13-249-SOL-00027_Mobile_Mammography.docx

PART I - THE SCHEDULE

SECTION B - SUPPLIES OR SERVICES AND PRICE/COSTS

12-249-SOL-00027

Mobile Mammography Services

B.1 PURPOSE OF CONTRACT:

The Tucson Area Indian Health Service (TAIHS) depends on contracting outside resources with a wide range of expertise in order to provide services not readily available within IHS. This firm-fixed unit priced contract will provide mammography screening services through the use of a mobile unit for those IHS patients who present themselves for healthcare at one of the following IHS (or Tohono O’odham Nation) facilities:

a) San Xavier Health Center (SXHC): located in Tucson, Arizona. For pricing purposes services for the SXHC is a 30 mile radius from the SXHC.

b) Sells Service Unit – Sells Indian Hospital (SSU): located in Sells, Arizona (60 miles west of Tucson). For pricing purposes services for the Sells area is a 60 mile radius from Sells, Arizona.

c) Santa Rosa Health Clinic (SRHC): located in Santa Rosa, Arizona (87 miles west of Tucson). For pricing purposes services for the Santa Rosa area is a 60 mile radius from Santa Rosa, Arizona.

d) San Simon Health Center (SSHC): located in San Simon, Arizona (98 miles west of Tucson). For pricing purposes services for the San Simon area is a 60 mile radius from San Simon, Arizona.

The unit price paid to the Contractor shall be considered as payment in full for services provided under this contract. In no way shall the contractor attempt to bill or collect any monies for services provided under this contract from any IHS patient (or any alternate resource for which the patient may be eligible).

B.2 PRICING:

The quantities in the Schedule are for pricing purposes and basis for evaluation for award and do not represent what the Government will order. The Government has a known need for mobile mammography services but cannot pre-determine precise quantities. The Contractor shall provide a price for each scenario (mobile mammography clinic including 1 to 5 exams; mobile mammography clinic including 5 to 10 exams, etc.) as described in the Line Items below. The Government is using the Indefinite-Delivery, Requirements type contract because exact quantities cannot be pre-determined. The Government will issue orders in accordance with the Ordering and Requirements Clauses as needs arise and the contractor will be reimbursed for exact quantities performed at the prices quoted. The Government will Order during the life of this contract a minimum of $5,000 and a maximum of $860,000. Each scheduled clinic may have a maximum of 40 exams scheduled. The Government ‘historically’ orders 6 clinics per year for each site.

a. BASE YEAR PRICING: JULY 01, 2013 – SEPTEMBER 30, 2013 Item No.

Type of Services/Location

Unit Price

Total Amount

NOTE: Each Mobile Mammography Item is inclusive of exams.

Mobile Mammography Services:

a.

Mobile Mammography Clinic including exams

1 to 5 exams b.

Mobile Mammography Clinic including exams

5 to 10 exams c.

Mobile Mammography Clinic including exams

10 to 15 exams d.

Mobile Mammography Clinic including exams

15 to 20 exams e.

Mobile Mammography Clinic including exams

20 to 25 exams f.

Mobile Mammography Clinic including exams

25 to 30 exams g.

Mobile Mammography Clinic including exams

30 to 35 exams h.

Mobile Mammography Clinic including exams

35 to 40 exams

XXXXXXXXX

XXXXXXXXX

Mobile Mammography Clinic including exams

1 to 5 exams

Mobile Mammography Clinic including exams

5 to 10 exams

Mobile Mammography Clinic including exams

10 to 15 exams

Mobile Mammography Clinic including exams

15 to 20 exams

Mobile Mammography Clinic including exams

20 to 25 exams

Mobile Mammography Clinic including exams

25 to 30 exams

Mobile Mammography Clinic including exams

30 to 35 exams

Mobile Mammography Clinic including exams

35 to 40 exams i.

SSU fairs/community clinic (weekday) up to 40 exams

Clinic

XXXXXXXXX

j.

SSU fairs/community clinic (weekend) up to 40 exams

Clinic

XXXXXXXXX

Mobile Mammography Clinic including exams

1 to 5 exams

Mobile Mammography Clinic including exams

5 to 10 exams

Mobile Mammography Clinic including exams

10 to 15 exams

Mobile Mammography Clinic including exams

15 to 20 exams

Mobile Mammography Clinic including exams

20 to 25 exams

Mobile Mammography Clinic including exams

25 to 30 exams

Mobile Mammography Clinic including exams

30 to 35 exams

Mobile Mammography Clinic including exams

35 to 40 exams

SRHC fairs/community clinic (weekday) up to 40 exams

Clinic

SRHC fairs/community clinic (weekend) up to 40 exams

Clinic

XXXXXXXXX

Mobile Mammography Clinic including exams

1 to 5 exams

Mobile Mammography Clinic including exams

5 to 10 exams

Mobile Mammography Clinic including exams

10 to 15 exams

Mobile Mammography Clinic including exams

15 to 20 exams

Mobile Mammography Clinic including exams

20 to 25 exams

Mobile Mammography Clinic including exams

25 to 30 exams

Mobile Mammography Clinic including exams

30 to 35 exams

Mobile Mammography Clinic including exams

35 to 40 exams

SSHC fairs/community clinic (weekday) up to 40 exams

Clinic

SSHC fairs/community clinic (weekend) up to 40 exams

Clinic

TOTAL FOR BASE YEAR $

b. OPTION YEAR I: OCTOBER 01, 2013 – SEPTEMBER 30, 2014 Item No.

