75H70520Q00002.pdf

75H70520Q00002

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

10/17/2019

1 35

522 Minnesota Ave NW Bemidji MN 56601

Indian Health Service 11/10/2020

IHSWHITEEARTH

Indian Health Service

40520 CO HWY 34

OGEMA MN 56569

OGEMA

MN 56569

218 444-0482LEAH AZURE

11/01/2019 1400 CT

FOB DESTINATION

OTHER

(See Schedule)X

ITEM NO.

(a)

SUPPLIES/SERVICES

(b)

QUANTITY

(c)

UNIT

(d)

UNIT PRICE

(e)

AMOUNT

(f)

By signing this form, SF-18, the prospective Contractor hereby certifies that he/she has read the solicitation in its entirety, has had the opportunity to ask questions, understands, and accepts all terms & conditions stated herein.

Should an award result from this solicitation, the prospective Contractor agrees to incorporate all terms & conditions or its equivalent into subcontract agreements to ensure full compliance by subcontract service provider(s).

Continued ...

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)

ITEM NO. SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

NAME OF OFFEROR OR CONTRACTOR

2 33

CONTINUATION SHEET

REFERENCE NO. OF DOCUMENT BEING CONTINUED PAGE OF

(A) (B) (C) (D) (E) (F)

75H70520Q00002

** DO NOT include contract provider protected information with offer**

Protected information would be social security number, date of birth, etc. A secure data network is required when sharing protected information therefore, the information will be requested at a later date when the credentialing process begins.

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in subpart 12.6, FAR Part 13, Subpart

13.5, and as supplemented with additional information included in this notice. This announcement constitutes the only solicitation;

quotations are being requested and a written solicitation will not be issued. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition

Circular (FAC) 2019-06/10-10-2019.

Set-aside: 100% Indian Economic Enterprise-Small

Business

Indian is defined as an enrolled member of a

United States federally recognized tribe.

Period of Performance: 11/11/2019 to 11/10/2020

1 PHARMACIST 2080 HR

Delivery: 11/10/2020

2 PHARMACIST (To be Determined at a Later Date) 2080 HR

Delivery: 11/10/2020

NSN 7540-01-152-8067 OPTIONAL FORM 336 (4-86)

Prospective vendor shall submit with quotation:

*SF-18: complete, sign, and date.

*Pricing *IEE Form: complete, sign, and date.

*Dun & Bradstreet Number *Provisions: complete all fillable sections if not listed in SAM.

*Shall be properly registered in www.sam.gov to include IEE and small business status.

*Confirmation of provider availability ARO.

*Evaluation Factors: please review and submit offer accordingly.

Incomplete offers will be removed from further consideration.

ADMINISTRATIVE DATA

1. Contract Type: Firm Fixed Price, Nonpersonal Services.

2. Period of Performance: Twelve (12) months from date of award.

3. Method of Payment

a. Payment for services shall be made in arrears.

b. Electronic Funds Transfer (EFT) shall be utilized as the method for processing payment.

c. The Contractor’s hourly rate identified for services described herein is considered to be an all-inclusive rate. All-inclusive is defined to include the cost of days worked paid for services, travel, lodging per diem expenses, liability insurance, and all other fees necessary to provide service.

4. Cost/Pricing

Description Period of Performance Quanity Unit of Issue Unit Price Total

Pharmacist 1 12 month from date of award 2080 Hours $ $

Pharmacist 2 To be determined 2080 Hours $ $

$Grand Total:

5. Invoice Instructions

The Contractor shall prepare and submit invoices to the designated billing office specified in the contract. A proper invoice must include the items listed below. If the invoice does not comply with these requirements, the designated billing office will return the invoice within 7 days after receipt with the reasons why it is not a proper invoice. The Government will take into account untimely notification when computing any interest penalty owed the Contractor.

a. Name and address of the Contractor;

b. Invoice date and invoice number. (The Contractor should date invoices as close as possible to the date of the mailing or transmission.);

c. IHS Contract number;

d. Description, quantity, unit of measure, unit price, and extended price of supplies delivered or services performed;

e. Shipping and payment terms (e.g., shipment number and date of shipment, discount for prompt payment terms). Bill of lading number and weight of shipment will be shown for shipments on Government bills of lading;

f. Name and address of Contractor official to whom payment is to be sent (must be the same as that in the contract or in a proper notice of assignment);

g. Name (where practicable), title, phone number, and mailing address of person to notify in the event of a defective invoice;

h. Taxpayer Identification Number (TIN); *

i. Dun & Bradstreet Number (DUNS). * *Shall be the same numbers used to create the company www.sam.gov registration*

Contracting Officer Representative:

Contracting Officer’s Representative (COR) with respect to technical matters within the scope of the contractual instrument referenced is authorized to act on behalf of the Contracting Officer in all matters related to the monitoring and oversight of the technical and programmatic aspects of the contract, subject to the limitations set forth in his/her appointment.

