, or request.

D. Safeguarding Electronic PHI: Business Associate agrees to use appropriate safeguards, as set forth in Subpart C of 45 C.F.R. Part 164 with respect to electronic PHI, to prevent use or disclosure of electronic PHI other than as authorized by this Agreement or required by law.

E. Reporting Use or Disclosures Not Authorized By this Agreement or Required by Law: Business Associate agrees to report to Covered Entity any use or disclosure of PHI not authorized by this Agreement or required by law within thirty (30) days of discovering the use or disclosure, or any security incident of which it becomes aware. In addition, Business Associate shall mitigate, to the extent practicable, any harmful effect that is known to Business Associate of the use, disclosure, or security incident.

F. Reporting of Breach: In accordance with the policy of the Department of Health and Human Services, Business Associate will report, within one hour of discovery, all suspected or confirmed breaches to Covered Entity.

G. Notification of Breach of Unsecured PHI: In addition to the above, Business

Associate shall notify Covered Entity of a breach, as set forth in 45 C.F.R. § 164.410, of the security of any unsecured PHI that Business Associate received from, or created or received on behalf of, Covered Entity within thirty (30) calendar days after the discovery of the breach by Business Associate, its employees, officers, and/or other agents, unless notification is specifically excepted by 45 C.F.R. § 164.412.

1. Requirements of Notice. Such notice shall include, to the extent possible, the identification of each individual whose unsecured PHI has been, or is reasonably believed by Business Associate to have been, accessed, acquired, or disclosed during such breach; a brief description of the circumstances of the breach of security, including the date of the breach and the date of Business Associate’s discovery of the breach; and the type of unsecured PHI involved in the breach. Business Associate agrees to provide any other available information that Covered Entity is required to include in notification to the individual under 45 §164.404(c). In the event notification is delayed, evidence demonstrating the necessity of the delay shall accompany the notification.

H. Individual Access to PHI: Business Associate shall maintain a designated record set for each individual for whom it maintains PHI. In accordance with an individual’s right to access his or her PHI, Business Associate shall make available all PHI in the individual’s designated record set to the individual to whom that information pertains, or, upon the request of the individual, to that individual’s authorized representative, as necessary to satisfy Covered Entity’s obligations under 45 C.F.R. § 164.524. Availability to access PHI shall be made within five (5) calendar days of receipt of a valid request.

I. Accounting of Disclosures: Business Associate shall maintain records of PHI received from, or created or received on behalf of, Covered Entity and shall document subsequent uses and disclosures of such information by Business Associate. Business Associate shall, within five (5) calendar days after receiving a request from Covered Entity, provide to Covered Entity such information as Covered Entity may require to fulfill its obligations to account for disclosures of PHI pursuant to 45 C.F.R. § 164.528.

J. Amendment of PHI: Business Associate shall, within five (5) calendar days of a request by Covered Entity, make PHI available to Covered Entity for Covered Entity to fulfill its obligations under 45 C.F.R. § 164.526 to amend PHI and shall, as directed by Covered Entity, within five (5) calendar days of receipt of such direction, incorporate any amendments into PHI held by Business Associate. In addition, Business Associate shall ensure incorporation of any such amendments into PHI held by its agents or subcontractors within ten (10) days of such direction, and shall notify Covered Entity within five (5) calendar days of when those agents or subcontractors have completed the incorporation of the amendments. Business Associate shall forward to Covered Entity all requests to amend PHI that it receives directly from individuals within five (5) calendar days of its receipt of a request.

K. Carrying out Covered Entity’s Obligations: To the extent Business Associate is to carry out one or more of Covered Entity’s obligation(s) under Subpart E of 45 C.F.R. Part 164, Business Associate agrees to comply with the requirements of Subpart E that apply to Covered Entity in the performance of such obligation(s).

L. Disclosures for Verifying Compliance: Upon request, Business Associate shall permit access by the Secretary and Covered Entity during normal business hours to its facilities, books, records, accounts, and any other sources of information, including PHI and any agreements that it has with subcontractors, vendors, and/or other agents relating to the use and disclosure of PHI received from Covered Entity, or created or received by Business Associate on behalf of Covered Entity, for purposes of determining both Business Associate’s and Covered Entity’s compliance with the HIPAA Rules.

IV. Permitted Uses and Disclosures by Business Associate:

A. Business Associate shall not use or disclose PHI except to perform functions, activities, or services on behalf of Covered Entity as provided for in the Contract, this Agreement, the HIPAA Rules, or other applicable law.