Type of Services/Location

Unit Price

Total Amount

NOTE: Each Mobile Mammography Item is inclusive of exams.

Mobile Mammography Services:

Mobile Mammography Clinic including exams

1 to 5 exams

Mobile Mammography Clinic including exams

5 to 10 exams

Mobile Mammography Clinic including exams

10 to 15 exams

Mobile Mammography Clinic including exams

15 to 20 exams

Mobile Mammography Clinic including exams

20 to 25 exams

Mobile Mammography Clinic including exams

25 to 30 exams

Mobile Mammography Clinic including exams

30 to 35 exams

Mobile Mammography Clinic including exams

35 to 40 exams

XXXXXXXXX

XXXXXXXXX

Mobile Mammography Clinic including exams

1 to 5 exams

Mobile Mammography Clinic including exams

5 to 10 exams

Mobile Mammography Clinic including exams

10 to 15 exams

Mobile Mammography Clinic including exams

15 to 20 exams

Mobile Mammography Clinic including exams

20 to 25 exams

Mobile Mammography Clinic including exams

25 to 30 exams

Mobile Mammography Clinic including exams

30 to 35 exams

Mobile Mammography Clinic including exams

35 to 40 exams

SSU fairs/community clinic (weekday) up to 40 exams

Clinic

SSU fairs/community clinic (weekend) up to 40 exams

Clinic

XXXXXXXXX

Mobile Mammography Clinic including exams

1 to 5 exams

Mobile Mammography Clinic including exams

5 to 10 exams

Mobile Mammography Clinic including exams

10 to 15 exams

Mobile Mammography Clinic including exams

15 to 20 exams

Mobile Mammography Clinic including exams

20 to 25 exams

Mobile Mammography Clinic including exams

25 to 30 exams

Mobile Mammography Clinic including exams

30 to 35 exams

Mobile Mammography Clinic including exams

35 to 40 exams

SRHC fairs/community clinic (weekday) up to 40 exams

Clinic

SRHC fairs/community clinic (weekend) up to 40 exams

Clinic

XXXXXXXXX

Mobile Mammography Clinic including exams

1 to 5 exams

Mobile Mammography Clinic including exams

5 to 10 exams

Mobile Mammography Clinic including exams

10 to 15 exams

Mobile Mammography Clinic including exams

15 to 20 exams

Mobile Mammography Clinic including exams

20 to 25 exams

Mobile Mammography Clinic including exams

25 to 30 exams

Mobile Mammography Clinic including exams

30 to 35 exams

Mobile Mammography Clinic including exams

35 to 40 exams

SSHC fairs/community clinic (weekday) up to 40 exams

Clinic

SSHC fairs/community clinic (weekend) up to 40 exams

Clinic

TOTAL FOR OPTION YEAR I $

c. OPTION YEAR II: OCTOBER 01, 2014 – SEPTEMBER 30, 2015 Item No.

Type of Services/Location

Unit Price

Total Amount

NOTE: Each Mobile Mammography Item is inclusive of exams.

Mobile Mammography Services:

Mobile Mammography Clinic including exams

1 to 5 exams

Mobile Mammography Clinic including exams

5 to 10 exams

Mobile Mammography Clinic including exams

10 to 15 exams

Mobile Mammography Clinic including exams

15 to 20 exams

Mobile Mammography Clinic including exams

20 to 25 exams

Mobile Mammography Clinic including exams

25 to 30 exams

Mobile Mammography Clinic including exams

30 to 35 exams

Mobile Mammography Clinic including exams

35 to 40 exams

XXXXXXXXX

XXXXXXXXX

Mobile Mammography Clinic including exams

1 to 5 exams

Mobile Mammography Clinic including exams

5 to 10 exams

Mobile Mammography Clinic including exams

10 to 15 exams

Mobile Mammography Clinic including exams

15 to 20 exams

Mobile Mammography Clinic including exams

20 to 25 exams

Mobile Mammography Clinic including exams

25 to 30 exams

Mobile Mammography Clinic including exams

30 to 35 exams

Mobile Mammography Clinic including exams

35 to 40 exams

SSU fairs/community clinic (weekday) up to 40 exams

Clinic

SSU fairs/community clinic (weekend) up to 40 exams

Clinic

XXXXXXXXX

Mobile Mammography Clinic including exams

1 to 5 exams

Mobile Mammography Clinic including exams

5 to 10 exams

Mobile Mammography Clinic including exams

10 to 15 exams

Mobile Mammography Clinic including exams

15 to 20 exams

Mobile Mammography Clinic including exams

20 to 25 exams

Mobile Mammography Clinic including exams

25 to 30 exams

Mobile Mammography Clinic including exams

30 to 35 exams

Mobile Mammography Clinic including exams

35 to 40 exams

SRHC fairs/community clinic (weekday) up to 40 exams

Clinic

SRHC fairs/community clinic (weekend) up to 40 exams

Clinic

XXXXXXXXX

Mobile Mammography Clinic including exams

1 to 5 exams

Mobile Mammography Clinic including exams

5 to 10 exams

Mobile Mammography Clinic including exams

10 to 15 exams

Mobile Mammography Clinic including exams

15 to 20 exams

Mobile Mammography Clinic including exams

20 to 25 exams

Mobile Mammography Clinic including exams

25 to 30 exams

Mobile Mammography Clinic including exams

30 to 35 exams

Mobile Mammography Clinic including exams

35 to 40 exams

SSHC fairs/community clinic (weekday) up to 40 exams

Clinic

SSHC fairs/community clinic (weekend) up to 40 exams

Clinic

TOTAL FOR OPTION YEAR II $

d. OPTION YEAR III: OCTOBER 01, 2015 – SEPTEMBER 30, 2016 Item No.

Type of Services/Location

Unit Price

Total Amount

NOTE: Each Mobile Mammography Item is inclusive of exams.

Mobile Mammography Services:

Mobile Mammography Clinic including exams

1 to 5 exams

Mobile Mammography Clinic including exams

5 to 10 exams

Mobile Mammography Clinic including exams

10 to 15 exams

Mobile Mammography Clinic including exams

15 to 20 exams

Mobile Mammography Clinic including exams

20 to 25 exams

Mobile Mammography Clinic including exams

25 to 30 exams

Mobile Mammography Clinic including exams

30 to 35 exams

Mobile Mammography Clinic including exams

35 to 40 exams

XXXXXXXXX

XXXXXXXXX

Mobile Mammography Clinic including exams

1 to 5 exams

Mobile Mammography Clinic including exams

5 to 10 exams

Mobile Mammography Clinic including exams

10 to 15 exams

Mobile Mammography Clinic including exams

15 to 20 exams

Mobile Mammography Clinic including exams

20 to 25 exams

Mobile Mammography Clinic including exams

25 to 30 exams

Mobile Mammography Clinic including exams

30 to 35 exams

Mobile Mammography Clinic including exams

35 to 40 exams

SSU fairs/community clinic (weekday) up to 40 exams

Clinic

SSU fairs/community clinic (weekend) up to 40 exams

Clinic

XXXXXXXXX

Mobile Mammography Clinic including exams

1 to 5 exams

Mobile Mammography Clinic including exams

5 to 10 exams

Mobile Mammography Clinic including exams

10 to 15 exams

Mobile Mammography Clinic including exams

15 to 20 exams

Mobile Mammography Clinic including exams

20 to 25 exams

Mobile Mammography Clinic including exams

25 to 30 exams

Mobile Mammography Clinic including exams

30 to 35 exams

Mobile Mammography Clinic including exams

35 to 40 exams

SRHC fairs/community clinic (weekday) up to 40 exams

Clinic

SRHC fairs/community clinic (weekend) up to 40 exams

Clinic

XXXXXXXXX

Mobile Mammography Clinic including exams

1 to 5 exams

Mobile Mammography Clinic including exams

5 to 10 exams

Mobile Mammography Clinic including exams

10 to 15 exams

Mobile Mammography Clinic including exams

15 to 20 exams

Mobile Mammography Clinic including exams

20 to 25 exams

Mobile Mammography Clinic including exams

25 to 30 exams

Mobile Mammography Clinic including exams

30 to 35 exams

Mobile Mammography Clinic including exams

35 to 40 exams

SSHC fairs/community clinic (weekday) up to 40 exams

Clinic

SSHC fairs/community clinic (weekend) up to 40 exams

Clinic

TOTAL FOR OPTION YEAR III $

e. OPTION YEAR IV: OCTOBER 01, 2016 – SEPTEMBER 30, 2017 Item No.

Type of Services/Location

Unit Price

Total Amount

NOTE: Each Mobile Mammography Item is inclusive of exams.

Mobile Mammography Services:

Mobile Mammography Clinic including exams

1 to 5 exams

Mobile Mammography Clinic including exams

5 to 10 exams

Mobile Mammography Clinic including exams

10 to 15 exams

Mobile Mammography Clinic including exams

15 to 20 exams

Mobile Mammography Clinic including exams

20 to 25 exams

Mobile Mammography Clinic including exams

25 to 30 exams

Mobile Mammography Clinic including exams

30 to 35 exams

Mobile Mammography Clinic including exams

35 to 40 exams

XXXXXXXXX

XXXXXXXXX

Mobile Mammography Clinic including exams

1 to 5 exams

Mobile Mammography Clinic including exams

5 to 10 exams

Mobile Mammography Clinic including exams

10 to 15 exams

Mobile Mammography Clinic including exams

15 to 20 exams

Mobile Mammography Clinic including exams

20 to 25 exams

Mobile Mammography Clinic including exams

25 to 30 exams

Mobile Mammography Clinic including exams

30 to 35 exams

Mobile Mammography Clinic including exams

35 to 40 exams

SSU fairs/community clinic (weekday) up to 40 exams

Clinic

SSU fairs/community clinic (weekend) up to 40 exams

Clinic

XXXXXXXXX

Mobile Mammography Clinic including exams

1 to 5 exams

Mobile Mammography Clinic including exams

5 to 10 exams

Mobile Mammography Clinic including exams

10 to 15 exams

Mobile Mammography Clinic including exams

15 to 20 exams

Mobile Mammography Clinic including exams

20 to 25 exams

Mobile Mammography Clinic including exams

25 to 30 exams

Mobile Mammography Clinic including exams

30 to 35 exams

Mobile Mammography Clinic including exams

35 to 40 exams

SRHC fairs/community clinic (weekday) up to 40 exams

Clinic

SRHC fairs/community clinic (weekend) up to 40 exams

Clinic

XXXXXXXXX

Mobile Mammography Clinic including exams

1 to 5 exams

Mobile Mammography Clinic including exams

5 to 10 exams

Mobile Mammography Clinic including exams

10 to 15 exams

Mobile Mammography Clinic including exams

15 to 20 exams

Mobile Mammography Clinic including exams

20 to 25 exams

Mobile Mammography Clinic including exams

25 to 30 exams

Mobile Mammography Clinic including exams

30 to 35 exams

Mobile Mammography Clinic including exams

35 to 40 exams

SSHC fairs/community clinic (weekday) up to 40 exams

Clinic

SSHC fairs/community clinic (weekend) up to 40 exams

Clinic

TOTAL FOR OPTION YEAR IV $

RECAP:

GRAND TOTAL:

SECTION C - DESCRIPTION/SPECIFICATIONS/STATEMENT OF WORK

The Contractor shall provide mobile mammography screening services (clinics) to Tucson Area Indian Health Service patients at four separate locations and areas within a 60 mile radius on a routine basis as described herein. All four locations are within the Tohono O’odham Nation in Southern Arizona (Attachment 1 for map).

C.1 MOBILE MAMMOGRAPHY SCREENING SERVICES SHALL INCLUDE:

a. Screening mammograms, diagnostic radiological interpretations, consultations, and reporting services.

b. All supplies (i.e. film, markers, large and small cassettes and other necessary supplies), materials, equipment, personnel and travel necessary for mammography services including gowns for the IHS patients.

c. Provision of a mobile mammography unit (with Food & Drug Administration (FDA) certified mammography equipment) that accommodates wheelchair patients.

d. Up to 40 patients per mobile mammography screening service (clinic).

e. Digital mammography screening;

f. Each mammogram shall include a minimum two views of each breast (mediolateral oblique & craniocaudal).

g. Breast cancer education shall be provided to each IHS patient being screened through video or pamphlets.

h. Case conference with IHS staff as necessary and as requested by each designated site contact.

C.2 SITE LOCATIONS:

a. The Contractor shall provide a Mammography Mobile Unit at location specified within respective catchment area located at or near each of the following sites (see Attachment I for map):

i. San Xavier Health Center - located 5 miles south of Central Tucson.

ii. Sells Indian Hospital- located 60 miles west of Tucson,

iii. Santa Rosa Health Center- located 87 miles northwest Tucson

iv. San Simon Health Center- located 98 miles west of Tucson.

d. The Contractor is responsible for set-up of the mobile unit and returning the site to its original condition upon completion of each service.

C.3 HOURS OF OPERATION & SCHEDULING:

C.4 TECHNICAL & PROFESSIONAL REQUIREMENTS:

In accordance with the Mammography Quality Standards Act (MQSA) mandated by the FDA, American College of Radiology (ACR) and the Joint Commission the contractor shall:

C.5 PERSONNEL QUALIFICATION REQUIREMENTS:

b. Medical Malpractice Insurance

C.6 SIGNED MEDICARE ASSIGNMENT OF BENEFITS:

The Contractor shall sign a Medicare Assignment of Benefits that allows the Indian Health Service to bill 3rd party payers for both technical and professional components of the mammography services.

SECTION D - PACKAGING AND MARKING

Mammography films and reports shall be labeled in accordance with the Mammography Quality Standards Act (MQSA) & the American College of Radiology (ACR). Reports shall be sent to the designated site contact person and marked for following individuals:

PO Box 548 Sells, Arizona 85634 520/383-7336 (P) 520/383-7325 (F)

PO Box 548 Sells, Arizona 85634 520/383-7336 (P) 520/383-7325 (F)

PO Box 548 Sells, Arizona 85634 520/383-5570 (P) 520/383-5572 (F)

7900 South J Stock Road Tucson, Arizona 85746 520/295-2550 (P) 520/295-2609 (F)

SECTION E - INSPECTION AND ACCEPTANCE

E.1 NOTICE LISTING CONTRACT CLAUSES INCORPORATED BY REFERENCE

The following contract clauses pertinent to this section are hereby incorporated by reference (by Citation Number, Title, and Date) in accordance with the clause at FAR "52.252-2 CLAUSES INCORPORATED BY REFERENCE" in Section I of this contract. See FAR 52.252-2 for an internet address www.acquisition.gov/far/ (if specified) for electronic access to the full text of a clause.