The appointment specifically authorizes the COR to perform the following duties:

• Serve as the primary liaison between the contractor and the Contracting Officer;

• Monitor and evaluate the contractor’s performance and make timely reports of your findings to the Contracting Officer;

• Inspect and evaluate products (including reports and drafts) and services delivered by the contractor, and make recommendations to the Contracting Officer regarding their acceptability;

• Review and approve/reject contractor’s invoices (fixed-price contracts) or vouchers (cost-reimbursement type contracts);

• Monitor the contractor’s use of key personnel and notify the Contracting Officer of any changes in key personnel proposed by the contractor;

• Review the qualifications of proposed subcontractors and the appropriateness of subcontracting contract work, and make recommendations to the Contracting Officer regarding consent to the placement of subcontracts;

• Provide the contractor with, monitor the use of, and report on Government-furnished property;

• Provide technical guidance to the contractor;

• Promptly notify the Contracting Officer immediately of any:

- Actual or potential contractor performance problems;

- Action or inaction by HHS StaffDiv/OPDIV personnel that may affect the contractor’s ability to perform; and

- Inappropriate action on the part of HHS StaffDiv/OPDIV personnel with regard to the contract (e.g., any action that creates a conflict of interest on the part of the contractor or causes the contractor to perform inherently governmental functions). The COR should concurrently notify the program office of any such action.

• As requested by the Contracting Officer, provide him/her with technical assistance on contract-related matters (e.g., disputes, settlements, litigation, patent and copyright issues, final payment during closeout, etc.);

• Provide timely reports on contractor performance to the Contracting Officer and other interested parties; and

• Ensure proper distribution of final products and other information resulting from the contract.

The COR does not have authorization to take any action that requires a Contracting Officer’s warrant, including:

• Changing any of the contract’s terms and conditions;

• Directing the contractor to perform work or make deliveries not specifically required under the contract;

• Waiving or relaxing, in any way, the Government’s rights with regard to the Contractor’s compliance with the specifications, price, delivery or any other terms or conditions of the contract; and,

• Making any commitments or approving any actions that would create any financial obligation on the part of the Government.

Contract Administrator:

The role of the contract administrator is to assist or advise the Contracting Officer in post-award administration.

Such activities include but are not limited to the following duties:

Processing disputes under the Disputes clause and any resultant appeals;

Modifying or terminating the contract; and Determining the allowability of: costs charged, and progress payments under fixed price contracts.

In addition to performing services the contract provider shall be able to meet the following criteria:

Education: Only attendance and/or degrees from schools accredited by accrediting institutions recognized by the U.S. Department of Education may be credited.

Foreign Education: If you are using education completed in foreign colleges or universities to meet the qualification requirements, you must show that the education credentials have been evaluated by a private organization that specializes in interpretation of foreign education programs and such education has been deemed equivalent to that gained in an accredited U.S. education program; or full credit has been given for the courses at a U.S. accredited college or university.

Licensure: Shall possess and maintain a current, valid, unrestricted professional license/registration. Shall possess and maintain DEA licensure.

Certifications: Basic Life Support

Malpractice Insurance: Shall possess and maintain malpractice insurance.

Privileges: Shall apply for and have approved privileges at the WEHC.

Experience: Shall have practiced clinically 12 months within the past 3 years.

Continuing Education: possess documentation of continuing education.

Immunizations: Contractor shall provide evidence of the following immunizations:

• MMR Immunization (measles, mumps, and rubella),

- Individuals born on or after 1957 can be considered immune and shall provide documentation of physician-diagnosed measles, laboratory evidence of measles immunity, or adequate immunization with two doses of live measles vaccine on or after their first birthday.

- Individuals born prior to 1957 need not be considered susceptible; measles vaccine or proof of immunity is therefore not required.