B. Business Associate agrees that it may use or disclose PHI on behalf of Covered Entity only:

1. Upon obtaining the authorization of the individual to whom the PHI pertains;

2. For the purposes of treatment, payment or health care operations unless Covered Entity has agreed to a restriction pursuant to 45 C.F.R. § 164.520(b)(iv)(A) or 45 C.F.R. § 164.522; or

3. Without an authorization or consent, if in accordance with 45 C.F.R. § 164.510, 45 C.F.R. § 164.512, 45 C.F.R. § 164.514(e), 45 C.F.R. § 164.514(f), or 45 C.F.R. § 164.514(g).

C. Business Associate shall use and disclose PHI in compliance with each applicable requirement of 45 C.F.R. § 164.504(e), which section is fully incorporated herein.

D. Business Associate agrees to make uses, disclosures, and requests for PHI consistent with Covered Entity’s minimum necessary policies and procedures.

E. It is anticipated that Business Associate will have access to the MPI.

F. Business Associate may not use or disclose PHI in a manner that would violate Subpart E of 45 C.F.R. Part 164 if done by Covered Entity, except for the specific uses and disclosures set forth below.

1. Business Associate may disclose PHI for the proper management and administration of Business Associate or to carry out the legal responsibilities of Business Associate, provided the disclosures are required by law, or Business Associate obtains reasonable assurances from the person to whom the information is disclosed that the information will remain confidential and used or further disclosed only as required by law or for the purposes for which it was disclosed to the person, and the person notifies Business Associate of any instances of which it is aware in which the confidentiality of the information has been breached.

V. Obligations of Covered Entity:

A. Covered Entity shall provide Business Associate with its Notice of Privacy

Practices and any changes to the Notice.

B. Covered Entity shall notify Business Associate of any limitation(s) in Covered Entity’s Notice of Privacy Practices under 45 C.F.R. § 164.520, to the extent that such limitation may affect Business Associate’s use or disclosure of PHI.

C. Covered Entity shall notify Business Associate of any change in, or revocation of, the permission by an individual to use or disclose his or her PHI to the extent that such changes may affect Business Associate’s use or disclosure of PHI.

D. Covered Entity shall notify Business Associate of any restriction on the use or disclosure of PHI that Covered Entity has agreed to or is required to abide by under 45 C.F.R. § 164.522, to the extent that such restriction may affect Business Associate’s use or disclosure of PHI.

E. Covered Entity shall not request Business Associate to use or disclose PHI in any manner that would not be permissible under Subpart E of 45 C.F.R. Part 164 if done by Covered Entity, except as provided in Part IV, Subpart F, Section 1.

VI. Termination:

A. Term: The Term of this Agreement shall be effective as of the date Business

Associate signs the underlying Contract and shall terminate when the Contract ends or on the date covered entity terminates for cause as authorized in paragraph

(b) of this Section, whichever is sooner.

B. Termination for Cause: Business Associate authorizes termination of this Agreement by Covered Entity, if Covered Entity determines Business Associate has violated a material term of the Agreement and Business Associate has not ended the violation within the time specified by Covered Entity.

C. Obligations of Business Associate Upon Termination: Upon termination of this Agreement for any reason, Business Associate, with respect to PHI received from Covered Entity, or created, maintained, or received by Business Associate on behalf of Covered Entity, shall:

1. Retain only that PHI which is necessary for Business Associate to continue its proper management and administration or to carry out its legal responsibilities;

2. Return to Covered Entity, or, if agreed to by Covered Entity, destroy, the remaining PHI that Business Associate does not need to continue its proper management and administration or to carry out its legal responsibilities;

3. Continue to use appropriate safeguards, in compliance with Subpart C of 45 C.F.R. Part 164, with respect to electronic PHI to prevent use or disclosure of electronic PHI, other than as provided for in this Part, for as long as Business Associate retains the PHI;

4. Not use or disclose PHI retained by Business Associate other than for the purposes for which such PHI was retained and subject to the same conditions set out above, at Part IV, Subpart F, Section 1 of the Agreement which applied prior to termination;

5. Return to Covered Entity, or, if agreed to by Covered Entity, destroy, the PHI retained by Business Associate when it is no longer needed by Business Associate for its proper management and administration or to carry out its legal responsibilities; and

6. If Business Associate or its agent or subcontractor destroys any PHI, Business Associate will provide Covered Entity with documentation evidencing such destruction within thirty (30) days of completion of destruction.

D. Survival: The obligations of Business Associate under this Part shall survive the termination of this Agreement.

VII. Indemnification:

In the event Business Associate is investigated and/or becomes a party to a civil or criminal cause of action in any forum relating to its failure to comply with the HIPAA Rules, Business Associate shall reimburse Covered Entity all reasonable costs and expenses Covered Entity may incur relating to such investigation and/or cause of action, and will otherwise hold Covered Entity harmless for any and all reasonable costs and expenses relating to the foregoing.