52.246-4 INSPECTION OF SERVICES--FIXED-PRICE AUG 1996

SECTION F - DELIVERIES OR PERFORMANCE

F.1 PERIOD OF PERFORMANCE:

Performance period of this contract is estimated to begin on July 1, 2013 and shall not extend beyond the completion date of September 30, 2013 (base year) plus four (4) option years, unless the period is changed by written modification of the contract issued and signed by the Contracting Officer. If the Government exercises its option to renew pursuant to FAR Clause No. 52.217-9, Option to Extend the Term of the Contract, the following schedule shall prevail:

1st Option Year: October 01, 2013 – September 30, 2014 2nd Option Year: October 01, 2014 – September 30, 2015 3rd Option Year: October 01, 2015 – September 30, 2016 4th Option Year: October 01, 2016 – September 30, 2017

F.2 PERFORMANCE CONDITIONS:

a. This contract is a non-personal services contract, as defined in FAR 37.101, under which the contractor is an independent contractor;

b. The Contractor shall perform the required services described independently of Government Supervision except as stated therein.

c. No employer-employee relationship exists. Direct supervision aspects of the relationship can be minimized to where they are incidental to the services required and are for administrative guidance only.

d. The Government may evaluate the quality of professional and administrative services provided, but retains no control over the medical professional aspects of services rendered (e.g., professional judgments, diagnosis for specific medical treatment).

e. None of the services furnished under the Statement of Work shall be subcontracted or transferred to another Contractor or organization without the specific prior written approval of the Contracting Officer.

F.3 DELIVERABLE REPORTS:

Mammography examinations and film interpretation:

a. The contractor shall provide typed transcriptions of mammography reports, including film interpretation to the three designated contact persons for each site within 7 working days of the examination, except when:

(1) There are abnormal findings. These shall be brought to the immediate attention of the designated contact person listed in Section D by telephone and facsimile report and patient’s original films shall be mailed to designated contact person within 24 hours.

(2) For patients, who have had previous mammogram films that are not readily available, the typed transcriptions shall be provided to the IHS within 7 days of the contractor’s receipt of the films.

b. All interpretations and reports shall be in compliance with FDA and American College of Radiology standards.

c. Typed transcriptions will be in the Breast Imaging Reporting & Data System (BIRADS) format.

d. Any films loaned to the Contractor by IHS or other facilities must be returned.

e. A list of mammography patients seen will be provided to each designated contact person and the project officer.

f. Patients shall receive notification of their results in layman terms per the Mammography Quality Standards Act (MQSA) within one week after exam.

g. The Contractor may charge film retrieval costs for patient’s films that are over one (1) year old. These films if requested are necessary for surgery or other needs by the Indian Health Service.

F.4 NOTICE LISTING CONTRACT CLAUSES INCORPORATED BY REFERENCE

The following contract clauses pertinent to this section are hereby incorporated by reference (by Citation Number, Title, and Date) in accordance with the clause at FAR "52.252-2 CLAUSES INCORPORATED BY REFERENCE" in Section I of this contract. See FAR 52.252-2 for an internet address www.acquisition.gov/far/ (if specified) for electronic access to the full text of a clause.

52.242-15 STOP-WORK ORDER AUG 1989

SECTION G - CONTRACT ADMINISTRATION DATA

G.1 CONTRACTING OFFICER RESPONSIBILITY:

Authority to negotiate changes in terms, conditions, or amounts cited in this contract is reserved to the Contracting Officer.

G.2 CONTRACTING OFFICER’S REPRESENTATIVE (COR) RESPONSIBILITIES:

The Contracting Officer shall designate in writing the Contracting Officer’s Representative (COR) representing the Government for the purpose of this contract. A copy of this designation will be provided to the Contractor. The major responsibility of the COR is to ensure contractor accountability, monitoring contract performance, and assist the Contractor in the resolution of program problems encountered during the performance of this contract. Other duties specifically delegated are as follows:

a. Interpreting the statement of work.

a. Recommending to the Contracting Officer changes in requirements.

G.3 GOVERNMENT RESPONSIBILITIES:

The Government shall schedule the IHS patients, inform patients of mammogram preparation requirements and provide the contractor a listing of patients scheduled at each site.

G.4 INVOICES:

a. The Contractor shall submit a proper invoice on a monthly basis to the following address:

Also, a courtesy copy shall be provided to the COR via email at michelle.eaglehawk@ihs.gov

b. Payment shall be made by Electronic Funds Transfer (EFT) upon receipt of a contractor’s proper invoice. A properly invoice is described in Section I.5, Prompt Payment. Improperly prepared invoices will be returned to the Contractor, which may result in delay of payment.

c. The unit price invoiced and paid to the Contractor shall be considered as payment in full for services provided under this contract.

SECTION H - SPECIAL CONTRACT REQUIREMENTS

H.1 QUALITY CONTROL:

a. The Contractor shall provide services within the terms and conditions of this contract and in accordance with the Mammography Quality Standards Act (MQSA) and American College of Radiology (ACR) standards.

b. The Contractor shall be responsible for monitoring and evaluating the safety, quality and appropriateness of the mammography services provided and shall maintain the quality control program.