- Individuals who are allergic to a component of vaccine and/or have a history of a severe reaction to vaccine will not be required to receive that vaccine.

• Hep B - Hepatitis B

• Tdap-Tetanus, diphtheria, acellular pertussis or, current Td booster.

• Polio

• Annual TB (tuberculosis) test results as negative.

• Flu – Influenza (seasonal)

Security Clearance: P.L. 101-630, the Indian Child Protection and Family Violence Act.

Contract provider shall be capable of passing a background investigation to include fingerprinting prior to commencement of work. The investigation at a minimum shall entail both a national criminal history fingerprint search performed by the FBI and an investigation of conduct in following areas; residence, employment, education, references.

The Contractor shall provide full cooperation during the investigation process as well as provide accurate and complete data to allow for timely processing. Providing partial or incomplete data which results in multiple requests for information or rework shall be considered failure to cooperate. The Contractor shall be removed from service should unnecessary delays occur.

HHS-Controlled Facilities and Information Systems Security

(a) To perform the work specified herein, Contractor personnel are expected to have routine (1) physical access to an HHS-controlled facility; (2) logical access to an HHS-controlled information system; (3) access to sensitive HHS data or information, whether in an HHS-controlled information system or in hard copy; or (4) any combination of circumstances (1) through (3).

(b) To gain routine physical access to an HHS facility, logical access to an HHS-controlled information system, and/or access to sensitive data or information, the Contractor and its employees shall comply with Homeland Security Presidential Directive (HSPD)-12, Policy for a Common Identification Standard for Federal Employees and Contractors; Office of Management and Budget memorandum (M-05-24); and Federal Information Processing Standards Publication (FIPS PUB) Number 201; and with the personal identity verification and investigation procedures contained in the following documents:

(1) HHS Information Security Program Policy.

(2) HHS Office of Security and Drug Testing, Personnel Security/Suitability Handbook, dated February 1, 2005.

(3) HHS HSPD-12 Policy Document, v. 2.0.

(c) This contract/order will entail the following position sensitivity level(s): sensitive

(d) The personnel investigation procedures for Contractor personnel require that the Contractor prepare and submit background check/investigation forms based on the type of investigation required. The minimum Government investigation for a non-sensitive position is a National Agency Check and Inquiries (NACI) with fingerprinting. More restricted positions--i.e., those above non-sensitive, require more extensive documentation and investigation. The Contractor shall notify the Contracting Officer in advance when any new personnel, who are subject to a background check/investigation, will work under the contract and if they have previously been the subject of national agency checks or background investigations.

(e) Investigations are expensive and may delay performance, regardless of the outcome of the investigation. Delays associated with rejections and consequent re-investigations may not be excusable in accordance with the FAR clause, Excusable Delays--see FAR 52.249-14. Accordingly, the Contractor shall ensure that any additional employees whose names it submits for work under this contract have a reasonable chance for approval.

(f) Typically, the Government investigates personnel at no cost to the Contractor. However, multiple investigations for the same position may, at the Contracting Officer's discretion, justify reduction(s) in the contract price of no more than the cost of the additional investigation(s).

(g) The Contractor shall include language similar to this ``HHS-Controlled Facilities and Information Systems Security'' language in all subcontracts that require subcontractor personnel to have the same frequency and duration of (1) physical access to an HHS-controlled facility; (2) logical access to an HHS-controlled information system; (3) access to sensitive HHS data/information, whether in an HHS-controlled information system or in hard copy; or(4) any combination of circumstances (1) through (3).

(h) The Contractor shall direct inquiries, including requests for forms and assistance, to the Contracting Officer or designee.

(i) Within 7 calendar days after the Government's final acceptance of the work under this contract, or upon termination of the contract, the Contractor shall return all identification badges to the Contracting Officer or designee.

Health and Human Services - Office of Inspector General (HHS/OIG) To ensure that the individuals providing services under the contract have not engaged in fraud or abuse regarding Sections 1128 and 1128A of the Social Security Act regarding federal health care programs, the contractor is required to check the Health and Human Services - Office of Inspector General (HHS/OIG), List of Excluded Individuals/Entities on the OIG Website (www.hhs.gov/oig) for each person providing services under this contract. Further, the Contractor is required to certify in its proposal that all persons or entities listed in the contractor’s proposal have been compared against the OIG list and are NOT listed. During the performance of this contract the Contractor is prohibited from using any individual or business listed on the list of Excluded Individuals/Entities.