VIII. Miscellaneous:

A. Incorporation: This Agreement is attached to and fully incorporated into the Contract.

B. Notices: All notices under this Agreement shall be provided by certified mailing, and shall require proof of date of receipt.

C. Regulatory References: A reference in this Agreement to a section in the HIPAA Rules means the section as in effect or as amended.

D. Amendment: The Parties agree to take such action as is necessary to amend this Agreement from time to time as is necessary for compliance with the requirements of the HIPAA Rules and any other applicable law.

E. Interpretation: Any ambiguity in this Agreement shall be interpreted to permit compliance with the HIPAA Rules.

F. Successors and Assigns: This Agreement shall be binding upon, inure to the benefit of and be enforceable by and against the Parties and their successors and assigns.

G. Severability: If a court of competent jurisdiction deems any provision of this Agreement unenforceable, such provision shall be severed from this Agreement and every other provision of the Agreement shall remain in full force and effect.

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Contract Clauses and Provisions

52.212-1 Instructions to Offerors - Commercial Items. (Jan 2017)

52.212-2 Evaluation - Commercial Items. (OCT 2014)

(a) The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered.

The following factors shall be used to evaluate offers:

Listed in descending order of importance

(i) technical capability

(ii) past performance

(iii) price

(b) Options. The Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. The Government may determine that an offer is unacceptable if the option prices are significantly unbalanced. Evaluation of options shall not obligate the Government to exercise the option(s).

(c) A written notice of award or acceptance of an offer, mailed or otherwise furnished to the successful offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offer’s specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award.

52.212-3 Offeror Representations and Certifications—Commercial Items (Nov 2017)

The Offeror shall complete only paragraph (b) of this provision if the Offeror has completed the annual representations and certification electronically via the System for Award Management (SAM) website located at https://www.sam.gov/portal. If the Offeror has not completed the annual representations and certifications electronically, the Offeror shall complete only paragraphs (c) through (u) of this provision.

(a) Definitions. As used in this provision— “Economically disadvantaged women-owned small business (EDWOSB) concern” means a small business concern that is at least 51 percent directly and unconditionally owned by, and the management and daily business operations of which are controlled by, one or more women who are citizens of the United States and who are economically disadvantaged in accordance with 13 CFR part 127. It automatically qualifies as a women-owned small business eligible under the WOSB Program.

“Highest-level owner” means the entity that owns or controls an immediate owner of the offeror, or that owns or controls one or more entities that control an immediate owner of the offeror. No entity owns or exercises control of the highest level owner.

“Immediate owner” means an entity, other than the offeror, that has direct control of the offeror. Indicators of control include, but are not limited to, one or more of the following: ownership or interlocking management, identity of interests among family members, shared facilities and equipment, and the common use of employees.

“Inverted domestic corporation”, means a foreign incorporated entity that meets the definition of an inverted domestic corporation under 6 U.S.C. 395(b), applied in accordance with the rules and definitions of 6 U.S.C. 395(c).

https://www.sam.gov/portal http://uscode.house.gov/ http://uscode.house.gov/

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“Manufactured end product” means any end product in product and service codes (PSCs) 1000-9999, except—

(1) PSC 5510, Lumber and Related Basic Wood Materials;

(2) Product or Service Group (PSG) 87, Agricultural Supplies;

(3) PSG 88, Live Animals;

(4) PSG 89, Subsistence;

(5) PSC 9410, Crude Grades of Plant Materials;

(6) PSC 9430, Miscellaneous Crude Animal Products, Inedible;

(7) PSC 9440, Miscellaneous Crude Agricultural and Forestry Products;

(8) PSC 9610, Ores;

(9) PSC 9620, Minerals, Natural and Synthetic; and

(10) PSC 9630, Additive Metal Materials.

“Place of manufacture” means the place where an end product is assembled out of components, or otherwise made or processed from raw materials into the finished product that is to be provided to the Government. If a product is disassembled and reassembled, the place of reassembly is not the place of manufacture.

“Predecessor” means an entity that is replaced by a successor and includes any predecessors of the predecessor.