H.2 MEDICAL MALPRACTICE INSURANCE:

See Section I.6

H.3 IMMUNIZATIONS/ CLEARANCES/ CREDENTIALING/ORIENTATIONS:

a. The Contractors’ employees shall be immunized against Rubeola (measles), Rubella (German measles) and Hepatitis B, plus provide annual negative TB test results. See Attachment 3. Exception(s) to Rubeola (measles) are as follows:

i. Individuals born in 1957 or after 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.

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

iii. 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.

b. The Contractor’s employees are subject to criminal background checks prior to performing services in accordance with contract terms and conditions. The contractor shall ensure that each of their employees comply with completing Attachment 4. The contractor shall be responsible for the cost of the criminal background checks and should consider this in their proposal pricing.

c. If required, the contractor shall complete the Sells Service Unit credentialing process for each of its employees as coordinated by the COR prior to performing services.

Pursuant to the Health Insurance Portability and Accountability Act (HIPAA) of 1996 and its implementing regulation, the Standards of Privacy of Individual Identifiable Health Information at 45 C.F.R. Parts 160 and 164, Subparts A and E ("Privacy Rule"), and 45 C.F.R. Parts 160 and 164, Subparts A and C (“Security Rule”), the Indian Health Service is required to enter into an agreement with the Business Associate, pursuant to which the Business Associate shall comply with and appropriately safeguard Protected Health Information ("PHI”) that it will use and disclose when performing functions, activities or services ("Services") for the Indian Health Service. The Business Associate by signing the contract shall comply with the following terms in addition to other applicable contract terms and conditions relating to the safekeeping, use and disclosure of PHI.

Definitions Terms used in this Agreement, but not otherwise defined, shall have the same meaning as those terms contained within the Privacy Rule.

a. Agreement: “Agreement” shall mean this clause and any other provisions of this contract that are incorporated by reference;

b. Business Associate: “Business Associate” shall mean the Contractor, also known as (INSERT BUSINESS NAME);

c. Covered Entity: “Covered Entity” shall mean the Indian Health Service;

d. Designated Record Set: “Designated Record Set” shall mean (1) a group of records maintained by or for a covered entity that is: (i) The medical records and billing records about individuals maintained by or for a covered health care provider, (ii) The enrollment, payment, claims adjudication, and case or medical management record systems maintained by or for a health plan, or (iii) Used, in whole or in part, by or for the covered entity to make decisions about individuals. (2) For purposes of this paragraph, the term record means any item, collection, or grouping of information that includes protected health information and is maintained, collected, used, or disseminated by or for a covered entity. (45 C.F.R. § 164.501)

e. Individual: “Individual” shall have the same meaning as the term "individual" in 45 C.F.R. § 160.103 and shall include a person who qualifies as a personal representative in accordance with 45 C.F.R. § 164.502(g);

f. Protected Health Information: “Protected Health Information” shall have the same meaning as the term “protected health information” in 45 C.F.R. § 160.103, limited to the information created or received by the Contractor from or on behalf of the IHS.

Section 1 - Privacy Rule Compliance The Business Associate agrees to comply with the applicable Business Associate Agreement requirements under the Privacy Rule and the provisions of this Agreement throughout the term of this Agreement. The Business Associate agrees that it will require that all of its agents, employees, subsidiaries, affiliates and subcontractors, to whom the Business Associate provides PHI, or who create or: receive PHI on behalf of the Business Associate for the IHS, agree to comply with the Privacy Rule. Any subcontracts shall be let as provided for in this contract but, notwithstanding any exemption from any requirement for written consent contained in the subcontracting clause, the Business Associate shall nonetheless obtain the Contracting Officer's written consent before placing any subcontract pursuant to which the Business Associate discloses PHI to the subcontractor.

Section 2 - Permitted Uses and Disclosures The Business Associate shall not use or disclose PHI except as provided for in this Agreement, the Privacy Rule or other applicable law, to perform functions, activities or services for or on behalf of the IHS as specified herein. The Business Associate agrees that it may use or disclose PHI on behalf of the IHS only; {I) upon obtaining the authorization of the patient to whom the PHI pertains (45 C.F.R. §§ 164.502(a)(I)(iv) and 164.508(b); (2) without an authorization for the purpose of treatment, payment or health care operations (45 C.F.R. §§ 164.502(a)(I)(ii) and 164.506); or (3) without an authorization or consent, if in accordance with 45 C.F.R. §§ 164.506, 164.510, 164.512, 164.514(e), 164.514(t) or 164.514(g). Except as otherwise limited in this Agreement, the Business Associate may use PHI for the management and administration of the Business Associate or to carry out responsibilities of the Business Associate that are required by law.

Section 3 - Safeguards The 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 permitted by the Privacy Rule or this Agreement. The 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 in accordance with the applicable requirements of the Privacy Rule.