Health Insurance Portability & Accountability Act (HIPAA) of 1996 Contractor personnel must adhere to the provisions of Public Law 104-191, Health Insurance Portability and Accountability Act (HIPAA) of 1996 and the National Standards to Protect the Privacy and Security of Protected Health Information (PHI).

SCOPE OF WORK

DESCRIPTION OF SERVICES

The Contractor shall provide two (2) Pharmacist to perform pharmaceutical services at the White Earth Health Center, herein referred to as WEHC. These services shall be performed in accordance with all federal, state, local laws and regulations, commercial professional standards, Indian Health Service policy and practice standards, the Accreditation Association for Ambulatory Healthcare (AAAHC) and this Performance‐based Work Statement (PWS).

HOURS OF OPERATION

Hours of operation are Monday through Friday, between 8:00am and 6:30pm; with a possibility of 4‐10 hour days. The work shifts will be scheduled as needed based on staffing needs and shall not exceed 40 hours per week. The typical work week will be 40 hours/week on Monday thru Friday. Work shifts will normally be eight (8) hour days, with a 30 minute lunch. Alternate shift of ten (10) hour days, with a 30 minute lunch depending on need.

Federal Government holidays, compensation time, including overtime are excluded.

SCHEDULED ABSENCES.

All scheduled absences shall be coordinated with the Prime contractor who will notify the COR.

UNSCHEDULED ABSENCES.

Unscheduled absences are those absences not coordinated at least two weeks in advance.

The contractor shall provide notice of an unscheduled absence as early as possible.

Notification must be given within a minimum of 1 hour of start of shift (ie, acute illness).

MAJOR DUTIES: Pharmacist Contractor shall possess the knowledge, skills and ability to perform a full range of service in his/her specialty, including the most difficult cases. Services include but are not limited to the following:

WORKLOAD. The contractor will dispense approximately 300‐400 prescriptions (mostly refill prescriptions) per day

Working knowledge of general computer applications/software to include Microsoft Office programs, MS outlook (E‐Mail), Access, Excel, PowerPoint, and internet familiarity is required.

Working knowledge of pharmacy computer systems, such as the IHS Electronic Health Record (EHR), Resource Patient Management System (RPMS), ScriptPro Central Workflow Management system and Omnicell.

Process prescription orders in the IHS Electronic Health Record (EHR), and check for completeness, appropriateness, dosing, and allergies.

Shall assure that all medications prescribed are on the White Earth Service Unit formulary.

Shall check for drug‐drug and food interactions, contraindications and warnings.

Will assess renal function by calculating the patient’s height, weight, age, and serum creatinine, and the creatinine clearance.

Shall provide instructions to all prescribing practitioners as to substitutions of medications as applicable and answer any medical questions pertaining to medications and patient care.

Deliver comprehensive pharmaceutical services within the personnel, supply, and equipment capabilities of the facility.

Counsel patients regarding safe and effective use of medications.

Review patient profiles in electronic health records to closely monitor medication therapy to identify medication‐related problems and propose solutions.

Ensure prescription directions for use, dose, medication interactions, therapeutic duplications or overlaps, allergy information, age specific dosage, and other pertinent data are appropriate for individual patients.

Compound medications as required.

Ensure accuracy of all pharmaceutical products prepared or processed by technical staff.

Work closely with clinical staff in developing patient wellness programs such as smoking cessation programs and asthma classes.

Provide medication related information to clinical staff (ie, appropriate use of medications;

comparison of current medication therapies; and other topics as deemed appropriate by the department head).

Provide clinical direction to pharmacy technicians.

Assist with inventory control of pharmaceuticals and supplies in the pharmacy, specifically scheduled pharmaceuticals, and maintain pharmacy security.

Maintain appropriate records and security of all scheduled controlled substances according to applicable regulations and local policy. This would include documenting scheduled medications per policy, reviewing and signing off on the daily controlled substance report within 24 hours of previous business day.

Consult with other specialty practitioners to provide optimal patient pharmaceutical care.

Participate in a quality improvement efforts.

Maintain clean and safe work areas are according to applicable regulations and local policy.

Document significant medication interactions and pharmacy interactions with prescribers.

Conduct Adverse Drug Reaction (ADR) and medication error reporting in accordance with local policy.