“Restricted business operations” means business operations in Sudan that include power production activities, mineral extraction activities, oil-related activities, or the production of military equipment, as those terms are defined in the Sudan Accountability and Divestment Act of 2007 (Pub. L. 110-174). Restricted business operations do not include business operations that the person (as that term is defined in Section 2 of the Sudan Accountability and Divestment Act of 2007) conducting the business can demonstrate—

(1) Are conducted under contract directly and exclusively with the regional government of southern Sudan;

(2) Are conducted pursuant to specific authorization from the Office of Foreign Assets Control in the Department of the Treasury, or are expressly exempted under Federal law from the requirement to be conducted under such authorization;

(3) Consist of providing goods or services to marginalized populations of Sudan;

(4) Consist of providing goods or services to an internationally recognized peacekeeping force or humanitarian organization;

(5) Consist of providing goods or services that are used only to promote health or education; or

(6) Have been voluntarily suspended.

“Sensitive technology”—

(1) Means hardware, software, telecommunications equipment, or any other technology that is to be used specifically—

(i) To restrict the free flow of unbiased information in Iran; or

(ii) To disrupt, monitor, or otherwise restrict speech of the people of Iran; and

(2) Does not include information or informational materials the export of which the President does not have the authority to regulate or prohibit pursuant to section 203(b)(3) of the International Emergency Economic Powers Act (50 U.S.C. 1702(b)(3)).

“Service-disabled veteran-owned small business concern”—

(1) Means a small business concern—

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(i) Not less than 51 percent of which is owned by one or more service-disabled veterans or, in the case of any publicly owned business, not less than 51 percent of the stock of which is owned by one or more service-disabled veterans; and

(ii) The management and daily business operations of which are controlled by one or more service-disabled veterans or, in the case of a service-disabled veteran with permanent and severe disability, the spouse or permanent caregiver of such veteran.

(2) Service-disabled veteran means a veteran, as defined in 38 U.S.C. 101(2), with a disability that is service-connected, as defined in 38 U.S.C. 101(16).

“Small business concern” means a concern, including its affiliates, that is independently owned and operated, not dominant in the field of operation in which it is bidding on Government contracts, and qualified as a small business under the criteria in 13 CFR Part 121 and size standards in this solicitation.

“Small disadvantaged business concern”, consistent with 13 CFR 124.1002, means a small business concern under the size standard applicable to the acquisition, that—

(1) Is at least 51 percent unconditionally and directly owned (as defined at 13 CFR 124.105) by—

(i) One or more socially disadvantaged (as defined at 13 CFR 124.103) and economically disadvantaged (as defined at 13 CFR 124.104) individuals who are citizens of the United States; and

(ii) Each individual claiming economic disadvantage has a net worth not exceeding $750,000 after taking into account the applicable exclusions set forth at 13 CFR 124.104(c)(2); and

(2) The management and daily business operations of which are controlled (as defined at 13.CFR

124.106) by individuals, who meet the criteria in paragraphs (1)(i) and (ii) of this definition.

“Subsidiary” means an entity in which more than 50 percent of the entity is owned—

(1) Directly by a parent corporation; or

(2) Through another subsidiary of a parent corporation.

“Veteran-owned small business concern” means a small business concern—

(1) Not less than 51 percent of which is owned by one or more veterans (as defined at 38 U.S.C. 101(2)) or, in the case of any publicly owned business, not less than 51 percent of the stock of which is owned by one or more veterans; and

(2) The management and daily business operations of which are controlled by one or more veterans.

“Successor” means an entity that has replaced a predecessor by acquiring the assets and carrying out the affairs of the predecessor under a new name (often through acquisition or merger). The term “successor” does not include new offices/divisions of the same company or a company that only changes its name. The extent of the responsibility of the successor for the liabilities of the predecessor may vary, depending on State law and specific circumstances.

“Women-owned business concern” means a concern which is at least 51 percent owned by one or more women; or in the case of any publicly owned business, at least 51 percent of its stock is owned by one or more women; and whose management and daily business operations are controlled by one or more women.

“Women-owned small business concern” means a small business concern—

(1) That is at least 51 percent owned by one or more women; or, in the case of any publicly owned business, at least 51 percent of the stock of which is owned by one or more women; and

(2) Whose management and daily business operations are controlled by one or more women.

“Women-owned small business (WOSB) concern eligible under the WOSB Program” (in accordance with 13 CFR part 127), means a small business concern that is at least 51 percent directly and unconditionally owned by, and the management and daily business operations of which are controlled by, one or more women who are citizens of the United States.

http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title38-section101(2)&num=0&edition=prelim http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title38-section101(16)&num=0&edition=prelim http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t37t40+200+2++%2838%29%20%20AND%20%28%2838%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20

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(b)(1) Annual Representations and Certifications. Any changes provided by the offeror in paragraph (b)(2) of this provision do not automatically change the representations and certifications posted on the SAM website.

(2) The offeror has completed the…