Section 4 - Safeguards for Electronic PHI The Business Associate shall implement administrative, physical, and technical safeguards that reasonably and appropriately protect the confidentiality, integrity and availability of any electronic PHI that it creates, receives, maintains, or transmits on behalf of the IHS as required by the Security Rule and ensure that any agent, including a subcontractor to who it provides such information, agrees to implement reasonable and appropriate safeguards to protect it.

Section 5- Reporting of Disclosure The Business Associate shall promptly report to the IHS any knowledge of uses or disclosures of PHI that are not in accordance with this Agreement or applicable law and any security incidents involving electronic PHI of which it becomes aware. In addition, the Business Associate shall mitigate, to the extent practicable, any harmful effect that is known to the Business Associate of a use or disclosure of PHI by the Business Associate in violation of the requirements of the Privacy Rule.

Section 6 - Records: IHS Access The Business Associate shall maintain records of PHI received from or created or received on behalf of the IHS and shall document subsequent uses and disclosures of such information by the Business Associate. The Business Associate shall promptly make available to the IHS, such information as the IHS may require to fulfill its obligations to provide access to, provides a copy of, and account for disclosures with respect to PHI pursuant to the Privacy Rule (e.g.. 45 C.F.R. § 164.528 (individual request for an accounting of PHI disclosure)) and other applicable law. The Business Associate shall provide such information to the IHS in a time frame that permits the IHS to meet obligations under 45 C.F.R. § 164.528.

Section 7 - Records; Individual Access The Business Associate shall maintain a designated record set, as defined by the Privacy Rule (45 C.F.R. § 164.501), for each patient for whom it has PHI. In accordance with a patient's right to access his PHI under the Privacy Rule, the Business Associate shall make available all PHI in the patient's designated record set to the patient to whom that information pertains, or to the patient's authorized representative, upon request by the patient or his authorized representative in a time and manner sufficient to meet the applicable requirements of 45 C.F.R. § 164.524. The Business Associate shall document all disclosures under this section and shall promptly make such information available to the IHS pursuant to section 6 above.

Section 8 - Disclosure Upon request, the Business Associate shall make available to the IHS or to the Secretary, PHI and the Business Associate's internal practices, books and records, including its policies and procedures, including any agreements required by Section 1 with subcontractors, vendors and other agents relating to the use and disclosure of PHI received from the IHS, or created or received by the Business Associate on behalf of the IHS, for purposes of determining the IHS’ compliance with the Privacy Rule. The Business Associate shall not disclose PHI to any requesting party other than as provided for in this section and sections 2 and 7 above. The Business Associate shall forward all other requests for PHI to the IHS for handling.

Section 9 - Amendments of Information The Business Associate shall make PHI available to the IHS for the IHS to fulfill its obligations pursuant to the Privacy Rule to amend PHI and shall, as directed by the IHS, incorporate any amendments into PHI held by the Business Associate and ensure incorporation of any such amendments into PHI held by its agents or subcontractors. The Business Associate shall not make any amendments to PHI and shall forward all amendment requests to the IHS Contracting Officer for approval.

Section 10 - Obligations of the IHS The IHS Contracting Officer shall provide the Business Associate with its notice of privacy practices, produced under 45 C.F.R. § 164.520 and any changes to the notice. The IHS Contracting Officer shall also provide the Business Associate with any changes in, or revocation of, individuals' authorizations to use or disclose PHI, if such changes affect the Business Associate's permitted or required uses or disclosures of PHI. The IHS Contracting Officer shall notify the Business Associate of any restrictions to the use or disclosure of PHI that the IHS has agreed to pursuant to an individual's request under 45 C.F.R. § 164.522. The IHS shall not request that the Business Associate use or disclose PHI in any manner that would violate the Privacy Rule if done by the IHS.

Section 11 - Material Breach: Termination If the Business Associate breaches a material obligation of this Agreement or fails to comply with the Privacy Rule or the Security Rule, the IHS will give the Business Associate an opportunity to cure the breach, but if the Business Associate fails to cure the breach, the IHS will terminate the Agreement, as provided in FAR 52.249-8 Default (Fixed-Price Supply and Service) (Apr 1984). If, at the determination of the IHS Contracting Officer, neither cure nor termination are feasible, IHS shall report the material breach to the Secretary. Termination of this Agreement shall not affect any provision of this Agreement which, by its wording or nature, is intended to remain in effect and to continue to operate in the event of termination. Termination of the underlying contract between the parties will result in the termination of this Agreement.

Section 12 - Return or Destruction of Information When this Agreement/contract terminates, the Business Associate, at the IHS's option, shall return to the IHS, or destroy, all PHI in its possession, and keep no copies of PHI except as requested by the IHS or required by law. The IHS Contracting Officer shall notify the Business Associate whether the Business Associate must return or destroy any PHI in its possession. If the Business Associate or its agent or subcontractor destroys any PHI, then the Business Associate will provide the IHS with documentation evidencing such destruction. Any PHI maintained by the Business Associate shall continue to be extended the same protections set forth in this Agreement for as long as it is maintained.

Section 13 - Term The term of this Agreement shall begin on the effective date of this modification and or contract award and end with the completion of the contract, except as provided in Section 12, provided that, insofar as any term of this Agreement relates to the Security Rule, compliance with such term is required only on or after April 20, 2005.