Participate in medication use evaluations as necessary.

Speak, understand, read, and write English fluently and communicate with sufficient clarity.

Knowledge of and ability to apply medical privacy and confidentiality standards including the HIPPA, accreditation standards of the AAAHC and WEHC clinical practice guidelines.

Shall be able to walk, stand, bend, sit, and use computers for prolonged periods of time.

Shall have the ability to hear well is necessary to perform the duties. Patient conversation occurs through a thick window.

Ensures compliance with standards of care and practice in accordance with all established policies, procedures, and guidelines.

Provides care within ethical and legal boundaries.

Serves and participates in committees, functions and other meetings as directed.

Provides relevant and timely information as needed and assists with decision making and process improvement.

Participates in customer service initiatives, and medical readiness activities designed to enhance health services.

Ensures a safe work environment, safe work habits and patient safety in accordance with regulatory agencies, infection control policies, and implemented process improvements.

Must understand and support local Service Unit and Departmental Policy, participate in problem‐resolution, and adapt and incorporate change as needed.

Shall immediately advise the COR of any problem(s) encountered or which may be encountered in connection with meeting the needs and concerns of patients.

Must demonstrate effective customer service skills with courtesy and respect to internal and external customers, face‐to‐face, electronic and by telephone.

Shall respect and maintain the basic rights of patients, demonstrating concern for personal dignity and human relationships.

Must be able to use conflict resolution skills when necessary.

DOCUMENTATION. All contract personnel shall prepare documentation to meet or exceed established standards of the WEHC. Contract personnel shall ensure complete patient identifying information is on all documentation that is to become part of a health care record.

All documentation shall comply with HIPAA and all required protected health information policies as required in this PWS.

RECORDS. The contractor shall manage all records created for Government use in accordance with records management procedures Records Disposition‐Procedures and Responsibilities. All records containing Privacy Act material when collecting, safeguarding, maintaining, using, accessing, amending, and disseminating personal information in a system of records, shall be protected per HIPAA guidelines.

ANNUAL TRAINING REQUIREMENTS. All contract personnel shall complete annual training as required to comply with HIPAA, AAAHC, IHS Computer Security Policy, IHS Safety and other relevant training that is deemed necessary during contract period.

APPEARANCE. Contract personnel shall present a neat, professional appearance, and clothing shall be appropriate for patient care. Personnel shall wear and have readily visible, IHS/WEHC issued identification at all times when on duty.

PRIVACY AND CONFIDENTIALITY: All patient lists shall be treated as privileged information.

Lists and/or names of patients shall not be disclosed to or revealed in any way for any use outside the WEHC without prior written permission by the Chief Contracting Officer and WEHC Chief Executive Officer.

REPLACEMENT STAFF: The Contractor shall have adequate replacement personnel available to meet contract replacement requirements to ensure a lapse in coverage does not occur. All replacement personnel shall meet or exceed position qualifications.

ORIENTATION AND TRAINING: The Government will provide mandatory orientation and training for all contract personnel prior to their providing services. No contract personnel shall begin orientation unless a complete credentials package has been submitted. Orientation takes approximately four hours to complete. Orientation consists of walk‐thru of the WEHC, fire and safety training, review of infection control policies, providing proof of immunizations and other training requirements.

At no time shall the contract provider or company attempt to bill the patient, patient insurance or alternate resources.

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.

Federal Acquisition Regulations

HEALTH & HUMAN SERVICES ACQUISTION REGULATION (HHSAR):

This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this address: http://www.hhs.gov/policies/hhsar/subpart301-1.html

CLAUSES:

352.222-70 Contractor Cooperation in Equal Employment Opportunity Investigations.

352.223-70 Safety and Health.

352.224-70 Privacy Act.

352.226-1 Indian Preference.

352.226-2 Indian Preference Program.

352.237-70 Pro-Children Act.

352.237-71 Crime Control Act—Reporting of Child Abuse.

352.237-72 Crime Control Act—Requirement for Background Checks.

352.237-73 Indian Child Protection and Family Violence Act.

352.237-74 Non-Discrimination in Service Delivery.

352.237-75 Key Personnel.

352.239-74 Electronic and Information Technology Accessibility.

352.224-71 Confidential Information.

(a) Confidential Information, as used in this clause, means information or data of a personal nature about an individual, or proprietary information or data submitted by or pertaining to an institution or organization.

(b) Specific information or categories of information that the Government will furnish to the Contractor, or that the Contractor is expected to generate, which are confidential may be identified elsewhere in this contract. The Contracting Officer may modify this contract to identify Confidential Information from time to time during performance.

(c) Confidential Information or records shall not be disclosed by the Contractor until:

(1) Written advance notice of at least 45 days shall be provided to the Contracting Officer of the Contractor's intent to release findings of studies or research, to which an agency response may be appropriate to protect the public interest or that of the agency.

(2) For information provided by or on behalf of the government,

(i) The publication or dissemination of the following types of information are restricted under this contract:

- Patient Identifiable Information (PII)

- Patient Health Information (PHI)

(ii) The reason(s) for restricting the types of information identified in subparagraph (i)is/are: PHI/PII is protected information.

(iii) Written advance notice of at least 45 days shall be provided to the Contracting Officer of the Contractor's intent to disseminate or publish information identified in subparagraph (2)(i). The contractor shall not disseminate or publish such information without the written consent of the Contracting Officer.

(d) Whenever the Contractor is uncertain with regard to the confidentiality of or a property interest in information under this contract, the Contractor should consult with the Contracting Officer prior to any release, disclosure, dissemination, or publication.

FEDERAL ACQUISITION REGULATIONS (FAR):

52.252-2 Clauses Incorporated by Reference.

This contract incorporates one or more clauses by reference, with same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this address: www.acquisition.gov

52.204-2 Security Requirements.

52.204-9 Personal Identity Verification of Contractor Personnel.

52.204-13 System for Award Management Maintenance.

52.204-18 Commercial and Government Entity Code Maintenance.

52.204-19 Incorporation by Reference of Representations and Certifications.

52.204-21 Basic Safeguarding of Covered Contractor Information Systems.

52.213-4 Terms and Conditions- Simplified Acquisitions

(Other Than Commercial Items). (Aug 2019) 52.217-8 Option to Extend Services.

52.223-18 Encouraging Contractor Policies to Ban Text Messaging While Driving.

52.224-1 Privacy Act Notification.

52.224-2 Privacy Act.

52.232-18 Availability of Funds.

52.232-40 Providing Accelerated Payments to Small Business Subcontractors.

52.237-2 Protection of Government Buildings, Equipment, and Vegetation.

52.216-24 Limitation of Government Liability.

(a) In performing this contract, the Contractor is not authorized to make expenditures or incur obligations exceeding the award amount in dollars.

(b) The maximum amount for which the Government shall be liable if this contract is terminated is for services or supplies received and accepted in dollars.

52.232-19 Availability of Funds for the Next Fiscal Year.

Funds are not presently available for performance under this contract beyond 9/30/2020. The Government’s obligation for performance of this contract beyond that date is contingent upon the availability of appropriated funds from which payment for contract purposes can be made. No legal liability on the part of the Government for any payment may arise for performance under this contract beyond 9/30/2020, until funds are made available to the Contracting Officer for performance and until the Contractor receives notice of availability, to be confirmed in writing by the Contracting Officer.

52.237-7 Indemnification and Medical Liability Insurance. (Jan 1997)

(a) It is expressly agreed and understood that this is a nonpersonal services contract, as defined in Federal Acquisition Regulation (FAR) 37.101, under which the professional services rendered by the Contractor are rendered in its capacity as an independent contractor. The Government may evaluate the quality of professional and administrative services provided, but retains no control over professional aspects of the services rendered, including by example, the Contractor’s professional medical judgment, diagnosis, or specific medical treatments. The Contractor shall be solely liable for and expressly agrees to indemnify the Government with respect to any liability producing acts or omissions by it or by its employees or agents. The Contractor shall maintain during the term of this contract liability insurance issued by a responsible insurance carrier.

(b) An apparently successful offeror, upon request by the Contracting Officer, shall furnish prior to contract award evidence of its insurability concerning the medical liability insurance required by paragraph (a) of this clause.

(c) Liability insurance may be on either an occurrences basis or on a claims-made basis. If the policy is on a claims-made basis, an extended reporting endorsement (tail) for a period of not less than 3 years after the end of the contract term must also be provided.

(d) Evidence of insurance documenting the required coverage for each health care provider who will perform under this contract shall be provided to the Contracting Officer prior to the…