Section 14 - Amendment of Agreement After the date of execution of this Agreement and after learning that material changes have been made to the Privacy Rule or the Security Rule, the parties agree to amend this Agreement to ensure that it complies with the Privacy Rule or the Security Rule as applicable, and that IHS can continue to comply with such.

Section 15 - Miscellaneous Provisions

Parties and their successors and assigns. Any novation, assignment, or other transfer of rights, interests, or duties under this Agreement by the Contractor shall be as provided in this contract;

Any ambiguity in this Agreement shall be resolved to bring the Agreement into compliance with the most current version of the Privacy Rule.

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

H.5 TAXES:

The Government is tax exempt under A.R.S. 42-5063.C.3(b), 42-5067.B.1, 42-5065.B.2(b), 42-5066.B.3(b), 42-5074.B.8, 42-5071.B.2(a), 42-5061.A.25(b), and 42-5159.A.13(d), STATE OF ARIZONA DEPARTMENT OF REVENUE. (Certificate available upon request.)

H.6 HHSAR 352.223-70 SAFETY AND HEALTH (JAN 2006):

(a) To help ensure the protection of the life and health of all persons, and to help prevent damage to property, the Contractor shall comply with all federal, State, and local laws and regulations applicable to the work being performed under this contract. These laws are implemented or enforced by the Environmental Protection Agency, Occupational Safety and Health Administration (OSHA) and other regulatory/enforcement agencies at the federal, State, and local levels.

(1) In addition, the Contractor shall comply with the following regulations when developing and implementing health and safety operating procedures and practices for both personnel and facilities involving the use or handling of hazardous materials and the conduct of research, development, or test projects: (i) 29 CFR 1910.1030, Bloodborne pathogens; 29 CFR 1910.1450, Occupational exposure to hazardous chemicals in laboratories; and other applicable occupational health and safety standards issued by OSHA and included in 29 CFR Part 1910. These regulations are available at http://www.osha.gov/. (ii) Nuclear Regulatory Commission Standards and Regulations, pursuant to the Energy Reorganization Act of 1974 (42 U.S.C. 5801 et seq.). The Contractor may obtain copies from the U.S. Nuclear Regulatory Commission, Washington, DC 20555–0001.

(2) The following Government guidelines are recommended for developing and implementing health and safety operating procedures and practices for both personnel and facilities: (i) Biosafety in Microbiological and Biomedical Laboratories, CDC. This publication is available at http://www.cdc.gov/biosafety/publications/index.htm. (ii) Prudent Practices for Safety in Laboratories (1995), National Research Council, National Academy Press, 500 Fifth Street, NW., Lockbox 285, Washington, DC 20055 (ISBN 0–309–05229– 7). This publication is available at http://www.nap.edu/catalog/4911.html.

(b) Further, the Contractor shall take or cause to be taken additional safety measures as the Contracting Officer, in conjunction with the Contracting Officer’s Technical Representative or other appropriate officials, determines to be reasonably necessary. If compliance with these additional safety measures results in an increase or decrease in the cost or time required for performance of any part of work under this contract, the Contracting Officer will make an equitable adjustment in accordance with the applicable ‘‘Changes’’ clause set forth in this contract.

(c) The Contractor shall maintain an accurate record of, and promptly report to the Contracting Officer, all accidents or incidents resulting in the exposure of persons to toxic substances, hazardous materials or hazardous operations; the injury or death of any person; or damage to property incidental to work performed under the contract and all violations for which the Contractor has been cited by any federal, State or local regulatory/enforcement agency. The report shall include a copy of the notice of violation and the findings of any inquiry or inspection, and an analysis addressing the impact these violations may have on the work remaining to be performed. The report shall also state the required action(s), if any, to be taken to correct any violation(s) noted by the federal, State or local regulatory/enforcement agency and the time frame allowed by the agency to accomplish the necessary corrective action.

(d) If the Contractor fails or refuses to comply with the federal, State or local regulatory/enforcement agency’s directive(s) regarding any violation(s) and prescribed corrective action(s), the Contracting Officer may issue an order stopping all or part of the work until satisfactory corrective action (as approved by the federal, State or local regulatory/enforcement agencies) has been taken and documented to the Contracting Officer. No part of the time lost due to any stop work order shall be subject to a claim for extension of time or costs or damages by the Contractor.

(e) The Contractor shall insert the substance of this clause in each subcontract involving toxic substances, hazardous materials, or hazardous operations. The Contractor is responsible for the compliance of its subcontractors with the provisions of this clause.

PART II - CONTRACT CLAUSES

SECTION I - CONTRACT CLAUSES

I.1 NOTICE LISTING CONTRACT CLAUSES INCORPORATED BY REFERENCE

The following contract clauses pertinent to this section are hereby incorporated by reference (by Citation Number, Title, and Date) in accordance with the clause at FAR "52.252-2 CLAUSES INCORPORATED BY REFERENCE" in Section I of this contract. See FAR 52.252-2 for an internet address www.acquisition.gov/far/ (if specified) for electronic access to the full text of a clause.